clinical research market

Clinical Trials Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

The Report Covers Global Clinical Trials Market Growth Analysis and is Segmented by Phase (Phase I, Phase II, Phase III, and Phase IV), Design (Treatment Studies and Observational Studies), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America).

Clinical Trial Market Size

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Clinical Trial Market Analysis

The Clinical Trials Market size is estimated at USD 50.66 billion in 2024, and is expected to reach USD 67.5 billion by 2029, growing at a CAGR of 5.91% during the forecast period (2024-2029).

The COVID-19 pandemic tremendously impacted the market for clinical trials, as there has been a rising focus on developing new therapeutics or vaccines to treat the disease. Also, COVID-19 brought a shift in terms of the way clinical trials are performed. There has been an increased interest in virtual/decentralized trials in the clinical trial space, and those have been featured on conference agendas and in articles for a long time. Moreover, COVID-19 forced some of the trials to move to a virtual model to keep the trials on track during the pandemic. Additionally, as of November 8, 2022, a total of 8,397 studies have been registered for COVID-19 on the ClinicalTrials.gov website, among which 2,932 studies were registered for Europe alone, followed by 2,290 studies in North America. Thus, such an increase in the number of clinical trials registered to find an effective treatment for the disease is anticipated to drive market growth. Therefore, COVID-19 is predicted to have a significant impact on the market studied.

The major factors propelling the market's growth include the high demand for clinical trials in emerging markets, increased research and development (R&D) spending in the pharmaceutical industry, an increasing prevalence of diseases; and the focus on rare diseases and multiple orphan drugs in the pipeline. For instance, Novartis AG, one of the major players in the studied market, invested USD 9,540 million in the year 2021, which increased from USD 8,980 million in 2020. In addition, another market player, Pfizer Inc., invested USD 13,829 million in 2021 on R&D as compared to USD 9,393 in FY 2020. Thus, the increased research and development expenses by the major players in the market are expected to drive the growth of the market.

Factors such as growing burden of diseases need more advanced and effective medicines for treatment and thus contributes to the growth of the market. For instance, as per IDF Atlas 2021 edition, in 2021, there were 536.6 million people aged 20-79 years living with diabetes around the world and this number is expected to reach 783.7 million by 2045. Such high burden of diseases also propel the growth of the market.

Additionally, the initiatives taken by the government in different regions also conbtribute to the growth of the market. For instance, in January 2022, the European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) launched an initiative to transform how clinical trials are initiated, designed, and ran, referred to as Accelerating Clinical Trials in the EU (ACT EU). The aim of ACT EU is to further develop Europe as a focal point for clinical research, to further promote the development of high-quality, safe, and effective medicines, and to better integrate clinical research into the European health system. Such, initiatives by governments across the globe are contributing to market growth.

Therefore, owing to the factors mentioned above, the studied market is anticipated to grow over the forecast period. However, the lack of a skilled workforce in clinical research and stringent regulations for patient enrolment are factors that are expected to hinder the market growth during the analysis period.

Clinical Trial Market Trends

Phase iii by phase segment is expected to grow over the forecast period.

Phase III clinical trials evaluate the comparative effect of the new medication over the previous medications available or conducted to confirm and expand on safety and effectiveness results from Phase 1 and 2 trials. This usually involves up to 3,000 participants with the condition that the new medication is meant to treat and may last for many years. Also, the number of Phase III clinical trials remains comparatively higher than Phase II and Phase I trials, owing to their greater complexity and need for a larger patient pool. Factors such as increasing research activities, the growing burden of diseases, and many investigative drugs in Phase III are propelling the growth of the market segment.

The high number of clinical trials in Phase III is driving the growth of the market segment. For instance, according to the data from clinicaltrials.gov, as of November 8, 2022, 9,137 clinical trials were in Phase III for cancer, 5,069 for cardiology, and 5,217 for respiratory studies. Thus, such a high number of clinical trials registered under phase III of clinical trials is expected to contribute to the segment's growth.

Additionally, the Phase III trials conducted by market players are also contributing to the growth of the market segment. For instance, in May 2022, Lipidor AB reported that half of the patients have been enrolled in the Phase III study of AKP02 skin spray for mild to moderate psoriasis. Also, in August 2022, Wockhardt Ltd initiated a global Phase III clinical study of its new antibiotic candidate WCK 5222. It is entirely a new class of antibiotic known as "β-lactam ENHANCER', and is targeted for the treatment of hospitalized adults with complicated urinary tract infections, including acute pyelonephritis. Such a high number of studies in Phase III depicts the growth of the segment.

Thus, the factors mentioned above are expected to propel the segment's growth over the forecast period.

North America is Expected to Dominate the Market Over The Forecast Period

The North American region is expected to contribute significantly to the market growth during the study period owing to factors such as high R&D expenditure of the pharmaceutical industry, presence of well-established players, robust regulatory framework, and rising prevalence of diseases, coupled with the significant contribution of the United States.

The American Cancer Society estimated that in the United States, around 1,918,0303 new cases are estimated to register in 2022. Thus, the high burden of cancer is expected to boost the demand for the development of drugs and devices for disease diagnosis and treatment, thereby driving the market growth.

Additionally, the support from the government of the countries in the region is also contributing to the growth of the market. For instance, in June 2022, the Government of Canada launched the Clinical Trials Fund (CTF), supported by a Budget 2021 investment of USD 250 million over three years for the Canadian Institutes of Health Research (CIHR). With this funding, the government aims to improve health outcomes for Canadians while ensuring Canada is well-positioned to respond to future pandemics and other health priorities. The CTF will strengthen the clinical trials infrastructure in Canada and support the training of new clinical researchers.

Furthermore, the major market players in the region are active in the innovation of new drugs and devices, which is another factor predicted to contribute to the market growth in the region. For instance, in September 2021, Janssen started the Phase III trial for the investigational respiratory syncytial virus (RSV) vaccine among older adults. The study will evaluate the efficacy, safety and immunogenicity of Janssen's investigational adult vaccine against lower respiratory tract disease (LRTD) throughout North America and some other countries of different regions. Such trials are expected to propel the growth of the market in the region.

Such continuous developments are expected to fuel the clinical trials market in the North American region.

Clinical Trial Industry Overview

The clinical trials market is moderately competitive. Strategic partnerships between pharmaceutical companies and CROs are expected to impact the market's growth significantly. Also, the quick adoption of advanced technology for improved healthcare contributes to the growth of the market. Some of the key players are Clinipace, Eli Lilly and Company, Laboratory Corporation of America, ICON PLC, and Novo Nordisk AS.

Clinical Trial Market Leaders

Laboratory Corporation of America

Eli Lilly and Company

Novo Nordisk AS

*Disclaimer: Major Players sorted in no particular order

Clinical Trial Market News

• July 2022: An early-stage clinical trial investigating an investigational vaccine to stave off Nipah virus infection was started by the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH) of the United States.
• May 2022: The International AIDS Vaccine Initiative (IAVI) and Moderna Inc. started a Phase I clinical trial of an mRNA vaccine antigen in Rwanda and South Africa.

Clinical Trial Market Report - Table of Contents

1. INTRODUCTION

1.1 Study Assumptions and Market Definition

1.2 Scope of the Study

2. RESEARCH METHODOLOGY

3. EXECUTIVE SUMMARY

4. MARKET DYNAMICS

4.1 Market Overview

4.2 Market Drivers

4.2.1 Demand for Clinical Trials in the Emerging Markets

4.2.2 High R&D Expenditure of the Pharmaceutical Industry

4.2.3 Rising Prevalence of Diseases

4.3 Market Restraints

4.3.1 Lack of Skilled Workforce in Clinical Research

4.3.2 Stringent Regulations for Patient Enrollment

4.4 Porter's Five Forces Analysis

4.4.1 Threat of New Entrants

4.4.2 Bargaining Power of Buyers/Consumers

4.4.3 Bargaining Power of Suppliers

4.4.4 Threat of Substitute Products

4.4.5 Intensity of Competitive Rivalry

5. MARKET SEGMENTATION (Market Size by Value - USD million)

5.1 By Phase

5.1.1 Phase I

5.1.2 Phase II

5.1.3 Phase III

5.1.4 Phase IV

5.2 By Design

5.2.1 Treatment Studies

5.2.1.1 Randomized Control Trial

5.2.1.2 Adaptive Clinical Trial

5.2.1.3 Non-randomized Control Trial

5.2.2 Observational Studies

5.2.2.1 Cohort Study

5.2.2.2 Case Control Study

5.2.2.3 Cross Sectional Study

5.2.2.4 Ecological Study

5.3 Geography

5.3.1 North America

5.3.1.1 United States

5.3.1.2 Canada

5.3.1.3 Mexico

5.3.2 Europe

5.3.2.1 Germany

5.3.2.2 United Kingdom

5.3.2.3 France

5.3.2.4 Italy

5.3.2.5 Spain

5.3.2.6 Rest of Europe

5.3.3 Asia-Pacific

5.3.3.1 China

5.3.3.2 Japan

5.3.3.3 India

5.3.3.4 Australia

5.3.3.5 South Korea

5.3.3.6 Rest of Asia-Pacific

5.3.4 Middle East and Africa

5.3.4.1 GCC

5.3.4.2 South Africa

5.3.4.3 Rest of Middle East and Africa

5.3.5 South America

5.3.5.1 Brazil

5.3.5.2 Argentina

5.3.5.3 Rest of South America

6. COMPETITIVE LANDSCAPE

6.1 Company Profiles

6.1.1 Clinipace

6.1.2 Laboratory Corporation of America

6.1.3 Eli Lilly and Company

6.1.4 ICON PLC

6.1.5 Novo Nordisk AS

6.1.6 PAREXEL International Corporation

6.1.7 Pfizer Inc.

6.1.8 Pharmaceutical Product Development LLC

6.1.9 IQVIA

6.1.10 F. Hoffmann-La Roche Ltd

6.1.11 Sanofi SA

6.1.12 Syneos Health

6.1.13 ClinDatrix Inc

6.1.14 Charles River Laboratory

• *List Not Exhaustive

7. MARKET OPPORTUNITIES AND FUTURE TRENDS

Clinical Trial Industry Segmentation

As per the scope of the report, clinical trials are experiments that are conducted under clinical research and follow a regulated protocol. These experiments are primarily performed to obtain data regarding the safety and efficacy of newly developed drugs. Clinical trial data is mandatory for drug approval and for it to be introduced in the market. This process is expensive and time-consuming and requires expertise at all stages. The Clinical Trials Market is Segmented by Phase (Phase I, Phase II, Phase III, and Phase IV), Design (Treatment Studies and Observational Studies), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers values (in USD million) for the above segments.

Clinical Trial Market Research FAQs

How big is the clinical trials market.

The Clinical Trials Market size is expected to reach USD 50.66 billion in 2024 and grow at a CAGR of 5.91% to reach USD 67.50 billion by 2029.

What is the current Clinical Trials Market size?

In 2024, the Clinical Trials Market size is expected to reach USD 50.66 billion.

Who are the key players in Clinical Trials Market?

Clinipace, Laboratory Corporation of America, ICON PLC, Eli Lilly and Company and Novo Nordisk AS are the major companies operating in the Clinical Trials Market.

Which is the fastest growing region in Clinical Trials Market?

North America is estimated to grow at the highest CAGR over the forecast period (2024-2029).

Which region has the biggest share in Clinical Trials Market?

In 2024, the Asia Pacific accounts for the largest market share in Clinical Trials Market.

What years does this Clinical Trials Market cover, and what was the market size in 2023?

In 2023, the Clinical Trials Market size was estimated at USD 47.83 billion. The report covers the Clinical Trials Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Clinical Trials Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.

Why is North America anticipated to witness a rapid growth rate in the Clinical Trials Market?

North America is anticipated to witness a rapid growth rate in the Clinical Trials Market due to a) High R&D expenditure of the pharmaceutical industry b) Presence of well-established players c) Robust regulatory framework d) Rising prevalence of diseases.

Which is the major segment in the Clinical Trials Market by phase?

The major segment in the Clinical Trials Market by phase is Phase III. This is mainly due to the high number of clinical trials conducted in this phase compared to others.

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Clinical Research Industry Report

This comprehensive report offers a deep dive into the clinical trials industry, providing a detailed analysis of key market drivers and market segments. Mordor Intelligence offers customization based on your specific interests, including: 1. Service - Laboratory, Analytical Testing, Bioanalytical Testing 2. Therapeutic Area - Oncology, Neurology, CNS, Autoimmune/Inflammation 3. Application - MABs, CGT 4. End-User - Hospitals, Laboratories, and Clinics

Clinical Research Market Report Snapshots

• Clinical Research Market Size
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• Clinical Research Market Trends
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• Health, Pharma & Medtech ›

Pharmaceutical Products & Market

Clinical trials – statistics & facts

How much do pharma companies spend on r&d, the complexities of clinical studies, drug developers seek approval, key insights.

Detailed statistics

Pharmaceuticals: cost of drug development in the U.S. since 1975

Total global pharmaceutical R&D spending 2014-2028

Number of drugs in the R&D pipeline worldwide 2001-2023

Editor’s Picks Current statistics on this topic

Current statistics on this topic.

Pharmaceuticals

Total number of registered clinical studies worldwide 2000-2024

CRO market size worldwide forecast 2028

Biotechnology

Top companies by COVID-19 treatment vaccines in development June 2022

Related topics

Recommended.

• Global pharmaceutical industry
• Pharmaceutical industry in the U.S.
• Top pharmaceutical drugs
• Coronavirus (COVID-19) vaccines and treatments
• Pharmaceutical research and development (R&D)

Recommended statistics

R&d overview.

• Premium Statistic Total global pharmaceutical R&D spending 2014-2028
• Premium Statistic Industry sectors - expenditure on research and development 2021
• Premium Statistic Top pharmaceutical R&D projects based on net present value August 2023
• Basic Statistic Research and development expenditure: U.S. pharmaceutical industry 1995-2022
• Premium Statistic Research and development in European pharmaceutical industry by country 2021
• Premium Statistic Total clinical research funding by National Institutes for Health 2013-2024

Total global pharmaceutical R&D spending 2014-2028

Total global spending on pharmaceutical research and development from 2014 to 2028 (in billion U.S. dollars)

Industry sectors - expenditure on research and development 2021

Percentage of spending on research and development of total revenue in 2021, by industrial sector

Top pharmaceutical R&D projects based on net present value August 2023

Selected top pharmaceutical R&D projects based on net present value (NPV) as of August 2023 (in billion U.S. dollars)

Research and development expenditure: U.S. pharmaceutical industry 1995-2022

Research and development expenditure of total U.S. pharmaceutical industry from 1995 to 2022 (in billion U.S. dollars)

Research and development in European pharmaceutical industry by country 2021

Pharmaceutical research and development spending in selected European countries in 2021 (in million euros)

Total clinical research funding by National Institutes for Health 2013-2024

Total clinical research funding by the National Institutes for Health (NIH) from FY 2013 to FY 2024 (in million U.S. dollars)

Top R&D companies

• Basic Statistic Global top pharmaceutical companies based on R&D spending 2026
• Basic Statistic Top 50 global pharmaceutical and biotech companies by R&D intensity in 2022
• Basic Statistic Top pharmaceutical companies in R&D spending growth 2022
• Premium Statistic Leading global contract research organizations based on revenue 2022
• Basic Statistic Roche: participation of patients in clinical trials 2009-2017

Global top pharmaceutical companies based on R&D spending 2026

Global top 10 pharmaceutical companies based on projected R&D spending in 2026 (in billion U.S. dollars)

Top 50 global pharmaceutical and biotech companies by R&D intensity in 2022

World's top 50 pharmaceutical and biotechnology companies based on R&D intensity in 2022

Top pharmaceutical companies in R&D spending growth 2022

World's top 50 pharmaceutical and biotechnology companies based on R&D spending growth in 2022

Leading global contract research organizations based on revenue 2022

Leading global contract research organizations (CROs) based on 2022 revenue (in million U.S. dollars)

Roche: participation of patients in clinical trials 2009-2017

Number of patients who took part in clinical trials for pharmaceutical company Roche from 2009 to 2017*

Clinical studies

• Basic Statistic Increase in clinical trials' complexity 2001-2015
• Premium Statistic Clinical trial success rates by therapeutic area 2020
• Basic Statistic Number of registered clinical studies by location worldwide 2024
• Basic Statistic Percent of registered clinical studies worldwide by location 2024
• Basic Statistic Share of recruiting clinical studies worldwide by location 2024
• Premium Statistic Total number of registered clinical studies worldwide 2000-2024
• Basic Statistic Total number of registered clinical studies with posted results worldwide 2008-2024

Increase in clinical trials' complexity 2001-2015

Increase in clinical trials' complexity between 2001-2005 and 2011-2015

Clinical trial success rates by therapeutic area 2020

Clinical trial success rates by therapeutic area as of 2020*

Number of registered clinical studies by location worldwide 2024

Number of registered clinical studies worldwide by location as of April 2024

Percent of registered clinical studies worldwide by location 2024

Percentage of registered clinical studies worldwide by location as of April 2024

Share of recruiting clinical studies worldwide by location 2024

Percentage of registered recruiting clinical studies worldwide by location as of April 2024

Total number of registered clinical studies worldwide since 2000 (as of April 2024)

Total number of registered clinical studies with posted results worldwide 2008-2024

Total number of registered clinical studies with posted results worldwide since 2008 (as of April 2024)

Participation

• Basic Statistic Top clinical trial participant countries worldwide 2015-19, by share
• Basic Statistic Clinical trial participants U.S. vs. rest of world by therapy area 2015-2019
• Basic Statistic Clinical trial participants gender share worldwide 2015-19, by geographic location
• Basic Statistic Clinical trial participants ethnicity share worldwide 2015-19, by geographic location

Top clinical trial participant countries worldwide 2015-19, by share

Top 20 clinical trial participant countries worldwide in 2015-2019, by share of participants

Clinical trial participants U.S. vs. rest of world by therapy area 2015-2019

Number of clinical trial participants in the U.S. and rest of the world in 2015-2019, by therapeutic area (in 1,000s)

Clinical trial participants gender share worldwide 2015-19, by geographic location

Gender share of clinical trial participants worldwide in 2015-2019, by geographic location

Clinical trial participants ethnicity share worldwide 2015-19, by geographic location

Ethnicity share of clinical trial participants worldwide in 2015-2019, by geographic location

Costs and market

• Basic Statistic Pharmaceuticals: cost of drug development in the U.S. since 1975
• Premium Statistic R&D expenditure of new therapeutic drugs 2009-2018
• Basic Statistic Estimated clinical trial cost per patient by therapeutic class 2015-2017
• Basic Statistic Estimated clinical trial cost per drug by therapeutic class 2015-2017
• Premium Statistic CRO market size worldwide forecast 2028
• Premium Statistic Global pharma CRO market size 2015-2024, by pre-clinical, clinical and discovery
• Premium Statistic Size of total U.S. clinical trial supplies market 2016-2025

Cost of developing a drug in the U.S. from the 1970s until today (in million U.S. dollars)*

R&D expenditure of new therapeutic drugs 2009-2018

Mean and median R&D expenditure on new drugs by therapeutic area between 2009 and 2018* (in million U.S. dollars)

Estimated clinical trial cost per patient by therapeutic class 2015-2017

Estimated clinical trial cost per patient by therapeutic area in 2015-2017* (in U.S. dollars)

Estimated clinical trial cost per drug by therapeutic class 2015-2017

Estimated clinical trial cost per drug by therapeutic area in 2015-2017* (in million U.S. dollars)

Global contract research organization (CRO) market in 2023 and 2028 (in billion U.S. dollars)

Global pharma CRO market size 2015-2024, by pre-clinical, clinical and discovery

Global pharmaceutical CRO market size from 2015 to 2024, by pre-clinical, clinical and discovery (in billion U.S. dollars)

Size of total U.S. clinical trial supplies market 2016-2025

Size of the total U.S. clinical trial supplies market from 2016 to 2025 (in million U.S. dollars)

Approvals, launches, setbacks

• Premium Statistic Pharmaceutical industry - number of new substances 1998-2022
• Premium Statistic Number of novel drugs approved annually by CDER 2008-2023
• Basic Statistic Key measurements of U.S. CDER drug approvals in 2023
• Basic Statistic FDA first premarket approvals for medtech products granted 2005-2022
• Premium Statistic Projection of top 2024 pharma and biotech launches by revenue 2028
• Basic Statistic Number of unsuccessful Alzheimer’s drugs in development in the U.S. 1998-2017

Pharmaceutical industry - number of new substances 1998-2022

Number of new chemical or biological entities developed between 1998 and 2022, by region of origin

Number of novel drugs approved annually by CDER 2008-2023

Total number of novel drugs approved by CDER from 2008 to 2023

Key measurements of U.S. CDER drug approvals in 2023

Percentage of drugs approved by the U.S. Center for Drug Evaluation and Research (CDER) in 2023 that met select key measurements

FDA first premarket approvals for medtech products granted 2005-2022

Number of first premarket approvals (PMA/HDE) granted by the FDA for medtech products from 2005 to 2022

Projection of top 2024 pharma and biotech launches by revenue 2028

Leading biotech and pharma product launches in 2024 and revenue forecasts for 2028 (in billion U.S. dollars)

Number of unsuccessful Alzheimer’s drugs in development in the U.S. 1998-2017

Number of unsuccessful Alzheimer’s drugs in development in the U.S. from 1998 to 2017

• Premium Statistic Top companies by COVID-19 treatment vaccines in development June 2022
• Basic Statistic Number of COVID-19 drugs in development worldwide by phase June 2022
• Basic Statistic Number of COVID-19 treatment vaccine trials worldwide by phase June 2022
• Basic Statistic Number of COVID-19 treatment vaccine trials worldwide by type June 2022

Leading companies by number of COVID-19 drugs and vaccines in development as of June 3, 2022

Number of COVID-19 drugs in development worldwide by phase June 2022

Number of coronavirus (COVID-19) drugs and vaccines in development worldwide as of June 3, 2022, by phase

Number of COVID-19 treatment vaccine trials worldwide by phase June 2022

Number of coronavirus (COVID-19) clinical trials for drugs and vaccines worldwide as of June 3, 2022, by phase

Number of COVID-19 treatment vaccine trials worldwide by type June 2022

Number of coronavirus (COVID-19) clinical trials for drugs and vaccines worldwide as of June 3, 2022, by type*

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Clinical Trials Market Size, Share & Industry Analysis, By Phase (Phase I, Phase II, Phase III, and Phase IV), By Application (Oncology, CNS Disorder, Cardiology, Infectious Disease, Metabolic Disorder, Renal/Nephrology, and Others), and Regional Forecast, 2024-2032

Last Updated: April 30, 2024 | Format: PDF | Report ID: FBI106930

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KEY MARKET INSIGHTS

The global clinical trials market size was valued at USD 57.76 billion in 2023 and is projected to grow from USD 61.58 billion in 2024 to USD 106.78 billion by 2032, exhibiting a CAGR of 7.1% during the forecast period (2024-2032). Clinical trials are an important process in developing new therapeutics or medical devices. These studies are performed to analyze novel pharmaceuticals, medical devices, or any other therapeutics. These studies provide a scientific foundation for guiding and treating patients and evaluating novel medications and equipment. Increasing R&D by pharmaceutical and biotechnological companies globally has fueled the number of clinical trials being conducted globally.

Furthermore, increased companies' focus on the development of novel treatments for chronic diseases and rising demand for outsourcing R&D activities have also been fueling the market’s growth. For instance, in July 2021, the Beijing Illness Challenge Foundation (ICF) in China formed a strategic relationship with Parexel. This ground-breaking collaboration aimed to obtain direct feedback from individuals with rare diseases to improve their access to and participation in these studies.

The impact of COVID-19 pandemic resulted in the slow growth of the market during the pandemic. Many clinical studies were put on hold after the sudden outbreak of COVID-19 due to lockdown restrictions and the low presence of resources.

However, many pharmaceutical and biotechnological companies increased their focus on the development of drugs, test kits, and vaccines against the SARS-CoV-2 virus. These companies increased their focus on collaboration and partnership with CRO service providers for R&D and clinical studies. 

• In January 2021, ICON plc, BioNTech, and Pfizer announced their partnership to develop an experimental COVID-19 vaccine program to provide clinical trial services.

However, the market experienced a significant recovery in 2021 compared to the prior year, due to the release of lockdown restrictions, mass vaccination, and increased demand for clinical trials to develop novel treatments.

Clinical Trials Market Trends

Pharmaceutical and Biotechnological Companies Increased their Investments in R&D

Many medical device, pharmaceutical, and biopharmaceutical companies continue to put significant resources into the development of technologies and new medications. The pharmaceutical sector, in particular, has been majorly making investments in R&D initiatives for the development of novel therapeutics. Pharmaceutical and biotechnology companies have increased their focus on expanding their R&D efficiencies by investing in R&D.

• For instance, according to the research article published by NCBI, in 2021, overall pharmaceutical expenditures in the U.S. increased by 7.7% as compared to 2020, for a total of USD 576.90 billion.

Moreover, over the past two decades, both R&D spending and the launch of new drugs have witnessed notable increases. This is due to the rapidly growing demand for innovative medicines to treat a wide range of diseases.

• For instance, as per the data published by the Congressional Budget Office in April 2021, the pharmaceutical industry’s research and development expenditure reached USD 83.00 billion in 2019, marking a tenfold increase compared to its yearly spending in the 1980s when adjusted for inflation.

Furthermore, these companies also initiated outsourcing of their R&D activities to CRO companies for time efficient and smooth conduction of these trials.

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Clinical Trials Market Growth Factors

Increasing Prevalence of Chronic Diseases to Increase the Demand for the Development of Efficient Therapeutics

The burden of chronic diseases, such as diabetes, several types of cancers, neurological disorders, and arthritis, has been increasing at a significant pace globally. This is expected to fuel the demand for the development of more effective therapeutics.

• For instance, as per the data provided by the University of Washington (UW) education, in June 2023, the global population of individuals living with diabetes currently exceeds half a billion, and projections indicate it will surpass 1.30 billion within the next three decades. This growth is anticipated across all countries, marking a significant global increase.
• Similarly, according to the data published by Globocan in 2020, Europe accounted for 22.8% of all cancer cases and 19.6% of cancer deaths, representing 9.7% of the global population.

People worldwide are affected by chronic diseases. Compared to developing countries, emerging countries are more prone to chronic disease-related public health problems. According to the World Health Organization (WHO), in five out of six regions, chronic disease is the major reason for mortality. Infectious diseases, such as malaria, TB, HIV/AIDS, and other conditions, are still predominant in Sub-Saharan Africa and are expected to prevail in the coming years.

The global market is anticipated to grow significantly due to the high prevalence of chronic diseases during the forecast period.

Rising Number of Clinical Trials Globally has been Fueling the Market Growth

Registration of trials has been growing at a significant rate annually to meet the increasing demand to treat chronic diseases.

• For instance, as per the data published by WHO in 2022, the total number of these trials conducted in 2021 experienced an increase of 11.7% from the prior year.

These study trials conducted in the U.S. are comparatively fewer than in other countries worldwide. Due to its cost-effectiveness and easy process, many of the trials are conducted outside of the U.S. and the European Union. Clinical trial success rates are majorly dependent on the stage of the study and the treatments or items being developed.

In recent years, the number of registered trials has increased significantly.

• For instance, as per the International Clinical Trials Registry Platform (ICTRP), the annual number of these registered trials by high-income countries increased from 21,028 in 2010 to 29,538 in 2020.

In addition, clinical trials have addressed chronic diseases, emerging infectious diseases, and other global health problems through research and development of novel medicines. Clinical trial research has recognized several necessary interventions for various diseases. Therefore, increase in development of new drugs & medical devices is expected to drive the clinical trials market growth during the forecast period.

RESTRAINING FACTORS

Limited Availability of Skilled Workforce and High Costs of Study Trials Limit the Market Growth

Increasing globalization has been fueling the adoption of advanced technology. New opportunities are emerging in terms of occupation. Furthermore, rising industrialization and the requirement for new amenities have fueled the need for new skills. This factor has also enhanced competency in job opportunities.

Contract Research Organization (CRO) services face issues in drawing and maintaining vastly proficient experts as they require qualified as well as experienced scientists from the field of pharmaceutical, biotechnology, academic & research institutes, and medical device businesses. Companies must give high rewards and other such recognitions to compete efficiently, impacting other players’ capitals and operational outcomes, majorly small-scale analytical testing providers. This limited availability of experienced specialists could limit the adoption of advanced technologies and processes, limiting the market’s growth in the coming years.

Furthermore, adherence to regulatory requirements significantly impacts clinical trial costs. From research to the final drug approval, the drug development process is quite costly. According to the Tufts Center for the Study of Drug Development, on average, the complete drug development process costs USD 2.60 billion to develop a new medicine, including the cost of failures. Moreover, only 12.0% of new drug candidates that enter study trials get the U.S. FDA approval.

An additional important factor affecting the costs of a trial is the complexity of the study design and protocol. Apart from financial costs, there are several obstructions to conducting clinical trials, including difficulties in recruitment, lengthy time frames, retention of participants, insufficiencies in the clinical research workforce, and drug sponsor-imposed barriers.

These factors are expected to restrict the market growth during the forecast period.

Clinical Trials Market Segmentation Analysis

By phase analysis.

Increased Registration of Clinical Trials along with the Emergence of CRO Services has been Fueling the Segment’s Growth

Based on phase, the market is segregated into phase I, phase II, phase III, and phase IV.

Phase III segment generated the highest revenue in 2023. The market players’ increased initiative to outsource their R&D activities is responsible for the segment’s dominance in the market.

Furthermore, the phase II segment is expected to grow at the fastest CAGR over the forecast period. The segment's growth is attributed to the increasing prevalence of chronic diseases and increasing investment by pharmaceutical companies in the R&D of novel treatments.

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By Application Analysis

Limited Presence for Effective Treatment of Cancer has been Fueling the Segment’s Growth

Based on application, the market is segmented into renal/nephrology, cardiology, metabolic disorder, infectious disease, CNS disorder, oncology, and others.

The oncology segment dominated the market by generating the highest revenue in 2023. The segment's growth is due to the growing demand for effective cancer treatment therapies and the rising number of drug approvals for cancer treatment.

• For instance, in 2020, Pralsetinib (Gavreto) received FDA approval. It is indicated for adult and pediatric patients aged 12 or older suffering from advanced or metastatic RET-mutant medullary thyroid cancer, which requires systemic therapy or RET fusion.  

Furthermore, CNS disorder is expected to grow at a significant CAGR during the forecast period. The increase in the prevalence of CNS disorders is expected to accelerate the segment's growth. For instance, in 2019, neurological conditions accounted for 47.39 per 100,000 among the American population.

Moreover, the metabolic disorder segment is expected to grow substantially during the forecast period. This is due to the rise in prevalence of chronic diseases, such as diabetes, globally. For instance, according to a published article in 2020 by OECD-iLibrary, in Asia Pacific, around 227 million people are living with type 2 diabetes; half of them are undiagnosed, and thus could develop long-term complications. These factors are propelling CRO services for the metabolic disorder segment.

REGIONAL INSIGHTS

North America Clinical Trials Market Size, 2023 (USD Billion)

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North America accounted for a major clinical trials market share, generating a revenue of USD 27.65 billion in 2023. Pharmaceutical companies have increased their spending on R&D to improve their drug development. This has been fueling the market growth during the forecast period in the region.

• For instance, as per the Pharmaceutical Research and Manufacturers of America (PhRMA) trade group, in 2021, PhRMA's member companies' Research & Development (R&D) expenditure reached around USD 102.3 billion worldwide.

The market in Europe accounted for a substantial market share in 2021 and is expected to witness stagnant growth during the forecast period. The market growth in the region is attributed to increased R&D expenditure by leading pharmaceutical, biotechnology, and MedTech companies.

• For instance, in 2020, Roche Diagnostics spent around USD 11.30 billion on R&D.

Moreover, the market across the Asia Pacific region is expected to expand at the fastest CAGR during the forecast. The increasing prevalence of infectious and chronic diseases across Asia Pacific is expected to propel the demand for new drugs, thereby increasing the overall market in Asia Pacific.

• For instance, as per the data published in December 2023, around 35.0% of the Indian population is suffering from chronic illnesses, including diabetes and cardiac-related disorders.

List of Key Companies in Clinical Trials Market

Pharmaceutical Companies with a Strong Focus on the Expansion of Product Portfolios to Hold Key Market Share

IQVIA, Laboratory Corporation of America Holdings, and Pfizer, Inc. are among the prominent players in the market and captured a considerable global market share in 2023.

IQVIA and Laboratory Corporation of America Holdings accounted for significant market share in 2023. This is due to their strong emphasis on R&D to introduce solutions and to upskill their offerings.

• For instance, in November 2021, IQVIA announced its data aggregation strategy as a foundation to improve market insights. This helped the company to connect the right data and services to help patients. This increased the efficacy of the company’s services.

Similarly, Pfizer, Inc. held a considerable share of the market in 2023. This was due to the company’s strong brand presence with a strong pipeline of products. Moreover, the company strongly focuses on developing advanced and highly efficient therapeutics for chronic disease treatment.

Other significant players operating in the market, such as Icon PLC, Syneos Health, and Pharmaceutical Product Development, LLC (Thermo Fisher Scientific), emphasize various strategic developments such as service expansion, partnerships, and collaborations.

LIST OF KEY COMPANIES PROFILED:

• IQVIA Inc. (U.S.)
• Laboratory Corporation of America Holdings (U.S.)
• Thermo Fisher Scientific Inc . (U.S.)
• Parexel International Corporation (U.S.)
• Medpace Holdings, Inc. (U.S.)
• Icon plc (Ireland)
• Syneos Health (U.S.)
• WuXi AppTec (China)
• Charles River Laboratories (U.S.)
• Pfizer Inc . (U.S.)
• Lilly (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• December 2023 – Thermo Fisher Scientific Inc. introduced CorEvidence, a cloud-based optimizing pharmacovigilance case processing and safety data management processes.
• December 2021 – Thermo Fisher Scientific Inc. announced the completion of the acquisition of Pharmaceutical Product Development, LLC. This acquisition expanded the key services and offerings provided by the company.
• December 2021 – Laboratory Corporation of America Holdings acquired Toxikon Corporation. This acquisition fueled the company’s strong non-clinical development portfolio.
• November 2021 – Icon plc announced the expansion of its Accellacare Site Network in reach and capabilities through new partnerships with six research sites across four countries.
• October 2021 - Parexel International Corporation and Kyoto University Hospital formed a strategic partnership to expand clinical research opportunities.
• July 2021 – Icon plc announced the acquisition of PRA Health Sciences, creating the world’s most advanced healthcare intelligence and clinical research organization.

REPORT COVERAGE

The research report provides a detailed competitive landscape. It includes the number of clinical trials and key industry developments such as partnerships, mergers, and acquisitions. Additionally, it focuses on key points such as new product launches in the market. Furthermore, the report covers regional analysis of different segments, company profiles of key players, and market trends. The report consists of quantitative and qualitative insights that contribute to the market growth.

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Report Scope & Segmentation

Frequently asked questions.

Fortune Business Insights says that the global market stood at USD 57.76 billion in 2023 and is projected to reach USD 106.78 billion by 2032.

The market is expected to exhibit a CAGR of 7.1% during the forecast period (2024-2032).

The phase III segment is set to lead the market by phase.

The key factors driving the market are increasing prevalence of chronic diseases and rising number of clinical trials.

IQVIA, Laboratory Corporation of America Holdings, and Pfizer, Inc. are the top players in the market.

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• STUDY PERIOD: 2019-2032
• BASE YEAR: 2023
• HISTORICAL DATA: 2019-2022
• NO OF PAGES: 151

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• Contract Research Organization (CRO) Services Market
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The global clinical trials market size is projected to grow from $61.58 billion in 2024 to $106.78 billion by 2032, at a CAGR of 7.1% during the forecast period

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Clinical Trials Market

Global Clinical Trials Market to Grow at a CAGR of 5.4% in the Forecast Period, Aided by the Increasing Focus on Therapeutic Drugs Generation

Global Clinical Trials Market Size, Share, Trends, Forecast: By Design: Treatment Studies, Observational Studies; By Phase; By Service Type: Site Identification, Patient Recruitment, Laboratory Services, Analytical Testing Services, Others; By Therapy Area; By Application; Regional Analysis; Patent Analysis; Supplier Landscape; 2024-2032

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Global Clinical Trials Market Outlook

The clinical trials market size attained a value of USD 49.22 billion in 2023. The market is anticipated to grow at a CAGR of 5.4% during the forecast period of 2024-2032 to attain a value of nearly USD 79.02 billion by 2032.

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Increasing Demand for Oncology to Augment the Clinical Trials Industry Growth

Oncology clinical trials are more complex than other therapeutic disciplines since they require advanced treatments for specific malignancies. An oncology trial looks not only into the efficacy and safety of an antibiotic against infection, but also how it can improve the subject's quality of life. Because cancer research is growing at a quick rate, immunotherapy has shifted away from chemotherapy procedures and toward molecularly targeted medicines. The evolution of oncology clinical trials has seen rapid development in available clinical data, as well as a strong and rising pipeline of therapeutic candidates.

North America to Provide Significant Growth Opportunities to the Clinical Trial Industry

Geographically, North America accounts for a dominant share in the industry owing to large investment for outsourcing the big R&D companies. This is mainly due to the major demand for investments in drug development. Due to the rising COVID-19 cases, many big R&D firms have collaborated with government and non-government organisations to manufacture therapeutic drug injections. The United States is one of the largest global manufacturers of clinical trials as they are investing more in R&D development. Meanwhile, the Asia Pacific is expected to witness a robust growth in the forecast period due to the increasing focus of manufacturers to produce vaccines to decrease death risk due to the COVID-19 pandemic.

Clinical Trials: Market Segmentation

Clinical trials are research studies that are used to assess the effectiveness of a medicinal, surgical, or behavioural intervention. They are the primary method by which scientists determine whether a new treatment, such as a new medicine, diet, or medical instrument, is safe and effective in humans. A clinical trial is frequently performed to determine whether a new medication is more effective and has fewer negative side effects.

By design, the market is divided into:

• Randomised Control Trial
• Adaptive Clinical Trail
• Non- Randomised Control Trial
• Cohort Studies
• Case Control Study
• Cross Section Study
• Ecological Study

The regional markets for clinical trials include North America, Europe, the Asia Pacific, Latin America, and the Middle East and Africa.

Increasing Focus on Therapeutic Drugs Generation to Bolster the Growth of Clinical Trials Industry

The global clinical trial industry is being driven by the increasing demand for the production of therapeutic drugs across the globe. Due to the COVID-19 pandemic, significant changes in the clinical trials industry has shifted the central point of many research and commercial companies to give attention on the development of new therapeutic drugs and vaccines for COVID-19. The industry is also predicted to develop as a result of government initiatives in emerging nations to promote medication discovery and constant technical advances. Over the forecast period, it can be expected that Phase III will grow and become significant as it is one of the most important stages in determining whether or not a new intervention is effective and useful for clinical purposes.

Key Industry Players in the Global Clinical Trials Market

The report presents a detailed analysis of the following key players in the global clinical trials market, looking into their capacity, market shares, and latest developments like capacity expansions, plant turnarounds, and mergers and acquisitions:

• Parexel International Corporation
• Charles River laboratory
• Syneos Health 

The comprehensive report looks into the macro and micro aspects of the industry. The EMR report gives an in-depth insight into the market by providing a SWOT analysis as well as an analysis of Porter’s Five Forces model.

Key Highlights of the Report

*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.

1    Preface     1.1    Objectives of the Study     1.2    Key Assumptions      1.3    Report Coverage – Key Segmentation and Scope       1.4    Research Methodology 2    Executive Summary 3    Global Clinical Trial Market Overview      3.1    Global Clinical Trial Market Historical Value (2017-2023)      3.2    Global Clinical Trial Market Forecast Value (2024-2032) 4    Global Clinical Trial Market Landscape     4.1    Global Clinical Trial Developers Landscape         4.1.1    Analysis by Year of Establishment         4.1.2    Analysis by Company Size         4.1.3    Analysis by Region     4.2    Global Clinical Trial Product Landscape         4.2.1    Analysis by Service Type         4.2.2    Analysis by Design         4.2.3    Analysis by Therapy Area 5    Global Clinical Trial Market Dynamics     5.1    Market Drivers and Constraints     5.2    SWOT Analysis     5.3    Porter’s Five Forces Model      5.4    Key Demand Indicators     5.5    Key Price Indicators     5.6    Industry Events, Initiatives, and Trends      5.7    Value Chain Analysis 6    Global Clinical Trial Market Segmentation     6.1    Global Clinical Trial Market by Design         6.1.1    Market Overview         6.1.2    Treatment Studies             6.1.2.1    Randomised Control Trial             6.1.2.2    Adaptive Clinical Trail             6.1.2.3    Non- Randomised Control Trial         6.1.3    Observational Studies             6.1.3.1    Cohort Studies             6.1.3.2    Case Control Studies             6.1.3.3    Cross Section Study             6.1.3.4    Ecological Study             6.1.3.5    Others     6.2    Global Clinical Trial Market by Phase         6.2.1    Market Overview         6.2.2    Phase I         6.2.3    Phase II         6.2.4    Phase III         6.2.5    Phase IV     6.3    Global Clinical Trial Market by Service Type         6.3.1    Market Overview         6.3.2    Site Identification         6.3.3    Patient Recruitment         6.3.4    Laboratory Services         6.3.5    Analytical Testing Services         6.3.6    Bio-Analytical Testing Services             6.3.6.1    Cell Based Assay             6.3.6.2    Virology Testing             6.3.6.3    PK/PD Testing Services             6.3.6.4    Method Development, Optimization, Validation             6.3.6.5    Serology, Immunogenicity & Neutralizing Antibodies             6.3.6.6    Bio Marker Testing Service             6.3.6.7    Other Bioanalytical Testing Services         6.3.7    Clinical Trial Data Management Services         6.3.8    Clinical Trial Supply and Logistic Services         6.3.9    Medical Device Testing Services         6.3.10    Other Clinical Trial Services     6.4    Global Clinical Trial Market by Therapy Area         6.4.1    Market Overview         6.4.2    Oncology         6.4.3    Infectious Disease         6.4.4    Neurology         6.4.5    Immunology         6.4.6    Cardiology         6.4.7    Genetic Disease         6.4.8    Women’s Health         6.4.9    Other Therapy Areas     6.5    Global Clinical Trial Market by Application         6.5.1    Market Overview         6.5.2    Small Molecule         6.5.3    Vaccine         6.5.4    Cell & Gene Therapy         6.5.5    Other Applications     6.6    Global Clinical Trial Market by Region         6.6.1    Market Overview         6.6.2    North America          6.6.3    Europe         6.6.4    Asia Pacific         6.6.5    Latin America         6.6.6    Middle East and Africa 7    North America Clinical Trial Market     7.1    Market Share by Country     7.2    United States of America     7.3    Canada 8    Europe Clinical Trial Market     8.1    Market Share by Country     8.2    United Kingdom     8.3    Germany     8.4    France     8.5    Italy     8.6    Others 9    Asia Pacific Clinical Trial Market     9.1    Market Share by Country     9.2    China     9.3    Japan     9.4    India     9.5    ASEAN     9.6    Australia     9.7    Others 10    Latin America Clinical Trial Market     10.1    Market Share by Country     10.2    Brazil     10.3    Argentina     10.4    Mexico     10.5    Others 11    Middle East and Africa Clinical Trial Market     11.1    Market Share by Country     11.2    Saudi Arabia     11.3    United Arab Emirates     11.4    Nigeria     11.5    South Africa     11.6    Others 12    Patent Analysis     12.1    Analysis by Type of Patent     12.2    Analysis by Publication year     12.3    Analysis by Issuing Authority     12.4    Analysis by Patent Age     12.5    Analysis by CPC Analysis     12.6    Analysis by Patent Valuation      12.7    Analysis by Key Players 13    Grants Analysis     13.1    Analysis by year     13.2    Analysis by Amount Awarded     13.3    Analysis by Issuing Authority     13.4    Analysis by Grant Application     13.5    Analysis by Funding Institute     13.6    Analysis by NIH Departments     13.7    Analysis by Recipient Organization  14    Funding Analysis     14.1    Analysis by Funding Instances     14.2    Analysis by Type of Funding     14.3    Analysis by Funding Amount     14.4    Analysis by Leading Players     14.5    Analysis by Leading Investors     14.6    Analysis by Geography 15    Partnership and Collaborations Analysis     15.1    Analysis by Partnership Instances     15.2    Analysis by Type of Partnership     15.3    Analysis by Leading Players     15.4    Analysis by Geography 16    Regulatory Framework     16.1    Regulatory Overview         16.1.1    US FDA         16.1.2    EU EMA         16.1.3    INDIA CDSCO         16.1.4    JAPAN PMDA         16.1.5    Others 17    Supplier Landscape     17.1    IQVIA         17.1.1    Financial Analysis         17.1.2    Service Portfolio         17.1.3    Demographic Reach and Achievements         17.1.4    Mergers and Acquisitions         17.1.5    Certifications     17.2    PAREXEL International Corporation         17.2.1    Financial Analysis         17.2.2    Service Portfolio         17.2.3    Demographic Reach and Achievements         17.2.4    Mergers and Acquisitions         17.2.5    Certifications     17.3    Charles River Laboratory         17.3.1    Financial Analysis         17.3.2    Service Portfolio         17.3.3    Demographic Reach and Achievements         17.3.4    Mergers and Acquisitions         17.3.5    Certifications     17.4    ICON Plc         17.4.1    Financial Analysis         17.4.2    Service Portfolio         17.4.3    Demographic Reach and Achievements         17.4.4    Mergers and Acquisitions         17.4.5    Certifications     17.5    Syneos Health         17.5.1    Financial Analysis         17.5.2    Service Portfolio         17.5.3    Demographic Reach and Achievements         17.5.4    Mergers and Acquisitions         17.5.5    Certifications     17.6    Labcorp Drug Development (COVANCE)         17.6.1    Financial Analysis         17.6.2    Service Portfolio         17.6.3    Demographic Reach and Achievements         17.6.4    Mergers and Acquisitions         17.6.5    Certifications     17.7    Wuxi Apptec         17.7.1    Financial Analysis         17.7.2    Service Portfolio         17.7.3    Demographic Reach and Achievements         17.7.4    Mergers and Acquisitions         17.7.5    Certifications     17.8    Charles River Laboratories         17.8.1    Financial Analysis         17.8.2    Service Portfolio         17.8.3    Demographic Reach and Achievements         17.8.4    Mergers and Acquisitions         17.8.5    Certifications     17.9    PPD Inc         17.9.1    Financial Analysis         17.9.2    Service Portfolio         17.9.3    Demographic Reach and Achievements         17.9.4    Mergers and Acquisitions         17.9.5    Certifications     17.10    ICON Plc         17.10.1    Financial Analysis         17.10.2    Service Portfolio         17.10.3    Demographic Reach and Achievements         17.10.4    Mergers and Acquisitions         17.10.5    Certifications     17.11    Medpace Holdings Inc         17.11.1    Financial Analysis         17.11.2    Service Portfolio         17.11.3    Demographic Reach and Achievements         17.11.4    Mergers and Acquisitions         17.11.5    Certifications     17.12    Acm Global Laboratories         17.12.1    Financial Analysis         17.12.2    Service Portfolio         17.12.3    Demographic Reach and Achievements         17.12.4    Mergers and Acquisitions         17.12.5    Certifications     17.13    Advanced Clinical         17.13.1    Financial Analysis         17.13.2    Service Portfolio         17.13.3    Demographic Reach and Achievements         17.13.4    Mergers and Acquisitions         17.13.5    Certifications     17.14    SGS         17.14.1    Financial Analysis         17.14.2    Service Portfolio         17.14.3    Demographic Reach and Achievements         17.14.4    Mergers and Acquisitions         17.14.5    Certifications     17.15    PSI CRO AG         17.15.1    Financial Analysis         17.15.2    Service Portfolio         17.15.3    Demographic Reach and Achievements         17.15.4    Mergers and Acquisitions         17.15.5    Certifications     17.16    Bio Agile Therapeutics         17.16.1    Financial Analysis         17.16.2    Service Portfolio         17.16.3    Demographic Reach and Achievements         17.16.4    Mergers and Acquisitions         17.16.5    Certifications 18    Global Clinical Trial Market- Distribution Model (Additional Insight)     18.1    Overview      18.2    Potential Distributors      18.3    Key Parameters for Distribution Partner Assessment  19    Key Opinion Leaders (KOL) Insights (Additional Insight) 20    Company Competitiveness Analysis (Additional Insight)     20.1    Very Small Companies     20.2    Small Companies     20.3    Mid-Sized Companies     20.4    Large Companies     20.5    Very Large Companies 21    Payment Methods (Additional Insight)     21.1    Government Funded     21.2    Private Insurance     21.3    Out-of-Pocket

*Additional insights provided are customisable as per client requirements.

What was the clinical trial market size in 2023?

The global clinical trial Market was valued at USD 49.22 billion in 2023.

What is the forecast outlook for the clinical trial market?

The market is expected to grow at a CAGR of 5.4% from 2024 to 2032 to reach a value of USD 79.02 billion by 2032.

What are the major industry drivers?

The industry is primarily being driven by the  growing rates of R&D projects for the development of therapeutic drugs, development in technologies, increasing focus of manufacturers to produce vaccines to decrease death risk due to the COVID-19 pandemic, and increasing cancer research.

What are the key industry trends of the global clinical trials market?

The key trends driving the market’s expansion are the increasing demand for the production of therapeutic drugs and increasing government initiatives.

What are the major regional markets of the global clinical trials market, according to the EMR report?

The major regions in the industry are North America, Latin America, Europe, Middle East and Africa, and the Asia Pacific with North America accounting for the largest share in the market.

What are the segments based on design in the market?

By design, the market is divided into treatment studies and observational studies. Treatment studies are further divided into randomised control trial, adaptive clinical trail and non-  andomized control trial while observational studies are segmented into cohort studies, case control study, cross section study, and ecological study, among others.

Who are the key industry players, according to the report?

The major players in the industry are IQVIA, PAREXEL International Corporation, Charles River Laboratory, ICON Plc, and Syneos Health, among others.

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Global Clinical Trials Market – Industry Trends and Forecast to 2030

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Market Size in USD Billion

CAGR :  5.15 %

Global Clinical Trials Market, By Phase (Phase I, Phase II, Phase III, Phase IV), Indication (Autoimmune/Inflammation, Pain Management, Oncology, CNS Condition, Diabetes, Obesity, Cardiovascular, Others), Design (Interventional, Treatment Studies, Observational Studies, Expanded Access), End User (Hospital, Laboratories, Clinics) – Industry Trends and Forecast to 2030. 

Clinical Trials Market Analysis and Size

The  growing demand for clinical trial in developing countries, growing geriatric population, globalization of clinical trials, technological evolution are the significant factors responsible for driving the growth of the clinical trials market. The leveraging online resources to increase patient recruitment rates in clinical trials is also projected to boost the market’s growth. In addition, the increasing occurrences of chronic diseases coupled with globalizing drug development activities also heighten the overall growth of the market.

Data Bridge Market Research analyzes that the global clinical trials market which was USD 269.18 million in 2022, is likely to reach USD 402.28 million by 2030, and is expected to undergo a CAGR of 5.15% during the forecast period. “Laboratories" dominates the end segment of the clinical trials market due to increase in the number of research and development activities. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Report Scope and Market Segmentation

Market Definition

Clinical trials are basically the research studies performed by researchers in people that are aimed to find out a new treatment, like a new drug or diet or medical device . It is also used to find out whether it is safe and effective in people.

Clinical Trials Market Dynamics

• Advancements in medical research

Increasing focus on developing novel therapies and treatments for various diseases drives the demand for clinical trials. Advances in genomics and personalized medicine also contribute to the growth.

• Rising prevalence of diseases

The growing incidence of chronic diseases like cancer, diabetes, and cardiovascular disorders necessitates extensive clinical trials for innovative drugs and therapies.

• Technological advancements

Integration of technologies like big data analytics, AI, and IoT in clinical trials streamlines processes, enhances data accuracy, and reduces costs, thereby driving market growth.

Opportunities

• Real-world evidence (RWE) studies

The integration of real-world data into clinical trials provides valuable insights into drug effectiveness and safety, opening avenues for more pragmatic and efficient trials

• Patient-centric trials

Emphasizing patient experience and convenience through methods like virtual trials and home healthcare services can enhance participation rates and data accuracy.

Restraints/Challenges

• Stringent regulatory procedures

Complex regulatory processes and the need for compliance with diverse guidelines in different countries pose challenges for sponsors, leading to delays and increased costs.

• Data security and privacy concerns

With the rise in digitalization, ensuring the security and privacy of patient data in clinical trials is a significant challenge. Adhering to data protection regulations adds complexity.

•   Patient recruitment and retention

Identifying suitable participants and retaining them throughout the trial period is challenging. This affects the timeline and success of the trials.

This clinical trials market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the clinical trials market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Global Clinical Trials Market Scope

Clinical trails market is segmented on the basis of phase, indication, design, and end user. The growth amongst these segments will help you analyze meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

• Autoimmune/inflammation
• Pain management
• Cns condition
• Cardiovascular
• Interventional
• Treatment studies
• Observational studies
• Expanded access
• Laboratories

Clinical Trials Market Regional Analysis/Insights

Clinical trials market is analyzed and market size insights and trends are provided by country, phase, indication, design and end user as referenced above.

The countries covered in the clinical trials market report is U.S., Canada, Mexico, Germany, Italy, U.K., France, Spain, Netherland, Belgium, Switzerland, Turkey, Russia, rest of Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, rest of Asia-Pacific, Brazil, Argentina, rest of South America, South Africa, Saudi Arabia, U.A.E, Egypt, Israel, rest of Middle East & Africa.

North America is expected to dominate the market due to increasing research and development and increasing adoption of new technologies in clinical research.

Asia-Pacific is expected to show fastest growth during the forecast period of 2023 to 2030 due to expected to show a rapid and lucrative growth rate in the forecast period owing to the increasing availability of large patient pool facilitating easy recruitment of candidates.

The country section of the report also provides individual market impacting factors and domestic regulation changes that impact the current and future trends of the market. Data points like down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, and case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, the impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.  

Healthcare Infrastructure growth Installed base and New Technology Penetration

The clinical trials market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for clinical trials market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on clinical trials market. The data is available for historic period 2010-2020.

Competitive Landscape and Clinical Trials Market Share Analysis

The clinical trials market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to clinical trials market.

Some of the major players operating in the global clinical trials market are:

• Clinipace (U.S.)
• Laboratory Corporation of America Holdings (LabCorp) (U.S.)
• Eli Lilly and Company (U.S.)
• ICON Plc. (Ireland)
• Novo Nordisk A/S (Denmark)
• Parexel International Corporation (U.S.)
• Pfizer Inc. (U.S.)
• PPD, Inc. (U.S.)
• IQVIA (U.S.)
• Sanofi (France)
• F. Hoffmann-La Roche Ltd (Switzerland)
• Alcami Corporation, Inc. (U.S.)
• Accell Clinical Research LLC (U.S.)
• Congenix LLP (U.S.)
• Labcorp Drug Development (U.S.)
• Ecron Acunova (India)
• Medpace (U.S.)
• LUMITOS AG (Germany)
• ICON plc (Ireland)
• SIRO Clapham Private Limited (India)

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Clinical Trials Market

Clinical Trials Market (Phase: Phase I, Phase II, Phase III, and Phase IV; Study Design: Interventional Trials, Observational Trials, and Expanded Access Trials; and Indication: Autoimmune/Inflammation, Pain Management, Cardiovascular, CNS Condition, Oncology, Diabetes, Obesity, and Others) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2020-2030

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Success of Clinical Trials for COVID-19 Vaccines Boosts Market Growth

The coronavirus pandemic has brought research labs and healthcare institutions under great scrutiny for accelerating the clinical trials for COVID-19 vaccines. As such, the success in these clinical trials has led to global recognition of India for supplying several lack of free doses to Brazil, Bangladesh, Algeria, and South Africa. Countries such as Sri Lanka are following suit whilst creating incremental opportunities for stakeholders in the clinical trials market.

The Food & Drug Administration (FDA) is creating awareness about Coronavirus Treatment Acceleration Program (CTAP) in order to bring economies to normal. Companies in the clinical trials market are taking advantage of this program to make new treatments available to patients as quickly as possible.

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Clinical Trial Recruitment Companies Essential for Matching Patients with Right Trial

The clinical trials market is estimated to cross US$ 83.5 Bn by the end of 2030 . However, finding the right patients is one of the most important pieces of the puzzle with respect to conducting clinical trials. Hence, stakeholders are working with experts at clinical trial recruitment companies to match patients with the right trials.

Slow recruitment is another challenge faced by companies in the market. Hence, companies are becoming aware about scrutinizing existing patient data to anticipate potential recruitment challenges in the long run. Clinical trial innovations are anticipated to bolster participation from volunteers.

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FDA Guidelines Pave Way for Innovations for At-home, At-clinic Clinical Trials

Companies in the market are following guidelines of the FDA to advance in processes. They are referring to FDA guidance about Severely Debilitating or Life-Threatening Hematologic Disorders (SDLTHDs) in patients. Companies are increasing efforts to fill in the gap between scientific and technical complexities of clinical trials. Thus, companies are investing in improving the academia and are developing new incentives that reward collaboration from volunteers.

Companies in the market are taking additional efforts to develop networks that enable procedures at a patient’s home or at their private doctor’s clinic. This has led to innovations in sensor devices, patient reported outcomes on their computers, and flash pictures of their lesions from their cellphones that contribute toward processes.

Coronavirus Pandemic Pushes Sponsors, Patients to Adopt Virtual Clinical Trials

Compliance with protocols is one of the key trends followed by stakeholders in the clinical trials market. Clinical trials supervised by Principal Investigators are gaining prominence in the market landscape. Continued positive cases for coronavirus have increased relevancy and role of stakeholders in the market. This shift has pushed clinical trials to go virtual.

Stakeholders in the market are teaming up with virtual clinical trial experts to capitalize on business opportunities during the ongoing pandemic. Even regulatory authorities have released guidelines to assist sponsors and patients via telemedicine and virtual trial tools to create viable solutions for current operational problems.

Digital Health Innovations Give Impetus to IoMT for Enhancing Clinical Development Programs

The proliferation of digital innovations with the help of wearables and sensors is translating into value grab opportunities for companies in the clinical trials market. ICON plc— a clinical research organization company is researching how digital endpoints, including digital biomarkers can improve trial outcomes. This has led to the adoption of digital health technologies that enable appropriate device selection and data strategies.

Digital health innovations hold promising potentials to better manage chronic diseases and improve patient access to healthcare services. Stakeholders and sponsors are taking efforts to improve adherence to medications and prevent its complications in patients. The Internet of Medical Things (IoMT) has the potential to enhance clinical development programs involving med-tech and pharmaceutical companies.

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Analysts’ Viewpoint There is a need for trial innovations since recently several volunteers were given wrong dose of the late stage clinical trial of the Oxford/AstraZeneca Covid-19 vaccine. The clinical trials market is predicted to advance at a modest CAGR of 5.4% during the forecast period. This is evident since stakeholders need to address challenges pertaining to site management and compliance in order to improve trial outcomes. Hence, companies are developing clinical trial timelines to avoid delays, and are increasing transparency with their sponsors to offer them a 360 degree view of the processes happening at development centers. IoMT is acting as a key driver for the market.

Clinical Trials Market: Overview

• According to Transparency Market Research’s latest report on the global market for the historical period 2018–2019 and forecast period 2020–2030 , high prevalence and increase in incidence rate of chronic diseases and rise in R&D activities in biotechnology & pharmaceuticals industries are projected to drive the global market during the forecast period
• According to the report, the global market was valued over US$ 46.7 Bn in 2019 and is anticipated to expand at a CAGR of 5.4% from 2020 to 2030

High Prevalence and Increase in Incidence Rate of Chronic Diseases to Drive Demand for Clinical Trials: Key Drivers

• Chronic diseases such as chronic respiratory diseases (CRD), diabetes, chronic kidney diseases (CKD), cancer, cardiac stroke, and neurological disorders are the leading causes of disability and mortality across the globe
• The emergence and outbreak of various infectious and chronic diseases have created challenges and new opportunities for researchers to develop new diagnostic tools, tests, drugs, and vaccines for early diagnosis, prevention, and cure of such diseases
• Hepatitis and HIV are the other major infectious diseases. According to the World Health Organization (WHO), as of October 2017, around 71 million people across the world were estimated to have hepatitis C infection. The WHO also stated that 36.7 million people were affected with HIV across the globe.
• An article published by Columbia, Mailman School of Public Health on infectious disease epidemiology stated that infectious diseases continue to have a substantial impact on the health of communities across the world. Various seasonal outbreaks of diseases in certain parts of the world, global epidemics, the threat of resistant bacteria, and the challenge of emerging and newly identified pathogens increase the need of new methods to detect such pathogens, to understand their pathogenesis, and to devise effective interventions for their prevention and control.
• These factors have led to an increase in demand for clinical trials, and are expected to drive the market for clinical trials from 2020 to 2030

Rise in R&D Activities in Biotechnology and Pharmaceuticals Industries Boosts Market Growth

• Clinical research organizations, diagnostic laboratories, and biotechnology players are engaged in the development of newer diagnostic tests to address the unmet needs in the healthcare industry. The life science industry’s R&D spending is driven primarily by the mass and research intensity of the biopharmaceutical sector, which accounts for nearly 85% of all expenditure.
• Additionally, laboratories strive to improve equipment cost and performance. UHPLC and ultra-fast mass spectrometers are more reliable, faster, and more sensitive as a result of research initiatives by major players.
• Acceleration in biopharmaceutical R&D innovation, buoyed by several contributing factors such as precision medicine getting into gear in rare diseases, cancer, and autoimmune diseases; immunotherapy, expansion of therapeutic modalities exploiting natural and synthetic biology innovation, and expedited regulatory pathways boost the growth of the clinical trials market

Patient Recruitment and Retention to Hamper Global Market

• Shift in focus toward genetic and rare diseases has made recruitment of relevant patient population a challenging task. Moreover, lack of awareness among patients of clinical trials presents a challenging environment for CROs.
• Lack of appropriate patient recruitment could have an impact on the scientific and financial viability. According to the Tufts Center for the Study of Drug Development, in 2013, 11% of the sites failed to recruit even a single patient for clinical trial.
• Other factors responsible for poor patient recruitment are patient’s fear of side effects, illiteracy, language barrier for region-specific clinical trials, and recording of the consent process
• Factors affecting the retention of patients for clinical trials include serious adverse events, fear of complex medical procedures, poor compliance of protocol, lack of dedication toward patient safety, and lack of support from family. This significantly affects the advancement of clinical trial process and product development.

Clinical Trials Market: Competition Landscape

• This report profiles major players in the global clinical trials industry based on various attributes such as company overview, financial overview, product portfolio, business strategies, and recent developments
• Laboratory Corporation of America Holdings
• IQVIA, Inc.
• Syneos Health
• Parexel International Corporation
• PRA Health Sciences, Inc.
• Charles River Laboratories, Inc.
• WuXi AppTec
• Medpace Holdings, Inc.

Key Developments

• In February 2020, Charles River Laboratories International, Inc. signed an agreement to acquire Citoxlab for US$ 510 Mn. Citoxlab is a non-clinical CRO specialized in regulated safety assessment services, non-regulated discovery services, and medical device testing.
• In November 2019, PPD, Inc. launched site coach where doctors and healthcare centers will receive clinical research at new sites, which will provide sufficient training for physicians and other academic institutions through online for the new clinical researchers
• In October 2019, Icon plc acquired Symphony Clinical Research to enhance the ability in offering customers hybrid trial solutions and site support services. This acquisition affected the clinical trials directly and improved the services in the research centers.
• In June 2019, Laboratory Corporation’s Covance Drug Development segment completed the acquisition of Envigo’s nonclinical contract research services business. This acquisition enabled the company to increase its global nonclinical drug development capabilities. As part of this move, Envigo acquired Covance’s research models & services business, leading to the establishment of an organization dedicated to offering a complete range of research models.
• In October 2018, Parexel International Corporation announced that it would launch new wearable, mobile tech for clinical trials, which will expand the services in clinical research. Microsoft's Azure App Services is one of the mobile tech services, which alerts a healthcare team when there is a patient safety threat.
• In February 2018, PPD, Inc. and Acurian introduced an innovative clinical trial patient concierge service that provides personalized patient support and improves customer retention. PPD’s Site Coach Service addresses this by providing specialized clinical research education, coaching, and support to new clinical research physicians, hospitals, and academic institutions.
• In April 2018, ICON plc, a global biopharmaceutical company, announced that it recently agreed with the Intel Pharma Analytics platform in clinical trials, which will help to reduce costs in clinical trials and delivers an excellent patient experience
• In August 2017, LabCorp, a leading company in life sciences, acquired Chiltren for around US$ 1.2 Bn. The company enhanced end-to-end drug development services and engaged patient care more effectively in the next few years.
• In May 2017, WuXi AppTec Co., Ltd. announced completion of the acquisition of HD Biosciences (HDB), a leading biology-focused preclinical drug discovery contract research organization (CRO). The acquisition would further strengthen WuXi’s R&D capability from target validation to lead discovery and optimization, improving and expanding WuXi’s open-access enabling service platform.
• In June 2016, IQVIA, the most significant research organization, launched a continuous glucose monitoring device, which is helpful to record a person's glucose levels throughout the day. Medical device CGM is combined with the consumer wearable devices to record the readings.
• In June 2015, IQVIA and PRA Health Sciences, two leading companies in pharmaceuticals, announced that with new predictive and advanced analytics technology they plan to improve the performance in clinical trials and improve safety issues
• In October 2014, Laboratory Corporation of America Holdings acquired Covance, Inc. for US$ 5.6 Bn and became world’s leading health care diagnostic company and leading end-to-end solutions provider for drug development and commercialization
• The report on the global clinical trials market discussed individual strategies, followed by company profiles of service providers of clinical trials. The competition landscape section has been included in the report to provide readers with a dashboard view and a company market share analysis of key players operating in the global market.

Clinical Trials Market – Segmentation

Frequently Asked Questions

What is the total market worth of clinical trials market.

It is projected to reach a value of US$ 83.5 Bn by the end of 2030

What will be the CAGR during the forecast period?

The CAGR is anticipated to be 5% from 2020 to 2030.

Which region will account for major share?

North America is expected to account for leading share during the forecast period.

What are the key driving factors for the growth of the clinical trials market?

High prevalence and increase in incidence rate of chronic diseases, and rise in R&D activities in biotechnology & pharmaceuticals industries are anticipated to drive the global market.

Who are the prominent players in the sector?

Laboratory Corporation of America Holdings, IQVIA, Inc., Syneos Health, Parexel International Corporation, PRA Health Sciences, Inc., PPD, Inc., Icon plc, Charles River Laboratories, Inc., WuXi AppTec, and Medpace Holdings, Inc.

    1.1. Market Definition and Scope

    1.2. Market Segmentation

    1.3. Key Research Objectives

    1.4. Research Highlights

2. Assumptions and Research Methodology

3. Executive Summary: Global Clinical Trials Market

4. Market Overview

    4.1. Introduction

    4.2. Overview

    4.3. Market Dynamics

        4.3.1. Drivers

        4.3.2. Restraints

        4.3.3. Opportunities

    4.4. Global Clinical Trials Market Analysis and Forecast, 2018–2030

        4.4.1. Market Revenue Projections (US$ Mn)

5. Key Insights

    5.1. Number of Clinical Trials

    5.2. Key Industry Events

    5.3. COVID-19 Pandemic Impact on Industry

6. Global Clinical Trials Market Analysis and Forecast, by Phase 

    6.1. Introduction & Definition

    6.2. Key Findings / Developments

    6.3. Market Value Forecast, by Phase, 2018–2030

        6.3.1. Phase I

        6.3.2. Phase II

        6.3.3. Phase III

        6.3.4. Phase IV

    6.4. Market Attractiveness Analysis, by Phase 

7. Global Clinical Trials Market Analysis and Forecast, by Study Design 

    7.1. Introduction & Definition

    7.2. Key Findings / Developments

    7.3. Market Value Forecast, by Study Design, 2018–2030

        7.3.1. Interventional Trials

        7.3.2. Observational Trials

        7.3.3. Expanded Access Trials

    7.4. Market Attractiveness Analysis, by Study Design 

8. Global Clinical Trials Market Analysis and Forecast, by Indication 

    8.1. Introduction & Definition

    8.2. Key Findings / Developments

    8.3. Market Value Forecast, by Indication, 2018–2030

        8.3.1. Autoimmune/Inflammation

        8.3.2. Pain Management

        8.3.3. Cardiovascular

        8.3.4. CNS Condition

        8.3.5. Oncology

        8.3.6. Diabetes

        8.3.7. Obesity

        8.3.8. Others

    8.4. Market Attractiveness Analysis, by Indication 

9. Global Clinical Trials Market Analysis and Forecast, by Region

    9.1. Key Findings

    9.2. Market Value Forecast, by Region

        9.2.1. North America 

        9.2.2. Europe 

        9.2.3. Asia Pacific

        9.2.4. Latin America 

        9.2.5. Middle East & Africa 

    9.3. Market Attractiveness Analysis, by Country/Region

10. North America Clinical Trials Market Analysis and Forecast

    10.1. Introduction

        10.1.1. Key Findings

    10.2. Market Value Forecast, by Phase, 2018–2030

        10.2.1. Phase I

        10.2.2. Phase II

        10.2.3. Phase III

        10.2.4. Phase IV

    10.3. Market Value Forecast, by Study Design, 2018–2030

        10.3.1. Interventional Trials

        10.3.2. Observational Trials

        10.3.3. Expanded Access Trials

    10.4. Market Value Forecast, by Indication, 2018–2030

        10.4.1. Autoimmune/Inflammation

        10.4.2. Pain Management

        10.4.3. Cardiovascular

        10.4.4. CNS Condition

        10.4.5. Oncology

        10.4.6. Diabetes

        10.4.7. Obesity

        10.4.8. Others

    10.5. Market Value Forecast, by Country, 2018–2030

        10.5.1. U.S.

        10.5.2. Canada

    10.6. Market Attractiveness Analysis 

        10.6.1. By Phase 

        10.6.2. By Study Design 

        10.6.3. By Indication 

        10.6.4. By Country

11. Europe Clinical Trials Market Analysis and Forecast

    11.1.Introduction

        11.1.1. Key Findings

    11.2.Market Value Forecast, by Phase, 2018–2030

        11.2.1. Phase I

        11.2.2. Phase II

        11.2.3. Phase III

        11.2.4. Phase IV

    11.3.Market Value Forecast, by Study Design, 2018–2030

        11.3.1. Interventional Trials

        11.3.2. Observational Trials

        11.3.3. Expanded Access Trials

    11.4.Market Value Forecast, by Indication, 2018–2030

        11.4.1. Autoimmune/Inflammation

        11.4.2. Pain Management

        11.4.3. Cardiovascular

        11.4.4. CNS Condition

        11.4.5. Oncology

        11.4.6. Diabetes

        11.4.7. Obesity

        11.4.8. Others

    11.5.Market Value Forecast, by Country/Sub-region, 2018–2030

        11.5.1. Germany

        11.5.2. U.K.

        11.5.3. France

        11.5.4. Spain

        11.5.5. Italy

        11.5.6. Rest of Europe

    11.6.Market Attractiveness Analysis 

        11.6.1. By Phase 

        11.6.2. By Study Design 

        11.6.3. By Indication 

        11.6.4. By Country/Sub-region

12. Asia Pacific Clinical Trials Market Analysis and Forecast

    12.1.Introduction

        12.1.1. Key Findings

    12.2.Market Value Forecast, by Phase, 2018–2030

        12.2.1. Phase I

        12.2.2. Phase II

        12.2.3. Phase III

        12.2.4. Phase IV

    12.3.Market Value Forecast, by Study Design, 2018–2030

        12.3.1. Interventional Trials

        12.3.2. Observational Trials

        12.3.3. Expanded Access Trials

    12.4.Market Value Forecast, by Indication, 2018–2030

        12.4.1. Autoimmune/Inflammation

        12.4.2. Pain Management

        12.4.3. Cardiovascular

        12.4.4. CNS Condition

        12.4.5. Oncology

        12.4.6. Diabetes

        12.4.7. Obesity

        12.4.8. Others

    12.5.Market Value Forecast, by Country/Sub-region, 2018–2030

        12.5.1. China

        12.5.2. Japan

        12.5.3. India

        12.5.4. Australia & New Zealand

        12.5.5. Rest of Asia Pacific

    12.6.Market Attractiveness Analysis 

        12.6.1. By Phase 

        12.6.2. By Study Design 

        12.6.3. By Indication 

        12.6.4. By Country/Sub-region

13. Latin America Clinical Trials Market Analysis and Forecast

    13.1.Introduction

        13.1.1. Key Findings

    13.2.Market Value Forecast, by Phase, 2018–2030

        13.2.1. Phase I

        13.2.2. Phase II

        13.2.3. Phase III

        13.2.4. Phase IV

    13.3.Market Value Forecast, by Study Design, 2018–2030

        13.3.1. Interventional Trials

        13.3.2. Observational Trials

        13.3.3. Expanded Access Trials

    13.4.Market Value Forecast, by Indication, 2018–2030

        13.4.1. Autoimmune/Inflammation

        13.4.2. Pain Management

        13.4.3. Cardiovascular

        13.4.4. CNS Condition

        13.4.5. Oncology

        13.4.6. Diabetes

        13.4.7. Obesity

        13.4.8. Others

    13.5.Market Value Forecast, by Country/Sub-region, 2018–2030

        13.5.1. Brazil

        13.5.2. Mexico

        13.5.3. Rest of Latin America

    13.6.Market Attractiveness Analysis 

        13.6.1. By Phase 

        13.6.2. By Study Design 

        13.6.3. By Indication 

        13.6.4. By Country/Sub-region

14. Middle East & Africa Clinical Trials Market Analysis and Forecast

    14.1.Introduction

        14.1.1. Key Findings

    14.2.Market Value Forecast, by Phase, 2018–2030

        14.2.1. Phase I

        14.2.2. Phase II

        14.2.3. Phase III

        14.2.4. Phase IV

    14.3.Market Value Forecast, by Study Design, 2018–2030

        14.3.1. Interventional Trials

        14.3.2. Observational Trials

        14.3.3. Expanded Access Trials

    14.4.Market Value Forecast, by Indication, 2018–2030

        14.4.1. Autoimmune/Inflammation

        14.4.2. Pain Management

        14.4.3. Cardiovascular

        14.4.4. CNS Condition

        14.4.5. Oncology

        14.4.6. Diabetes

        14.4.7. Obesity

        14.4.8. Others

    14.5.Market Value Forecast, by Country/Sub-region, 2018–2030

        14.5.1. GCC Countries

        14.5.2. South Africa

        14.5.3. Rest of Middle East & Africa

    14.6.Market Attractiveness Analysis 

        14.6.1. By Phase 

        14.6.2. By Study Design 

        14.6.3. By Indication 

        14.6.4. By Country/Sub-region

15. Competitive Landscape

    15.1. Market Player - Competition Matrix (by tier and size of companies)

    15.2. Market Share Analysis, by Company, 2019

    15.3. Company Profiles

        15.3.1. Laboratory Corporation of America Holdings

            15.3.1.1. Company Overview (HQ, Business Segments, Employee Strength)

            15.3.1.2. Financial Overview

            15.3.1.3. Product Portfolio

            15.3.1.4. Strategic Overview

            15.3.1.5. SWOT Analysis

        15.3.2. IQVIA Inc.

            15.3.2.1. Company Overview (HQ, Business Segments, Employee Strength)

            15.3.2.2. Financial Overview

            15.3.2.3. Product Portfolio

            15.3.2.4. Strategic Overview

            15.3.2.5. SWOT Analysis

        15.3.3. Syneos Health

            15.3.3.1. Company Overview (HQ, Business Segments, Employee Strength)

            15.3.3.2. Financial Overview

            15.3.3.3. Product Portfolio

            15.3.3.4. Strategic Overview

            15.3.3.5. SWOT Analysis

        15.3.4. Parexel International Corporation 

            15.3.4.1. Company Overview (HQ, Business Segments, Employee Strength)

            15.3.4.2. Financial Overview

            15.3.4.3. Product Portfolio

            15.3.4.4. Strategic Overview

            15.3.4.5. SWOT Analysis

        15.3.5. PPD Inc.

            15.3.5.1. Company Overview (HQ, Business Segments, Employee Strength)

            15.3.5.2. Financial Overview

            15.3.5.3. Product Portfolio

            15.3.5.4. Strategic Overview

            15.3.5.5. SWOT Analysis

        15.3.6. Icon plc

            15.3.6.1. Company Overview (HQ, Business Segments, Employee Strength)

            15.3.6.2. Financial Overview

            15.3.6.3. Product Portfolio

            15.3.6.4. Strategic Overview

            15.3.6.5. SWOT Analysis

        15.3.7. Charles River Laboratories, Inc.

            15.3.7.1. Company Overview (HQ, Business Segments, Employee Strength)

            15.3.7.2. Financial Overview

            15.3.7.3. Product Portfolio

            15.3.7.4. Strategic Overview

        15.3.8. WuXi AppTec

            15.3.8.1. Company Overview (HQ, Business Segments, Employee Strength)

            15.3.8.2. Financial Overview

            15.3.8.3. Product Portfolio

            15.3.8.4. Strategic Overview

            15.3.8.5. SWOT Analysis

        15.3.9. Medpace Holdings, Inc.

            15.3.9.1. Company Overview (HQ, Business Segments, Employee Strength)

            15.3.9.2. Financial Overview

            15.3.9.3. Product Portfolio

            15.3.9.4. Strategic Overview

            15.3.9.5. SWOT Analysis

List of Tables

Table 01: Global Clinical Trials Market Value (US$ Mn) Forecast, by Phase, 2018–2030

Table 02: Global Clinical Trials Market Value (US$ Mn) Forecast, by Study Design, 2018–2030

Table 03: Global Clinical Trials Market Value (US$ Mn) Forecast, by Indication, 2018–2030

Table 04: Global Clinical Trials Market Value (US$ Mn) Forecast, by Region, 2018–2030

Table 05: North America Clinical Trials Market Value (US$ Mn) Forecast, by Country, 2018–2030

Table 06: North America Clinical Trials Market Value (US$ Mn) Forecast, by Phase, 2018–2030

Table 07: North America Clinical Trials Market Value (US$ Mn) Forecast, by Phase, 2018–2030

Table 08: North America Clinical Trials Market Value (US$ Mn) Forecast, by Indication, 2018–2030

Table 09: Europe Clinical Trials Market Value (US$ Mn) Forecast, by Country/Sub-region, 2018–2030

Table 10: Europe Clinical Trials Market Value (US$ Mn) Forecast, by Phase, 2018–2030

Table 11: Europe Clinical Trials Market Value (US$ Mn) Forecast, by Study Design, 2018–2030

Table 12: Europe Clinical Trials Market Value (US$ Mn) Forecast, by Indication, 2018–2030

Table 13: Asia Pacific Clinical Trials Market Value (US$ Mn) Forecast, by Country/Sub-region, 2018–2030

Table 14: Asia Pacific Clinical Trials Market Value (US$ Mn) Forecast, by Phase, 2018–2030

Table 15: Asia Pacific Clinical Trials Market Value (US$ Mn) Forecast, by Study Design, 2018–2030

Table 16: Asia Pacific Clinical Trials Market Value (US$ Mn) Forecast, by Indication, 2018–2030

Table 17: Latin America Clinical Trials Market Value (US$ Mn) Forecast, by Country/Sub-region, 2018–2030

Table 18: Latin America Clinical Trials Market Value (US$ Mn) Forecast, by Phase, 2018–2030

Table 19: Latin America Clinical Trials Market Value (US$ Mn) Forecast, by Study Design, 2018–2030

Table 20: Latin America Clinical Trials Market Value (US$ Mn) Forecast, by Indication, 2018–2030

Table 21: Middle East & Africa Clinical Trials Market Value (US$ Mn) Forecast, by Country/Sub-region, 2018–2030

Table 22: Middle East & Africa Clinical Trials Market Value (US$ Mn) Forecast, by Phase, 2018–2030

Table 23: Middle East & Africa Clinical Trials Market Value (US$ Mn) Forecast, by Study Design, 2018–2030

Table 24: Middle East & Africa Clinical Trials Market Value (US$ Mn) Forecast, by Indication, 2018–2030

List of Figures

Figure 01: Global Clinical Trials Market Value (US$ Mn) Forecast, 2018–2030

Figure 02: Global Clinical Trials Market Value Share, by Phase, 2019

Figure 03: Global Clinical Trials Market Value Share, by Indication, 2019

Figure 04: Global Clinical Trials Market Value Share, by Study Design, 2019

Figure 05: Global Clinical Trials Market Value Share, by Region, 2019

Figure 06: Global Clinical Trials Market Value Share Analysis, by Phase, 2019 and 2030

Figure 07: Global Clinical Trials Market Value (US$ Mn), by Phase I, 2018–2030

Figure 08: Global Clinical Trials Market Value (US$ Mn), by Phase II, 2018–2030

Figure 09: Global Clinical Trials Market Value (US$ Mn), by Phase III, 2018–2030

Figure 10: Global Clinical Trials Market Value (US$ Mn), by Phase IV, 2018–2030

Figure 11: Global Clinical Trials Market Attractiveness Analysis, by Phase, 2020–2030

Figure 12: Global Clinical Trials Market Value Share Analysis, by Study Design, 2019 and 2030

Figure 13: Global Clinical Trials Market Value (US$ Mn), Interventional Trials, 2018–2030

Figure 14: Global Clinical Trials Market Value (US$ Mn), Observational Trials, 2018–2030

Figure 15: Global Clinical Trials Market Value (US$ Mn), Expanded Access Trials, 2018–2030

Figure 16: Global Clinical Trials Market Attractiveness Analysis, by Study Design, 2020–2030

Figure 17: Global Clinical Trials Market Value Share Analysis, by Indication, 2019 and 2030

Figure 18: Global Clinical Trials Market Value (US$ Mn), Autoimmune /Inflammation, 2018–2030

Figure 19: Global Clinical Trials Market Value (US$ Mn), Pain Management, 2018–2030

Figure 20: Global Clinical Trials Market Value (US$ Mn), Cardiovascular, 2018–2030

Figure 21: Global Clinical Trials Market Value (US$ Mn), CNS Condition, 2018–2030

Figure 22: Global Clinical Trials Market Value (US$ Mn), Oncology, 2018–2030

Figure 23: Global Clinical Trials Market Value (US$ Mn), Diabetes, 2018–2030

Figure 24: Global Clinical Trials Market Value (US$ Mn), Obesity, 2018–2030

Figure 25: Global Clinical Trials Market Value (US$ Mn), Others, 2018–2030

Figure 26: Global Clinical Trials Market Attractiveness Analysis, by Indication, 2020–2030

Figure 27: Global Clinical Trials Market Value Share Analysis, by Region, 2019 and 2030

Figure 28: Global Clinical Trials Market Attractiveness Analysis, by Region, 2020–2030

Figure 29: North America Clinical Trials Market Value (US$ Mn) Forecast and Y-o-Y Growth (%) Projection, 2018–2030

Figure 30: North America Clinical Trials Market Value Share (%), by Country, 2019 and 2030

Figure 31: North America Clinical Trials Market Attractiveness, by Country, 2020–2030

Figure 32: North America Clinical Trials Market Value Share Analysis, by Phase, 2019 and 2030

Figure 33: North America Clinical Trials Market Attractiveness Analysis, by Phase, 2020–2030

Figure 34: North America Clinical Trials Market Value Share Analysis, by Study Design, 2019 and 2030

Figure 35: North America Clinical Trials Market Attractiveness Analysis, by Study Design, 2020–2030

Figure 36: North America Clinical Trials Market Value Share Analysis, by Indication, 2019 and 2030

Figure 37: North America Clinical Trials Market Attractiveness Analysis, by Indication, 2020–2030

Figure 38: Europe Clinical Trials Market Value (US$ Mn) Forecast, 2018–2030

Figure 39: Europe Clinical Trials Market Value Share Analysis, by Country/Sub-region, 2019 and 2030

Figure 40: Europe Clinical Trials Market Attractiveness Analysis, by Country/Sub-region, 2020–2030

Figure 41: Europe Clinical Trials Market Value Share Analysis, by Phase, 2019 and 2030

Figure 42: Europe Clinical Trials Market Attractiveness Analysis, by Phase, 2020–2030

Figure 43: Europe Clinical Trials Market Value Share Analysis, by Study Design, 2019 and 2030

Figure 44: Europe Clinical Trials Market Attractiveness Analysis, by Study Design, 2020–2030

Figure 45: Europe Clinical Trials Market Value Share Analysis, by Indication, 2019 and 2030

Figure 46: Europe Clinical Trials Market Attractiveness Analysis, by Indication, 2020–2030

Figure 47: Asia Pacific Clinical Trials Market Value (US$ Mn) Forecast, 2018–2030

Figure 48: Asia Pacific Clinical Trials Market Value Share Analysis, by Country/Sub-region, 2019 and 2030

Figure 49: Asia Pacific Clinical Trials Market Attractiveness Analysis, by Country/Sub-region, 2020–2030

Figure 50: Asia Pacific Clinical Trials Market Value Share Analysis, by Phase, 2019 and 2030

Figure 51: Asia Pacific Clinical Trials Market Attractiveness Analysis, by Phase, 2020–2030

Figure 52: Asia Pacific Clinical Trials Market Value Share Analysis, by Study Design, 2019 and 2030

Figure 53: Asia Pacific Clinical Trials Market Attractiveness Analysis, by Study Design, 2020–2030

Figure 54: Asia Pacific Clinical Trials Market Value Share Analysis, by Indication, 2019 and 2030

Figure 55: Asia Pacific Clinical Trials Market Attractiveness Analysis, by Indication, 2020–2030

Figure 56: Latin America Clinical Trials Market Value (US$ Mn) Forecast, 2018–2030

Figure 57: Latin America Clinical Trials Market Value Share Analysis, by Country/Sub-region, 2019 and 2030

Figure 58: Latin America Clinical Trials Market Attractiveness Analysis, by Country/Sub-region, 2020–2030

Figure 59: Latin America Clinical Trials Market Value Share Analysis, by Phase, 2019 and 2030

Figure 60: Latin America Clinical Trials Market Attractiveness Analysis, by Phase, 2020–2030

Figure 61: Latin America Clinical Trials Market Value Share Analysis, by Study Design, 2019 and 2030

Figure 62: Latin America Clinical Trials Market Attractiveness Analysis, by Study Design, 2020–2030

Figure 63: Latin America Clinical Trials Market Value Share Analysis, by Indication, 2019 and 2030

Figure 64: Latin America Clinical Trials Market Attractiveness Analysis, by Indication, 2020–2030

Figure 65: Middle East & Africa Clinical Trials Market Value (US$ Mn) Forecast, 2018–2030

Figure 66: Middle East & Africa Clinical Trials Market Value Share Analysis, by Country/Sub-region, 2019 and 2030

Figure 67: Middle East & Africa Clinical Trials Market Attractiveness Analysis, by Country/Sub-region, 2020–2030

Figure 68: Middle East & Africa Clinical Trials Market Value Share Analysis, by Phase, 2019 and 2030

Figure 69: Middle East & Africa Clinical Trials Market Attractiveness Analysis, by Phase, 2020–2030

Figure 70: Middle East & Africa Clinical Trials Market Value Share Analysis, by Study Design, 2019 and 2030

Figure 71: Middle East & Africa Clinical Trials Market Attractiveness Analysis, by Study Design, 2020–2030

Figure 72: Middle East & Africa Clinical Trials Market Value Share Analysis, by Indication, 2019 and 2030

Figure 73: Middle East & Africa Clinical Trials Market Attractiveness Analysis, by Indication, 2020–2030

Figure 74: Global Clinical Trials Market Share Analysis, by Company, 2019

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Clinical Trials Market

Clinical trials market size, share & trends analysis report by phase (phase i, phase ii, phase iii, phase iv), by study design (interventional, observational, expanded access), by indication (autoimmune/inflammation, pain management, oncology, cns condition, diabetes, obesity, cardiovascular, others ) and by region(north america, europe, apac, middle east and africa, latam) forecasts, 2023-2031.

Market Dynamics

Regional analysis, report scope, segmental analysis.

• Recent Development

Top Key Players

• Report Overview
• Table of Content
• Segmentation

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Market overview.

The global clinical trials market size was valued at USD 49.49 billion in 2022. It is estimated to reach USD 16.77 billion by 2031, growing at a CAGR of 5.2% during the forecast period (2023–2031). Globalization of clinical trials has led to an increase in investment in new product development in emerging nations, thereby positively impacting the overall clinical trials market. 

Clinical trials are investigation studies conducted with human participants to evaluate the safety and success of new medical interventions. These interventions can include drugs, vaccines, medical devices, diagnostic tests, or treatment methods. The primary motive of clinical trials is to gather scientifically rigorous evidence regarding the intervention under investigation. The trials aim to determine whether the new intervention is safe, how well it works, and how it compares to existing treatments or standard care. A clinical trial follows a well-defined protocol or plan that outlines various aspects of the study. This protocol includes the trial's objectives, the study design, participant eligibility criteria, treatment procedures, data collection methods, and statistical analysis. By adhering to this protocol, researchers ensure that the trial is conducted consistently and reliably.

Clinical trials are typically conducted in various phases. In Phase 1, a few healthy participants are enrolled to assess the intervention's safety, dosage, and potential side effects. Phase 2 trials concern a larger group of participants, including patients with the target condition or disease. The main objective of Phase 2 is to gather preliminary data on the intervention's effectiveness and further evaluate its safety. Phase 3 trials involve a larger population and are usually randomized and controlled. They compare the new intervention against the current standard treatment or placebo to determine its overall efficacy, safety, and side effects. Phase 4 trials are conducted after the intervention is approved and available to the public. They aim to monitor its long-term safety, effectiveness in different populations, and any rare or long-term side effects that may emerge over time.

Global Market Drivers

Globalization of clinical trials.

The number of clinical studies in each area is slowly changing from growing nations to emerging countries. The rising cost of clinical trials and difficulty in patient recruitment have led biopharmaceutical companies to shift towards regions like central and Eastern Europe, Asia pacific, Latin America, and the Middle East for cost savings and quick patient recruitment. Emerging countries also possess greater disease variation than the West, where traditional diseases are growing. The greater disease variation among developing countries helps biopharmaceutical companies to perform clinical trials for rare diseases.

Additionally, regions like Asia-Pacific provide greater economic benefits to biopharmaceutical companies as governments in countries like Singapore and China allocate funds to promote biomedical research. Regions like Latin America, where the population speaks only Portuguese and Spanish, also reduce barriers to informed consent, which helps in easy patient recruitment and faster clinical trials. The Middle East is expected to be a potential region for clinical research owing to its increasing population, improved infrastructure, and greater disease variation. Globalization of clinical trials has led to an increase in investment in new product development in emerging nations, thereby positively impacting the overall Clinical trials market.

Shift Toward Personalized Medicine

The paradigm shift towards personalized medicine will positively impact the clinical trial market. The classic clinical trial process is carried out on thousands of people, while personalized medicine focuses only on the effect of drugs on individual patients for a specific period. Due to the traditional clinical trial approach, few medicines in the development phase pass all clinical trial phases. The mentality of “one size will fit all” is a barrier for drugs currently in the pipeline, but we will never see the day.

The use of pharmacogenetics in the clinical trial process is expected to increase the number of drugs passing all phases of the clinical trial process. The shift towards personalized medicine is expected to increase the use of pharmacogenetics in the clinical trial phase, thereby increasing the pipeline of drugs. This trend is expected to instigate biopharmaceutical companies to invest more in the clinical trial phase.

Global Market Restraints

Regulations in new drug development.

The complex regulation in the clinical trial process, from the dossier application to the approval of new drugs, is a major barrier for biopharmaceuticals to invest in the recent drug development phase. Biopharmaceutical companies file applications in different countries for approval of a specific drug. In regions like the EU, companies file separate applications in different countries, and this process is very tedious and discourages companies from investing in R&D. Majority of the drugs in preclinical studies are not passed through the final stages of a clinical trial, and this discourages biopharmaceutical companies from investing heavily on the clinical trial process. The regulations in the EU are expected to streamline the drug development and approval process, which is a positive sign for the global clinical trials market.

Global Market Opportunities

Expansion of precision medicine.

The expansion of precision medicine presents a significant opportunity in the global clinical trials market. Precision medicine involves tailoring treatments to individual patients based on their genetic and molecular characteristics. This approach represents a shift from a generalized treatment approach to a more personalized and targeted approach to patient care. Clinical trials plays an important role in advancing precision medicine by identifying biomarkers, validating diagnostic tests, and assessing the effectiveness of targeted therapies.

One key contribution of clinical trials is identifying and validating biomarkers associated with specific diseases or treatment responses. Through careful analysis of patient samples and monitoring of biomarkers throughout the trial, researchers gain insights into disease mechanisms, treatment effectiveness, and patient stratification.

North America Dominates the Global Market

Based on region, the global clinical trials market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global clinical trials market shareholder and is estimated to grow at a CAGR of 4.9% over the forecast period. North America dominates global clinical trials, accounting for the largest market share in 2020. This is primarily attributed to several factors, including significant investments in research and development, the presence of global players, and efforts to develop newer patents.

In addition, the region has witnessed substantial R&D investments, contributing to its market leadership. One notable example is the precision medicine initiative announced by President Obama in January 2015. The initiative involved a substantial investment of USD 215 million in the National Institutes of Health (NIH), the National Cancer Institute, and the Food and Drug Administration. The funding was allocated to various areas, such as encouraging volunteer participation, genomic driver identification in cancer, and evaluating Next Generation Sequencing for enhanced patient care.

Europe is anticipated to exhibit a CAGR of 5.7% over the forecast period. Countries like Germany and the U.K. have a large patient pool and advanced medical expertise. The doctors advocate for these trials, thus increasing patient recruitment and benefiting research and patients. The legal aspects are developing in Germany but fully evolved in the U.K. and France. The regulations are formulated to ensure volunteers' safety, rights, and proper reimbursement. With clearer protocols and increased funding, Europe is expected to be a promising region for clinical trials. Factors such as greater access to the treatment-naïve patient pool, a higher concentration of patients near sites, cheap labor costs, and close relationships between doctors and patients drive the clinical research market in Europe.

Asia-Pacific is the fastest-growing market as many developed nations invest in Asia-Pacific regions. In October 2014, the Australian CRO Novotech started a new office in China with its ninth office in Asia. Novotech as a company has expanded in many developing nations owing to the requests of its U.S. and EU clients. In the case of China, Novotech is not the only company. Even Charles River Laboratories, in February 2014, declared China as having disproportionate growth and expressed interest in merging with potential regions.

In Latin America, 80% of the residents live in metropolitan cities. Three megacities, Sao Paulo, Buenos Aires, and Mexico City, have a huge patient pool. Though the regulatory timelines in Latin America are a drawback, the time saved in patient recruitment compensates for it. In addition to patient recruitment, patient retention is very high due to the healthy patient-physician relationship. Lower cost, highly qualified investigators, medical personnel, and study coordinators with GCP-compliant knowledge contribute to a higher clinical trial success rate. Moreover, Mexico and Brazil are expected to witness lucrative growth in the CRO market due to their cost advantage over developed economies such as the U.S. and European nations such as Germany.

Conducting clinical trials in the Middle East and Africa offers advantages such as patient diversity, cost advantage, infrastructure, and world-class medical facilities. The only drawback is discrepancies between the laws of different regions. Many regions are initiating to adapt to the global standards and collaborating with other global CROs to mark their presence. For instance, Hassan Labs of Egypt and Saham Group of North Africa joined hands to provide international medical expertise across Africa. MCT participated in the Partnership in Clinical Trials in April 2014 to reach out to clients and expand in developed countries. Through this, even MCT met sponsors from North America and presented the advantages of conducting trials in MEA.

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The global clinical trials market is bifurcated into phase, study design, and indication.

Based on phase, the global market is bifurcated into phase I, phase II, phase III, and phase IV. 

The phase I segment dominates the global market and is projected to exhibit a CAGR of 6.8% over the forecast period. Phase I studies evaluate the safety of a device or drug and the tolerability and pharmacokinetics of molecules. It determines the result of a device or drug on the person, including how it is absorbed, metabolized, and excreted. It also examines the side effects of the drug in case of increased dosage levels. The stage includes 20 to 100 healthy volunteers or people with the disease.

In addition, conducting other studies to assess drug-drug interaction and the effects of food is also necessary in this phase. For patients with clear tolerability studies, oncology studies must be conducted as a primary endpoint. The main aim of phase I is to evaluate doses and their adverse effects, which includes testing about 70% of experimental drugs.

The global market is bifurcated based on study design into interventional, observational, and expanded access. 

The interventional segment dominates the global market and is projected to exhibit a CAGR of 5.5% over the forecast period. The growth can be attributed to many interventional studies being conducted on autoimmune/inflammation across the globe. Over 7,000 interventional studies listed on clinicaltrails.gov related to autoimmune/inflammation. For instance, an interventional study titled Immunoadsorption or Plasma Exchange - What is the Best Treatment Option of Steroid Refractory Neurological Autoimmune Diseases was completed on December 1, 2019.

Based on the study design, the global market is bifurcated into Autoimmune/inflammation, pain management , oncology, CNS conditions, diabetes, obesity, cardiovascular, and others. 

The autoimmune/inflammation segment dominates the global market and is projected to exhibit a CAGR of 5.4% over the forecast period. Autoimmune diseases have increased considerably in the past decade and are expected to rise further owing to the lifestyle and aging population. Due to significant growth in the prevalence of autoimmune diseases, there has been a significant increase in R&D spend on autoimmune diseases. The autoimmune diseases affect one in 15 Americans, including 18 million women and 5 million men. They are among the top 10 causes of death in women and female children in all age groups up to 64 years of age. According to the NIH’s estimate, autoimmune medical care costs approximately USD 100 billion yearly.

Market Size By Phase

Recent developments.

• January 2023- the FDA announced that it would streamline the clinical trial process for certain drugs and biologics. This is expected to make it easier and faster for companies to bring new therapies to market.
• February 2023- the European Medicines Agency (EMA) announced that it would be launching a new initiative to improve the efficiency of clinical trials. This initiative is expected to reduce the time and cost of bringing new therapies to market in Europe.

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Clinical Trials Market (By Phase: Phase 1, Phase 2, Phase 3, and Phase 4; By Study Design: Observational, Interventional, and Expanded Access; By Indication: Oncology, Autoimmune/Inflammation, Diabetes, Central Nervous System, Cardiovascular, Pain Management, and Others) - Global Market Size, Share, Trends Analysis, Segment Forecasts, Regional Outlook 2023 - 2032

• Report Description
• Table of Content

The global clinical trials market size was valued at USD 48.68 billion in 2022 and is predicted to hit USD 83.55 bn by 2032 with a registered CAGR of 5.6% during the forecast period 2023 to 2032. U.S. clinical trials market was valued at USD 24.61 billion in 2022.

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Key Takeaway:

• North America has held 51.7% of the total market share in 2022.
• Asia Pacific region is growing at a CAGR of 6.8% during the forecast period.
• By indication, the oncology segment has held a market share of around 24.7% in 2022.
• The cardiovascular condition segment is growing at a CAGR of 6.4% during the forecast period.
• By sponsor, The pharmaceutical & biopharmaceutical companies has generated the largest revenue share of around 72% in 2022.
• By Indication by study design, the interventional trials market for autoimmune/inflammation has captured 83% market share in 2022.
• By study design, the interventional design segment has accounted revenue share of 46% in 2022.
• The expanded access trials segment is projected to register at a CAGR of 6.4% over the forecast period.

Key market Insights:

Clinical trials are a process of clinical research that is governed by a defined protocol which is carefully established to answer a precise patient care query. Clinical trials can be divided into five phases, with every phase playing a distinct purpose within the clinical trial. Every trial adheres to a procedure that designates what types of individuals may participate in the study.

The trials also outline exact plan of procedures, tests, medications, and doses within the trial apart from specifying the span of the study. In recent years, the costs associated with drug development have increased significantly, driving pharma and biotech companies to look for modernizations and smarter ways of conducting business.

One important trend is the outsourcing of clinical research activities by manufacturers. By subcontracting their R&D activities, pharma and biotech companies are reforming the drug development facilities business. The R&D service providers have risen from just a few establishments providing restricted clinical trial facilities to big conglomerates offering a extensive range of facilities like study design, preclinical evaluations, clinical trial management and planning, autonomous safety data audit, bio-statistical analysis and several more. CROs (Contract Research Organizations) started off by providing preclinical & clinical trial services, however they are now venturing into project administration.

Crucial factors accountable for market growth are:

• Growing prevalence of chronic disorders
• Increasing number of clinical trials in developing regions
• Growing number of biologics
• Increasing demand for advanced treatments such as personalized medicines

Production, manufacturing, investment data and market statistics Clinical Trials Market

• According to the U.S. National Library of Medicine, as of June 2023, approximately 55,483 interventional clinical studies were posted with results on the Clinicatrial.gov. website.
• According to the World Health Organization (WHO), as of 2022, approximately 39% clinical trials were done for non-communicable diseases across the globe. Whereas the clinical trials for communicable diseases reached 60%.
• Europe registered almost 13,254 clinical trials in 2022. Whereas South-East Asia enrolled 11,052 number of clinical trials in the same year.
• In 2022, approximately 54% clinical trial initiations reached at the Phase-III level in India. Whereas 28% of them made it to the Phase IV level.
• Charles River Laboratory, a globally leading clinical trial company witnessed a significant growth in drug research fundings in 2022, the company’s annual generated revenue for 2022 was $3.98 billion. The revenue represented the growth of 12.3% over the previous year.
• The Cancer Research UK funded 193 million Euros on clinical research projects that focus on specific cancers in the financial year 2021-2022
• Japan accounted for 4.7% share in the worldwide clinical trial activities in 2022. The industry sponsored clinical trials held 54% share of the total Japanese industry in 2022
• For year 2022, in Japan, the oncology sector led the clinical trial activities with 25.1% share of the overall industry for clinical trials in the country. Whereas clinicals trials on infectious diseases held 7% share.
• The United Kingdom held total 178 Advanced Therapy Medicinal Product (ATMP) clinical trials in 2022.
• MedPace, a globally leading contract research organization’s annual revenue increased by 27.7% in 2022 and reached $394.1 million.

Report Scope of the Clinical Trials Market

Market drivers.

ADOPTION OF NEW TECHNOLOGY IN CLINICAL RESEARCH

Digitization in biomedical research is also paving the way for the market growth. Digitization also helps in meeting stringent regulations by maintaining patient data records that reduces trial process errors through adoption of software such as electronic clinical outcome assessment (e-COA). Digitization helps in streamlining the clinical trial process thereby probing sponsors to invest more in the clinical trial process as chances of successful clinical trials are more through the adoption of newer technologies.

SHIFT TOWARDS PERSONALIZED MEDICINE

The paradigm shift towards personalized medicine is expected to have a positive impact on the clinical trial market. The classic clinical trial process is carried out on thousands of people while personalized medicine will focus only on the effect of drugs on individual patients for a specific period. Very few medicines in the development phase pass all phases of a clinical trial due to the traditional clinical trial approach. The mentality of “one size will fit all” is acting as a barrier for drugs that are currently in pipeline but would never see the day. The use of pharmacogenetics in the clinical trial process is expected to increase the number of drugs passing all phases of the clinical trial process. The shift towards personalized medicine is expected to increase the use of pharmacogenetics in the clinical trial phase thereby increasing the pipeline of drugs. This trend is expected to instigate biopharmaceutical companies to invest more in the clinical trial phase.

GROWING DISEASE VARIATION AND PREVALENCE

Growing prevalence of disease and incidence of new disease is expected to give further boost to the clinical trial market. Worldwide population has varied disease profile with emerging countries having the most diverse disease profile. This is expected to boost the clinical trial of new or rare disease which otherwise would not have found any sponsors. More number of patients having a specific disease would act as a stimulus for biopharmaceutical companies to invest more in clinical trials for a disease segment. Diverse population would also mean easy recruitment of patients and faster clinical trial process. Rare diseases are given a status of “Orphan disease” in U.S and biopharmaceutical companies who sponsor clinical trials for Orphan drugs would get incentives for the process. This trend is likely to have a positive impact on clinical trials for rare disease thereby increasing the global clinical trials market.

INCREASING COLLABORATION IN BIOMEDICAL RESEARCH

The trend of combination trials and collaborations in clinical trial is expected to rise which would further boost the global clinical trials market. Due to high drug development cost biopharmaceutical companies are now forming an alliance with each other to increase the resources and share the risk of high cost. Immuno-oncology collaborations in 2015 is a prime example of increase collaboration to combat risk associated with clinical trials. Recent example of immuno-oncology collaboration is of MSD and Lily for clinical trial phase for treatment of advanced soft tissue sarcoma.

The race to launch the molecule in the market in a feasible timeline and cost will propel the need for CROs service provides. The pharmaceutical companies, along with the increased research cost, also witness global regulation complexity. All of these variables create a need for expertise in different portfolios, driving the need for outsourcing the market. Drug companies are not only outsourcing the production of medicines but also clinical trials. With the increasing clinical trial privatization, there is a surge in outsourcing to developing countries such as India, China, and Latin America.

Phase Insights

Phase 3 Segment Reported Foremost Market Stake in 2022

Phase 3 segment recorded the major market stake in the worldwide clinical trials market in 2022 and has garnered revenue share 54.6%. Implementation on a large scale is the major reason for high market share of phase 3. Other factors such as high cost and increasing trend of outsourcing are expected to boost the demand over the estimate period.

The Phase 2 clinical trials are anticipated to advance at the maximum CAGR through the forecast period. The Phase II segment held market share for 19.5% in 2021.

Study Design

Interventional Study is Projected to Dominate the Study Design Segment of Clinical Trials Market Revenue

The requirement of clinical trials in developing diagnostic tests and vaccines for viral diseases such as the SARS CoV-2 has augmented the demand for clinical trials exponentially. Thus, high incidence of novel viral diseases and ongoing technological improvements in clinical trials are major reason for the high revenue share of interventional study. Interventional study segment is expected to grow at a CAGR of 5.4% from 2022 to 2030. The interventional design segment accounted largest market share 46% in 2022.

Indication Insights

Oncology is Projected to Dominate the Indication Segment of Clinical Trials Market Revenue

Constant research on cancer treatment and increasing demand for precision medicine are the major reasons responsible for high market share of oncology. The oncology segment is expected to witness growth at a CAGR of 6.4% over the forecast period 2022 to 2030.

Regional Insights

North America is Estimated to be the Largest Market for Clinical Trials

The research study covers key prospects and trends of clinical trials products throughout different regions including Europe, North America, Asia-Pacific, Middle East and Africa, and Latin America. Regionally, clinical trials market is dominated by North America due to high incidence of chronic disorders and presence of latest healthcare infrastructure. North America accounted largest revenue share 51.7% in 2022.

On the other hand, Asia-Pacific is anticipated to witness the rapid growth rate 6.8%, on account of increasing investment by governments in research and growing awareness regarding precision medicine.

• The North America clinical trials market was valued at USD  27.5 billion in 2022 and it is expected to grow at a CAGR of 5.6% over the forecast period.
• The Europe clinical trials market was valued at USD 14.8 billion in 2022 and it is expected to grow at a CAGR of 5.8% over the forecast period.
• The Asia Pacific clinical trials market was valued at USD 10.7 billion in 2022 and it is expected to grow at a CAGR of 6.8% over the forecast period.

Clinical Trials Market Companies

• Charles River Laboratory
• Pharmaceutical Product Development, LLC

In order to better recognize the current status of clinical trials, and policies adopted by the foremost countries, Precedence Research predicted the future evolution of the clinical trials market. This research study bids qualitative and quantitative insights on clinical trials market and assessment of market size and growth trend for potential market segments.

Major Market Segments Covered:

By Study Design

• Observational
• Interventional
• Expanded Access

By Indication

• Rheumatoid arthritis
• Multiple Sclerosis
• Osteoarthritis
• Irritable Bowel Syndrome (IBS)
• Chronic Pain
• Blood Cancer
• Solid Tumors
• Parkinson's Disease (PD)
• Huntington's Disease
• Traumatic Brain Injury (TBI)
• Amyotrophic Lateral Sclerosis (ALS)
• Muscle Regeneration
• Cardiovascular

By Service Type

• Protocol Designing
• Patient Recruitment
• Laboratory Services
• Site Identification
• Cell-based Assays
• Virology Testing
• Method Development, Optimization, & Validation
• Serology, Immunogenicity, & Neutralizing Antibodies
• Biomarker Testing Services
• PK/PD (Pharmacokinetics/Pharmacodynamics) Testing Services
• Other Bioanalytical Testing Services
• Analytical Testing Services
• Clinical Trial Supply & Logistic Services
• Clinical Trial Data Management Services
• Decentralized Clinical Services
• Medical Device Testing Services
• Pharmaceutical & Biopharmaceutical Companies
• Medical Device Companies

By End User

• Laboratories

By Application

• Cell & Gene Therapy
• Small Molecules
• Other Applications

By Geography

• North America
• United Kingdom
• Rest of Europe
• Asia Pacific
• Southeast Asia
• Rest of Asia Pacific
• Latin America
• Rest of Latin America
• Middle East & Africa (MEA)
• North Africa
• South Africa
• Rest of Middle East & Africa

Frequently Asked Questions

• Report Code: 1185
• Category: Healthcare
• No. of Pages: 150+
• Format: PDF/PPT/Excel
• Published: December 2022
• Historical Year: 2021-2022
• Base Year: 2023
• Estimated Years: 2024-2033

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• Pharmaceuticals /
• Clinical Trials

Clinical Trials Market Size, Share & Trends Analysis Report by Phase (Phase I, Phase II, Phase III, Phase IV), by Study Design, by Indication (Pain Management, Oncology, CNS Condition, Diabetes, Obesity), by Region, and Segment Forecasts, 2022-2030

• Region: Global
• Grand View Research
• ID: 4396385
• Description

Table of Contents

Companies mentioned, methodology, related topics, related reports.

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Clinical Trials Market Report Highlights

• The phase III clinical trials segment dominated the market with a 53.4% share in 2021. This can be attributed to the complexity of this phase.
• The interventional design segment accounted for the largest share of 45.7% in 2021 in the study design segment owing to the increasing demand for the intervention for clinical trials by researchers.
• North America held 50.7% of the market share in 2021. Favorable government initiatives and the presence of a large number of players in the U.S. that offer advanced services are responsible for market growth.
• The Asia Pacific region is expected to grow at the fastest CAGR of 6.8% over the forecast period owing to the increasing patient pool and cost-efficient services.
• PAREXEL International Corporation
• Pharmaceutical Product Development, LLC
• Charles River Laboratory
• Wuxi AppTec Inc
• PRA Health Sciences
• Syneos Health
• Chiltern International Ltd
• Eli Lilly and Company
• Novo Nordisk A/S

Table Information

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• February 2024

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Analysis and Review: Clinical Research Organization Market by Service (Drug Discovery Services, Pre-Clinical Services, Clinical Services, Post-Approval Services), by Production (In-House, Outsourced), by Indication (Oncology, CNS, Cardiovascular Diseases, Metabolic Disorders, Immunology, Respiratory, Musculoskeletal Disorders, Hematological Disorders), by End User (Pharmaceutical & Biotechnology Companies, Medical Device Companies, Governments & Private Firms, Academic Institutions, Others) and By Region- Forecast for 2023 – 2033

Market Insights on Clinical Research Organization Market covering sales outlook, demand forecast and up-to-date key trends

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Clinical Research Organization Market Snapshot (2023 to 2033)

According to Future Market Insights (FMI) analysis in a recent market survey, the global clinical research organization market was valued at US$ 58.0 Billion in 2022 and is expected to reach US$ 139.6 Billion by 2033.

Market Outlook:

The Clinical Research Organization (CRO) market refers to the industry segment companies and organizations providing clinical research services to pharmaceutical, biotechnology, and medical device companies. It encompasses the commercial activities and financial transactions associated with outsourcing clinical trials and research studies.

The market is driven by the increasing demand for efficient and cost-effective drug development processes. Pharmaceutical and biotech companies often outsource clinical research activities to CROs to leverage their specialized expertise, infrastructure, and resources. This allows the companies to focus on their core competencies, such as drug discovery and marketing, while relying on CROs for the execution of clinical trials.

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Sales Analysis of Clinical Research Organization Market from 2018 to 2022 Vs Market Outlook for 2023 to 2033

Sales of the market grew at a CAGR of 6.4% between 2018 to 2022.

With a historical forecast of stable growth, the clinical research organization (CRO) industry has seen significant growth in recent years. The rise in demand for outsourced clinical trials from pharmaceutical, biotechnology, and medical device businesses is what is causing this surge.

The clinical research organization (CRO) market is anticipated to maintain its growth trajectory in the upcoming years, according to the projection. The expansion of the CRO market is anticipated to be fueled by an increase in clinical trials, a rise in the need for personalized medication, and the prevalence of chronic diseases. Various clinical trial processes, including patient recruiting and retention, data analysis, and medication discovery, are using these technologies.

Considering this, FMI expects the global clinical research organization market to grow at a CAGR of 8.4% through the forecasted years.

What are the Key Opportunities in the Clinical Research Organization Market?

CROs can provide specialized services for carrying out clinical studies in this field as personalized medicine and targeted medicines gain popularity. This covers the identification of biomarkers, patient screening, and customized trial planning. CROs now have more potential due to the use of real-world data and virtual trials.

Companies with expertise in these fields can provide pharma/biotech firms with specialized services and assistance for real-world research as well as for virtual studies, which can shorten the trial duration and expense. It can also include telemedicine and digital health technology in clinical trials to raise study compliance, increase patient participation, and offer ongoing monitoring. CROs can be assisted in adopting these technologies and incorporating them into clinical trial designs by businesses offering specialised services.

They are now also able to provide specialized services in data analytics and machine learning due to the increased availability of real-time data in clinical trials. To do this, one can employ predictive analytics to foresee dangers, spot trends, and improve study design, which thereby helps in the growth of the global market.

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Which Factors Could Possibly Restrain the Growth of the Clinical Research Organization Market?

Ensuring compliance with regulatory regulations is one of the biggest issues for CRO businesses. Navigating through each nation's unique legislation can be time-consuming and expensive. To make sure that all applicable regulations are followed, CROs must have a strong regulatory staff. Companies in the pharma and biotech industries are increasingly looking for CROs that can offer services at a low cost without sacrificing quality or timeliness. To remain competitive, CROs may need to modify their pricing strategies and business models in response to margin concerns.

Large-scale multicenter trials might be difficult to finance since there is sometimes a lack of funding for clinical trials. To maximize the cost-effectiveness of clinical studies, sponsors, researchers, and CROs must collaborate due to the high cost of drug development and growing cost constraints. The capabilities of CROs may also be constrained by a lack of highly skilled workers, including researchers, data administrators, and statisticians. Lack of qualified personnel may cause inefficiencies, delays in hiring and retaining staff, and a general decline in the quality of project outputs.

Country-wise Insights

What makes the usa the dominating country in the clinical research organization market.

The USA clinical research organization market is expected to register 32.0% in the global market in 2022.

There are several life science businesses in the United States, and these businesses are embracing innovations in clinical research. CROs that offer these services are in demand as technological innovations like telemedicine and virtual trials are used more frequently. Drug development efforts by biotech and pharmaceutical firms are increasing in the USA These businesses are turning more and more to CROs for assistance, including access to facilities and programs for current patients, enrollment and recruiting information, personalized protocol design, higher trial completion rates, and lower costs.

Why is China considered a Lucrative Market for Clinical Research Organization Services?

China accounted for around 9.3% market share in 2022 globally.

The clinical research organization (CRO) market in China is expanding due to several factors. The rapidly ageing and expanding Chinese population is a significant contributing element, which has raised demand for cutting-edge medical cures and treatments. Furthermore, recent reforms and laws adopted by the Chinese government have made it simpler to conduct clinical trials and research there.

The government has put in place many steps to hasten the regulatory approval procedure for novel pharmaceuticals and therapies, luring multinational companies to locate their research and development operations in the nation. Additionally, the development of healthcare and rising income levels in China have raised the demand for advanced healthcare services, such as clinical research and triage.

What Makes India an Emerging Market for Clinical Research Organization?

India holds a 7.4% value share in the global market in 2022.

The clinical research organization (CRO) market is expanding in India for a variety of reasons. Large and diversified patient populations are a significant contributing element, which makes India a desirable location for carrying out clinical studies. Due to the country's accessible healthcare services and cheaper cost of living, clinical trials in India are also more economical than in many other nations.

The supportive regulatory environment created by the Indian government, which promotes clinical research activities by streamlining the approval procedure for clinical trials and cutting the time needed to secure regulatory approvals, is another important aspect. More foreign money has also been invested in India's clinical research sector as a result of the rise in medical tourism there.

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Category-wise Insights

Which service is largely adopted for clinical research organizations.

The post-approval services segment held the major chunk of about 45.7% of the global market by the end of 2022.

A key factor in the expansion of the clinical research organization (CRO) market is post-approval services. Post-approval services are the actions taken after regulatory bodies or authorities have given their clearance for the use of a product or therapy. These services are essential for maintaining the product's safety and effectiveness as well as for carrying out additional studies that could increase the product or therapy's effectiveness.

In order to diversify their service portfolio and give their clients value-added services, several CROs offer post-approval services. Pharmacovigilance, medical monitoring, safety monitoring, data management, statistical analysis, quality assurance, and regulatory compliance are a few examples of the services that may be provided.

Which production type is largely preferred for the clinical research organization market?

The In-house production segment contribute 58.3% share of the global market in 2022.

The term in-house describes a method of conducting all phases of clinical research within a single organization, often comprising study design, data management, monitoring, and statistical analysis. Clinical research organizations (CRO) market development is still mostly fueled by internal clinical research conducted by pharmaceutical and biotech corporations. The in-house methodology has several benefits, including more control over studies, quicker decision-making, and reduced reliance on outside suppliers.

A pharmaceutical or biotech company's ability to quickly and efficiently react to any noteworthy events or changes in the study protocol can be facilitated by in-house clinical research, which provides better control over study data and technological competence.

Which Indication Dominates the Global Market in 2022?

The oncology by indication segment accounted for a revenue share of 23.4% in the global market at the end of 2022.

One of the markets for clinical research organizations (CROs) that is expanding the quickest is oncology, which has had a big impact on the development of the sector. Cancer research is an appealing subject for CROs to concentrate their attention on because it is a complex and fast-developing field of medicine that calls for a high degree of knowledge and resources.

Many variables, such as the rising cancer burden globally, developments in molecular biology and genomics, and the creation of more advanced and novel immuno-oncology medicines, all contribute to the expansion of oncology research and the CRO business. The need for more advanced oncology therapies that can address patients' complicated requirements is growing as cancer rates are expected to keep rising.

Which End User Segment Propels the Market Growth?

The pharmaceutical and biotechnology companies hold a share of 45.6% of the global market in 2022.

The market for clinical research organizations (CROs) is expanding mostly due to the efforts of the pharmaceutical and biotechnology industries. These businesses invest a lot of money in the discovery of novel treatments and medications, and they frequently contract out some or all of the clinical research work to CROs to increase productivity and access to funding.

A great deal of financing for clinical research studies-particularly those involving new medicinal compounds-comes from pharmaceutical and biotech corporations. These businesses frequently look to collaborate with CROs who can offer specialized knowledge in research design, data administration, and general project management. Pharmaceutical and biotech companies can shorten the time it takes to develop new drugs by outsourcing clinical trial efforts to CROs and concentrating internal resources on core research and development tasks.

Competitive Landscape

The market's key vendors are concentrating on diversifying their product offerings to strengthen their market share in clinical research organizations and to broaden their presence in developing nations. Pricing strategies, market strategies, technology improvements, regulatory compliance, and acquisition and distribution agreements with other companies to extend their business are the main tactics used by manufacturers to acquire a competitive edge in the market.

For instance:

• In January 2020, Charles River announced a scientific collaboration with Takeda Pharmaceutical Company Limited in order to focus on drug discovery in the four core therapeutic areas that Takeda works on. These four therapeutic areas include oncology, gastroenterology, neuroscience, and rare disease. This collaboration focuses on delivering preclinical candidates.
• In July 2022, Labcorp launched a new test called the neurofilament light chain (NfL) blood test, which will help in the identification and confirmation of neurodegenerative diseases like multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, and others.

Similarly, recent developments have been tracked by the team at Future Market Insights related to companies in the clinical research organization market space, which are available in the full report

Scope of the Clinical Research Organization Report

Key segments covered in clinical research organization industry research, by service:.

• Drug discovery Services
• Pre-clinical Services
• Clinical Services
• Post Approval Services

By Production:

By indication:.

• Cardiovascular Diseases
• Metabolic Disorders
• Respiratory
• Musculoskeletal Disorders
• Hematological Disorders

By End User:

• Pharmaceutical & Biotechnology Companies
• Medical Device Companies
• Governments & Private Firms
• Academic Institutions
• North America
• Latin America
• Middle East and Africa (MEA)

Frequently Asked Questions

How big is the clinical research organization market.

The clinical research organization market is slated to attain US$ 62.43 billion in 2023.

What Might be the Market’s Size by 2033?

The market is expected to attain a value of US$ 139.56 billion by 2033.

Which Opportunities are Emerging in the Market?

Increasing popularity of targeted medicines and personalized medicines are creating opportunities for key players.

Which Factors Pull Back the Market Growth?

Strict regulatory regulations and lack of funding for clinical trials are pulling back the market’s growth.

Who are the Key Players in the CRO Industry?

IQVIA Inc, Parexel International Corporation, and ICON plc. are the key players in the CRO industry.

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Clinical Research Trends & Insights for 2023

In our 2023 preview, 14 experts from WCG share the important shifts, trends, regulations, and priorities that will inform clinical trial development this year and beyond.

After the disruptions to the clinical research field in 2020 and 2021, many looked forward to 2022 as a year of “getting back to normal.” Instead, we found that many pandemic-associated changes have forced us to look at a lot of issues through a new lens.

Certainly, “decentralized trials” dominated our conversations, and considerations of the importance of proactive efforts to facilitate the inclusion of historically underrepresented populations in research is finally being recognized. Both biopharma sponsors and clinical sites are finding their footing again, allowing them to renegotiate some old practices from new perspectives (e.g., investigator oversight responsibilities in decentralized trials, how much of site monitoring really needs to be on-site).

Our clinical trials continued to evolve in response to new therapeutic advances, with more protocols incorporating complex design elements, earlier evaluations of efficacy, and an increasing number of platform studies to move potential drug candidates to decisions more quickly.

2023 looks like it will be just as exciting. In this report, WCG experts from a variety of areas talk about what they’re watching, expecting, and looking forward to in 2023. We’re exploring study design, study conduct, new proposed regulations and guidance, and even at the types of therapeutic agents moving into clinical investigation. 

Thank you for joining us as we look ahead to the next exciting year!

Explore Insights:

Perspectives on clinical research sites in 2023, redesigning the clinical research landscape, diversity strategies and empowering sites to support them, the fda’s recent notice of proposed rulemaking (nprm) and guidance, diversifying clinical research by providing research participants payments, clinical trial technology integration now and into the future, interoperability required for the future of clinical trials, quality by design and slowing down to speed up, the emerging use of adjudication in oncology for determining patient eligibility, mrna: not just for vaccines.

Current Trends in Neurodevelopmental and Rare Pediatric Disease

Neuroscience Research Trends to Pay Attention to in 2023

Epilepsy treatments and research: where we started and where we are heading, watch our 2023 trends & insights webinar.

Hear our online panel of clinical trial experts discuss the future of clinical trials, and answer questions from your peers.

This engaging discussion is facilitated by Jill Johnston, Chief Innovation Officer of WCG.

Sandra Smith, RN, MSN, AOCN

Senior Vice President, Clinical Solutions & Strategic Partnerships, WCG

To combat the tumultuous conditions of the industry, research organizations have been forced to look internally to identify operational efficiencies over the last two years, and institutional reconfiguration will continue to evolve in 2023. Centralization of research services, embedding enabling technologies, and establishing research partnerships – both with service providers and with sponsors – will remain key themes in addressing site capacity challenges. Many non-institutional research sites will aggregate into networks to achieve higher operational performance.

Human capital remains critical, and the skillset for research expertise will continue to be in high demand in 2023. Sites are reporting fewer vacant positions, but turnover will persist, and training the newly hired, less experienced research personnel will remain critical. Sponsor-supported staffing augmentation solutions will be key to trial conduct for many organizations.

Oncology will endure as a dominant therapeutic area in clinical research in 2023. Approximately 50 percent of all clinical trials started in 2022 1 were in oncology, with more than 1M patients (about the population of Delaware) needed to complete those open trials 2 . Increasing trial complexity will challenge sites with narrow inclusion/exclusion criteria, multiple study arms (i.e., 19-20 percent increase in four to five arm trials in oncology) 3 , and an increasing number of amendments per clinical trial (i.e., 57 percent increase since 2017) 4 .

Declining average rates of enrollment per site 5 and the need for increased enrollment diversity will accelerate sponsor interest in opening trials at community-based sites and in supporting new investigators/sites. Rapid trial activation, bringing trial access to new participant populations, and utilization of decentralized trial components, will be critical components for trial success.

References:

1, 2, 3, 4, 5 WCG Knowledge Base TM , 2022

Jamie Harper, MHA

Director of Site Engagement and Relations, WCG

In 2023, clinical trial access and improving participant diversity will remain key concerns within the clinical research and healthcare community. Compounded by the number of physician investigators continuing to decrease, the industry will be tasked with developing solutions to ensure scientific medical advancements continue while supporting these diverse populations. Identifying and supporting new physician investigators at research sites, especially those ingrained into the community setting, is critical to offsetting these concerns and accelerating advancements.

Redesigning the clinical trial landscape to mitigate these challenges and create an environment that allows engaged community physicians to provide clinical trial access to the communities they serve is a must. By engaging community sites and physicians who may not have previously considered clinical research as an option, it presents a path toward addressing the concerns of clinical trial access and participant diversity. However, this pathway will require the clinical research industry to provide support for the tools and mentorship needed to successfully conduct compliant clinical trials.

The new environment will require evolution of the current collaborations between sponsors, clinical research organizations (CROs), third-party clinical research vendors, and experienced physician investigators. This collaboration’s success will depend on a shared focus to cultivating a redesigned clinical research landscape through inclusion.

Katherine Cornish, PhD, PMP

Former Associate Director, Patient Advocacy & Clinical Trial Diversity, WCG

As the FDA (U.S. Food and Drug Administration) moves closer to finalizing the current draft guidance on establishing diversity plans 1 to improve clinical trial participation of underrepresented racial and ethnic populations, it becomes imperative to ensure that the strategies outlined in these plans are translated to the site level in intentional and actionable ways.

Sponsors must empower their sites by providing pragmatic strategies that site staff can use to effectively identify, engage, enroll, and retain underrepresented populations. This should be done through the creation of site-focused diversity plans that tie into the overarching diversity plan. Key partnerships with advocacy groups, community-based organizations, and other similar entities outlined in diversity plans at a national level should be translated to individual sites locally. Sponsors must also provide the necessary support to ensure these strategies can be enacted by their sites.

Additionally, these strategies must be identified, documented, and mobilized early in the trial lifecycle; they must be thought about proactively rather than as rescue methods. Sponsors should reach out to the FDA to discuss their diversity plans as early as possible – certainly prior to study start. Thinking about these approaches early on can also ensure that the necessary support is preemptively budgeted at the site level, allowing sites to initiate local advocacy and community engagement efforts from the start. This ensures that sites are prepared and ready when recruitment begins and can enact their action plans from first patient to last visit.

• https://www.fda.gov/media/157635/download

Dave Borasky, MPH, CIP

Vice President, IRB Compliance WCG IRB

The year 2022 ended with two interesting developments for Institutional Review Boards (IRBs) and industry on the FDA front. First, the FDA published two Notices of Proposed Rulemaking (NPRMs) 1,2 that  are intended to bring greater harmony between the FDA regulations for human subjects research, and the Common Rule regulations that apply to U.S. federally funded research that is not subject to FDA regulation. While this harmonization is expected – it was mandated by the 21st Century Cures Act – it was not clear when the NPRMs would be issued. Harmonization on issues of informed consent requirements and the use of a single IRB for multisite trials will improve the review and implementation of clinical research in 2023 and beyond.

The second late-year offering from the FDA was the draft guidance Ethical Considerations for Clinical Investigations of Medical Products Involving Children . Through this guidance, the FDA has finally provided clear direction on the expectation that IRBs use component analysis when reviewing research with children that includes multiple research-related interventions or procedures. Component analysis, which has the IRB assess each study procedure (and each study arm), considering the risks and benefits, is often confusing to sponsors. The guidance also provides direction on the FDA’s thinking on what constitutes a “minor increase over minimal risk” (21 CFR 56.102(i)), which is not defined in the regulation, but represents an important threshold for reviewing research involving children, particularly in the context of component analysis.

• https://www.federalregister.gov/documents/2022/09/28/2022-21088/protection-of-human-subjects-and-institutional-review-boards
• https://www.federalregister.gov/documents/2022/09/28/2022-21089/institutional-review-boards-cooperative-research

Kelly Fitzgerald, PhD

IRB Executive Chair and Vice President, IBC Affairs WCG IRB

Payment to research participants is a critical aspect of diversifying clinical research participation. There will be a continued increase in awareness of this issue in 2023. IRBs are often seen as a barrier to paying participants, and that may have been true in the past, but the thinking on this topic has evolved significantly in the last few years, informed in part by the recognition of the importance of research participants as partners rather than as research “subjects. ”1

IRBs are tasked with ensuring that research-recruiting and consenting processes do not exert undue influence on participants, and high payments may be seen by IRB members as unduly influential 2 . Some people believe that payments could incentivize someone to participate in activities they would otherwise choose not to do, particularly people with low incomes. However, when an IRB insists on lower payments, participants who have less free time, less available income, or more burdensome lives are less likely to participate, and the study ends up with a participant population that does not match society because those people who can bear the financial burdens of research participation will participate.

The clinical research world now recognizes that payments can incentivize without being unduly influential. While there is a perception that IRBs will not approve high payments for participants, this is changing. During the last 24 months, out of approximately 10,000 IRB reviews, only 13 reviews resulted in the IRB specifically requiring modifications to the payment plan (see table), and no records included a request to decrease the proposed payments to participants.

IRB members reflect the values and norms of their communities, and the events of the last few years have led to the awareness of the importance, both scientifically and ethically, of diverse representation in clinical trials. To improve in this area, there must be support for higher payments for research participation and a reliance on mechanisms other than limiting payment to ensure participants are recruited ethically. In 2023, there needs to be more discussions around accurately assessing participant costs for research participation and providing just compensation for their service 3 . 

• National Academies of Sciences, Engineering, and Medicine 2022. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. Washington, DC: The National Academies Press. https://doi.org/10.17226/26479.
• Payment and Reimbursement to Research Subjects, FDA, Jan 2018.
• Largent EA, Lynch HF. Paying Research Participants: The Outsized Influence of “Undue Influence”. IRB. 2017 Jul-Aug;39(4):1-9. PMID: 29038611; PMCID: PMC5640154.

Sonia Abrol

Senior Vice President, Product and Strategy, WCG Velos

The COVID-19 pandemic made many stakeholders in clinical research reassess their technology infrastructure. To sustain and accelerate research, they prioritized taking various research management workflows online to vendor managed systems, ensuring centralized, easy, and secure access to data. As sites and sponsors expanded their technology portfolio, sites are now carrying a bigger technology burden. They are supporting the costs of multiple site technologies and then putting additional time and effort into entering data in both site and sponsor systems. Approximately 90 percent of data needed by sponsors now lives in one or more site systems 1 . 

Additionally, the uptick in adoption of innovative technologies for helping with decentralized trials, patient recruitment, patient retention, and engagement has produced new data silos for sites and sponsors. As a result, clinical research stakeholders are recognizing the need for more interoperability and workflow-driven integrations.

In 2023, sites and sponsors will continue to make technology integration one of their top priorities as they select the right solutions, enhance their technology infrastructure, and budget for such investments. Sites starting their journeys toward integrated ecosystems may begin with key multi-level integrations between their e-regulatory/e-Binder, EHR/EMR, CTMS, IRB and Financial systems. Those that are already ahead of the curve will continue to expand and develop new integration workflows by connecting one silo at a time.

In parallel, technology vendors will continue to work toward offering more open systems and actively defining their own integration roadmaps to help sites and sponsors gain operational efficiencies and reduce the technology burden on users.

Also, it will be interesting to see what the gained momentum in collaboration among sites, sponsors, and vendors will bring in 2023. As these consortia and partnerships come together to help define data exchange standards, map best workflows among site systems and site-sponsor systems and prioritize implementation of cost-effective and standard technology integrations, we will see remarkable growth and acceleration in conducting clinical research and drug development.

• WCG Knowledge Base TM , 2022

Rahul Bafna

Former Chief Product Officer, WCG

The use of healthcare technology at the consumer level has exploded over the past decade. This started with the broad availability and adoption of wearable devices, taking advantage of smaller sensors, better batteries, and always-on connectivity. Over this same time period, there has been a ton of investment in healthcare technology for clinicians – the HITECH Act of 2009 was designed to accelerate medical product development. Many of these advancements in technology have the potential to be transformative in the realm of clinical trials, which for decades have suffered from low patient participation, unrepresentative study populations, heavy operational burden, and long timelines. The key to making these advancements work in real-world settings is the seamless interoperability of patient data. 

As an example, patient-trial matching is one of the most time-consuming operations of running a trial. Multiple software platforms exist that can match eligible patients – based on the clinical record stored in one or more EHRs and lab systems – to the various inclusion and exclusion criteria of trials. But for this matching to happen, these solutions need access to those clinical records in a standardized format. Once found, matches need to be pushed back into the physician’s daily workflow – often the EHR – to drive patient conversations, consent and enrollment. Once enrolled, technology can simplify or even automate the data collection necessary for some types of studies. This will be critical for enabling decentralized trials (DCT).

DCTs will allow more patients to participate, potentially from underserved communities who would benefit from trial designs that require fewer or no site visits. The use of technology can also enable more frequent collection of study data, and any data collected in novel systems will need to be pushed back to a unified source, such as an EHR or EDC. 

Making sense of clinical data from multiple sources – whether for clinical trials or routine care – requires that data to be collected, retained, transformed, transmitted, standardized, and made available to researchers and clinicians at the right time and in the correct format. Interoperability between all these systems is critical to driving innovation and bringing new treatments to patients. For several years now, the Office of the National Coordinator for Health Information Technology (ONC) has been leading the charge to improve the interoperability of patient clinical data through regulation – mandating specific data standards that enable data to be exported in standardized formats. The 21st Century Cures Act, which includes interoperability standards not only for accessing clinical data but also for enabling new workflows and within platforms like EHRs, will continue to drive advancement in 2023. 

Cristin MacDonald, PhD

VP Client Delivery, WCG Avoca

The year 2023 should be seen as an opportunity for everyone in the clinical research industry to embrace the concept of “slowing down to speed up.” While the concept of Quality by Design is not new, the newly finalized ICH E8 guidance, EU CTR, along with the upcoming ICH E6 R3 and FDA’s Diversity guidance are all examples of the regulators prioritizing efficiency in clinical trial execution by forcing quality into the forefront of study design.

Whether it is by requiring that sponsors show their diversity strategies in advance of launching a pivotal trial, or by subjecting sponsors to regulatory holds for failed submissions, it is time to spend more resources early in study planning. It is time to slow down, think ahead, and ensure quality is built in study design.

Gone are the days of rushing to a first subject in timeframe and reactive protocol amendments that have negative time and budget impacts. Entirely new benchmarks need to be established that encourage study teams to invest the appropriate time and effort in study planning and reward those who demonstrate rapid study completion with minimal amendments by leveraging the proper resourcing up front.

Shaena Kauffman

Executive Director, Operations EAC, WCG

One of the most interesting trends over the past year has been the increased use of Endpoint Adjudication Committees (EACs) to determine patient eligibility, especially in oncology clinical trials. This trend will likely continue in 2023. Adjudication of inclusion criteria, or eligibility adjudication, has been used in clinical trials where inclusion criteria are subjective. The independent assessment by an EAC gives regulators and scientists confidence in the comparability of clinical trial subjects. Previously, this type of adjudication has been applied to areas such as progressive neurological disease or heart failure, where medical expertise is required, or eligibility is subjective. However, there is a rising trend in using EACs to confirm oncology disease progression to demonstrate a consistent evaluation for patient eligibility and provide real-time feedback to the Investigator study sites.

In the area of disease progression, adjudication has the potential to mitigate variability and increase the strength of the clinical trial results.  In addition to bolstering the clinical trial data against the regulatory and scientific rigors, EAC members can serve as a resource to investigator study sites that may need access to experts to assess some of the more complex patient eligibility criteria. Of course, the most significant benefits are that adjudication of inclusion criteria reduces protocol deviations and enforces scientific rigor through a pre-randomization, standardized, objective assessment. The use of eligibility EACs will continue to expand in 2023 as sponsors and sites report the benefits.

Daniel Kavanagh , PhD

Senior Scientific Advisor, Gene Therapy, WCG

Reflecting a new emphasis on cell and gene therapy (CGT) for 2023, the FDA recently announced a new “Super Office,” the Office of Therapeutic Products (OTP), to replace the former Office of Tissues and Advanced Therapies. Included in the announcement are plans to increase hiring and issue more CGT guidance documents in the coming year.

The year 2022 saw many new advances in cell and gene therapy, including FDA approvals for new products and supplemental indications for genetically modified cellular therapies and vectored gene therapies. In 2023, one area to watch closely is that of “vectorless” mRNA therapeutics. Synthetic mRNA is a powerful tool that can program cells for new therapeutic functions. When combined with rapidly developing nanoparticle technologies, mRNA therapeutics may be targeted to a wide array of cell types and tissues. One potential application of gene transfer technology is to bypass the complex in-vitro manufacturing process currently required for biologics and turn the body’s own cells into temporary factories to produce antibodies, enzymes, or vaccine antigens. Many such approaches in development rely on mRNA.

Currently approved gene therapies tend to produce long-lasting or permanent changes in cellular programming and may induce immune responses that prevent re-dosing. For these reasons, many gene therapies are designed for “one-and-done” curative administration. This offers new hope to patients and their families, but also presents challenges for safety, commercialization, and reimbursement. In contrast, mRNA molecules are normally short-lived and exert transient effects on cell biology. Thus, for some applications, mRNA is an important alternative to DNA-based therapies, with potential advantages for safety, re-dosing, and commercialization.

Current Trends in Neuro-developmental and Rare Pediatric Disease

Scott Hunter, PhD

Senior Scientific Expert, Neurodevelopment Disorders, WCG

In 2023, there will continue to be an emphasis on developing new outcome measures that can be used across rare pediatric and Central Nervous System (CNS) diseases. This has been an area of shared concern among caregivers regarding challenges observed with their impacted children that affect both individual and family engagement and quality of life. Moving from broader cognitive measures that are often experienced as less sensitive, focus has moved more to communication (specifically receptive and expressive language skills in areas including Fragile-X, Angelman, Rett, Autism Spectrum Disorders) and motor control (e.g., Rett, Angelman, Fragile-X).

Seeking greater sensitivity with scales developed, foundation and patient advocacy partners are developing mechanisms to build disorder-specific scales to address key areas of caregiver and patient concern, while also collaborating across indications to support better measurement design. The goal of this is to amplify acceptance by the FDA of caregiver and clinician report measures (ClinROs and patient reported outcomes, or PROs) in the rare disease space.

We will move toward using wearables and engaging more directly with samples collected from these technologies that can be expert reviewed and rated. Collecting simultaneous biological and behavioral outcomes through direct movement assessment, recording of communication efforts, and video monitoring of responses, provides significant multipoint data that can be aggregated in tandem with use of performance measurements in rare and neurodevelopmental disease.

Mark G. A. Opler, PhD, MPH

Chief Research Officer, WCG Endpoint Solutions

The last five years have brought a remarkable burst of innovation in neuroscience drug development. From the approval of the first, rapid-acting agent to treat depression, to the past year’s massive surge of activity in the study of psychedelic compounds, to the ongoing, exploratory use of wearables and other technology-oriented methods for data collection, there has been a tremendous degree of change. In the coming year, we’ll see some of these exciting yet unproven innovations begin to demonstrate their promise in a more substantive way with enduring, real-world impacts. 

A few of the most important trends to watch include: 

• Late-Stage Studies of Psychedelics and Cannabinoids:  The first large-scale, Phase III industry-sponsored studies of psilocybin by Compass Pathways should help prove the viability of the psychedelics movement in neuroscience. The published results of the Compass Phase II program, if confirmed in Phase III, would solidify this while also clarifying the direction that this exciting new class of treatments is likely to take in years to come. 
• Development of Wearables and “Digital Biomarkers ”: Although regulatory agencies have held off on explicitly approving the use of novel endpoints related to wearable devices or similar device-rated digital biomarkers, the proliferation of these tools as exploratory endpoints is creating a growing wealth of data. As the evidence base for them continues to grow, standardization and adoption will almost certainly follow.

Mike Cioffi

Senior Vice President, Clinical Solutions and Strategic Partnerships, WCG

Currently, there are more than 30 antiseizure medications (ASMs) available to clinicians to treat patients. But even with such a significant amount of treatment options, there are still over 30 percent of individuals who do not respond to common ASMs and are addressed as “drug-resistant.” 1 This will drive innovation in both pharmacological and non-pharmacological interventions aimed at improving symptoms and quality of life for patients along with their caregivers.

Research is ongoing in many areas, and we will see important advances in the field in the coming years. An increased application of technologies to aid in epilepsy management is likely. Smartwatches that can detect imminent seizures and alert caregivers to the location of the patient, and apps that can inform clinicians with real-time information on their patients’ status and seizure counts are all on the horizon.

Precision medicine has begun to take a more prominent role as we understand more about the pathogenesis of epilepsies. Significant advancement has been made in identifying the genetics of epilepsies, and the discovery of gene mutations responsible for a large portion of patients with developmental and epileptic encephalopathies (DEEs) 2 . 

Additionally, the search for biomarkers to guide drug development is moving at a fast pace and will potentially allow clinicians to improve diagnostic accuracy, predict response to ASMs, and improve outcomes for patients.

While there are certainly limitations to current technologies and biomarker identification, and despite precision medicine being further researched, this multidisciplinary approach will redefine our ability to improve the treatment and management of epilepsy in the future.

• Kalilani L, Sun X, Pelgrims B, Noack-Rink M, Villanueva V. The epidemiology of drug-resistant epilepsy: a systematic review and meta-analysis.  Epilepsia.  (2018) 59:2179–93. doi: 10.1111/epi.14596
• Perucca P, Bahlo M, Berkovic SF. The genetics of epilepsy. Annu Rev Genomics Hum Genet. 2020;21(1):205–30

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2024 Avoca Quality Consortium Summit

Event Details

• Arcus Biosciences-stock
• News for Arcus Biosciences

Promising Outlook for Arcus Biosciences Anchored by Strong Clinical Trials and Strategic Market Positioning

Analyst Kaveri Pohlman of BTIG maintained a Buy rating on Arcus Biosciences ( RCUS – Research Report ), retaining the price target of $70.00.

Kaveri Pohlman’s rating is based on the promising clinical trial data and strategic positioning of Arcus Biosciences in the competitive landscape of cancer treatments. The upcoming presentations at ASCO 2024 for both the Edge-Gastric and ARC-9 studies are pivotal, with the Edge-Gastric study showing encouraging six-month progression-free survival (PFS) rates that align with historical benchmarks. Additionally, Arcus’ TIGIT program, despite expected efficacy similar to competitors, stands out with a cleaner safety profile, which may offer a competitive advantage over treatments associated with gastrointestinal toxicities.

Furthermore, the ARC-9 study targets a market with limited competition for the third-line treatment of metastatic colorectal cancer (mCRC), and Arcus’s inclusive approach to patients with liver metastases, who represent a substantial portion of the mCRC patient population, presents a significant opportunity. The breadth of the TIGIT franchise, with multiple ongoing Phase 3 trials and expected data readouts, including from partner Roche’s Skyscraper-01 study, underscores the potential for Arcus’s therapies in areas of high unmet need. Pohlman’s Buy rating reflects confidence in Arcus’s ability to deliver value through its robust pipeline and strategic clinical development.

According to TipRanks , Pohlman is a 4-star analyst with an average return of 5.9% and a 31.54% success rate. Pohlman covers the Healthcare sector, focusing on stocks such as Gritstone Oncology, Arcus Biosciences, and Nuvation Bio.

In another report released on April 28, Citi also maintained a Buy rating on the stock with a $37.00 price target.

TipRanks tracks over 100,000 company insiders, identifying the select few who excel in timing their transactions. By upgrading to TipRanks Premium, you will gain access to this exclusive data and discover crucial insights to guide your investment decisions. Begin your TipRanks Premium journey today.

Arcus Biosciences (RCUS) Company Description:

Arcus Biosciences, Inc. engages in the development and commercialization of immunotherapies. The firm compete in the segments of the pharmaceutical, biotechnology and other related markets that develop immunotherapies for the treatment of cancer. The company was founded by Terry J. Rosen and Juan Carlos Jaen in 2015 and is headquartered in Hayward, CA.

Read More on RCUS:

• Arcus Biosciences price target lowered to $37 from $44 at Citi

Arcus Biosciences News MORE

Related stocks.

Stop COVID Cohort: An Observational Study of 3480 Patients Admitted to the Sechenov University Hospital Network in Moscow City for Suspected Coronavirus Disease 2019 (COVID-19) Infection

Collaborators.

• Sechenov StopCOVID Research Team : Anna Berbenyuk ,  Polina Bobkova ,  Semyon Bordyugov ,  Aleksandra Borisenko ,  Ekaterina Bugaiskaya ,  Olesya Druzhkova ,  Dmitry Eliseev ,  Yasmin El-Taravi ,  Natalia Gorbova ,  Elizaveta Gribaleva ,  Rina Grigoryan ,  Shabnam Ibragimova ,  Khadizhat Kabieva ,  Alena Khrapkova ,  Natalia Kogut ,  Karina Kovygina ,  Margaret Kvaratskheliya ,  Maria Lobova ,  Anna Lunicheva ,  Anastasia Maystrenko ,  Daria Nikolaeva ,  Anna Pavlenko ,  Olga Perekosova ,  Olga Romanova ,  Olga Sokova ,  Veronika Solovieva ,  Olga Spasskaya ,  Ekaterina Spiridonova ,  Olga Sukhodolskaya ,  Shakir Suleimanov ,  Nailya Urmantaeva ,  Olga Usalka ,  Margarita Zaikina ,  Anastasia Zorina ,  Nadezhda Khitrina

Affiliations

• 1 Department of Pediatrics and Pediatric Infectious Diseases, Institute of Child's Health, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• 2 Inflammation, Repair, and Development Section, National Heart and Lung Institute, Faculty of Medicine, Imperial College London, London, United Kingdom.
• 3 Soloviev Research and Clinical Center for Neuropsychiatry, Moscow, Russia.
• 4 School of Physics, Astronomy, and Mathematics, University of Hertfordshire, Hatfield, United Kingdom.
• 5 Biobank, Institute for Regenerative Medicine, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• 6 Institute for Regenerative Medicine, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• 7 Chemistry Department, Lomonosov Moscow State University, Moscow, Russia.
• 8 Department of Polymers and Composites, N. N. Semenov Institute of Chemical Physics, Moscow, Russia.
• 9 Department of Clinical and Experimental Medicine, Section of Pediatrics, University of Pisa, Pisa, Italy.
• 10 Institute of Social Medicine and Health Systems Research, Faculty of Medicine, Otto von Guericke University Magdeburg, Magdeburg, Germany.
• 11 Institute for Urology and Reproductive Health, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• 12 Department of Intensive Care, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• 13 Clinic of Pulmonology, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• 14 Department of Internal Medicine No. 1, Institute of Clinical Medicine, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• 15 Department of Forensic Medicine, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• 16 Department of Statistics, University of Oxford, Oxford, United Kingdom.
• 17 Medical Research Council Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.
• 18 Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom.
• 19 Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, United Kingdom.
• 20 Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
• PMID: 33035307
• PMCID: PMC7665333
• DOI: 10.1093/cid/ciaa1535

Background: The epidemiology, clinical course, and outcomes of patients with coronavirus disease 2019 (COVID-19) in the Russian population are unknown. Information on the differences between laboratory-confirmed and clinically diagnosed COVID-19 in real-life settings is lacking.

Methods: We extracted data from the medical records of adult patients who were consecutively admitted for suspected COVID-19 infection in Moscow between 8 April and 28 May 2020.

Results: Of the 4261 patients hospitalized for suspected COVID-19, outcomes were available for 3480 patients (median age, 56 years; interquartile range, 45-66). The most common comorbidities were hypertension, obesity, chronic cardiovascular disease, and diabetes. Half of the patients (n = 1728) had a positive reverse transcriptase-polymerase chain reaction (RT-PCR), while 1748 had a negative RT-PCR but had clinical symptoms and characteristic computed tomography signs suggestive of COVID-19. No significant differences in frequency of symptoms, laboratory test results, and risk factors for in-hospital mortality were found between those exclusively clinically diagnosed or with positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RT-PCR. In a multivariable logistic regression model the following were associated with in-hospital mortality: older age (per 1-year increase; odds ratio, 1.05; 95% confidence interval, 1.03-1.06), male sex (1.71; 1.24-2.37), chronic kidney disease (2.99; 1.89-4.64), diabetes (2.1; 1.46-2.99), chronic cardiovascular disease (1.78; 1.24-2.57), and dementia (2.73; 1.34-5.47).

Conclusions: Age, male sex, and chronic comorbidities were risk factors for in-hospital mortality. The combination of clinical features was sufficient to diagnose COVID-19 infection, indicating that laboratory testing is not critical in real-life clinical practice.

Keywords: COVID-19; Russia; SARS-CoV-2; cohort; mortality risk factors.

© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: [email protected].

Publication types

• Observational Study
• Research Support, Non-U.S. Gov't
• Hospitalization
• Middle Aged

Grants and funding

• 20-04-60063/Russian Foundation for Basic Research