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Clinical Trials Market - Growth, Trends, COVID-19 Impact, and Forecasts (2021-2026)

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 report offers values (in USD million) for the above segments.

Market Snapshot

 Clinical Trials Market Overview
Study Period: 2018-2026
Base Year: 2020
Fastest Growing Market: North America
Largest Market: Asia Pacific
CAGR: 5.05 %

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Market Overview

The clinical trials market was valued at approximately USD 38,213.3 million in 2020, and it is expected to reach USD 51,356.0 million by 2026, registering a CAGR of 5.05% during the forecast period, 2021-2026.

The major factors propelling the growth of the market include the high demand for clinical trials in emerging markets, high R&D spending of the pharmaceutical industry, an increasing prevalence of diseases, and the focus on rare diseases and multiple orphan drugs in the pipeline.

The COVID-19 pandemic has tremendously impacted the market for clinical trials, as there has been a rising focus on the development of new therapeutics or vaccines to curb or treat the disease. Also, COVID-19 has brought a slight shift in terms of the way clinical trials were performed. In the clinical trial space, usually, there has been an increased interest in virtual/decentralized trials and those have been featured on conference agendas and in magazine articles for a long time. Despite that, most companies are still opting for the same processes. However, COVID-19 has essentially forced some of the trials to move to a virtual model to keep the trials on track during this pandemic situation.

Aging is also found to be the major factor driving the burden of diseases and demand in the market studied. With the increasing burden of diseases, there has been a rising focus of the market players on developing new therapeutics for rare or genetic disorders that need specialization and focused clinical trials, which is expected to boost the market growth.

As per the World Health Organization (WHO), the burden of chronic diseases is increasing. This is expected to increase the demand for the development of new drugs and further raise the demand for clinical trials. It has been observed that almost half of the total chronic disease deaths are attributable to cardiovascular diseases, obesity, and diabetes, which are showing increasing trends. The WHO 2018 Report has also stated that chronic diseases kill 41 million people every year, which is equivalent to 71% of all deaths globally.​

The market is growing at a robust pace, owing to the advancements in healthcare and growing patented new chemical entities (NCE) indicated for various health conditions. There are also government initiatives that have motivated the small, medium, and large players to enter into drug development. Thus, there are multiple drugs in the pipeline. As a result, Novartis, GlaxoSmithKline, and Pfizer (among others) have entered this field. It has been found that the clinical trials market has taken bigger strides in the developing countries of Asia-Pacific and the Middle East, and there is still very less development in the market.

There are also stringent regulations for countries like China and India that are currently working on overcoming this issue and are successful to a considerable extent. Most emerging countries still suffer from poor regulatory infrastructure. Hence, these stringent regulations in the emerging markets are hindering the growth of the market studied.

Scope of the Report

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, as well as for it to be introduced in the market. These trials are performed under three phases (I, II, and III), which depend upon various factors. This process is not only expensive but also 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 report offers values (in USD million) for the above segments.

By Phase
Phase I
Phase II
Phase III
Phase IV
By Design
Treatment Studies
Randomized Control Trial
Adaptive Clinical Trial
Non-randomized Control Trial
Observational Studies
Cohort Study
Case Control Study
Cross Sectional Study
Ecological Study
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle-East and Africa
GCC
South Africa
Rest of Middle-East and Africa
South America
Brazil
Argentina
Rest of South America

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Key Market Trends

Phase III is the Largest Segment Under Phases that is Expected to Grow During the Forecast Period

The market is expected to be dominated by Phase III, with Phase I expected to witness the fastest growth. Phase III is one of the most critical phases assessing the effectiveness of the new intervention, as well as its value in clinical practice.

Moreover, the COVID-19 pandemic has brought significant changes in the clinical trials industry and shifted the focus of many research and commercial organizations to focus on the development of new therapies and vaccines for COVID-19. For instance, in August 2020, China-based Sinopharm commenced a Phase III clinical trial of its COVID-19 vaccine candidate at the Bahrain International Exhibition and Convention Centre (BIECC).

These Phase III clinical trials are done to 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 I and II trials. These clinical trials remain a comparatively higher need for outsourcing services than Phase II and Phase I trials, owing to their greater complexity and need for a larger patient pool.

The government initiatives in emerging economies for the promotion of drug discovery and continuous technological innovations are also expected to propel the market growth.

 Clinical Trials Market Key Trends

North America Reported the Largest Growth and is Expected to Follow the Same Trend over the Forecast Period

North America has been dominating the overall market, owing to the presence of big outsourcing firms and increasing R&D in the region. This is mainly due to factors such as the increasing R&D investments and increasing demand for drug development, which are the major factors responsible for the market emergence in the United States.

With the rising COVID-19 pandemic, there is an increased burden that has shifted the focus of many organizations to the development of new therapeutics for COVID-19 with the support of the government and non-government organizations. Hence, with the rising number of COVID-19 infections, there are increasing investments in R&D activities that have led to a growing market for clinical trials.

There are also favorable government initiatives regarding clinical trials in the United States that are anticipated to boost the market growth. For instance, in March 2020, the FDA launched a Coronavirus Treatment Acceleration Program (CTAP) for possible therapies to speed up the development of treatment for the global disease caused by the coronavirus.

In the United States, pharmaceutical companies are found spending more money, time, and energy on R&D than most organizations. According to the National Institute of Health data, in the fiscal year 2017, clinical research funding by the NIH was around USD 12.7 billion, and it increased to USD 15 billion in 2019. Also, the R&D budgets of the pharmaceutical companies have increased in the past few years, owing to the rising burden of diseases, complex molecules, and therapy segments. Moreover, with the increasing of diseases, the number of clinical trials is expected to rise in the coming few years.

 Clinical Trials Market Growth by Region

Competitive Landscape

The market is highly competitive in nature, and therefore, the major pharmaceutical companies are found making enormous investments in R&D, especially in the emerging nations, to gain opportunities for market growth in the major regions. The strategic partnerships among pharmaceutical companies and the CROs are expected to have a significant impact on the market's growth. In the coming years, few other players are expected to enter the market.

Also, a significant factor affecting the competitive nature is the quick adoption of advanced technology for improved healthcare. Also, to retain share and expand the product portfolio, major players are often involved in mergers and acquisitions along with new product launches.

Recent Developments

In September 2021, Pfizer and Biontech had announced the positive topline result of COVID-19 vaccine in children age 5-11 years of age.


In October 2020, the COVID-19 vaccine AZD1222 clinical trial resumed in Japan, followed by the restart of trials in the United Kingdom, Brazil, South Africa, and India.

Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Demand for Clinical Trials in the Emerging Markets

      2. 4.2.2 High R&D Expenditure of the Pharmaceutical Industry

      3. 4.2.3 Rising Prevalence of Diseases

    3. 4.3 Market Restraints

      1. 4.3.1 Lack of Skilled Workforce in Clinical Research

      2. 4.3.2 Stringent Regulations for Patient Enrollment

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION

    1. 5.1 By Phase

      1. 5.1.1 Phase I

      2. 5.1.2 Phase II

      3. 5.1.3 Phase III

      4. 5.1.4 Phase IV

    2. 5.2 By Design

      1. 5.2.1 Treatment Studies

        1. 5.2.1.1 Randomized Control Trial

        2. 5.2.1.2 Adaptive Clinical Trial

        3. 5.2.1.3 Non-randomized Control Trial

      2. 5.2.2 Observational Studies

        1. 5.2.2.1 Cohort Study

        2. 5.2.2.2 Case Control Study

        3. 5.2.2.3 Cross Sectional Study

        4. 5.2.2.4 Ecological Study

    3. 5.3 Geography

      1. 5.3.1 North America

        1. 5.3.1.1 United States

        2. 5.3.1.2 Canada

        3. 5.3.1.3 Mexico

      2. 5.3.2 Europe

        1. 5.3.2.1 Germany

        2. 5.3.2.2 United Kingdom

        3. 5.3.2.3 France

        4. 5.3.2.4 Italy

        5. 5.3.2.5 Spain

        6. 5.3.2.6 Rest of Europe

      3. 5.3.3 Asia-Pacific

        1. 5.3.3.1 China

        2. 5.3.3.2 Japan

        3. 5.3.3.3 India

        4. 5.3.3.4 Australia

        5. 5.3.3.5 South Korea

        6. 5.3.3.6 Rest of Asia-Pacific

      4. 5.3.4 Middle-East and Africa

        1. 5.3.4.1 GCC

        2. 5.3.4.2 South Africa

        3. 5.3.4.3 Rest of Middle-East and Africa

      5. 5.3.5 South America

        1. 5.3.5.1 Brazil

        2. 5.3.5.2 Argentina

        3. 5.3.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Clinipace

      2. 6.1.2 Laboratory Corporation of America

      3. 6.1.3 Eli Lilly and Company

      4. 6.1.4 ICON PLC

      5. 6.1.5 Novo Nordisk AS

      6. 6.1.6 PAREXEL International Corporation

      7. 6.1.7 Pfizer Inc.

      8. 6.1.8 Pharmaceutical Product Development LLC

      9. 6.1.9 IQVIA

      10. 6.1.10 F. Hoffmann-La Roche Ltd

      11. 6.1.11 Sanofi SA

      12. 6.1.12 Syneos Health

      13. 6.1.13 ClinDatrix Inc

      14. 6.1.14 Charles River Laboratory

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments

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Frequently Asked Questions

The Global Clinical Trials Market market is studied from 2018 - 2026.

The Global Clinical Trials Market is growing at a CAGR of 5.05% over the next 5 years.

North America is growing at the highest CAGR over 2021- 2026.

Asia Pacific holds highest share in 2020.

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

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