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

Report Overview

The global clinical trials market size was valued at USD 47.0 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 5.8% from 2022 to 2030. However, the market growth was hindered in 2020 due to the COVID-19 pandemic. In 2020, Parexel and Synairgen plc formed a strategic collaboration for conducting a Phase III study of an Interferon-beta (IFN-beta) treatment for COVID-19 patients. Such strategic initiatives by CROs are expected to minimize the hindrance and boost the market growth. Hence, the market is expected to grow owing to factors such as globalization of clinical trials, rapid technological evolution, and a rise in demand for CROs for conducting research activities.

The current pandemic has led to changing the ways of conducting ongoing or upcoming clinical trials. Regulatory agencies, such as the U.S. FDA, the European Medicines Agency (EMA), the National Institutes of Health (NIH), and China’s National Medical Products Administration, have issued various guidelines for conducting trials during the pandemic, which completely supports the implementation of virtual services. The current scenario across the globe and the need for several new treatment options have also led to the conducting of fast-track clinical trials.

Favorable government support is boosting the market growth, for instance, the WHO launched “Solidarity”, an international clinical trial launched to determine effective treatment against COVID-19. It includes comparing four treatment options against the standard of care to evaluate their effectiveness against the coronavirus. The WHO also announced an international alliance in May, for simultaneously developing multiple candidate vaccines to prevent the spread of the coronavirus disease, calling this effort the Solidarity trial for vaccines.

Phase Insights

The Phase III segment accounted for the largest revenue share in 2021, contributing to 53.4% of the global market. This is because Phase III trials are the most expensive and involve huge subjects. The median cost for a single Phase III trial is around USD 19.0 million with 59 new therapeutic agents approved by the FDA from 2015 to 2016. Also, Phase III requires a higher number of patients and often a longer treatment period. The Phase II segment followed in terms of market share accounting for 19.4% in 2021. It is also the second most expensive stage after Phase III. This study is performed in two parts; the first part includes exploring a range of doses along with efficacy studies and the second part includes finalizing the dose.

Phase II plays a crucial role, especially in oncology-related studies. The FDA estimates that about 33.0% of the medications are usually under Phase II trial. Moreover, there are various therapeutics and vaccines currently in Phase II that are indicated for the treatment of COVID-19, thereby boosting the market growth. For instance, currently, there are 43 therapeutics under Phase II for COVID-19. Companies engaged in the development of these vaccines are AstraZeneca plc; Arch Biopartners, Inc.; Applied Therapeutics, Inc.; Apeiron Biologics GmbH; 4D Pharma plc; AB Science SA; and others.

Companies are collaborating to accelerate the development of therapeutics and vaccines. For example, Eli Lilly partnered with AbCellera for the development of vaccines; GSK, Novartis, and MSD are working with the Bill & Melinda Gates Foundation; and GSK and Sanofi are working together to develop an adjuvanted COVID-19 vaccine.

Study Design Insights

The interventional design segment dominated the market and accounted for the largest revenue share with 45.7% in 2021. It is one of the most prominent methods used in clinical trials. Interventional studies comprised 79.0% of the total registered studies as of May 2020, out of which the majority of studies were for drug or biologics, followed by behavioral, clinical procedure, and device interventional studies. These studies contribute to 94.0% of the total studies that posted results, out of which drug or biologics contribute the most, followed by behavioral, devices, and clinical procedure intervention studies.

The expanded access trials segment also referred to as compassionate use trials, is anticipated to register a CAGR of 6.0% during the forecast period. It is a potential pathway for patients with serious disease conditions to carry out treatment outside the trial when no satisfactory therapies are available. Increasing innovation in clinical trial methods is projected to drive the expanded access trials segment. For example, numerous oncology drugs are regularly administered to patients before their approval by the U.S. FDA and are considered part of the expanded access trial. Currently, there are 20 COVID-19 drugs in expanded access trials/compassionate use in Phase II/III.

Some of the companies currently engaged in expanded access trials include Incyte Corp.; Novartis AG; Capricor Therapeutics, Inc.; Alexion Pharmaceuticals, Inc.; Bellerophon Therapeutics, Inc.; Algernon Pharmaceuticals Inc. and its subsidiary Nash Pharmaceuticals; and Ansun Biopharma, Inc.

Indication by Study Design Insights

The interventional trials market for autoimmune/inflammation accounted for the largest share with 82.0% in 2021. This can be attributed to a large number of interventional studies on autoimmune/inflammation worldwide. The growth can also be attributed to advantages of interventional studies, such as minimization of the effects of confounding, avoidance of bias in allocation to exposure groups, and efficient detection of small to moderate clinically important effects. There are over 7,000 interventional studies listed on clinicaltrails.gov related to autoimmune/inflammation.

The observational trials market for autoimmune/inflammation accounted for the second-largest share in 2021. Out of the total autoimmune/inflammation studies listed on clinicaltrials.gov, more than 2,000 are observational. The expanded access segment accounted for the lowest share for autoimmune/inflammation in 2021. There are fewer than 40 expanded access studies as of 2020 for autoimmune/inflammation. For instance, there is an ongoing expanded access study titled “Expanded Access Protocol Thymus Transplantation for Immunodeficiency, Hematologic Malignancies, and Autoimmune Disease Related to Poor Thymic Function” as of March 7, 2021.

Sponsor Insights

The report further provides a deep dive into the sponsors of the industry, wherein it was identified that pharmaceutical & biopharmaceutical companies accounted for the largest share with 70.0% in 2021. This can be attributed to the greater interest of the pharmaceutical industry in the research field. In addition, there has been an increase in the number of clinical trials funded by pharmaceutical & biopharmaceutical companies. The pharmaceutical industry plays a vital role in financing the research for the development of new drugs.

Although grants from the National Institutes of Health (NIH) fund most of the basic research in academic laboratories, it is largely the industry that bears the cost of identifying new molecular entities and testing them on animal models and human subjects. Clinical studies account for the major portion of the estimated cost, ranging from USD 266 million to USD 802 million for bringing each new drug to the market. Currently, in the U.S., around 75% of all funding for clinical studies is received from corporate sponsors.

Indication Insights

The oncology segment accounted for the largest revenue share with 23.5% in the global market in 2021. The segment is also anticipated to witness the fastest CAGR of 6.3% over the forecast period. As per U.S. FDA and various other sources, more than USD 38.0 billion is currently being spent by the pharmaceutical industry on the preclinical and clinical development of oncology therapy products. The cardiovascular condition segment is also anticipated to witness lucrative growth at a CAGR of 6.1% over the forecast period. The growing prevalence and increased demand for cost-effective medications worldwide have led to significant investment in R&D in this segment with more than 190 drugs in the pipeline.

The majority of the drugs in the pipeline are indicated for heart failure, lipid disorders, vascular diseases, and stroke. Growing demand for cost-effective medicines in low- and middle-income countries is expected to boost the R&D investment by the government, thereby strengthening the market growth. However, the current pandemic has hindered clinical trials in finding effective treatments and cures. At least 18 pharma or biotech companies have reported disruption in clinical trials due to the pandemic. In March 2020, there was around a 65.0% global average decline in the enrollment of new patients year-over-year. An 84.0% and 43.0% decrease was reported in India and Japan, respectively, whereas the U.S. exhibited a decline of 67.0%.

Regional Insights

North America accounted for 50.7% of the global market in 2021 and is expected to continue its dominance over the forecast period. This can be attributed to an increase in R&D investments and a rise in the adoption of new technologies in clinical trials in this region. For instance, the implementation of virtual services in various stages of clinical trials by market players, such as IQVIA and PRA Health Sciences, is anticipated to further fuel the North American market growth.

Moreover, favorable government support in the U.S. market for clinical trials is anticipated to boost the demand. For instance, in March 2020, the FDA launched a Coronavirus Treatment Acceleration Program (CTAP) for possible therapies to accelerate the development of treatment for global diseases caused by the coronavirus. The program employs every available way to provide novel treatment to patients as rapidly as possible, simultaneously finding out whether they are harmful or helpful.

Asia Pacific region is anticipated to grow at the fastest CAGR of 6.8% over the forecast period owing to the availability of a large patient pool allowing easy recruitment. The global pandemic is one of the major factors driving the market. The Asia Pacific’s largest, expertized biotech CRO “Novotech”, has reported an increase in demand from biotechnology sponsors for studies due to good quality and quick turnaround. An increasing number of biotechnology firms prefer the APAC region for conducting COVID-19 trials to leverage a large patient pool and fast-track procedures.

Key Companies and Market Share Insights

The global clinical trials market is highly competitive. Some of the players operating in the market include IQVIA, PAREXEL International Corporation, Pharmaceutical Product Development, LLC, and Charles River Laboratory. The major factor influencing the competitive nature is the quick adoption of advanced technology for improved healthcare. In addition, to retain their market share and expand their product portfolio, major players are often involved in mergers and acquisitions as well as initiating new product launches.

For instance, in January 2020, Wuxi AppTec announced offering a fully integrated adeno-associated virus vector suspension platform to accelerate the development, manufacture, and launch of cell & gene therapy, thus expanding its service capabilities. Another instance from June 2018 is of Acurian and Synexus, a part of PPD, wherein they launched SynexusPlus, a site solution for patient enrollment in clinical studies. This initiative is anticipated to improve clinical trial productivity. Moreover, it is also helpful in the current pandemic as it helps in the reduction of on-site footprints. Some prominent players in the global clinical trials market include:

• IQVIA

• PAREXEL International Corporation

• Pharmaceutical Product Development, LLC

• Charles River Laboratory

• ICON Plc

• PRA Health Sciences

• Syneos Health

• Eli Lilly and Company

• Novo Nordisk A/S

• Pfizer

• Clinipace

Clinical Trials Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For this study, Grand View Research has segmented the global clinical trials market report based on phase, study design, indication, indication by study design, sponsor, service type and region:

• Phase Outlook (Revenue, USD Million, 2017 - 2030)

  • Phase I

  • Phase II

  • Phase III

  • Phase IV

• Study Design Outlook (Revenue, USD Million, 2017 - 2030)

  • Interventional

  • Observational

  • Expanded Access

• Indication Outlook (Revenue, USD Million, 2017 - 2030)

  • Autoimmune/Inflammation

    • Rheumatoid arthritis

    • Multiple Sclerosis

    • Osteoarthritis

    • Irritable Bowel Syndrome (IBS)

    • Others

  • Pain Management

    • Chronic Pain

    • Acute Pain

  • Oncology

    • Blood Cancer

    • Solid Tumors

    • Other

  • CNS Condition

    • Epilepsy

    • Parkinson's Disease (PD)

    • Huntington's Disease

    • Stroke

    • Traumatic Brain Injury (TBI)

    • Amyotrophic Lateral Sclerosis (ALS)

    • Muscle Regeneration

    • Others

  • Diabetes

  • Obesity

  • Cardiovascular

  • Others

• Indication by Study Design Outlook (Revenue, USD Million, 2017 - 2030)

  • Autoimmune/Inflammation

  • Interventional

  • Observational

  • Expanded Access

  • Pain Management

  • Interventional

  • Observational

  • Expanded Access

  • Oncology

  • Interventional

  • Observational

  • Expanded Access

  • CNS Condition

  • Interventional

  • Observational

  • Expanded Access

  • Diabetes

  • Interventional

  • Observational

  • Expanded Access

  • Obesity

  • Interventional

  • Observational

  • Expanded Access

  • Cardiovascular

  • Interventional

  • Observational

  • Expanded Access

  • Others

  • Interventional

  • Observational

  • Expanded Access

• Sponsor Outlook (Revenue, USD Million, 2017 - 2030)

  • Pharmaceutical & Biopharmaceutical Companies

  • Medical Device Companies

  • Others

• Service Type Outlook (Revenue, USD Million, 2017 - 2030)

  • Protocol Designing

  • Site Identification

  • Patient Recruitment

  • Laboratory Services

  • Bioanalytical Testing Services

  • Clinical Trial Data Management Services

  • Others

• Regional Outlook (Revenue, USD Million, 2017 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Spain

    • Italy

  • Asia Pacific

    • India

    • Japan

    • China

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE