Clinical Trials Market Size, Share & Trends Report

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, By Region, And Segment Forecasts, 2021 - 2028

  • Published Date: Jan, 2021
  • Base Year for Estimate: 2020
  • Report ID: GVR-1-68038-975-3
  • Format: Electronic (PDF)
  • Historical Data: 2016 - 2019
  • Number of Pages: 120

Report Overview

The global clinical trials market size was estimated at 44.3 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 5.7% from 2021 to 2028. The increasing prevalence of chronic disease and the growing demand for clinical trials in developing countries is fueling this market’s growth. The market is also driven by a rising number of biologics, the need for personalized medicines and orphan drugs, and the demand for advanced technologies. Factors such as globalization of clinical trials, technological evolution, and demand for CROs to conduct clinical trials are further projected to drive the market.

U.S. clinical trials market size, by phase, 2016 - 2028 (USD Billion)

The growing demand of CROs for conducting clinical trials in the pharmaceutical sector due to the diversified expertise of CROs and the adoption of advanced technologies in clinical trials is supporting the market growth. Digitization in biomedical research is also paving the way for market growth. Incorporating advanced technologies such as Electronic Data Capture (EDC) aid market participants in managing patient data that ultimately reduce monitoring cost. Digitization also helps in meeting stringent regulations by maintaining patient data records that reduce the trial process errors through the adoption of software such as e-COA (Electronic Clinical Outcome Assessment).

The market is also driven by the emergence of the global pandemic caused by coronavirus. The rapidly evolving threat due to the outbreak of COVID-19 is impacting lives, communities, businesses, and industries around the world. The pandemic has also negatively impacted the current ecosystem of clinical trials. It has affected many ongoing trials for various therapeutic areas. However, to overcome this, researchers are rapidly trying to develop innovative therapeutics and vaccines against COVID-19, which is supporting market growth.

The current pandemic is changing the way of conducting ongoing or upcoming clinical trials. Regulatory agencies such as the U.S. FDA, the European Medicines Agency (EMA), National Institutes of Health (NIH), and China’s National Medical Products Administration, and several others have issued guidelines related to the conduct of trials during the outbreak of coronavirus, which are in complete support of incorporating virtual services.

The current scenario across the globe and the need to come up with treatment options has also led to the fast-track of clinical trials. The favorable government support is boosting the market growth. The WHO launched “Solidarity”, an international clinical trial launched, to find effective treatment against COVID-19. It includes comparing four treatment options against the standard of care to evaluate their effectiveness against Coronavirus. The WHO also announced in May, an international alliance for simultaneously developing numerous candidate vaccines to prevent the spread of coronavirus disease, calling this effort the Solidarity trial for vaccines.

Phase Insights

The Phase III segment accounted for the largest revenue share of 53.2% in 2020. This growth is attributed to the fact that Phase III trials are the most expensive ones and involves 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 Phase III in terms of market share accounting for 19.6% in 2020. 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 medication goes into the Phase III trial. Besides, there are various therapeutic and vaccines currently in Phase II for the treatment of coronavirus, thereby, boosting the market growth.

For instance, there are currently 43 therapeutics in Phase II for COVID-19. Companies engaged in the development are AstraZeneca plc; Arch Biopartners Inc.; Applied Therapeutics Inc.; Apeiron Biologics GmbH; 4D Pharma plc; and AB Science SA. Companies are collaborating with other firms to accelerate the development of therapeutics and vaccines. Examples include Eli Lilly partnered with AbCellera for the development of vaccines; GSK, Novartis, and MSD working with the Bill and Melinda Gates Foundation. GSK and Sanofi are working together to develop an adjuvanted COVID-19 vaccine.

Study Design Insights

The interventional design segment led the market and accounted for the largest revenue share of 45.6% in 2020. It is one of the most prominent methods used in clinical trials. The interventional studies comprise 79.0% of total registered studies as of May 2020, out of which the majority of studies are for drug or biologics, followed by behavioral, clinical procedure, and device intervention studies. Intervention studies contribute to 94.0% of total studies with 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 the fastest CAGR of 5.9% 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 market growth of 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 as a part of expanded access trial. Also, there are currently 20 therapeutics for COVID-19 in expanded access trials/compassionate use in Phase II/III. Firms currently engaged in expanded access include Incyte Corp.; Novartis AG; Capricor Therapeutics Inc.; Alexion Pharmaceuticals Inc.; Bellerophon Therapeutics Inc.; Algernon Pharmaceuticals Inc.; subsidiary Nash Pharmaceuticals, and Ansun Biopharma Inc.

Indication Insights

Oncology segment dominated the clinical trials market and accounted for the largest revenue share of 23.4% in 2020. The segment is also anticipated to witness the fastest CAGR of 6.2% over the forecast period. As per the U.S. FDA and various other sources, more than USD 38.0 billion is currently spent by the pharmaceutical industry towards preclinical and clinical development of oncology therapy products.

The cardiovascular condition segment is also anticipated to witness a lucrative growth rate of 6.0% over the forecast period. The growing prevalence and increased demand for cost-effective medication across the world led to significant investment in R&D in this segment with more than 190 drugs in the pipeline. The majority of drugs in the pipeline are for heart failure, lipid disorders, vascular diseases, and stroke. Growing demand for cost-effective medicine in low and middle-income countries is expected to boost the R&D investment by the government in this segment, thereby strengthening market growth.

Global clinical trials market share, by indication, 2020 (%)

However, the current pandemic is creating a threat and acting as an obstacle in the clinical trials for finding effective treatments and cures for a myriad of diseases. At least 18 pharma or biotech companies have reported disruption to a clinical trial due to this pandemic. In March, there was around 65.0% global average decrease in the enrollment of new patients year-over-year. 84.0% reduction in India and a 43.0% decrease in Japan were also observed. The U.S. is down with an average of 67.0%.

Regional Insights

North America dominated the market and accounted for the largest revenue share of 51.0% in 2020. The region is expected to continue its dominance over the forecast period. This can be attributed to increasing R&D in this region and increasing adoption of new technologies in clinical research. For instance, the incorporation of virtual services in the clinical trial protocol by market players such as IQVIA, and PRA Health Sciences is anticipated to further fuel the North American market’s growth.

Moreover, the favorable government initiatives regarding the clinical trials in the U.S. are anticipated to boost the market growth. For instance, in March 2020, the FDA has 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. 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.

In Asia Pacific, the market is anticipated to witness the fastest CAGR of 6.7% over the forecast period owing to the increasing availability of a large patient pool facilitating easy recruitment of candidates. The global pandemic is also the main contributing factor to market growth. As per Asia Pacific’s largest expertized biotech CRO “Novotech”, the company is observing an increase in the demand from biotechnology sponsors for studies in the APAC region due to the availability of quality and speed. An increasing number of biotechnology firms are looking at the APAC region for their COVID-19 trials to take advantage of the large patient pool and fast-track procedures.

Key Companies and Market Share Insights

The market is highly competitive in nature. 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.

For instance, in January 2020, Wuxi AppTec announced offering a fully integrated adeno-associated virus Vector Suspension Platform to speed up the cell & gene therapy development, manufacturing, and launch, thus, expanding its service capabilities. Another instance occurred in June 2018, where Acurian and Synexus, a part of PPD, launched SynexusPlus. SynexusPlus is a site solution for patient enrollment in clinical studies. This initiative is anticipated to improve clinical trial productivity. Besides, the solution is also helpful in the current pandemic of COVID-19 as it helps in the reduction of the site footprints. Some of the prominent players in the clinical trials market include:

  • ICON Plc

  • Wuxi AppTec

  • PRA Health Sciences

  • SGS SA

  • Syneos Health

  • Eli Lilly and Company

  • Novo Nordisk A/S

  • Pfizer

  • Clinipace

Clinical Trials Market Report Scope

Report Attribute


Market Size value in 2021

USD 47.0 billion

Revenue forecast in 2028

USD 69.5 billion

Growth Rate

CAGR of 5.7% from 2021 to 2028

Base year for estimation


Historical data

2016 - 2019

Forecast period

2021 - 2028

Quantitative units

Revenue in USD Million and CAGR from 2021 to 2028

Report coverage

Revenue forecast, company ranking, competitive landscape, growth factors, and trends

Segments covered

Phase, study design, indication, region

Regional scope

North America; Europe; Asia Pacific; Latin America; Middle East & Africa

Country scope

U.S.; Canada; U.K.; Germany; France; Italy; Spain; China; India; Japan; Australia; South Korea; Mexico; Brazil; Argentina; Colombia; South Africa; Saudi Arabia; UAE

Key companies profiled

ICON Plc; Wuxi AppTec; PRA Health Sciences; SGS SA; Syneos Health; Eli Lilly and Company; Novo Nordisk A/S; Pfizer; Clinipace

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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 2016 to 2028. For the purpose of this study, Grand View Research has segmented the global clinical trials market report on the basis of phase, study design, indication, and region:

  • Phase Outlook (Revenue, USD Million, 2016 - 2028)

    • Phase I

    • Phase II

    • Phase III

    • Phase IV

  • Study Design Outlook (Revenue, USD Million, 2016 - 2028)

    • Interventional

    • Observational

    • Expanded Access

  • Indication Outlook (Revenue, USD Million, 2016 - 2028)

    • Autoimmune/Inflammation

    • Pain management

    • Cardiovascular

    • CNS condition

    • Oncology

    • Diabetes

    • Obesity

    • Others

  • Regional Outlook (Revenue, USD Million, 2016 - 2028)

    • 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

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