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: Jun, 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 USD 44.3 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 5.7% from 2021 to 2028. However, the market growth was hindered in 2020 due to the COVID-19 pandemic. Nevertheless, the future seems promising for the market owing to factors such as globalization of clinical trials, rapid technological evolution, and augmenting demand for CROs to conduct research activities. The increasing prevalence of chronic disease and the growing demand for clinical trials in developing countries are also 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 demand for advanced technologies.

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

The rapidly evolving threat due to the outbreak of COVID-19 is impacting lives, communities, businesses, and industries around the globe. The pandemic also negatively impacted the ecosystem of clinical trials during the first half of 2020. It affected many ongoing clinical trials for various therapeutic areas. However, to overcome this, researchers developed innovative therapeutics and vaccines against COVID-19, which has supported the market recovery and growth. Growing demand for CROs for conducting clinical trials in the pharmaceutical sector due to the diversified expertise of CROs and adoption of advanced technologies in clinical trials is supporting 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 costs. Digitization also helps in meeting stringent regulations by maintaining patient data records that reduce trial process errors through the adoption of software such as e-COA (Electronic Clinical Outcome Assessment).

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, have issued guidelines related to the conduct of clinical trials during the outbreak of coronavirus, which is in complete support of incorporating virtual services.

COVID19 impact: "Go-Expedite" being the key strategy adopted by clinical trial firms in 2020, 106 vaccines and 288 therapeutics were in development phase for Covid-19

Pandemic Impact

Post COVID Outlook

In 2020, about 288 new therapeutics and about 106 vaccines were brought into clinical development, promoting a rapid rise in the R&D budget influx

Companies are anticipated to maintain a higher R&D budget, facilitating higher clinical trial conductions over the next 3 years. This is owing to the need to completely profiling the identified potent vaccines and therapeutics for Covid-19

In April 2020, the National Institute of Health together with the Foundation for the NIH (FNIH) launched a public-private partnership to accelerate treatment & vaccine options for Coronavirus

As the industry continues to learn and innovate, the domino effect will drive 50-70% increases in trial access and efficiency-ultimately leading to more effective therapies for more people around the world.

This past year, the decentralized model provided a vital stopgap to overcome the halt of clinical trials for thousands of shut-in patients and trial staff.

 

 

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 growth of the market for clinical trials. 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 dominated the market for clinical trials and accounted for the largest revenue share of 53.2% in 2020. This growth is attributed to the fact that phase III clinical trials are the most expensive ones and involves huge subjects. The median cost for a single-phase III clinical 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 accounted for a revenue share of 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 phase III clinical trial. Besides, there are various therapeutic and vaccines currently in phase II for the treatment of coronavirus, thereby, boosting the growth of the market for clinical trials.

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; AB Science SA; and others. 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 for clinical trials and accounted for the largest revenue share with 82.1% in 2020. It is one of the most prominent methods used in a clinical trial. 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.

Expanded access trials, also referred to as compassionate use trials are anticipated to register a CAGR of 4.5% 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 as a part of expanded access trials. 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. and subsidiary Nash Pharmaceuticals, and Ansun Biopharma Inc.

Indication by Study Design Insights

The report further provides a deep dive into the various indications and mostly adopted study designs. The interventional trials for autoimmune/inflammation accounted for the largest revenue share of 82.1% in 2020. The high share can be attributed to a large number of interventional studies being conducted on autoimmune/inflammation across the globe. There are over 7,000 interventional studies listed on clinicaltrials.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. Furthermore, the largest share is also attributable to advantages of interventional studies such as effective minimization of the effect of confounding, avoidance of bias in allocation to exposure groups, and efficient detection of small to moderate clinically important effects.

The observational trials for autoimmune/inflammation accounted for the second-largest revenue share in 2020. Out of the total autoimmune/inflammation studies listed on clinicaltrials.gov, more than 2,000 are observational. For instance, an observational study titled “Quantitative Magnetic Resonance Imaging to Aid Clinical Decision Making in Autoimmune Hepatitis was completed on December 31, 2019.

The expanded access accounted for the lowest share for autoimmune/inflammation in 2020. There are less than 40 expanded access studies as of 2020 for autoimmune/inflammation. For instance, there 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. A similar analysis for the rest of the indications shall be provided in our report study.

Indication Insights

The oncology segment dominated the clinical trials market and accounted for the largest revenue share of 36.3% in 2020. The segment is also anticipated to witness the fastest CAGR of 5.9% 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 the preclinical and clinical development of oncology therapy products.

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

The cardiovascular condition segment is also anticipated to witness a lucrative CAGR of 5.7% 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 the market for clinical trials.

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% of the 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 for clinical trials 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 market growth.

Moreover, the favorable government support in the U.S. market regarding clinical trials is anticipated to boost the demand. 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 for clinical trials 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 for the 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 & Market Share Insights

The market for clinical trials is highly competitive in nature. Significant factors affecting competitive nature are 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 and 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

Details

Market Size value in 2021

USD 47.0 billion

Revenue forecast in 2028

USD 69.3 billion

Growth Rate

CAGR of 5.7% from 2021 to 2028

Base year for estimation

2020

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, indication by study design, 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

Report coverage

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

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 on the basis of phase, study design, indication, indication by study design, 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

      •  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, 2016 - 2028)

    • 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

  • 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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