Clinical Trials Market Size By Phases (Phase I, Phase II, Phase III, Phase IV), By Study Design (Interventional Study, Observational Study, Expanded Access Study), By Therapeutic Area (Autoimmune Disease, Oncology, Cardiology, Infectious Disease, Dermatology, Ophthalmology) Industry Analysis Report, Regional Outlook, Application Potential, Covid-19 Impact Analysis, Price Trends, Competitive Market Share & Forecast, 2022 – 2030

Industry Overview

Clinical Trials Market size accounted for USD 53.9 billion in 2021 and is estimated to grow at over 4.9% CAGR between 2022 and 2030. Increasing prevalence of chronic diseases and the growing demand for the development of novel drugs & therapies is primarily driving the global market growth.
 

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Increasing penetration of technologically advanced digital solutions coupled with several government initiatives are anticipated to contribute to the market expansion. Rising geriatric population base is another factor surging the burden of chronic disorders and demand for the clinical trials market. With the growing burden of such diseases, there has been a growing focus of the companies on developing novel medications for genetic or rare disorders requiring focused and specialized clinical trials. This is anticipated to fuel the industry development.
 

Clinical trials are wide-ranging research studies evaluating new tests & treatments and assessing their impact on human health outcomes. Different sets of individuals/patients willingly participate in clinical trials to test medical interventions including medical devices, drugs, and other biological products. The clinical trials are performed in four phases and are stringently monitored by the regulatory bodies throughout the study timeline.
 

The COVID-19 pandemic has disrupted the transport systems and the population movements across the world, restricting many clinical trial patients from visiting trial sites and limiting PIs (principal investigators) and other clinical staff to their houses. Thus, COVID-19 pandemic had slight negative impact on the overall clinical trials market. During 2020, the market faced a major hindrance owing to less or no recruitment of patients to carry out clinical trials to avoid getting infected by the virus. But soon, the industry witnessed the surge in its growth. This is attributable to the rise in the clinical research activities and surge in demand for effective and novel drugs and vaccines.
 

The COVID-19 pandemic has likewise brought important changes in the market and shifted the focus of many commercial and research organizations to emphasize on the development of new vaccines and therapies for COVID-19. The expansion of dedicated services for COVID-19 by clinical research organizations is set to add to the market development further. High investments to support the manufacturing capabilities focused at completing the needed production of COVID-19 vaccines/drugs has proved as a catalyst for the market.
 

Growing number of clinical trials resulting in increased outsourcing to CROs surging the market demand

The demand for the clinical trials industry is increasing owing to the growing penetration of advanced medical technologies and rising demand for novel medications. Moreover, the drug development process is extremely risky for pharmaceutical and biotechnology businesses, with much lesser approval rates associated with high expenses, which limits the growth for clinical trials market. Consequently, outsourcing clinical trials to contract research organizations (CROs) is observed to result in significant time- and cost-savings for sponsors, allowing them to focus largely on drug discovery and boosts the market outlook.
 

In addition, as the commercial approach to clinical research spreads from Europe and U.S. to most parts across the world, the number of clinical trials has grown continuously, and have become larger. This has increased pressure on pharmaceutical organizations regarding the timelines. Even large pharmaceutical organizations are facing difficulties to deal with the increased workload, resulting into a rise in outsourcing. Hence, the increase in demand for clinical trials outsourcing is boosting the development of the market over the forecast period.
 

Inadequate research infrastructure poses a threat to the market growth

One of the barriers limiting market growth is inadequate research facilities and infrastructures to support their management and development, particularly when trial sites are spread across multiple countries. Research infrastructures include specialised academic clinical trial units (CTUs) and clinical research centres (CRCs) that are built to offer services such as clinical research for any specific disease. However, such facilities are not only completely missing but also are scarce in some countries, especially in the middle-income nations where government funding for clinical research is insufficient. Thus, the inadequate infrastructure poses a threat to the market development, demanding availability of well-developed infrastructure in low- and middle-income countries for conducting clinical trials.
 

Increasing demand to evaluate the novel treatment with existing treatment in phase III is expected to influence the industry development

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Based on phase, the clinical trials market is segmented into phase I, phase II, phase III, and phase IV. Phase III clinical trials accounted for over 49% revenue share in 2021 and is anticipated to register a lucrative CAGR over the forecast period. Phase III clinical trials demonstrate if the new combination of drugs is improved or equal to the standard of care. In addition, the aim of phase III clinical trials is to determine and confirm that the primary evidence collected in the previous phases for the drug candidate is beneficial, safe and offers efficient treatment for the intended action, thus increasing demand for the segment. The phase III of the clinical trial lasts from one to four years and involves around 3,000 participants to conduct the trial. Thus, growing demand to assess the new treatment with current treatment in the phase III is expected to boost the market demand over the forecast years.
 

Several advantages offered by interventional study will fuel the demand over the coming years

The interventional study segment accounted for USD 41,827.5 million in 2021 and is expected to register considerable growth over the forecast period. The advantages offered by this study that drives the market are diminishing of recall bias, as the information on exposure is gained before disease develops. Moreover, interventional study provides relatively more evidence, as interventional study is an improved way of measuring the efficacy of new intermediation. The study is conducted for majority of biologics or drugs followed by clinical device and procedure intervention studies, thus leading to a healthy segmental growth over the forecast period.
 

Rising prevalence of cancer globally will surge the clinical research activities for disease treatment

Oncology segment accounted for a significant market proportion in 2021 and is expected to expand at a 5.7% CAGR between 2022 to 2030. High growth rate is owing to increasing incidence of cancer and subsequent clinical research activities as well as government funding. For instance, according to the Association of National Cancer Institute article 2019, the federal government invested nearly USD 1.36 billion in 2017 on oncology trials, which is accounting for USD 7.5 million per study or USD 16.6 million per principal investigator (PI) trial. Thus, growing government funding along with increasing number of services offered by CROs for oncology therapeutic area is significantly contributing to the segmental expansion.
 

Increasing clinical research activities in North America is expected to propel the regional market landscape

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North America clinical trials market surpassed USD 29.6 billion in 2021 and is anticipated to show lucrative CAGR throughout the forecast period. Rising focus of pharmaceutical organizations on new drug development for treatment of several chronic diseases is expected to foster the industry revenue. In addition, aging population suffering from several chronic diseases as well as age-related disorders is expected to surge the demand for drugs, medical devices as well as medicinal therapies, which in turn boosts the market statistics. For instance, according to the U.S. Census Bureau, in 2019, population aged over 65 in the U.S. was noted to be about 54 million and is expected to reach 98.2 million by the end of 2060. Therefore, companies are relatively spending more resources on R&D activities to cater the rising geriatric diseases, thereby escalating the clinical trials, and driving the overall regional market trends.
 

Adoption of business strategies will pave growth opportunities for companies operating in the market

Prominent market players operating in the clinical trials industry include Laboratory Corporation of America Holdings, IQVIA, Pharmaceutical Product Development, Syneos Health PAREXEL International and ICON plc, among others. A significant factor impacting the competitive nature is the rapid adoption of advanced technology for better healthcare. Also, to maintain shares and increase the product portfolio to sustain the market competition.
 

Some of the recent industry developments:

• In April 2021, ERT, a clinical endpoint data solutions provider, announced its complete merger with Bioclinica, a technological and scientific leader in clinical imaging. The merger is aimed to provide best-in-class technology, scientific and therapeutic expertise, and digital innovation. This strategy helped company to expand its business portfolio as well as service offerings across various therapeutic area. However, in November 2021, the combined company was renamed to Clario.
   
• In April 2021, IQVIA Holdings Inc. acquired the remaining 40 percent shares of Q2 Solutions from Quest Diagnostics, a diagnostic information services provider, for a deal valued around USD 760 million, leading to the company’s 100 percent ownership with IQVIA. This acquisition was targeted at supporting IQVIA’s laboratory services segment, thereby strengthening its market position.
   

The clinical trials market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2017 to 2030, for the following segments:

By Phase

• Phase I
• Phase II
• Phase III
• Phase IV

By Study Design

• Interventional Study
• Observational Study
• Expanded Access Study

By Therapeutic Area

• Autoimmune Disease
• Oncology
• Cardiology
• Infectious Disease
• Dermatology
• Ophthalmology
• Others

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Singapore
  • Malaysia
  • Indonesia
  • Thailand
  • Philippines
• Latin America
  • Brazil
  • Mexico
• Middle East & Africa
  • South Africa
  • Saudi Arabia