The global clinical trials market is expected to grow from USD 39,710.2 million in 2021 to USD 59570.1 million by 2030, at a CAGR of 5.2% from 2022 to 2030. In conjunction with the rising burden of diseases, the increasing patient population led to a rise in the R&D of drug discovery, which helped increase clinical trials in the industry. In addition, investments in clinical trials are projected to positively influence market growth in the future. For instance, Small molecule drug discovery is a priority for Cancer Research UK. It funds milestone-driven projects at all stages of drug discovery, from target identification to early pre-clinical studies, through a program called “Small Molecule Drug Discovery Project Award.” It provides annual funding of GBP 100,000 for 12 to 36 months.
Furthermore, with the growing demand for generic medicines and biologics, the capital-intensive nature of the business, and the complex manufacturing requirements, many pharmaceutical companies have identified the potential profitability of contracting with CROs for clinical trials.
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According to a report on CRO strategic partnerships published by Tufts University in collaboration with ICON PLC, 70% of all clinical trials will be transferred to CROs by 2020. As CROs become more involved in clinical research and are seen as calculated partners, providing access to dedicated expertise and patients worldwide, their role has grown in importance. Furthermore, the emergence of COVID-19 and the development of novel therapeutics are expected to boost market growth during the forecast period.
COVID–19 Impact on the Global Clinical Trials Market
A global race has been underway to discover a vaccine, drug, or combination of treatments that can disrupt the SARS-CoV-2 virus, which causes the COVID-19 disease, and prevent widespread deaths. The ongoing COVID-19 pandemic has slowed down various drug discovery processes due to the pause of various clinical trials. However, on a brighter note, pharmaceutical companies expect generous incentives to invest in developing drugs and vaccines against infectious diseases.
In March 2021, Moderna Inc. announced the first participants dosed in Phase 2/3 of the COVID-19 vaccine candidate in the pediatric population. COVID-19 has affected recruiting patients for new trials and keeping the registered patients in line with their study schedules. According to a report published by Continuum Clinical in 2020, 56% of the American medical research centers and 81% of European sites have recorded that registered patients have very little or no chance of continuing their clinical trials. However, many contract research organizations (CRO)s have gone digital with the clinical trials in response to the COVID-19 pandemic. PPD Inc., one of the largest CROs, has partnered with Medable and Science 37, two key players in virtual clinical trials.
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Global Clinical Trials Market Dynamics
Drivers: Demand for Clinical Trials in the Developing Countries
Many unmet clinical needs still exist in emerging countries due to the prevalence of infectious and tropical diseases. India and China have the highest prevalence rate for metabolic disorders due to increased individuals, combined with insulin resistance, hyperlipidemia, and obesity. One of the most evident benefits of conducting clinical trials in Asian countries, such as India, is the potential for cost savings. Clinical trials account for over 40% of the costs of developing a new drug. In terms of cost-efficiency, India offers substantial advantages. Conducting cost of a trial in India is 50% lesser than in the United States. Clinical trials also remain exempt from service tax as per NITI Aayog ( the public policy think tank of the Government of India).
Medical expenses tend to be more expensive in these countries, as healthcare is provided chiefly by private hospitals. It is to be noted that insurance coverage on healthcare is extremely low compared to developed countries. Owing to the aforementioned factors, a large section of the population participates in clinical trials to access high-quality healthcare free of cost.
Restraints: Lack of Skilled Workforce Clinical Research
Despite being the most sought-after destinations for clinical trials, most countries in the emerging markets currently have extremely poor and underperforming professionals that lack the basic skills required for clinical trials. The contract research organization industry is increasing, but talent growth is not growing simultaneously. Most clinical research is being outsourced in the emerging markets from big pharmaceutical and biopharmaceutical companies. However, there’s been a lack of expertise due to the shortage of skilled personnel to handle the trial project aptly.
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Different kinds of clinical trials are conducted in different manners, and they need skilled professionals to handle the data generated from the study. Suppose the person is not skilled in handling the data and other related material; the results from the study may be impacted and manipulated, which can incur a heavy loss to the companies or organizations conducting the clinical research and can cost them many years.
Scope of the Clinical Trials
The study categorizes the clinical trials market based on phase and design at the regional and global levels.
By Phase Outlook (Sales, USD Million, 2017–2030)
- Phase I
- Phase II
- Phase III
- Phase IV
By Design Outlook (Sales, USD Million, 2017–2030)
- Treatment Studies
- Observational Studies
By Region Outlook (Sales, USD Million, 2017–2030)
- North America (US, Canada, Mexico)
- South America (Brazil, Argentina, Colombia, Peru, Rest of Latin America)
- Europe (Germany, Italy, France, UK, Spain, Poland, Russia, Slovenia, Slovakia, Hungary, Czech Republic, Belgium, the Netherlands, Norway, Sweden, Denmark, Rest of Europe)
- Asia Pacific (China, Japan, India, South Korea, Indonesia, Malaysia, Thailand, Vietnam, Myanmar, Cambodia, the Philippines, Singapore, Australia & New Zealand, Rest of Asia Pacific)
- The Middle East & Africa (Saudi Arabia, UAE, South Africa, Northern Africa, Rest of MEA)
The phase III segment is projected to account for the largest market share, by phase
Based on phase, the global clinical trials market is divided into phase I, phase II, phase III, and phase IV. In 2021, the phase III segment accounted for the largest market share of 35.1% in the global clinical trials market. Phase III is one of the most critical phases in evaluating the effectiveness of the new intervention and its value in clinical practice. The New Drug Application (NDA) is submitted to the Food and Drug Administration (FDA) for consideration for marketing approval. Because Phase III trial results often provide the basis for approval, these trials are sometimes also called pivotal trials.
Furthermore, phase III segment growth is attributed to these clinical trials being the most expensive and involving huge subjects. Also, it requires a higher number of patients and often a longer treatment period. Increasing demand to evaluate the new treatment with existing treatment in phase III will fuel the market demand in the upcoming years.
Asia Pacific accounts for the highest CAGR during the forecast period
Based on the regions, the global clinical trials market has been segmented across North America, Asia–Pacific, Europe, South America, and the Middle East & Africa. Globally, Asia Pacific is estimated to hold the highest CAGR of 5.9% in the global clinical trials market during the forecast period. In the Asia Pacific, China had the largest market revenue share of 30.4% in 2021. China’s pharmaceutical industry is in the midst of a transformation. China is one of the largest medicine markets in the world, and it is poised to become a global hub for drug innovation and a global leader in drug development technology. Other factors include importing and exporting new drugs and domestic companies, such as Jiangsu Hengrui Medicine and Zhejiang Hisun Pharmaceuticals.
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Moreover, India is the fastest-growing region with a CAGR of 6.9% during the forecast period. India is constantly using its large domestic market space, product development skills, and scientific workforce to offer solutions to the global pharmaceutical industry to address the challenges in growth and innovation. India can execute clinical trials at much lower costs, accounting for around half of the total costs incurred in the United States or other economies. Owing to this reason, India has shown a marked rise in the number of trials over recent years.
Key Market Players
The clinical trials market is mildly concentrated in nature with few numbers global players operating in the market such as Clinipace, Laboratory Corporation of America Holdings (Covance Inc.), ICON PLC, Novo Nordisk AS, Parexel International, Eli Lilly and Company, Pfizer Inc., PPD Inc., IQVIA Inc., F. Hoffmann-La Roche Ltd., Sanofi SA, Syneos Health, ClinDatrix Inc., and Charles River Laboratories International Inc.
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