The global clinical trials market reached a valuation of USD 80.7 billion in 2023, with an expected compound annual growth rate (CAGR) of 6.49% from 2024 to 2030. A significant increase in market growth was observed in 2020 due to the COVID-19 pandemic, impacting both virtual and traditional clinical trials. Many pharmaceutical and biotech companies prioritized novel drug development in response to the pandemic, seeking to reduce the impact of COVID-19 on patient health. An example of such efforts was in 2020, when Synairgen plc partnered with Parexel for a Phase III trial evaluating Interferon-beta (IFN-beta) as a treatment for COVID-19. The market's positive growth is also influenced by rapid advancements in technology, the rising prevalence of chronic diseases, globalization in clinical trials, a push for personalized medicine, and increased demand for contract research organizations (CROs) to support research activities.
The pandemic also changed how clinical trials were conducted. Regulatory agencies like the U.S. FDA, European Medicines Agency (EMA), National Institutes of Health (NIH), and China’s National Medical Products Administration issued guidelines during COVID-19 to facilitate decentralized and virtual trials. These adaptations helped support remote methods, like telehealth and home-based patient monitoring, to continue trials despite social distancing measures. This evolving approach to research and development, driven by the urgency of finding new treatment options, led to the adoption of fast-track clinical trials. As a result, the clinical trials market is expected to continue expanding as new opportunities emerge for faster, more flexible trial designs.
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Government support and initiatives are also playing a crucial role in enhancing market growth potential. For instance, the World Health Organization (WHO) launched the Solidarity trial, a large-scale international clinical trial aiming to identify effective COVID-19 treatments. This trial tested multiple treatments against a standard care approach to evaluate their efficacy in combatting COVID-19. In May 2020, the WHO also initiated an international collaboration for the rapid development of multiple vaccine candidates, known as the Solidarity Vaccine Trials, to accelerate COVID-19 vaccine development.
Phase Segmentation Insights:
The Phase III segment dominated the market, capturing 53.3% of the total revenue share in 2023. Phase III trials are a significant contributor to market growth due to the high volume of participants involved. The median cost for a single Phase III trial exceeds USD 19.0 million. Phase III trials are essential for assessing drug efficacy and safety on a larger scale, requiring a substantial number of participants and often a more extended treatment duration than previous phases. According to a clinical trial logistics survey conducted by Nice Insights, 35% of Phase III trials are outsourced to CROs, a figure expected to grow as more investigational drugs progress to Phase III.
The Phase II segment is also projected to grow considerably throughout the forecast period. Phase II trials are the second most expensive stage after Phase III and typically involve two parts. The first part focuses on exploring a range of doses along with initial efficacy studies, while the second part aims to determine the optimal dose. Phase II trials are critical in oncology research, where effective dosing is paramount. According to FDA estimates, approximately 33% of investigational drugs are in Phase II trials. A significant number of oncology-related therapies and vaccines are currently in Phase II, which is helping drive the growth of this segment. The rising number of both industry-sponsored and independent clinical trials in Phase II, as well as the complex nature of these trials and the international expansion of clinical research, are factors contributing to the growth of the clinical trials market.
Overall, the clinical trials market is experiencing strong momentum driven by increasing demands for innovative medical treatments, regulatory adjustments for flexible trial processes, and significant financial investments. As the need for more efficient and effective clinical research rises, particularly in areas like oncology and infectious diseases, the market is well-positioned to see sustained growth over the coming years.
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