Clinical Trials Market Report By Insights, Size, and Growth - 2031

The clinical trials market is projected to expand significantly, growing from US$ 43.37 billion in 2023 to an estimated US$ 73.33 billion by 2031. This growth represents a compound annual growth rate (CAGR) of 6.8% during the period from 2023 to 2031. The increase in the number of clinical trials, coupled with a thriving pharmaceutical sector and heightened research and development (R&D) activities, is driving this market expansion. However, the high costs and lengthy timelines associated with clinical trials pose challenges to market growth. Additionally, the emergence of AI-driven clinical trials is anticipated to introduce new trends in the clinical trials market in the near future.

Clinical trials are essential research studies that evaluate medical, surgical, or behavioral interventions in human subjects. These trials serve as the primary method for researchers to assess the safety and efficacy of new treatments or preventive measures, including new medications, dietary approaches, or medical devices like pacemakers. Typically, a clinical trial aims to determine whether a new treatment is more effective or has fewer adverse effects compared to existing options.

In 2023, North America held a significant portion of the global clinical trials market. This market segment includes the United States, Canada, and Mexico, with the US emerging as a premier destination for clinical research. Approximately half of all clinical trials are conducted in the US, as many pharmaceutical companies prefer this location due to its well-established medical infrastructure, swift approval processes, favorable regulatory environment, and global acceptance of clinical trial data. According to a report from the World Health Organization (WHO), the US recorded the highest number of clinical trials, totaling 157,618 in 2021.

The growth of the clinical trials market in the US can be attributed to the introduction of innovative products by companies aimed at enhancing clinical trial applications. For instance, Medical Metrics, a clinical research organization (CRO), offers a product named "Assessa," which aids in the decision-making process for drug discovery and related clinical studies. This tool is particularly beneficial for identifying treatments for neurological disorders, including dementia, cognitive impairment, Alzheimer's disease, Parkinson's disease, schizophrenia, and other memory-related conditions. The increasing number of clinical trials in the US is a positive indicator for the market's growth in this region.

The adoption of decentralized clinical trials (DCT) and hybrid clinical trials is expected to create new opportunities in the market. In decentralized clinical trials, participants do not need to frequently visit hospital-based trial sites. Instead, digital technologies facilitate patient access to clinical research, enabling remote data collection, monitoring, and communication between investigators and participants. Hybrid clinical trials combine home-based and on-site activities, optimizing patient experience while adhering to complex protocol requirements. Initially, the uptake of DCT faced hurdles such as concerns over patient privacy, data security, regulatory challenges, and intricate protocols. However, the COVID-19 pandemic accelerated the adoption of decentralized and hybrid methodologies, as traditional in-person studies became impractical during the health crisis. With travel restrictions in place, remote data collection became essential for maintaining trial continuity.

Data from McKinsey indicates that approximately 70% of potential clinical trial participants do not engage with trial sites. Therefore, decentralization enhances trial accessibility, allowing for a broader and more diverse participant pool. Hybrid clinical trials enable sponsors to strategically integrate DCT elements into their study designs, offering unprecedented flexibility. As a result, more companies are expressing interest in hybrid trials, which are reshaping the industry landscape. According to ObvioHealth, the FDA plans to introduce protocols in 2023 to support DCT methodologies, thereby enhancing the credibility of future clinical research. Consequently, the growing emphasis on decentralized and hybrid clinical trials over traditional methods is expected to present lucrative opportunities for the clinical trials market in the coming years.

Insights based on study design categorize the market into interventional trials and expanded access trials. Furthermore, by indication, the market is segmented into various categories, including cardiovascular diseases, oncological conditions, neurological disorders, autoimmune diseases/inflammation, pain management, diabetes, obesity, metabolic disorders, and others. The clinical trials market is also divided by phase into Phase I, Phase II, and Phase III trials.

In terms of competition, key players in the clinical trials market include IQVIA Holdings Inc, Parexel International Corporation, IXICO Plc, Charles River Laboratories Inc, ICON Plc, WuXi AppTec Co Ltd, SGS SA, Syneos Health Inc, SIRO Clinpharm Private Limited, Thermo Fisher Scientific Inc, Laboratory Corp of America Holdings, CliniRx, Caidya, Oracle Corp, and Medpace.

For the preparation of the clinical trials market report, primary and secondary sources such as the US Food and Drug Administration, Centers for Disease Control and Prevention (CDC), and the Global Burden of Disease Study were utilized.