Clinical Trials Market is expected to reach US$ 73.33 Billion by 2031

Interventional Trials Segment to Bolster Clinical Trials Market Growth During 2023–2031

According to our new research study on "Clinical Trials Market Forecast to 2031 – Global Analysis – by Study Design, Indications, and Phase," the market is expected to grow from US$ 43.37 billion in 2023 to US$ 73.33 billion by 2031; it is anticipated to record a CAGR of 6.8% from 2023 to 2031. The clinical trials market report emphasizes the trends prevalent in the global market, along with drivers and deterrents affecting its growth.

The practice of outsourcing clinical studies with a massive rise in the number of trials and the flourishing pharmaceutical industry with a surge in R&D activities are contributing to the clinical trials market growth. However, the expensive and time-consuming nature of trials hampers market growth. Further, AI-driven clinical trials are expected to bring new clinical trials market trends in the coming years.

Clinical Trials Market Share, by Region, 2023 (%)

Source: The Insight Partners Analysis

Flourishing Pharmaceutical Industry with Surge in R&D Activities Bolsters Clinical Trials Market

Research is a significant and essential part of the pharmaceutical, biopharmaceutical, and medical device industries, among others, which enables them to come up with new solutions for various therapeutic applications with significant medical and commercial potential. The pharmaceutical industry is one of the most R&D-intensive industries in the world. Efforts are being made to achieve greater effectiveness and efficiency in fulfilling patients' needs. The cost of medicines has been a prime concern for pharmaceutical companies as they bank on their R&D activities to achieve intended cost targets. Over the last decade, the number of new drugs approved yearly has also increased. The Food and Drug Administration (FDA) approved 37 new drugs in 2022. Globally, the US is a leading country in terms of R&D investments, and it produced over 50% of the world's new molecules in the past decade. As per the European Federation of Pharmaceutical Industries and Associations (EFPIA), in 2021, North America accounted for 49.1% of global pharmaceutical sales. The US accounted for 64.4% of sales of new medicines launched during 2016–2021.

R&D Investments by Major Pharmaceutical Companies

Note: The current conversion rate has been considered for presenting the currencies.

Source: Annual Reports and The Insight Partners Analysis

R&D expenditure is instrumental in companies' efforts to discover, examine, and produce new products; make upfront payments; improve existing outcomes; and demonstrate product efficacy and regulatory compliance before launch. These investments differ as per the need and demand for clinical trials. The cost includes materials, supplies used, and employee salaries, along with the cost of developing and establishing quality control processes. According to PhRMA Member Companies 2021 report, the top 15 largest pharmaceutical companies by revenue invested US$ 133 billion in R&D cumulatively, and ~44% of the total R&D investment was allocated to clinical trials. These companies, in collaboration with hospitals, are investing in developing products to treat various diseases and disorders, including immunological disorders. In June 2021, Takeda announced ADVANCE-1, a randomized, placebo-controlled, double-blind Phase 3 clinical trial to evaluate HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] to maintain treatment of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) as its primary endpoint. Thus, increasing R&D investments by companies bolster the clinical trials market size.

The clinical trials market analysis has been carried out by considering the following segments: study design, indications, phase, and geography. Based on study design, the market is bifurcated into interventional trials and expanded access trials. The interventional trials segment held a larger clinical trials market share in 2023. Interventional studies are a specific type of clinical trial designed to evaluate the effectiveness and safety of new medical treatments, therapies, or interventions. It is a type of clinical research study wherein individual participants receive one or more interventional drugs/treatments for a specific period, and researchers evaluate the effects of the drug/treatment on their health. New potential medications/medical equipment/therapies must pass through phases of interventional testing as a market of their safety and effectiveness before receiving approval from the Food and Drug Administration (FDA). There are ~16,000 active, industry-funded interventional clinical trial studies, showing no indication of this count decreasing significantly in the near future.

By indication, the market is segmented into cardiovascular diseases, oncological conditions, neurological disorders, autoimmune diseases/inflammation, pain management, diabetes, obesity, metabolic disorders, and others. The oncological conditions segment held the largest market share in 2023. Clinical oncology trials are dedicated to conducting research studies or clinical trials for novel medications, therapies, or treatments intended for cancer patients. The incidence rate of cancer increases with age. Thus, the increasing prevalence of cancer and the rising geriatric population contribute to the growth of the market for the oncology segment. As per the World Health Organization, 20 million new cancer cases and 9.7 million deaths occurred in 2022 globally. As per estimates by the American Cancer Society, ~1.96 million new cancer cases and ~0.61 million cancer-related deaths were reported in the US in 2023. Despite the significant progress in cancer diagnosis, prevention, and treatment, there is a significant unmet medical need for treatments for primary cancers (e.g., lung, prostate, breast, and colon cancer). This creates a significant scope for improvement in cancer research and development activities for continuous innovation in treatments and therapies. As per Mayo Clinic data, currently, 535 clinical studies are being conducted in the oncology (medical) field.

Based on phase, the clinical trials market is divided into Phase I, Phase II, and Phase III. The Phase II segment held the largest market share in 2023.

The geographic scope of the clinical trials market report includes the assessment of the market performance in North America (US, Canada, and Mexico), Europe (Spain, UK, Germany, France, Italy, and Rest of Europe), Asia Pacific (South Korea, China, India, Japan, Australia, and Rest of Asia Pacific), the South & Central America (Brazil, Argentina, and Rest of South & Central America), and the Middle East & Africa (South Africa, Saudi Arabia, UAE, and Rest of Middle East & Africa).

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