The global clinical trials market size was evaluated at US$ 57.37 billion in 2023 and is expected to attain around US$ 90.59 billion by 2033, growing at a CAGR of 4.67% from 2024 to 2033. Clinical trials serve as crucial mechanisms for addressing questions regarding the efficacy and safety of medical treatments, ultimately enhancing the health and quality of life for patients.
Clinical Trials Market Overview
The clinical trials market is experiencing rapid growth, serving as essential research studies to evaluate the efficacy and safety of medical, surgical, or behavioral interventions in individuals. These trials play a pivotal role in determining the safety and effectiveness of new treatments or preventive measures, ranging from drugs to medical devices. Often, clinical trials compare new interventions with existing treatments to assess their relative benefits and risks. Volunteers, including individuals of all ages, participate in these trials to test various medical interventions, including drugs, surgical procedures, and preventive care measures. With careful design, review, and approval processes in place, clinical trials contribute significantly to advancing medical knowledge and improving human health outcomes.
- In September 2023, the FDA initiated a pilot program to accelerate the development of therapies for rare diseases, underscoring its dedication to addressing unmet medical needs.
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Key Insights
- North America has accounted market share of 53.48% in 2023.
- Asia Pacific region is growing at a CAGR 7.16% during the forecast period.
- By phases, phase III has accounted largest market share of 48.93% in 2023.
- By study design, the interventional study segment has captured largest market share of 77.77% in 2023.
- By therapeutic area, the oncology segment has held a highest market share 38.10% in 2023.
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Regional Stance
The clinical trials market exhibits dominance in North America, primarily attributable to the region's high prevalence of chronic disorders and its cutting-edge healthcare infrastructure. The U.S. clinical trials market size was valued at USD 27.81 billion in 2023 and is projected to hit around USD 39.24 billion by 2033 with a CAGR of 3.50% from 2024 to 2033. According to data from the National Library of Medicine (NLM) as of January 2024, the United States alone accounted for 20,465 ongoing clinical trials, reflecting a significant portion of global trial activity. Worldwide, NLM reported a total of 65,474 trials recruiting subjects, underscoring the substantial contribution of North America to the global clinical trials landscape. While clinical trials are mandated by the FDA for all new treatments, including drugs, medical devices, vaccines, and gene therapies, they also yield invaluable data instrumental in guiding healthcare decisions beyond regulatory requirements.
- In January 2024, Sanofi announced its acquisition of Inhibrx, Inc., enhancing its pipeline with a potential best-in-class rare disease asset for Alpha-1 Antitrypsin Deficiency.
- In May 2022, GSK revealed its plan to acquire clinical-stage biopharmaceutical company Affinivax, Inc., reinforcing its presence in the biopharmaceutical sector.
The Asia-Pacific region is poised to experience rapid growth in the clinical trials market, emerging as a key hotspot for such activities. In 2021, APAC contributed nearly 50% of new clinical trial endeavors globally and is expected to surpass trials conducted in the rest of the world (ROW) by 2022. Notably, there has been a significant increase in early phase trials conducted in APAC, indicative of a notable shift in trial dynamics. The region has also taken a leading role in cell and gene clinical trials, accounting for a substantial portion of new trials in the first half of 2022.
This trend can be attributed to the development of robust trial infrastructure and capabilities, including the expansion of clinical research networks and the emergence of indigenous biotech and pharma companies. the region's diverse population base, representing over 40% of the global population, further reinforces its attractiveness for conducting clinical trials. These factors underscore the current and future prospects for successful clinical trial strategies in the APAC region.
- In October 2023, Roche Pharma initiated a clinical trial excellence project in India, demonstrating its commitment to advancing clinical research in the region.
- In February 2024, FedEx strengthened its commitment to the clinical trial supply chain with the launch of the FedEx Life Science Center in Mumbai, India.
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Report Highlights
By Phase
The Phase III segment has emerged as a significant player in the global clinical trials market, capturing a major market share. Phase III clinical trials play a pivotal role in comparing the safety and efficacy of new treatments with existing standard therapies. Typically involving a large cohort of patients, often spanning several hundred individuals, these trials are conducted across multiple locations simultaneously, including local community hospitals and doctor's offices. Phase III trials serve as a crucial determinant in establishing new treatment standards, as outcomes from different patient groups are directly compared upon completion. This phase represents a critical stage in the clinical trial process, facilitating informed decisions regarding the adoption of novel treatments into standard clinical practice.
By Study Design
The interventional studies segment is poised to lead the clinical trials market, commanding a dominant market share. These studies, which encompass the testing of potential drugs, medical devices, activities, or procedures in human subjects, are often referred to as clinical trials. A significant proportion of interventional studies employ a placebo-controlled design, wherein some participants receive the treatment under investigation while others receive a placebo. This design allows researchers to effectively compare the efficacy of the treatment against the control group, facilitating robust evaluations of treatment effectiveness. As a result, interventional studies play a crucial role in advancing medical knowledge and informing clinical practice decisions.
By Indication
The oncology segment is forecasted to dominate the clinical trials market, underscoring its significant impact on clinical research endeavors. Cancer immunotherapy clinical trials, in particular, play a pivotal role in introducing novel and potentially life-saving treatments to a broader spectrum of cancer patients. These trials offer a beacon of hope for individuals grappling with the disease, with immunotherapy increasingly accessible as a first-line treatment option or for early-stage cancers. The rapid advancements in clinical research, many patients remain unaware of recent breakthroughs in immunotherapy and the expanding opportunities to participate in new cancer clinical trials. The lack of awareness poses challenges for patients in identifying suitable clinical trials tailored to their specific needs. Hence, enhancing patient education and outreach efforts is imperative to ensure broader participation and facilitate access to innovative cancer treatments through clinical trials.
- In November 2023, AbbVie announced its acquisition of ImmunoGen, expanding its solid tumor portfolio with ImmunoGen's flagship cancer therapy ELAHERE.
Market Dynamics
Driver
Advancement of Healthcare Interventions through Clinical Trials
Clinical trials serve as a pivotal research tool to assess the impact of various healthcare interventions on individuals, encompassing the evaluation of new treatments, disease prevention methods, early detection strategies, and enhancements in quality of life. Researchers continuously strive to enhance standard treatments available to patients, with clinical research studies playing a crucial role in this endeavor. Participation in clinical trials offers individuals the opportunity to access potentially more effective treatments compared to existing options.
For those with diseases or conditions that lack effective treatment options through current standards of care, clinical research studies provide the best chance for successful treatment outcomes. Consequently, the ongoing advancement of healthcare interventions through clinical trials serves as a driving force behind the growth of the clinical trials market.
- In August 2023, Kohlberg signed a definitive agreement to acquire a majority stake in Worldwide Clinical Trials, reflecting its strategic investment in the clinical research sector.
Restraint
Regulatory Hurdles in Multi-Country Clinical Trials
Conducting multi-country clinical trials necessitates compliance with regulatory requirements across all involved nations, including review and approval by national drug regulatory authorities (NDRAs) and recognized research ethics committees (RECs). The efficiency of such trials is impeded by varying regulatory environments in each collaborating country, characterized by differences in laws, procedures, and lengthy regulatory processes, particularly in resource-limited regions. These hurdles not only hinder the timely implementation of multi-site clinical trials but also delay critical research vital to population health, incurring substantial financial costs amounting to millions of doDellars annually. As a result, the growth of the clinical trials market is constrained by these regulatory complexities and inefficiencies.
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Opportunities
Advancement in Clinical Trial Designs with Wearable Technology
The evolution of clinical trial designs is anticipated to embrace greater complexity, leading to the generation of larger volumes and diverse sets of data. A edge in this advancement lies in the discussion surrounding wearable technology, which holds immense potential in responsive drug delivery. Particularly for individuals managing chronic health conditions, the prospect of responsive drug delivery offers a revolutionary approach to medication management, potentially alleviating the burden on patients and enhancing disease management.
For instance, diabetes management, where manual blood sugar monitoring and insulin administration may be replaced by electromedical devices capable of not only monitoring but also administering precise and variable dosages based on individual patient needs. This innovative approach presents a significant opportunity for the clinical trials market, facilitating the exploration of novel interventions and therapies enabled by wearable technology, ultimately enhancing patient care and treatment outcomes.
- In November 2023, AstraZeneca launched Evinova, a health-tech business aimed at accelerating innovation in the life sciences sector, improving the delivery of clinical trials, and enhancing health outcomes.
- In April 2024, CDER inaugurated a Center for Clinical Trial Innovation, aiming to enhance the efficiency and effectiveness of clinical trials.
Recent Developments
- In April 2024, Parexel and Palantir expanded their collaboration to accelerate clinical data delivery and improve clinical outcomes for patients.
- In October 2023, Medidata announced an expansion of its partnership with Catalyst Clinical Research for oncology trials, aiming to drive innovation in oncology research.
- In September 2023, BARDA partnered with ICON to execute next-generation COVID-19 vaccine clinical trials, highlighting collaborative efforts to combat the pandemic.
- In February 2023, Cytel and GSK announced a partnership to advance clinical trial design with Solara, aiming to improve efficiency and effectiveness in clinical research.
Key Players in the Clinical Trials Market
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- Parexel
- IQVIA
- Charles River Laboratory
- Omnicare
- Kendle
- Chiltern
- Pharmaceutical Product Development, LLC
Market Segmentation
By Phase
- Phase 1
- Phase 2
- Phase 3
- Phase 4
By Study Design
- Observational Study
- Interventional Study
- Expanded Access Study
By Indication
-
- Autoimmune/Inflammation
- Rheumatoid arthritis
- Multiple Sclerosis
- Osteoarthritis
- Irritable Bowel Syndrome (IBS)
- Others
- Pain Management
- Chronic Pain
- Acute Pain
- Oncology
- Blood Cancer
- Solid Tumors
- Other
- CNS Condition
- Epilepsy
- Parkinson's Disease (PD)
- Huntington's Disease
- Stroke
- Traumatic Brain Injury (TBI)
- Amyotrophic Lateral Sclerosis (ALS)
- Muscle Regeneration
- Others
- Diabetes
- Obesity
- Cardiovascular
- Others
- Autoimmune/Inflammation
By Geography
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa (MEA)
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