Clinical Trials Market Size Estimated to Surpass USD 83.55 Billion by 2032 | Precedence Research

OTAWA, ON, Nov. 20, 2023 /PRNewswire/ -- The global clinical trials market size reached USD 48.68 billion in 2022 and is projected to surpass around USD 83.55 billion by 2032, expanding at a CAGR of 5.6% during the forecast period, according to the Precedence Research.

The global clinical trials market size accounted for USD 51.15 billion in 2023. North America led the market with the largest market share of 51.7% in 2022.

Clinical Trials are research studies that test the safety and efficacy of new medical, surgical, or behavioral interventions in humans. These trials are the primary way researchers determine if a new treatment or prevention is safe and effective in humans. Clinical trials are research studies in which participants are assigned at random to one or more interventions to see what happens in individuals. As a result, clinical trials are also known as interventional studies. Sometimes, the intervention is investigational, which means that doctors cannot prescribe it to patients.

In some clinical trials, participants are assigned to interventions at random. This means that the participants are chosen at random by the researchers. When they join a clinical trial, participants (or their doctors) usually do not get to choose which intervention they will receive.

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The clinical trials are done in five phases: preclinical Trial, Phase I, Phase II, Phase III, and Phase IV. A preclinical Trial is usually done on animals with small sample size to determine the drug safety for human testing in In vitro and In vivo animals. In Phase I, Pharmacological actions and tolerability are determined among the healthy population or maybe targeted diseases like cancer, TB, etc. Safety and efficacy are evaluated in Phase II with the population with the target disease. Phase III-evaluation of effectiveness and risk-benefit ratio in a diverse population with target disease. Phase IV includes monitoring long-term effects and effectiveness in diverse populations with target diseases & new age groups, and gender.

The clinical trial market is segmented based on Phase, Study Design, Indication, service type, sponsor, end-user, application, and region. The factors such as the high prevalence of chronic diseases, increasing number of clinical trials in developing countries, rising number of biologics, and increasing demand for advanced treatments such as personalized medicines is driving the clinical trial market. However, the decline in the number of clinical trials registration, high cost of clinical trials, and ethical and stringent regulatory concerns are expected to hamper the growth of the market. Furthermore, technological advancement and surging demand for CRO services are expected to offer ample opportunities for the market.

Key Insights:

• The Asia Pacific region is expected to expand at the fastest CAGR of 6.8% during the forecast period.
• By Indication, the oncology segment has held the largest market share of 24.7% in 2022.
• By Indication, the Cardiovascular Condition segment is growing at a CAGR of 6.4% during the forecast period.
• By Sponsor, the pharmaceutical & biopharmaceutical companies' segment has generated the largest revenue share of 72% in 2022.
• By Study Design, the interventional segment has accounted for revenue share of 46% in 2022.
• By Study Design, the expanded access trials segment is projected to register at a CAGR of 6.4% over the forecast period.

Crucial factors accountable for market growth are:

• Growing prevalence of chronic disorders
• Increasing number of clinical trials in developing regions
• Growing number of biologics
• Increasing demand for advanced treatments such as personalized medicines

Regional Snapshot

North America region dominated the clinical trial market in 2022 and is expected to maintain the dominant position during the forecast period. The growth is due to the high incidence of chronic disorders and the presence of advanced healthcare infrastructure.

The U.S. is the largest market for clinical trials in North America, owing to the strong regulatory framework led by the Food and Drug Administration (FDA).  The U.S. clinical trials market size surpassed USD 24.61 billion in 2022 and is estimated to reach around USD 39.62 billion by 2032, growing at a CAGR of 4.88% during the forecast period 2023 to 2032.

The diverse U.S. market focuses on innovative research and integrating advanced technologies. The presence of recognized research institutions and a large patient population contributes to the country's importance in the global clinical trials field. Moreover, The U.S. spends more per person on health care than any other industrialized country. According to the most recent international data from the OECD, the United States invests 17.7 percent of its economy in health care.

On the other hand, Asia-Pacific is expected to expand at a remarkable growth rate of 6.8%, on account of increasing investment by governments in research and growing awareness regarding precision medicine.

• The Asia Pacific clinical trials market was valued at USD 10.7 billion in 2022 and it is expected to grow at a CAGR of 6.8% over the forecast period.
• The North America clinical trials market was valued at USD 27.5 billion in 2022 and it is expected to grow at a CAGR of 5.6% over the forecast period.
• The Europe clinical trials market was valued at USD 14.8 billion in 2022 and it is expected to grow at a CAGR of 5.8% over the forecast period.

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Market Dynamics

Drivers: Increased accessibility and visibility

ClinicalTrials.gov currently lists 473,211 studies with locations in all 50 States and 222 countries. As of March 2021, ClinicalTrials.gov receives about 4.5 million visitors monthly. This indicates increased accessibility and visibility of clinical trials, driving the growth of the clinical trial market, leading to the attraction of more participants and boosting collaboration among researchers, sponsors, and the public.

Restraint: Decline in Clinical Trail Registration

The number of trials registered in the International Clinical Trials Registry Platform (ICTRP) has consistently increased globally between 1999 and 2022. However, in 2022, decline is visible globally, particularly in the Western Pacific area. Africa has the fewest ICTRP registrations, with the Americas, Europe, and Western Pacific being the regions with the highest number of clinical trial registrations.

Even though 94% of trials in South-East Asia and 74% of trials in the Eastern Mediterranean were registered within a year of the trials' initial enrollment in 2022, a significant proportion of trials remained unregistered after that time. As an instance, 18% of trials registered in the Americas in 2022 were retrospective, indicating persistent difficulties in timely trial registration. This decline, along with the challenges in timely trial registration highlighted in certain regions, pose some concerns for the clinical trials market.

Opportunity: The surging demand for CROs Services

Pharmaceutical and biotech companies are increasingly outsourcing crucial trial components, driving demand for Contract Research Organization (CRO) services in clinical trials. CROs offer specific expertise in trial design, patient recruitment, data management, monitoring, and regulatory affairs. Their global reach enables international trials while managing a variety of regulatory environments.

CROs increase trial efficiency by incorporating modern innovations like artificial intelligence and electronic data capture. This promotes innovation and specialization despite industry competition. Challenges, such as changing regulations, allow CROs to stand out and assure compliance. The long-term perspective for CRO services is vital due to the increasing complexity of clinical trials and the industry's goal of higher effectiveness.

Production, manufacturing, investment data and market statistics Clinical Trials Market

• According to the U.S. National Library of Medicine, as of June 2023, approximately 55,483 interventional clinical studies were posted with results on the Clinicatrial.gov. website.
• According to the World Health Organization (WHO), as of 2022, approximately 39% clinical trials were done for non-communicable diseases across the globe. Whereas the clinical trials for communicable diseases reached 60%.
• Europe registered almost 13,254 clinical trials in 2022. Whereas South-East Asia enrolled 11,052 number of clinical trials in the same year.
• In 2022, approximately 54% clinical trial initiations reached at the Phase-III level in India. Whereas 28% of them made it to the Phase IV level.
• Charles River Laboratory, a globally leading clinical trial company witnessed a significant growth in drug research fundings in 2022, the company's annual generated revenue for 2022 was $3.98 billion. The revenue represented the growth of 12.3% over the previous year.
• The Cancer Research UK funded 193 million Euros on clinical research projects that focus on specific cancers in the financial year 2021-2022
• Japan accounted for 4.7% share in the worldwide clinical trial activities in 2022. The industry sponsored clinical trials held 54% share of the total Japanese industry in 2022
• For year 2022, in Japan, the oncology sector led the clinical trial activities with 25.1% share of the overall industry for clinical trials in the country. Whereas clinicals trials on infectious diseases held 7% share.
• The United Kingdom held total 178 Advanced Therapy Medicinal Product (ATMP) clinical trials in 2022.
• MedPace, a globally leading contract research organization's annual revenue increased by 27.7% in 2022 and reached $394.1 million.

Segmental Landscape

Phase Insights

The phase II segment is expected to grow faster during the forecast period due to its crucial function in advancing potential treatments. With a broader group of patients with the targeted disease or condition, researchers investigate a new drug's safety and effectiveness in greater detail during this phase of research. In accordance with the personalized medicine paradigm, phase II trials present an essential opportunity to optimize dosage levels, refine treatment regimens, and investigate patient subpopulations. Phase II increasingly focuses on identifying biomarkers that inform patient selection and treatment response.

The analysis of combination therapies, innovative trial designs, and initial proof of concept development are other aspects that drive the growth of Phase II trials. Beneficial results in Phase II not only assist in determining which studies advance on to Phase III but also create possible advances in treating complex diseases. This stage, which determines the therapeutic development process, is a crucial link between early safety evaluations and later-stage trials.

Study Design Insights

The observational study design is expected to grow faster during the forecast period owing to their exceptional capacity to offer practical insights into patient experiences and treatment outcomes. These investigations provide a more comprehensive view of treatment efficacy in various contexts, which enhances controlled trials. Since real-world evidence (RWE) is becoming more and more important in healthcare decision-making, observational studies are essential for evaluating the efficacy of treatments for a variety of patient populations. Large-scale observational studies are now feasible with greater efficiency due to developments in big data analytics and the widespread use of electronic health records. These studies are able to utilize huge amounts of data to draw insightful conclusions.

Furthermore, the focus on personalized medicine and patient-centered research illustrates the value of observational studies for discovering how different patients react to different treatments. Expanded Access programs, where observational elements are crucial for tracking treatment outcomes in real-world situations, are additionally driving the growth.

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Indication Insights

Based on the indication, the CNS condition segment is expected to grow significantly during the forecast period owing to the growing demand for effective treatments and rising focus on neurological disorders in research. Increased clinical trial activities are driven by advancements in neuroscience, a greater awareness of molecular mechanisms, and the growing global burden of CNS conditions. Scientists' initiatives to address specific obstacles associated with neurological disorders have led to a growth in this segment as a result of the search for new approaches, better symptom management, and disease-modifying therapies.

Service Type Insights

The clinical trial data management services segment dominated the market in 2022, owing to the rising importance of safe and effective data handling throughout the trial process. Ensuring accuracy and regulation, this service type includes managing, organizing, and validating clinical trial data. Effective data management becomes essential for maintaining data integrity and assisting in decision-making throughout the trial lifecycle as the volume and complexity of clinical trial data increases.

Sponsor Insights

Based on the sponsor segment, the pharmaceutical & biopharmaceutical companies dominated the market, implying their essential function in driving and funding most clinical research. The Leading pharmaceutical and biotech companies in drug development and innovation are part of this industry. Their involvement illustrates the significance of these organizations to the advancement of medical therapies and treatments through stringent clinical trials.

End-User Insights

Hospital segment dominated the market in 2022 due to its vital role in patient care and healthcare research. The extensive infrastructure and medical expertise inherent in hospitals makes them central hubs for clinical trials. The segment growth is due to seamless integration. Research into patient care procedures promotes cooperative settings where researchers and clinicians collaborate.

Clinical trials are conducted in a practical applications healthcare context as diverse patient populations are readily accessible in a hospital setting, which facilitates efficient participant recruitment. This integration enhances the overall effectiveness and relevance of the research, positioning hospitals as critical entities in advancing medical knowledge and therapeutic innovations.

Browse More Insights:

• Cell and Gene Therapy Clinical Trials Market: The market size reached USD 10.05 billion in 2022 and is expected to hit around USD 40.98 billion by 2032, growing at a CAGR of 15.09% from 2023 to 2032.
• Cell Culture Market: The market size was accounted at US$ 24.19 billion in 2022 and it is expected to surpass around US$ 63.60 billion by 2032 with a remarkable CAGR of 10.20% from 2023 to 2032.
• Single-Use Bioprocessing Market: The market size was estimated at USD 25.44 billion in 2022 and is expected to hit USD 84.12 billion by 2030, growing at a noteworthy CAGR of 16.1% from 2023 to 2030.
• Gene Therapy Market: The market was valued at US$ 6.50 billion in 2022 and is expected to reach over US$ 38.76 billion by 2032, expanding at a healthy CAGR of 19.60% from 2023 to 2032.
• Primary Cell Culture Market: The market size was estimated at USD 6.28 billion in 2022 and it is projected to hit around USD 19.56 billion by 2032, expanding at a CAGR of 12.04% from 2023 to 2032.
• In-Vitro Toxicology Testing Market: The market size reached USD 30.72 billion in 2022 and it is projected to be worth around USD 90.42 billion by 2032, poised to grow at a CAGR of 11.4% from 2023 to 2032.
• Cell and Gene Therapy Market: The market size was exhibited at USD 15.46 billion in 2022 and is projected to hit around USD 82.24 billion by 2032, growing at a CAGR of 18.3% during the forecast period from 2023 to 2032.
• 3D Cell Culture Market: The market size accounted for USD 1.42 billion in 2022 and it is expected to hit around USD 5.29 billion by 2032, poised to grow at a CAGR of 14.1% from 2023 to 2032.
• Bioprocess Technology Market: The market size was evaluated at USD 20.8 billion in 2022 and is projected to hit around USD 79 billion by 2032, growing at a CAGR of 14.26% from 2023 to 2032.
• Life Science Reagents Market: The market size was estimated at USD 50 billion in 2022, and it is expected to reach around USD 90.05 billion by 2032, growing at a CAGR of 6.10% from 2023 to 2032.

Application Insights

The Cell & Gene Therapy segment is expected to grow faster during the forecast period. The growth is driven by the surge in research and development activities focused on innovative cellular and genetic treatments. The rising focus on personalized medicine and breakthroughs in gene editing technologies contribute to the growth of clinical trials within the cell & gene therapy application. Clinical trials in this field are rapidly growing to examine these therapies' efficacy, safety, and long-term outcomes, which maintain enormous potential for treating various diseases at the genetic level.

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Recent Developments:

• Nov 2023, AstraZeneca announced that the Phase III PACIFIC-2 clinical trial assessing Imfinzi (durvalumab) in combination with chemoradiotherapy (CRT) for unresectable Stage III non-small cell lung cancer (NSCLC) did not meet its primary endpoint.
• Nov 2023, UNITE4TB, a global collaboration of public and private entities aimed to accelerate the development of innovative Tuberculosis (TB) treatments, has launched its phase 2B/C clinical trial program, with the enrollment of the first participant in Cape Town, South Africa, marking a significant milestone. This announcement is a significant step forward for the project and the broader TB community, contributing to advancing TB research and improving the efficacy of delivering new treatments.
• Nov 2023, A standardized metric to enhance clinical trial design and outcome interpretation in type 1 diabetes.
• Oct 2023, Nivolumab and ipilimumab in recurrent or refractory cancer of unknown primary, a phase II trial.
• Oct 2023, CLDN6-specific CAR-T cells amplifying RNA vaccine in relapsed or refractory solid tumors: the phase 1 BNT211-01 trial.
• Oct 2023, Clinical trial links oncolytic immune activation to survival in glioblastoma.
• Oct 2023, Dalpiciclib and pyrotinib in women with HER2-positive advanced breast cancer: a single-arm phase II trial.
• Sept 2023 Amivantamab plus Lazertinib in Osimertinib-relapsed EGFR-mutant advanced non-small cell lung cancer: a phase 1 trial

Key Market Players:

• Parexel
• IQVIA
• Charles River Laboratory
• Omnicare
• Kendle
• Chiltern
• Pharmaceutical Product Development, LLC

Major Market Segments Covered:

By Phase

• Phase 1
• Phase 2
• Phase 3
• Phase 4

By Study Design

• Observational
• Interventional
• Expanded Access

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

By Service Type

• Protocol Designing
• Patient Recruitment
• Laboratory Services
• Site Identification
• Bioanalytical Testing Services
• Cell-based Assays
• Virology Testing
• Method Development, Optimization, & Validation
• Serology, Immunogenicity, & Neutralizing Antibodies
• Biomarker Testing Services
• PK/PD (Pharmacokinetics/Pharmacodynamics) Testing Services
• Other Bioanalytical Testing Services
• Analytical Testing Services
• Clinical Trial Supply & Logistic Services
• Clinical Trial Data Management Services
• Decentralized Clinical Services
• Medical Device Testing Services
• Others

By Sponsor

• Pharmaceutical & Biopharmaceutical Companies
• Medical Device Companies
• Others

By End User

• Hospital
• Laboratories
• Clinics

By Application

• Vaccine
• Cell & Gene Therapy
• Small Molecules
• Other Applications

By Geography

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa (MEA)

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