Clinical Trials Market - By Phase (I, II, III, IV), Study Design (Interventional, Observational, Expanded Access), Service Type (Outsourcing, In-house), Therapeutic Area (Oncology, Dermatology, Neurology, Cardiology) – Global Forecast (2024 – 2032)

Clinical Trials Market - By Phase (I, II, III, IV), Study Design (Interventional, Observational, Expanded Access), Service Type (Outsourcing, In-house), Therapeutic Area (Oncology, Dermatology, Neurology, Cardiology) – Global Forecast (2024 – 2032)

Clinical Trials Market Size

Clinical Trials Market size was valued at USD 55.8 billion in 2023 and is estimated to grow at 5.4% CAGR from 2024 to 2032. The market has seen considerable growth due to the increasing prevalence of chronic diseases and the subsequent demand for innovative therapies.

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The growing incidence of chronic conditions such as cancer, diabetes, and cardiovascular diseases has underscored the need for cutting-edge and effective treatments, thereby fueling the demand for novel therapies and interventions that aim to expand clinical studies and improve patient outcomes. According to the data by ClinicalTrials.gov reports, as of May 17, 2023, a total of 452,604 registered clinical trials, with 64,838 actively recruiting participants globally. This marked a significant rise from the roughly 365,000 trials recorded in early 2021.

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The evident growth featured the continuous expansion of clinical studies at a significant pace, drawing significant investments from pharmaceutical companies and healthcare organizations, thereby expanding market growth. Additionally, advancements in biotechnology and personalized medicine are accelerating the development of targeted therapies, further driving the growth of the clinical trials market.

Clinical trials is a prospective biomedical or behavioral research study involving human participants to evaluate the safety and efficacy of experimental medical treatments or behavioral interventions. It is designed to answer specific questions about new treatments, including novel vaccines, drugs, dietary choices, dietary supplements, and medical devices. Clinical trials generate data on dosage, safety, and efficacy and are conducted after receiving approval from health authorities and ethics committees.

Clinical Trials Market Trends

High trial complexity, coupled with robust pipelines and stringent regulations for conducting trials are factors influencing the spending on clinical development services outsourcing. The complexity involves a greater number of trial procedures, access to specialized patient populations, regulatory challenges in emerging markets, and mandated documentation such as REACH legislation and other regulatory requirements that have diverted the companies towards outsourcing. This has resulted in significant outsourcing of clinical trials, thereby propelling the market growth.

• Research indicates that, on average, approximately 64% of clinical development services are outsourced, contrasting with only 38% to 40% conducted internally. More than 60% of sponsors have expanded outsourcing by forming strategic partnerships and utilizing functional outsourcing. This increasing preference for outsourcing is a significant driver of market growth, facilitating enhanced efficiency, access to specialized expertise, and streamlined operations in clinical trials.
• Additionally, leveraging contract research organization services enables manufacturers and sponsors to focus on production capacity and improve internal processes. The wide range of available services, from drug discovery to post-marketing surveillance, simplified operations for mid-sized and small-scale pharmaceutical and biotechnology firms, allowing them to outsource research and development activities and reduce infrastructure investments.
• For instance, in November 2023, Syneos Health expanded its clinical trial capabilities in China through a collaboration with GoBroad Healthcare Group. This collaborative agreement aimed to expand the opportunities in the China market.

Clinical Trials Market Analysis

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Based on the phase, the market is categorized as phase I, phase II, phase III, and phase IV. The phase II segment is set to lead the market, accounting for the largest revenue of USD 23.4 billion in 2023, anticipating its dominance throughout the forecast period with a CAGR of 5.2%.

• The high segmental revenue is due to the growing number of industry-sponsored and non-industry-sponsored clinical trials in phase II, the complexity associated with phase II clinical trials, and the globalization of clinical trials.
• Phase II trials are the second most expensive stage after phase III studies, involving two parts that include exploring a range of doses and efficacy studies and finalizing the dose. The FDA estimated that around 33% of investigational drugs are usually under phase II trial, and numerous therapeutics and vaccines are currently in phase II for oncology treatment.
• For instance, according to the World Health Organization’s International Clinical Trials Registry Platform (ICTRP), as of February 2023, out of 271,906 clinical trials in a known phase of development, 35% were in Phase II. By May 2023, Phase II trials accounted for 74,432 clinical studies, constituting 36% of the total registrations. This significant representation of Phase II trials underscored their pivotal role in evaluating the efficacy and safety of new treatments before advancing to larger-scale Phase III trials and eventual regulatory approval processes.

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Based on study design, the clinical trials market is classified into an interventional study, observational study, and expanded access study. The interventional study segment holds the largest market share of 76.6% in 2023 and is expected to maintain dominance throughout the analysis period.

• The interventional study segment dominated the market due to its widespread use and effectiveness in evaluating new medical interventions.
• Interventional studies account for the largest percentage of all clinical investigations, with the majority focused on testing new drugs, biologics, clinical procedures, behavioral interventions, and medical devices.
• Also, they are preferred for researchers as it allows to actively control and manipulate the variables being studied, minimizing confounding effects and efficiently detecting even small to moderate clinically important impacts. Therefore, growing number of industry-sponsored and non-industry-sponsored interventional trials is a key driver of the segment's dominance in the market.

Based on the service type, the clinical trials market is segmented into outsourcing service and in-house service. The outsourcing service segment is projected to reach USD 58.3 billion by 2032.

• The outsourcing segment dominated the market due to the increasing complexity of clinical trials and the need for specialized expertise. Pharmaceutical and biotechnology companies outsource clinical trials to CROs to streamline operations, reduce costs, and access specialized services. Also, CROs provide comprehensive services, including clinical trial management, data management, regulatory affairs, and patient recruitment.
• Thus, the growing demand for innovative treatments, advancements in technology, and the need for efficient resource utilization drive the outsourcing trend further expanding the market growth.

Based on the therapeutic area, the clinical trials market is segmented into autoimmune disease, oncology, cardiology, infectious disease, dermatology, ophthalmology, neurology, hematology, and other therapeutic areas. The oncology segment dominated the market with the highest share in 2023 exhibiting a growth rate of 4.5% during the analysis period

• The prevalence of cancer continues to rise globally, necessitating continuous innovation in treatments and therapies.
• Oncology trials often involve a diverse range of studies, including those focused on chemotherapy, immunotherapy, targeted therapy, and combination therapies, addressing various types and stages of cancer. For instance, according to the WHO ICTRP, the number of registered oncology clinical trials has steadily increased, from approximately 19,211 in 2013 to 26,396 in 2022. The uptrend was observed due to the significant breakthroughs in immunotherapies, precision medicine, gene therapy, and combination therapy, thereby solidifying the oncology prominence.
• Further, pharmaceutical and biotech companies are heavily investing in oncology research to capitalize on the significant market potential and address the pressing need for effective treatments. Similarly, advancements in molecular biology and genetics have enabled the development of personalized oncology treatments, further driving the demand for clinical trials in the oncology segment.

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The U.S. dominated the North American clinical trials market accounting for USD 27.3 billion in 2023 and is anticipated to show considerable growth over the analysis period.

• The U.S. holds a leading position in the North American market driven by a well-established healthcare system and infrastructure, with significant government and private investments in R&D. For instance, according to the National Institutes of Health (NIH), the U.S. federal government's investment in biomedical research reached USD 42.1 billion in 2022, providing a strong foundation for clinical trials.
• In addition, the high prevalence of chronic diseases, such as cancer, cardiovascular diseases, and diabetes, drives the demand for new and innovative treatments in the U.S. market. For instance, according to the American Cancer Society, cancer is the second leading cause of death in the U.S., with an estimated 1.9 million new cases and 609,360 deaths in 2022. Thus, the high prevalence of chronic diseases led to a surge in demand for personalized medicines, which in turn accelerated the research activities and expanded clinical trials studies in the country.
• Additionally, the well-established regulatory framework for clinical trials, providing guidelines streamlining approval processes, and the presence of leading pharmaceutical and CRO companies further bolsters the U.S. market's growth.

Germany exhibited a high growth potential in the European clinical trials market.

• Germany boasts a strong research base with large and diverse pharmaceutical industry players and academic institutions actively involved in clinical trials. According to a report published by Germany Trade & Invest, Germany has a robust research infrastructure, with 45 university hospitals and 118 clinical institutes involved in clinical trials, providing a strong foundation for conducting clinical trials.
• In addition, Germany's prominence in the European market is further bolstered by regulatory support for clinical research. Initiatives such as the Federal Ministry of Education and Research (BMBF) and the German Research Association (DFG) provide funding for clinical trials, solidifying Germany's position as a hub for research studies in the region.

The Asia Pacific clinical trials market is poised for rapid growth with a CAGR of 6% during the forecast period.
 

• The rising prevalence of chronic disease emerged the need for novel treatment options to explore opportunities number in the Asia Pacific region market. For instance, over the past five years, the number of clinical trials in the APAC region has consistently risen, from 11,571 trials in 2019 to 14,346 trials in 2023. This rise in trials is owing to supportive environment, patient population and per patient recruitment cost.
• This has further aimed to enhance the APAC's clinical research capabilities, with countries such as Australia, that offer incentives such as the Research and Development Tax Incentive (R&DTI), while Taiwan provides additional incentives to attract global clinical trials, including extended market exclusivity and higher reimbursement rates for drugs tested in the country.
• Thus, growing government support and research investment fosters the market in the region.

Clinical Trials Market Share

The global clinical trials industry is marked by a diverse range of stakeholders, including pharmaceutical and biotechnology companies, CROs, academic institutions, and healthcare providers. Key players in the market have established themselves through comprehensive service offerings that include clinical trial management, clinical trial data management systems, regulatory affairs, and patient recruitment. In addition, the companies are leveraging cutting-edge technologies such as artificial intelligence (AI) and machine learning to streamline trial efficiency and enhance data analysis capabilities to further solidify their market presence.

Clinical Trials Market Companies

Few of the prominent players operating in the clinical trials industry include

• Charles River Laboratories (MPI Research)
• Clinipace Inc.
• Eli Lilly and Company
• ICON plc
• IQVIA Inc
• Laboratory Corporation of America Holdings (Covance Inc)
• Medpace, Inc.
• Merck & Co
• Parexel International Corporation
• Pfizer Inc.
• SGS SA
• Syneos Health
• The Emmes Company, LLC
• Thermo Fisher Scientific (PPD Inc)
• Veeda Clinical Research
• Worldwide Clinical Trials
• WuXi AppTech

Clinical Trials Industry News

• In April 2024, Hanmi Pharmaceutical has partnered with MSD (Merck & Co.) to collaborate on clinical trials and supply agreements for BH3120, an immuno-oncology drug. The Phase I trial will evaluate BH3120's safety and efficacy in combination with Keytruda (pembrolizumab), MSD's anti-PD-1 therapy. This collaboration aimed to accelerate the clinical development of BH3120 for potential future treatments in oncology.
• In April 2024, Parexel forged a strategic partnership with Palantir Technologies Inc. to utilize AI in accelerating the delivery of safe and effective clinical trials for global biopharmaceutical customers. Through this collaboration, Parexel will harness Palantir’s Foundry and Artificial Intelligence Platform (AIP) to bolster its clinical data platform, aiming to enhance trial efficiency while upholding stringent safety and regulatory standards.

The clinical trials market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments

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Market, By Phase

• Phase I
• Phase II
• Phase III
• Phase IV

Market, By Study Design

• Interventional study
• Observational study
• Expanded access study

Market, By Service Type

• Outsourcing service
• In-house service

Market, By Therapeutic Area

• Autoimmune disease
• Oncology
• Cardiology
• Infectious disease
• Dermatology
• Ophthalmology
• Neurology
• Hematology
• Other therapeutic areas

The above information is provided for the following regions and countries

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Poland
  • Netherlands
  • Switzerland
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Singapore
  • Malaysia
  • Indonesia
  • Thialand
  • Philippines
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East and Africa