Clinical Trials Market (By Phase: Phase 1, Phase 2, Phase 3, and Phase 4; By Study Design: Observational, Interventional, and Expanded Access; By Indication: Oncology, Autoimmune/Inflammation, Diabetes, Central Nervous System, Cardiovascular, Pain Management, and Others) - Global Market Size, Share, Trends Analysis, Segment Forecasts, Regional Outlook 2024 - 2033


Clinical Trials Market Size and Growth 2024 to 2033

The global clinical trials market size was valued at USD 57.37 billion in 2023 and is predicted to hit USD 90.59 bn by 2033 with a registered CAGR of 4.67% during the forecast period 2024 to 2033. The U.S. clinical trials market size was valued at USD 27.81 billion in 2023.

Clinical Trials Market Size 2024-2033

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Clinical Trials Market Key Takeaways

  • North America has held 53.48% of the total market share in 2023.
  • Asia Pacific region is growing at a CAGR of 7.16% during the forecast period.
  • By therapeutic area, the oncology segment has held a market share of around 38.10% in 2023.
  • By study design, the interventional study segment has captured 77.77% market share in 2023.
  • By phases, phase III has accounted for a market share of 48.93% in 2023.

Key Market Insights:

Clinical trials are a process of clinical research that is governed by a defined protocol which is carefully established to answer a precise patient care query. Clinical trials can be divided into five phases, with every phase playing a distinct purpose within the clinical trial. Every trial adheres to a procedure that designates what types of individuals may participate in the study.

The trials also outline exact plan of procedures, tests, medications, and doses within the trial apart from specifying the span of the study. In recent years, the costs associated with drug development have increased significantly, driving pharma and biotech companies to look for modernizations and smarter ways of conducting business.

One important trend is the outsourcing of clinical research activities by manufacturers. By subcontracting their R&D activities, pharma and biotech companies are reforming the drug development facilities business. The R&D service providers have risen from just a few establishments providing restricted clinical trial facilities to big conglomerates offering a extensive range of facilities like study design, preclinical evaluations, clinical trial management and planning, autonomous safety data audit, bio-statistical analysis and several more. CROs (Contract Research Organizations) started off by providing preclinical & clinical trial services, however they are now venturing into project administration.

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

Clinical Trials Market Size in U.S. 2024 to 2033

The U.S. clinical trials market size was estimated at USD 27.81 billion in 2023 and is expected to reach around USD 39.24 billion by 2033 with a CAGR of 3.50% from 2024 to 2033.

Clinical Trials Market Size in U.S. 2024 to 2033

The research study covers key prospects and trends of clinical trials products throughout different regions including Europe, North America, Asia-Pacific, Middle East and Africa, and Latin America. Regionally, clinical trials market is dominated by North America due to high incidence of chronic disorders and presence of latest healthcare infrastructure. North America accounted largest revenue share 53.48% in 2023.

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

On the other hand, Asia-Pacific is anticipated to witness the rapid growth rate 7.16%, on account of increasing investment by governments in research and growing awareness regarding precision medicine.

  • The North America clinical trials market was valued at USD 30.68 billion in 2023 and it is expected to grow at a CAGR of 3.41% over the forecast period.
  • The Europe clinical trials market was valued at USD 13.62 billion in 2023 and it is expected to grow at a CAGR of 4.83% over the forecast period.
  • The Asia Pacific clinical trials market was valued at USD 9.92 billion in 2023 and it is expected to grow at a CAGR of 7.16% over the forecast period.
  • The MEA clinical trials market size was valued at USD 757.9 million in 2023 and is expected to reach at a CAGR of 6.08% from 2024 to 2033.

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

  • 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.

Clinical Trials Market Report Scope

Report Highlights Details
Market Size USD 90.59 Billion by 2033
Growth Rate CAGR of 4.67% from 2024 to 2033
Largest Market North America
Fastest Growing Market Asia Pacific
Base Year 2023
Forecast Period 2024 to 2033
Segments Covered Phase, Study Design, Indication
Companies Mentioned Parexel, IQVIA, Charles River Laboratory, Omnicare, Kendle, Chiltern, and Pharmaceutical Product Development, LLC.

 

Clinical Trials Market Drivers

ADOPTION OF NEW TECHNOLOGY IN CLINICAL RESEARCH

Digitization in biomedical research is also paving the way for the market growth. Digitization also helps in meeting stringent regulations by maintaining patient data records that reduces trial process errors through adoption of software such as electronic clinical outcome assessment (e-COA). Digitization helps in streamlining the clinical trial process thereby probing sponsors to invest more in the clinical trial process as chances of successful clinical trials are more through the adoption of newer technologies.

SHIFT TOWARDS PERSONALIZED MEDICINE

The paradigm shift towards personalized medicine is expected to have a positive impact on the clinical trial market. The classic clinical trial process is carried out on thousands of people while personalized medicine will focus only on the effect of drugs on individual patients for a specific period. Very few medicines in the development phase pass all phases of a clinical trial due to the traditional clinical trial approach. The mentality of “one size will fit all” is acting as a barrier for drugs that are currently in pipeline but would never see the day. The use of pharmacogenetics in the clinical trial process is expected to increase the number of drugs passing all phases of the clinical trial process. The shift towards personalized medicine is expected to increase the use of pharmacogenetics in the clinical trial phase thereby increasing the pipeline of drugs. This trend is expected to instigate biopharmaceutical companies to invest more in the clinical trial phase.

GROWING DISEASE VARIATION AND PREVALENCE

Growing prevalence of disease and incidence of new disease is expected to give further boost to the clinical trial market. Worldwide population has varied disease profile with emerging countries having the most diverse disease profile. This is expected to boost the clinical trial of new or rare disease which otherwise would not have found any sponsors. More number of patients having a specific disease would act as a stimulus for biopharmaceutical companies to invest more in clinical trials for a disease segment. Diverse population would also mean easy recruitment of patients and faster clinical trial process. Rare diseases are given a status of “Orphan disease” in U.S and biopharmaceutical companies who sponsor clinical trials for Orphan drugs would get incentives for the process. This trend is likely to have a positive impact on clinical trials for rare disease thereby increasing the global clinical trials market.

INCREASING COLLABORATION IN BIOMEDICAL RESEARCH

The trend of combination trials and collaborations in clinical trial is expected to rise which would further boost the global clinical trials market. Due to high drug development cost biopharmaceutical companies are now forming an alliance with each other to increase the resources and share the risk of high cost. Immuno-oncology collaborations in 2015 is a prime example of increase collaboration to combat risk associated with clinical trials. Recent example of immuno-oncology collaboration is of MSD and Lily for clinical trial phase for treatment of advanced soft tissue sarcoma.

The race to launch the molecule in the market in a feasible timeline and cost will propel the need for CROs service provides. The pharmaceutical companies, along with the increased research cost, also witness global regulation complexity. All of these variables create a need for expertise in different portfolios, driving the need for outsourcing the market. Drug companies are not only outsourcing the production of medicines but also clinical trials. With the increasing clinical trial privatization, there is a surge in outsourcing to developing countries such as India, China, and Latin America.

Phase Insights

The phase 3 segment held the largest share in clinical trials market in 2023. The phase 3 clinical trials market includes a wide range of activities associated with the last phase of testing for novel medications, medical devices, and treatments prior to their approval for use by the general public by regulatory bodies such as the European Medicines Agency (EMA) in Europe or the Food and Drug Administration (FDA) in the United States. Phase 3 trials demand a substantial time and financial commitment. To support these studies, companies frequently look to investors, venture capitalists, or government grants for funding. Risk management is considerably more important in Phase 3 studies because a larger and more diversified patient group is being tested.

Clinical Trials Market Share, By Phases, 2023 (%)

On the other hand, the phase 2 segment is expected to be the fastest growing market. One important phase in the medication development process is the phase 2 stage of clinical trials. Phase 1 trials come after it, while Phase 3 trials come first. In phase 2, the main goals are to further analyze the safety profile of the drug candidate and determine how effectively it works in treating the intended condition or disease. The development of orphan medications and therapies for uncommon diseases is receiving more attention. In order to examine these innovative medicines in smaller patient populations, phase 2 trials are essential. Pharmaceutical companies frequently use CROs to handle their clinical trial operations in order to take advantage of their infrastructure and experience. This tendency of outsourcing helps fuel the market expansion for phase 2 clinical trials.

Study Design

The interventional studies segment held the largest share in the clinical trials market. In the clinical trials market, interventional studies are a particular subset of clinical trials that are intended to assess the efficacy and safety of novel medical procedures, therapies, or interventions. These studies are usually carried out with human subjects in order to collect information about the possible advantages and disadvantages of the intervention under study. Evaluating the efficacy and safety of novel medical devices, such as implantable gadgets, diagnostic tools, or surgical instruments, is the goal of clinical trials. In certain interventional research, a combination of intervention, such as a novel medication used in conjunction with an established therapy—may be tested to see if the combined strategy produces better results than either treatment alone.

Clinical Trials Market Share, By Study Design, 2023 (%)

The observational studies segment is expected to be fastest growing market. Because observational studies offer important insights into real-world patient experiences, treatment outcomes, and disease trends, they are vital to the clinical trials market. Researchers can collect information on a variety of aspects of health and disease through these investigations, which usually include observing people in their natural habitats without intervention. Studies that compare the efficacy of various therapies or interventions in actual environments are observational in nature. Through the examination of various outcomes, including survival rates, disease progression, and quality of life, scientists can determine which medicines work best for specific patient populations. Observational studies look at healthcare inequities, resource use, and delivery systems. Researchers can determine areas where healthcare delivery needs to be improved by examining variables including patient outcomes, healthcare costs, and access to care.

Indication Insights

The oncology segment holds the largest share in clinical trials market. A subset of the pharmaceutical and healthcare industries, the oncology clinical trials market is dedicated to carrying out research studies, or clinical trials, for novel medications, therapies, or treatments that are intended especially for cancer patients. Through assessing the safety and effectiveness of novel treatments prior to their approval for general use, this market is essential to the advancement of cancer research and the improvement of patient care. The value of patient participation in clinical research is becoming increasingly apparent. More patient-centered trials are being conducted as a result of the active participation of patient advocacy groups and organizations in clinical trial design and recruiting. Pharmacies are progressively carrying out clinical studies in a variety of geographical locations in order to reach a wider patient base, cut expenses, and expedite the medication development process.

The cardiovascular segment is expected to be fastest growing market. The market for cardiovascular clinical trials includes a wide range of research projects aimed at evaluating novel therapies, drugs, and medical equipment for different cardiovascular ailments. These studies are crucial for expanding our understanding of medicine, enhancing patient care, and getting new treatments approved by regulators. The need for clinical trials to create more potent therapies and interventions is fueled by the increased prevalence of cardiovascular illnesses (CVDs), which include heart disease, stroke, hypertension, and other conditions. As stakeholders work to alleviate the burden of cardiovascular diseases on healthcare systems, rising healthcare spending, especially in industrialized nations, makes funding for cardiovascular clinical trials easier. Expanding healthcare facilities and the increased incidence of cardiovascular disorders in developing nations offer chances to carry out clinical trials in areas with a variety of patient demographics and possibly reduced running expenses.

Clinical Trials Market Companies

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

In order to better recognize the current status of clinical trials, and policies adopted by the foremost countries, Precedence Research predicted the future evolution of the clinical trials market. This research study bids qualitative and quantitative insights on clinical trials market and assessment of market size and growth trend for potential market segments.

Major Market Segments Covered:

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

By Geography

    • North America
      • U.S.
      • Canada
    • Europe
      • Germany
      • France
      • United Kingdom
      • Rest of Europe
    • Asia Pacific
      • China
      • Japan
      • India
      • Southeast Asia
      • Rest of Asia Pacific
    • Latin America
      • Brazil
      • Rest of Latin America
    • Middle East & Africa (MEA)
      • GCC
      • North Africa
      • South Africa
      • Rest of Middle East & Africa

Frequently Asked Questions

What is the current size of the global clinical trials market?
Precedence Research announced, the global clinical trials market size was valued at USD 57.37 billion in 2023 and is expected to reach USD 90.59 billion by 2033.
What is the growth rate of clinical trials market?
The global clinical trials market is growing at a impressive CAGR of 4.67% during the forecast period 2024 to 2033.
Which factors driving the growth of the clinical trials market?
Factors such as 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, outbreak of viral diseases, increasing cases of cancer globally, growing geriatric population and growing research and development expenditure are propelling the clinical trials market expansion across the globe.
Which major companies are operating in the worldwide clinical trials market?
The major companies operating in the worldwide clinical trials market are Parexel, IQVIA, Charles River Laboratory, Omnicare, Kendle, Chiltern, and Pharmaceutical Product Development, LLC. among others.
Which study design segment is projected to dominate the clinical trials market revenue?
Interventional Study is projected to dominate the study design segment of clinical trials market revenue.
Why oncology segment is projected to dominate the clinical trials market?
Constant research on cancer treatment and increasing demand for precision medicine are the major reasons responsible for high market share of oncology.?
Why Asia-Pacific is anticipated to witness the rapid growth rate in the clinical trials market?
Asia-Pacific is anticipated to witness the rapid growth rate, on account of increasing investment by governments in research and growing awareness regarding precision medicine.
Why clinical trials?
Clinical Trials are a type of clinical research that are performed in people and are intended at assessing a behavioral, surgical, or medical intervention. Clinical Trials act as the prime way employed by the scientists to investigate if a new therapy, a medical device or anovel drug is secure and efficient in individuals.

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