Clinical Trials Market – By Phase, By Study Design, By Therapeutic Area, By Service Type – Global Forecast 2025 – 2034

Clinical Trials Market Size

The global clinical trials market accounted for USD 59 billion in 2024. The market is anticipated to grow from USD 62.4 billion in 2025 to USD 98.9 billion in 2034 growing at a CAGR of 5.2%. Increasing prevalence of chronic diseases and a consequent rise in the demand for novel therapeutics is a key factor driving the market.
 

The growing incidence of chronic conditions such as cancer, diabetes, and cardiovascular diseases has underscored the need for cutting-edge and effective treatments, thereby fuelling the demand for novel therapies and interventions that aim to expand clinical studies and improve patient outcomes. Chronic diseases are currently the major cause of death among adults in almost all countries, and the toll is projected to increase by a further 17% in the next 10 years. Globally, approximately one in three of all adults suffer from multiple chronic conditions.
 

With rising prevalence of chronic diseases, the demand for effective therapies also increases, prompting pharmaceutical and biotechnology companies to develop new drugs. 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. This increasing number of clinical trials being conducted worldwide is the major factor driving the market growth over the forecast period.
 

Additionally, growing R&D expenditure and increasing number of drugs in various phases is anticipated to significantly boost the clinical trials market growth. Pharmaceutical and biopharmaceutical industry has one of the highest R&D expenses worldwide. Therefore, this will encourage various biopharma and pharma companies to outsource clinical trials services, thereby augmenting the market growth.  For example, Center for Drug Evaluation and Research (CDER) approved 50 novel drugs in the U.S. during 2024 alone.
 

Thus, the need for well-established contract research organizations for outsourcing clinical trials is expected to fuel the market growth over the forecast period. Moreover, innovations in technology and personalized medicine are accelerating the development of targeted therapies, are another key driver accelerating industry growth.
 

Clinical trials are large-scale research studies assessing novel tests and treatments and evaluating its effects on human health outcomes. Individuals voluntarily participate in clinical trials to test medical interventions including drugs, medical devices, and other biological products. The clinical trials are conducted in four phases and require to be approved before initiation. People of all ages can participate in clinical trials.
 

Clinical Trials Market Trends

• The emergence and outburst of various chronic and infectious diseases have produced several challenges and lucrative opportunities for researchers to develop new diagnostic tests, tools, vaccines, and drugs for early detection, prevention, and treatment of such diseases. Hence, the growing prevalence of chronic diseases and increasing awareness against these diseases has surged the demand for effective medications in turn increasing the demand for clinical trials, thus boosting the market growth over the forecast period.
   
• The Asia Pacific region has recognized to be the hot spot for performing clinical trials owing to the growing patient population, low cost of conducting studies, the ease of regulatory compliance, and the availability of some of the top clinical institutions acting as trial locations. For instance, the total clinical trial expenditure in Asia is noted to be around 30 – 40% lower than the EU and the U.S. Hence, the demand for clinical trial services is rising tremendously in emerging economies such as Asian countries.
   
• For instance, between 2017 and 2021, over 70,000 new clinical trials were registered in the APAC region, the U.S., and the EU5. The APAC region was the largest contributor, with more than 50% of the trials followed by the U.S. (29%) and the EU5 (17%). Thus, as an increasing number of clinical trials are conducted in the emerging economies of Asia Pacific, the clinical trials market anticipated to witness an optimistic market growth.
   
• Furthermore, increasing R&D investments for the development of innovative medications are expected to propel the market growth over the forecast period. Some of the leading pharmaceutical and medical device companies are noted to significantly increase spending on their research activities. For instance, in 2023, research and development spending in the pharmaceutical industry exceeded USD 300 billion globally.
• Moreover, pharmaceutical companies are increasingly adopting R&D outsourcing strategies to maximize their operational performance. Such strategic initiatives offer flexibility and a competitive edge for technological advancement, specialized services with highly skilled professionals, and economic stability to these firms.
   
• Furthermore, favorable government funding is expected to boost the market growth. The government funding agencies and pharmaceutical companies are increasingly funding several clinical trials. For example, in UK, the government sponsors health associated research through organizations such as the Medical Research Council (MRC) and the National Institute for Health Research (NIHR). They also assist to coordinate cancer research on a national level through the NCRI (National Cancer Research Institute). Similarly, the NCI (National Cancer Institute) funds about half of all cancer trials in the U.S. Thus, increasing funding from the government and non-government organizations are supporting the growth of the market.
   

Clinical Trials Market Analysis

Based on the phase, the market is classified into phase I, II, III, and IV. The phase III segment accounted for USD 29.3 billion in 2024. The segment was valued at USD 26.4 billion, 27.3 billion, and 27.5 billion in 2021, 2022, and 2023, respectively.
 

• Due to their crucial contribution, resource allocation, and confirmatory role in drug development, phase III clinical trials dominate the market. These trials are performed to validate the effectiveness and safety measures of a drug on a large scale, usually comprising thousands of subjects distributed over many geographical locations or sites. The aim of phase III clinical trials is to determine and confirm the primary evidence collected in the earlier phase trials that drug is beneficial, safe and provides effective treatment for the desired indication.
   
• Before granting a marketing authorization, regulatory bodies such as the FDA and EMA need sufficient phase III evidence, making this the most time-consuming and costly stage of clinical development.
   
• Moreover, pharmaceutical and biotechnology companies allocate significant resources into phase III trials because of their essential role in establishing a drug's market potential. These trials frequently need elaborate physical facilities and partnerships with CROs for proper large-scale processing, thus contributing towards high market growth.
   

Based on the study design, the clinical trials market is segmented into interventional study, observational study, and expanded access study. The interventional study segment dominated the market in 2024 and is anticipated to grow at a CAGR of 5% over the forecast years.
 

• Interventional study segment is anticipated to witness considerable market growth owing to various advantages associated with this study. The advantages include elimination of recall bias, as the data on exposure are obtained before disease develops.
   
• Furthermore, interventional study is considered to be among the highest hierarchical pyramid of evidence, as it provides an enhanced way to measure the efficiency of new interventions.
   
• The study is likewise noted to be used in most of the clinical trials, thus resulting into an increased demand and high segmental development.
   
• The study is carried for majority of drugs or biologics followed by clinical procedures and device intervention studies, thereby increasing the demand for such studies in the future.
   

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 38.4% market share in 2024 and is anticipated to grow at a CAGR of 5.9% over the forecast years.
 

• Increasing prevalence of cancer has compelled sponsors to focus on developing different therapies and medical devices for better management of cancer, resulting in increased number of clinical trials and discovery of various drugs for the cancer treatment.
   
• For instance, as per the WHO, over 35 million new cancer cases are predicted in 2050, a 77% increase from the estimated 20 million cases in 2022. Such rising cancer burden increases the demand for new cancer treatments resulting in high R&D investments to develop cancer drugs. In 2023, the U.S. FDA issued more than 60 oncology approvals, including for 11 first-in-class therapeutics.
   
• Hence, growing prevalence of cancer burden coupled with rising development and approvals of cancer drugs will foster the oncology segment growth.
   
• Moreover, the rising focus of manufacturers for development of novel diagnostic technologies is anticipated to influence the growth potential of the oncology segment.
   

Based on the service type, the clinical trials market is bifurcated into outsourcing service and in-house service. The outsourcing service segment held dominated the market in 2024 and is anticipated to reach USD 67.3 billion by 2034.
 

• Pharmaceutical, biotechnology, and medical device companies outsource their trial management to CROs for efficiency and cost saving. The growing complexity in conducting clinical trials has also fuelled the need for outsourcing services.
   
• In addition, the increasing number of firms conducting global clinical trials makes it essential to utilize CRO services because these firms have established regional hubs around the world for easier and quicker subject enrolment and regulatory approval processes.
   
• Moreover, pharmaceutical companies are increasingly adopting R&D outsourcing strategies to maximize their operational performance. Outsourcing clinical trials offers flexibility and a competitive edge for technological advancement, specialized services with highly skilled professionals, and economic stability to these firms. This also helps to reduce capital investment associated with huge lab equipment and allows the companies to focus on core expertise.
   
• Additionally, small to medium biopharma companies tend to lack the resources necessary to perform large-scale trials and as a result are highly dependent on CROs to manage intricate regulatory hurdles and resource distribution.
   

The North America clinical trials market dominated the global market in 2024 with a market share of 54.6%. The U.S. market was valued at USD 27 billion in 2021. In 2023, the U.S. dominated the North America market with a revenue of USD 27.8 billion growing from USD 27.7 billion in 2022.
 

• The significant market growth is attributed to higher density of pharmaceutical and biotechnology companies across the North America region. For example, the U.S. pharmaceutical industry is at the forefront of the global pharmaceutical industry, capturing almost half of the global sales revenue of pharmaceuticals.
   
• Further, increasing complexity in drug development, including precision medicine and biologics, makes it necessary for biopharmaceutical and pharmaceutical companies to invest into clinical trials.
   
• Further, significant funding from government bodies to promote clinical trials aids in the market growth. For instance, in 2023, clinical research funding by the NIH was around USD 18.9 billion.
   
• Moreover, increasing focus of pharmaceutical and biotechnology for outsourcing clinical trials for treatment of various disease is expected to fuel the North America market growth.
   

Europe clinical trials market is projected to reach USD 24.2 billion by the end of 2034.
 

• The increasing market growth is attributed to growth disease burden and increasing awareness for early diagnosis and effective treatment. Furthermore, the presence of key market players in the region adds up to the increasing regional growth.
   
• Additionally, growing R&D expenditure in the region further exacerbates the market growth. For instance, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA), the pharmaceutical R&D expenditure increased from USD 48.8 billion in 2022 to USD 51 billion in 2023.
   
• Also, government funding for drug discovery and related research studies are some of the prominent factors fostering market growth.
   

Germany clinical trials market is anticipated to witness rapid growth over the forecast years.
 

• Factors such as increasing number of clinical trials in the country, high R&D investments, and presence of leading pharma and medical device companies in the country foster market growth.
   
• As per sources, in 2021, Germany invested over USD around 9 billion in pharmaceutical R&D. This is more than any other European country. Similarly, in 2024, around USD 12.5 billion of expenditure was planned for pharmaceutical product innovation in Germany.
   
• Such high investments in the pharmaceutical R&D are anticipated to boost the market growth.
   

Asia Pacific clinical trials market is estimated to show robust CAGR of 5.7% during the forecast period.
 

• This substantial growth is attributed to increasing prevalence of chronic diseases such as cardiac diseases, cancer, and diabetes in the region, which is expected fuel the demand for drugs thereby accelerating the clinical trials industry growth.
   
• Furthermore, the regional disease burden, increase in outsourcing by pharmaceutical and biotechnology companies, and a paradigm shift towards outsourcing has led to positive conditions for the market revenue in the Asia Pacific countries.
   
• Increasing number of trials being outsourced to countries such as India, China, Japan, and South Korea as well as ASEAN countries due to a large patient pool and low cost is propelling the market in Asia Pacific.
   

China clinical trials market is anticipated to experience remarkable growth over the forecast period.
 

• High market growth in the country can be attributed to the strong government support for healthcare research, expanding pharmaceutical and biotechnology industries, and increasing demand for innovative therapies.
   
• The country is becoming a leading hub for early-phase trials, especially in oncology, neurology, and rare diseases owing to the presence of large number of CRO's in the region and low price compared to the U.S. and Europe.
   
• Also, large patient pool, digital health technologies, and favorable regulatory policies are other factors that drive the market growth.
   

Brazil clinical trials market is expected to showcase significant growth in the Latin America market.
 

• With its highly skilled workforce and low operational costs, the country is ideal for clinical trials. Also, its diverse patient population attracts global pharmaceutical and biotechnology enterprises.
   
• Further, the country's improving regulatory environment, along with a growing focus on research and development, enhances its attractiveness for global pharmaceutical companies.
   

South Africa clinical trials industry is anticipated to witness rapid growth in the Middle East and Africa clinical trials market.
 

• The country's developing healthcare infrastructure, large patient pool, and low operational costs make it attractive for global pharmaceutical companies.
   
• Additionally, South Africa's favourable regulatory framework and increasing focus on development of new therapeutics drives the market in the country.
   

Clinical Trials Market Share

The major players operating in the clinical trials industry include Charles River Laboratories, Laboratory Corporation of America Holdings, IQVIA, ICON plc, and Syneos Health, among others. These top 5 players account for approximately 38% of the global market. These market players focus on strategies such as mergers, acquisitions, innovative service development and launches, and collaboration to generate more revenue and withstand market competition.
 

For instance, in September 2021, IQVIA announced the partnership with NRx Pharmaceuticals. This partnership was focused on providing medical information and pharmacovigilance services in preparation for effective regulatory actions and allow NRx to use IQVIA’s domain experience with COVID-19, data analytics, and assets to assist potential EUA (emergency use authorization) of ZYESAMI.
 

Other players such as PAREXEL International Corporation, Veeda Clinical Research, and Medpace among others have also undertaken various strategic initiatives including service approval and launch to develop a competitive edge. For instance, in July 2021, Parexel collaborated with CHCAMS (Cancer Hospital Chinese Academy of Medical Sciences) to design patient-centric protocol methodologies and designs for clinical trials in China. This collaboration improved the quantitative research to boost the clinical trial experience of cancer patients. This strategy aided the company in strengthening its market presence.
 

Clinical Trials Market Companies

Prominent players operating in the clinical trials industry include:

• Charles River Laboratories
• Clinipace
• Eli Lilly and Company
• ICON
• IQVIA
• Laboratory Corporation of America Holdings (Covance Inc)
• Medpace
• Merck & Co
• Parexel International Corporation
• Pfizer
• SGS SA
• Syneos Health
• The Emmes Company
• Thermo Fisher Scientific (PPD)
• Veeda Clinical Research
• Worldwide Clinical Trials
• WuXi AppTech
   
• IQVIA is a leading global contract research organization (CRO) that provides advanced clinical trial services, leveraging AI-driven analytics, real-world evidence, and decentralized trial solutions. In October 2021, IQVIA established a 160,000-square-foot lab center for its Q2 Solutions subsidiary. The new center provided innovative suite of laboratory abilities, comprising of cutting edge bioanalytical, genomics, vaccine, and biomarker laboratories and offers solution to the industry with several laboratory disciplines under the same facility for biomarker development and delivery. This strategy was targeted at improving the company’s overall market presence.
   
• LabCorp offers comprehensive clinical trial services, including drug development, central laboratory testing, and patient recruitment. In December 2021, Labcorp acquired Toxikon Corporation, a CRO providing nonclinical testing services. The acquisition of Toxikon improves the company’s robust nonclinical development portfolio and helps in creating a strategic footprint for the company to collaborate with biotechnology and pharmaceutical clients.
   

Clinical Trials Industry News:

• In February 2024, ICON plc acquired HumanFirst, a cloud-based technology company specializing in precision measurement for patient-centered clinical research. By integrating HumanFirst's cutting-edge technology, ICON plc enhances its ability to measure patient outcomes with greater accuracy and reliability, thereby increasing the precision and efficiency of clinical trials. This acquisition aligns with ICON's dedication to providing high-quality, data-driven solutions, ultimately advancing more effective and personalized research results for its clients.
   
• In January 2024, Parexel and the Japanese Foundation for Cancer Research (JFCR) announced a strategic alliance to accelerate access to oncology clinical trials in Japan.
   
• In February 2023, LabCorp announced the spin-off of its Clinical Development business into Fortrea, an independent publicly traded global CRO with over 19,000 employees, providing comprehensive drug and medical device development services. Following this spin-off, LabCorp restructured its operations, renaming the remaining drug development segment as the biopharma laboratory services segment.
   
• In September 2021, Syneos Health acquired StudyKIK, a leading technology-enabled and retention clinical trial recruitment organization. This acquisition augmented Syneos Health’s ability to offer insight-powered solutions and boost the clinical trial recruitment, diversity, and retention of the company.
   
• In July 2021, ICON plc completed the acquisition of PRA Health Sciences. The combined company was reported to retain the name ICON and incorporate over 38,000 employees across 47 countries. This consolidation helped the company  enhance its operational capabilities using the outstanding talent of both companies to deliver enhanced value to patients, customers, employees and shareholders.
   
• In April 2021, Clinipace Inc. and dMed Global, a full service clinical CRO based in China, declared their merger. The merger was focused at growing the company’s geographic presence across the world.
   

The clinical trials market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 – 2034 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 Therapeutic Area

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

Market, By Service Type

• Outsourcing service
• In-house service

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
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Singapore
  • Malaysia
  • Indonesia
  • Thailand
  • Philippines
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE