Contract Research Organization (CRO) Market – By Service Type, By Therapeutic Area, By End Use, Global Forecast (2024 – 2032)

Contract Research Organization Market Size

The global contract research organization market accounted for USD 59.8 billion in 2023. The market is anticipated to grow from USD 63.3 billion in 2024 to USD 118.2 billion in 2032 growing at a CAGR of 8.1%. Increasing number of clinical trials being conducted worldwide is the major factor driving contract research organization industry growth over the forecast period. Growing emphasis of pharma companies on R&D activities for development of novel products will render positive impact on the CRO business. Also, innovations in technological advancements in clinical trials are another key driver accelerating industry growth.
 

Increasing focus of pharmaceutical companies on novel drug development for the treatment of various chronic diseases is the major factor driving the contract research organization industry growth. For example, Center for Drug Evaluation and Research (CDER) approved 50 novel drugs in the U.S. during 2024 alone. Moreover, increasing prevalence of chronic diseases is another prominent factor contributing to the rising number of clinical trials. 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. Thus, the need for well-established contract research organizations for outsourcing clinical trials is expected to fuel the market growth over the forecast period.
 

Contract research organization, also known as clinical research organization, is a company that assists in managing complex clinical research and trial responsibilities, drug discovery, clinical development, and commercialization of new products for sponsor companies, primarily in the biotechnology, pharmaceutical, and medical device industries. These organizations offer services such as clinical trial management, preclinical research, clinical research, commercialization, and pharmacovigilance among other research services. These are outsourced on contract basis, also known as fee-for-service basis.
 

Contract Research Organization Market Trends

• Over the last five years, the global clinical trial landscape has changed significantly. An increasing number of clinical trials are noted to be conducted in developing countries of Asia Pacific. This is mainly owing to the high population base in the region coupled with relatively lower capital investment as well as simplified regulatory pathways for conducting clinical trials.
   
• The high prevalence rate of various illnesses and limited access to treatments is another factor propelling the demand for clinical trials in the region. Also, 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 CRO services is rising tremendously in emerging economies such as Asian countries.
   
• For instance, between 2017-2021, 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 demand for contract research organizations is anticipated to witness an optimistic market growth.
   
• Furthermore, few 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.
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• Therefore, 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.
   
• This also helps to reduce capital investment associated with huge lab equipment and allows the companies to focus on core expertise. Thus, as numerous companies are outsourcing R&D activities owing to aforementioned benefits, it is expected to positively influence the industry revenue growth during the forecast period.
   
• Further, technology plays a valuable part in simplifying the clinical trial projects and in post-approval phase in the terms of clinical phase evidence. Thus, adoption of technologies by various contract research organizations will boost the market growth over the forecast period.
   

Contract Research Organization Market Analysis

Based on the service type, the contract research organization industry is classified into early phase development services, clinical research services, laboratory services, and regulatory consulting services. The clinical research services segment accounted for USD 31 billion in 2021. The segment dominated the market in 2023 with a revenue of USD 34.5 billion growing from USD 32.6 billion in 2022. The clinical research services are further sub-segmented into Phase I, Phase II, Phase III, Phase IV.
 

• The segmental growth is attributed to the increasing prevalence of chronic diseases and increasing demand for effective medications and diagnostics products.
   
• In addition, growing trend of outsourcing clinical trials by pharmaceutical and biotechnology companies has increased the demand for clinical research services. For instance, it is estimated that nearly three out of every four clinical trials are conducted by contract research organizations (CROs), thus highlighting high adoption of clinical research services.
   
• Also, the growing biopharmaceutical industry and the internationalization of clinical trials, especially in new areas, has increased the need for clinical research services.
   
• Various contract research organizations offer a wide range of clinical trial research services and support different areas of medical device and drug development.
   
• Moreover, strong emphasis by emerging economies towards the modification of public healthcare infrastructure will proliferate the demand for clinical research organizations during forecast years.
   

Based on the therapeutic area, the contract research organization market is segmented into oncology, clinical pharmacology, cardiology, infectious diseases, neurology, gastroenterology and hepatology, ophthalmology, and other therapeutic areas. The oncology segment dominated the market with 54.6% market share in 2023 and is anticipated to grow at a CAGR of 8.5% 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. Similarly, 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 end use, the contract research organization market is bifurcated into pharmaceutical and biopharmaceutical companies, medical device companies, and academic institutes. The pharmaceutical and biopharmaceutical companies segment held significant market share of 56% in 2023 and is anticipated to grow at 8.7% over the analysis period.
 

• The increasing segmental growth is majorly attributed to surge in outsourcing of clinical trials by pharmaceutical and biotechnology companies.
   
• Also, the growing complexity of clinical trials and the need for specialized expertise in areas like biologics and precision medicine is rising the demand for contract research organization, thereby facilitating the market growth.
   
• Moreover, increasing government support with increasing funding as well as subsidies with respect to conducting clinical trials is expected to promote the market over the forecast period.
   
• Additionally, increasing investment of pharma and biopharma companies in development of novel drugs coupled with growing prevalence of various chronic diseases such as cancer, cardiac diseases, neurological, and infectious diseases will further upsurge the demand for CRO services by pharmaceutical and biopharmaceutical firms.
   

The North America contract research organization market was valued at USD 23.4 billion in 2021. The U.S. dominated the North America contract research organization industry with a revenue of USD 22.6 billion in 2023 and is expected to reach USD 44.4 billion by 2032.
 

• Presence of numerous pharmaceutical and biotechnology companies in the U.S. increases the demand for CRO services. 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.
   
• Also, increasing complexity in drug development, including precision medicine and biologics, makes it necessary for biopharmaceutical and pharmaceutical companies to integrate into the CROs which provides partnership for the required level of skill and facilities.
   
• Further, stringent FDA regulations and the need for compliance with Good Clinical Practice (GCP) guidelines encourage companies to partner with CROs for streamlined operations.
   

Europe contract research organization market is projected to reach USD 39.5 billion by the end of 2032.
 

• The increasing market growth is attributed to disease burden and increasing awareness for early diagnosis and effective treatment. Additionally, growing R&D expenditure in the region further exacerbates 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.
   
• 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 expected to boost the market growth.
   
• Further, government funding for drug discovery and related research studies are some of the prominent factors fostering market growth.
   

Asia Pacific contract research organization market is estimated to show robust CAGR of 8.6% 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 contract research organization industry growth.
   
• The regional disease burden increases outsourcing by pharmaceutical and biotechnology companies, and this paradigm shift towards outsourcing has led to positive conditions for the market revenue in the Asia Pacific countries.
   
• Moreover, increasing government funding for drug discovery and support for conducting clinical trials and related research is expected to drive the market growth in the Asia Pacific region.
   

China contract research organization 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. This is 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 is expected to showcase significant growth in the Latin America contract research organization 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 contract research organizations market is anticipated to grow at a rapid CAGR over the forecast period.
 

• The country's well-established 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 research drive CRO demand, enhancing its position in the Middle east and Africa contract research organizations market.
   

Contract Research Organization Market Share

The major players operating in the contract research organization 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 35% - 45% of the global CRO 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 March 2021, Charles River Laboratories acquired Retrogenix. This acquisition enhanced Charles River’s scientific expertise with supplementary large molecule and cell therapy discovery capabilities. This helped the firm to strengthen its end-to-end solution offerings for therapeutic antibody and cell and gene therapy discovery and development.
 

Other players such as PAREXEL International Corporation, TFS HealthScience, and Medpace among others have also undertaken various strategic initiatives including service approval and launch to develop a competitive edge. For instance, in January 2020, LabCorp and Covance launched extensive preclinical, clinical, and post-approval cell and gene therapy development solutions. The solutions are designed to reduce risk and time for sponsors at each phase and across the full continuum of therapy development. This strategy is enhanced its service offering and strengthening its service portfolio.
 

IQVIA focuses on expansion and collaborative strategy to maintain their competitive edge in the market. In March 2022, IQVIA announced collaboration with argenx SE. This strategy is aimed for the development of new indications for VYVGART (Efgartigimod alfa fcab) for the treatment of generalized myasthenia gravis in adult patients that has a specific antibody receptor. The collaboration will support clinical development, commercial, regulatory, and real-world evidence strategy to accelerate the development of new indications for VYVGART. This strategy will increase the customer base, thereby drive revenue growth.
 

LabCorp focuses on development and launch of new service offerings. In January 2020, LabCorp and Covance launched extensive preclinical, clinical, and post-approval cell and gene therapy development solutions. The solutions are designed to reduce risk and time for sponsors at each phase and across the full continuum of therapy development. This strategy is enhanced its service offering and strengthening its service portfolio.
 

Contract Research Organization Market Companies

Prominent players operating in the contract research organization industry include:

• Caidya
• Charles River Laboratories
• CMIC HOLDINGS
• EPS Holdings
• ICON plc
• IQVIA (Quintiles IMS)
• Iris Pharma
• Laboratory Corporation of America Holdings
• Lexitas Pharma Services
• Medpace Holdings
• Ora
• Parexel International (MA)
• Pharmaceutical Product Development (Thermo Fisher Scientific)
• Premier Research
• ProTrials Research
• Syneos Health
• TFS HealthScience
• The Emmes Company
• Trial Runners
• Veristat
• Worldwide Clinical Trials
• WuXi Clinical (WuXi AppTec)
   

Contract Research Organization 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, Clinipace Inc., and Triumph Research Intelligence (TRI), a global leader in risk-based quality management (RBQM) technology, announced their partnership for enhancing the quality, efficiency, and patient safety of global clinical trials. The partnership was primarily motivated due to the rising regulatory implications compelling the pharmaceutical industry to adopt RBQM strategies. Hence, the company opted for TRI’s advanced OPRA platform and ensure ICH E6 (R2) compliance.
   
• 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 to enhance its operational capabilities using the outstanding talent of both companies to deliver enhanced value to patients, customers, employees and shareholders.
   

The contract research organization market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments:

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Market, By Service Type

• Early phase development services
  • Discovery services
  • Chemistry, manufacturing and control (CMC)
  • Preclinical services
    • Pharmacokinetics/pharmacodynamics (PK/PD)
    • Toxicology services
    • Other preclinical services
• Clinical research services
  • Phase I
  • Phase II
  • Phase III
  • Phase IV
• Laboratory services
  • Bioanalytical testing services
  • Analytical testing services
    • Physical characterization
    • Raw material testing
    • Batch release testing
    • Stability testing
    • Other analytical testing services
• Regulatory consulting services

Market, By Therapeutic Area

• Oncology
• Clinical pharmacology
• Cardiology
• Infectious disease
• Neurology
• Gastroenterology and hepatology
• Ophthalmology
• Other therapeutic areas

Market, By End Use

• Pharmaceutical and biopharmaceutical companies
• Medical device companies
• Academic institutes

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
• Latin America
  • Brazil
  • Mexico
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE