CONTRACT CLINICAL RESEARCH ORGANIZATION MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2024-2031)

Contract Clinical Research Organization Market Size and Forecast – 2024-2031

The Global Contract Clinical Research Organization Market is estimated to be valued at USD 80.10 Bn in 2024 and is expected to reach USD 149.21 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 9.3% from 2024 to 2031.

Key Takeaways of the Global Contract Clinical Research Organization Market:

• The clinical trial service segment is expected to contribute the highest share of the market with 42.1% in 2024.
• The oncology segment is expected to contribute the highest share of the market with 37.1% in 2024.
• The pharmaceutical company’s segment is expected to contribute the highest share of the market with 40.3% in 2024.
• North America is expected to top the market with 37.3% of the market share, followed by Asia Pacific with 28.7% of the market share in 2024.

Market Overview:

There is an increase in research and development activities in the pharmaceutical and biotechnology industry. Moreover, outsourcing of clinical trials and research activities help companies reduce costs and improve efficiency. Research organizations provide high quality research services to various sponsors which is also driving the market growth. However, lack of skilled workforce and strict regulatory requirements associated with clinical trials may hamper the market growth during the forecast period.

Segmental Insights

To learn more about this report, Request sample copy

Service Type Insights – Complexities in Clinical Trial Design Fuel Clinical Trial Service’s Share

In terms of service type, the clinical trial service segment is expected to contribute the highest share of the market with 42.1% in 2024 owing to the complexities involved in clinical trial design and conduct. Clinical trial service provides end-to-end support for clinical development programs including protocol design, site selection and management, patient recruitment, data management, statistical analysis, medical monitoring, and regulatory support. The success of clinical trials hinges critically on robust trial design and seamless execution. 

Therapeutic Area Insights - Oncology Segment Growth Fueled by Unmet Medical Needs

In terms of therapeutic area, the oncology segment is expected to contribute the highest share of the market with 37.1% in 2024 owing to the immense unmet medical needs. Cancer prevalence is rising globally due to aging population and changing lifestyle factors. However, only a few highly toxic drugs have been approved each year to treat various cancers. There is tremendous urgency to accelerate the discovery and development of novel targeted therapies, immunotherapies, combination regimens, and personalized medicine approaches.

End User Insights - Outsourcing of Non-Core Functions drives Adoption in Pharmaceutical Companies

In terms of end user, the pharmaceutical companies segment is expected to contribute the highest share of the market with 40.3% in 2024 owing to the increasing trend of outsourcing non-core functions. Rising costs of drug development have challenged in-house R&D budgets and timelines of pharmaceutical firms. At the same time, intense market competition necessitates the rapid delivery of innovative medicines. This has prompted pharmaceutical firms to increasingly rely on CROs to perform non-core critical path services like clinical operations, biostatistics, and regulatory consultancy. 

Regional Insights

To learn more about this report, Request sample copy

North America Contract Clinical Research Organization Market Trends

North America's leadership in the contract clinical research organization market, with a 37.3% share projected for 2024, is driven by the strong presence of established CROs and a supportive regulatory framework. Additionally, high healthcare expenditures and the focus of pharmaceutical companies to outsource non-core activities have further strengthened North America's position.

Asia Pacific Contract Clinical Research Organization Market Trends

The Asia Pacific region exhibits the fastest growth with 28.7% in 2024 and is expected to witness significant opportunities over the coming years. This can be credited to the region's low-cost advantages and the ongoing expansion of the pharmaceutical industry in countries such as China and India. Further, government initiatives to develop healthcare infrastructure have amplified clinical research activities.

Contract Clinical Research Organization Market Outlook for Key Countries

United States Contract Clinical Research Organization Market Trends

Rising chronic diseases are driving pharmaceutical companies to outsource clinical trials, fueling contract clinical research organization market growth. In January 2024, according to the American Cancer Society's 2024 update, approximately 2 million new cancer cases are projected to be diagnosed in the United States in 2024, equating to around 5,480 new cases daily. This substantial cancer burden underscores the urgent need for expedited regulatory approvals and clinical trial support for cancer therapies.

Canada Contract Clinical Research Organization Market Trends

Canada drives growth in the contract clinical research organization market due to its advanced healthcare infrastructure, rising prevalence of chronic diseases, and diverse patient demographics. In November 2023. according to the Canadian Cancer Society, in 2023, 239,100 Canadians were diagnosed with cancer, with one in five expected to develop the disease in their lifetime. This significant prevalence is driving demand for CRO services.

China Contract Clinical Research Organization Market Trends

China contract clinical research organization market is experiencing rapid growth, driven by the country’s expanding pharmaceutical industry and a strong focus on enhancing domestic R&D capabilities. In November 2024, Merck signed a USD$ 3.3 billion deal with China-based, LaNova Medicines, to license an experimental cancer drug, highlighting China’s growing R&D capabilities. The country’s advanced clinical trial infrastructure, competitive costs, and diverse patient pool further drive its contract clinical research organization market growth.

India Contract Clinical Research Organization Market Trends

India continues to lead as a preferred destination for clinical trials owing to its large patient pools and cost advantages. India is emerging as a key player in the contract clinical research organization market, offering cost-effective clinical trial services. The "Make in India" initiative launched in March 2023 promotes local CROs to attract global pharmaceutical companies. Major Indian CROs like Synchrony Bank and IQVIA Inc. offer comprehensive services to global as well as local sponsors.

Market Players, Key Devlopment, and Competitive Intelligence

Get actionable strategies to beat competition: Request sample copy

Key Developments:

• In June 2024, QPS Holdings, LLC, a global contract research organization (CRO), announced new clinical research operations leadership. This move aims to align its global medical affairs, regulatory affairs, data services, and clinical operations with its Phase I clinics, enhancing agility and efficiency to meet the evolving demands of drug development.
• In February 2024, Ergomed Group, a leading provider of clinical research and pharmacovigilance services, expanded its U.S. footprint by opening a new office in Massachusetts, U.S.
• In February 2024, Charles River Laboratories, a premier provider of preclinical and clinical laboratory services, partnered with Wheeler Bio, a biomanufacturing company, to accelerate the transition from therapeutic discovery to manufacturing for its clients.
• In January 2024, WuXi Biologics, a global leader in biologics R&D and manufacturing, announced a collaboration with BioNTech SE, a biotechnology company, to identify investigational monoclonal antibodies for next-generation therapeutic development
• In December 2021, Thermo Fisher Scientific Inc., a global leader in scientific instrumentation and research services, completed the acquisition of Pharmaceutical Product Development, LLC, a global contract research organization (CRO) strengthening its service portfolio and capabilities

Top Strategies Followed by Global Contract Clinical Research Organization Market Players

• Established Players: Leading CRO companies extensively focus on research and development to innovate high-quality and cost-effective solutions.
  • For example, IQVIA invests over 10% of its annual revenue into R&D to develop advanced technologies like artificial intelligence platforms and real-world data solutions. Parexel allocates significant funds to expand its laboratory and biorepository networks.
• Mid-Level Players: Mid-sized CROs focus on delivering value through affordable yet reliable offerings. PRA Health Sciences provides streamlined solutions at competitive prices targeting small biotech companies and startups.
  • Medpace offers both full-service and customizable a la carte solutions, catering to cost-sensitive customers without compromising on quality. Icon focuses on functional service outsourcing and standardized processes to keep costs low.
• Small-Scale Players: Boutique CROs target specialized therapeutic areas or services where they can establish expertise.
  • For example, Clintec focuses exclusively on oncology trials. SynteractHCR concentrates on decentralized and virtual trials. EsgeeClinical specializes in rare disease patient recruitment. By developing deep niche expertise, small players grow competitive in targeted domains.

 Emerging Startups - Global Contract Clinical Research Organization Industry Ecosystem

• Innovative Technologies: Companies like Science 37 use digital technologies for virtual and hybrid trials. NoviSci focuses on predictive biomarkers through machine learning applications. Clinicea applies artificial intelligence to extract insights from medical images. These startups bring novel solutions that could transform clinical research models and operations.
• Sustainable Solutions: Certain startups focus on sustainability, such as Greenpharma, with its reusable packaging alternatives. ClinMonista promotes eco-friendly monitoring devices and Telehealth. Trialtx develops technologies that enhance trial diversity and participation. These startups contribute to improving the industry's sustainability performance and social impact.
• Market Contribution: Startups frequently collaborate to leverage their strengths. For instance, Valo Health partners with Ology Bioservices to combine drug discovery and development expertise, while EQRx collaborates with AI startup, Anthropic, to create more affordable medicines. These partnerships enable shared knowledge and innovation, addressing unmet market needs effectively.

Market Report Scope

Market Dynamics

Discover market dynamics shaping the industry: Request sample copy

Global Contract Clinical Research Organization Market Growth Factors - Increasing demand for outsourcing clinical trials by pharmaceutical companies

Pharmaceutical companies increasingly outsource clinical trials to CROs due to the complexity of drug development, which involves extensive research, global site coordination, and large-scale volunteer recruitment across various trial phases. For instance, in July 2023, Merck, a global pharmaceutical company, Moderna, a biotechnology company, and PPD Inc., a leading Contract Research Organization (CRO) initiated a Phase 3 trial of V940 (mRNA-4157), an investigational neoantigen therapy, combined with KEYTRUDA for treating high-risk melanoma.

Global Contract Clinical Research Organization Market Challenge - High costs associated with clinical trials and CRO services

One of the major challenges faced by the global contract clinical research organization market is the high costs associated with clinical trials and CRO services. Conducting clinical trials and supporting drug development activities requires massive investments. From patient recruitment and drug development to data management and regulatory compliance, clinical trials involve several expenditures. Additional costs such as services of CROs, opportunity costs for sponsor companies, and regulatory and compliance costs further increase the overall expense of clinical trials.

Global Contract Clinical Research Organization Market Opportunity - Expansion of CRO services in emerging markets

The expansion of CRO services in emerging markets presents a major opportunity for the growth of the global contract clinical research organization market. Countries such as China, India, Brazil, and others are emerging as top destinations for the outsourcing of clinical trials due to advantages such as large patient pools, low costs, and expanding medical expertise. These markets offer attractive opportunities for global CROs to expand their geographic footprint and offer clinical research services at competitive costs.

Analyst Opinion (Expert Opinion)

• Key drivers of growth include the increasing R&D expenditure of large pharmaceutical companies and their aim to outsource non-core functions. Additionally, the need to conduct clinical trials efficiently and cost-effectively will drive more sponsors to use CROs.
• However, risks around data privacy and regulatory changes pose challenges. Strict data privacy laws are being implemented worldwide which can increase compliance costs. Additionally, delays in site initiation and subject enrollment can negatively impact project timelines and budgets.
• North America will continue dominating the market given the presence of majority of big pharma companies and biotech startups actively outsourcing clinical trials. Asia Pacific is expected to exhibit the fastest growth owing to lower costs of conducting trials and growing clinical research expertise in countries like China and India.
• Some of the prominent players in the market are strengthening their capabilities and global footprint to capture more outsourced projects. Many CROs are offering new services like clinical trial modelling and solutions for post marketing studies. Use of technologies such as e-clinical solutions, artificial intelligence, and Blockchain by CROs may help improve efficiency and quality of clinical trials going forward.

Market Segmentation

•  Service Type Insights (Revenue, USD Bn, 2019 - 2031)
• • Clinical Trial Service
    • Phase III
    • Phase II
    • Phase I
    • Phase IV
  • Clinical Monitoring
    • Site Monitoring
    • Data Monitoring
  • Early phase development Services
    • Chemistry, Manufacturing and Controls Services
    • Preclinical Services
  • Laboratory Services
    • Analytical Testing Services
    • Bioanalytical Testing Services
  • Regulatory Affairs Services
•  Therapeutic Area Insights (Revenue, USD Bn, 2019 - 2031)
• • Oncology
  • Cardiovascular Diseases
  • Infectious Diseases
  • Neurology
  • Other Therapeutic Areas
•  End User Insights (Revenue, USD Bn, 2019 - 2031)
• • Pharmaceutical Companies
  • Biotechnology Companies
  • Medical Device Companies
  • Research & Academic Institutions
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
• • • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • IQVIA
  • Covance
  • Syneos Health
  • PPD (Pharmaceutical Product Development)
  • ICON plc
  • Charles River Laboratories
  • Medpace
  • Parexel International
  • WuXi AppTec
  • PRA Health Sciences
  • KCR
  • Celerion
  • Catalent
  • BioClinica
  • Clinipace