The U.S. Contract Research Organization (CROs) Market, estimated at USD 21.85 Bn in 2025, is expected to exhibit a CAGR of 12.4% and reach USD 49.56 Bn by 2032.
The market growth is driven by increasing demand for innovative and effective drugs across diverse therapeutic areas. Advances in drug discovery, biopharmaceuticals, and digital technologies are improving treatment outcomes and operational efficiency. Supportive regulations, rising R&D investments, and a strong focus on patient-centric care are creating new opportunities for pharmaceutical companies.
Market Dynamics:
The growth of the U.S. contract research organization (CROs) market is driven by the increasing demand for clinical outsourcing services and growing adoption of artificial intelligence. Pharmaceutical and biotechnology companies are increasingly outsourcing clinical trials and other non-core drug development services to optimize operational costs and focuses on other core functions outsourcing clinical trials to CROs help reduce timelines and cost compared to in-house clinical trials. Additionally, the growing adoption of artificial intelligence tools in clinical trials is expected to boost efficiency through better patient enrollment, optimization of site selection and by streamlining monitoring activities. This will be a major driver for the U.S. contract research organization (CROs) market over the forecast period.
Increasing Research and Development Expenditure of Pharmaceutical Companies
One of the major market drivers for the growth of the U.S. contract research organization (CROs) market is the rising R&D expenditure of pharmaceutical companies. Over the past decade, pharmaceutical companies have significantly increased their R&D budgets to develop new drugs and therapies. However, many big pharma companies also lack internal capabilities and infrastructure to efficiently conduct all stages of clinical research. To reduce costs and improve efficiency, they are increasingly outsourcing clinical trial activities to CROs. This rising reliance on CROs is a key factor boosting the U.S. contract research organization (CROs) market.
Demand for Specialized Expertise and Technologies
Another key driver is the growing demand for specialized expertise and technologies at different phases of clinical research. Modern drug development requires expertise in areas like oncology, rare diseases, gene therapy, etc. It also demands advanced clinical trial technologies for activities like patient recruitment, endpoint analysis, and regulatory submission. CROs are well-equipped to offer these specialized services using their therapeutic and technological expertise. Their ability to provide customized solutions is attracting more customers from big pharmaceutical companies and boosting the U.S. contract research organization (CROs) market.
Budget Constraints of Small Biotechnological Companies
One major restraint is the tight budget of small and mid-sized biotech companies, which form a significant customer base for CROs. As developing a new drug requires massive investments, biotech firms often have limited funds that restrict their outsourcing potential. Any uncertainty or delays in drug development can further strain their budgets, limiting new project approvals and restraining CRO revenue growth.
Expansion in Cell and Gene Therapy Research
The surge in cell and gene therapy research presents a major growth opportunity. Developing advanced therapies requires very specialized expertise and infrastructure for activities like vector production and characterization. CROs are well-poised to assist sponsors in navigating the complex development process and facilitating rapid clinical progress. This need is stimulating demand for CROs with capabilities in cell and gene therapy research.
Adoption of Virtual and Remote Clinical Trials
The COVID-19 pandemic has accelerated the adoption of virtual/decentralized clinical trial models. Regulators are open to more remote features in trials to ensure patient safety and business continuity. CROs can capitalize on this shift by expanding their digital health offerings like telemedicine, eDiary, wearables, etc. It allows reaching more patients and locations, thus improving trial performance. The growth of virtual trials post-COVID-19 promises significant revenue potential.
*Link: https://www.coherentmarketinsights.com/market-insight/us-contract-research-organizations-market-3179
Key Development
- In February 2024, Divergent CRO, a leading provider of clinical services to biotech and device companies, announced the official launch of its new Contract Research Organization (CRO). This new venture aims to revolutionize the research and development process by offering comprehensive and tailored clinical services to meet the unique needs of the biotech and device industries.
- In November 2023, Daré Bioscience, Inc., a leader in women’s health innovation, and Premier Research International, LLC, a global clinical research, product development, and consulting company, announced that the companies extended their partnership agreement under which Premier Research International, LLC will continue to provide an exclusive basis contract research organization (CRO) service within the U.S. to support the clinical development of Daré’s reproductive health portfolio.
- In November 2022, Ichor Life Sciences, a full-service contract research organization (CRO) and longevity biotechnology company, announced the launch of Ichor Clinical Trial Services. With the founding of Ichor Clinical, the company is able to serve biotechnology and pharmaceutical clients from early preclinical studies through late-stage clinical trials and U.S. FDA approval.
- In June 2022, Medidata, a Dassault Systèmes company, announced its renewed, expanded partnership with Novotech, a leading contract research organization (CRO), to continue scaling clinical studies in various therapeutic areas from 2022. Leveraging Rave EDC, Rave RTSM, eCOA and eConsent technology from Medidata, Novotech is equipped with flexible, configurable tools that can address clinical research needs at scale and facilitate accelerated drug and device development in Asia Pacific and the U.S.
Key Players: IQVIA INC., ICON plc, Labcorp, Syneos Health, PROMETRIKA, LLC., Premier Research, Caidya, Charles River Laboratories, Inc., Parexel International Corporation, Medpace, Inc., WuXi AppTec, Courante Oncology, EPS Corporation, Worldwide Clinical Trials, and Tigermed
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