CROs for cell and gene therapy support research and development of advanced therapies such as in vivo gene therapies, gene-modified cell therapies, CAR-T and TCR therapies, and non-gene-modified cell therapies. According to Polaris Market Research, the cell & gene therapy contract research organizations market was valued at USD 5.28 billion in 2025, is estimated at USD 5.79 billion in 2026, and is projected to reach USD 12.29 billion by 2034, at a CAGR of 9.84% from 2026 to 2034. Growth is driven by expanding pipelines of clinical candidates, increasing outsourcing among start-up biotech firms, and stringent regulations and safety standards.

Why Sponsors Outsource

Biotech and pharma companies outsource to use CRO expertise, technologies, and research personnel, with the aim of saving costs and shortening development times. Outsourcing also gives firms access to advanced laboratory equipment without large investments, and it has become crucial as cell and gene therapies grow increasingly complicated. Firms carry out research and innovation while CROs develop the programs further. Emerging biotechnology companies are set to witness the fastest growth among sponsors, as venture capital investment, innovation in gene and cell therapies, and a rising number of early-stage biotechs boost demand for outsourced services.

The report also points to rising demand for end-to-end outsourcing partnerships, in which one CRO delivers all phases under a single contract, from preclinical testing and bioanalysis to regulatory affairs, manufacturing, and commercialization. This approach solves coordination problems and saves time and cost, and it is especially common among small biotech organizations that lack experience and infrastructure.

How CROs Support the Development Pathway

CRO involvement spans the development pathway: identifying the therapy concept, preclinical research on safety, efficacy, and biological activity, manufacturing process development, clinical trial conduct and management, regulatory assistance, and commercialization support.

Service Type and Therapy Platform Leaders

By service type, clinical operations and monitoring led with a 38.7% share in 2025, because the number of cell and gene therapy trials requires expert operations management, safety monitoring, and compliance. Adoption of decentralized and hybrid trials is another factor boosting demand for clinical monitoring.

By therapy platform, ex vivo gene-modified cell therapy held the largest share of 43.21% in 2025, reflecting increasing use of CAR-T and other genetically modified cells for cancers and rare diseases. In the report's key takeaways, viral vectors accounted for the largest share of 56.0% because of their established role as delivery systems for both gene therapies and genetically modified cell therapies. By therapeutic area, oncology held the largest share at 41.2%, backed by a robust pipeline of CAR-T, TIL, and genetically modified immunotherapy trials.

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Regional Outlook

North America accounted for a 43.0% share in 2025, attributed to robust regulatory frameworks and expedited approval pathways, and the U.S. held 86.5% of the regional value. Europe accounted for 28.6%. Asia Pacific is projected to grow at a 10.8% CAGR on expanding biotech ecosystems in China, Japan, South Korea, and Australia, and India is projected to grow at a 12.4% CAGR.

Key Players in the Cell & Gene Therapy CRO Market

The market is highly competitive, spanning global full-service CROs, biotech-focused CROs, regional clinical research facilities, bioanalytical laboratories, and regulatory consultancies. Key companies include:

• Altasciences
• Allucent
• Aixial Group
• CMIC Group
• ICON plc
• Fortrea
• Linical
• Medpace, Inc.
• Novotech
• PharmaLex (Part of Cencora)
• PPD (Thermo Fisher Scientific, Inc.)
• Precision for Medicine
• QPS Holdings, LLC
• Syneos Health, Inc.
• Syngene International Limited
• Parexel
• Avance Clinical

Conclusion

The cell & gene therapy contract research organizations market is driven by pipeline growth, outsourcing among young biotechs, and the specialized demands of advanced-therapy trials. Clinical operations and oncology lead today, while integrated service models and Asia Pacific offer notable growth potential. CROs with broad capabilities and global regulatory experience are well positioned for the 2026–2034 period.

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