Outsourced cell and gene therapy manufacturing is set to grow nearly 6-fold by 2035 as biotech pipelines outpace in-house capacity.
The global cell and gene therapy (CGT) contract development and manufacturing organization (CDMO)
Cell therapy held the leading therapy-type share in 2025 at approximately 49%, driven by the volume of clinical-stage and commercial chimeric antigen receptor T cell, T-cell receptor, and stem cell-based programs, while gene therapy is the fastest-growing segment on the strength of expanding adeno-associated virus and lentiviral pipelines for rare genetic, neurodegenerative, and inherited metabolic diseases. By service type,
Viral vectors dominated vector type with roughly 69% share, while non-viral vectors, including lipid nanoparticles and plasmid DNA platforms, are growing fastest. Biopharmaceutical companies accounted for about 61% of end-user demand, with biotechnology startups projected as the fastest-growing end-user segment as virtual biotech models and venture funding expand.¹
North America held the largest regional share in 2025, at approximately 45%, supported by a dense concentration of biotech and pharmaceutical companies, an extensive CGT clinical pipeline, and a favorable regulatory environment, including FDA programs such as the regenerative medicine advanced therapy designation and accelerated approval pathways.² The US CDMO market alone was valued at $2.09 billion in 2025 and is projected to reach $10.28 billion by 2035, a CAGR of 17.26%, while Europe's market was valued at $1.17 billion in 2025 and is projected to reach $8.57 billion by 2035, a CAGR of 18.50%.¹ Asia-Pacific is expected to be the fastest-growing region, at a projected CAGR of 23.05% from 2026 to 2035, driven by expanding biomanufacturing capacity, cost-efficient production, and government initiatives supporting advanced therapies in China, Japan, and South Korea.¹
The report points to accelerating adoption of automation, closed-system manufacturing, and single-use bioreactors as CDMOs work to improve efficiency and consistency, alongside growing biopharma preference for end-to-end CDMO partnerships to streamline development and reduce time to market.²
"Human oversight and final review will always be necessary, but some of the detail work will be handled by AI," said
High production costs, limited global viral vector manufacturing capacity, and technical challenges around scalability and reproducibility are cited as key restraints on market growth, compounded by evolving regulations and complex technology-transfer processes.²
The report identifies Lonza Group, Catalent, Thermo Fisher Scientific, WuXi Advanced Therapies, and Samsung Biologics among the market's leading players.¹ Recent capacity expansions include Lonza's expansion of US CGT manufacturing capacity in February 2025 to support late-stage and commercial CGT programs and Catalent's viral vector manufacturing upgrades in January 2025 aimed at supporting high-volume gene therapy programs.²
