The North America Cell & Gene Therapy Manufacturing Services Market is witnessing substantial growth driven by technological advancements and increasing investments in regenerative medicine. The market size was valued at USD 3,740 Million in 2025 and is expected to reach USD 13,820 Million by 2035, expanding at a CAGR of 12.8% from 2024 to 2035. The region benefits from an established healthcare infrastructure, favorable regulatory landscape, and presence of leading pharmaceutical and biotechnology companies.
The economic impact of tariffs on "North America Cell & Gene Therapy Manufacturing Services Market".
Market Growth Drivers
Increased Investment in Regenerative Medicine: The expanding investments from both government and private sectors toward regenerative medicine are accelerating the demand for cell and gene therapy manufacturing services. For example, Thermo Fisher Scientific expanded its viral vector development and manufacturing capabilities in North America in 2023, aiming to meet the accelerated demand for gene therapies and improve scalability.
Advancements in Manufacturing Technologies: Rapid technological developments such as automation, closed-system manufacturing, and improved bioprocessing are enhancing efficiency and quality for cell & gene therapy manufacturing. Catalent has introduced new, automated systems for advanced cell therapy manufacturing, reducing costs and increasing throughput for therapy developers.
Latest Market Trends
Strategic Partnerships and Collaborations: The market is experiencing a significant rise in long-term partnerships and collaboration agreements between contract development and manufacturing organizations (CDMOs) and therapy developers. In March 2024, Lonza partnered with Adaptimmune Therapeutics to expand cell therapy manufacturing, leveraging Lonza’s expertise to accelerate Adaptimmune’s T-cell therapy pipeline.
Emphasis on Allogeneic Therapies: There is a strong shift towards developing allogeneic (off-the-shelf) therapies due to scalability and reduced production costs. In February 2024, BlueRock Therapeutics announced a major investment into allogeneic manufacturing platforms to support a range of gene-edited cell therapies.
Market Opportunities
Growing Demand for Personalized Medicine: Increasing acceptance and adoption of personalized therapies create ample opportunities for manufacturing providers. Companies like WuXi Advanced Therapies are expanding personalized cell therapy capabilities with enhanced GMP (Good Manufacturing Practice) compliant facilities.
Expansion of Manufacturing Infrastructure: As the clinical pipeline matures, there is significant opportunity in expanding regional manufacturing infrastructure, with firms such as Brammer Bio (a Thermo Fisher Co.) investing in new plants to meet surging client demands.
North America Cell & Gene Therapy Manufacturing Services Market Revenue (USD Million), 2020-2035
The chart showcases the robust growth of the North America Cell & Gene Therapy Manufacturing Services Market from 2020 through 2035. Beginning at USD 1,150 Million in 2020, the market steadily increases each year, crossing an estimated USD 3,740 Million in 2025. As investment, technological advancements, and clinical demand accelerate, revenue continues to surge, reaching USD 9,160 Million in 2030 and ultimately peaking at USD 13,820 Million by 2035. This growth illustrates the compounding impact of innovation in manufacturing capabilities, the expanding therapeutic pipeline, and enhanced focus on gene and cell therapies. The consistent CAGR above 12% underlines the market’s resilience and strategic importance in the evolving biopharmaceutical landscape.
North America Cell & Gene Therapy Manufacturing Services Market Share by Region (2025)
The 2025 regional market share analysis shows the United States holding a dominant share at 81%, propelled by extensive investments, leading healthcare infrastructure, and the presence of major pharmaceutical firms. Canada follows with 12%, driven by favorable government policies and emerging biotech clusters. Mexico, accounting for 4%, is witnessing gradual growth, bolstered by rising healthcare expenditures. The remaining 3% includes Other North American geographies, contributing to market expansion through niche services and cross-border collaborations. This distribution underscores the United States’ vital role in shaping the region’s manufacturing capabilities and the rising potential in Canada and Mexico.
Recent Developments (June-November 2024)
November 2024: Thermo Fisher Scientific announced the grand opening of its new state-of-the-art cell and gene therapy manufacturing facility in Greenville, North Carolina. This expansion is aimed at supporting late-stage clinical and commercial production, further strengthening Thermo Fisher's contract manufacturing footprint in the region.
September 2024: Catalent entered into a multi-year collaboration agreement with Beam Therapeutics to scale advanced gene editing therapies. The partnership focuses on leveraging Catalent’s automated manufacturing systems and expertise to accelerate the clinical development and commercialization of Beam’s pipeline.
July 2024: Lonza Group expanded its Houston facility by adding new clean rooms and implementing innovative closed-system processing technologies. The move is designed to accommodate growing client demand for large-scale gene therapy manufacturing and enhance process efficiency and compliance.
Press Releases