North America Cell & Gene Therapy Manufacturing Services Market (2025-2035)
The North America Cell & Gene Therapy Manufacturing Services Market encompasses solutions for the efficient, compliant manufacturing of novel therapies targeting genetic and cellular mechanisms, addressing unmet medical needs in diverse indications. These services include allogeneic and autologous therapy production, viral and non-viral vector manufacturing, plasmid DNA production, and specialized support for various therapeutic applications. Major regional growth is driven by increasing approvals of advanced therapies, strategic partnerships among biopharmaceutical companies, and investments in next-generation manufacturing technologies. The market is witnessing rapid adaptation of automation and digitalization to enhance throughput, scalability, and regulatory adherence. This robust landscape supports the evolving needs of oncology, rare, neurological, and cardiovascular disease therapy development in North America.
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Latest Market Dynamics
Key Drivers
- Rising FDA approvals and clinical trial activities for cell and gene therapies in North America are accelerating demand for specialized manufacturing services. For instance, in June 2024, Bristol Myers Squibb expanded its cell therapy manufacturing capacity in the US to meet increased patient demand.
- Strong investments and collaborations between biotechs and contract manufacturing organizations are streamlining production cycles. Recently, Thermo Fisher Scientific announced an expanded partnership with bluebird bio (July 2024) for commercial gene therapy manufacturing.
Key Trends
- Adoption of automation and digital bioprocessing is enhancing the scalability and consistency of cell and gene therapy manufacturing. WuXi AppTec launched a new digital manufacturing suite in June 2024 to optimize operations and turnaround time.
- Increasing outsourcing of plasmid DNA and viral vector production to contract manufacturers—Lonza reported a 40% increase in viral vector contracts in early 2024, indicating a shift toward deeper collaboration with therapy developers.
Key Opportunities
- Emerging demand for personalized therapies, especially in oncology and rare diseases, is enabling service providers to diversify portfolios. Catalent expanded its California facility in July 2024 to support rapid manufacturing of autologous therapies.
- Expansion into allogeneic off-the-shelf therapies provides scalable opportunities—Fujifilm Diosynth Biotechnologies initiated a new project for allogeneic CAR-T production in July 2024.
Key Challenges
- Manufacturing scale-up and supply chain complexities remain persistent challenges for service providers—Charles River Laboratories reported delays in cell therapy batch releases due to raw material shortages in June 2024.
- Stringent regulatory and quality compliance requirements demand sophisticated systems and skilled labor. Oxford Biomedica highlighted increased regulatory scrutiny leading to extended project timelines in 2024.
Key Restraints
- High capital investment and operational costs are restraining entry for new players and smaller firms. Samsung Biologics faced increased overheads during facility expansions in 2024.
- Limited skilled workforce and expertise in advanced cell and gene therapy processes are constraining capacity expansion. Novartis reported workforce shortages delaying some new product launches in early 2024.
Market Share (%) by Type, 2025
In 2025, allogeneic therapies capture the largest market share in North America, driven by their scalability and potential for off-the-shelf solutions. Autologous therapies maintain a significant segment, particularly for personalized oncology applications. Viral vector manufacturing also remains vital, given its central role in enabling gene therapy development across therapeutic areas. The distribution reflects a diversified marketplace focused on both innovative, patient-customized solutions and broader-access products supporting multiple disease categories.
Market Share (%) by Application, 2025
Oncology represents the dominant application area for cell and gene therapy manufacturing services in North America for 2025, reflecting the growing clinical pipeline and payer support for advanced cancer treatments. Cardiovascular diseases and rare disorders are gaining traction due to increased gene therapy approvals and the success of precision medicine initiatives. Neurological and infectious diseases continue to present growth opportunities, as new indications enter late-stage development following robust clinical results.
Market Revenue (USD Million), 2020-2035
The North America Cell & Gene Therapy Manufacturing Services Market revenue is projected to witness exponential growth during 2020-2035. Supported by accelerating FDA approvals, investment flows, and expanding contract manufacturing capacities, the market is expected to rise from USD 1,600 Million in 2020 to over USD 8,300 Million by 2035. Key growth drivers include the advancement of personalized medicine and consistent investment in scalable manufacturing platforms to address rising demand across major therapeutic areas.
Market YOY (%) Growth, 2020-2035
Year-over-year growth in the North America Cell & Gene Therapy Manufacturing Services Market remains robust, averaging 12-14% across the projection period. The highest spikes are observed between 2025 and 2030, primarily due to expanding commercialization of gene-editing therapies and larger patient populations accessing these modalities. Growth moderates slightly post-2030 as the market matures, driven by continued innovation and new applications.
Market Share (%) by Region, 2025
The US dominates the North American cell and gene therapy manufacturing services market, accounting for an estimated 74% share in 2025 due to significant infrastructure, investments, and the presence of major industry players. Canada follows with an 18% share, reflecting strong government support and expanding biotech clusters. Mexico captures 8%, with ongoing initiatives to build manufacturing capabilities in collaboration with US and Canadian firms.
Market Share (%) by Key Players, 2025
The competitive landscape is led by Thermo Fisher Scientific (18%), followed by Lonza (15%), Catalent (12%), and WuXi AppTec (10%). Collectively, the top five players account for over 55% of the total market share, reflecting consolidation and strategic investments in manufacturing expansion throughout the US and Canada.
Market Share (%) by Buyers, 2025
Biopharmaceutical companies represent the largest buyer segment for manufacturing services (45%), driven by both established firms and emerging biotech players leveraging contract services for clinical and commercial production. Academic and research institutes (28%), hospitals and specialty clinics (17%), and others (10%) follow, each playing a pivotal role in preclinical research and early-stage clinical trial activities.
Study Coverage
| Metrics | Details |
|---|
| Years | 2020-2035 |
| Base Year | 2025 |
| Market Size | 2600 |
| Regions | US, Canada, Mexico |
| Segments | By Type (Allogeneic, Autologous, Viral Vector, Non-viral Vector, Plasmid DNA, Others); By Application (Oncology, Cardiovascular Diseases, Neurological Disorders, Rare Diseases, Infectious Diseases, Others); By Technology (Gene Editing, Cell Expansion, Viral Vector Production, Cryopreservation, Automation, Others); By Distribution Channels (Direct Tenders, Third-Party Distributors, Online Platforms, Hospital Pharmacies, Retail Pharmacies, Others); By Organization Size (Small, Medium, Large) |
| Players | Thermo Fisher Scientific, Lonza, Catalent, WuXi AppTec, Charles River Laboratories, Oxford Biomedica, Samsung Biologics, FUJIFILM Diosynth Biotechnologies, Bluebird Bio, Cell and Gene Therapy Catapult, uniQure, Novartis, BioNTech, Bristol Myers Squibb, Editas Medicine |
Key Recent Developments
- July 2024: Thermo Fisher Scientific expanded its gene therapy manufacturing collaboration with bluebird bio for commercial-scale production.
- July 2024: Catalent completed the expansion of its California facility, focusing on autologous cell therapy manufacturing.
- July 2024: Fujifilm Diosynth Biotechnologies commenced construction of a new allogeneic CAR-T cell therapy facility in Texas.
- June 2024: WuXi AppTec launched a cloud-based digital manufacturing suite to optimize cell and gene therapy production.
- June 2024: Bristol Myers Squibb announced a significant investment to double its cell therapy manufacturing capacity in the United States.
