Cell and Gene Therapy Manufacturing Services Market to Reach US$ 26.95 Billion by 2033 as CDMOs Scale Complex Biologics, CAR-T Therapies and Commercial Manufacturing

The global cell and gene therapy manufacturing services market reached US$7.61 billion in 2025 and is projected to reach US$26.95 billion by 2033, expanding at a CAGR of 15.2% during 2026-2033, according to DataM Intelligence. Manufacturing services are becoming a critical capacity layer for advanced therapies moving from clinical development into commercial treatment. The opportunity extends beyond adding cleanrooms: successful supply requires reproducible processes, validated analytics, viral-vector availability, GMP compliance and tightly controlled patient-specific logistics.

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2026 Official Developments in CGT Manufacturing Capacity, CDMO Expansions, Partnerships and Commercial Supply Agreements

- Lonza extended its commercial manufacturing agreement with Genetix Biotherapeutics in March 2026. Production will continue at Lonza's Houston cell and gene therapy facility, extending a relationship that supported the development and commercialization of an approved gene therapy. The agreement illustrates how sponsors are securing long-term capacity for therapies that have moved beyond clinical batches.

- OXB signed a multiyear commercial supply agreement with Bristol Myers Squibb in February 2026. OXB will manufacture and supply lentiviral vectors for CAR-T programs under an initial five-year term, with an extension option. The agreement demonstrates the commercial value of dependable vector capacity linked to established cell therapy portfolios.

- Merck formed a manufacturing collaboration with Cyto-Facto in March 2026. The companies plan to establish a scalable lentiviral-vector process using Merck's VirusExpress 293T cell line, supported by process optimization, training and technical services across Asian collaboration centers.

- FUJIFILM Cellular Dynamics opened a new iPSC development and manufacturing facility in Madison in May 2026. The site expands the company's capacity for producing induced pluripotent stem cells and supporting applications in drug development, disease modeling and cell-based therapies.

- Made Scientific and Pluristyx launched an integrated iPSC development and manufacturing partnership in June 2026. The offering connects clinical-grade iPSC lines and derived cell types with process development and GMP manufacturing, creating a more unified path from starting material to commercial supply.

Manufacturing Capacity Is Now a Development Risk

A promising clinical result does not automatically create a commercially viable therapy. Developers must prove that the process used for a small clinical study can be transferred, scaled and repeatedly executed without changing the therapy's critical quality attributes.

This challenge is especially pronounced in autologous cell therapy. Each patient represents an individual manufacturing lot, requiring coordinated collection, transportation, processing, quality release and return to the treatment center. Traditional scale-up is often replaced by scale-out, where multiple patient batches must be processed simultaneously without identity errors, contamination or scheduling delays. Lonza identifies small patient-level batch sizes, complex production and high cost as central barriers to autologous manufacturing.

Gene therapy has a different bottleneck. Viral vectors must meet demanding standards for potency, purity, safety and consistency, yet vector processes can produce variable yields. Limited manufacturing slots, long lead times and extensive analytical requirements can delay trials or leave commercial launches dependent on a single site.

Approvals and Pipeline Growth Are Increasing Outsourcing Demand

More advanced therapies entering late-stage development are increasing demand for CDMOs that can manage process development, technology transfer, GMP production, testing and regulatory documentation within one operating model.

Regulatory policy is also becoming more manufacturing-focused. In May 2026, the US FDA issued final guidance describing flexibility in chemistry, manufacturing and controls requirements for cellular and gene therapy products seeking biologics licence approval. The guidance does not reduce the need for product quality; instead, it provides a framework for applying science-based manufacturing controls to highly complex therapies.

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The strongest outsourcing demand is likely to concentrate around services that reduce transition risk between development stages:

- Viral-vector and plasmid manufacturing
- Autologous and allogeneic cell processing
- Analytical development and release testing
- Process characterization and comparability
- Fill-and-finish, cryopreservation and logistics
- Regulatory support and commercial supply planning

However, outsourcing does not eliminate execution risk. Sponsors remain responsible for technology transfer, supplier oversight, process knowledge and continuity planning. A poorly defined process transferred late to a CDMO can create additional validation work rather than accelerate commercialization.

Automation and Platform Processes Offer the Clearest Productivity Gains

Automation can reduce manual interventions, improve batch records and support more consistent execution across multiple patient lots. Closed manufacturing systems are particularly relevant to autologous therapies because they can reduce contamination risk and lower dependence on large classified cleanroom environments.

Platform processes offer similar advantages in gene therapy. Reusable producer cell lines, vector platforms, analytical methods and standardized unit operations can shorten development timelines across related programs. OXB, for example, provides development and GMP manufacturing across lentiviral, AAV and other vector types, while supporting programs from early development through commercial launch.

Regional manufacturing is another important opportunity. For therapies involving fresh cells, short shelf lives or time-sensitive patient material, a distant centralized facility can create avoidable logistics risk. Regional production and backup-site strategies can improve resilience, although they require comparable processes, aligned quality systems and consistent regulatory documentation.

Cell Therapy Holds the Largest Market Position

DataM Intelligence segments the market by cell therapy and gene therapy, with cell therapy expected to account for approximately 51.6% of global revenue. The market also covers clinical and commercial manufacturing across oncology, cardiovascular disease, orthopedics, ophthalmology, central nervous system disorders, infectious diseases and other indications. Pharmaceutical and biotechnology companies represent a core end-user group, alongside academic and research institutions.

Clinical manufacturing remains essential because of the expanding development pipeline, but commercial manufacturing carries greater long-term value. It requires validated processes, continued regulatory compliance, predictable scheduling, supply-chain redundancy and the ability to respond to changes in patient demand.

Regional Manufacturing Models Are Becoming More Distinct

The USA remains the principal commercial center, with North America expected to hold approximately 41.2% of the market, supported by a large biotechnology ecosystem, advanced therapy developers and established regulatory pathways.

Japan combines a dedicated regenerative-medicine framework with active investment in local process development and viral-vector capabilities. PMDA provides specific quality and safety guidance for cellular, tissue-based and gene therapy products, while the 2026 Merck-Cyto-Facto collaboration shows growing demand for domestic manufacturing platforms.

Germany benefits from its pharmaceutical and life-sciences base and access to the European advanced-therapy regulatory system, under which developers must address GMP, clinical and product-specific requirements throughout development and commercialization.

South Korea offers an established biologics ecosystem and a dedicated MFDS division responsible for evaluating the quality, safety and efficacy of cell therapies, gene therapies and tissue-engineered products. This provides a defined regulatory foundation for developers considering local or regional manufacturing.

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Leading Companies Are Building Different Capacity Advantages

Lonza offers process development and GMP manufacturing for autologous therapies, allogeneic therapies and viral vectors across a multi-continent network. Its extended Genetix agreement strengthens its position in long-term commercial supply.

OXB specializes in viral-vector development, scale-up and GMP manufacturing. Its Bristol Myers Squibb agreement positions the company within the commercial CAR-T supply chain, where lentiviral-vector consistency and availability directly influence treatment capacity.

Merck combines viral-vector process technologies, testing services, manufacturing tools and technical support. Its 2026 agreements with Cyto-Facto and Genetix reinforce a strategy spanning both manufacturing enablement and commercial product-release testing.

FUJIFILM supports autologous and allogeneic cell therapies through process development, analytics, scale-up and cGMP manufacturing. The new Madison iPSC facility expands its starting-material and cell-development capabilities within a broader advanced-therapy offering.

Commercial Readiness Depends on Supply-Chain Readiness

The next stage of the cell and gene therapy manufacturing services market will be determined by whether manufacturing networks can deliver reliable products at clinically meaningful scale. Capacity alone will not be sufficient.

The strongest platforms will connect process development, automation, analytics, regulatory readiness, logistics and commercial supply under one controlled strategy. For advanced therapies, manufacturing is no longer a downstream operational function. It is a central determinant of development speed, treatment availability and long-term commercial viability.

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Contact:
Fabian Mathew
DataM Intelligence 4market Research LLP
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Email: fabian@datamintelligence.com

About DataM Intelligence
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