Cell & Gene Therapy Manufacturing: The Race to Scale
Cell and gene therapy is moving from clinical promise to commercial execution.
Manufacturing capability, process control and supply-chain readiness increasingly determine which therapies reach patients and which programmes fall behind.
Visiongain estimates that the global cell and gene therapy manufacturing market will grow from US$13.7bn in 2026 to US$63.0bn by 2036, at a CAGR of 16.5%.
In this week’s Market Watch: Healthcare, Pharma & Biotech, we examine which developers, technologies and operating models are best placed to deliver at scale.
Visiongain Top Takeaways
- Manufacturing decisions are moving earlier: Process design, technology transfer and commercial supply now need attention before pivotal development.
- Usable capacity matters more than installed capacity: Modality expertise, analytics and quality systems determine whether a facility can deliver.
- Viral-vector economics remain difficult: Low yields, complex purification and release testing continue to raise costs and delay supply.
- Autologous therapies scale through orchestration: Vein-to-vein time, manufacturing success and chain-of-identity controls determine patient throughput.
- FDA flexibility does not lower the quality bar: Sponsors still need robust comparability, potency and process data.
A Broader Pipeline Raises the Manufacturing Bar
Advanced therapies are moving beyond rare diseases and blood cancers into autoimmune disorders, solid tumours and larger genetically defined populations.
ASGCT and Citeline counted 4,233 gene, cell and RNA therapies in development in the first quarter of 2026, from preclinical development to pre-registration. The total includes RNA and non-genetically modified cell therapies as well as CGT programmes.
Processes built for small patient cohorts may not deliver the throughput, reliability or economics required for broader indications.
Investment has become more selective, but pharma continues to back differentiated platforms. Chiesi’s agreement with Arbor Biotechnologies covers a clinical-stage gene-editing programme and additional liver-targeted rare-disease assets, with potential payments exceeding US$2bn.
The transaction is a technology deal rather than a manufacturing agreement. Successful programmes will nevertheless require specialist processes, validated facilities and dependable supply.
Visiongain Insight: Moving into larger indications will expose processes whose costs and failure rates were tolerable in rare disease but become unsustainable at greater volume.
Manufacturing Decisions Move Upstream
Processes designed for small clinical studies may be difficult to scale, automate or validate. Moving production later can trigger comparability work, additional regulatory scrutiny and delay.
Smaller biotechs often lack the capital and specialist workforce to build internal GMP capabilities, while larger groups use CDMOs for vectors, cell-processing platforms and analytical expertise.
GenSight Biologics shows the risk. Following earlier manufacturing setbacks, it transferred LUMEVOQ production to Catalent, which manufactured clinical supply and is expected to support its planned Phase III study and regulatory requirements.
Visiongain Insight: The lowest-cost partner in early development may not offer the lowest-risk route to launch. Sponsors must balance manufacturing continuity against supplier dependence and the expense of transferring a process later.
Viral Vectors Remain a Manufacturing Constraint
Viral-vector production is difficult to standardise. Yield, purity, potency and batch consistency can vary by vector, capsid, cell line and manufacturing method.
A facility equipped for one vector or production platform may not be suitable for another. Purification methods, analytical capabilities and technical experience are highly programme-specific.
Companies are investing in higher-yield systems, platform processes and improved purification. Interest is also growing in lipid nanoparticles and other non-viral approaches that could reduce dependence on viral vectors in suitable applications.
Vertex’s collaboration with Orna Therapeutics reflects that interest. The programmes use Orna’s lipid nanoparticle platform to pursue in-vivo gene editing for sickle cell disease and beta thalassaemia. The agreement signals strategic intent, but not yet clinical or manufacturing validation.
Visiongain Insight: Viral-vector competitiveness rests on reproducible yield, product quality and platform-specific expertise. Non-viral delivery may ease some vector constraints, but creates different formulation, targeting and scale-up challenges.
Autologous Cell Therapy Scales Through Logistics
Autologous therapies turn each patient’s cells into an individual manufacturing batch. Collection, transport, processing, testing and return to the treatment centre must be coordinated without losing product identity or compromising viability.
Vein-to-vein time, manufacturing success rates, treatment-centre scheduling and chain-of-identity controls determine how many patients can be treated and at what cost.
Closed processing, automation and decentralised production are intended to improve throughput. Galapagos’s 2025 collaboration with Catalent added a New Jersey site to its decentralised US manufacturing network for clinical studies of the investigational CAR-T therapy GLPG5101.
Closer production may reduce transport and turnaround times. It can also make site consistency, workforce training, utilisation and regulatory oversight harder to manage.
Visiongain Insight: Autologous manufacturing will be judged by patient throughput, not facility size. Companies that shorten vein-to-vein time and reduce batch failures without duplicating excessive infrastructure will have the strongest commercial model.
FDA Flexibility Does Not Remove Manufacturing Risk
Traditional biologics development models can be difficult to apply to complex, patient-specific CGT products.
In May 2026, the FDA issued final guidance on CMC flexibility for products moving towards a biologics licence application. It provides scope for prior knowledge, platform analytical methods and risk-based approaches to comparability, validation and commercial specifications where scientifically justified.
The flexibility is not automatic. Sponsors must still show that manufacturing changes do not compromise product quality, and the FDA recommends early discussion with the relevant review division.
Visiongain Insight: The guidance should favour companies with strong process knowledge and well-supported comparability strategies. It is unlikely to rescue programmes weakened by late characterisation, repeated process changes or poor control of critical quality attributes.
CGT Manufacturing: Scale Alone Will Not Win
Large CDMOs offer broad service portfolios, international networks and greater financial resources. Specialists compete through deeper expertise in a particular vector, cell type or production method.
The deciding issue is technical and commercial fit. Early clinical experience does not prove that a provider can validate a process, support regulatory approval and supply a launch. Equally, a large facility may lack the flexibility or specialist knowledge required by an evolving programme.
The strongest providers combine process and analytical expertise, reliable technology transfer, commercial manufacturing experience and quality systems suited to the relevant modality. Financial resilience and access to experienced staff also matter over development timelines that can run for years.
Visiongain Insight: Installed capacity is easy to announce but difficult to convert into validated, reliable supply. Developers and investors should judge providers by proven output, technical fit and commercial readiness, not facility size.
Market Outlook: CGT Must Move Beyond Bespoke Manufacturing
The next stage of CGT growth depends on turning complex production into repeatable commercial operations.
Complete standardisation is unlikely. Platform processes, automation and stronger analytics can still reduce manual work, variability and release times while improving output from existing facilities and staff.
Complex release testing, limited analytical resources and short shelf lives can delay supply even after production is complete.
The demand case also requires discipline. A large clinical pipeline does not guarantee enough commercial volume to support every new facility. Some advanced therapies have faced slow uptake, treatment-centre constraints and difficult launch economics.
CDMOs must align investment with credible programmes, realistic utilisation and a clear route through validation and launch. Providers that expanded ahead of demand may need to specialise, partner or reduce underused capacity.
Visiongain Insight: The strongest commercial positions will belong to developers and manufacturers that reduce costs and failure rates, secure viable programmes and deliver products reliably enough to support routine patient access.
