The cell and gene therapy sector is moving from promise to execution. Contract manufacturers and development partners are becoming more central as sponsors face the harder work of turning complex science into reliable, scalable supply.
Industry forecasts underline the scale of the opportunity. Contract Pharma cited projections showing the wider market rising from $16.5 billion in 2026 to $143.6 billion by 2034, while Grand View Research estimated the cell and gene therapy CDMO ...
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segment was worth $4.3 billion in 2024 and could reach $27.1 billion by 2033. That growth reflects a pipeline that is deepening, more therapies reaching approval, and a sharper focus on commercial manufacturing rather than only discovery and early clinical work.
The shift is changing how sponsors think about partnerships. Rather than waiting until late-stage development, many are engaging CDMOs earlier to secure specialist know-how, validate processes and reduce the risk of costly delays. In advanced therapies, the technical burden is high: manufacturing often depends on tightly controlled facilities, highly trained staff, robust analytical methods and a supply chain that can withstand regulatory scrutiny.
Several executives quoted by Contract Pharma said the first reason companies outsource is simple: many do not have the infrastructure to manufacture under GMP conditions in-house. But even organisations with some internal capability may still prefer external partners when the programme demands capacity, experience or timing they cannot easily provide themselves.
Regulatory pressure is another major factor. Sponsors now need more than production slots; they are looking for partners who understand IND and BLA preparation, can support chemistry, manufacturing and controls documentation, and are ready for inspection. As therapies mature, the ability to deliver robust comparability packages and commercial-grade supply is becoming as important as getting material into the clinic.
Product complexity is also reshaping the market. Some programmes combine several distinct manufacturing processes, making in-house execution difficult without major capital investment. Non-viral approaches such as RNA and lipid nanoparticle platforms, for example, may require separate synthesis, fermentation and formulation expertise. In parallel, the market is showing structural imbalance, with some capacity available in adeno-associated virus production but persistent pressure in labour-intensive autologous cell therapy.
That is pushing sponsors to be more selective. They are increasingly seeking CDMOs with a clear track record in their exact modality, whether that means viral vectors, autologous cells, allogeneic cells or newer in vivo approaches. Analytical capability is also under closer scrutiny, with sponsors favouring partners able to build and apply methods that properly characterise a product through development and into commercial supply.
Commercial proof matters too. According to AGC Biologics, sponsors are paying more attention to whether a CDMO has already guided therapies through US and European approvals, not just manufactured clinical batches. A history of regulatory success is now seen as evidence of quality systems, technical depth and operational discipline.
Flexibility is another selection criterion. Contract Pharma quoted industry leaders saying some sponsors want a close, embedded relationship in which the CDMO acts as an extension of the internal team, while others prefer a narrower service model with clearer boundaries. The right fit depends on the sponsor’s size, maturity and internal resources. Location and supply resilience also matter, particularly when clinical sites, target markets and regulatory obligations are spread across regions.
What emerges from these views is a more mature model of collaboration. The strongest partnerships are no longer purely transactional. They involve early alignment on process design, analytical strategy and regulatory expectations, with both sides sharing responsibility for development decisions and risk management. For smaller biotech firms, that may mean substantial support on CMC strategy. For larger pharmaceutical companies, it may mean a highly defined service arrangement built around a specialist capability gap.
The commercial logic is clear. CDMOs can help sponsors avoid overbuilding too soon, preserve capital and maintain momentum in a market where timelines are tight and failure is expensive. For their part, sponsors bring scientific insight and programme ambition, while CDMOs contribute manufacturing discipline, regulatory experience and scalable infrastructure.
In a field where technical complexity is rising and more therapies are moving towards the market, those alliances are becoming one of the sector’s most important assets.
Source: Noah Wire Services
