Our Take
Outsourcing CGT manufacturing is now table stakes for competitiveness, not a fallback for capacity — but only CDMOs with approved commercial products and modality-specific expertise will capture value.
Why it matters
49 approved CGT products in the U.S. signal market maturity; pipelines are accelerating. Sponsors now pick CDMO partners years earlier than before, making regulatory track record and analytical depth the real differentiator, not just facility availability.
Do this week
CDMO business development: Audit your portfolio for FDA or EMA-approved CGT products in your claimed modality; if you have fewer than three, add that gap to your pitch materials before next quarter.
The outsourcing shift is structural, not cyclical
Cell and gene therapy manufacturing is consolidating around specialized contract partners. The global CGT market was valued at $12.2 billion in 2025 and is projected to reach $143.6 billion by 2034, growing at a compound annual rate of 31% (per Contract Pharma analysis of industry forecasts). With 49 approved CGT products already in the U.S. market and pipelines maturing, demand for manufacturing and supply chain expertise has outpaced in-house capacity at most sponsors.
Sponsors are now engaging CDMOs earlier in development, not just for capacity but for risk mitigation and regulatory certainty. The most common driver is lack of in-house GMP infrastructure. But according to eXmoor Pharma consultants Harvey Branton and Drew Hope, many sponsors with internal capability still outsource because their existing resources don't match the specialized experience, capacity, or timelines a specific program requires.
Product complexity is the second major driver. RNA/LNP-based gene therapies, for example, require oligonucleotide synthesis, plasmid production via microbial fermentation, and lipid nanoparticle formulation—three distinct manufacturing approaches that are difficult to build in-house without substantial investment. There is also a structural supply-demand imbalance: overcapacity in AAV vector manufacturing paired with persistent bottlenecks in labor-intensive autologous cell therapies (per AGC Biologics executive Luca Alberici).
What sponsors really value in a CDMO partner
Regulatory track record now dominates the selection process. Sponsors are prioritizing CDMOs with a portfolio of FDA or EMA-approved commercial products. This is the ultimate proof of regulatory skill, quality systems, and execution at scale, according to Alberici. Modality-specific expertise is non-negotiable—whether in AAV, lentivirus, adenovirus, autologous cells, or emerging platforms like in-vivo CAR-T and gene editing.
Analytical capability ranks alongside manufacturing. Sponsors explicitly value CDMOs with in-house analytical depth and the expertise to develop phase-appropriate methods for product characterization. Cost of goods and manufacturability matter, but Lonza's Thomas Fellner noted that many advanced therapies fail to achieve commercial viability; sponsors therefore value CDMOs that apply platform-based approaches and design scalable processes early in development.
Operational reliability also factors heavily. Sponsors evaluate quality systems, process documentation, deviation management, and consistency over time. Availability is critical—CGT programs often run on tight timelines, and a CDMO unable to commit capacity at the right development phase has limited value regardless of technical skill. Geography matters too: proximity to clinical trial centers or target markets can reduce logistical complexity and regulatory burden.
Partnership structure is now the deal-breaker
Successful CGT partnerships are deeply integrated and begin early, with CDMOs working alongside sponsors to shape development strategies and design scalable processes from the outset. Early alignment on process strategy, analytical methods, and regulatory expectations directly influences cost, timelines, and commercialization likelihood.
The model has shifted from transactional to shared-risk-reward. Andelyn Biosciences CEO Wade Macedone emphasized that partnerships require ongoing data sharing, joint decision-making, and a willingness to pause and modify when necessary to safeguard quality and patient safety. As programs advance, the relationship extends across tech transfer, process verification, comparability planning, and regulatory alignment across regions.
Trust is the foundation. Fujifilm Biotechnologies' Katherine Schewe stated that enduring partnerships are built on mutual investment and accountability. CDMOs are now expected to proactively invest in next-generation technologies and capacity before the market demands it—a stabilizing force that reduces sponsor risk in an unpredictable market.