66% to 90%: The Outsourcing Numbers Driving CGT Contracting

Between 66% and 90% of all cell and gene therapy production is outsourced to external manufacturers, according to two divergent market estimates that frame how dependent CGT developers have become on contractors. The lower figure comes from Grand View Research's analysis of the cell and gene therapy manufacturing market; the higher, 90%, appears in Deloitte's 2024 US advanced therapy report. The gap between the two numbers is itself a data point: nobody in the industry disputes that outsourcing dominates, only by how much.

The reason, according to Alan Smith, PhD, global head of innovation at the recently founded CDMO Rose Biosolutions, is straightforward. Therapy developers lack real-world production expertise that contractors already have.

"Highly experienced CDMOs offer broad experience and capability, along with mastery of the activities required for a successful manufacturing, quality, and regulatory strategy needed to realize the partner developer's vision," Smith said.

Rose Biosolutions was formed when GI Partners completed its acquisition of the CDMO and cell solutions businesses from Charles River Laboratories, folding the units into a new standalone contractor. Its executives' views on where the CGT outsourcing market is heading therefore come from inside a company actively repositioning itself in that market — a context worth noting when weighing their optimism about contractor opportunity.

What drives the outsourcing decision?

Quality control expertise is a major factor, Smith said. "Strong quality systems employed by CDMO partners limit risk to product quality attributes that are of key concern in the logistics chain."

He tied the argument to concrete development practice: "A thorough understanding of key product quality attributes and appropriate product characterization lead to development of control strategies that ensure product consistency and meet the requirements of logistics chain."

For R&D managers weighing build-versus-buy decisions on CGT capacity, the claim translates to a specific proposition — that an experienced contractor's control strategies and characterization work de-risk the cold-chain and release steps that routinely threaten autologous and patient-specific products.

Smith also framed contractor relationships as the differentiator. "Good CDMOs build relationships; great CDMOs build relationships on trust, defined by competency and intimacy with their partners. The relationship has evolved with the needs of partner developers and grown to include expertise, experience, and trust," he said.

How does decentralization change the picture?

Decentralized CGT manufacturing — producing patient-specific therapies local to the intended recipients — has emerged in recent years as a way to minimize transportation requirements. Rather than threatening contractors, Jeff Mocny, PhD, vice president of scientific leadership at Rose, argues the model creates new openings.

"CDMOs can be uniquely positioned to accommodate the manufacturing needs of decentralized paradigms. Drawing on the expertise in product manufacture, required quality elements and expedited release strategies, they can enable high-quality, safe and effective delivery preparations to enable bedside production," Mocny said.

The claim rests on contractors transferring three things to decentralized sites: manufacturing know-how, quality systems, and rapid-release testing — the last being critical when a bedside-produced therapy cannot sit through conventional release timelines.

Where is the technology heading?

According to Simon-Kucher's CDMO growth report analysis, the contract manufacturing space is competitive, with most contractors differentiating on price and capabilities. That competitive pressure, Mocny said, keeps contractors well informed about market-reshaping technology advances.

"There are many new gene editing strategies and gene delivery strategies which are likely to have a significant impact on the CGT space. Additionally, in vivo gene editing and gene delivery are showing promise in early studies and will likely have an impact on the direction that the industry is going," he said.

The in vivo caveat matters: the promise Smith and Mocny cite rests on early-stage studies, not validated clinical outcomes, and both executives stand to benefit from a growing outsourcing market. The measured fact remains the market share — 66% to 90% of CGT production already external — while decentralization and in vivo editing represent projections of where that share moves next.