Gene Therapy held a 52.15% share of the advanced therapy medicinal products CDMO market in 2025, making it the leading product segment. This leadership is maintained through the strong outsourcing need associated with gene therapy manufacturing, where developers rely on CDMOs for highly specialized process development, vector production, and quality control capabilities that are difficult to build internally. The segment’s share is also underpinned by the operational complexity of gene therapy programs, which tends to favor established external manufacturing partners with validated infrastructure and regulatory handling experience.

Cell Therapy is emerging as the fastest-growing product segment in the advanced therapy medicinal products CDMO market as development activity increasingly requires flexible manufacturing models tailored to living cell-based products. Its growth momentum is being driven by the practical need for CDMOs that can manage complex handling, shorter production windows, and evolving scale-up requirements more effectively than many therapy developers can achieve on their own. Compared with alternatives, Cell Therapy is seeing wider adoption because its manufacturing pathway often demands closer technical support and adaptable capacity, creating stronger outsourcing intensity within the market.

Phase Segment Analysis: Phase I (Largest Segment) vs Phase II (Fastest-Growing Segment)

Within the advanced therapy medicinal products CDMO market, Phase I accounted for the largest share in 2025. Its dominant position reflects the concentration of early-stage programs entering outsourced development and manufacturing workflows, where sponsors typically seek external support to establish initial process feasibility, analytical methods, and clinical-grade material production. The segment maintains its share because early-phase ATMP development carries high technical uncertainty, making CDMO involvement a practical route for controlling upfront infrastructure demands while advancing first-in-human studies.

Phase II is the fastest-growing phase segment in the advanced therapy medicinal products CDMO market, underpinned by the increasing need to translate early clinical progress into more consistent and scalable manufacturing operations. Growth at this stage is tied to the shift from exploratory production toward tighter process control, larger batch requirements, and greater reproducibility expectations, all of which increase dependence on CDMO expertise. Relative to Phase I, Phase II gains momentum because developers moving forward in clinical validation require manufacturing systems that can better support expanded trials without the delay and cost of internal capacity buildout.