Viral Vector Manufacturing: A Key Segment in the U.S. ATMP CDMO Market

Posted on 2025-04-15 by researchinsights in Internet & Online // 0 Comments

U.S. Advanced Therapy Medicinal Products CDMO Market Growth & Trends

The U.S. Advanced Therapy Medicinal Products CDMO Market size was estimated at USD 2.34 billion in 2023 and is expected to register a CAGR of 18.29% from 2024 to 2030. Key drivers behind this growth include the increasing incidence of rare and severe diseases, significant investments in ATMP R&D, and expanding trend of outsourcing. The complexity of manufacturing ATMPs and growing need for specialized expertise and advanced technologies have fueled the demand for CDMO services, which play a vital role in facilitating the development and commercialization of innovative therapies, thus contributing to market growth.

The U.S. advanced therapy medicinal products CDMO market held the largest share of over 40% of the global advanced therapy medicinal products CDMO market in 2023. Driving factors include a rising number of ATMP clinical trials, growing adoption of advanced therapies, and increasing outsourcing activities. Innovation in technology and manufacturing capabilities by biotech companies create commercial opportunities for market expansion. Recent product approvals have accelerated R&D activities in this field. In addition, a consistent supply of funds and grants has led to the proliferation of ATMP clinical trials. Noncommercial entities, such as universities, sponsor ongoing trials to accelerate their progress.

Outsourcing activities in the ATMP domain are on the rise, as it enables companies to acquire additional competencies for successful development and commercialization of ATMPs. Outsourcing offers extended expertise, better management of cash flows, and significant manufacturing advantages like risk reduction. The low incidence-to-prevalence ratio for genetic and rare diseases makes outsourcing a favorable alternative. In-house facility construction for single gene therapies requires fast cost recovery, and outsourcing serves as an effective strategy until market demand is established. Limited understanding of final scale requirements for current and future products also supports outsourcing preferences.

Public awareness about ATMP treatment options is increasing due to initiatives aimed at informing people about their benefits. This, in turn, is leading to increased adoption of advanced therapies and fueling market growth for CDMOs. For example, OVID Health launched the Cell and Gene Collective in May 2021 with support from companies like Astellas, bluebird bio, Kite, Bristol Myers Squibb, and Novartis, aiming to raise awareness about cell and gene therapies.

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