AAV manufacturing remains a capacity race

Adeno-associated virus manufacturing is still a capacity race: more gene therapies use these vectors, and making enough high-quality doses remains a bottleneck. (grandviewresearch.com) Adeno-associated virus, or AAV, is a delivery shell that carries a working gene into a patient’s cells. The United States Food and Drug Administration has approved AAV-based products including Luxturna, Zolgensma, Hemgenix, Beqvez and Elevidys. (fda.gov; fda.gov; fda.gov; fda.gov; fda.gov) The manufacturing problem is not just volume. Producers also have to separate “full” capsids that carry the gene from empty shells, while keeping potency and batch consistency through scale-up. (pmc.ncbi.nlm.nih.gov; nature.com; sciencedirect.com) That is why companies keep spending on process technology as much as on buildings. Lonza says its AAV suspension platform is designed to improve productivity and optimize full-versus-empty capsids early in development, and recent academic work points to better chromatography and quality-by-design controls as the main route to cleaner output. (lonza.com; pmc.ncbi.nlm.nih.gov) The market data still points up. Grand View Research estimated the global AAV vector manufacturing market at $1.02 billion in 2024 and projected it to reach $2.78 billion by 2030, with 18.5% annual growth from 2025 through 2030. (grandviewresearch.com) In the United States, the AAV contract development and manufacturing organization market was valued at $375.4 million in 2024, according to the same research firm, with a projected 16.5% annual growth rate through 2030. The firm tied that demand to wider use of gene therapies for diseases including spinal muscular atrophy and inherited retinal disorders. (grandviewresearch.com) Capacity is still being added across the supply chain. Fujifilm’s Holly Springs site in North Carolina opened in 2025, and the town says a 2024 expansion added $1.2 billion in planned investment and nearly 700 jobs. (cbs17.com; hollyspringsnc.gov) But expansion has not made demand steady. Catalent disclosed in a 2024 filing that AAV vectors were a core part of its cell and gene business, while reports in 2025 said the company cut jobs at Maryland gene-therapy sites after a large customer reduced orders. (sec.gov; pharmamanufacturing.com; bioprocessintl.com) Safety and regulation also shape the manufacturing race. In December 2025, the Food and Drug Administration added a boxed warning and narrowed Elevidys use after reports of fatal acute liver failure in some Duchenne muscular dystrophy patients, a reminder that vector design, dose and product consistency are tied to commercial risk. (content.govdelivery.com; pharmaceutical-technology.com) So the contest is no longer just who can build the next suite first. It is who can deliver reliable AAV batches, at commercial scale, with cleaner capsids, tighter analytics and enough spare capacity when the next therapy wins approval. (pmc.ncbi.nlm.nih.gov; grandviewresearch.com; grandviewresearch.com)