According to the report, the global gene therapy manufacturing market is projected to expand from USD 1.3 billion in 2025 to USD 5.2 billion by 2035, registering a CAGR of 14.8%, the highest during the forecast period. The demand for specialized manufacturing capabilities is increasing due to the expansion of gene therapy pipelines and clinical development.
Increased use of AAV and viral-vector technologies and outsourcing to specialized CDMOs are additional drivers of market growth. In January 2026, Charles River Laboratories announced an agreement with Gazi University to supply research grade AAV plasmids for rare-disease gene therapy research, as well as academic development capabilities, and support early-stage gene therapy programs, merging CDMO expertise with academic development capabilities.
Industry capacity is also growing to meet rising demand for viral vectors for clinical use, as well as for custom manufacturing services. Expanding development pipelines and outsourced manufacturing are strengthening demand for scalable, integrated gene therapy production capabilities.
Key Driver, Restraint, and Growth Opportunity Shaping the Global Gene Therapy Manufacturing Market
The lack of experienced professionals in GMP operations and the production of viral-vectors, analytical development, quality control and regulatory affairs can limit capacity expansion in production. Process complexity can also drive up training needs, the time to develop new workers, and potentially the operating expenses of sustaining specialized workforce through manufacturing.
The progress in continuous and automated plasmid DNA manufacturing offers the potential to increase production efficiency, reduce process variability and material loss, and enhance the supply of key materials for viral-vector manufacturing. Consistent quality, enhanced scalability, and reliable raw-material supply for commercial gene therapy production can also be achieved through greater process automation.
Expansion of Global Gene Therapy Manufacturing Market
Expansion of GMP mRNA Manufacturing Infrastructure
Regional Analysis of Global Gene Therapy Manufacturing Market
Prominent players operating in the global gene therapy manufacturing market is Andelyn Biosciences, Catalent, Inc., Charles River Laboratories, Forge Biologics, FUJIFILM Diosynth Biotechnologies, Genetix Biotherapeutics, Kaneka Eurogentec, Lonza Group AG, Merck KGaA, Novartis AG, Oxford Biomedica, Recipharm AB, Samsung Biologics, Sarepta Therapeutics, Inc., Thermo Fisher Scientific, WuXi Advanced Therapies, Others.
The global gene therapy manufacturing market has been segmented as follows:
Global Gene Therapy Manufacturing Market Analysis, By Product Type
Global Gene Therapy Manufacturing Market Analysis, By Therapy Type
Global Gene Therapy Manufacturing Market Analysis, By Workflow/Process
Global Gene Therapy Manufacturing Market Analysis, By Manufacturing Mode
Global Gene Therapy Manufacturing Market Analysis, By Scale of Operation
Global Gene Therapy Manufacturing Market Analysis, By Therapeutic Area
Global Gene Therapy Manufacturing Market Analysis, By End User
Global Gene Therapy Manufacturing Market Analysis, By Region
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