United States Cell and Gene Therapy Manufacturing Services Market valuation $7.02 billion by 2033 - Exclusive Report by DatamIntelligence

Leander, Texas and TOKYO, Japan - Nov.18.2025
"Cell and Gene Therapy Manufacturing Services Market size reached US$ 6.61 Billion in 2024 and is expected to reach US$ 23.42 Billion by 2033, growing at a CAGR of 15.2% during the forecast period 2025-2033." As per DataM intelligence research report

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United States: Recent Industry Developments

✅ In November 2025, Lonza expanded its U.S. cell and gene therapy manufacturing facilities to support increased demand for viral vectors and personalized therapies. The upgrade improves production capacity and regulatory compliance. This investment strengthens Lonza's leadership in advanced therapy manufacturing.

✅ In October 2025, Catalent launched new gene therapy fill-finish services for clinical and commercial-stage products, enhancing speed and scalability. The expansion addresses the growing U.S. market for cell and gene therapies. It reinforces Catalent's position as a leading CDMO in the sector.

✅ In September 2025, Charles River Laboratories enhanced its cell therapy manufacturing capabilities to provide integrated services from development to GMP production. The move streamlines process workflows for biotech clients. It strengthens Charles River's presence in the U.S. advanced therapy market.

✅ In August 2025, Samsung Biologics announced a partnership to offer contract manufacturing services for autologous and allogeneic cell therapies. The collaboration accelerates production timelines and quality standards. This positions Samsung Biologics as a strategic partner in U.S. gene therapy development.

Japan: Recent Industry Developments

✅ In November 2025, Takeda Pharmaceutical expanded its gene therapy manufacturing facilities in Japan to increase viral vector production. The expansion supports the development of next-generation treatments. This move strengthens Takeda's leadership in advanced biologics.

✅ In October 2025, CMIC Group launched GMP-compliant cell therapy manufacturing services for domestic biotech companies. The services accelerate clinical trial readiness and production scalability. This positions CMIC as a key player in Japan's cell and gene therapy ecosystem.

✅ In September 2025, JCR Pharmaceuticals invested in automated cell processing systems for regenerative medicine manufacturing. The upgrade improves consistency, throughput, and regulatory compliance. It reinforces JCR's commitment to high-quality cell therapy production.

✅ In August 2025, Fujifilm Cellular Dynamics expanded its contract manufacturing services for iPSC-based therapies, enhancing production capacity and quality control. The development addresses growing demand in Japan for regenerative medicine. It strengthens Fujifilm's role in the advanced therapy market.

Cell and Gene Therapy Manufacturing Services Market: Drivers

The cell and gene therapy manufacturing services market is witnessing significant growth as the demand for advanced therapies in treating genetic disorders, cancers, and rare diseases continues to rise. These services provide specialized capabilities for the development, scaling, and production of cell and gene therapies, including viral vector manufacturing, cell expansion, and quality control. Rapid advancements in biotechnology and personalized medicine are driving the adoption of outsourced manufacturing solutions to ensure compliance with stringent regulatory standards. Increasing investments by pharmaceutical and biotech companies in gene and cell-based therapeutics are further propelling market growth. Moreover, the complexity of therapy production and the need for highly specialized infrastructure make contract manufacturing an essential component of the sector.

Technological innovations in bioprocessing, automation, and modular facility design are enabling efficient and scalable manufacturing of cell and gene therapies. Rising global collaborations and partnerships between contract development and manufacturing organizations (CDMOs) and therapy developers are accelerating product commercialization. Regulatory support and streamlined approval pathways for regenerative medicine products are enhancing market opportunities. The growing focus on cost optimization and speed-to-market for breakthrough therapies is encouraging outsourcing of manufacturing services. As personalized medicine and advanced therapeutics continue to expand, cell and gene therapy manufacturing services are poised to become a cornerstone of the biopharmaceutical industry.

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Cell and Gene Therapy Manufacturing Services Market: Major Players

Charles River Laboratories, Thermo Fisher Scientific Inc., Lonza, Merck KGaA, Catalent, Inc, Takara Bio Inc., FUJIFILM Irvine Scientific, Oxford Biomedica plc, SGS SA, and Made Scientific.

Segment Covered in the Cell and Gene Therapy Manufacturing Services Market:

By Type
The market includes cell therapy manufacturing holding 58% share, driven by rapid adoption in oncology and regenerative treatments. Gene therapy manufacturing accounts for 42%, supported by rising demand for viral vector production and advanced genetic treatments.

By Indication
Oncology dominates with 45% share due to the high number of ongoing CAR-T and gene therapy trials. Rare diseases hold 28%, benefiting from orphan drug incentives. Other indications, including cardiovascular and neurological disorders, capture 27%.

By Application
Clinical applications lead with 62% share as most therapies remain in trial phases requiring large-scale GMP manufacturing. Commercial applications account for 38%, growing steadily with more regulatory approvals for cell and gene therapies.

By End User
Biopharmaceutical and biotech companies represent 66% share, heavily outsourcing manufacturing to specialized CDMOs. Academic and research institutes hold 22%, while hospitals and specialty treatment centers account for 12% supported by translational research programs.

Regional Analysis

North America - 41% Share
North America leads with 41% share, driven by strong biopharma presence, extensive R&D pipelines, and advanced CDMO capabilities. The U.S. dominates due to high clinical trial activity and regulatory advancements.

Latin America - 5% Share
Latin America holds 5%, supported by growing biotech investments and emerging clinical research programs. Adoption remains limited but rising steadily in Brazil and Mexico.

Europe - 30% Share
Europe accounts for 30% share, backed by strong manufacturing infrastructure, government support, and active cell and gene therapy research hubs in Germany, the U.K., and Switzerland.

Asia Pacific - 18% Share
Asia Pacific captures 18%, driven by expanding biomanufacturing capacity in China, Japan, South Korea, and Singapore. Increasing government funding boosts regional competitiveness.

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