Austin, United States, Aug. 17, 2026 (GLOBE NEWSWIRE) -- According to SNS Insider, the Cell and Gene Therapy CDMO Market was valued at USD 5.23 billion in 2025 and is projected to reach USD 29.49 billion by 2035, expanding at a CAGR of 18.90% from 2026 to 2035. The growth of this market can be attributed to increasing pipeline of cell & gene therapies, complex manufacturing process, high capital investment, strict regulations, and rising demands for outsourcing development and manufacturing activities among the biopharmaceuticals industry.
The global cell and gene therapy CDMO industry is expected to grow significantly as the number of pipeline products for treating cancer, rare diseases, genetic disorders, and other difficult diseases continues to rise. The complexity and costs involved in manufacturing cell and gene therapy have driven biopharmaceutical and biotech companies to outsource the development and manufacturing of these products. In light of this, prominent players in the CDMO industry are making investments in increasing capacity and manufacturing technology for viral vectors.
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KEY TAKEAWAYS:
- Leading Therapy Type: Cell Therapy, approximately 49% market share in 2025
- Leading Service Type: Manufacturing, approximately 57% market share
- Leading Vector Type: Viral Vectors, approximately 69% market share
- Leading End User: Biopharmaceutical Companies, approximately 61% market share
- Largest Regional Market: North America, approximately 45% market share
- Fastest-Growing Region: Asia Pacific, projected CAGR of 23.05% from 2026–2035
RISING ADVANCED THERAPY PIPELINES UNDERPIN STEADY GROWTH GLOBALLY
Since the growth of cell and gene therapies in both clinical and commercial settings is increasing in conjunction with advanced manufacturing challenges, high capital investments, and strict regulatory guidelines, the demand for CDMOs continues to rise. Biotech firms are turning more often to specialized CDMOs for the development and manufacture of their biopharmaceuticals in order to save on costs and increase scalability.
SEGMENTATION ANALYSIS
By Therapy Type: The cell therapy market holds the dominance of about 49% in 2025 and has acquired a major share owing to the number of clinical stage and commercial product development, especially CAR-T, TCR, and stem cell-based therapy products. Gene Therapy is the fastest growing segment owing to the expanding pipeline of AAV and Lentiviral products for rare genetic, neurodegenerative and inherited metabolic diseases.
By Service Type: Manufacturing accounted for a substantial market share of around 57% in 2025 due to its being capital-intensive, complex from a technical perspective, and highly regulated. Process & analytical development is one of the fastest-growing segments in the market due to the increased CGT pipeline in the early stages and demand for scalable processes.
By Vector Type: The viral vectors segment occupied a dominant position with around 69% market share in 2025 owing to the high transduction efficiency, clinical performance, and regulatory approval of these vectors. The non-viral vectors segment is growing at a fast pace thanks to innovations in lipid nanoparticles, plasmid DNA, and gene editing delivery vectors.
By End User: With the biggest number of CGT pipelines and reliance on CDMOs for program development and commercial production, biopharmaceuticals emerged as the major end users, making up 61% of the market in 2025. With virtual biotech model gaining traction, increasing investments from VC funds, and spinouts from academia, startups will be the fastest growing end user segment.
REGIONAL ANALYSIS
North America accounted for around 45% of total market share in 2025 due to the presence of many biotechnology and pharmaceutical firms, an enormous pipeline of advanced cell and gene therapies, and favorable regulatory environment such as FDA. The existing capabilities of CDMO manufacturing, investment in viral vectors capacity, and advanced manufacturing technology have fueled the region's growth.
U.S. Cell and Gene Therapy CDMO Market: $10.28 Billion Opportunity by 2035
The U.S. Cell and Gene Therapy CDMO Market was valued at approximately USD 2.09 billion in 2025 and is projected to reach USD 10.28 billion by 2035, growing at a CAGR of 17.26% from 2026 to 2035. The U.S. market will retain its dominance owing to the growth in the cell and gene therapy pipeline, outsourcing of cell and gene therapies by biopharmaceutical companies, growing demand for viral vector manufacturing, and investments made in state-of-the-art manufacturing facilities. There are many such trends that are offering ample opportunities in the field of U.S. cell and gene therapy manufacturing.
Europe Cell and Gene Therapy CDMO Market: $8.57 Billion Forecast by 2035
The Europe Cell and Gene Therapy CDMO Market was valued at USD 1.17 billion in 2025 and is projected to reach USD 8.57 billion by 2035, growing at a CAGR of 18.50% from 2026 to 2035. Increasing viral vector production capabilities, growing collaboration between CDMOs and pharmaceutical organizations, and increasing pipeline of cell and gene therapy products are driving Europe’s competitiveness in the clinical and commercial development of CGTs. There is potential for organizations looking at cell and gene therapy CDMO collaborations and outsourcing development in Europe.
Asia-Pacific is expected to witness fastest growth rate at a CAGR of 23.05% for 2026-2035, attributed to increase in biomanufacturing capacity, cost-efficient production, and government initiatives in favor of advanced medicines. Increasing number of clinical trials along with biotechnology ecosystem in countries like China, Japan, and South Korea is driving the demand for outsourced cell and gene therapy development & manufacturing services in the region.
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Leading Market Players Listed in this Report are:
- Lonza Group
- Catalent, Inc.
- Thermo Fisher Scientific
- WuXi Advanced Therapies
- Samsung Biologics
- Charles River Laboratories
- AGC Biologics
- Oxford Biomedica
- Fujifilm Diosynth Biotechnologies
- Viralgen Vector Core
- Kite Pharma Manufacturing
- Resilience
- Bayer Cell Therapy Manufacturing
- Yposkesi
- KBI Biopharma
- Brammer Bio
- Cobra Biologics
- Cell and Gene Therapy Catapult Manufacturing Innovation Centre
- Porton Advanced Solutions
- Novasep
RECENT DEVELOPMENTS
- 2025: Lonza expanded its cell and gene therapy manufacturing capacity in the United States to support increasing demand for late-stage and commercial CGT programs.
- 2025: Catalent strengthened its viral vector manufacturing capabilities through facility upgrades and technology investments aimed at supporting high-volume gene therapy programs.
FREQUENTLY ASKED QUESTIONS (FAQs):
Q: What is the expected CAGR of the Cell and Gene Therapy CDMO Market from 2026 to 2035? A: The market is expected to grow at a CAGR of 18.90% from 2026 to 2035.
Q: What was the size of the Cell and Gene Therapy CDMO Market in 2025? A: The market was valued at USD 5.23 billion in 2025.
Q: What is the major growth factor driving the Cell and Gene Therapy CDMO Market? A: Increasing cell and gene therapy pipelines, rising manufacturing complexity, capital-intensive facilities, and stringent regulatory requirements are the major growth drivers.
Q: Which By Therapy Type segment held the largest share in 2025? A: Cell Therapy held the largest share at around 49% in 2025.
Q: Which region held the largest share of the Cell and Gene Therapy CDMO Market in 2025? A: North America held the largest share at around 45% in 2025.
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Cell and Gene Therapy CDMO Market Report Scope
| Report Attributes | Details |
| Market Size in 2025 | USD 5.23 Billion |
| Market Size by 2035 | USD 29.49 Billion |
| CAGR | CAGR of 18.90% From 2026 to 2035 |
| Base Year | 2025 |
| Forecast Period | 2026-2035 |
| Historical Data | 2022-2024 |
| Key Segments | • By Therapy Type: (Cell Therapy, Gene Therapy, Gene-Modified Cell Therapy) • By Service Type: (Process & Analytical Development, Manufacturing, Fill & Finish Services) • By Vector Type: (Viral Vectors, Non-Viral Vectors, Cell-Based Delivery Systems) • By End User: (Biopharmaceutical Companies, Biotechnology Startups, Academic & Research Institutes) |
| Regional Analysis/Coverage | North America (US, Canada), Europe (Germany, UK, France, Italy, Spain, Russia, Poland, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Australia, ASEAN Countries, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Mexico, Colombia, Rest of Latin America). |
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