Cell and Gene Therapy Manufacturing Market: Growth, Trends, and Leading Innovators
The Cell and Gene Therapy Manufacturing Market size was valued at USD 134.48 billion in the year 2024 and is expected to grow to USD 834.1 billion by 2035, with a CAGR of 15.5% during the predicted term (2025-2035). The increasing number of approved gene and cell therapies, new manufacturing technology, and the growing number of Contract Development and Manufacturing Organizations (CDMOs) are driving factors of market growth.
The ongoing investment of and product partnerships among leading pharma and biotech firms is transforming the competitive landscape of the industry.
Strong CDMO presence and major players in cell and gene therapy manufacturing include Lonza Group (Switzerland), Bluebird Bio, Inc. (US), Catalent Inc. (US), F. Hoffmann-La Roche Ltd. (Switzerland), Samsung Biologics (South Korea), Boehringer Ingelheim (Germany), Takara Bio Inc. (Japan), Hitachi Chemical Co., Ltd. (Japan), etc.
These firms deploy strategies across a number of areas, including development of innovative manufacturing platforms, technology partnership, acquisition, and geographic expansion to gain the competitive edge.
Major Cell and Gene Therapy Manufacturing Companies Include:
- Lonza Group (Switzerland)
- Bluebird Bio, Inc. (United States)
- Catalent Inc. (United States)
- F. Hoffmann-La Roche Ltd. (Switzerland)
- Samsung Biologics (South Korea)
- Boehringer Ingelheim (Germany)
- Takara Bio Inc. (Japan)
- Hitachi Chemical Co., Ltd. (Japan)
1. Lonza Group (Switzerland) is a leading global CDMO specializing in providing comprehensive and integrated manufacturing solutions for cell and gene therapies, ranging from process development to large-scale commercialization. Lonza was founded in 1897, and has a history of packaging and delivering whatever the client requires. Lonza reliably invests in advanced automation platforms used in manufacturing to scale to meet the increasing need for product development and commercialization. The company has particularly invested in capacity expansion of viral vector and cell therapy facilities to serve the increasing global demand.
2. Bluebird Bio, Inc. (US) is focused on gene therapies for rare diseases and for severe genetic disorders. Founded in 1992, Bluebird Bio is known primarily for moving FDA-approved therapies into commercialization and developing a strong in-house manufacturing capacity. Over the last couple of years, the company has commercialized lentiviral vector production and announced partnerships aimed improving pipeline therapies.
3. Catalent Inc. (US) is a premier provider of delivery technologies and CMDO services, including the manufacture of gene and cell therapies. Founded in 2007, Catalent has invested in dedicated gene therapy campuses and expanded its suite of cell expansion labs, playing a global role in speeding the commercialization of therapies to market.
4. F. Hoffmann-La Roche Ltd. (Switzerland), one of the largest biotech companies in the world (founded 1896), has significant expertise in clinical manufacturing and study of tenorizmab (Columvi) for the treatment of DLBCL, which should - spur the need for specialize maufacturing and analytics linewidths.
5. Samsung Biologics (South Korea) was founded in 2011 and quickly became an important CDMO player -- expanding size operations for both human biologics and cell/gene therapy manufacturing. They have made large expansions in capacity and international partnerships for delivery viratl vectors and advance manufacturing capabilities.
6. Boehringer Ingelheim (Germany), a well-established innovator in pharmaceuticals (1875), invests heavily in biomanufacturing infrastructure and strategic partnerships. Boehringer Ingelheim recently increased its engagement in cell/gene therapy with new investments in R&D and GMP-compliant biomanufacturing.
7. Takara Bio Inc. (Japan) founded in 1967, provides molecular biology and high-throughput testing solutions. The SmartChip ND Real-Time PCR System was launched in November 2024 and helps to advance analytical workflow processes that are important for quality control in cell and gene therapy biomanufacturing.
8. Hitachi Chemical Co., Ltd. (Japan), established in 1912 now Showa Denko, serves as a CDMO and specializes in the biomanufacturing of regenerative and cell therapies and its recent development includes cell processing solutions that are automated and closed to improve cost efficiencies and scalability in manufacturing for their clients.
Regional Analysis: Leadership and Emerging Markets
North America: The Global Epicenter
With approximately 47.42% of the market by 2024, North America holds a leading position in the global cell and gene therapy manufacturing landscape. Major American biopharma firms, world-class researchers, the funding to support research, and a regulatory environment that moves quickly to develop new medicines are all factors that facilitate American leadership.
The U.S. has a strong fast-track approval training program and support all parts of the pipe line, from basic research and development of a new therapy to full commercialization.
Asia-Pacific: The Fastest Growing Region
Asia-Pacific is emerging as the world's fastest growing region of the cell and gene therapy product market, with approximately 19.7% of revenues by 2024.
Increased healthcare expenditure, government investments in biomanufacturing infrastructure, and rising patient awareness are all stimulating regional growth in country markets like China, Japan, and South Korea where governments have made investments in biomanufacturing capacity and have engaged in partnerships that establish a stronger international presence.
Europe and Other Regions
Europe continues to be important and loyal to cell and gene therapy development because of its established research base and regulatory environment. Progressive investments in both Latin America and the Middle East, are emerging as local governments are in "start-up" mode exploring biopharma innovations and investment in building capacity.
Key Factors Supporting Market Growth
Developing Pipeline & Approvals: The arrival of new approvals will create a consistent requirement for manufacturing services when products advance from preclinical to commercial statuses.
Increased Investment: Funding from both private and public entities is sparking research and the expansion of infrastructure; life science venture capital and public grants will allow companies to move candidates into commercial manufacturing without halting their innovation trail.
Innovation: Improving workflows, continuous manufacturing, and closed systems will improve workflows, reduce costs and offer better consistency and scalability.
Expansion of CDMOs: Contract Development and Manufacturing Organizations have become an important partner for companies, specifically smaller biotechs, with less internal capacity for process development to commercial manufacturing.
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Market Segmentation Analysis
By Therapy Type
Within therapy type, Cell Therapy Manufacturing represents the largest market share at an estimated rate of 60.19% in 2024, largely due to the success seen in gaining approvals and commercialization for additional cell therapy products so far.
Gene Therapy Manufacturing will see rapid growth due to accelerated advancement of gene therapy candidates through late-stage trials and regulations.
By Scale
Pre-commercial/R&D Scale Manufacturing holds the largest revenue share at approximately 73.34%, confirming there are many therapies under development in the early stages of clinical trials.
Commercial-Scale Manufacturing will experience the highest CAGR as the list of approved therapies for the market and commercial scale manufacturing increases.
By Mode & Workflow
Contract Manufacturing and In-house Manufacturing: Each mode is important to the market. Contract Manufacturing is typically more geared to working small biotech organizations, while In-house Manufacturing is leveraged by larger pharmaceutical organizations, and academic medical centers.
Workflow should be segmented by cell processing, banking, process development, fill & finish, analytical & quality testing, and raw material & vector production.
Conclusion
The cell and gene therapy market is accelerating growth due to the need for transformative treatment modalities and next generation biologics. Those companies investing in scalable manufacturing, new technologies, and global partnerships into the future, will help shape the new era of precision medicine.
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