Cell & Gene Therapy Manufacturing Services Market size was over USD 7.2 billion in 2024 and is estimated to reach USD 58.6 billion by the end of 2037, expanding at a CAGR of 19.1% during the forecast timeline, i.e., 2025-2037. In 2025, the industry size of the cell & gene therapy manufacturing services is evaluated at USD 8.5 billion.
The growth is majorly due to the rising demand for advanced therapies fueled by the increasing prevalence of conditions such as cancer, neurological disorders, and inherited diseases. Furthermore, automation, AI, and closed-system manufacturing processes are being adopted to enhance capabilities.
Governments worldwide are also providing regulatory support for faster approvals, and funding several research programs. This is encouraging biotech and pharma companies to develop cell and gene therapies. For instance, in October 2024, the 57th Governor of New York State funded USD 430 million, for New York BioGenesis Park which is a Cell and Gene Therapy Innovation Hub, in Long Island. As the therapies progress for clinical trials and toward commercialization, there’s a greater need for specialized manufacturing services to support their production.
Growth Drivers
Challenges
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Base Year |
2024 |
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Forecast Year |
2025-2037 |
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CAGR |
19.1% |
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Base Year Market Size (2024) |
USD 7.2 billion |
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Forecast Year Market Size (2037) |
USD 58.6 billion |
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Regional Scope |
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Mode (Contract manufacturing, In-house manufacturing)
The contract manufacturing segment is poised to hold over 87.8% cell & gene therapy manufacturing services market share by the end of 2037. Companies’ rising outsourcing of manufacturing activities to streamline production procedures and fast-track time-to-market for their therapies is majorly driving the segment’s growth. The dynamic regulatory landscape, in addition to the requirement for flexibility in manufacturing capacity, is driving the growth further. In January 2024, Israeli cell technology company Pluri announced the expansion of the contract development and manufacturing division, PluriCDMO. The company intends to share its knowledge base, technology, and facilities to develop stem cells, induced pluripotent stem cells, exosomes, and Immunotherapeutics, with other businesses.
Type (Cell therapy, Gene therapy)
Based on type, gene therapy is projected to expand at a considerable CAGR during the forecast period in the cell & gene therapy manufacturing services market. A wide range of products are currently up for clinical trials, and manufacturing process improvement has become a significant need in the market. As per an article on gene therapy by Wiley, over 3,900 gene therapy trials were undertaken in 46 countries as per the March 2023 update. Furthermore, prominent companies are increasingly focusing on manufacturing and commercialization owing to rising funding and the clinical success of more products. Companies are undertaking several initiatives to enhance their presence in the manufacturing market.
Our in-depth analysis of the market includes the following segments:
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Type |
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Mode |
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Indication |
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End user |
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North America Market Analysis
Domestic companies in North America have amplified their manufacturing operations in the cell & gene therapy manufacturing services market. Moreover, a strong network of CDMOs enables scalable production of the therapies in the region. In March 2023, Thermo Fisher Scientific Inc., in collaboration with the University of California, San Francisco (UCSF) announced the acceleration of advanced cell therapies for difficult-to-treat conditions. This includes cancer, rare diseases, and other illnesses.
As per the National Cancer Institute, in 2024, an estimated 2,001,140 new cases of cancer were diagnosed in the U.S., leading to nearly 611,720 people dying from the disease. The country dominates the North America region, driven by a mixture of strong technological infrastructure, substantial funding in biotechnology, and an exceedingly skilled workforce. Moreover, supportive regulations have enhanced R&D activities, leading to a flow in the number of clinical trials and approvals of advanced groundbreaking therapies in the market.
Canada market is growing steadily, supported by the government, a strong academic research environment, and collaborative industry partnerships. The country’s focus on innovation and regulatory advancements, such as the Pathway to Licensing advanced therapies is strengthening the cell & gene therapy manufacturing services market in the country. Scaling domestic production is enhancing the supply chain in the country, and accelerating cross-border partnerships.
APAC Market Statistics
APAC region houses a large and assorted population, including a substantial patient number from diseases which can be treated potentially through cell and gene therapies. This grants a considerable market prospect for establishments providing manufacturing services in the region, further driving market growth. The region is also progressively identifying the capabilities of the life sciences segment. These factors are boosting the region’s market.
South Korea
market is particularly supported by a robust biotech industry. Regulatory reforms and financial support for biopharmaceuticals have spurred the establishment of cutting-edge production facilities, aiming to position South Korea as a regional hub for cell and gene therapy. For instance, in October 2024, Samsung Biologics launched a new high-concentration formulation platform, S-HiCon, to boost high-dose biopharmaceutical development and manufacturing.
China cell & gene therapy manufacturing services market is driven by a large patient base with unmet medical needs. The government’s commitment to supporting biotech innovation, combined with favorable regulatory adjustments for faster approvals, has fostered an environment where biotech companies can rapidly advance cell and gene therapies from research to commercialization. Hence, the country’s market is anticipated to witness considerable growth during the forecast period.
One of the key strategies adopted by the companies in the cell & gene therapy manufacturing services market is investing in capacity expansion. This is majorly done through building new facilities or upgrading existing ones to accommodate high-demand gene and cell therapy projects. In January 2023, FUJIFILM Irvine Scientific, Inc. launched the BalanCD HEK293 Viral Feed, which is intended to enhance AAV production for gene therapy applications and viral vector-based vaccines. These launches, in addition to other strategic activities, including geographical expansion, and partnerships between firms are projected to influence positive significant market activities, maintaining healthy competition between the players. Some of the prominent players are:
Author Credits: Radhika Pawar
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