Table of Contents
Overview
New York, NY – June 18, 2025 – Global Cell And Gene Therapy Manufacturing Market size is expected to be worth around US$ 60.3 Billion by 2034 from US$ 6.9 Billion in 2024, growing at a CAGR of 24.3% during the forecast period from 2025 to 2034. In 2024, North America led the market, achieving over 48.1% share with a revenue of US$ 3.29 Billion.
A major breakthrough in the field of regenerative medicine is underway, as recent advancements in cell and gene therapy (CGT) manufacturing are paving the way for faster, safer, and more scalable therapeutic solutions. These therapies are designed to treat, modify, or even cure genetic and acquired diseases by targeting the root cause at the cellular level.
The manufacturing of cell and gene therapies requires precision, strict regulatory compliance, and advanced technologies such as automated bioreactors, closed-system processing, and AI-enabled quality control. Biopharmaceutical companies and contract development and manufacturing organizations (CDMOs) are rapidly expanding capabilities to meet increasing global demand.
With the growing number of FDA-approved CGT products and clinical trials for rare diseases, cancers, and inherited disorders, the need for robust manufacturing platforms is critical. Initiatives by the U.S. FDA’s Center for Biologics Evaluation and Research (CBER) and EMA’s ATMP regulation are playing a key role in accelerating product approvals while ensuring safety.
As of 2024, over 2,000 clinical trials involving cell and gene therapies are underway globally. Investment in manufacturing infrastructure and workforce development is expected to further fuel innovation and patient access.
Key Takeaways
- Market Size Overview: The global cell and gene therapy manufacturing market is projected to grow from US$ 6.9 billion in 2024 to approximately US$ 60.3 billion by 2034.
- Growth Forecast: The market is expected to expand at a compound annual growth rate (CAGR) of 24.3% during the forecast period from 2025 to 2034.
- Therapy Type Insights: Cell therapies dominate the market, contributing to approximately 58.2% of the total revenue share.
- Mode of Manufacturing: Contract manufacturing is currently the leading segment, holding a significant 67.5% of the overall market share.
- Manufacturing Scale Analysis: Preclinical and clinical-scale manufacturing constitutes the majority of activity, representing 74.1% of the market share.
- Application Segmentation: Oncology remains the primary area of application, accounting for 48.9% of the total market value.
- End-Use Distribution: Pharmaceutical and biotechnology companies are the principal end-users, occupying a dominant 69.2% share of the market.
- Regional Outlook: North America is expected to lead the global market in 2024, with a commanding 48.1% share of the total revenue.
Segmentation Analysis
- Therapy Type Analysis: The cell and gene therapy manufacturing market is segmented into cell therapies and gene therapies. Cell therapies lead with 58.2% market share, driven by increased adoption in cancer, autoimmune, and regenerative treatments. Their dominance is supported by a strong product pipeline and expanded manufacturing infrastructure. Gene therapies, while holding a smaller share, are growing due to breakthroughs in gene-editing and rising clinical approvals, with expectations of narrowing the gap as delivery technologies and targeted therapies advance.
- Mode of Manufacturing Analysis: Manufacturing is categorized into contract and in-house modes, with contract manufacturing holding a dominant 67.5% share. This is due to increasing reliance on CDMOs offering scalable infrastructure, technical expertise, and cost-efficiency. Small-to-mid-size biotech firms particularly benefit from outsourcing. In-house manufacturing, preferred by large pharma for IP protection and process control, holds a smaller share. However, high infrastructure costs keep contract manufacturing in the lead despite steady internal capability investments by major pharmaceutical firms.
- Scale of Manufacturing Analysis: The market is segmented by production scale into preclinical/clinical-scale and commercial-scale. Preclinical and clinical-scale manufacturing currently dominates with a 74.1% share, supported by a large number of trials and research programs requiring smaller, flexible production batches. This stage benefits from modular systems and adaptive processes for individualized therapies. While commercial-scale output is expanding as approvals rise, early-stage pipeline activity continues to drive the dominance of preclinical and clinical-scale production in the current market environment.
- Application Analysis: Applications span oncology, neurological disorders, genetic diseases, cardiovascular conditions, and more. Oncology leads with 48.9% market share, fueled by rising cancer cases and success of CAR-T therapies in blood cancers. Innovations in immunotherapy and personalized medicine sustain this dominance. Neurological and rare disease applications are expanding rapidly as gene therapy advances. While oncology remains the primary driver, broader application diversification signals strong future potential for cell and gene therapies across various disease categories worldwide.
- End-User Analysis: The market is segmented by end-users into pharmaceutical and biotech firms, CDMOs, academic institutions, and hospitals. Pharmaceutical and biotech companies dominate with a 69.2% share, owing to large R\&D investments, regulatory expertise, and integrated capabilities. CDMOs serve as vital partners for emerging firms lacking infrastructure. Research institutions drive early innovation, while hospitals contribute through personalized, small-batch manufacturing. Though pharma leads, collaboration across all user groups is essential for driving innovation and advancing therapy commercialization.
Market Segments
Therapy Type
- Cell therapy
- Gene therapy
Mode
- In-house Manufacturing
- Contract Manufacturing (CDMOs & CMOs)
Scale
- Preclinical and Clinical-Scale
- Commercial-Scale
Application
- Oncology (Cancer Treatment)
- Neurological Disorders
- Cardiovascular Diseases
- Rare & Genetic Disorders
- Infectious Diseases
- Musculoskeletal Disorders
- Autoimmune Diseases
- Other Applications
By End-user
- Pharmaceutical & Biotechnology Companies
- Contract Development & Manufacturing Organizations (CDMOs/CMOs)
- Research Institutes & Academic Organizations
- Hospitals & Clinics
Regional Analysis
In 2024, North America is expected to lead the global Cell and Gene Therapy Manufacturing Market, capturing approximately 48.1% of the total market share. This regional dominance is primarily driven by the presence of a well-established healthcare infrastructure, significant investments in the biotechnology sector, and an extensive pipeline of cell and gene therapy candidates.
The region benefits from the presence of leading pharmaceutical and biotech companies, along with favorable regulatory support that accelerates manufacturing innovation. Rising incidences of chronic and genetic disorders continue to fuel demand for advanced therapeutic solutions.
Additionally, strong collaboration between academic research centers and industry stakeholders has strengthened research and development efforts. As personalized medicine and novel gene-editing technologies continue to advance, North America is projected to retain its leadership in the global cell and gene therapy manufacturing landscape.
Emerging Trends
- Adoption of advanced manufacturing technologies: Continuous and automated manufacturing systems are being embraced to improve quality and speed up production. These technologies reduce manual steps and help address drug shortages by enabling faster scale-up of therapies.
- Standardization of CMC processes: Chemistry, Manufacturing, and Control (CMC) requirements are being formalized through regulatory guidance and town halls. A strategic plan has emphasized the need for clear standards to speed licensure under the 21st Century Cures Act.
- Enhanced product characterization methods: Novel laboratory assays are under development to better predict safety and effectiveness. These methods allow regulators to more reliably assess potency and quality before clinical use.
- Modular, scalable manufacturing facilities: Institutions are building flexible sites dedicated solely to production. For example, an 8,000 ft² modular facility with four clean rooms has been opened to meet changing trial demands.
Use Cases
- Dedicated clinical-trial production: A new Modular Terrace Facility was funded at $20 million to supply therapies for first-in-human trials. It offers 3,000 ft² of clean-room space for manufacturing and takes several months to complete one patient’s product run.
- Viral vector manufacture for gene transfer: The NCI’s Biopharmaceutical Development Program now produces lentiviral and retroviral vectors. Typical projects span 9–13 months from start to final testing before release for clinical use.
- Regulatory readiness for Biologics License Applications: FDA has convened its first town hall on CMC preparedness for gene therapy BLAs, following two earlier meetings on investigational products. This demonstrates a focus on licensing pathways for advanced therapies.
Conclusion
The global cell and gene therapy (CGT) manufacturing market is experiencing rapid growth, driven by increasing clinical demand, technological advancements, and supportive regulatory frameworks. The dominance of cell therapies, widespread reliance on contract manufacturing, and a strong focus on oncology indicate clear market priorities.
North America remains the leading region due to its robust infrastructure and innovation ecosystem. With over 2,000 ongoing clinical trials and rising investments in modular and automated facilities, the industry is moving toward scalable and efficient production. Continued regulatory support and cross-sector collaboration will be essential to ensure wider access and sustainable growth.
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