The global cell and gene therapy contract development and manufacturing organization (CDMO) market is poised for explosive growth, with projections indicating an expansion from $8.07 billion in 2025 to $74.03 billion by 2034, representing a compound annual growth rate (CAGR) of 27.92%.
This remarkable growth trajectory is being fueled by increasing demand for innovative therapies, significant unmet medical needs, and strategic market consolidation by key industry players.
Market Dynamics and Regional Leadership
North America currently dominates the global cell and gene therapy CDMO landscape, holding approximately 67% of the market share in 2024. The region's leadership position is reinforced by well-established healthcare infrastructure, substantial R&D investments, and a supportive regulatory environment. The U.S. FDA's Office of Therapeutic Products has approved 43 licensed cell and gene therapy products as of December 2024, highlighting the region's progressive approach.
Meanwhile, the Asia Pacific region is emerging as the fastest-growing market, with an anticipated CAGR of 29.03% through 2034. This growth is being driven by:
- Strategic facility expansions by major CDMO players
- Government initiatives to streamline regulatory frameworks
- Increasing healthcare expenditure
- Growing focus on mRNA-based therapies
A notable development in this region was the October 2024 partnership between Teijin Limited and Singapore-based Hilleman Laboratories, aimed at expanding cell and gene therapy CDMO services across Asia Pacific.
Segment Analysis: Phases, Products, and Indications
Phase Segmentation
The pre-clinical segment dominated the market in 2024, accounting for 67% of the total share. This segment's growth is being propelled by:
- Optimization in vector delivery for improved tissue tropism
- Development of pluripotent stem cells for personalized therapies
- Implementation of advanced in vivo imaging techniques
- Application of data analytics and computational modeling
The clinical segment is expected to expand at a CAGR of 27.8% during the forecast period, driven by effective technology transfer strategies, specialized expertise, and accelerated market reach times.
Product Type Analysis
Cell therapy represented the largest segment in 2024 with a 42% market share. The segment's dominance can be attributed to:
- Increased automation and closed-loop manufacturing systems
- Advanced analytical tools for yield improvement
- Technological advancements in off-the-shelf allogeneic cell therapies
- Integration of robotics and AI
The gene-modified cell therapy segment is projected to grow at a robust 29% CAGR, with CAR T-cell therapies leading this category. Enhancements in cell manipulation techniques, investments in large-scale cell culture systems, and research into non-viral gene delivery methods are driving this growth.
Indication Analysis
Oncology applications currently represent the largest market segment, accounting for 50% of the total in 2024. This dominance reflects the urgent need for effective cancer treatments and the application of advanced technologies such as:
- Chimeric antigen receptor (CAR) T-cell therapies
- Tumor-infiltrating lymphocytes (TILs)
- Gene editing and cell manipulation techniques
- Viral vectors for targeted cancer therapies
The rare diseases segment is expected to show significant growth in the coming years, supported by advancements in CRISPR-Cas9 technology and induced pluripotent stem cell (iPSC) therapies.
Technological Transformations
Artificial intelligence is emerging as a transformative force in the cell and gene therapy CDMO market. AI algorithms are being deployed to:
- Characterize and select cells for improved product quality
- Design gene therapy vectors
- Optimize processes through real-time data analysis
- Implement predictive maintenance strategies
- Automate quality control procedures
- Identify potential candidates for personalized medicine approaches
Industry Trends and Developments
Several key trends are shaping the future of the cell and gene therapy CDMO market:
Clinical Innovation Acceleration
The development of dedicated manufacturing facilities with integrated platforms and large-scale capabilities is encouraging drug developers to invest in innovative therapies. Increased collaboration between research organizations, biopharmaceutical companies, and CDMOs is further accelerating clinical innovation.
Global Manufacturing Expansion
Significant investments in new CDMO manufacturing facilities and capacity expansions are driving market growth. In October 2024, OmniaBio launched Ontario's largest dedicated cell and gene therapy manufacturing facility and AI center of excellence, representing a $417 million investment.
Strategic Partnerships
Industry collaborations are becoming increasingly important. In January 2025, Charles River Laboratories International Inc. and Akron Bio announced the incorporation of Akron's Closed System Solutions line of liquid cytokines with Charles River's Therapy Flex Platform for Process Development.
Market Challenges and Opportunities
While the market presents significant growth opportunities, several challenges remain:
- Complex manufacturing processes requiring specialized expertise
- High development and production costs
- Regulatory complexities across different regions
- Supply chain management for time-sensitive therapies
However, these challenges are being addressed through technological innovations, strategic partnerships, and evolving regulatory frameworks, creating a more favorable environment for market expansion.
Future Outlook
The cell and gene therapy CDMO market is expected to continue its robust growth trajectory, driven by:
- Increasing prevalence of chronic diseases
- Growing demand for personalized medicine
- Technological advancements in manufacturing processes
- Expanding pipeline of cell and gene therapy candidates
- Rising investments from pharmaceutical companies and venture capital
As manufacturing technologies become more efficient and scalable, and as regulatory pathways become more defined, the market is likely to see accelerated growth and broader adoption of cell and gene therapies across various therapeutic areas.
