The global cell and gene therapy CDMO market size is calculated at USD 8.07 billion in 2025 and is projected to surpass around USD 74.03 billion by 2034, registering a solid CAGR of 27.92% from 2025 to 2034.
The growth of the cell and gene therapy CDMO market is fostered by the growing appetite for innovative therapies, unmet medical needs and increased focus of CDMOs on market consolidation strategies.
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Cell and Gene Therapy CDMO Market Highlights:
• North America led the global market with the highest share of 67% in 2024.
• Asia Pacific is projected to grow at a notable CAGR of 29.03% over the projected period.
• The pre-clinical segment held a largest market share of 67% in 2024.
• The clinical segment is expanding a solid CAGR of 27.8% over the forecast period.
• The cell therapy segment accounted for a significant market share of 42% in 2024.
• The gene-modified cell therapy segment is anticipated to grow at a healthy CAGR of 29% during the studied years.
• The oncology segment contributed the biggest market share of 50% in 2024.
• The rare diseases segment is projected to expand rapidly in the coming years.
Market Overview and Industry Potential
Cell and gene therapy CDMO (Contract Development and Manufacturing Organization) companies offer outsourcing services for the development and manufacturing of cell and gene therapies. CDMOs assist drug developers in streamlining manufacturing processes, in evaluating various technologies for process development, for enhancing regulatory compliance and increasing reliability of clinical trials.
The process of developing cell and gene therapies by converting a biological hypothesis for a drug into a scalable and producible therapy for patient treatment can be challenging for drug developers. CDMOs offer valuable assistance for to pharmaceutical companies with an integrated approach of merging R&D with Chemistry, Manufacturing, and Controls (CMC) thereby augmenting knowledge transfer and boosting the drug development process by reducing bottlenecks.
Furthermore, the surging demand for advanced cell and gene therapies, expansion of dedicated manufacturing facilities and increased emphasis on decentralized manufacturing processes is boosting the growth of the market.
Role of Artificial Intelligence in the Cell and Gene Therapy CDMO Market
Integrating Artificial Intelligence (AI) into cell and gene therapy CDMO can help in enhancing the quality and potency ultimately bringing about accelerated development cycles while mitigating errors and reducing the costs.
AI algorithms can help in the characterization and selection of cells for improving the quality of products, for designing gene therapy vectors, in optimizing processes by surveying real-time data, for minimizing downtime with predictive maintenance strategies, automating quality control and for identifying potential candidates for expediting personalized medicine approaches.
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Major Trends in the Cell and Gene Therapy CDMO Market
Advancements Fostering Clinical Innovations:
The development of dedicated manufacturing facilities equipped with integrated platforms, industrial experts, large scale manufacturing capabilities and end-to-end services encourages drug developers to invest in creating innovative therapies with the potential to transform healthcare.
Furthermore, increased collaboration of research organizations and biopharmaceutical companies with CDMOs, supportive regulatory incentives, growing emphasis on point-of-care manufacturing, accelerated market reach times and reduced costs fosters clinical innovations.
Global Expansion of Manufacturing Facilities:
The increased investments for the development new CDMO manufacturing facilities and expansion of capacities in various regions across the globe drives the market growth. Moreover, the implementation of advanced automated technologies and data analytics systems, increased scalability, growing strategic collaborations and acquisitions for expanding service offerings, development of advanced manufacturing techniques, burgeoning global demand for cell and gene therapies (CGT), growing pipelines of CGT and enhanced regulatory compliance offered by the CDMOs drives the global expansion.
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Cell and Gene Therapy CDMO Market Report Scope
|
Report Coverage |
Details |
|
Market Size by 2034 |
USD 74.03 Billion |
|
Market Size in 2025 |
USD 8.07 Billion |
|
Market Size in 2024 |
USD 6.31 Billion |
|
CAGR 2025 to 2034 |
27.92% |
|
Leading Region |
North America |
|
Fastest Growing Region |
Asia Pacific |
|
Base Year |
2024 |
|
Forecast Period |
2025 to 2034 |
|
Segments Covered and Regions |
Phase, Product Type, Indication, and Regions. |
|
Regions Covered |
North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa |
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U.S. Cell and Gene Therapy CDMO Market Size to Reach USD 74.03 Billion by 2034
The U.S. cell and gene therapy CDMO market size accounted for USD 3.08 billion in 2025 and is projected to reach around USD 28.73 billion by 2034, expanding at a CAGR of 28.12% from 2025 to 2034.
Presence of Significant Investments: North America to Sustain as a Leader
North America dominated the global market with the largest share in 2024. The large presence of CDMOs for cell and gene therapy equipped with advanced facilities, rising investments in R&D activities, major market players operating in the region, well-established healthcare infrastructure, ongoing clinical trials for creating effective innovative therapies, growing demand for personalized treatments and the supportive regulatory agencies foster the global market dominance of this region.
• For instance, as of December 2024, the Office of Therapeutic Products (OTP) of the U.S. FDA has approved 43 licensed cell and gene therapy products.
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Asia Pacific is expected to witness lucrative growth over the forecast period. The market growth of this region can be attributed to the growing focus on navigating the distinctive market dynamics for optimization of clinical trial processes, development of dedicated facilities by major CDMO players, active involvement of governments for streamlining regulatory frameworks, increasing healthcare expenditure, strategic collaborations, surging patient demand and increased emphasis on developing innovative mRNA- based therapies. Additionally, the presence of strong regional players such as South Korea, India and China are expanding the market potential of this region.
• For instance, in October 2024, Teijin Limited and Hilleman Laboratories, a Singapore-based biotechnology company signed a Memorandum of Understanding (MoU) thereby initiating a strategic international business partnership. The collaboration aims at advancing the expansion of cell and gene therapy CDMO in Asia Pacific.
Cell and Gene Therapy CDMO Market Segmentation Analysis:
Phase Analysis
The pre-clinical segment dominated the market with the largest share in 2024. The latest advancements such as optimization in vector delivery for improving tissue tropism, development of pluripotent stem cells for delivering personalized therapies, implementation of advanced in vivo imaging techniques, utilizing high-throughput screening platforms, sophisticated genetically engineered animal platforms, increased emphasis on applying data analytics and computational modelling for analysing complex preclinical data and optimizing strategies for treatment for predict clinical outcomes are the various applications which foster the market growth of this segment.
Furthermore, the growing focus of CDMOs on developing scalable and streamlined processes for manufacturing of cell and gene therapies while adhering to regulatory standards is leading to accelerated preclinical development opening pathways for broader aspects of therapeutic applications as well as for personalized medicine with enhanced efficiency and safety.
The clinical segment is expected to witness lucrative growth over the forecast period. The development of effective technology transfer strategies with transparency by CDMOs, exclusive support in clinical trials and increased access to specialized expertise with adherence to regulatory guidelines resulting in accelerated market reach times is boosting the market growth of this segment.
Furthermore, CDMOs assist in understanding the process variability for aligning with the constant changes in aggressive clinical programs for cell and gene therapy developers thereby reducing the costs and duration of various developmental stages.
Product Type Analysis
The cell therapy segment dominated the market accounting the largest share in 2024. The market dominance of this segment can be attributed to the increased focus on replacing manual processes with automation and closed-loop manufacturing systems for minimizing risk of contamination and application of advanced analytical tools for increasing yields by the cell therapy CDMOs.
Furthermore, technological advancements for the production of off-the-shell allogeneic cell therapies, utilization of robotics, AI integration and development of mobile manufacturing units are the factors driving the market growth of this segment.
The gene-modified cell therapy segment is expected to witness lucrative growth over the forecast period. The growth of this segment can be attributed to the enhancement in cell manipulation techniques, rising investments for the adoption of large-scale cell culture systems as well as closed-system manufacturing, increased research for the development non-viral gene delivery methods and incorporation of advanced technologies such as artificial intelligence and machine learning methodologies by the CDMOs.
CAR T-cell therapies category dominated the gene-modified cell therapy segment. Growing influence of CDMOs on clinical manufacturing of CAR-T cell products, optimization of development processes, and increased emphasis on commercialization strategies is expanding the market potential of these therapies.
Indication Analysis
The oncology segment held the largest market share in 2024. The market dominance of this segment can be attributed to the growing need for developing effective and targeted cancer treatments to treat the large patient pool, leveraging chimeric antigen receptor (CAR) T-cell therapies and tumour-infiltrating lymphocytes (TILs) as well as the utilization of advanced technologies such as gene editing, cell manipulation techniques and viral vectors for generating tailored therapies targeting specific cancer antigens.
Moreover, the rising collaborations among universities and CDMOs, growing number of oncology outsourcing service providers and advancements in developing sophisticated facilities equipped with cutting-edge technologies and experts providing insights to align with regulatory guidelines is helping in streamlining manufacturing processes while ensuring patient safety.
For instance, in June 2024, Charles River Laboratories International Inc., signed a lentiviral CDMO agreement with the Gates Institute at the University of Colorado Anschutz Medical Campus. The contract permits Gates Institute for developing Good Manufacturing Practice (GMP)-grade lentiviral vectors (LVVs) for application in novel CAR T-cell therapies for haematological cancers by leveraging Charles River’s leading cell and gene therapy CDMO expertise.
The rare diseases segment is seen to grow at a notable rate over the forecast period. The increased emphasis on developing on rare disease therapies through clinical studies, growing regulatory approvals, advancements in CRISPR-Cas9 technology and ongoing research for unlocking the potential of induced pluripotent stem cell (iPSC) therapies derived from patients for delivering a personalized approach are the factors expected to drive the market growth of this segment in the upcoming years.
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Cell and Gene Therapy CDMO Market Companies:
• Charles River Laboratories
• Cytiva
• Novartis AG
• Lonza
• WuXi AppTec
• AGC Biologics
• Catalent, Inc
• OmniaBio
• Rentschler Biopharma SE
• Samsung Biologics
• Thermo Fisher Scientific Inc.
What is Going Around the Globe?
• In January 2025, Charles River Laboratories International Inc., and Akron Bio, a leading supplier of critical materials services for dedicated therapies declared the incorporation of Akron’s Closed System Solutions (CSS) line of liquid cytokines developed under current Good Manufacturing Practices (CGMP) with the Therapy Flex Platform for Process Development provided by Charles River.
• In October 2024, a CDMO OmniaBio, launched the largest dedicated cell and gene therapy manufacturing facility and AI center of excellence in Ontario, Canada which will focus on developing a cell-based product for osteoarthritis patients. The 120,000 square foot facility cost $417 million for building.
The research report categorizes the Cell and Gene Therapy CDMO market into the following segments and subsegments:
By Phase
• Pre-clinical
• Clinical
By Product Type
• Gene Therapy
o Ex-vivo
o In-vivo
• Gene-Modified Cell Therapy
o CAR T-cell Therapies
o CAR-NK Cell Therapy
o TCR-T Cell Therapy
o Other
• Cell Therapy
By Indication
• Oncology
• Infectious Diseases
• Neurological Disorders
• Rare Diseases
• Others
By Region
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa (MEA)
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