Cell and Gene Therapy CDMO Market

Cell and Gene Therapy CDMO Market Forecast and Outlook 2026 to 2036

The global cell and gene therapy CDMO market is set to grow from USD 5.2 billion in 2026 to USD 42.2 billion by 2036, adding USD 37.0 billion in new revenue and advancing at a CAGR of 23.3%. Growth is driven by escalating demand for advanced therapeutic manufacturing validation, expanding regenerative medicine infrastructure across regulated markets, and accelerating regulatory approval requirements among pharmaceutical and biotechnology organizations seeking specialized production solutions.

Key Takeaways from Cell and Gene Therapy CDMO Market

• Cell and Gene Therapy CDMO Market Value (2026): USD 5.2 billion
• Cell and Gene Therapy CDMO Market Forecast Value (2036): USD 42.2 billion
• Cell and Gene Therapy CDMO Market Forecast CAGR: 23.3%
• Leading Phase in Cell and Gene Therapy CDMO Market: Pre-clinical (64.9%)
• Key Growth Regions in Cell and Gene Therapy CDMO Market: Asia Pacific, North America, and Europe
• Top Players in Cell and Gene Therapy CDMO Market: Lonza, Catalent Inc., Cytiva, Samsung Biologics, Thermo Fisher Scientific Inc.

Cell and gene therapy CDMO technologies are increasingly recognized as essential services for biopharmaceutical practitioners, offering precise viral vector production capabilities, regulatory compliance assurance, and comprehensive manufacturing characteristics compared to traditional in-house production approaches.

Pre-clinical phase services dominate the market, favored in research and development environments for their established validation properties, providing early-stage development mechanisms, scalability assessment capabilities, and regulatory pathway acceptance across diverse therapeutic applications and development demographics.

Cell Therapy remains fundamental in manufacturing protocols where routine process development and clinical material production match operational requirements and quality assurance confidence standards. Pre-clinical phase users are advancing among development categories as specialized CDMO facility networks expand and early-stage development infrastructure increases accessibility in research-convenient locations with stringent quality structures.

Cell and Gene Therapy CDMO Market Key Takeaways

At-a-Glance Metrics

Metric	Value
Market Value (2026)	USD 5.2 billion
Market Forecast (2036)	USD 42.2 billion
Growth Rate	23.3% CAGR
Leading Phase	Pre-clinical
Primary Product	Cell Therapy

Category

Category	Segments
Phase	Pre-clinical; Clinical
Product	Gene Therapy (Ex-vivo; In-vivo); Gene-Modified Cell Therapy (CAR T-cell Therapies; CAR-NK Cell Therapy; TCR-T Cell Therapy; Others); Cell Therapy
Indication	Oncology; Infectious Diseases; Neurological Disorders; Rare Diseases; Others
Region	North America; Europe; Asia Pacific; Latin America; Middle East & Africa

Segmental Analysis

What Makes Pre-clinical Phase Command the Largest Share in the Cell and Gene Therapy CDMO Market?

Pre-clinical phase commands the leading position in the cell and gene therapy CDMO market with a 64.9% market share through superior early-stage development characteristics, including established research partnerships, extensive process development documentation, and proven scalability pathways that enable biotechnology companies to achieve predictable manufacturing outcomes across varied therapeutic categories and diverse development demographics.

How does Cell Therapy Dominance Shape Product Preferences in CDMO Services?

Cell therapy demonstrates product leadership in the cell and gene therapy CDMO market with a 42.8% share due to widespread therapeutic application requirements and established focus on autologous production, allogeneic manufacturing, and process optimization that maximizes clinical efficacy while maintaining consistent quality manufacturing characteristics.

What establishes Oncology's Market Leadership in Cell and Gene Therapy CDMO?

Oncology establishes market leadership in the cell and gene therapy CDMO sector with commanding 48.0% share due to comprehensive CAR-T development requirements and sustained focus on hematological malignancy treatment, solid tumor applications, and immunotherapy manufacturing that maximizes therapeutic outcomes while maintaining appropriate regulatory standards.

Pharmaceutical companies and clinical teams prioritize oncology applications for CAR-T commercialization, comprehensive clinical trial programs, and integration with precision medicine requirements that enables coordinated development experiences across multiple cancer categories.

What are the Drivers, Restraints, and Key Trends of the Cell and Gene Therapy CDMO Market?

The cell and gene therapy CDMO market is driven primarily by rising CAR-T therapy approvals and commercialization, which are expanding demand for GMP-compliant manufacturing at commercial scale. Rapid growth in gene therapy pipelines, particularly for rare and genetic diseases, is further increasing requirements for viral vector production, validated processes, and specialized facilities. Pharmaceutical outsourcing trends also support market expansion, as developers seek capital efficiency, flexible capacity, and access to specialized manufacturing expertise.

Market restraints include high manufacturing and facility investment costs associated with GMP infrastructure, cleanrooms, and advanced equipment, which limit adoption among early-stage and resource-constrained biotechnology firms. Technical complexity, scale-up challenges, and process transfer risks further constrain utilization, particularly for novel modalities.

Key trends include accelerating adoption of automated and closed manufacturing systems to improve scalability, reduce contamination risk, and lower costs. CDMOs are also expanding regional manufacturing footprints to strengthen supply chain resilience, improve regulatory access, and support geographically distributed clinical and commercial demand.

Analysis of the Cell and Gene Therapy CDMO Market by Key Countries

Country	CAGR 2026-2036
India	27.0%
China	26.0%
South Korea	25.0%
USA	24.0%
UK	23.0%
Japan	22.5%
Germany	21.5%

Why does India Drive the Fastest Growth in Cell and Gene Therapy CDMO Services?

India records the fastest growth rate at 27.0%, driven by rapid biotechnology manufacturing expansion and strengthening CDMO infrastructure. Growth is concentrated in hubs such as Hyderabad, Bangalore, and Pune, where facilities are scaling capacity to meet international GMP standards.

Rising biotechnology investment and expanding clinical trial activity are increasing demand for cost-efficient manufacturing services across early-stage and commercial therapies. Indian CDMOs are standardizing production protocols, integrating global technology platforms, and leveraging skilled workforce availability to support process development and regulatory requirements.

How does China Establish Leadership Through Large-Scale Biomanufacturing Capacity?

China grows at a 26.0% rate, supported by strong government backing for biotechnology and extensive manufacturing infrastructure investment. CDMO adoption is accelerating in Shanghai, Beijing, and Suzhou, where integrated service platforms combine process development with commercial-scale production. Biotech park development and expanding clinical trial infrastructure support both domestic and international demand.

Chinese CDMOs emphasize capacity flexibility, cost efficiency, and regulatory documentation to attract global clients. Quality system development and compliance alignment are strengthening confidence in large-scale cell and gene therapy manufacturing partnerships.

Why does the USA Lead CAR-T and Advanced Therapy Manufacturing?

The USA maintains a 24.0% growth rate, anchored in CAR-T commercialization leadership and a mature FDA regulatory ecosystem. Growth centers in Massachusetts, California, and New Jersey, where CDMOs support clinical and commercial manufacturing for biotech firms and academic centers. Established quality systems, inspection readiness, and regulatory documentation remain critical differentiators.

Strong demand for premium CDMO services reflects expanding gene therapy approvals and ongoing investment in process optimization. The US market benefits from deep integration between innovation, regulation, and manufacturing execution.

How does South Korea Strengthen CDMO Adoption through Integrated Manufacturing Models?

South Korea records 25.0% growth, driven by government-backed biotechnology initiatives and integrated CDMO development. Hubs such as Incheon, Seoul, and Songdo emphasize automation, quality systems, and regulatory support within advanced therapy manufacturing.

CDMOs focus on platform-based services that align with global quality expectations and efficient commercialization pathways. Strong biopharmaceutical cluster development and national bioeconomy strategies continue to support scalable cell and gene therapy manufacturing capabilities.

Why is the UK Recognized for ATMP Manufacturing and Regulatory Precision?

The UK grows at 23.0%, supported by strong ATMP infrastructure and regulatory rigor. CDMO activity is concentrated in the Oxford-Cambridge corridor, London, and Manchester, where GMP compliance and validation depth guide manufacturing selection.

UK CDMOs emphasize MHRA inspection readiness, comparative process studies, and detailed technical documentation. Established cell and gene therapy development pipelines and regulatory maturity support sustained demand for specialized, compliance-driven manufacturing services.

How does Japan Integrate Regenerative Medicine Expertise into CDMO Growth?

Japan achieves 22.5% growth, driven by regenerative medicine leadership and accelerated approval pathways. CDMO adoption is supported by strong pharmaceutical participation and specialized facilities with iPSC manufacturing expertise.

Japanese partners prioritize quality assurance, validation depth, and regulatory alignment with PMDA requirements. Integration of advanced manufacturing technologies and disciplined process control supports premium positioning in cell and gene therapy production.

Why does Germany Maintain Excellence in Biopharmaceutical Manufacturing Services?

Germany records 21.5% growth, leveraging its pharmaceutical engineering heritage and stringent regulatory standards. CDMO activity in Bavaria, North Rhine-Westphalia, and Hesse emphasizes process robustness, quality by design, and comprehensive documentation.

German CDMOs focus on precision manufacturing, analytical integration, and EMA compliance. Strong technical expertise and quality-driven production culture continue to attract global partners seeking reliable and validated advanced therapy manufacturing services.

Competitive Landscape of the Cell and Gene Therapy CDMO Market

The cell and gene therapy CDMO market is moderately consolidated, with 40 to 70 active participants spanning global biomanufacturing networks and regional service providers. Competition reflects the maturation of advanced therapy manufacturing, where scale, regulatory credibility, and technical depth increasingly determine positioning. Large CDMOs benefit from established client relationships, validated manufacturing records of accomplishment, and broad service portfolios covering multiple cell and gene therapy modalities.

Lonza holds a leading position, supported by a diversified global manufacturing footprint, extensive process development capabilities, and long-standing relationships with biotechnology and pharmaceutical developers. Other established CDMOs compete by leveraging GMP-compliant facilities, technology transfer expertise, and regulatory support services that reduce development and commercialization risk for clients.

Specialized and regional CDMOs create competitive pressure through focused therapeutic expertise, cost advantages, and localized client support. Differentiation is increasingly visible in gene-modified cell therapies, automation, and closed-system manufacturing, where innovation-driven providers offer efficiency and contamination control benefits. Overall, competitiveness favors CDMOs combining global regulatory readiness, manufacturing efficiency, and integrated service offerings that extend beyond transactional production toward long-term development partnerships.

Key Players in the Cell and Gene Therapy CDMO Market

• Lonza
• Catalent, Inc.
• Cytiva
• Samsung Biologics
• Thermo Fisher Scientific Inc.
• Novartis AG
• WuXi AppTec
• AGC Biologics
• OmniaBio
• Rentschler Biopharma SE
• Charles River Laboratories

Scope of the Report

Items	Values
Quantitative Units (2026)	USD 5.2 billion
Phase	Pre-clinical, Clinical
Product	Gene Therapy (Ex-vivo, In-vivo), Gene-Modified Cell Therapy (CAR T-cell therapies, CAR-NK cell therapy, TCR-T cell therapy, Other), Cell Therapy
Indication	Oncology, Infectious Diseases, Neurological disorders, Rare Diseases, Others
Regions Covered	North America, Europe, Asia Pacific, Latin America, MEA
Countries Covered	USA, China, India, Germany, UK, France, Japan, South Korea, and 15+ additional countries
Key Companies Profiled	Lonza, Catalent Inc., Cytiva, Samsung Biologics, Thermo Fisher Scientific Inc., Novartis AG
Additional Attributes	Dollar sales by phase and product categories, regional adoption trends across Asia Pacific, North America, and Europe, competitive landscape with established CDMO corporations and specialized biomanufacturing companies, pharmaceutical preferences for Pre-clinical phase services and manufacturing flexibility, integration with biotechnology development facilities and pharmaceutical commercialization organizations, innovations in automated manufacturing technologies and closed-system platforms, and development of sophisticated GMP systems with enhanced scalability profiles and comprehensive regulatory documentation frameworks.

Cell and Gene Therapy CDMO Market by Segments

• Phase :

  • Pre-clinical
  • Clinical

• Product :

  • Gene Therapy
    • Ex-vivo
    • In-vivo
  • Gene-Modified Cell Therapy
    • CAR T-cell therapies
    • CAR-NK cell therapy
    • TCR-T cell therapy
    • Other
  • Cell Therapy

• Indication :

  • Oncology
  • Infectious Diseases
  • Neurological disorders
  • Rare Diseases
  • Others

• Region :

  • North America
    • USA
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • UK
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific
    • India
    • China
    • Japan
    • South Korea
    • ASEAN
    • Australia & New Zealand
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Rest of Latin America
  • MEA
    • GCC Countries
    • South Africa
    • Rest of MEA