Cell and Gene Therapy Manufacturing Services Market Size to Reach USD 31.30 Billion by 2035, Driven by Rising Biopharmaceutical R&D Investment

According to DataM Intelligence, the Cell and Gene Therapy Manufacturing Services Market size was valued at USD 7.61 billion in 2025 and is expected to reach USD 31.30 billion by 2035, registering a 15.2% CAGR from 2026 to 2035. The market is projected to reach USD 8.77 billion in 2026.
The market is being supported by rising demand for advanced and personalized therapies for cancer and other chronic diseases, alongside higher pharmaceutical and biopharmaceutical R&D spending. Growing therapy pipelines are increasing the need for scalable, compliant, and efficient manufacturing capabilities. Partnerships between pharmaceutical companies and CDMOs are also supporting the development and commercialization of complex therapies. At the manufacturing level, automation, viral vector production, single-use technologies, advanced analytics, and digital manufacturing are gaining importance. High specialized manufacturing costs, stringent GMP requirements, complex production processes, and cold-chain requirements remain important challenges for service providers and therapy developers.

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Recent Developments

• Charles River Laboratories International, Inc. - 2026: Expanded its cell and gene therapy capabilities through integrated CDMO services covering viral vector development, analytical testing, and GMP manufacturing.
• Thermo Fisher Scientific Inc. - 2026: Enhanced its end-to-end manufacturing services with customized solutions for cell culture media, gene editing, and commercial-scale manufacturing support.
• Lonza Group AG - 2026: Advanced its cell and gene therapy manufacturing platform through investments in cGMP manufacturing technologies for autologous and allogeneic cell therapies and viral vector production.
• Merck KGaA - 2026: Expanded technologies and manufacturing solutions supporting cell and gene therapy development, process optimization, and quality control.
• Catalent, Inc. - 2026: Expanded its commercial licensing agreement with Cartherics to support manufacturing and commercialization of iPSC-derived CAR-NK cell therapies.
• Takara Bio Inc. - 2026: Continued advancing cell processing technologies and GMP-compliant manufacturing capabilities for regenerative medicine and gene-modified cell therapy programs.
• FUJIFILM Irvine Scientific - 2026: Strengthened its cell culture media and bioprocessing solutions for cell and gene therapies, supporting scalable clinical and commercial manufacturing.
• Oxford Biomedica plc - 2026: Entered a multi-year commercial supply agreement with Bristol Myers Squibb for manufacturing lentiviral vectors used in CAR-T therapy programs.
• SGS SA - 2026: Expanded analytical testing services for cell and gene therapies, including product characterization, potency testing, and regulatory compliance support.

Mergers & Acquisitions

• Catalent, Inc. - 2026: Expanded its commercial licensing agreement with Cartherics to support the manufacturing and commercialization of iPSC-derived CAR-NK cell therapies for cancer treatment.
• Oxford Biomedica plc - 2026: Entered a new multi-year commercial supply agreement with Bristol Myers Squibb for lentiviral vector manufacturing used in CAR-T therapy programs.

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Market Segmentation

By Type
• Cell Therapy
• Gene Therapy
Cell therapy represented the larger segment in the report, supported by demand associated with CAR-T therapies, stem cell-based treatments, and personalized medicine applications. The report indicates that cell therapy accounted for 51.6% of the market.

By Indication
• Oncology Diseases
• Cardiovascular Diseases
• Orthopedic Diseases
• Ophthalmology Diseases
• Central Nervous System Disorders
• Infectious Diseases
• Others
These indications reflect the broad therapeutic applications requiring specialized cell and gene therapy manufacturing services across clinical and commercial development programs.

By Application
• Clinical Manufacturing
• Commercial Manufacturing
Clinical manufacturing is supported by the growing number of cell and gene therapy clinical trials progressing through regulatory pathways, while commercial manufacturing is becoming increasingly important as advanced therapies progress toward broader commercialization.

By End User
• Pharmaceutical and Biotechnology Companies
• Academic and Research Institutes
• Others
Pharmaceutical and biotechnology companies represent a major source of outsourcing demand, with specialized manufacturing partners supporting development, production, and commercialization activities.

By Region
• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa
Regional demand varies according to biotechnology infrastructure, manufacturing capabilities, R&D activity, investment, and regulatory conditions.

Competitive Landscape

The Cell and Gene Therapy Manufacturing Services Market features a competitive group of specialized manufacturing, bioprocessing, analytical testing, and life sciences companies.

Key Players

• Charles River Laboratories
• Thermo Fisher Scientific Inc.
• Lonza
• Merck KGaA
• Catalent, Inc.

Company Profiles

Charles River Laboratories: The company strengthened its integrated CDMO capabilities in 2026, covering viral vector development, analytical testing, and GMP manufacturing for advanced therapy programs.

Thermo Fisher Scientific Inc.: Its 2026 development focused on expanding end-to-end manufacturing support, including cell culture media, gene editing, and commercial-scale solutions.

Lonza: The company continued investing in cGMP manufacturing technologies for autologous and allogeneic cell therapies as well as viral vector production.

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Regional Analysis

North America is the dominant region, accounting for 41.2% of the global market, according to the report. Its position is associated with a strong biopharmaceutical ecosystem, substantial R&D activity, advanced therapy commercialization, manufacturing infrastructure, and a favorable regulatory environment.
The report identifies Asia-Pacific as the fastest-growing region, supported by expanding biotechnology infrastructure, increasing investments in advanced therapeutics manufacturing, and government initiatives encouraging biopharmaceutical innovation.

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Conclusion

The Cell and Gene Therapy Manufacturing Services Market is expanding alongside the growing development and commercialization of advanced therapeutics. Rising biopharmaceutical R&D investment, increasing clinical pipelines, and greater reliance on specialized CDMOs are supporting demand for manufacturing services. Cell therapy remains an important segment, while clinical and commercial manufacturing requirements continue to shape service demand.
Manufacturing capacity expansion, viral vector production, automation, closed-system technologies, process development, and technology transfer are among the areas influencing the market. At the same time, high specialized manufacturing costs, GMP requirements, complex production processes, and cold-chain logistics create operational challenges. North America maintains the leading regional position, while Asia-Pacific is identified as the fastest-growing market. The competitive environment includes major manufacturing and life sciences service providers such as Charles River Laboratories, Thermo Fisher Scientific, Lonza, Merck KGaA, and Catalent, with continued investments and collaborations supporting the industry's development.

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