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Key Strategic Developments and Emerging Changes Shaping the Good Manufacturing Practice (GMP) Services Market for Cell and Gene Therapy
Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market
Forecasted Market Value and Growth Trajectory of the GMP Services for Cell and Gene Therapy Market
The GMP services market for cell and gene therapy is expected to experience robust growth, reaching a valuation of $5.88 billion by 2030. This expansion corresponds to a compound annual growth rate (CAGR) of 18.9%. The surge is largely fueled by the increasing commercialization of gene therapies, escalating need for scalable manufacturing capacity, expanding pipelines in personalized medicine, greater outsourcing to contract development and manufacturing organizations (CDMOs), and the widespread adoption of automated quality control technologies. Key trends shaping this growth include rising demand for commercial-scale manufacturing of these therapies, enhanced use of viral vector production services, growing emphasis on GMP-compliant automation, broader fill-finish and cold chain service offerings, and a stronger focus on regulatory compliance.
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Leading Players in the GMP Services Market for Cell and Gene Therapy
Several notable companies are driving innovation and market expansion in this sector. Major players include Novartis AG, Boehringer Ingelheim BioXcellence GmbH, Batavia Biosciences B.V., FUJIFILM Diosynth Biotechnologies, AGC Biologics Inc., Lonza Group AG, WuXi AppTec Co. Ltd., BioNTech Innovative Manufacturing Services, Charles River Laboratories International Inc., Catalent Inc., Samsung Biologics Co. Ltd., Miltenyi Biotec GmbH, SK pharmteco Co. Ltd., KBI Biopharma Inc., Oxford Biomedica plc, OmniaBio Inc., RoslinCT Ltd., Pluri CDMO, SCTbio Inc., Made Scientific Inc., and ENCell Co. Ltd.
In a notable development, Altaris LLC, a U.S.-based healthcare investment firm, acquired Minaris Regenerative Medicine GmbH in May 2025. This acquisition aims to enhance Altaris's global GMP capabilities within cell and gene therapy by leveraging Minaris's expertise in compliant manufacturing of advanced therapy medicinal products. Minaris Regenerative Medicine GmbH operates as a German CDMO specializing in GMP-compliant cell and gene therapy production.
Key Drivers Supporting Growth in the GMP Services Market
Leading companies in the GMP services sector are increasingly focused on broadening their advanced manufacturing capabilities to support regional clinical trials and accelerate the development of novel therapies. Cell therapy manufacturing is a critical area, involving GMP-compliant processes such as cell collection, modification, expansion, and formulation to ensure product quality, safety, and clinical efficacy.
For example, in July 2025, AGC Biologics, a U.S.-based CDMO, introduced cell therapy process development and clinical manufacturing services at its Yokohama Technical Center in Japan. This facility supports GMP-compliant production for preclinical and clinical stages, including CAR-T therapies, induced pluripotent stem cells, and other stem cell platforms. This expansion strengthens the company's global GMP footprint across Europe, North America, and Asia, enabling quicker and more compliant advancement of cell and gene therapies toward market approval.
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Emerging Trends Boosting the GMP Services Market Growth
The GMP services market is witnessing a rising adoption of viral vector production services, which are vital for gene therapy development and manufacturing. Companies are also focusing on integrating automation compliant with GMP standards to improve manufacturing efficiency and consistency.
Additionally, the market is seeing expansion in fill-finish and cold chain logistics services, which are crucial for maintaining product integrity during handling and distribution. There is also an enhanced emphasis on regulatory compliance, ensuring therapies meet stringent quality standards required by health authorities worldwide.
Breakdown of Key Segments in the GMP Services for Cell and Gene Therapy Market
This market is segmented across several dimensions to provide a detailed understanding of service offerings and application areas:
1) By Service Type: Process Development; Manufacturing; Analytical and Quality Control; Fill-Finish; Other Services
2) By Therapy Type: Cell Therapy; Gene Therapy; Combination Therapy
3) By Development Phase: Preclinical; Clinical; Commercial
4) By End-User: Pharmaceutical and Biotechnology Companies; Academic and Research Institutes; Other End-Users
Further subcategories include:
- Process Development: Vector Design Optimization; Cell Line Development; Upstream Process Optimization; Downstream Purification Development; Process Scale-Up Studies
- Manufacturing: Clinical Trial Material Production; Commercial Scale Manufacturing; Viral Vector Manufacturing; Plasmid Production Services; Cell Therapy Manufacturing
- Analytical and Quality Control: Method Development and Validation; Potency and Efficacy Testing; Safety and Sterility Testing; Stability and Shelf Life Studies; Release Testing Services
- Fill-Finish: Aseptic Filling Services; Vial and Syringe Filling; Lyophilization Services; Packaging and Labeling; Cold Chain Handling
- Other Services: Regulatory Support Services; Technology Transfer Services; Supply Chain Management; Storage and Distribution; Post Manufacturing Support
Global Market Outlook and Regional Focus
While North America currently holds the largest share of the GMP services market for cell and gene therapy, the Asia-Pacific region is anticipated to exhibit the fastest growth during the forecast period. The comprehensive market analysis spans key regions including Asia-Pacific, Western Europe, Eastern Europe, North America, South America, and the Middle East and Africa, providing insights into global market dynamics.
In summary, the GMP services market for cell and gene therapy is set for dynamic growth, driven by technological advancements, increasing therapy commercialization, and evolving regulatory requirements. The continued focus on scalable manufacturing, automation, and expanded service offerings will likely define the future trajectory of this promising sector.
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