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Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market Size And Revenue Outlook Through 2030
The good manufacturing practice (gmp) services for cell and gene therapy market has witnessed substantial growth in recent years. It is anticipated to expand from $2.49 billion in 2025 to $2.95 billion in 2026, demonstrating a compound annual growth rate (CAGR) of 18.6%. This historical growth can be linked to several factors, including an increase in clinical trials for advanced therapies, the expansion of cell therapy research initiatives, heightened regulatory standardization, the establishment of early-stage gmp facilities, and growing investment in biopharmaceutical manufacturing.
The good manufacturing practice (gmp) services for cell and gene therapy market is set for substantial growth in the upcoming years, with projections indicating an increase to $5.88 billion by 2030, driven by a compound annual growth rate (CAGR) of 18.9%. This expansion is attributed to the escalating commercialization of gene therapies, a greater requirement for scalable manufacturing capabilities, the broadening scope of personalized medicine pipelines, increased outsourcing to CDMOs, and the growing adoption of automated quality control systems. Over the forecast period, significant trends will include an elevated demand for commercial-scale cell and gene therapy manufacturing, a rise in the utilization of viral vector production services, an intensified focus on GMP-compliant automation, the expansion of fill-finish and cold chain services, and a stronger emphasis on regulatory compliance.
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Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market Opportunity Drivers: What’s Unlocking New Revenue Potential?
The good manufacturing practice (GMP) services for cell and gene therapy market is anticipated to experience growth, driven by the rising volume of cell and gene therapy clinical trials. These trials are regulated investigations assessing the safety, effectiveness, and quality of advanced therapies, which utilize genetically modified or living cells to address conditions like cancer, rare genetic disorders, and autoimmune diseases. This growth in trials stems from expanded research and development in advanced therapies, coupled with increased investments from biotechnology and pharmaceutical firms, and a growing need for innovative solutions for currently untreatable medical conditions. Due to the absence of internal GMP manufacturing capabilities among numerous trial sponsors, there’s a growing dependence on specialized GMP service providers for compliant manufacturing, analytical testing, quality control, and quality assurance. Such services are essential to guarantee a safe, consistent, and prompt provision of clinical-grade materials throughout all stages of trials. For example, in January 2026, the Bioindustry Association (BIA), a national trade association based in the UK, reported 193 active advanced therapy clinical trials in the UK, with over half in early stages and more than 80% specifically targeting gene therapies. Consequently, the rising number of cell and gene therapy clinical trials is a key driver for the expansion of the good manufacturing practice (GMP) services for cell and gene therapy market.
Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market Segment Breakdown: Which Categories Lead On Revenue?
The good manufacturing practice (gmp) services for cell and gene therapy market covered in this report is segmented –
1) By Service Type: Process Development; Manufacturing; Analytical and Quality Control; Fill-Finish; Other Service Types
2) By Therapy Type: Cell Therapy; Gene Therapy; Combination Therapy
3) By Phase: Preclinical; Clinical; Commercial
4) By End-User: Pharmaceutical and Biotechnology Companies; Academic and Research Institutes; Other End-Users
Subsegments:
1) By Process Development: Vector Design Optimization; Cell Line Development; Upstream Process Optimization; Downstream Purification Development; Process Scale Up Studies
2) By Manufacturing: Clinical Trial Material Production; Commercial Scale Manufacturing; Viral Vector Manufacturing; Plasmid Production Services; Cell Therapy Manufacturing
3) By Analytical and Quality Control: Method Development And Validation; Potency And Efficacy Testing; Safety And Sterility Testing; Stability And Shelf Life Studies; Release Testing Services
4) By Fill-Finish: Aseptic Filling Services; Vial And Syringe Filling; Lyophilization Services; Packaging And Labeling; Cold Chain Handling
5) By Other Service Types: Regulatory Support Services; Technology Transfer Services; Supply Chain Management; Storage And Distribution; Post Manufacturing Support
Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market Innovation Trends Shaping Future Development
Key players within the good manufacturing practice (GMP) services for cell and gene therapy market are increasingly prioritizing the expansion of advanced manufacturing capabilities, specifically cell therapy manufacturing, to support regional clinical trials and accelerate the progression of new therapies. Cell therapy manufacturing encompasses GMP-compliant procedures for the collection, modification, expansion, and formulation of therapeutic cells, ensuring product safety, quality, and clinical efficacy. A notable example occurred in July 2025 when AGC Biologics, a US-based contract development and manufacturing organization (CDMO), initiated cell therapy process development and clinical manufacturing services at its Yokohama Technical Center in Japan. This facility is equipped to provide GMP-compliant production for preclinical and clinical trials, including treatments like CAR-T therapies, induced pluripotent stem cells, and other stem cell platforms. This strategic expansion significantly enhances AGC Biologics’ worldwide GMP presence across Europe, North America, and Asia, thereby enabling a more rapid and compliant journey for cell and gene therapies towards commercialization.
Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market Company Landscape And Competitive Strategy
Major companies operating in the good manufacturing practice (gmp) services for cell and gene therapy market are 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., ENCell Co. Ltd.
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Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market Largest Region: Which Geography Holds The Biggest Share?
North America was the largest region in the good manufacturing practice (GMP) services for cell and gene therapy market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the good manufacturing practice (gmp) services for cell and gene therapy market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.
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