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How Is The Market Size Of The Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market Expected To Change From 2026 To 2030?
The market size for good manufacturing practice (gmp) services for cell and gene therapy has experienced rapid expansion in recent years. It is anticipated to grow from $2.49 billion in 2025 to $2.95 billion in 2026, achieving a compound annual growth rate (CAGR) of 18.6%. This historical growth can be attributed to several factors: an increase in clinical trials for advanced therapies, the expansion of cell therapy research programs, increasing regulatory standardization, the development of early-stage gmp facilities, and rising investment in biopharmaceutical manufacturing.
The good manufacturing practice (gmp) services for cell and gene therapy market size is projected to experience swift expansion in the coming years. This market is anticipated to reach $5.88 billion by 2030, exhibiting a compound annual growth rate (CAGR) of 18.9%. The projected growth during this period stems from factors such as the increasing commercialization of gene therapies, an escalating need for scalable manufacturing capabilities, the expansion of personalized medicine pipelines, a rise in outsourcing activities to CDMOs, and the broader adoption of automated quality control systems. Key trends expected over the forecast period encompass a surging demand for commercial-scale cell and gene therapy manufacturing, the increasing utilization of viral vector production services, a heightened concentration on GMP-compliant automation, the expansion of fill-finish and cold chain services, and an intensified focus on regulatory compliance.
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What Key Factors Are Shaping The Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market Landscape?
The good manufacturing practice (GMP) services for cell and gene therapy market is projected to grow, driven by the increasing volume of cell and gene therapy clinical trials. These trials are defined as regulated investigations assessing the safety, effectiveness, and quality of advanced therapies, which employ genetically modified or live cells to address conditions like cancer, uncommon genetic disorders, and autoimmune diseases. The surge in these studies is attributed to greater research and development efforts in advanced therapies, increased funding from biotechnology and pharmaceutical firms, and a growing demand for novel treatments for unmet medical needs. Given that numerous trial sponsors lack internal GMP manufacturing capabilities, they are increasingly turning to specialized GMP service providers for compliant manufacturing, along with analytical testing, quality control, and quality assurance. Such services are vital to guaranteeing a secure, consistent, and prompt provision of clinical-grade materials throughout all stages of a trial. For example, in January 2026, the Bioindustry Association (BIA), a national trade association located in the UK, reported 193 active advanced therapy clinical trials in the UK; over half of these were in early stages, and more than 80% concentrated on gene therapies. Hence, the rising number of cell and gene therapy clinical trials is indeed fueling the expansion of the good manufacturing practice (GMP) services for cell and gene therapy market.
How Are Segments Identified Within The Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market Segment Framework?
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
What Market Trends Are Affecting The Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market?
Companies operating in the good manufacturing practice (GMP) services for cell and gene therapy market are increasingly emphasizing the expansion of advanced manufacturing capabilities, particularly in cell therapy production, to back regional clinical trials and speed up therapy development. Cell therapy manufacturing encompasses GMP-compliant procedures for the collection, alteration, propagation, and preparation of therapeutic cells, guaranteeing product safety, quality, and clinical efficacy. For example, in July 2025, AGC Biologics, a US-based contract development and manufacturing organization (CDMO), introduced cell therapy process development and clinical manufacturing services at its Yokohama Technical Center in Japan. This facility supports GMP-compliant manufacturing for both preclinical and clinical trials, covering CAR-T therapies, induced pluripotent stem cells, and other stem cell platforms. Such an expansion bolsters AGC Biologics’ global GMP presence across Europe, North America, and Asia, enabling a more rapid and compliant journey for cell and gene therapies towards commercialization.
Who Are The Companies Competing Within The Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market?
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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Which Region Dominates The Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market By Market 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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