Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market Growth Is Reshaping Competitive Advantage Across The Industry
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Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market Size Outlook: How Fast Will Revenue Grow Through 2030?
The good manufacturing practice (gmp) services for cell and gene therapy market has experienced rapid expansion in recent years. This market is set to expand from $2.49 billion in 2025 to $2.95 billion in 2026, achieving a compound annual growth rate (CAGR) of 18.6%. The historical growth of this market can be attributed to several factors, including an increase in clinical trials for advanced therapies, the enlargement of cell therapy research programs, greater regulatory standardization, the establishment of early-stage gmp facilities, and rising investment within biopharmaceutical manufacturing.
The market for good manufacturing practice (gmp) services in cell and gene therapy is anticipated to experience swift expansion over the coming years. This market is projected to reach $5.88 billion by 2030, exhibiting a compound annual growth rate (CAGR) of 18.9%. This projected expansion is fueled by factors such as the increasing commercialization of gene therapies, a greater need for scalable manufacturing capabilities, the broadening of personalized medicine pipelines, an uptick in outsourcing to CDMOs, and the wider implementation of automated quality control systems. Key trends anticipated during this period involve a heightened demand for commercial-scale manufacturing of cell and gene therapies, an increase in the use of viral vector production services, a stronger emphasis on GMP-compliant automation, the growth of fill-finish and cold chain services, and an increased focus on regulatory compliance.
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Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market Growth Factors Supporting Long-Term Expansion
The market for good manufacturing practice (GMP) services catering to cell and gene therapy is anticipated to grow due to a rising number of cell and gene therapy clinical trials. These trials are regulated investigations assessing the safety, effectiveness, and quality of advanced therapies that utilize genetically modified or living cells to address conditions like cancer, rare genetic disorders, and autoimmune diseases. This increase in trials is driven by heightened research and development in advanced therapies, greater financial contributions from biotechnology and pharmaceutical firms, and a growing need for novel treatments for previously unaddressed medical conditions. Since numerous trial sponsors do not possess internal GMP manufacturing capabilities, they increasingly depend on specialized GMP service providers for manufacturing compliance, analytical testing, quality control, and quality assurance. Such services are essential to guarantee a secure, uniform, and prompt provision of clinical-grade materials throughout all trial stages. As an example, the Bioindustry Association (BIA), a national trade association based in the UK, reported 193 active advanced therapy clinical trials in the UK in January 2026, with over half being in early stages and more than 80% specifically targeting gene therapies. Consequently, the rising volume of cell and gene therapy clinical trials is propelling 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 Analysis: What Are The Major Market Categories?
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 Industry Trends Shaping Future Revenue Growth
Leading companies operating within the good manufacturing practice (GMP) services for cell and gene therapy market are increasingly prioritizing the expansion of advanced manufacturing capabilities, particularly cell therapy manufacturing, to aid regional clinical trials and accelerate the development of therapies. Cell therapy manufacturing involves GMP-compliant processes for the collection, modification, expansion, and formulation of therapeutic cells, ensuring product safety, quality, and clinical effectiveness. For example, in July 2025, 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 provides GMP-compliant production support for preclinical and clinical trials, including CAR-T therapies, induced pluripotent stem cells, and other stem cell platforms. This strategic expansion enhances AGC Biologics’ global GMP footprint across Europe, North America, and Asia, enabling faster and more compliant advancement of cell and gene therapies towards commercialization.
Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market Leading Companies Driving Competitive Growth
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 By Revenue And 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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