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How Much Is The Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market Expected To Grow In Terms Of Market Value Between 2026 And 2030?
The good manufacturing practice (gmp) services for cell and gene therapy market has witnessed rapid expansion in recent years. This market is anticipated to expand from $2.49 billion in 2025 to $2.95 billion in 2026, reflecting a compound annual growth rate (CAGR) of 18.6%. Historically, this growth was primarily driven by the increasing number of clinical trials for advanced therapies, the expansion of cell therapy research programs, improved regulatory standardization, the establishment of early-stage gmp facilities, and heightened investment in biopharmaceutical manufacturing.
The good manufacturing practice (gmp) services for cell and gene therapy market is poised for significant expansion in the coming years. Its valuation is projected to reach $5.88 billion by 2030, exhibiting a compound annual growth rate (CAGR) of 18.9%. This anticipated growth stems from factors such as the accelerated commercialization of gene therapies, a greater need for scalable manufacturing capabilities, the enlargement of personalized medicine portfolios, increased reliance on CDMOs for outsourcing, and the broader implementation of automated quality control systems. Key developments expected during this forecast timeframe encompass a surge in the demand for commercial-scale cell and gene therapy production, a rise in the uptake of viral vector manufacturing services, a heightened emphasis on automation that complies with GMP standards, an expansion of fill-finish and cold chain solutions, and a stronger focus on adherence to regulatory guidelines.
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Which Major Factors Are Driving The Expansion Of The Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market?
The growing number of cell and gene therapy clinical trials is projected to fuel the expansion of the good manufacturing practice (GMP) services for cell and gene therapy market in the coming years. Cell and gene therapy trials are regulated studies designed to evaluate the safety, efficacy, and quality of advanced therapies, which employ genetically modified or living cells to treat conditions such as cancer, rare genetic disorders, and autoimmune diseases. The increase in these trials is being propelled by expanded research and development in advanced therapies, heightened investment from biotechnology and pharmaceutical companies, and an escalating demand for innovative treatments addressing unmet medical needs. Given that many trial sponsors lack internal GMP manufacturing capabilities, they increasingly turn to specialized GMP service providers for compliant manufacturing, analytical testing, quality control, and quality assurance. These services are crucial for ensuring the safe, consistent, and timely delivery of clinical-grade materials throughout all trial phases. For instance, in January 2026, the Bioindustry Association (BIA), a UK-based national trade association, indicated that the UK had 193 ongoing advanced therapy clinical trials, with more than half in early stages and over 80% focused on gene therapies. Therefore, the rising number of cell and gene therapy clinical trials is driving the growth of the good manufacturing practice (GMP) services for cell and gene therapy market.
What Major Segment Divisions Exist Within The Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market?
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
How Are Trends Shaping The Direction Of The Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market?
Major companies engaged in the good manufacturing practice (GMP) services for cell and gene therapy market are increasingly dedicating efforts to expand their advanced manufacturing capabilities, including cell therapy manufacturing, to facilitate regional clinical trials and accelerate the development of new therapies. Cell therapy manufacturing encompasses GMP-compliant processes for the collection, modification, expansion, and formulation of therapeutic cells, ensuring the safety, quality, and clinical effectiveness of these products. For instance, 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 supports GMP-compliant production for preclinical and clinical trials, covering therapies like CAR-T therapies, induced pluripotent stem cells, and other stem cell platforms. This expansion enhances AGC Biologics’ global GMP footprint across Europe, North America, and Asia, enabling a faster and more compliant progression of cell and gene therapies towards commercialization.
Which Major Players Dominate 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 Geographic Areas Are Emerging As Strong Markets For The Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market?
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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