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What Will Be The Estimated Market Size Of The Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market By 2030?

The good manufacturing practice (gmp) services for cell and gene therapy market size has experienced rapid expansion in recent years. This market is projected to increase from $2.49 billion in 2025 to $2.95 billion in 2026, achieving a compound annual growth rate (CAGR) of 18.6%. Historically, this market’s growth can be attributed to several factors including an uptick in clinical trials for advanced therapies, the enlargement of cell therapy research programs, intensified regulatory standardization, the creation of early-stage GMP facilities, and increased investment in 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%. The expansion during this forecast timeframe stems from factors such as the heightened commercialization of gene therapies, a greater need for scalable manufacturing capabilities, the enlargement of personalized medicine development pipelines, an increase in outsourcing to CDMOs, and the wider implementation of automated quality control systems. Key developments anticipated in the forecast period encompass a surging requirement for commercial-scale cell and gene therapy manufacturing, a growing uptake of viral vector production services, an intensified concentration on GMP-compliant automation, the broadening of fill-finish and cold chain offerings, and a strengthened commitment to adhering to regulatory standards.

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What Major Growth Factors Are Impacting The Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market?

The rising volume of cell and gene therapy clinical trials is anticipated to boost the good manufacturing practice (GMP) services for cell and gene therapy market in the future. These trials are regulated investigations assessing the safety, effectiveness, and quality of advanced therapies that utilize genetically altered or live cells to address ailments like cancer, rare genetic conditions, and autoimmune disorders. This surge in trials stems from expanded research and development in advanced therapies, increased funding from biotechnology and pharmaceutical companies, and a growing need for novel treatments for currently unaddressed medical requirements. Given that numerous trial sponsors do not possess internal GMP manufacturing capabilities, they are progressively turning to specialized GMP service providers for compliant manufacturing, analytical testing, quality control, and quality assurance. Such services are vital for guaranteeing the secure, consistent, and prompt provision of clinical-grade materials throughout all trial stages. For example, data from January 2026, reported by the Bioindustry Association (BIA), a UK-based national trade association, indicated that the UK had 193 active advanced therapy clinical trials, with over half in early phases and more than 80% concentrating on gene therapies. Consequently, the growing count of cell and gene therapy clinical trials is propelling the expansion of the good manufacturing practice (GMP) services for cell and gene therapy market.

How Is The Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market Distributed Across Key Segments?

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

Which Trends Are Influencing The Direction Of The Good Manufacturing Practice (GMP) Services For Cell And Gene Therapy Market?

Leading firms within the good manufacturing practice (GMP) services for cell and gene therapy market are dedicating more effort to enhancing their advanced manufacturing infrastructure, which encompasses cell therapy production, to facilitate regional clinical studies and expedite the progression of therapies. The production of cell therapies necessitates processes that comply with GMP standards for gathering, altering, multiplying, and preparing therapeutic cells, thereby guaranteeing the product’s safety, quality, and efficacy in clinical settings. As an illustration, in July 2025, AGC Biologics, a US-headquartered contract development and manufacturing organization (CDMO), inaugurated services for cell therapy process development and clinical manufacturing at its facility located in Yokohama, Japan. This center provides support for GMP-adherent production tailored for both preclinical and clinical investigations, encompassing CAR-T treatments, induced pluripotent stem cells, and various other stem cell methodologies. Such growth enhances AGC Biologics’ worldwide GMP presence spanning Europe, North America, and Asia, thereby facilitating the quicker and more compliant progression of cell and gene therapies toward market availability.

Who Are The Prominent Players Across 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 Is The Dominant Market In 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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