Good Manufacturing Practice (GMP) Services for Cell and Gene Therapy Market Report 2026

The good manufacturing practice (gmp) services for cell and gene therapy market size has grown rapidly in recent years. It will grow from $2.49 billion in 2025 to $2.95 billion in 2026 at a compound annual growth rate (CAGR) of 18.6%. The growth in the historic period can be attributed to growth in clinical trials for advanced therapies, expansion of cell therapy research programs, increasing regulatory standardization, development of early-stage gmp facilities, rising investment in biopharmaceutical manufacturing.

The good manufacturing practice (gmp) services for cell and gene therapy market size is expected to see rapid growth in the next few years. It will grow to $5.88 billion in 2030 at a compound annual growth rate (CAGR) of 18.9%. The growth in the forecast period can be attributed to increasing commercialization of gene therapies, rising demand for scalable manufacturing capacity, expansion of personalized medicine pipelines, growing outsourcing to cdmos, increasing adoption of automated quality control systems. Major trends in the forecast period include increasing demand for commercial-scale cell and gene therapy manufacturing, rising adoption of viral vector production services, growing focus on gmp-compliant automation, expansion of fill-finish and cold chain services, enhanced emphasis on regulatory compliance.

The growing number of cell and gene therapy clinical trials is expected to propel the growth of the good manufacturing practice (GMP) services for cell and gene therapy market going forward. Cell and gene therapy trials are regulated studies that evaluate the safety, efficacy, and quality of advanced therapies using genetically modified or living cells to treat conditions such as cancer, rare genetic disorders, and autoimmune diseases. The expansion of these trials is driven by increased research and development in advanced therapies, rising investments from biotechnology and pharmaceutical companies, and growing demand for innovative treatments addressing unmet medical needs. As many trial sponsors lack in-house GMP manufacturing capabilities, they increasingly depend on specialized GMP service providers for compliant manufacturing, analytical testing, quality control, and quality assurance. These services are essential to ensure the safe, consistent, and timely supply of clinical-grade materials across trial phases. For instance, in January 2026, according to the Bioindustry Association (BIA), a UK-based national trade association, the UK had 193 ongoing advanced therapy clinical trials, with over half in early stages and more than 80% focused on gene therapies. Therefore, the increasing 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.

Key companies operating in the good manufacturing practice (GMP) services for cell and gene therapy market are increasingly concentrating on expanding advanced manufacturing capabilities, including cell therapy manufacturing, to support regional clinical trials and accelerate therapy development timelines. Cell therapy manufacturing involves GMP-compliant processes for the collection, modification, expansion, and formulation of therapeutic cells to ensure product safety, quality, and clinical effectiveness. For example, in July 2025, AGC Biologics, a US-based contract development and manufacturing organization (CDMO), launched cell therapy process development and clinical manufacturing services at its Yokohama Technical Center in Japan. The facility supports GMP-compliant production for preclinical and clinical trials, including 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 faster and more compliant advancement of cell and gene therapies toward commercialization.

In May 2025, Altaris LLC, a US-based healthcare investment firm, acquired Minaris Regenerative Medicine GmbH for an undisclosed amount. Through this acquisition, Altaris, LLC aims to expand its global GMP capabilities in cell and gene therapy by integrating Minaris Regenerative Medicine’s expertise in compliant manufacturing of advanced therapy products. Minaris Regenerative Medicine GmbH is a Germany-based contract development and manufacturing organization (CDMO) specializing in GMP-compliant cell and gene therapy manufacturing.

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.

Tariffs are impacting the GMP services for cell and gene therapy market by increasing costs of imported bioprocessing equipment, single-use consumables, analytical instruments, cold chain systems, and cleanroom infrastructure components. Pharmaceutical and biotechnology companies in North America and Europe are most affected due to reliance on specialized imported equipment, while Asia-Pacific faces higher costs for facility expansion and technology transfer. These tariffs are increasing manufacturing service pricing and extending capacity build timelines. However, they are also driving domestic biomanufacturing investments, regional supplier development, and the establishment of localized GMP-compliant production hubs for advanced therapies.

The good manufacturing practice (gmp) services for cell and gene therapy market research report is one of a series of new reports that provides good manufacturing practice (gmp) services for cell and gene therapy market statistics, including good manufacturing practice (gmp) services for cell and gene therapy industry global market size, regional shares, competitors with a good manufacturing practice (gmp) services for cell and gene therapy market share, detailed good manufacturing practice (gmp) services for cell and gene therapy market segments, market trends and opportunities, and any further data you may need to thrive in the good manufacturing practice (gmp) services for cell and gene therapy industry. This good manufacturing practice (gmp) services for cell and gene therapy market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Good manufacturing practice (GMP) services for cell and gene therapy involve regulated manufacturing and quality-control procedures that ensure cell- and gene-based therapies are produced safely, consistently, and in accordance with global regulatory standards. These services encompass GMP-compliant facilities, cell and viral vector processing, testing, documentation, and regulatory support for clinical and commercial applications.

The primary service types of good manufacturing practice (GMP) services for cell and gene therapy include process development, manufacturing, analytical and quality control, fill-finish, and other service types. Process development involves the design, optimization, and scale-up of cell and gene therapy production processes to ensure consistency, safety, and compliance with regulatory standards. These services are applied across therapy types including cell therapy, gene therapy, and combination therapy, and phases including preclinical, clinical, and commercial. End users include pharmaceutical and biotechnology companies, academic and research institutes, and other users.

The good manufacturing practice (GMP) services for cell and gene therapy market includes revenues earned by entities through clinical manufacturing support, commercial scale manufacturing support, fill-finish services, cell banking services, raw material management services, quality control testing services, analytical testing services, regulatory support services, and quality assurance and compliance services. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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