Global Regulatory Affairs Management for Cell and Gene Therapy Market Size is predicted to develop a 14.2% CAGR during the forecast period for 2025-2034.
Regulatory Affairs Management for Cell and Gene Therapy (CGT) involves overseeing the development, submission, and compliance of regulatory documentation to ensure that CGT products meet the safety, efficacy, and quality standards set by global health authorities such as the FDA, EMA, and others. This field navigates the unique challenges of CGTs, which are often complex, personalized therapies involving genetic material or patient-specific cells, and therefore, require tailored regulatory frameworks.
A critical early step is determining whether the product is classified as a somatic cell therapy, gene therapy, tissue-engineered product, or a combination product, as this classification dictates the regulatory pathway. Regulatory Affairs Management for CGT is a highly specialized function that demands interdisciplinary expertise in regulatory science, biotechnology, quality systems, and clinical strategy to ensure timely and compliant product development and approval.
Gene therapy is rapidly transforming the landscape of medical treatment for a wide range of complex disorders, and with its advancement, the role of regulatory affairs has expanded significantly to ensure these novel therapies meet rigorous safety and efficacy standards. The growing number of gene therapy clinical trials and regulatory approvals highlights the momentum in this field. For instance, the steady increase in gene therapy Investigational New Drug (IND) applications submitted to the FDA reflects the field's growth and regulatory engagement. Landmark approvals, such as Luxturna for retinal dystrophy and Zolgensma for spinal muscular atrophy, showcase regulatory agencies' willingness to embrace innovative treatments, which in turn has fueled further research and investment.
A notable early milestone was the 2012 approval of Glybera in Europe for lipoprotein lipase deficiency (LPLD), which, despite its groundbreaking nature, faced substantial regulatory scrutiny, including rigorous safety monitoring and post-market requirements. Similarly, Luxturna's approval in the U.S. followed extensive clinical trials and careful alignment with evolving FDA guidelines. These pioneering cases not only paved the way for subsequent gene therapies but also helped refine regulatory frameworks, creating a more structured and predictable environment for future development.
Competitive Landscape
Some of the Major Key Players in the Regulatory Affairs Management for Cell and Gene Therapy Market are:
- Novartis AG
- Amgen Inc.
- Pfizer Inc.
- Biogen Inc.
- Gilead Sciences Inc.
- Roche
- Johnson & Johnson
- Sanofi
- Bayer AG
- AstraZeneca PLC
- Lonza Group Ltd.
- Catalent, Inc.
- Thermo Fisher Scientific Inc.
- Charles River Laboratories International, Inc.
- WuXi AppTec
- IQVIA Holdings Inc.
- Parexel International Corporation
- Syneos Health, Inc.
- PPD, Inc.
- CMIC Group
Market Segmentation
The regulatory affairs management for the cell and gene therapy market is segmented based on service type, application, and therapy type. Based on service type, the market is segmented into in-house regulatory affairs and outsourced regulatory affairs. Based on the application, the market is divided into oncology, rare diseases, genetic disorders, and other applications. Based on the therapy type, the market is divided into cell therapy, gene therapy, and gene-modified cell therapy.
The Outsourced Regulatory Affairs Segment is Expected to Have the Highest Growth Rate During the Forecast Period
Based on service type, the market is segmented into in-house regulatory affairs and outsourced regulatory affairs. Among these, the outsourced regulatory affairs segment is expected to have the highest growth rate during the forecast period. The cell and gene therapy (CGT) market heavily favors outsourced regulatory affairs over in-house regulatory affairs management, with outsourcing holding the largest share. The CGT sector relies extensively on Contract Development and Manufacturing Organizations (CDMOs) and Contract Research Organizations (CROs) for regulatory tasks due to the need for expertise in navigating complex, evolving regulatory frameworks like those of the FDA and EMA. Outsourcing offers cost savings of 50-80% compared to in-house operations, alongside access to specialized regulatory knowledge critical for CGT, such as compliance with Good Manufacturing Practices (GMP) and managing long-term safety data requirements.
The Gene-Modified Cell Therapy Segment Dominates the Market
Based on the therapy type, the market is divided into cell therapy, gene therapy, and gene-modified cell therapy. Among these, the gene-modified cell therapy segment dominates the market. Gene-modified cell therapies involve both cellular manipulation and genetic engineering, requiring oversight for both cell therapy and gene therapy. This dual complexity increases the demand for regulatory affairs expertise, including Chemistry, Manufacturing, and Controls (CMC) documentation and risk management. This segment, which includes therapies like CAR-T cell therapies (e.g., Kymriah, Yescarta), commands the largest share of regulatory affairs management due to its rapid growth and complex regulatory requirements.
North America Has the Largest Market Share During the Forecast Period.
North America leads the global biologics regulatory affairs outsourcing market, driven by stringent regulations and a high concentration of biologics manufacturers. The U.S. FDA, with its collaborative engagement (e.g., RMAT, Breakthrough Designation), fosters innovation and simplifies market entry. Hundreds of biotech companies and CDMOs are based in the U.S., creating economies of scale and demand for regulatory and manufacturing services. CGT regulatory affairs, supported by a mature biotech ecosystem, robust regulatory support, and comprehensive infrastructure across development, manufacturing, and clinical domains.
Recent Developments:
- In Mar 2025, AstraZeneca reached a final deal to purchase EsoBiotec, a biotechnology business that is leading the way in vivo cell therapies and has shown encouraging early clinical results. In contrast to the existing procedure, which takes weeks, the EsoBiotec Engineered NanoBody Lentiviral (ENaBL) platform enables the immune system to combat malignancies and may provide many more patients with access to revolutionary cell therapy treatments administered in a matter of minutes. In order to teach some immune cells, including T cells, to identify and eliminate tumor cells in order to cure cancer or autoreactive cells for possible application in immunologically mediated disorders, ENaBL employs highly focused lentiviruses to transfer genetic instructions to these cells.
- In Jun 2023, Vertex Pharmaceuticals Incorporated and Lonza declared a strategic partnership to assist in the production of Vertex's line of fully differentiated insulin-producing islet cell therapies for individuals with type 1 diabetes that are produced from experimental stem cells. The partnership will primarily support the VX-880 and VX-264 programs, which are presently undergoing clinical studies. Clinical proof-of-concept has already been shown by Vertex's first clinical study, VX-880. All six patients treated with VX-880 engrafted islet cells produced endogenous insulin (C-peptide), improved glycemic control, and reduced or eliminated their use of insulin, according to fresh results revealed last week.
Regulatory Affairs Management for Cell and Gene Therapy Market Report Scope:
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Report Attribute |
Specifications |
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Growth Rate CAGR |
CAGR of 14.2% from 2025 to 2034 |
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Quantitative Units |
Representation of revenue in US$ Bn and CAGR from 2025 to 2034 |
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Historic Year |
2021 to 2024 |
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Forecast Year |
2025-2034 |
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Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
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Segments Covered |
By Service Type, Application, Therapy Type |
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Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
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Country Scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; The UK; France; Italy; Spain; China; Japan; India; South Korea; Southeast Asia; South Korea; South East Asia |
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Competitive Landscape |
Novartis AG, Amgen Inc, Pfizer Inc, Biogen Inc, Gilead Sciences Inc, Roche, Johnson & Johnson, Sanofi, Bayer AG, AstraZeneca PLC, Lonza Group Ltd, Catalent, Inc, Thermo Fisher Scientific Inc, Charles River Laboratories International, Inc, WuXi AppTec, IQVIA Holdings Inc, Parexel International Corporation, Syneos Health, Inc, PPD, Inc, CMIC Group |
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Customization Scope |
Free customization report with the procurement of the report and modifications to the regional and segment scope. Particular Geographic competitive landscape. |
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Pricing and Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |
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