The Cell and Gene Therapy Biomanufacturing Market is projected to register a strong CAGR during the forecast period (2026-2031).
The Cell and Gene Therapy (CGT) biomanufacturing industry is experiencing growth because of increasing demand for high-tech therapies that mainly focus on cancer, genetic, and chronic illnesses. Expansion in the market is being driven not only by breakthroughs in technology but also by a rise in capital investment and a broader array of clinical stage products. At the same time, automation and scaling up of production processes in manufacturing have been continuous sources of improvements in both efficiency and cost savings. Despite these significant advances, issues such as the high cost of production, stringent regulatory frameworks, and shortages of adequately trained personnel continue to be problematic.
The Cell and Gene Therapy (CGT) biomanufacturing market is growing owing to multiple factors such as more commercialization of advanced therapies, more clinical trial activities and constant innovations in manufacturing processes. Biomanufacturing is essential to support the mass production of very complex therapies like gene therapies made with viral vectors, CAR-T cell therapies, and stem cell-based regenerative treatments. The market is also receiving support from the increasing incidences of chronic and genetic diseases, including cancer, rare inherited disorders, and autoimmune conditions that are driving the need for personalized and precision medicine approaches. Besides that, advancements in upstream and downstream processing, automation, and closed-system manufacturing are making it possible to increase production capacity, minimize the potential for contamination, and reduce production costs.
Increasing Prevalence of Chronic and Genetic Diseases: One major factor contributing to the expansion of CGT biomanufacturing is the increasing worldwide incidence of diseases like cancer, rare genetic disorders, cardiovascular ailments, and neurological disorders. Conventional treatment methods are often limited or temporally effective. In contrast, cell and gene therapies have the capability for long-lasting or even curative results. The rising requirement for highly effective therapeutical options is substantially raising the demand for sophisticated manufacturing technologies.
Growing Number of Approved Cell and Gene Therapies: The constant rise in the number of regulatory approvals of CGT products is speeding up market growth. With more therapies moving from clinical trials to commercialization, the requirement for large-scale, top-quality biomanufacturing facilities becomes higher. This development is driving a continuous demand for both in-house and outsourced manufacturing solutions.
Expanding Clinical Pipeline and Research Activities: The cell and gene therapy market is growing with a variety of new candidates being developed. This growth has put manufacturing services in high demand to accommodate these new therapies. Research breakthroughs along with increase in clinical trials have set a very strong base for future commercial sales and therefore the demand for large, efficient and scalable production systems is on the rise.
Technological Advancements in Manufacturing Platforms: Advances in bioprocessing technologies, such as better viral vector production systems, closed and automated manufacturing platforms, and cell expansion methods that are highly advanced, not only increasing production efficiency but also ensuring consistency in quality. These technological developments are giving the opportunity to manufacturers to expand their production capacity without compromising on quality standards.
High Cost of Manufacturing and Therapy Production: The high production cost is one of the obstacles in the CGT biomanufacturing market. Using costly raw materials like viral vectors, plasmids, and specialized reagents coupled with maintaining controlled environments (cleanrooms, GMP facilities) are the major contributors to the high operational costs. On top of that, patient-specific (autologous) therapies, as they require individual production batches, further raise the cost per treatment and, hence, reduce affordability and wide-scale accessibility.
Complex and Evolving Regulatory Landscape: Regulations that govern cell and gene therapies are very strict and change all the time because these treatments are quite new. Producers are required to follow rules concerning safety, effectiveness, documentation, and quality assurance. Differences from region to region in the rules make it even harder to market such products globally and often lead to approval delays and higher compliance costs for companies.
Scalability and Standardization Challenges: Unlike traditional pharmaceuticals, CGT products are biologically complex and often patient-specific, making standardization difficult. Scaling up manufacturing from clinical-scale to commercial-scale production without compromising product quality, consistency, and efficacy remains a major technical challenge. This is particularly evident in autologous therapies, where each batch is unique.
Expansion of Contract Development and Manufacturing Organizations: One of the main drivers behind the expansion of contract development and manufacturing organizations (CDMOs) is the growing trend of outsourcing manufacturing activities. These organizations provide specialized expertise, infrastructure, and scalability, allowing biotech companies to focus on research and development while accelerating time-to-market.
October 2025: King Faisal Specialist Hospital and Research Centre announced its plan to launch by the end of 2025 the first gene and cell therapy manufacturing facility in the kingdom, which aims at making advanced treatments available to thousands of patients without the need to travel abroad.
September 2025: The Advanced Research Projects Agency for Health (ARPA-H), a federal agency under the U.S. Department of Health and Human Services (HHS), declared a funding initiative under its Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program. ARPA-H is initiating a program to promote novel biomanufacturing for cell and gene therapies.
Reagents and consumables are the fastest growing part of the product category since they are heavily and repeatedly used in every stage of CGT biomanufacturing. Essentially the list of items includes cell culture media, sera, plasmids, viral vectors, buffers, and single-use components, which are necessary to keep cells alive, ensure process consistency, and produce high yield of products. The usage of these materials is going up at clinical trials level and commercial scale production of cell and gene therapies is the major cause for this increase.
Upstream processing is the fastest-growing segment in the workflow category, primarily driven by the increasing complexity of cell and gene therapy production and the need for efficient cell expansion and viral vector generation. This stage involves critical processes such as cell isolation, culture, expansion, transfection, and vector production, all of which directly impact the quality and efficacy of the final product. With the rising demand for viral vectors, particularly for gene therapies, upstream processes are becoming more advanced and resource intensive.
The CGT biomanufacturing market in North America leads because of its highly developed biotechnology environment, advanced healthcare system, and significant presence of major companies in the industry such as Thermo Fisher Scientific, Catalent, Inc., and Lonza Group. In addition, the area has an R&D intensive culture, many clinical trials, and a faster rate of accepting novel therapies. Besides, more FDA-approved cell and gene therapy products and the increasing number of manufacturing facilities are some of the factors that are pushing North America's market leadership forward.
The South America Cell and Gene Therapy (CGT) Biomanufacturing Market is gradually evolving and presents significant growth potential, driven by increasing investments in biotechnology, improving healthcare infrastructure, and rising demand for advanced therapeutic solutions. The region is witnessing a steady increase in the prevalence of chronic diseases, cancer, and rare genetic disorders, which is encouraging the adoption of innovative treatments such as cell and gene therapies. Countries like Brazil, Argentina, and Chile are emerging as key contributors, with Brazil leading the market due to its relatively advanced healthcare system, growing research capabilities, and supportive government initiatives aimed at strengthening the biotechnology sector.
Europe accounts for a significant portion of the CGT biomanufacturing market due to various factors such as robust governmental support, a greater number of research activities, and a presence of vital biotech centers in nations like Germany, UK, and France. The regulatory backing from the European Medicines Agency, along with the introduction of advanced therapy medicinal product (ATMP) guidelines, has been a key factor in fostering innovation and taking products to market. Besides, the area is seeing a rise in capital expenditures on production facilities and an upsurge in partnerships between universities and other industrial players, etc., all of which are propelling the growth of the sector.
The Middle East & Africa region is still in the early phases of development in terms of the CGT biomanufacturing industry, but it is slowly moving forward as the healthcare investments are rising and the governments of countries like United Arab Emirates and Saudi Arabia are making significant efforts in this area. These countries are adopting advanced therapies because of their economic diversification and healthcare system improvements. On the other hand, limited technical expertise, infrastructure gaps, and lower awareness levels are still major issues.
Increased healthcare spending, rapidly growing biotechnological industries, and greater government backing are the main reasons why the Asia-Pacific region will be the fastest growing CGT biomanufacturing market. China, Japan, South Korea and India are the main countries driving this growth. The region is increasingly becoming the major center for clinical trials and manufacturing at minimum cost which is why global companies want to open production facilities there. Besides that, better regulatory environments and higher public understanding of the latest treatments are the main factors responsible for the rapidly expanding market. A large population of patients and high demand for innovative medicines will provide further push to growth.
Lonza Group
Thermo Fisher Scientific
Merck KGaA
Danaher Corporation
WuXi AppTec
Catalent, Inc.
Samsung Biologics
Fujifilm Diosynth Biotechnologies
Charles River Laboratories
Cytiva
Lonza Group is among the global companies in the Cell and Gene Therapy (CGT) biomanufacturing sector. It is known for its CDMO (contract development and manufacturing organization) capabilities. The company offers comprehensive solutions that cater not only cell and gene therapy production but also support the entire therapy lifecycle-from the earliest research stages and process development to clinical and commercial-scale manufacturing. The Cell & Gene Division at Lonza is organized around complementary business units such as Cell & Gene Technologies, Bioscience, and Personalized Medicine. This allows the company to serve different customer needs through a mix of manufacturing services, specialty products, and innovative platforms like automated cell therapy systems.
Thermo Fisher Scientific is a prominent leader in the Cell and Gene Therapy (CGT) biomanufacturing market, offering a comprehensive range of solutions that span the entire therapy development lifecycle. The company plays a critical role in enabling biotechnology and pharmaceutical firms to bring advanced therapies to market by providing integrated services, including process development, clinical and commercial manufacturing, and supply chain support.
| Report Metric | Details |
|---|---|
| Forecast Unit | Billion |
| Growth Rate | Ask for a sample |
| Study Period | 2021 to 2031 |
| Historical Data | 2021 to 2024 |
| Base Year | 2025 |
| Forecast Period | 2026 – 2031 |