The global market for CGT manufacturing is forecast to grow from USD 32,117.1 Million in 2025 to USD 403,548.1 Million by 2035, at a compound annual growth rate (CAGR) of 28.8% during that period.

Key Market Metrics

Metric	Value
Market Size in 2025	USD 32,117.1 Million
Projected Market Size in 2035	USD 403,548.1 Million
CAGR (2025 to 2035)	28.8%

Country-Wise Outlook

Country	CAGR (2025 to 2035)
United States	29.3%

Country	CAGR (2025 to 2035)
United Kingdom	28.1%

Country	CAGR (2025 to 2035)
European Union	28.8%

Country	CAGR (2025 to 2035)
Japan	27.6%

Country	CAGR (2025 to 2035)
South Korea	29.0%

Segmentation Outlook

Therapy Type	Market Share (2025)
Gene Therapy Manufacturing	63.9%

Scale	Market Share (2025)
Commercial Scale Manufacturing	67.5%

Competitive Outlook

Company Name	Estimated Market Share (%)
Lonza Group	14-17%
Thermo Fisher Scientific	11-14%
Catalent Inc.	9-12%
WuXi Advanced Therapies	7-10%
Fujifilm Diosynth Biotechnologies	6-9%
Other Providers	38-45%

Cell and gene therapy manufacturing market size is expected to grow from USD 11.9 bn in 2024 to USD 15.1 bn in 2025 and USD 160.0 bn by 2035, at CAGR of 26.64%

Cell and Gene Therapy Manufacturing Market Outlook

According to our latest research, the global cell and gene therapy manufacturing market size reached USD 16.8 billion in 2024, reflecting robust growth driven by increasing investments in advanced therapies and rising demand for personalized medicine. The market is expected to expand at a CAGR of 18.2% from 2025 to 2033, reaching a projected value of USD 80.5 billion by 2033. This growth is primarily fueled by the accelerating pace of clinical trials, regulatory support for innovative treatments, and the expanding pipeline of cell and gene therapies targeting a wide spectrum of diseases.

A primary growth factor for the cell and gene therapy manufacturing market is the surging prevalence and complexity of chronic and rare diseases globally. Conditions such as cancer, cardiovascular diseases, and genetic disorders have witnessed a sharp rise, prompting pharmaceutical and biotechnology companies to intensify their focus on developing advanced therapies. Cell and gene therapies offer the potential for curative treatment, particularly for patients who do not respond to traditional modalities. This paradigm shift towards personalized and regenerative medicine is driving substantial investments in research, development, and manufacturing infrastructure, thereby fueling market expansion. Additionally, the increasing number of cell and gene therapy approvals by regulatory authorities such as the FDA and EMA is further validating the efficacy of these therapies, encouraging more players to enter the market.

Technological advancements in manufacturing platforms and process optimization are also pivotal in shaping the trajectory of the cell and gene therapy manufacturing market. The industry has witnessed significant progress in automation, closed-system processing, and the integration of artificial intelligence and digital tools for quality control and process monitoring. These innovations are not only enhancing production efficiency and scalability but also reducing the risk of contamination and batch failures. As a result, manufacturers are better equipped to meet the stringent regulatory requirements and the growing demand for high-quality, reproducible therapies. Furthermore, collaborative efforts between academia, industry, and regulatory bodies are fostering the development of standardized manufacturing protocols, which are critical for ensuring product consistency and patient safety.

Another significant driver is the evolving regulatory landscape, which is increasingly supportive of cell and gene therapy development and commercialization. Regulatory agencies are introducing expedited pathways, such as the FDAÂ’s Regenerative Medicine Advanced Therapy (RMAT) designation and the EMAÂ’s Priority Medicines (PRIME) scheme, to facilitate faster approval and market access for innovative therapies. These initiatives are reducing the time-to-market for breakthrough treatments and encouraging greater investment in manufacturing capabilities. Moreover, the growing trend of public-private partnerships, government funding, and venture capital investments is providing the necessary financial impetus for scaling up manufacturing operations and expanding the global footprint of cell and gene therapy developers.

The role of Cell Therapy Contract Manufacturing is becoming increasingly vital in the cell and gene therapy landscape. As the demand for personalized and regenerative medicine grows, many pharmaceutical and biotechnology companies are turning to contract manufacturers to help scale up production. These organizations provide specialized expertise and infrastructure that enable therapy developers to focus on core research and development activities while ensuring that manufacturing processes meet stringent regulatory standards. By partnering with contract manufacturers, companies can accelerate the time-to-market for new therapies, manage costs more effectively, and navigate the complexities of large-scale production. This collaboration is crucial for meeting the rising demand for cell therapies and ensuring that patients have access to innovative treatments.

From a regional perspective, North America continues to dominate the cell and gene therapy manufacturing market, accounting for the largest share in 2024, followed closely by Europe and the Asia Paci

Overview

New York, NY – Nov 21, 2025 – Global Cell And Gene Therapy Manufacturing Market size is expected to be worth around US$ 60.3 Billion by 2034 from US$ 6.9 Billion in 2024, growing at a CAGR of 24.3% during the forecast period from 2025 to 2034. In 2024, North America led the market, achieving over 48.1% share with a revenue of US$ 3.29 Billion.

The cell and gene therapy manufacturing landscape has been experiencing significant expansion as demand for advanced therapeutic modalities continues to rise. Strong growth has been observed as companies accelerate investments in next-generation platforms, optimized production workflows, and scalable bioprocessing solutions. The market has been driven by an increasing number of approved therapies, a robust clinical pipeline, and continuous advancements in viral vector technologies.

Manufacturing processes for cell and gene therapies have been characterized by high complexity, owing to stringent quality standards, specialized raw materials, and sensitive production environments. The adoption of automated systems, closed processing, and high-efficiency bioreactors has been increasing, as these technologies enable improved consistency and reduce contamination risks. Capacity expansion initiatives have been undertaken globally as manufacturers respond to rising clinical and commercial volumes.

Strategic collaborations between biotechnology firms, contract development and manufacturing organizations, and research institutions have supported faster development cycles and enhanced technological capabilities. Regulatory frameworks have become more defined, allowing clearer pathways for scale-up and commercialization. The growth of the market can be attributed to rising prevalence of chronic and genetic disorders, increasing investment in personalized medicine, and active government support for advanced therapeutic development.

The sector is expected to maintain strong momentum, supported by continuous innovation and the shift toward more efficient and cost-effective manufacturing platforms. The overall outlook remains positive as cell and gene therapies progress toward broader clinical adoption and global market expansion.

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Global Cell and Gene Therapy Manufacturing Market size worth at USD 2.11 Billion in 2023 and projected to USD 4.77 Billion by 2032, with a CAGR of around 9.5%.

The global cell and gene therapy manufacturing QC market was valued at $1.95 billion in 2022, and the market is expected to grow with a CAGR of 16.85% and reach $10.65 billion by 2033.

The Cell And Gene Therapy Manufacturing Market size is expected to reach USD 42.6 billion in 2017 growing at a CAGR of 11.2. Cell And Gene Therapy Manufacturing Market report classified by demand analysis, segmentation, competitive positioning, growth drivers, and forecast.

The Cell and Gene Therapy Manufacturing QC Market will grow from USD 1.35 Billion in 2025 to USD 2.01 Billion by 2031 at a 6.87% CAGR.

Pages	185
Market Size	2025 USD 1.35 Billion
Forecast Market Size	USD 2.01 Billion
CAGR	6.87%
Fastest Growing Segment	Gene Therapy
Largest Market	North America
Key Players	['Bio-Techne Corporation', 'Biomerieux SA', 'F. Hoffmann-La Roche Ltd', 'Lonza Group Ltd.', 'Miltenyi Biotec India Pvt Ltd.', 'Sartorius AG', 'Thermo Fisher Scientific Inc.', 'AGC Inc.', 'Charles River Laboratories International, Inc.', 'Merck KGaA']

The global cell and gene therapy manufacturing market is projected to be valued at $45 billion in 2024, driven by factors such as increasing consumer awareness and the rising prevalence of industry-specific trends. The market is expected to grow at a CAGR of 7.8%, reaching approximately $95 billion by 2034.

The global cell and gene therapy market size is projected to grow from USD 37.14 billion in 2025 to USD 190.82 billion by 2033, exhibiting a CAGR of 22.7%.
Report Scope:

Report Metric	Details
Market Size in 2025	USD 37.28 billion
Market Size in 2026	USD 45.96 billion
Market Size in 2034	USD 250.64 billion
CAGR	23.62% (2026-2034)
Base Year for Estimation	2025
Historical Data	2022-2024
Forecast Period	2026-2034
Report Coverage	Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends
Segments Covered	By Therapy Type,By Application,By Manufacturers,By Region.
Geographies Covered	North America, Europe, APAC, Middle East and Africa, LATAM,
Countries Covered	U.S., Canada, U.K., Germany, France, Spain, Italy, Russia, Nordic, Benelux, China, Korea, Japan, India, Australia, Taiwan, South East Asia, UAE, Turkey, Saudi Arabia, South Africa, Egypt, Nigeria, Brazil, Mexico, Argentina, Chile, Colombia,

The Cell And Gene Therapy Manufacturing Market size was valued at USD 9.1 billion in 2023 and is projected to reach USD 47.43 billion by 2032, exhibiting a CAGR of 26.6 % during the forecasts period.

Cell and Gene Therapy Manufacturing QC market to grow at a significant CAGR of 22.80% during 2020-2030. The report by BIS Research provide deep market insight, industry analysis, trends & forecast to 2030 that will help your business to grow.

BCC Research Market Report says global cell and gene therapy manufacturing services market reached $4.9 billion in 2022 should reach $5.7 billion by 2023 and $11.8 billion by 2028 with a CAGR of 15.7%.

The size of the Cell and Gene Therapy Manufacturing Services Market was valued at USD XX Million in 2023 and is projected to reach USD XXX Million by 2032, with an expected CAGR of 12.50% during the forecast period. Recent developments include: March 2023: Thermo Fisher Scientific opened a cell therapy facility at the University of California, San Francisco (UCSF) to accelerate the development of breakthrough therapies for cancer, rare diseases, and other illnesses., January 2022: AllogeneTherapeutics Inc. and AntionBiosciences Inc. entered into an exclusive collaboration and global license agreement for Antion'smiRNA technology (miCAR) to advance multiplex gene silencing as an additional tool to develop next-generation allogeneic CAR T products.. Key drivers for this market are: High Prevalence of Cancer and Other Target Diseases, Increasing Grants and R&D Investments in the Pharmaceutical Sector; Increasing Organic and Inorganic Developments Between Pharmaceutical Companies and CDMOs. Potential restraints include: High Operational Costs Associated with the Cell and Gene Therapy Manufacturing. Notable trends are: Allogeneic Segment is Expected to Have a Significant Market Share During the Forecast Period.

The Cell and Gene Therapy Contract Development and Manufacturing Organization Market Report is Segmented by Product (Cell Therapy {Stem-Cell-Based, and More} Gene Therapy {Viral Vectors, Non-Viral Vectors}), Stage (Pre-Clinical, Clinical, Commercial), Service Type (Process Development, GMP Manufacturing, and More), and Geography (North America, Europe, Asia Pacific, More). The Market Forecasts are Provided in Terms of Value (USD).

The Asia-Pacific cell and gene therapy manufacturing QC market was valued at $246.4 million in 2023 and is expected to reach $1,317.3 million by 2033, growing at a CAGR of 18.36% during the forecast period 2024-2033

Asia Pacific Contract Cell and Gene Therapy Manufacturing Market is expected to grow during 2025-2031

Gene Therapy Manufacturing Market Outlook

According to our latest research, the global gene therapy manufacturing market size stood at USD 7.5 billion in 2024. The market is experiencing robust expansion, registering a CAGR of 20.8% from 2025 to 2033. By the end of 2033, the market is forecasted to reach an impressive USD 49.1 billion. This remarkable growth trajectory is primarily driven by the increasing number of gene therapy approvals, expanding clinical pipeline, and rising investments in advanced manufacturing technologies. The gene therapy manufacturing market is witnessing a paradigm shift as biopharmaceutical companies and research institutions accelerate efforts to bring innovative therapies to patients with unmet medical needs.

One of the most significant growth factors in the gene therapy manufacturing market is the rapid advancement of gene-editing technologies, such as CRISPR/Cas9 and TALENs. These technologies have revolutionized the field by enabling precise genetic modifications, making gene therapies safer and more effective. As a result, there has been a surge in the number of gene therapy candidates entering clinical trials, necessitating large-scale, high-quality manufacturing capabilities. Furthermore, regulatory agencies such as the FDA and EMA have introduced expedited approval pathways for breakthrough gene therapies, further incentivizing investment in manufacturing infrastructure and quality control systems. The synergy between scientific innovation and regulatory support is expected to sustain the marketÂ’s growth momentum over the next decade.

Another critical driver is the growing prevalence of genetic and rare diseases, which has created an urgent demand for curative treatments. Gene therapies offer the potential for one-time, long-lasting solutions to conditions that were previously considered untreatable. This has spurred pharmaceutical and biotechnology companies to invest heavily in gene therapy R&D and manufacturing. The expansion of personalized medicine, coupled with advances in vector engineering and delivery systems, has also contributed to the diversification of gene therapy applications. As a result, the gene therapy manufacturing market is expanding beyond oncology to encompass cardiovascular, neurological, and metabolic disorders, among others. This broadening scope is expected to further fuel market growth and attract new entrants.

In addition to technological and clinical advancements, the gene therapy manufacturing market is benefiting from increased public and private sector funding. Governments across North America, Europe, and Asia Pacific are providing grants, tax incentives, and infrastructure support to accelerate the development and commercialization of gene therapies. Venture capital and strategic collaborations between academic institutions, contract manufacturing organizations (CMOs), and pharmaceutical companies are also playing a pivotal role. These partnerships are helping to address key challenges such as scalability, cost-effectiveness, and regulatory compliance. The influx of capital and expertise is enabling the industry to overcome manufacturing bottlenecks and bring novel therapies to market more efficiently.

From a regional perspective, North America currently dominates the gene therapy manufacturing market, accounting for over 45% of global revenue in 2024. This leadership position is attributed to the presence of major biotechnology hubs, advanced healthcare infrastructure, and a favorable regulatory environment. Europe follows closely, driven by robust R&D investments and government support for innovative therapies. Meanwhile, the Asia Pacific region is emerging as a high-growth market, supported by increasing healthcare expenditure, a large patient pool, and rising adoption of advanced biomanufacturing technologies. As the global landscape evolves, regional collaborations and technology transfers are expected to play a crucial role in shaping the future of the gene therapy manufacturing market.

Cell and Gene Therapy Manufacturing is becoming increasingly critical as the industry shifts towards more personalized and targeted treatment options. The integration of cell and gene therapies into mainstream healthcare is driving the need for specialized manufacturing processes that can accommodate the un

The South Korea Cell and Gene Therapy Manufacturing QC Market size was valued at is estimated to reach USD 519.37 million by 2033, growing at a CAGR of 27.2% during the forecast period (2025–2033).
Report Scope:

Report Metric	Details
Market Size in 2024	USD 59.58 Million
Market Size in 2025	USD 75.78 Million
Market Size in 2033	USD 519.37 Million
CAGR	27.2% (2025-2033)
Base Year for Estimation	2024
Historical Data	2021-2023
Forecast Period	2025-2033
Report Coverage	Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends
Segments Covered	By Therapy Type,By Scale,By Mode,By Workflow,By Process,By End-User,By Technology Type,By Region.

The booming cell & gene therapy manufacturing services market is projected to reach $25 billion by 2033, driven by advancements in gene editing and increasing demand for CAR T-cell and other innovative therapies. Explore market size, growth trends, key players (Thermo Fisher, Merck KGaA, etc.), and regional analysis in this comprehensive report.