Cell And Gene Therapy Manufacturing Market to Grow at 16.25% CAGR to reach USD 26.59 Billion in 2035

April 27, 2026 |

1 min read

The global cell and gene therapy manufacturing market size is calculated at USD 5.90 billion in 2025, grew to USD 6.86 billion in 2026, and is projected to reach around USD 26.59 billion by 2035. The market is expanding at a CAGR of 16.25% between 2025 and 2035.

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The growing prevalence of a wide range of diseases, including cancer, neurodegenerative diseases, obesity, chronic conditions, diabetes, asthma, nervous system disorders, and many others, has raised the need for robust research and development of targeted therapies. The cell and gene therapies include CAR-T cell therapies, stem cell therapies, gene editing, and many other therapies that aim to treat cancers, genetic diseases, and tissue regeneration and repair.

The U.S. FDA-Approved Cellular and Gene Therapy Products in 2025

Sr. No.	Name of the Product	Manufacturer
	ABECMA	Celgene Corporation, a Bristol-Myers Squibb Company
	ADSTILADRIN	Ferring Pharmaceuticals A/S
	ALLOCORD	SSM Cardinal Glennon Children's Medical Center
	AMTAGVI	Iovance Biotherapeutics, Inc.
	AUCATZYL	Autolus Limited
	BEQVEZ	Pfizer, Inc.
	BREYANZI	Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
	CARVYKTI	Janssen Biotech, Inc.
	CASGEVY	Vertex Pharmaceuticals Incorporated
	CLEVECORD	Cleveland Cord Blood Center

The Cell And Gene Therapy Manufacturing Market: Highlights

➔ North America dominated the cell and gene therapy manufacturing market share by 37% in 2025.

➔ Asia-Pacific is anticipated to grow at the fastest rate in the market during the forecast period.

➔ By therapy, the allogeneic cell therapy segment held a dominant presence in the market share by 62% in 2025.

➔ By therapy, the autologous cell therapy segment is expected to be the fastest-growing in the studied years.

➔ By technology, the somatic cell technology segment led the global market share by 28% in 2025.

➔ By technology, the viral vector technology segment is expected to grow at the fastest rate in the coming years.

➔ By source, the induced pluripotent stem cells segment registered its dominance over the global market by 34% in 2025.

➔ By source, the bone marrow segment is expected to grow rapidly during 2025-2035.

➔ By application, the musculoskeletal segment held the largest share by 26% of the market in 2025.

➔ By application, the oncology segment is expected to grow fastest over the projected period.

Market Overview: Promising Healthcare and Transparency in Decision-Making

The cell and gene therapy manufacturing market revolves around excellent scientific research and development strategies of the leading pharmaceutical and biotechnology companies. Some of the prominent players in the manufacturing of cell and gene therapies are Thermo Fisher Scientific Inc., Sanofi, Bio-Rad Laboratories, Novartis, GE Healthcare, Pfizer, Samsung Biologics, Catalent, Roche, and Merck. They aim to expand their businesses across the globe, particularly leading in the North America and the Asia Pacific regions.

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Cell and Gene Therapy Manufacturing Solutions: Major Footprint for Biologics

The globally leading companies in the cell and gene therapy manufacturing market, like Thermo Fisher Scientific Inc., are dedicated to expanding the manufacturing of cell and gene therapy products through clinical trials and commercial approval. Apart from reagents and instrumentation, this company provides deep expertise, custom solutions, technical consultation, innovative technologies, and services to the manufacturing partners. Thermo Fisher Scientific Inc. provides single-use technologies and closed systems to offer the flexibility to innovate new processes and technologies. The robust, sustainable, and repeatable processes are designed to accelerate production and avoid delays in manufacturing to transfer.

Significance of Single-Use Technology:

A single-use technology reduces contamination risk and minimizes turnover time for equipment. It enables cell and gene therapy developers to establish replicable processes and control platforms. It helps them to scale up their solutions through robust clinical trials and commercial manufacturing. The single-use consumables include cell factory systems, fluid transfer assemblies, and bottles. The single-use bioprocessing equipment, including mixers and bioreactors, is used from bench scale to production to meet specific cell and gene therapy needs that further expand the cell and gene therapy manufacturing market globally.

Significance of Closed Manufacturing Solutions:

Closed manufacturing systems are used in cell therapy to reduce contamination risks and reduce ISO cleanroom requirements. These systems are combined with digital connectivity, which further enables trackable, repeatable, and GMP-compliant manufacturing processes.

Potential Limitations Revolving around Scalability, Automation, and Cost

The cell and gene therapy manufacturing market imposes major challenges from laboratory to commercial production. Accordingly, living cells are hard to grow inside the laboratory in large batches using heavy equipment. Researchers need to implement specialized automation approaches for each laboratory step of biological processes, including cell isolation, cell expansion, genetic modification, and quality control. The cell and gene therapy manufacturing leads to effective pricing from hundreds of thousands or millions of dollars per treatment, which limits their access to patients and commercial expansion.

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Cell And Gene Therapy Manufacturing Market: Regional Analysis

North America dominated the market share by 37% in 2025, owing to surging FDA approvals, massive investments in infrastructure, and a shift to contract manufacturing. In September 2025, the Advanced Research Projects Agency for Health (ARPA-H) launched a program and a funding opportunity to advance innovative biomanufacturing for cell and gene therapy. This program aims to build and position the U.S. in advanced manufacturing methods for high-quality genetic medicines through cutting-edge production technologies. This program ensures a distributed manufacturing process combined with automated quality assurance.

For instance,

➔ In April 2025, Cellares made a partnership with the University of Wisconsin School of Medicine and Public Health to support its clinical production and regulatory advancement of CRISPR-edited GD2 CAR-T investigational therapy for solid tumors. The GD2 CAR-T program is designed to modify patients’ T cells through electroporation by using CRISPR gene editing.

U.S. Market Trends

The U.S. witnesses the expansion of clinical research and development, manufacturing innovation and automation, and increased outsourcing to CDMOs that expand the cell and gene therapy manufacturing market. The Advanced Research Projects Agency for Health (ARPA-H) aims to produce novel kinds of genetic medicines to make revolutionary treatments accessible, affordable, and ready to dose within a week of diagnosis. The domestic manufacturing in the U.S. ensures accessibility of the latest therapeutic capabilities to researchers and patients.

For instance,

➔ In January 2026, the U.S. Food and Drug Administration (FDA) announced that it had increased flexibility for the manufacturers of cell and gene therapies through clinical and commercial quality control tests. The agency presented its new requirements and reforms that will help researchers address the unique characteristics of cell and gene therapies and boost innovation.

In 2025, the Asia Pacific dominated the cell and gene therapy manufacturing market due to advancements in manufacturing technology, expansion of biomanufacturing hubs, and regulatory reforms. Cell and gene therapy studies are gaining traction in the Asia Pacific region due to the growing patient demand for life-saving drugs and therapies, and novel innovations in healthcare. China witnessed the rising prevalence of solid tumors, which has raised the urgent need for advanced therapies. There is an increased government and regulatory support for cell and gene therapy trials, along with a surge in investments in cell and gene therapy products.

For instance,

➔ In August 2025, Tony Acciarito, President of Thermo Fisher Scientific Inc. for the Asia Pacific and the Middle East and Africa, proclaimed that the company’s integrated solutions from research to manufacturing will help customers innovate faster, maintain the highest quality standards, and increase productivity. He also reported that India is one of the company’s fastest-growing markets, and it is building capacity and capabilities through crucial investments in India.

India Market Analysis

India is advancing in the cell and gene therapy manufacturing market due to the affordability and accessibility of treatments, government funding and policies, and the growth of contract development and manufacturing organizations (CDMOs). Research suggests that India’s biopharmaceutical market was $8.1 billion in size in 2024, and is expected to double to $15.9 billion by 2030. Studies implied that Bharat Biotech in India has expanded its business from vaccine production to cell and gene therapy production, which is expected to grow from $21.28 billion in 2024 and will reach over five-fold to $117.46 billion by 2034.

For instance,

➔ In March 2025, Bharat Biotech, the vaccine maker in India, launched a cell and gene therapy facility in the southern Indian state of Telangana through the investment of $75 million in its first CGT facility. It also expects that its new advanced therapies will gain momentum in the market in the next three years.

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Cell And Gene Therapy Manufacturing Market: Segmentation Analysis

Therapy Insights

Therapy Type	Market Share (%)
Allogeneic Cell Therapy	62%
Autologous Cell Therapy	38%

The allogeneic cell therapy segment dominated the market by 62% share in 2025, owing to its role in manufacturing, which enables industrial scalability and reduces the cost per patient. It standardizes quality control and eliminates manufacturing bottlenecks. Allogeneic therapy is critical for acute or rapidly progressing diseases, which reduces the wait of patients for custom manufacturing.

On the other hand, the autologous cell therapy segment is expected to grow at the fastest rate in the cell and gene therapy manufacturing market due to the safety and efficacy associated with this therapy. It shows proven clinical success for breakthrough treatments, specifically CAR-T cell therapies for hematologic cancers. This therapy is also used in regenerative medicine to treat cardiovascular diseases, neurodegenerative disorders, and autoimmune conditions.

Technology Insights

Technology Type	Market Share (%)
Somatic Cell Technology	28%
Viral Vector Technology	22%
Genome Editing Technology	16%
Cell Immortalization Technology	12%
Cell Plasticity Technology	11%
3D Technology	11%

The somatic cell technology dominated the market by 28% in 2025, owing to the increased focus of this technology on creating delivery systems like lipid nanoparticles in some manufacturing strategies. Somatic cells are ideal for regenerative medicine and are reprogrammed to create functional tissues or organoids for drug testing or transplantation. The manufacturing depends on single-use technologies and closed-system processing to prevent contamination.

The viral vector technology segment is expected to grow fastest in the cell and gene therapy manufacturing market in the coming years due to the common viral vectors used in gene therapy, which include retroviral vectors, lentiviral vectors, Herpes simplex virus vectors, adenovirus vectors, and adeno-associated virus. It shows an incredible potential in gene therapy, which transforms the treatment of genetic disorders like cystic fibrosis.

Source Insights

Source Type	Market Share (%)
Induced Pluripotent Stem Cells (iPSCs)	34%
Bone Marrow	20%
Umbilical Cord	16%
Adipose Tissue	13%
Neural Stem Cells	17%

The induced pluripotent stem cells dominated the market by 34% in 2025, owing to their contribution in transforming in vitro research and advancing regenerative medicine. They are widely used for drug screening, modeling human development and disease, and developing cell therapies. The development of induced pluripotent stem cell technology has opened up wide opportunities for in vitro modelling of human biology and cell therapy applications.

The bone marrow segment is expected to grow rapidly in the cell and gene therapy manufacturing market due to the use of bone marrow components to create biomimetic niches that support the expansion of engineered cells ex vivo. Bone marrow clots also act as natural scaffolds to deliver modified cells directly to injury sites. Hematopoietic stem cells are the most widely used targets in gene therapy trials.

Application Insights

Application	Market Share (%)
Musculoskeletal	26%
Oncology	22%
Cardiovascular	14%
Neurological	16%
Dermatology	9%
Gastrointestinal	7%
Others	6%

The musculoskeletal segment dominated the market by 26% share in 2025, owing to the pivotal role of cell and gene therapy manufacturing in overcoming the limited self-repair capacity of tissues like tendons and cartilage. Cell and gene therapy has wide musculoskeletal applications, such as regenerative medicine, gene delivery, gene modification, biomaterial-assisted therapy, and immune system modulation. The manufacturing processes, like ex vivo and in vivo methods, induce tissue-specific repair.

The oncology segment is expected to grow at the fastest rate in the cell and gene therapy manufacturing market during the predicted timeframe due to the major oncology applications of cell and gene therapy manufacturing. These include CAR-T cell production, gene modification, oncolytic virotherapy, and process optimization for scale. The manufacturing processes are central to developing personalized therapies.

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Cell And Gene Therapy Manufacturing Market Companies

• Wuxi Advanced Therapies

• Boehringer Ingelheim

• Cellular Therapeutics

• Miltenyi Biotec

• Thermo Fisher Scientific

• F. Hoffmann-La Roche Ltd

• Bluebird Bio Inc.

• Catalent Inc.

• F. Hoffmann-La Roche Ltd.

• Samsung Biologics

•Novartis AG

• Lonza

• Merck KGaA

• Bluebird Bio Inc.

• Hitachi Chemical Co., Ltd.

• Takara Bio Inc.

Segments Covered in the Report

By Therapy

• Allogeneic Cell Therapy

• Autologous Cell Therapy

By Technology

• Somatic Cell Technology

• Cell Immortalization Technology

• Viral Vector Technology

• Genome Editing Technology

• Cell Plasticity Technology

• 3D Technology

By Source

• Induced Pluripotent Stem Cells

• Umbilical Cord

• Neural Stem

• Bone Marrow

• Adipose Tissue

By Application

• Musculoskeletal

• Cardiovascular

• Gastrointestinal

• Neurological

• Oncology

• Dermatology

• Others

By Region

• North America

• Asia Pacific

• Europe

• Latin America

• Middle East and Africa (MEA)

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