Cell And Gene Therapy Market Size, Share, Trends, And Forecast 2026-2035 Market To Reach USD 172.22 Billion As AI, Gene Editing, And CAR-T Drive 23.17% CAGR
Dublin, Oct. 07, 2026 (GLOBE NEWSWIRE) -- "Cell and Gene Therapy Market Size, Share and Forecast Trends - Growth Analysis and Outlook Report (2026-2035)" has been added to ResearchAndMarkets.com's offering.
The global cell and gene therapy market was valued at USD 21.43 Billion in 2025 and is projected to reach USD 172.22 Billion by 2035. The market is expected to expand at a CAGR of 23.17% from 2026 to 2035, supported by the rising prevalence of genetic and rare diseases, increasing adoption of personalized treatments, expanding clinical pipelines, and continued advancements in gene editing, manufacturing, and delivery technologies.
Cell and Gene Therapy Market Highlights
- Market size in 2025: USD 21.43 Billion Projected market size in 2035: USD 172.22 Billion Forecast CAGR from 2026 to 2035: 23.17% North America accounted for more than 47% of historical market revenue. Cell therapy manufacturing represented above 59% of historical revenue by therapy type. Viral vectors held approximately 65% of the historical market by vector type.
Market Growth Drivers
Growth in the cell and gene therapy market is being accelerated by regulatory approvals, substantial biotechnology investment, and demand for targeted treatments across oncology, hematology, neurology, cardiology, and inherited disorders. The commercialization of CAR-T therapies and other advanced therapy medicinal products is strengthening clinical confidence and encouraging healthcare providers to adopt innovative treatment options.
Regulatory support remains an important market catalyst. In March 2026, the U.S. FDA approved the first gene therapy for leukocyte adhesion deficiency-I. The approval demonstrated continued progress in treatments for rare genetic diseases and reinforced the commercial potential of advanced therapeutic platforms.
Manufacturing innovation is also improving scalability, quality control, and production efficiency. Investments in specialized facilities, automated systems, and optimized delivery platforms are helping companies address complex development requirements while expanding access to approved therapies.
Emerging Cell and Gene Therapy Market Trends
Artificial intelligence, CRISPR-Cas9 research, strategic partnerships, and broader clinical development activity are shaping the competitive landscape. Artificial intelligence platforms are increasingly being applied to target identification, therapy design, patient selection, and development planning.
In October 2025, AstraZeneca entered a USD 555 million partnership with Algen Biotechnologies to develop gene therapies using artificial intelligence platforms. The collaboration is expected to support CRISPR-Cas9 innovation, improve precision, and shorten discovery timelines. Similar partnerships between pharmaceutical companies, biotechnology developers, research institutions, and technology providers are likely to strengthen market expansion through 2035.
Market Segmentation
The cell and gene therapy market is analyzed by therapy type, treatment type, delivery mode, vector type, therapeutic area, end user, and region.
- Therapy type: Autologous cell therapy, allogeneic cell therapy, somatic gene therapy, and germline gene therapy Type: Stem cell, non-stem cell, antigen, cytokine, tumor suppressor, growth factors, receptors, and others Delivery mode: In Vivo and Ex Vivo Vector type: Viral vector and non-viral techniques Therapeutic area: Oncology, cardiology diseases, neurological disorders, genetic disorders, infectious diseases, hematological disorders, musculoskeletal disorders, and others End user: Hospitals, cancer care centers, academic and research institutes, and others Region: North America, Europe, Asia Pacific, Latin America, and Middle East and Africa
Therapy Type and Vector Analysis
Cell therapy manufacturing generated more than 59% of historical market revenue by therapy type. Its leadership was supported by the expanding commercialization of personalized treatments, particularly CAR-T therapies in oncology. Increasing production capacity, investment in specialized manufacturing infrastructure, and a growing pipeline of clinical candidates are expected to maintain the segment's strong position.
Viral vectors accounted for approximately 65% of historical market revenue by vector type. High transfection efficiency and widespread use in approved gene therapies supported the segment. Lentiviral and adeno-associated virus delivery systems continue to play important roles in clinical development, although investment in non-viral techniques is increasing.
Regional Market Outlook
North America led the global market with a historical revenue share exceeding 47%. The region benefits from advanced healthcare infrastructure, established regulatory frameworks, significant biotechnology funding, strong clinical trial activity, and the presence of major pharmaceutical and biotechnology companies. Continued investment in CRISPR-Cas9 platforms and next-generation manufacturing is expected to support regional growth.
Europe and Asia Pacific also present substantial opportunities as clinical research expands, regulatory pathways evolve, and public and private investment increases. Growing healthcare capacity and demand for advanced treatments are expected to support adoption across these regions during the forecast period.
Competitive Landscape
Leading companies are advancing the market through research and development, patent activity, clinical trials, licensing agreements, partnerships, funding initiatives, and manufacturing investments.
- Amgen Inc. is advancing next-generation therapeutic platforms across oncology, cardiovascular disease, and rare diseases, supported by global research and commercialization capabilities. Novartis AG maintains a strong position through KYMRIAH and continued investment in oncology, immunology, cell therapy, and gene therapy programs. Pfizer Inc. is developing gene therapies using internal research and strategic partnerships, with programs focused on rare genetic disorders, oncology, and AAV delivery systems. Bluebird Bio, Inc. specializes in lentiviral vector-based gene therapies for severe genetic diseases, including sickle cell disease and beta-thalassemia.
Other notable participants include Castle Creek Pharmaceutical Holdings, Bristol-Myers Squibb, Kite Pharma, Inc., Vericel Corporation Inc., Kolon TissueGene Inc., Vertex Pharmaceuticals, Inc., Spark Therapeutics, Inc., CORESTEM Inc., Biogen Inc., Dendreon Pharmaceuticals LLC., and JCR Pharmaceuticals Co. Ltd.
The market outlook remains highly favorable as regulatory momentum, scientific innovation, strategic collaboration, and investment in commercial-scale manufacturing expand the availability of transformative therapies worldwide.
Key Topics Covered
1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage - Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Global Cell and Gene Therapy Market Overview
3.1 Global Cell and Gene Therapy Market Historical Value (2019-2025)
3.2 Global Cell and Gene Therapy Market Forecast Value (2026-2035)
4 Vendor Positioning Analysis
4.1 Key Vendors
4.2 Prospective Leaders
4.3 Niche Leaders
4.4 Disruptors
5 Global Cell and Gene Therapy Market Landscape
5.1 Global Cell and Gene Therapy: Developers Landscape
5.1.1 Analysis by Year of Establishment
5.1.2 Analysis by Company Size
5.1.3 Analysis by Region
5.2 Global Cell and Gene Therapy: Product Landscape
5.2.1 Analysis by Therapy Type
5.2.2 Analysis by Indication
6 Global Cell and Gene Therapy Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
6.2.1 Strengths
6.2.2 Weaknesses
6.2.3 Opportunities
6.2.4 Threats
6.3 PESTEL Analysis
6.3.1 Political
6.3.2 Economic
6.3.3 Social
6.3.4 Technological
6.3.5 Legal
6.3.6 Environment
6.4 Porter's Five Forces Model
6.4.1 Bargaining Power of Suppliers
6.4.2 Bargaining Power of Buyers
6.4.3 Threat of New Entrants
6.4.4 Threat of Substitutes
6.4.5 Degree of Rivalry
6.5 Key Demand Indicators
6.6 Key Price Indicators
6.7 Industry Events, Initiatives, and Trends
6.8 Value Chain Analysis
7 Global Cell and Gene Therapy Market Segmentation (2019-2035)
7.1 Market by Therapy Type
7.1.1 Market Overview
7.1.2 Cell Therapy Types
7.1.2.1 Autologous Cell Therapy
7.1.2.2 Allogenic Cell Therapy
7.1.3 Gene Therapy Types
7.1.3.1 Somatic Gene Therapy
7.1.3.2 Germline Gene Therapy
7.2 Market by Type
7.2.1 Market Overview
7.2.2 Cell Type
7.2.2.1 Stem Cell
7.2.2.2 Non-Stem Cell
7.2.3 Gene Type
7.2.3.1 Antigen
7.2.3.2 Cytokine
7.2.3.3 Tumor Suppressor
7.2.3.4 Growth Factors
7.2.3.5 Receptors
7.2.3.6 Others
7.3 Market by Delivery Mode
7.3.1 Market Overview
7.3.2 In Vivo
7.3.3 Ex Vivo
7.4 Market by Vector Type
7.4.1 Market Overview
7.4.2 Viral Vector
7.4.3 Non-viral Techniques
7.5 Market by Therapeutic Area
7.5.1 Market Overview
7.5.2 Oncology
7.5.3 Cardiovascular Diseases
7.5.4 Neurological Disorders
7.5.5 Genetic Disorders
7.5.6 Infectious Diseases
7.5.7 Hematological Disorders
7.5.8 Musculoskeletal Disorders
7.5.9 Others
7.6 Market by End User
7.6.1 Market Overview
7.6.2 Hospitals
7.6.3 Cancer Care Centers
7.6.4 Academic and Research Institutes
7.6.5 Others
7.7 Market by Region
7.7.1 Market Overview
7.7.2 North America
7.7.3 Europe
7.7.4 Asia Pacific
7.7.5 Latin America
7.7.6 Middle East and Africa
8 Regional Cell and Gene Therapy Market Analysis (2019-2035)
8.1 Regional Market Segmentation Framework
8.1.1 By Therapy Type: Autologous Cell Therapy, Allogenic Cell Therapy, Somatic Gene Therapy, and Germline Gene Therapy
8.1.2 By Type: Stem Cell, Non-Stem Cell, Antigen, Cytokine, Tumor Suppressor, Growth Factors, Receptors, and Others
8.1.3 By Delivery Mode: In Vivo and Ex Vivo
8.1.4 By Vector Type: Viral Vector and Non-viral Techniques
8.1.5 By Indication: Oncology, Cardiovascular Diseases, Neurological Disorders, Genetic Disorders, Infectious Diseases, Hematological Disorders, Musculoskeletal Disorders, and Others
8.1.6 By End User: Hospitals, Cancer Care Centers, Academic and Research Institutes, and Others
8.2 North America Market Analysis
8.2.1 United States of America
8.2.2 Canada
8.3 Europe Market Analysis
8.3.1 United Kingdom
8.3.2 Germany
8.3.3 France
8.3.4 Italy
8.3.5 Others
8.4 Asia Pacific Market Analysis
8.4.1 China
8.4.2 Japan
8.4.3 India
8.4.4 ASEAN
8.4.5 Australia
8.4.6 Others
8.5 Latin America Market Analysis
8.5.1 Brazil
8.5.2 Argentina
8.5.3 Mexico
8.5.4 Others
8.6 Middle East and Africa Market Analysis
8.6.1 Saudi Arabia
8.6.2 United Arab Emirates
8.6.3 Nigeria
8.6.4 South Africa
8.6.5 Others
9 Regulatory Framework
9.1 Regulatory Overview
9.2 US FDA
9.3 EU EMA
9.4 INDIA CDSCO
9.5 JAPAN PMDA
9.6 Others
10 Clinical Trial Analysis
10.1 Analysis by Trial Registration Year
10.2 Analysis by Trial Status
10.3 Analysis by Trial Phase
10.4 Analysis by Therapeutic Area
10.5 Analysis by Geography
11 Grant Analysis
11.1 Analysis by Year
11.2 Analysis by Amount Awarded
11.3 Analysis by Issuing Authority
11.4 Analysis by Grant Product
11.5 Analysis by Funding Institute
11.6 Analysis by Departments
11.7 Analysis by Recipient Organization
12 Funding and Investment Analysis
12.1 Analysis by Funding Instances
12.2 Analysis by Type of Funding
12.3 Analysis by Funding Amount
12.4 Analysis by Leading Players
12.5 Analysis by Leading Investors
12.6 Analysis by Geography
13 Strategic Initiatives
13.1 Analysis by Partnership Instances
13.2 Analysis by Type of Partnership
13.3 Analysis by Leading Players
13.4 Analysis by Geography
14 Supplier Landscape
14.1 Market Share Analysis, By Region (Top 5 Companies)
14.1.1 Global
14.1.2 North America
14.1.3 Europe
14.1.4 Asia Pacific
14.1.5 Others
14.2 Company Profile Assessment Framework
14.2.1 Financial Analysis
14.2.2 Product Portfolio
14.2.3 Demographic Reach and Achievements
14.2.4 Company News and Developments
14.2.5 Certifications
14.3 Companies Profiled
14.3.1 Amgen Inc.
14.3.2 Novartis AG
14.3.3 Pfizer Inc.
14.3.4 Bluebird Bio, Inc.
14.3.5 Castle Creek Pharmaceutical Holdings
14.3.6 Bristol-Myers Squibb
14.3.7 Kite Pharma, Inc.
14.3.8 Vericel Corporation Inc.
14.3.9 Kolon TissueGene Inc.
14.3.10 Vertex Pharmaceuticals, Inc.
14.3.11 Spark Therapeutics, Inc.
14.3.12 CORESTEM Inc.
14.3.13 Biogen Inc.
14.3.14 Dendreon Pharmaceuticals LLC.
14.3.15 JCR Pharmaceuticals Co. Ltd.
15 Global Cell and Gene Therapy Market - Distribution Model (Additional Insight)
15.1 Overview
15.2 Potential Distributors
15.3 Key Parameters for Distribution Partner Assessment
16 Key Opinion Leaders (KOL) Insights (Additional Insight)
17 Payment Methods (Additional Insight)
17.1 Government Funded
17.2 Private Insurance
17.3 Out-of-Pocket
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