Global Cell Sheet-based Gene Therapy Market Size is valued at US$ 719.9 Mn in 2024 and is predicted to reach US$ 2,405.4 Bn by the year 2034 at an 13.1% CAGR during the forecast period for 2025-2034.
Cell sheet-based gene therapy is an advanced regenerative approach that combines gene therapy with tissue engineering. In this method, cells are genetically modified ex vivo and cultured into intact sheets on temperature-responsive surfaces. These sheets preserve the extracellular matrix and cell-to-cell connections, allowing them to be transplanted directly onto damaged tissues or organs. This technique improves cell survival, engraftment, and therapeutic protein delivery, making it promising for applications such as heart repair, corneal regeneration, skin healing, and periodontal therapy.
Global frameworks that have advanced the clinical and regulatory trajectory of these medicines, such as the FDA's RMAT designation, the EMA's ATMP pathway, and Japan's conditional approval approach, further fuel the growth of the cell sheet-based gene therapy market. Additionally, the market is witnessing technological convergence as a result of advancements in cryopreservation methods, gene editing integration, and temperature-responsive polymers, which enable more reliable and scalable product delivery. Despite this momentum, challenges remain, including fragmented late-stage clinical data, high manufacturing costs, and unclear reimbursement. However, these obstacles are being gradually addressed through cross-sector collaborations, positive real-world results, and increasing payer trust.
Some of the Key Players in the Cell Sheet-based Gene Therapy Market:
The cell sheet-based gene therapy market is segmented by cell-sheet type, source type, technology, application, and end-user. By cell-sheet type, the market is segmented into monolayer cell-sheet type, co-culture cell-sheet type, multilayered cell-sheet type, and others. By source type, the market is segmented into allogenic, autologous, and stem-cell derived. By technology, the market is segmented into cell sheet-based engineering techniques [scaffold-free techniques, light-induced cell sheet technology, layer-by-layer assembly, temperature-responsive culture surfaces, others] and gene delivery methods [crispr/cas9, viral vector-based (e.g., lentivirus, adenovirus), non-viral vector-based (e.g., liposomes, nanoparticles), others]. By application, the market is segmented into oncology, cardiology, genetic disorders, ophthalmology, and others. By end-user, the market is segmented into hospitals and clinics, biotech and pharma companies, research and academic institutions, others.
In 2024, the Monolayer Cell-sheet Type segment dominated the global market for cell sheet-based gene therapy. Due to its easier manufacturing method, intact cell-cell connections, and suitability for early-stage regenerative applications, monolayer cell sheets are expected to continue to dominate. While continuous clinical developments continue to broaden their therapeutic potential across a range of indications, their extensive use in skin, ocular, and mucosal therapies sustains steady demand.
The oncology segment leads the global market for cell sheet-based gene therapy. Due to the increasing demand for innovative, targeted delivery and tissue regeneration techniques, oncology is expected to maintain its market-leading position. Through scaffold-free, biocompatible platforms, cell sheet therapies improve therapeutic results and facilitate repair after resection, demonstrating tremendous potential in solid tumour therapy.
The market for cell sheet-based gene therapy is expanding significantly in North America, largely because of the region's advanced healthcare system, high concentration of biotechnology and gene therapy companies, and substantial investment in regenerative medicine research. The United States is now the industry leader due to the presence of large companies, favourable regulatory environments, and expanding clinical research focused on cell sheet engineering for diseases of the skin, eyes, and heart.
The Asia-Pacific market for cell sheet-based gene therapy is expected to increase rapidly over the next five years as a result of Japan's strict regulations, increasing clinical activity, and strong collaboration between academia and industry. Advanced frameworks for regenerative medicine that help the region include Japan's Act on the Safety of Regenerative Medicine and the PMDA's fast-track approval processes. Furthermore, academic collaborations and public-private initiatives are supporting translational research, and greater infrastructure and biomanufacturing investment is anticipated to facilitate wider commercialization and accessibility.
|
Report Attribute |
Specifications |
|
Market Size Value In 2024 |
USD 719.9 Mn |
|
Revenue Forecast In 2034 |
USD 2,405.4 Mn |
|
Growth Rate CAGR |
CAGR of 13.1% from 2025 to 2034 |
|
Quantitative Units |
Representation of revenue in US$ Bn and CAGR from 2025 to 2034 |
|
Historic Year |
2021 to 2024 |
|
Forecast Year |
2025-2034 |
|
Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
|
Segments Covered |
By Cell-Sheet Type, By Source Type, By Technology, By Application, By End-user |
|
Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
|
Country Scope |
U.S.; Canada; Germany; The UK; France; Italy; Spain; Rest of Europe; China; Japan; India; South Korea; Southeast Asia; Rest of Asia Pacific; Brazil; Argentina; Mexico; Rest of Latin America; GCC Countries; South Africa; Rest of the Middle East and Africa |
|
Competitive Landscape |
Abeona Therapeutics Inc., Emmaus Medical, Inc, CellSeed Inc., Fujifilm Cellular Dynamics, Inc. (FCDI) (FUJIFILM Holdings Corporation), Japan Tissue Engineering Co. Ltd., and Foundation ENEA Tech Biomedical |
|
Customization Scope |
Free customization report with the procurement of the report, Modifications to the regional and segment scope. Geographic competitive landscape. |
|
Pricing and Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |
Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions
Chapter 2. Executive Summary
Chapter 3. Global Cell Sheet-based Gene Therapy Market Snapshot
Chapter 4. Global Cell Sheet-based Gene Therapy Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends
4.5. Investment and Funding Analysis
4.6. Porter's Five Forces Analysis
4.7. Incremental Opportunity Analysis (US$ MN), 2025-2034
4.8. Global Cell Sheet-based Gene Therapy Market Penetration & Growth Prospect Mapping (US$ Mn), 2024-2034
4.9. Competitive Landscape & Market Share Analysis, By Key Player (2024)
4.10. Use/impact of AI on CELL SHEET-BASED GENE THERAPY MARKET Industry Trends
Chapter 5. Cell Sheet-based Gene Therapy Market Segmentation 1: By Cell-Sheet Type, Estimates & Trend Analysis
5.1. Market Share by Cell-Sheet Type, 2024 & 2034
5.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following Cell-Sheet Type:
5.2.1. Monolayer Cell-sheet Type
5.2.2. Co-culture Cell-sheet Type
5.2.3. Multilayered Cell-sheet Type
5.2.4. Others
Chapter 6. Cell Sheet-based Gene Therapy Market Segmentation 2: By Technology, Estimates & Trend Analysis
6.1. Market Share by Technology, 2024 & 2034
6.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following Technology:
6.2.1. Cell sheet-based Engineering Techniques
6.2.1.1. Light-induced cell sheet technology
6.2.1.2. Temperature-Responsive Culture Surfaces
6.2.1.3. Scaffold-Free Techniques
6.2.1.4. Layer-by-Layer Assembly
6.2.1.5. Other Techniques
6.2.2. Gene Delivery Methods
6.2.2.1. Viral Vector-Based (e.g., Lentivirus, Adenovirus)
6.2.2.2. Non-Viral Vector-Based (e.g., Liposomes, Nanoparticles)
6.2.2.3. CRISPR/Cas9
6.2.2.4. Other Gene Delivery Methods
Chapter 7. Cell Sheet-based Gene Therapy Market Segmentation 3: By Source Type, Estimates & Trend Analysis
7.1. Market Share by Source Type, 2024 & 2034
7.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following Source Type:
7.2.1. Autologous
7.2.2. Allogenic
7.2.3. Stem-cell Derived
Chapter 8. Cell Sheet-based Gene Therapy Market Segmentation 4: By Application, Estimates & Trend Analysis
8.1. Market Share by Application, 2024 & 2034
8.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following Application:
8.2.1. Oncology
8.2.2. Ophthalmology
8.2.3. Genetic Disorders
8.2.4. Cardiology
8.2.5. Others
Chapter 9. Cell Sheet-based Gene Therapy Market Segmentation 5: By End-User, Estimates & Trend Analysis
9.1. Market Share by End-User, 2024 & 2034
9.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following End-User:
9.2.1. Hospitals and Clinics
9.2.2. Research and Academic Institutions
9.2.3. Biotech and Pharma Companies
9.2.4. Others
Chapter 10. Cell Sheet-based Gene Therapy Market Segmentation 6: Regional Estimates & Trend Analysis
10.1. Global Cell Sheet-based Gene Therapy Market, Regional Snapshot 2024 & 2034
10.2. North America
10.2.1. North America Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
10.2.1.1. US
10.2.1.2. Canada
10.2.2. North America Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Cell-Sheet Type, 2021-2034
10.2.3. North America Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
10.2.4. North America Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Source Type, 2021-2034
10.2.5. North America Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
10.2.6. North America Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034
10.3. Europe
10.3.1. Europe Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
10.3.1.1. Germany
10.3.1.2. U.K.
10.3.1.3. France
10.3.1.4. Italy
10.3.1.5. Spain
10.3.1.6. Rest of Europe
10.3.2. Europe Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Cell-Sheet Type, 2021-2034
10.3.3. Europe Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
10.3.4. Europe Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Source Type, 2021-2034
10.3.5. Europe Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
10.3.6. Europe Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034
10.4. Asia Pacific
10.4.1. Asia Pacific Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
10.4.1.1. India
10.4.1.2. China
10.4.1.3. Japan
10.4.1.4. Australia
10.4.1.5. South Korea
10.4.1.6. Hong Kong
10.4.1.7. Southeast Asia
10.4.1.8. Rest of Asia Pacific
10.4.2. Asia Pacific Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Cell-Sheet Type, 2021-2034
10.4.3. Asia Pacific Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
10.4.4. Asia Pacific Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Source Type, 2021-2034
10.4.5. Asia Pacific Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts By Application, 2021-2034
10.4.6. Asia Pacific Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034
10.5. Latin America
10.5.1. Latin America Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
10.5.1.1. Brazil
10.5.1.2. Mexico
10.5.1.3. Rest of Latin America
10.5.2. Latin America Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Cell-Sheet Type, 2021-2034
10.5.3. Latin America Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
10.5.4. Latin America Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Source Type, 2021-2034
10.5.5. Latin America Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
10.5.6. Latin America Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034
10.6. Middle East & Africa
10.6.1. Middle East & Africa Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
10.6.1.1. GCC Countries
10.6.1.2. Israel
10.6.1.3. South Africa
10.6.1.4. Rest of Middle East and Africa
10.6.2. Middle East & Africa Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Cell-Sheet Type, 2021-2034
10.6.3. Middle East & Africa Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
10.6.4. Middle East & Africa Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Source Type, 2021-2034
10.6.5. Middle East & Africa Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
10.6.6. Middle East & Africa Cell Sheet-based Gene Therapy Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034
Chapter 11. Competitive Landscape
11.1. Major Mergers and Acquisitions/Strategic Alliances
11.2. Company Profiles
11.2.1. Abeona Therapeutics, Inc.
11.2.1.1. Business Overview
11.2.1.2. Key Product/Service
11.2.1.3. Financial Performance
11.2.1.4. Geographical Presence
11.2.1.5. Recent Developments with Business Strategy
11.2.2. Foundation ENEA Tech Biomedical
11.2.3. Fujifilm Cellular Dynamics, Inc. (FCDI)
11.2.4. CellSeed Inc.
11.2.5. Japan Tissue Engineering Co., Ltd
11.2.6. Emmaus Medical, Inc.
Segmentation of Cell Sheet-based Gene Therapy Market -
Cell Sheet-based Gene Therapy Market by Cell-Sheet Type-
Cell Sheet-based Gene Therapy Market by Source Type -
Cell Sheet-based Gene Therapy Market by Technology-
Cell Sheet-based Gene Therapy Market by Application-
Cell Sheet-based Gene Therapy Market by End-user-
Cell Sheet-based Gene Therapy Market by Region-
North America-
Europe-
Asia-Pacific-
Latin America-
Middle East & Africa-
InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.
Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.
Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.
Secondary research
The secondary research sources that are typically mentioned to include, but are not limited to:
The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista
Primary Research:
Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies
The contributors who typically take part in such a course include, but are not limited to:
Data Modeling and Analysis:
In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.
The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.
To know more about the research methodology used for this study, kindly contact us/click here.
