Report cover image

Europe Cell Sheet-based Gene Therapy Market: Focus on Technology Type, Cell-sheet Type, Source Type, Application Type, End User, and Country - Analysis and Forecast, 2025-2035

Publisher BIS Research
Published Jul 31, 2025
Length 54 Pages
SKU # BIS20291130

Description

Introduction to Europe Cell Sheet-based Gene Therapy Market

The Europe cell sheet–based gene therapy market is projected to reach $926.0 million by 2035 from $219.6 million in 2024, growing at a CAGR of 13.98% during the forecast period 2025-2035. The presence of important biotechnology leaders and regenerative medicine inventors shapes the cell sheet-based gene therapy market in Europe. Significantly, Foundation ENEA Tech Biomedical has become a major force, particularly after acquiring Holostem S.r.l. in December 2023. Holoclar is a groundbreaking treatment for corneal regeneration that was developed by Holostem, the first European biotech business solely focused on breakthrough medicines based on epithelial stem cells. By creating national hubs that connect translational research with clinical application, ENEA is further strengthening the biomedical capability of the area. It also prioritizes industrial scalability and cultivates public-private collaborations.

Through cooperative R&D, licensing, and manufacturing endeavors, well-known companies like CellSeed Inc. and Japan Tissue Engineering Co. (J-TEC) also sustain a rising presence in the European market. These businesses aid in the development of autologous, scaffold-free cell sheet technologies for use in cardiovascular, ophthalmological, and dermatological fields.

Even though some foreign companies, like Abeona Therapeutics, still concentrate their manufacturing efforts on the United States, their technologies, such ZEVASKYN for RDEB, show a great deal of relevance in the European rare illness market. Together, these participants are establishing Europe as a vibrant center for the creation and marketing of gene treatments based on cell sheets that tackle intricate tissue-specific and epithelial disorders.

Market Introduction

The market for cell sheet-based gene therapy in Europe is expanding as the need for individualized therapies rises and advances in cell therapy and regenerative medicine come together. There is great promise for treating issues including corneal damage, heart problems, esophageal injuries, and dermatological diseases with this novel therapeutic technique, which uses viable, scaffold-free cell layers for tissue repair or gene delivery.

Innovation and market preparedness are being accelerated by Europe's robust biopharmaceutical and university research ecosystem as well as the helpful regulatory channels provided by the EMA's Advanced Therapy Medicinal Products (ATMP) framework. Leading nations in translational research and clinical trials include Germany, the United Kingdom, and Italy. Commercialization efforts are also being aided by technologies that allow for the transportation, cryopreservation, and precision manufacture of delicate cell sheets.

The market is confronted with obstacles, nonetheless, such as restricted scalability for autologous therapies, complicated GMP compliance, and high development and production costs. Despite this, long-term development is anticipated to be driven by sustained investment in biotech infrastructure, expanding public-private collaborations, and expanded indications in wound healing, cardiology, and ophthalmology. Europe is poised to become a major center for next-generation, cell-based gene therapy solutions as additional treatments go through clinical pipelines and receive EMA approval.

Market Segmentation:

Segmentation 1: By Technology Type

Cell sheet-based Engineering Techniques
Light-induced cell sheet technology
Temperature-Responsive Culture Surfaces
Scaffold-Free Techniques
Layer-by-Layer Assembly
Other Techniques
Gene Delivery Methods
Viral Vector-Based (e.g., Lentivirus, Adenovirus)
Non-Viral Vector-Based (e.g., Liposomes, Nanoparticles)
CRISPR/Cas9
Other Gene Delivery Methods

Segmentation 2: By Cell-Sheet Type

Monolayer Cell-sheet Type
Co-culture Cell-sheet Type
Multilayered Cell-sheet Type
Others

Segmentation 3: By Source Type

Autologous
Allogenic
Stem-cell Derived

Segmentation 4: By Application

Oncology
Ophthalmology
Genetic Disorders
Cardiology
Others

Segmentation 5: By End-User

Hospitals and Clinics
Research and Academic Institutions
Biotech and Pharma Companies
Others

Segmentation 6: By Region

Europe
Germany
U.K.
France
Italy
Spain o Rest-of-Europe

Europe Cell Sheet-Based Gene Therapy Market Trends, Drivers and Challenges

Market Trends

Rising focus on scaffold-free tissue engineering using cell sheet technologies.
Growing number of clinical trials in ophthalmology, dermatology, and cardiology.
Integration of gene-editing techniques (e.g., CRISPR, TALEN) with cell sheets for targeted therapy.
Increased academic-industry collaborations for regenerative applications.
Expansion of decentralized manufacturing and cleanroom infrastructure.

Market Drivers

High demand for advanced therapies targeting rare and degenerative diseases (e.g., RDEB, corneal blindness).
Favorable regulatory framework under EMA’s Advanced Therapy Medicinal Products (ATMP) pathway.
Strong presence of biobanks and stem cell research centers across Western and Northern Europe.
Public and private funding initiatives supporting ATMP research and commercialization.
Aging population driving need for innovative regenerative treatments.

Market Challenges

High production costs and complex logistics for autologous therapies.
Stringent quality control and regulatory compliance requirements.
Limited reimbursement pathways for novel gene and cell therapies.
Slow adoption across Central and Eastern Europe due to lack of infrastructure.
Need for more long-term safety and efficacy data to support widespread use.

How can this report add value to an organization?

Product/Innovation Strategy: The report offers in-depth insights into the latest technological advancements in EUROPE cell sheet-based gene therapy, enabling organizations to drive innovation and develop cutting-edge products tailored to market needs.

Growth/Marketing Strategy: By providing comprehensive market analysis and identifying key growth opportunities, the report equips organizations with the knowledge to craft targeted marketing strategies and expand their market presence effectively.

Competitive Strategy: The report includes a thorough competitive landscape analysis, helping organizations understand their competitors’ strengths and weaknesses and allowing them to strategize effectively to gain a competitive edge in the market.

Regulatory and Compliance Strategy: It provides updates on evolving regulatory frameworks, approvals, and industry guidelines, ensuring organizations stay compliant and accelerate market entry for new EUROPE cell sheet-based gene therapy.

Investment and Business Expansion Strategy: By analyzing market trends, funding patterns, and partnership opportunities, the report assists organizations in making informed investment decisions and identifying potential M&A opportunities for business growth.

*PDF email from publisher allows for 1-3 users, with permission to print*

Please Note:
It will take 1-5 business days to complete the report upon order confirmation.

Table of Contents

54 Pages
Executive Summary
Scope and Definition
1 Europe Cell sheet-based Gene Therapy Market: Industry Outlook
1.1 Trends in Cell Sheet-based Gene Therapy Market
1.1.1 Emerging Convergence of Regenerative Medicine and Genetic Engineering
1.2 Approved Drugs, Cell sheet-based Gene Therapy
1.3 Pipeline Drugs, Cell sheet-based Gene Therapy
1.4 Regulatory Landscape
1.4.1 Europe
1.5 Market Dynamics
1.5.1 Trends, Drivers, Challenges, and Opportunities: Current and Future Impact Assessment
1.5.2 Market Drivers
1.5.2.1 Advancement in Regenerative Medicine
1.5.2.2 Growing Investment in Personalized Medicine
1.5.2.3 Technological Advancements in Cell Sheet Therapy
1.5.3 Market Restraints
1.5.3.1 Rising Cost of Development and Manufacturing
1.5.4 Market Opportunities
1.5.4.1 Substantial Surge in the Rise of Cell Sheet Approaches
1.5.4.2 Rising Application for Localized and Minimally Invasive Treatments
1.6 Market Challenges
1.6.1 Regulatory Approval and Ethical Issues
2 Cell Sheet-based Gene Therapy Market (by Region), Value ($million), 2023-2035
2.1 Regional Summary
2.2 Europe
2.2.1 Regional Overview
2.2.2 Driving Factors for Market Growth
2.2.3 Factors Challenging the Market
2.2.4 U.K.
2.2.5 France
2.2.6 Germany
2.2.7 Italy
2.2.8 Spain
2.2.9 Rest-of-Europe
3 Markets - Competitive Benchmarking & Company Profiles
3.1 Foundation ENEA Tech Biomedical
3.1.1 Overview
3.1.2 Top Products/Product Portfolio
3.1.3 Top Competitors
3.1.4 Target Customers
3.1.5 Strategic Positioning and Market Impact
3.1.6 Analyst View
3.1.7 Pipeline and Research Initiatives
4 Research Methodology
4.1 Data Sources
4.1.1 Primary Data Sources
4.1.2 Secondary Data Sources
4.1.3 Inclusion and Exclusion
4.1.4 Data Triangulation
4.2 Market Estimation and Forecast
List of Figures
Figure 1: Europe Cell Sheet-based Gene Therapy Market (by Scenario), $Million, 2024, 2028, and 2035
Figure 2: Europe Cell Sheet-based Gene Therapy Market, 2024-2035
Figure 3: Europe Cell Sheet-based Gene Therapy Market Snapshot
Figure 4: Cell Sheet-based Gene Therapy Market, $Million, 2024 and 2035
Figure 5: Europe Cell Sheet-based Gene Therapy Market (by Technology Type), $Million, 2024, 2028, and 2035
Figure 6: Europe Cell Sheet-based Gene Therapy Market (by Cell-Sheet Type), $Million, 2024, 2028, and 2035
Figure 7: Europe Cell Sheet-based Gene Therapy Market (by Source Type), $Million, 2024, 2028, and 2035
Figure 8: Europe Cell Sheet-based Gene Therapy Market (by Application Type), $Million, 2024, 2028, and 2035
Figure 9: Europe Cell Sheet-based Gene Therapy Market (by End User), $Million, 2024, 2028, and 2035
Figure 10: Europe Cell Sheet-based Gene Therapy Market Segmentation
Figure 11: U.K. Cell Sheet-based Gene Therapy Market, $Million, 2023-2035
Figure 12: France Cell Sheet-based Gene Therapy Market, $Million, 2023-2035
Figure 13: Germany Cell Sheet-based Gene Therapy Market, $Million, 2023-2035
Figure 14: Italy Cell Sheet-based Gene Therapy Market, $Million, 2023-2035
Figure 15: Spain Cell Sheet-based Gene Therapy Market, $Million, 2023-2035
Figure 16: Rest of Europe Cell Sheet-based Gene Therapy Market, $Million, 2023-2035
Figure 17: Inclusion and Exclusion Criteria for Europe Cell Sheet-based Gene Therapy Market
Figure 18: Data Triangulation
Figure 19: Top-Down and Bottom-Up Approach
Figure 20: Assumptions and Limitations
List of Tables
Table 1: Market Snapshot
Table 2: Approved Drugs in Cell-Sheet based Gene Therapy Market
Table 3: Pipeline Drugs in Cell-Sheet based Gene Therapy Market
Table 4: Cell Sheet-based Gene Therapy Market (by Region), $Million, 2023-2035
Table 5: Europe Cell Sheet-based Gene Therapy Market (by Technology Type), $Million, 2023-2035
Table 6: Europe Cell Sheet-based Gene Therapy Market (by Cell sheet-based Engineering Techniques Type), $Million, 2023-2035
Table 7: Europe Cell Sheet-based Gene Therapy Market (by Gene Delivery Methods), $Million, 2023-2035
Table 8: Europe Cell Sheet-based Gene Therapy Market (by Cell-sheet Type), $Million, 2023-2035
Table 9: Europe Cell Sheet-based Gene Therapy Market (by Source Type), $Million, 2023-2035
Table 10: Europe Cell Sheet-based Gene Therapy Market (by Application Type), $Million, 2023-2035
Table 11: Europe Cell Sheet-based Gene Therapy Market (by End User), $Million, 2023-2035
How Do Licenses Work?
Request A Sample
Head shot

Questions or Comments?

Our team has the ability to search within reports to verify it suits your needs. We can also help maximize your budget by finding sections of reports you can purchase.