Tuesday, 02 January 2024 12:17 GMT

Europe Cell Sheet-Based Gene Therapy Market Analysis And Forecast, 2025-2035 - Favorable Regulatory Framework Under EMA's Advanced Therapy Medicinal Products (ATMP) Pathway


(MENAFN- GlobeNewsWire - Nasdaq) Despite challenges like high costs and regulatory complexities, Europe's vibrant research ecosystem and EMA's supportive ATMP framework are propelling market expansion. Emphasis on public-private partnerships, scalability, and diverse collaborations underpins Europe as a hub for cutting-edge gene therapies targeting complex disorders.

Dublin, Oct. 31, 2025 (GLOBE NEWSWIRE) -- The "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" has been added to ResearchAndMarkets's offering.
The Europe cell sheet-based gene therapy market is projected to reach $926 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 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
  • Rest-of-Europe

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.

Key Attributes

Report Attribute Details
No. of Pages 54
Forecast Period 2025-2035
Estimated Market Value (USD) in 2025 $246.6 Million
Forecasted Market Value (USD) by 2035 $926 Million
Compound Annual Growth Rate 13.9%
Regions Covered Europe

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Attachment

  • European Cell Sheet-based Gene Therapy Market
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