Cell sheet-based gene therapy involves transplanting engineered sheets of living cells modified to deliver genetic material into patients to restore or repair damaged tissues and organs. Unlike conventional scaffold-based methods, cell sheets maintain natural cell-to-cell connections and extracellular matrix, leading to better tissue integration, reduced immune response, and improved healing outcomes.
Why It Matters:
This next-generation approach is transforming regenerative medicine by enabling personalized, long-lasting treatments for diseases previously considered untreatable, including heart disease, eye disorders, and severe wounds. As clinical results and regulatory approvals multiply, cell sheet-based gene therapy is poised to change the standard of care in tissue engineering and precision medicine.
According to BIS Research, global cell sheet-based gene therapy market was valued at $757.7 million in 2024 and is expected to reach $3,355.1 million by 2035 at a CAGR of 14.48%.
Key Drivers:
Key Challenges:
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• In May 2025, Japan Tissue Engineering Co., Ltd (J-TEC) received regulatory approval for an expanded indication of its autologous cultured cartilage product, JACC, to include the treatment of knee osteoarthritis, extending its orthopedic applications beyond initial indications.
• In September 2023, Cell seed Inc. submitted a clinical trial notification for a Phase III study of allogeneic cartilage cell sheet (CLS2901C).
• In December 2024, J-TEC entered a capital and business alliance with VCCT Inc. to jointly develop iPS cell-derived retinal regenerative therapies using cell sheet engineering. VCCT will support preclinical development and pipeline scale-up, reinforcing both companies’ positions in the ophthalmic regenerative space.
By Technology Type
• Cell sheet-based Engineering Techniques
o Light-induced cell sheet technology
o Temperature-Responsive Culture Surfaces
o Scaffold-Free Techniques
o Layer-by-Layer Assembly
o Other Techniques
• Gene Delivery Methods
o Viral Vector-Based (e.g., Lentivirus, Adenovirus)
o Non-Viral Vector-Based (e.g., Liposomes, Nanoparticles)
o CRISPR/Cas9
o Other Gene Delivery Methods
By Cell-Sheet Type
• Monolayer Cell-sheet Type
• Co-culture Cell-sheet Type
• Multilayered Cell-sheet Type
• Others
By Source Type
• Autologous
• Allogenic
• Stem-cell Derived
By Application
• Oncology
• Ophthalmology
• Genetic Disorders
• Cardiology
• Others
By End-User
• Hospitals and Clinics
• Research and Academic Institutions
• Biotech and Pharma Companies
• Others
By Region
• North America
o U.S.
o Canada
• Europe
o Germany
o U.K.
o France
o Italy
o Spain
o Rest-of-Europe
• Asia-Pacific
o Japan
o India
o China
o Australia
o South Korea
o Rest-of-Asia-Pacific
• Rest-of-the-World
The cell sheet-based gene therapy market is moving from experimental to mainstream, fueled by rapid advances in regenerative medicine and personalized healthcare. Ongoing clinical trials, next-generation gene editing tools, and expanded manufacturing capabilities are accelerating market adoption. However, overcoming production, regulatory, and reimbursement hurdles will be crucial for sustained growth. As the industry matures, collaborative innovation and investment will play key roles in scaling up safe, effective, and affordable therapies worldwide.
— BIS Research Analyst Team
The market is expected to grow at a CAGR of 14.48% from 2025–2035.
Key leaders include Abeona Therapeutics, Inc, Foundation ENEA Tech Biomedical, Fujifilm Cellular Dynamics, Inc. (FCDI), CellSeed Inc, Japan Tissue Engineering Co., Ltd, Emmaus Medical, Inc.
Technologies in demand include advanced cell sheet fabrication, gene delivery vectors, CAR-T based sheet therapies, and bioengineered tissue integration platforms.
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