세포 시트 기반 유전자 치료제 시장의 주요 기업으로는 Abeona Therapeutics, Inc. 및 Foundation ENEA Tech Biomedical과 같은 첨단 생명공학 기업 및 재생의료 기업이 포함되며, CellSeed, Inc.와 J-TEC와 같은 기존 대기업도 존재감을 드러내고 있습니다.
Abeona는 미국 오하이오주 클리블랜드에 cGMP를 준수하는 통합 제조시설을 갖추고 있으며, 임상 및 상업적 규모의 첨단 치료제를 생산할 수 있습니다. 주력 제품인 제바스킨(ZEVASKYN, prademagene zamikeracel)은 열성 영양결핍성 표피수포증(RDEB)에 대한 자가유래 유전자교정 세포치료제로 희귀 피부질환 분야에서 높은 상업적 잠재력을 보여주고 있습니다.
| 주요 시장 통계 | |
|---|---|
| 예측 기간 | 2025-2035년 |
| 2025년 평가액 | 8억 5,470만 달러 |
| 2035년 예측 | 33억 5,510만 달러 |
| CAGR | 14.48% |
세계 세포 시트 기반 유전자 치료제 시장은 2035년 33억 3,510만 달러에 달할 것으로 예상되며, 큰 폭의 성장이 예상되고 있습니다. 이러한 성장을 촉진하는 것은 사지간세포결핍증, 허혈성 심장질환, 유전성 피부질환 등 기존 치료법으로 충분한 효과를 얻지 못하는 만성질환, 퇴행성 질환, 희귀질환의 유병률 증가입니다. 세포시트를 이용한 유전자 치료는 재생능력을 가진 비계가 필요 없는 접근법으로, 손상된 조직에 완전한 기능성 세포층을 직접 전달하여 우수한 조직 복구, 조직과의 일체화, 국소적 유전자 발현을 실현합니다.
이 혁신적인 플랫폼은 재생의료와 유전자 전달 기술을 결합하여 개인화된 최소 침습적 치료 중재를 가능하게 하는 혁신적인 플랫폼입니다. 각막 재생을 위한 Holoclar의 EMA 승인과 RDEB(열성 영양결핍성 표피수포증)에 대한 Zevaskyn의 FDA 승인과 같은 중요한 임상적 이정표는 이 치료 모델의 유효성을 입증하고 자가유래 및 유전자 교정 재생 치료의 새로운 영역을 확립하고 있습니다. 새로운 영역을 구축하고 있습니다.
이 분야의 성장은 FDA의 RMAT 지정, EMA의 ATMP 제도, 일본의 조건부 승인 제도와 같은 각국의 지원적인 제도적 프레임워크에 의해 더욱 가속화되고 있습니다. 또한 미국의 NIH, 일본의 AMED, 유럽의 Horizon Europe과 같은 공공 기관의 연구 보조금이 중개연구를 촉진하고 있습니다. 또한 이탈리아, 미국, 한국, 독일 등의 국가에서는 GMP 인증을 받은 인프라와 제조 능력의 확충이 진행되고 있습니다.
기술적으로는 온도 반응성 고분자, 유전자 편집과의 통합, 동결보존 기술 등의 혁신으로 보다 안정적이고 확장 가능한 제품 공급이 가능해졌습니다. 현재는 단층 세포 시트, 자가 유래 세포, 암 분야에서의 적용이 주류를 이루고 있지만, 안과, 순환기, 피부과 등으로 적응증 확대가 진행되고 있으며, 폭넓은 치료 분야에서의 유용성이 입증되고 있습니다.
세계의 세포 시트 기반 유전자 치료 시장을 조사했으며, 주요 동향, 시장 영향요인의 분석, 법규제 환경, 임상시험의 동향, 시장 규모 추이·예측, 각종 구분·지역/주요 국가별 상세 분석, 경쟁 구도, 주요 기업의 개요 등을 정리하여 전해드립니다.
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Introduction of Cell Sheet-based Gene Therapy
Key players in the cell sheet-based gene therapy market include leading biotech and regenerative medicine firms such as Abeona Therapeutics, Inc. and Foundation ENEA Tech Biomedical, alongside established players such as CellSeed Inc. and J-TEC. Abeona operates a fully integrated, cGMP-compliant manufacturing facility in Cleveland, Ohio, enabling clinical and commercial-scale production of advanced therapies. Its flagship product, ZEVASKYN (prademagene zamikeracel), is an autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa (RDEB), demonstrating strong commercial potential in rare dermatological conditions.
| KEY MARKET STATISTICS | |
|---|---|
| Forecast Period | 2025 - 2035 |
| 2025 Evaluation | $854.7 Million |
| 2035 Forecast | $3,355.1 Million |
| CAGR | 14.48% |
Foundation ENEA Tech Biomedical has significantly expanded its regenerative medicine portfolio through the acquisition of Holostem S.r.l. in December 2023. Holostem, the first biotech company dedicated to epithelial stem cell-based ATMPs, is behind therapies Holoclar, targeting corneal regeneration. ENEA is building national biomedical hubs to connect translational research with clinical application, emphasizing industrial scalability and public-private collaboration. These strategic efforts aim to advance therapies for complex epithelial diseases affecting the skin and eye, while safeguarding Italy's biomedical autonomy.
Market Introduction
The global cell sheet-based gene therapy market is expected to witness significant expansion, projected to reach $3,335.1 million by 2035. This growth is driven by the rising prevalence of chronic, degenerative, and rare conditions such as limbal stem cell deficiency, ischemic heart disease, and inherited skin disorders that are poorly served by conventional therapies. Cell sheet-based gene therapy offers a regenerative, scaffold-free solution that delivers intact, functional cell layers directly to damaged tissues, enabling superior tissue repair, integration, and localized gene expression.
This transformative platform merges regenerative medicine with gene delivery, allowing for personalized, minimally invasive interventions. Key clinical milestones such as EMA's approval of Holoclar for corneal regeneration and FDA's approval of Zevaskyn for RDEB have validated the therapeutic model, establishing a new frontier in autologous and gene-corrected regenerative treatments.
Growth is further fueled by supportive global frameworks such as FDA's RMAT designation, EMA's ATMP pathway, and Japan's conditional approval model, which have accelerated the clinical and regulatory trajectory of these therapies. Public investments through NIH (U.S.), AMED (Japan), and Horizon Europe are fostering translational research, while countries such as Italy, the U.S., South Korea, and Germany are scaling GMP-certified infrastructure and manufacturing capacity.
The market is also witnessing technological convergence with innovations in temperature-responsive polymers, gene editing integration, and cryopreservation techniques, enabling more stable and scalable product delivery. While monolayer cell sheets, autologous cell sources, and oncology applications currently dominate, expanding indications in ophthalmology, cardiology, and dermatology signal broad therapeutic relevance.
Despite this momentum, challenges such as high manufacturing costs, limited reimbursement clarity, and fragmented late-stage clinical data remain. However, growing payer confidence, successful real-world outcomes, and cross-sector partnerships are steadily addressing these barriers.
The competitive landscape is led by companies such as Abeona Therapeutics, CellSeed Inc., Japan Tissue Engineering Co. (J-TEC), and Holostem, all of which are advancing first-in-class therapies and building robust commercialization strategies. As healthcare systems increasingly embrace regenerative, precision-based approaches, cell sheet-based gene therapy stands at the intersection of high clinical need and disruptive innovation, with the potential to redefine treatment paradigms across multiple medical disciplines.
Industrial Impact
Cell sheet-based gene therapy is reshaping the healthcare industry by introducing regenerative, patient-specific treatments that offer improved healing and functional recovery across a range of conditions. For instance, in ophthalmology, Holoclar, a stem cell-based cell sheet therapy, has transformed treatment for limbal stem cell deficiency, enabling vision restoration using the patient's own epithelial cells. This personalized approach enhances safety and long-term outcomes by eliminating the risks associated with immune rejection.
Beyond individual patient care, cell sheet-based gene therapy is driving innovation across biomanufacturing and clinical delivery systems. The integration of temperature-responsive culture surfaces and scaffold-free platforms is enabling the scalable production of high-integrity cell sheets, which is revolutionizing how advanced tissue therapies are developed and deployed. Companies such as J-TEC and CellSeed Inc. are pioneering late-stage clinical programs for indications such as cartilage repair and skin regeneration, backed by robust regulatory support in markets such as Japan.
In parallel, public-private partnerships such as those initiated by Foundation ENEA Tech Biomedical in Europe are establishing biomedical hubs that bridge translational research with commercial-scale deployment, reinforcing industrial scalability and healthcare resilience. These advancements are not only improving individual outcomes but also optimizing treatment workflows, reducing surgical complications, and accelerating the pathway to broader access in regenerative care.
The continued evolution of cell sheet-based therapies promises to redefine the role of regenerative medicine in mainstream healthcare by promoting durable, biologically integrated treatments that align with the growing shift toward precision and minimally invasive care.
Market Segmentation
Segmentation 1: By Technology Type
Cell sheet-based engineering techniques remain the leading segment by technology type in the cell sheet-based gene therapy market, holding a 75.32% market share in 2024 with a projected CAGR of 14.79% during the forecast period 2025-2035. Among its key subsegments-Light-induced cell sheet technology, Temperature-Responsive Culture Surfaces, Scaffold-Free Techniques, and Layer-by-Layer Assembly-Light-induced cell sheet technology leads the market, owing to its precise control over cell detachment and viability without chemical or enzymatic treatments. This technology is gaining traction for its ability to preserve cell functionality, improve sheet integrity, and support advanced tissue engineering applications across ophthalmology, dermatology, and orthopedics.
Segmentation 2: By Cell-Sheet Type
Based on cell sheet type, the global cell sheet-based gene therapy market was led by the Monolayer Cell-sheet Type segment, which held a 35.69% share in 2024. Monolayer cell sheets are projected to maintain dominance due to their simpler fabrication process, preserved cell-cell junctions, and suitability for early-stage regenerative applications. Their widespread use in skin, ocular, and mucosal therapies supports consistent demand, while ongoing clinical advancements continue to expand their therapeutic potential across various indications.
Segmentation 3: By Source Type
Based on source type, the global cell sheet-based gene therapy market was led by the Autologous segment, which held a 78.65% share in 2024. Autologous cell sources are expected to continue dominating the market due to their lower risk of immune rejection, better biocompatibility, and established clinical outcomes. These therapies are particularly favored in personalized regenerative treatments, offering safer and more effective options for conditions such as skin injuries, corneal damage, and cartilage repair.
Segmentation 4: By Application
Based on application type, the global cell sheet-based gene therapy market was led by the Oncology segment, which held a 43.46% share in 2024. Oncology is expected to continue leading the market due to the rising demand for innovative, localized treatment approaches that offer enhanced tissue regeneration and targeted delivery. Cell sheet therapies show strong potential in solid tumor management by supporting reconstruction post-resection and improving therapeutic outcomes through scaffold-free, biocompatible platforms.
Segmentation 5: By End-User
Based on end-user, the global cell sheet-based gene therapy market was led by the Hospitals and Clinics segment, which held a 40.18% share in 2024. Hospitals and clinics are expected to dominate the market as they serve as primary centers for administering advanced regenerative therapies. Their access to specialized surgical infrastructure, trained professionals, and controlled clinical settings makes them ideal for cell sheet transplantation procedures, especially in oncology, ophthalmology, and orthopedic indications.
Segmentation 6: By Region
The cell sheet-based gene therapy market in the Asia-Pacific region is expected to witness substantial growth over the next five years, driven by Japan's progressive regulatory environment, expanding clinical activity, and strong academic-industry collaboration. The region benefits from advanced regenerative medicine frameworks such as Japan's Act on the Safety of Regenerative Medicine and the PMDA's fast-track approval pathways, which have accelerated the development and approval of therapies such as JACC and Holoclar. Key developments include the late-stage clinical advancement of autologous and allogeneic cartilage cell sheets for osteoarthritis and ongoing efforts in iPS cell-derived retinal therapies. Companies such as CellSeed, J-TEC, and Abeona Therapeutics are actively exploring scalable, clinically viable platforms with a focus on skin, corneal, and cartilage repair. Additionally, public-private initiatives and academic partnerships are fostering translational research, while increasing investment in biomanufacturing and infrastructure is expected to support broader commercialization and access.
Recent Developments in the Cell Sheet-based Gene Therapy Market
Demand -Drivers, Challenges, and Opportunities
Market Demand Drivers:
Cell Sheet Engineering and Culture Technology
Thermoresponsive Culture Systems: One of the significant innovations in cell-sheet technology is the use of thermoresponsive culture dishes, which allow cells to be grown in sheets and then detached easily without the need for harsh enzymatic treatments. This innovation helps preserve the integrity of the cells, ensuring that they are viable for transplantation.'A study published in Stem Cell Research & Therapy in 2024' discusses the use of thermoresponsive culture dishes for fabricating patterned cell sheets. These sheets, when transplanted, have shown improved survival and functionality due to the preservation of native cell structures during harvesting.
Stem Cells in Regenerative Medicine: Stem cells are central to regenerative medicine, as they can differentiate into a variety of cell types, aiding in tissue regeneration. In cell-sheet-based gene therapy, stem cells (especially mesenchymal stem cells and induced pluripotent stem cells) are often used to form cell sheets. According to a 2018 report by the National Institutes of Health (NIH), stem cell-based therapies have seen a 25-30% increase in successful clinical outcomes for patients with heart disease and cartilage regeneration when combined with cell-sheet technology.
Some of the other driving factors include:
Note: All of the above factors will be evaluated in detail in the report.
Market Challenges:
Genetic editing raises significant ethical concerns, particularly when it involves altering human DNA. In gene therapies involving cell-sheet technology, concerns include the potential for germline editing (altering DNA in a way that affects future generations) and the risk of unforeseen consequences from permanent genetic modifications. Ethical concerns can lead to public resistance, regulatory delays, and heightened scrutiny, all of which may slow down the development and acceptance of cell-sheet-based gene therapies.
Some of the other factors challenging the market growth include:
Note: All of the above factors will be evaluated in detail in the report.
Market Opportunities:
Cell sheet-based gene therapy is expected to witness significant growth, driven by powerful trends across the cell and gene therapy (CGT) and regenerative medicine sectors. With the global CGT market valued at over $21 billion in 2024 and projected to exceed $100 billion by the early 2030s, opportunities for cell-sheet technologies are expanding rapidly. The regenerative medicine segment alone is expected to grow from around $35 billion to over $90 billion by 2030. Cell sheet therapies are particularly well-positioned to meet the growing demand for personalized, non-oncology treatments, as evidenced by the increasing share of gene therapy trials targeting non-cancer conditions
Some of the other factors creating an opportunity for market growth include:
Note: All of the above factors will be evaluated in detail in the report.
Market Trends:
Current Trends Driving the Field:
Some of the other emerging trends in the market include:
Note: All of the above trends will be evaluated in detail in the report.
How can this report add value to an organization?
Product/Innovation Strategy: The report offers in-depth insights into the latest technological advancements in 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 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.
Methodology
Key Considerations and Assumptions in Market Engineering and Validation
Primary Research:
The primary sources involve industry experts in cell sheet-based gene therapy , including the market players offering products and services. Resources such as CEOs, vice presidents, marketing directors, and technology and innovation directors have been interviewed to obtain and verify both qualitative and quantitative aspects of this research study.
The key data points taken from the primary sources include:
Secondary Research:
Open Sources
The key data points taken from the secondary sources include:
Key Market Players and Competition Synopsis
Profiled companies have been selected based on inputs gathered from primary experts, as well as analyzing company coverage, product portfolio, and market penetration.
Key players in the cell sheet-based gene therapy market include leading biotech and regenerative medicine firms such as Abeona Therapeutics, Inc. and Foundation ENEA Tech Biomedical, alongside established players such as CellSeed Inc. and J-TEC. Abeona operates a fully integrated, cGMP-compliant manufacturing facility in Cleveland, Ohio, enabling clinical and commercial-scale production of advanced therapies. Its flagship product, ZEVASKYN (prademagene zamikeracel), is an autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa (RDEB), demonstrating strong commercial potential in rare dermatological conditions.
Foundation ENEA Tech Biomedical has significantly expanded its regenerative medicine portfolio through the acquisition of Holostem S.r.l. in December 2023. Holostem, the first biotech company dedicated to epithelial stem cell-based ATMPs, is behind therapies such as Holoclar, targeting corneal regeneration. ENEA is building national biomedical hubs to connect translational research with clinical application, emphasizing industrial scalability and public-private collaboration. These strategic efforts aim to advance therapies for complex epithelial diseases affecting the skin and eye, while safeguarding Italy's biomedical autonomy.
Some prominent names established in this market are:
Scope and Definition