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상품코드
1764706

세포 시트 기반 유전자 치료 시장 : 기술 유형, 세포 시트 유형, 유래·용도, 최종사용자, 지역별 분석과 예측(2025-2035년)

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

발행일: | 리서치사: BIS Research | 페이지 정보: 영문 | 배송안내 : 1-5일 (영업일 기준)

    
    
    




■ 보고서에 따라 최신 정보로 업데이트하여 보내드립니다. 배송일정은 문의해 주시기 바랍니다.

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.

목차

개요

제1장 세계의 세포 시트 기반 유전자 치료 시장 : 업계 전망

  • 세포 시트를 이용한 유전자 치료 시장의 동향
    • 재생의료와 유전자 공학의 새로운 융합
  • 경쟁 구도
    • 사업 전략
    • 기업 전략
  • 승인약
  • 파이프라인 의약품
  • 규제 상황
    • 미국
    • 유럽
    • 아시아태평양
  • 시장 역학
    • 동향, 촉진요인, 과제, 기회 : 현재 및 향후 영향 평가
    • 시장 성장 촉진요인
    • 시장 성장 억제요인
    • 시장 기회
  • 시장이 해결해야 할 과제
    • 규제기관의 승인과 윤리적 문제

제2장 세포 시트 기반 유전자 치료 시장 : 기술 유형별

  • 세포 시트 기반 공학 기술
    • 광유도형 세포 분리 기술
    • 온도 반응형 배양 표면
    • 스캐폴드 불요 기술
    • 다층 적층 기술
    • 기타
  • 유전자 전달법
    • 바이러스 벡터 기반
    • 비바이러스 벡터 기반
    • CRISP/Cas9
    • 기타

제3장 세포 시트 기반 유전자 치료 시장 : 유래별

  • 자기 유래
  • 동종 유래(기성품)
  • 줄기세포 유래

제4장 세포 시트 기반 유전자 치료 시장 : 세포 시트 유형별

  • 단층 세포 시트
  • 공배양 세포 시트
  • 다층 세포 시트
  • 기타

제5장 세포 시트 기반 유전자 치료 시장 : 용도별

  • 용도의 개요
  • 종양
  • 안과
  • 유전성 질환
  • 심장병
  • 기타

제6장 세포 시트 기반 유전자 치료 시장 : 최종사용자별

  • 병원·진료소
  • 연구·학술기관
  • 바이오테크놀러지·제약회사
  • 기타

제7장 세계의 세포 시트 기반 유전자 치료 시장 : 지역별

  • 지역 요약
  • 북미
    • 지역 개요
    • 시장 성장 원동력
    • 시장이 해결해야 할 과제
    • 미국
    • 캐나다
  • 유럽
    • 지역 개요
    • 시장 성장 원동력
    • 시장이 해결해야 할 과제
    • 영국
    • 프랑스
    • 독일
    • 이탈리아
    • 스페인
    • 기타
  • 아시아태평양
    • 지역 개요
    • 시장 성장 원동력
    • 시장이 해결해야 할 과제
    • 일본
    • 중국
    • 인도
    • 호주
    • 한국
    • 기타
  • 기타 지역
    • 지역 개요
    • 시장 성장 원동력
    • 시장이 해결해야 할 과제

제8장 시장 : 경쟁 벤치마킹·기업 개요

  • Abeona Therapeutics Inc.
  • Emmaus Medical, Inc
  • CellSeed Inc.
  • Fujifilm Cellular Dynamics, Inc.(FCDI)(FUJIFILM Holdings Corporation)
  • Japan Tissue Engineering Co. Ltd.
  • Foundation ENEA Tech Biomedical

제9장 조사 방법

KSA 25.07.16

This report can be delivered within 1 working day.

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 Period2025 - 2035
2025 Evaluation$854.7 Million
2035 Forecast$3,355.1 Million
CAGR14.48%

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
    • 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

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

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

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

  • Autologous
  • Allogenic
  • Stem-cell Derived

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

  • Oncology
  • Ophthalmology
  • Genetic Disorders
  • Cardiology
  • Others

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

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

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

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Rest-of-Europe
  • Asia-Pacific
    • Japan
    • India
    • China
    • Australia
    • South Korea
    • Rest-of-Asia-Pacific
  • Rest-of-the-World

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

  • 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, CellSeed Inc. submitted a Phase III clinical trial notification for an allogeneic chondrocyte sheet targeting knee osteoarthritis, marking a major milestone toward commercialization of off-the-shelf regenerative cartilage therapies.
  • 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.
  • In February 2023, CellSeed Inc. partnered with Tokai University to conduct a clinical trial for CLS2701C, an autologous cartilage cell sheet therapy for knee cartilage defects. Tokai University is leading surgical procedures and clinical feasibility studies under ethical oversight at its affiliated hospital.

Demand -Drivers, Challenges, and Opportunities

Market Demand Drivers:

  • Advancement in Regenerative Medicine: One of the main drivers of the market is the advancement in regenerative medicine technologies. Cell sheet-based gene therapy leverages stem cells and other cell types to regenerate damaged or degenerated tissues. As the understanding of stem cell biology and tissue engineering grows, the feasibility and effectiveness of cell-sheet therapies become more prominent. These technologies enable the repair of tissues that cannot naturally regenerate, such as cartilage in joints, heart muscle after a heart attack, and corneal tissue in the eye.

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:

  • Growing Investment in Personalized Medicine
  • Technological Advancements in Cell Sheet Therapy

Note: All of the above factors will be evaluated in detail in the report.

Market Challenges:

  • Regulatory Approval and Ethical Issues: Gene therapies, particularly those involving complex technologies such as cell-sheet engineering, face stringent regulatory scrutiny from bodies such as the FDA and EMA. The approval process can be long, expensive, and uncertain, and the regulatory frameworks for these therapies are still evolving. The lengthy and costly regulatory approval process delays the availability of these therapies to patients and adds to the overall cost of development. There is also the challenge of establishing clear guidelines for cell-sheet-based gene therapies, as these therapies are still relatively new to the field.

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:

  • Limited Commercial Scalability

Note: All of the above factors will be evaluated in detail in the report.

Market Opportunities:

  • Substantial Surge in the Rise of Cell Sheet Approaches: Cell sheet-based gene therapy stands at a strategic inflection point, anchored in the multi-billion-dollar growth of CGT, clinical expansion into diverse indications, validated ultra-high pricing models, parental-level investments in manufacturing, and emerging reimbursement frameworks. Taken together, these signal strong momentum for accelerating clinical translation and commercial adoption of this transformative platform.

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:

  • Rising Application for Localized and Minimally Invasive Treatments

Note: All of the above factors will be evaluated in detail in the report.

Market Trends:

  • Emerging Convergence of Regenerative Medicine and Genetic Engineering: Cell sheet-based gene therapy has transitioned from foundational tissue engineering into a clinically and commercially viable modality. Practices have been advancing from preclinical demonstrations to early clinical use, enhanced by gene editing integration and improved manufacturing processes. Positioned within the rapidly expanding cell and gene therapy market, this hybrid technology is set to expand across fields such as regenerative medicine, ophthalmology, and orthopedics, driven by robust regulatory support and emerging investment trends.

Current Trends Driving the Field:

  • Scaffold free, extracellular matrix preserving techniques: These methods support complex tissue regeneration (e.g., cartilage, cardiac patches, cornea) with high viability, enhancing clinical translation.

Some of the other emerging trends in the market include:

  • Expansion into Oncology and Cardiology

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

  • The base year considered for the calculation of the market size is 2024. A historical year analysis has been done for the period FY2023. The market size has been estimated for FY2024 and projected for the period FY2025-FY2035.
  • The scope of this report has been carefully derived based on extensive interactions with experts and stakeholders across leading companies and research institutions worldwide. This report provides a comprehensive market analysis of regenerative medicine, cell-based engineering technologies, and gene-modified therapies within the cell sheet-based gene therapy market.
  • The market contribution of the precision therapeutics anticipated to be launched in the future has been calculated based on the historical analysis of the products.
  • Revenues of the companies have been referenced from their annual reports for FY2023 and FY2024. For private companies, revenues have been estimated based on factors such as inputs obtained from primary research, funding history, market collaborations, and operational history.
  • The market has been mapped based on the available cell sheet-based gene therapy. All the key companies with significant offerings in this field have been considered and profiled in this report.

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:

  • Validation and triangulation of all the numbers and graphs
  • Validation of the report's segmentation and key qualitative findings
  • Understanding the competitive landscape and business model
  • Current and proposed production values of a product by market players
  • Validation of the numbers of the different segments of the market in focus
  • Percentage split of individual markets for regional analysis

Secondary Research:

Open Sources

  • Certified publications, articles from recognized authors, white papers, directories, and major databases, among others
  • Annual reports, SEC filings, and investor presentations of the leading market players
  • Company websites and detailed study of their product portfolio
  • Gold standard magazines, journals, white papers, press releases, and news articles
  • Paid databases

The key data points taken from the secondary sources include:

  • Segmentations and percentage shares
  • Data for market value
  • Key industry trends of the top players of the market
  • Qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
  • Quantitative data for mathematical and statistical calculations

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:

  • Abeona Therapeutics, Inc.
  • Foundation ENEA Tech Biomedical
  • Fujifilm Cellular Dynamics, Inc. (FCDI)
  • CellSeed Inc.
  • Japan Tissue Engineering Co., Ltd
  • Emmaus Medical, Inc.

Table of Contents

Executive Summary

Scope and Definition

1 Global 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 Competitive Landscape
    • 1.2.1 Business Strategies
      • 1.2.1.1 Product Developments
    • 1.2.2 Corporate Strategies
      • 1.2.2.1 Partnerships and Joint Ventures
  • 1.3 Approved Drugs, Cell sheet-based Gene Therapy
  • 1.4 Pipeline Drugs, Cell sheet-based Gene Therapy
  • 1.5 Regulatory Landscape
    • 1.5.1 U.S.
    • 1.5.2 Europe
    • 1.5.3 Asia-Pacific
      • 1.5.3.1 Japan
      • 1.5.3.2 China
      • 1.5.3.3 South Korea
  • 1.6 Market Dynamics
    • 1.6.1 Trends, Drivers, Challenges, and Opportunities: Current and Future Impact Assessment
    • 1.6.2 Market Drivers
      • 1.6.2.1 Advancement in Regenerative Medicine
      • 1.6.2.2 Growing Investment in Personalized Medicine
      • 1.6.2.3 Technological Advancements in Cell Sheet Therapy
    • 1.6.3 Market Restraints
      • 1.6.3.1 Rising Cost of Development and Manufacturing
    • 1.6.4 Market Opportunities
      • 1.6.4.1 Substantial Surge in the Rise of Cell Sheet Approaches
      • 1.6.4.2 Rising Application for Localized and Minimally Invasive Treatments
  • 1.7 Market Challenges
    • 1.7.1 Regulatory Approval and Ethical Issues

2 Cell Sheet-based Gene Therapy Market (Technology Type), Value ($million), 2023-2035

  • 2.1 Cell Sheet-based Engineering Techniques
    • 2.1.1 Light-Induced Cell Technology
    • 2.1.2 Temperature-Responsive Culture Surfaces
    • 2.1.3 Scaffold-Free Techniques
    • 2.1.4 Layer-by-Layer Assembly
    • 2.1.5 Other Techniques
  • 2.2 Gene Delivery Methods
    • 2.2.1 Viral-Vector based
    • 2.2.2 Non-Viral Vector based
    • 2.2.3 CRISP/Cas9
    • 2.2.4 Other Methods

3 Cell Sheet-based Gene Therapy Market (Source Type), Value ($million), 2023-2035

  • 3.1 Autologous
  • 3.2 Allogenic (''of the shelf'' Product)
  • 3.3 Stem-Cell Derived

4 Cell Sheet-based Gene Therapy Market (Cell Sheet Type), Value ($million), 2023-2035

  • 4.1 Monolayered Cell Sheet Type
  • 4.2 Co-Cultured Cell Sheet Type
  • 4.3 Multilayered Cell Sheet Type
  • 4.4 Other Cell Sheet Type

5 Cell Sheet-based Gene Therapy Market (Application Type), Value ($million), 2023-2035

  • 5.1 Application Overview
  • 5.2 Oncology
  • 5.3 Ophthalmology
  • 5.4 Genetic Disorders
  • 5.5 Cardiology
  • 5.6 Other Applications

6 Cell Sheet-based Gene Therapy Market (End User), Value ($million), 2023-2035

  • 6.1 Hospitals and Clinics
  • 6.2 Research and Academic Institutions
  • 6.3 Biotech and Pharma Companies
  • 6.4 Other End Users

7 Global Cell Sheet-based Gene Therapy Market (by Region), Value ($million), 2023-2035

  • 7.1 Regional Summary
  • 7.2 North America
    • 7.2.1 Regional Overview
    • 7.2.2 Driving Factors for Market Growth
    • 7.2.3 Factors Challenging the Market
    • 7.2.4 U.S.
    • 7.2.5 Canada
  • 7.3 Europe
    • 7.3.1 Regional Overview
    • 7.3.2 Driving Factors for Market Growth
    • 7.3.3 Factors Challenging the Market
    • 7.3.4 U.K.
    • 7.3.5 France
    • 7.3.6 Germany
    • 7.3.7 Italy
    • 7.3.8 Spain
    • 7.3.9 Rest-of-Europe
  • 7.4 Asia-Pacific
    • 7.4.1 Regional Overview
    • 7.4.2 Driving Factors for Market Growth
    • 7.4.3 Factors Challenging the Market
    • 7.4.4 Japan
    • 7.4.5 China
    • 7.4.6 India
    • 7.4.7 Australia
    • 7.4.8 South Korea
    • 7.4.9 Rest-of-Asia-Pacific
  • 7.5 Rest-of-the-World
    • 7.5.1 Regional Overview
    • 7.5.2 Driving Factors for Market Growth
    • 7.5.3 Factors Challenging the Market

8 Markets - Competitive Benchmarking & Company Profiles

  • 8.1 Abeona Therapeutics Inc.
    • 8.1.1 Overview
    • 8.1.2 Top Products/Product Portfolio
    • 8.1.3 Top Competitors
    • 8.1.4 Target Customers
    • 8.1.5 Strategic Positioning and Market Impact
    • 8.1.6 Analyst View
    • 8.1.7 Pipeline and Research Initiatives
  • 8.2 Emmaus Medical, Inc
    • 8.2.1 Overview
    • 8.2.2 Top Products/Product Portfolio
    • 8.2.3 Top Competitors
    • 8.2.4 Strategic Positioning and Market Impact
    • 8.2.5 Key Personal
    • 8.2.6 Analyst View
    • 8.2.7 Research Initiatives
  • 8.3 CellSeed Inc.
    • 8.3.1 Overview
    • 8.3.2 Top Products/Product Portfolio
    • 8.3.3 Top Competitors
    • 8.3.4 Target Customers
    • 8.3.5 Strategic Positioning and Market Impact
    • 8.3.6 Analyst View
    • 8.3.7 Research Initiatives
  • 8.4 Fujifilm Cellular Dynamics, Inc. (FCDI) (FUJIFILM Holdings Corporation)
    • 8.4.1 Overview
    • 8.4.2 Top Products/Product Portfolio
    • 8.4.3 Top Competitors
    • 8.4.4 Target Customers
    • 8.4.5 Strategic Positioning and Market Impact
    • 8.4.6 Analyst View
    • 8.4.7 Research Initiatives
  • 8.5 Japan Tissue Engineering Co. Ltd.
    • 8.5.1 Overview
    • 8.5.2 Top Products/Product Portfolio
    • 8.5.3 Top Competitors
    • 8.5.4 Target Customers
    • 8.5.5 Strategic Positioning and Market Impact
    • 8.5.6 Analyst View
    • 8.5.7 Pipeline and Research Initiatives
  • 8.6 Foundation ENEA Tech Biomedical
    • 8.6.1 Overview
    • 8.6.2 Top Products/Product Portfolio
    • 8.6.3 Top Competitors
    • 8.6.4 Target Customers
    • 8.6.5 Strategic Positioning and Market Impact
    • 8.6.6 Analyst View
    • 8.6.7 Pipeline and Research Initiatives

9 Research Methodology

  • 9.1 Data Sources
    • 9.1.1 Primary Data Sources
    • 9.1.2 Secondary Data Sources
    • 9.1.3 Inclusion and Exclusion
    • 9.1.4 Data Triangulation
  • 9.2 Market Estimation and Forecast
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