歐洲基於細胞片的基因治療市場：按技術類型、細胞片類型、來源、用途、最終用戶和國家進行分析（2025-2035年）

歐洲以細胞片為基礎的基因治療市場預計將從2024年的2.196億美元成長到2035年的9.26億美元，預測期內的年複合成長率為 13.98%。

在歐洲，領先的生物技術公司和再生醫學領域的先驅企業的存在對市場格局產生重大影響。尤其值得注意的是，ENEA Tech Biomedical 在2023年 12月收購 Holostem Srl 後，已成為市場的關鍵驅動力。 Holoclar 由 Holostem 研發，是一種突破性的角膜再生治療方法，使其成為歐洲首家致力於基於上皮幹細胞創新療法的生物技術公司。 ENEA 透過建立一個連結轉化研究與臨床應用的國家級中心，進一步增強該地區的生物醫學能力。此外，ENEA 還注重產業擴充性，並促進公私合營關係。

隨著個人化醫療需求的不斷成長以及細胞治療和再生醫學的不斷進步，歐洲基於細胞片的基因治療市場不斷擴大。這種新治療方法無需支架，將活細胞加工成細胞片，用於組織修復和基因轉移，在治療角膜損傷、心臟疾病、食道損傷、皮膚病和其他疾病方面具有巨大潛力。

歐洲蓬勃發展的生物製藥產業、大學研究生態系統以及歐洲藥品管理局（EMA）先進療法藥物（ATMP）體系下的支持性法規環境，幫助加速創新和市場推廣。德國、英國和義大利被認為是轉化研究和臨床試驗領域的領先國家。商業化過程也得益於運輸、冷凍保存和精密細胞片製造技術的支援。

然而，該市場確實面臨挑戰，包括自體療法擴充性、GMP合規性複雜性以及高昂的開發和製造成本。儘管如此，對生物技術平台的持續投資、日益壯大的公私合作夥伴關係以及創傷治療、循環系統和眼科領域適應症的擴大預計將推動其長期成長。隨著更多治療方法在臨床研發管線中取得進展並獲得EMA核准，歐洲預計將成為下一代細胞基因療法解決方案的主要樞紐。

市場區隔:

細分1：依技術類型

• 細胞片層工程
  • 光誘導細胞片技術
  • 溫度回應培養表面
  • 無支架技術
  • 逐層組裝
  • 其他技術
• 基因轉移方法
  • 基於病毒載體的方法（例如慢病毒、腺病毒）
  • 非病毒載體方法（例如脂質體、奈米粒子）
  • CRISPR/Cas9
  • 其他基因轉移方法

細分2：依細胞片類型

• 單層細胞片
• 共培養細胞片
• 多層細胞片
• 其他

細分3：依來源地

• 自體
• 同源
• 幹細胞衍生

細分 4：依應用

• 腫瘤
• 眼科
• 遺傳性疾病
• 心臟病
• 其他

細分 5：依最終用戶

• 醫院和診所
• 研究和學術機構
• 生物技術和製藥公司
• 其他

細分6：依地區

• 歐洲
  • 德國
  • 英國
  • 法國
  • 義大利
  • 西班牙
  • 其他

本報告調查了歐洲基於細胞片的基因治療市場，並總結了關鍵趨勢、市場影響因素分析、法律制度、技術和專利分析、市場規模趨勢和預測、各個細分市場、地區/主要國家的詳細分析、競爭格局以及主要企業的概況。

目錄

執行摘要

範圍和定義

第1章 歐洲基於細胞片的基因治療市場：產業展望

• 歐洲細胞片基因治療市場趨勢
  • 再生醫學與基因工程的新融合
• 認證核可藥、利用細胞片層的基因治療
• 研發藥物、利用細胞片層的基因治療
• 監管狀況
  • 歐洲
• 市場動態
  • 趨勢、促進因素、挑戰和機會：評估當前和未來的影響
  • 市場促進因素
  • 市場限制
  • 市場機會
• 市場挑戰
  • 核准和道德問題

第2章 細胞片基因治療市場（依地區）

• 區域摘要
• 歐洲
  • 區域概況
  • 市場成長動力
  • 市場問題
  • 英國
  • 法國
  • 德國
  • 義大利
  • 西班牙
  • 其他

第3章 市場：競爭基準化分析與公司概況

• Foundation ENEA Tech Biomedical
  • 概述
  • 熱門商品/產品系列
  • 主要競爭對手
  • 目標客戶
  • 策略定位與市場影響
  • 分析師觀點
  • 管道和研究舉措

第4章 調查方法

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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
  • 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.

Table of Contents

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