欧洲基于细胞片的基因治疗市场：按技术类型、细胞片类型、来源、用途、最终用户和国家进行分析（2025 年至 2035 年）

欧洲以细胞片为基础的基因治疗市场预计将从 2024 年的 2.196 亿美元成长到 2035 年的 9.26 亿美元，预测期内的复合年增长率为 13.98%。

在欧洲，领先的生物技术公司和再生医学领域的先驱企业的存在正在对市场格局产生重大影响。尤其值得注意的是，ENEA Tech Biomedical 在 2023 年 12 月收购 Holostem Srl 后，已成为市场的关键驱动力。 Holoclar 由 Holostem 研发，是一种突破性的角膜再生治疗方法，使其成为欧洲首家致力于基于上皮干细胞创新疗法的生物技术公司。 ENEA 正在透过建立一个连结转化研究与临床应用的国家级中心，进一步增强该地区的生物医学能力。此外，ENEA 还注重产业扩充性，并促进公私合营关係。

随着个人化医疗需求的不断增长以及细胞治疗和再生医学的不断进步，欧洲基于细胞片的基因治疗市场正在不断扩大。这种新治疗方法无需支架，将活细胞加工成细胞片，用于组织修復和基因转移，在治疗角膜损伤、心臟疾病、食道损伤、皮肤病和其他疾病方面具有巨大潜力。

欧洲蓬勃发展的生物製药产业、大学研究生态系统以及欧洲药品管理局 (EMA) 先进疗法药物 (ATMP) 体系下的支持性法规环境，正在帮助加速创新和市场推广。德国、英国和义大利被认为是转化研究和临床试验领域的领先国家。商业化过程也得益于运输、冷冻保存和精密细胞片製造技术的支援。

然而，该市场确实面临挑战，包括自体疗法扩充性、GMP合规性复杂性以及高昂的开发和製造成本。儘管如此，对生物技术平台的持续投资、日益壮大的公私合作伙伴关係以及创伤治疗、循环系统和眼科领域适应症的扩大预计将推动其长期成长。随着更多治疗方法在临床研发管线中取得进展并获得EMA核准，欧洲预计将成为下一代细胞基因疗法解决方案的主要枢纽。

市场区隔:

细分一：按技术类型

• 细胞片层工程
  • 光诱导细胞片技术
  • 温度响应培养表面
  • 无支架技术
  • 逐层组装
  • 其他技术
• 基因转移方法
  • 基于病毒载体的方法（例如慢病毒、腺病毒）
  • 非病毒载体方法（例如脂质体、奈米粒子）
  • CRISPR/Cas9
  • 其他基因转移方法

细分2：按细胞片类型

• 单层细胞片
• 共培养细胞片
• 多层细胞片
• 其他的

细分3：按来源地

• 自体
• 同源
• 干细胞衍生

细分 4：按应用

• 瘤
• 眼科
• 遗传性疾病
• 心臟病
• 其他的

细分 5：按最终用户

• 医院和诊所
• 研究和学术机构
• 生物技术和製药公司
• 其他的

细分6：按地区

• 欧洲
  • 德国
  • 英国
  • 法国
  • 义大利
  • 西班牙
  • 其他的

本报告调查了欧洲基于细胞片的基因治疗市场，并总结了关键趋势、市场影响因素分析、法律制度、技术和专利分析、市场规模趋势和预测、各个细分市场、地区/主要国家的详细分析、竞争格局以及主要企业的概况。

目录

执行摘要

范围和定义

第一章欧洲基于细胞片的基因治疗市场：产业展望

• 欧洲细胞片基因治疗市场趋势
  • 再生医学与基因工程的新融合
• 认证核可药、利用细胞片层的基因治疗
• 研发药物、利用细胞片层的基因治疗
• 监管状况
  • 欧洲
• 市场动态
  • 趋势、驱动因素、挑战和机会：评估当前和未来的影响
  • 市场驱动因素
  • 市场限制
  • 市场机会
• 市场挑战
  • 核准和道德问题

第二章 细胞片基因治疗市场（按地区）

• 区域摘要
• 欧洲
  • 区域概况
  • 市场成长动力
  • 市场问题
  • 英国
  • 法国
  • 德国
  • 义大利
  • 西班牙
  • 其他的

第三章市场：竞争基准化分析与公司概况

• Foundation ENEA Tech Biomedical
  • 概述
  • 热门商品/产品系列
  • 主要竞争对手
  • 目标客户
  • 策略定位与市场影响
  • 分析师观点
  • 管道和研究倡议

第四章调查方法

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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