欧州の細胞シートによる遺伝子治療市場：技術タイプ・細胞シートタイプ・由来・用途・エンドユーザー・国別分析 (2025-2035年)

欧州の細胞シートによる遺伝子治療の市場規模は、2024年の2億1,960万米ドルから、予測期間中はCAGR 13.98%で推移し、2035年には9億2,600万米ドルに成長すると予測されています。

欧州では、主要なバイオテクノロジー企業や再生医療の先駆者たちの存在が同市場の形成に大きな影響を与えています。特に注目すべきは、2023年12月にHolostem S.r.l.を買収したことにより、ENEA Tech Biomedicalが主要な推進力として台頭している点です。Holostemが開発したHoloclarは、角膜再生のための画期的な治療法であり、上皮幹細胞に基づく革新的な治療に専念する初の欧州バイオテク企業として注目を集めました。ENEAは、トランスレーショナルリサーチと臨床応用をつなぐ国内の拠点を整備することで、地域のバイオメディカル分野の能力をさらに強化しています。また、産業化の拡張性を重視し、官民連携の育成にも取り組んでいます。

欧州の細胞シートによる遺伝子治療市場は、個別化医療へのニーズの高まりと、細胞治療および再生医療の進展が融合する中で拡大しています。この新しい治療法は、生きた細胞を足場なしでシート状に加工して組織修復や遺伝子導入に用いるものであり、角膜損傷、心疾患、食道損傷、皮膚疾患などの治療に大きな可能性を秘めています。

欧州の強固なバイオ医薬品産業や大学の研究エコシステム、EMA (欧州医薬品庁) の先進治療医薬品 (ATMP) 制度による支援的な規制環境がイノベーションと市場導入の加速を後押ししています。ドイツ、英国、イタリアは、トランスレーショナルリサーチおよび臨床試験において先進的な国々とされています。また、繊細な細胞シートの輸送、凍結保存、精密製造を可能にする技術も、商業化の取り組みを支えています。

一方で、この市場には課題も存在します。自己由来治療における拡張性の制限、複雑なGMP遵守、高額な開発・製造コストなどが障壁となっています。それでも、バイオテクノロジー基盤への継続的な投資、公民連携の拡大、創傷治癒・循環器・眼科領域における適応拡大によって、長期的な成長が見込まれます。今後、さらなる治療法が臨床パイプラインを経てEMAの承認を受けるにつれ、欧州は次世代の細胞ベース遺伝子治療ソリューションの一大拠点となることが期待されています。

市場の分類：

セグメンテーション1：技術タイプ別

• 細胞シートによる工学技術
  • 光誘導型細胞シート技術
  • 温度応答性培養表面
  • 足場不要技術 (スキャフォールドフリー)
  • レイヤーバイレイヤー組立法
  • その他の技術
• 遺伝子導入法
  • ウイルスベクターによる方法 (例：レンチウイルス、アデノウイルス)
  • 非ウイルスベクターによる方法 (例：リポソーム、ナノ粒子)
  • CRISPR/Cas9
  • その他の遺伝子導入法

セグメンテーション2：細胞シートタイプ別

• 単層細胞シート
• 共培養細胞シート
• 多層細胞シート
• その他

セグメンテーション3：由来別

• 自家由来
• 同種由来
• 幹細胞由来

セグメンテーション4：用途別

• 腫瘍
• 眼科
• 遺伝子疾患
• 心臓病
• その他

セグメンテーション5：エンドユーザー別

• 病院および診療所
• 研究・学術機関
• バイオテクノロジーおよび製薬会社
• その他

セグメンテーション6：地域別

• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他

当レポートでは、欧州の細胞シートによる遺伝子治療の市場を調査し、主要動向、市場影響因子の分析、法規制環境、技術・特許の分析、市場規模の推移・予測、各種区分・地域/主要国別の詳細分析、競合情勢、主要企業のプロファイルなどをまとめています。

目次

エグゼクティブサマリー

範囲と定義

第1章 欧州の細胞シートによる遺伝子治療市場：業界展望

• 欧州の細胞シートによる遺伝子治療市場の動向
  • 再生医療と遺伝子工学の新たな融合
• 承認薬、細胞シートによる遺伝子治療
• パイプライン医薬品、細胞シートによる遺伝子治療
• 規制状況
  • 欧州
• 市場力学
  • 動向、促進要因、課題、機会：現在および将来の影響評価
  • 市場促進要因
  • 市場抑制要因
  • 市場機会
• 市場の課題
  • 規制当局の承認と倫理的問題

第2章 細胞シートによる遺伝子治療市場：地域別

• 地域サマリー
• 欧州
  • 地域概要
  • 市場成長の原動力
  • 市場課題
  • 英国
  • フランス
  • ドイツ
  • イタリア
  • スペイン
  • その他

第3章 市場：競合ベンチマーキングと企業プロファイル

• Foundation ENEA Tech Biomedical
  • 概要
  • トップ製品/製品ポートフォリオ
  • 主要競合
  • ターゲット顧客
  • 戦略的ポジショニングと市場への影響
  • アナリストの見解
  • パイプライン・研究イニシアチブ

第4章 調査手法

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

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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