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市場調查報告書

再生醫學 - 療法的未來

Regenerative Medicine - The Future of Therapy

出版商 Technical Insights (Frost & Sullivan) 商品編碼 369100
出版日期 內容資訊 英文 133 Pages
商品交期: 最快1-2個工作天內
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再生醫學 - 療法的未來 Regenerative Medicine - The Future of Therapy
出版日期: 2016年07月07日 內容資訊: 英文 133 Pages
簡介

在經歷漫長的基礎研究之後,再生醫學終於達成了醫療照護中最了不起的技術創新革命。組合了幹細胞技術原理及組織工程,並在先進生物材料中加入了小分子及生物製劑,再生醫學手段可替換、再生並回復人體組織及器官功能,顯然成為最有相乘效果價值的技術。

本報告以再生醫學的全球市場為調查對象,聚焦於其技術藍圖、動向、能力、標的應用,以及利害關係人的活動、影響、產業構想、投資環境、支援體制,乃至於地區性及國際法規環境、為了克服挑戰在標準化方面的努力等面向,並包含為了特定用途的技術基準評價分析,一同探索市場的現況及最新動態。

第1章 執行摘要

  • 調查範圍 - 描繪醫學治療的未來
  • 調查大綱:技術革新的價值
  • 調查方法 - 核心價值
  • 重要因素及發現:病患是最重要的因素
  • 分析的重要元素 - 找到最好的方法

第2章 技術概要與動向

  • 技術區隔 - 四大療法
  • 重要技術革新 - 技術達到相乘效果的理想方案
  • 重要方法 - 聚集最多目光的CAR-T細胞療法

第3章 環境分析

  • 技術革新生態系統 - 公私合作的重視
  • 產業的拓展 - 超越療法之路
  • 全球責任環境 - 價值的構築
  • 技術、商業的加速要因 - 幹細胞技術吸引最多注意
  • 技術、商業的加速要因 - 通用標準規格訂立的必要性
  • 技術、商業的方向性 - 策略性諮詢機構的確立

第4章 價值鏈評估

  • 再生醫療價值鏈 - 強力公私投資
  • 商業及流程的反響 - 新商業模型及生產策略
  • 再生醫療的新商業模型 - 6大方向
  • 價值鏈互動式模型 - 六大互動關鍵元素
  • 價值鏈管理 - 從細胞採收到治療實施甚至監視
  • 同種異體產品的生產流程 - 擴張型隨選生產
  • 同種異體產品的生產流程 - 以病患為中心,診所專科化生產
  • 去細胞產品的生產流程 - 市售商品生產
  • 3D生物印刷產品的生產流程 - 存於市售商品生產與客製化生產之間

第5章 影響評估及策略分析

  • 全新努力 - 日本上市後調查策略
  • 法規框架 - 再生醫療的安全及促進法
  • 產品開發與量產化 - 有附加條件的認證策略
  • 到商品化為止的所需時間 - 傳統產品週期
  • 到商品化為止的所需時間 - 上市後調查週期
  • 產業交互作用策略 - 日本
  • 產業交互作用策略 - 日本產業間主要參與企業
  • 重要國際策略協定 - 億萬富翁中uniQure N.V.與Bristol-Myers Squibb
  • 關鍵的第一次公開認購:甫上櫃就展現了1億8520萬美金股價漲勢的Spark Therapeutics

第6章 技術革新的發展性與臨床分析

  • 要點:顧客利基與生物價值的創造
  • 開發候補藥物的各地區分佈:最大開發國為美國
  • 開發候補藥物的各療法分佈:用途及商業化機會的多樣化世界
  • 再生醫療候補藥物 - 結束第三階段鬱血性心衰竭治療的Celyad
  • 再生醫療候補藥物 - Mesoblast導入MLC以治療類風濕性關節炎
  • 再生醫療候補藥物 - uniQure導入活體內基因療法以治療B型血友病

第7章 產業環境與市場動向

  • 市場的發展性 -在2015~2025年間,再生市場的全球規模將以年複合成長率 22.4%擴大
  • 市場分類 - 名列前茅的細胞免疫療法
  • 資金籌集與投資動向 - 過去兩年間沒有變化
  • 對市場的影響及機會 - 對具備世界級評鑑的生產設施之大型投資
  • 標的治療領域 - 主要標的領域之一的組織工程
  • 全球足跡 - 北美促進產業發產
  • 智慧財產權環境
  • 專利認證的趨勢
  • 頂尖代理人
    • 頂尖國際專利事務所
    • 為求成功的主要疑問

第8章 業界最佳實務與策略見解

  • 未來道路 - 促進再生醫療的技術革新模型
  • 未來道路 - 開放合作模型以領導特定領域的發展
  • 未來道路 - 在價值鏈內增加智慧生產流程
  • M&A模型 - 富士軟片公司的範例
  • 科學主導模型 - Osiris Therapeutics的範例
  • 智慧財產及生產模型 - Pluristem Therapeutics的範例
  • 迴避臨床及財務風險模型 - BioTime的範例

第9章 業績基準評價與策略建言

  • 業績基準評價的多準則方法
  • 業績基準評價的多準則方法 - 策略組合管理
  • 業績基準評價的多準則方法 - 層級0
  • 業績基準評價的多準則方法 - 層級1:研究開發
  • 業績基準評價的多準則方法 - 層級1:財務支援及資金籌集
  • 業績基準評價的多準則方法 - 層級1:市場環境
  • 業績基準評價的多準則方法 - 層級2
  • 多準則方法 - 分析結果
  • 多準則方法 - 結語
  • 策略評估
  • 策略案例的評估
  • 結語

第10章 附錄

  • 北美的主要企業
  • 歐洲的主要企業
  • 亞洲的主要企業
  • 產業主要影響因素
  • 重要的專利認證
  • 免責聲明

第11章 關於FROST & SULLIVAN

  • 關於FROST & SULLIVAN
  • 價值提案 - 貴公司與事業的未來
  • 全球觀點
  • 產業聚合
  • 全方位的調查觀點
  • 卓越的執行力
  • 本公司的藍海策略
目錄
Product Code: D6EC-01-00-00-00

After many years of basic research, regenerative medicine represents a remarkable foremost innovation in medical care. Comprising principles of stem cell technology and tissue engineering, also combining advanced biomaterials with small molecules and biologics, to replace or regenerate human tissues and organs and restore their functions, regenerative medicine approaches appears as the most valuable technological synergies.

Beyond the treatment option for acute injuries, chronic diseases and congenital malformations, regenerative medicine opens a plethora of opportunities in therapeutics, across multiple fields of research, including difficult-to-treat diseases and physically impaired tissues. Although still demanding more specialization for both scientists and clinicians, regenerative medicine is destined to address the most concerning challenges of the current medical therapies.

Significant financial support from both public and private funding sources is still needed for research and clinical innovation. Due to the impact of this technology in the healthcare sector, long-term vision and strategy are crucial to accelerate the development of novel therapies and to promote the stability of long-term established collaborations worldwide. Beyond financial and technical affairs, process development, manufacturing, and logistics, as well as, and intellectual protection concerns through patents and utility models, need to be essentially covered, for success.

This research service (RS) depicts the current landscape and the new trends in regenerative medicine, focusing on:

  • Technology roadmap, trends, capability, and applications targeted
  • Stakeholder activities, influence, industry initiatives, investment environment and support
  • Regional and global regulation landscape, standardization approaches for tackling challenges
  • Technology benchmarking for specific applications

An appendix is included, comprising lists with major participants in the study and most notable patents in the field.

Table of Contents

1. EXECUTIVE SUMMARY

  • 1. 1.1 Research Scope: Depicting the Future of Therapy
  • 2. 1.2 Research Framework: Value of Innovation
  • 3. 1.3 Research Methodology: The Core Value
  • 4. 1.4 Key Facts and Findings: Patents as the Vital Component
  • 5. 1.5 Key Elements of Analysis: Finding the Best Approach

2. TECHNOLOGY SNAPSHOT AND TRENDS

  • 1. 2.1 Technology Segmentation: The Four Therapies
  • 2. 2.2 Key Innovations: Perfect Scenario for Tech Synergy
  • 3. 2.3 Key Approaches: CAR-T Cell Calling Most Attention

3. ENVIRONMENTAL ANALYSIS

  • 1. 3.1 Innovation Ecosystem: Focus on Public/Private Cooperation
  • 2. 3.2 Breadth of Industries: The Road Beyond Therapeutics
  • 3. 3.3 Global Responsibility Environment: Building Values
  • 4. 3.4 Technology/Business Accelerators: Stem Cells Are Attracting Maximum Attention
  • 5. 3.5 Technology/Business Challenges: There is the Need for Setting Common Standards
  • 6. 3.6 Technology/Business Trends: Prevalence of Strategic Advisory Bodies

4. VALUE CHAIN ASSESSMENT

  • 1. 4.1 Regenerative Medicine Value Chain: Strong Public and Private Investment
  • 2. 4.2 Repercussions in Business and Processes: New Business Models and Manufacturing Strategies
  • 3. 4.3 Emerging Business Models in Regenerative Medicine: The Six Pathways to Follow
  • 4. 4.4 Value Chain Interactive Model: The Six Key Elements of Interaction
  • 5. 4.5 Supply Chain Management: From Cell Collection to Therapy Administration and Surveillance
  • 6. 4.6 Manufacturing Workflow for Allogeneic Products: Scale-up-based, On-demand Production
  • 7. 4.7 Manufacturing Workflow for Autologous Products: Patient-centered, Clinic-specific Production
  • 8. 4.8 Manufacturing Workflow for Decellularized Products: Off-the-shell Production
  • 9. 4.9 Manufacturing Workflow for 3D Bioprinted Products: Between Off-the-shell and Customized Production

5. IMPACT ASSESSMENT AND STRATEGIC ANALYSIS

  • 1. 5.1 New Initiatives: The Japan's Post Market Surveillance Strategy
  • 2. 5.2 Legal Framework: Safety and Promotion Act for Regenerative Medicine
  • 3. 5.3 Product Development and Commercialization: Conditional Approval Strategy
  • 4. 5.4 Time to Market: Conventional Product Cycle Time
  • 5. 5.5 Time to Market: Post Market Surveillance Cycle Time
  • 6. 5.6 Industry Interaction Strategy: The Case of Japan
  • 7. 5.7 Industry Interaction Strategy: Key Players across Industries in Japan
  • 8. 5.8 Key Global Strategic Agreements: uniQure N.V. and Bristol-Myers Squibb in Billionaire Collaboration
  • 9. 5.9 Key Initial Public Offerings: Spark Therapeutics Raises $185.2 Million in IPO

6. INNOVATION POTENTIAL AND CLINICAL TRANSLATION

  • 1. 6.1 Key Positions: Customer Niches and Biovalue Creation
  • 2. 6.2 Pipeline Regional Distribution: North America is the Largest Developer
  • 3. 6.3 Pipeline Therapeutic Distribution: The Diverse World of Applications and Commercialization Opportunities
  • 4. 6.4 Regenerative Medicine Pipeline: Celyad to Complete Phase III for Congestive Heart Failure
  • 5. 6.5 Regenerative Medicine Pipeline: Mesoblast to Launch MLCs for Rheumatoid Arthritis
  • 6. 6.6 Regenerative Medicine Pipeline: uniQure to Launch in Vivo Gene Therapy for Hemophilia B

7. INDUSTRY LANDSCAPE AND MARKET TRENDS

  • 1. 7.1 Market Potential: The Global Regenerative Medicine Market to Rise at a CAGR of 22.4% from 2015-2025
  • 2. 7.2 Market Segmentation: Immune Cellular Therapy at the Front
  • 3. 7.3 Funding and Investment Trends: Operations Duplicated in the past Two Years
  • 4. 7.4 Market Impact and Opportunities: Massive Investment in World Class-accredited Manufacturing Facilities
  • 5. 7.5 Targeted Therapeutic Areas: Tissue Engineering One of the Main Target Areas
  • 6. 7.6 Global Footprint: North America Advances Industry Development
  • 7. 7.7 Intellectual Property Landscape
  • 8. 7.8 Patent Publishing Trends
  • 9. 7.9 Top Assignees
  • 10. 7.10 Top International Patent Offices
  • 11. 7.11 Key Questions for Success

8. INDUSTRY BEST PRACTICES AND STRATEGIC INSIGHTS

  • 1. 8.1 The Road Ahead: Innovation Model Driving Regenerative Medicine
  • 2. 8.2 The Road Ahead: Open Collaboration Models to Lead Developments in Selected Areas
  • 3. 8.3 The Road Ahead: Increasingly Intelligent Manufacturing Processes in the Value Chain
  • 4. 8.4 Mergers and Acquisitions Model: The Case of Fujifilm Corporation
  • 5. 8.5 Science Driven Model: The Case of Osiris Therapeutics
  • 6. 8.6 IP and Manufacturing Model: The Case of Pluristem Therapeutics
  • 7. 8.7 Clinical and Financial De-risking Model : The Case of BioTime

9. PERFORMANCE BENCHMARKING AND STRATEGIC RECOMMENDATIONS

  • 1. 9.1 Multicriteria Approach for Benchmarking
  • 2. 9.2 Multicriteria Approach for Benchmarking: Strategic Portfolio Management
  • 3. 9.3 Multicriteria Approach for Benchmarking: Level 0 Criteria
  • 4. 9.4 Multicriteria Approach for Benchmarking Level 1 Criteria: Research and Development
  • 5. 9.5 Multicriteria Approach for Benchmarking Level 1 Criteria: Financial Support and Funding
  • 6. 9.6 Multicriteria Approach for Benchmarking Level 1 Criteria: Market Landscape
  • 7. 9.7 Multicriteria Approach for Benchmarking: Level 2 Criteria
  • 8. 9.8 Multicriteria Approach Analytic Results
  • 9. 9.9 Multicriteria Approach Final Remarks
  • 10. 9.10 Assessment of Strategies
  • 11. 9.11 Assessment of Strategic Cases
  • 12. 9.12 Final Remarks

10. APPENDIX

  • 1. 10.1 Key Companies in North America
  • 2. 10.1 Key Companies in North America (continued)
  • 3. 10.1 Key Companies in North America (continued)
  • 4. 10.1 Key Companies in North America (continued)
  • 5. 10.1 Key Companies in North America (continued)
  • 6. 10. 1 Key Companies in North America (continued)
  • 7. 10. 1 Key Companies in North America (continued)
  • 8. 10. 1 Key Companies in North America (continued)
  • 9. 10. 1 Key Companies in North America (continued)
  • 10. 10.1 Key Companies in North America (continued)
  • 11. 10.1 Key Companies in North America (continued)
  • 12. 10.1 Key Companies in North America (continued)
  • 13. 10.1 Key Companies in North America (continued)
  • 14. 10.1 Key Companies in North America (continued)
  • 15. 10.1 Key Companies in North America (continued)
  • 16. 10.1 Key Companies in North America (continued)
  • 17. 10.1 Key Companies in North America (continued)
  • 18. 10.1 Key Companies in North America (continued)
  • 19. 10.1 Key Companies in North America (continued)
  • 20. 10.1 Key Companies in North America (continued)
  • 21. 10.1 Key Companies in North America (continued)
  • 22. 10.2 Key Companies in Europe
  • 23. 10.2 Key Companies in Europe (continued)
  • 24. 10.2 Key Companies in Europe (continued)
  • 25. 10.2 Key Companies in Europe (continued)
  • 26. 10.2 Key Companies in Europe (continued)
  • 27. 10.2 Key Companies in Europe (continued)
  • 28. 10.2 Key Companies in Europe (continued)
  • 29. 10.2 Key Companies in Europe (continued)
  • 30. 10.2 Key Companies in Europe (continued)
  • 31. 10.3 Key Companies in Asia-Pacific
  • 32. 10.3 Key Companies in Asia-Pacific (continued)
  • 33. 10.3 Key Companies in Asia-Pacific (continued)
  • 34. 10.4 Key Industry Influencers
  • 35. 10.4 Key Industry Influencers (continued)
  • 36. 10.4 Key Industry Influencers (continued)
  • 37. 10.4 Key Industry Influencers (continued)
  • 38. 10.5 Key Granted Patents
  • 39. 10.5 Key Granted Patents (continued)
  • 40. 10.5 Key Granted Patents (continued)
  • 41. Legal Disclaimer

11. THE FROST & SULLIVAN STORY

  • 1. 11.1 The Frost & Sullivan Story
  • 2. 11.2 Value Proposition: Future of Your Company & Career
  • 3. 11.3 Global Perspective
  • 4. 11.4 Industry Convergence
  • 5. 11.5 360° Research Perspective
  • 6. 11.6 Implementation Excellence
  • 7. 11.7 Our Blue Ocean Strategy
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