Regenerative Medicine - The Future of Therapy (TechVision)

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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

1.0 Executive Summary1.1 Research Scope: Depicting the Future of Therapy1.2 Research Framework: Value of Innovation1.3 Research Methodology: The Core Value1.4 Key Facts and Findings: Patents as the Vital Component1.5 Key Elements of Analysis: Finding the Best Approach 2.0 Technology Snapshot and Trends2.1 Technology Segmentation: The Four Therapies2.2 Key Innovations: Perfect Scenario for Tech Synergy2.3 Key Approaches: CAR-T Cell Calling Most Attention3.0 Environmental Analysis3.1 Innovation Ecosystem: Focus on Public/Private Cooperation3.2 Breadth of Industries: The Road Beyond Therapeutics3.3 Global Responsibility Environment: Building Values3.4 Technology/Business Accelerators: Stem Cells Are Attracting Maximum Attention3.5 Technology/Business Challenges: There is the Need for Setting Common Standards3.6 Technology/Business Trends: Prevalence of Strategic Advisory Bodies4.0 Value Chain Assessment4.1 Regenerative Medicine Value Chain: Strong Public and Private Investment4.2 Repercussions in Business and Processes: New Business Models and Manufacturing Strategies4.3 Emerging Business Models in Regenerative Medicine: The Six Pathways to Follow4.4 Value Chain Interactive Model: The Six Key Elements of Interaction4.5 Supply Chain Management: From Cell Collection to Therapy Administration and Surveillance4.6 Manufacturing Workflow for Allogeneic Products: Scale-up-based, On-demand Production4.7 Manufacturing Workflow for Autologous Products: Patient-centered, Clinic-specific Production4.8 Manufacturing Workflow for Decellularized Products: Off-the-shell Production4.9 Manufacturing Workflow for 3D Bioprinted Products: Between Off-the-shell and Customized Production5.0 Impact Assessment and Strategic Analysis5.1 New Initiatives: The Japan’s Post Market Surveillance Strategy5.2 Legal Framework: Safety and Promotion Act for Regenerative Medicine5.3 Product Development and Commercialization: Conditional Approval Strategy 5.4 Time to Market: Conventional Product Cycle Time5.5 Time to Market: Post Market Surveillance Cycle Time 5.6 Industry Interaction Strategy: The Case of Japan5.7 Industry Interaction Strategy: Key Players across Industries in Japan5.8 Key Global Strategic Agreements: uniQure N.V. and Bristol-Myers Squibb in Billionaire Collaboration5.9 Key Initial Public Offerings: Spark Therapeutics Raises $185.2 Million in IPO6.0 Innovation Potential and Clinical Translation6.1 Key Positions: Customer Niches and Biovalue Creation 6.2 Pipeline Regional Distribution: North America is the Largest Developer6.3 Pipeline Therapeutic Distribution: The Diverse World of Applications and Commercialization Opportunities6.4 Regenerative Medicine Pipeline: Celyad to Complete Phase III for Congestive Heart Failure6.5 Regenerative Medicine Pipeline: Mesoblast to Launch MLCs for Rheumatoid Arthritis6.6 Regenerative Medicine Pipeline: uniQure to Launch in Vivo Gene Therapy for Hemophilia B7.0 Industry Landscape and Market Trends7.1 Market Potential: The Global Regenerative Medicine Market to Rise at a CAGR of 22.4% from 2015–20257.2 Market Segmentation: Immune Cellular Therapy at the Front7.3 Funding and Investment Trends: Operations Duplicated in the past Two Years7.4 Market Impact and Opportunities: Massive Investment in World Class-accredited Manufacturing Facilities 7.5 Targeted Therapeutic Areas: Tissue Engineering One of the Main Target Areas7.6 Global Footprint: North America Advances Industry Development7.7 Intellectual Property Landscape 7.8 Patent Publishing Trends7.9 Top Assignees7.10 Top International Patent Offices7.11 Key Questions for Success8.0 Industry Best Practices and Strategic Insights8.1 The Road Ahead: Innovation Model Driving Regenerative Medicine8.2 The Road Ahead: Open Collaboration Models to Lead Developments in Selected Areas8.3 The Road Ahead: Increasingly Intelligent Manufacturing Processes in the Value Chain8.4 Mergers and Acquisitions Model: The Case of Fujifilm Corporation8.5 Science Driven Model: The Case of Osiris Therapeutics8.6 IP and Manufacturing Model: The Case of Pluristem Therapeutics 8.7 Clinical and Financial De-risking Model : The Case of BioTime9.0 Performance Benchmarking and Strategic Recommendations9.1 Multicriteria Approach for Benchmarking 9.2 Multicriteria Approach for Benchmarking: Strategic Portfolio Management9.3 Multicriteria Approach for Benchmarking: Level 0 Criteria9.4 Multicriteria Approach for Benchmarking Level 1 Criteria: Research and Development9.5 Multicriteria Approach for Benchmarking Level 1 Criteria: Financial Support and Funding9.6 Multicriteria Approach for Benchmarking Level 1 Criteria: Market Landscape9.7 Multicriteria Approach for Benchmarking: Level 2 Criteria9.8 Multicriteria Approach Analytic Results9.9 Multicriteria Approach Final Remarks9.10 Assessment of Strategies9.11 Assessment of Strategic Cases9.12 Final Remarks10.0 Appendix10.1 Key Companies in North America10.1 Key Companies in North America (continued)10.1 Key Companies in North America (continued)10.1 Key Companies in North America (continued)10.1 Key Companies in North America (continued)10. 1 Key Companies in North America (continued)10. 1 Key Companies in North America (continued)10. 1 Key Companies in North America (continued)10. 1 Key Companies in North America (continued)10.1 Key Companies in North America (continued)10.1 Key Companies in North America (continued)10.1 Key Companies in North America (continued)10.1 Key Companies in North America (continued)10.1 Key Companies in North America (continued)10.1 Key Companies in North America (continued)10.1 Key Companies in North America (continued)10.1 Key Companies in North America (continued)10.1 Key Companies in North America (continued)10.1 Key Companies in North America (continued)10.1 Key Companies in North America (continued)10.1 Key Companies in North America (continued)10.2 Key Companies in Europe10.2 Key Companies in Europe (continued)10.2 Key Companies in Europe (continued)10.2 Key Companies in Europe (continued)10.2 Key Companies in Europe (continued)10.2 Key Companies in Europe (continued)10.2 Key Companies in Europe (continued)10.2 Key Companies in Europe (continued)10.2 Key Companies in Europe (continued)10.3 Key Companies in Asia-Pacific10.3 Key Companies in Asia-Pacific (continued)10.3 Key Companies in Asia-Pacific (continued)10.4 Key Industry Influencers10.4 Key Industry Influencers (continued)10.4 Key Industry Influencers (continued)10.4 Key Industry Influencers (continued)10.5 Key Granted Patents10.5 Key Granted Patents (continued)10.5 Key Granted Patents (continued)Legal Disclaimer11.0 The Frost & Sullivan Story11.1 The Frost & Sullivan Story11.2 Value Proposition: Future of Your Company & Career11.3 Global Perspective11.4 Industry Convergence11.5 360º Research Perspective11.6 Implementation Excellence11.7 Our Blue Ocean Strategy




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