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Regenerative Medicine - The Future of Therapy (TechVision)

Regenerative Medicine - The Future of Therapy (TechVision)

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.

  • Executive Summary
    • Research Scope: Depicting the Future of Therapy
    • Research Framework: Value of Innovation
    • Research Methodology: The Core Value
    • Key Facts and Findings: Patents as the Vital Component
    • Key Elements of Analysis: Finding the Best Approach
  • Technology Snapshot and Trends
    • Technology Segmentation: The Four Therapies
    • Key Innovations: Perfect Scenario for Tech Synergy
    • Key Approaches: CAR-T Cell Calling Most Attention
  • Environmental Analysis
    • Innovation Ecosystem: Focus on Public/Private Cooperation
    • Breadth of Industries: The Road Beyond Therapeutics
    • Global Responsibility Environment: Building Values
    • Technology/Business Accelerators: Stem Cells are Attracting Maximum Attention
    • Technology/Business Challenges: There is the Need for Setting Common Standards
    • Technology/Business Trends: Prevalence of Strategic Advisory Bodies
  • Value Chain Assessment
    • Regenerative Medicine Value Chain: Strong Public and Private Investment
    • Repercussions in Business and Processes: New Business Models and Manufacturing Strategies
    • Emerging Business Models in Regenerative Medicine: The Six Pathways to Follow
    • Value Chain Interactive Model: The Six Key Elements of Interaction
    • Supply Chain Management: From Cell Collection to Therapy Administration and Surveillance
    • Manufacturing Workflow for Allogeneic Products: Scaleup-based, On-demand Production
    • Manufacturing Workflow for Autologous Products: Patient-centered, Clinic-specific Production
    • Manufacturing Workflow for Decellularized Products: Off-the-shell Production
    • Manufacturing Workflow for 3D Bioprinted Products: Between Off-the-shell and Customized Production
  • Impact Assessment and Strategic Analysis
    • New Initiatives: The Japan's Post Market Surveillance Strategy
    • Legal Framework: Safety and Promotion Act for Regenerative Medicine
    • Product Development and Commercialization: Conditional Approval Strategy
    • Time to Market: Conventional Product Cycle Time
    • Time to Market: Post Market Surveillance Cycle Time
    • Industry Interaction Strategy: The Case of Japan
    • Industry Interaction Strategy: Key Players Across Industries in Japan
    • Key Global Strategic Agreements: uniQure N.V. and Bristol-Myers Squibb in Billionaire Collaboration
    • Key Initial Public Offerings: Spark Therapeutics Raises $185.2 Million in IPO
  • Innovation Potential and Clinical Translation
    • Key Positions: Customer Niches and Biovalue Creation
    • Pipeline Regional Distribution: North America is the Largest Developer
    • Pipeline Therapeutic Distribution: The Diverse World of Applications and Commercialization Opportunities
    • Regenerative Medicine Pipeline: Celyad to Complete Phase III for Congestive Heart Failure
    • Regenerative Medicine Pipeline: Mesoblast to Launch MLCs for Rheumatoid Arthritis
    • Regenerative Medicine Pipeline: uniQure to Launch In Vivo Gene Therapy for Hemophilia B
  • Industry Landscape and Market Trends
    • Market Potential: The global regenerative medicine market to rise at a CAGR of 22.4% from 2015-2025
    • Market Segmentation: Immune Cellular Therapy at the Front
    • Funding and Investment Trends: Operations Duplicated in the Past Two Years
    • Market Impact and Opportunities: Massive Investment in World Class-accredited Manufacturing Facilities
    • Targeted Therapeutic Areas: Tissue Engineering One of the Main Target Areas
    • Global Footprint: North America Advances Industry Development
    • Intellectual Property Landscape
    • Patent Publishing Trends
    • Top Assignees
    • Top International Patent Offices
    • Key Questions for Success
  • Industry Best Practices and Strategic Insights
    • The Road Ahead: Innovation Model Driving Regenerative Medicine
    • The Road Ahead: Open Collaboration Models to Lead Developments in Selected Areas
    • The Road Ahead: Increasingly Intelligent Manufacturing Processes in the Value Chain
    • Mergers and Acquisitions Model: The Case of Fujifilm Corporation
    • Science Driven Model: The Case of Osiris Therapeutics
    • IP and Manufacturing Model: The Case of Pluristem Therapeutics
    • Clinical and Financial De-risking Model : The Case of BioTime
  • Performance Benchmarking and Strategic Recommendations
    • Multicriteria Approach for Benchmarking
    • Multicriteria Approach for Benchmarking: Strategic Portfolio Management
    • Multicriteria Approach for Benchmarking: Level 0 Criteria
    • Multicriteria Approach for Benchmarking Level 1 Criteria: Research and Development
    • Multicriteria Approach for Benchmarking Level 1 Criteria: Financial Support and Funding
    • Multicriteria Approach for Benchmarking Level 1 Criteria: Market Landscape
    • Multicriteria Approach for Benchmarking: Level 2 Criteria
    • Multicriteria Approach Analytic Results
    • Multicriteria Approach Final Remarks
    • Assessment of Strategies
    • Assessment of Strategic Cases
    • Final Remarks
  • Appendix
    • Key Companies in North America
    • Key Companies in Europe
    • Key Companies in Asia-Pacific
    • Key Industry Influencers
    • Key Granted Patents

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