Regenerative Medicine Landscape

  • ID: 4421393
  • Report
  • 103 pages
  • Datamonitor Healthcare
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The competitive landscape for regenerative medicine continues to evolve. As private sector investment in active players continues, efforts by governments in the US and EU are helping to advance the field, including the recent passage of the 21st Century Cures Act in the US, providing a special status pathway for regenerative medicine advanced therapies. Over the past five years, deal-making has occurred at a rapid pace, and regenerative medicine-focused biotech companies have drawn top dollar in both partnering and mergers and acquisitions.

The regenerative medicine market is undergoing many changes, and involves several modalities, from cell and gene therapies, to gene editing technologies, and tissue regeneration products. Devices, including tissue engineering products, currently dominate the marketed regenerative medicine portfolio, but this is expected to change as the pipeline for pharmaceuticals, namely cell and gene therapies, numbers in the thousands and includes a strong Phase II program as well as many novel candidates awaiting approval.

For the purposes of this report, the regenerative medicine market is broadly divided into device and therapy categories in the Key Company Players in Regenerative Medicine, Regenerative Medicine Approved Product Trends, and Regenerative Medicine Pipeline Trends chapters, followed by further market segmentation. The regenerative medicine device category includes biologic bone regenerative and repair devices, biologic soft tissue regeneration and repair devices, musculoskeletal scaffolds, and other tissue engineering products. The regenerative medicine therapy category covers cell therapies, gene therapies, and gene editing.
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1 EXECUTIVE SUMMARY

2 THE REGENERATIVE MEDICINE LANDSCAPE
  • Both the US and EU have specialized pathways for regenerative medicines
  • Modalities in regenerative medicine
  • Bibliography
3 KEY COMPANY PLAYERS IN REGENERATIVE MEDICINE
  • Across the marketed product portfolio, many players are emerging as leaders
  • Active developers in the pipeline include large and small companies
  • Bibliography
4 REGENERATIVE MEDICINE APPROVED PRODUCT TRENDS
  • Marketed products in regenerative medicine are dominated by devices
  • Bone grafts and cell therapies account for the largest concentration of marketed regenerative medicines
  • Musculoskeletal conditions lead the indications for approved or launched regenerative medicines
  • Availability of launched regenerative medicine products varies between therapies and devices
  • Bibliography
5 REGENERATIVE MEDICINE PIPELINE TRENDS
  • The pipeline is being driven by cell and gene therapies
  • Devices in development span multiple product types, but tend to focus on bone fractures and defects
  • Early-stage research is supporting regenerative medicine therapies
  • Noteworthy regenerative medicines are on the brink of approval
  • In vivo gene therapies represent nearly one-third of the regenerative medicine pharmaceuticals pipeline
  • The majority of regenerative medicines are in development for cancer or rare diseases
  • The regenerative medicine product type employed varies across therapy areas
  • Bibliography
6 DEAL-MAKING TRENDS IN REGENERATIVE MEDICINE
  • Regenerative medicine financing trends
  • Regenerative medicine mergers and acquisitions trends
  • Regenerative medicine alliances trends
  • Bibliography
7 APPENDIX
  • Scope
  • Methodology
List of Figures
Figure 1: Multiple modalities in regenerative medicine
Figure 2: Active regenerative medicine device developers with approved or launched products
Figure 3: Active regenerative medicine therapy developers with approved or launched products
Figure 4: Active regenerative medicine device developers in the pipeline
Figure 5: Active regenerative medicine therapy developers in the pipeline, preclinical to pre-registration
Figure 6: Celprogen's regenerative medicine pipeline by indication, May 2017
Figure 7: Devices comprise the majority of approved regenerative medicines
Figure 8: Global regenerative medicine approvals/launches, 2000-17*
Figure 9: Marketed regenerative medicine devices by product type
Figure 10: Marketed regenerative medicine therapies by product type
Figure 11: Leading indications among marketed regenerative medicine devices
Figure 12: Therapy area breakdown of marketed regenerative medicine therapies
Figure 13: Leading indications among marketed regenerative medicine therapies
Figure 14: The majority of regenerative medicine devices are available in North America
Figure 15: Approved/launched regenerative medicine devices by country/region
Figure 16: Asia-Pacific region leads in regenerative medicine therapy approvals/launches
Figure 17: Approved/launched regenerative medicine therapies globally
Figure 18: Approved/launched regenerative medicine therapies by country
Figure 19: Therapies comprise the majority of the regenerative medicine pipeline
Figure 20: Pipeline regenerative medicine devices by product type
Figure 21: Leading indications among pipeline regenerative medicine devices
Figure 22: Steady growth in the regenerative medicine therapy pipeline, 1995-2017
Figure 23: Proportion of the regenerative medicine pipeline by phase, 1995-2017
Figure 24: Phase status of ongoing clinical trials in regenerative medicine, May 2017
Figure 25: Regenerative medicine clinical trial activity by country, May 2017
Figure 26: Outcomes for completed regenerative medicine trials show most are successful, May 2017
Figure 27: Primary reasons for the termination of regenerative medicine clinical trials, May 2017
Figure 28: Pipeline regenerative medicine therapies by product type
Figure 29: Therapy area breakdown of pipeline regenerative medicine therapies, preclinical to pre-registration
Figure 30: Leading indications among pipeline regenerative medicine pharmaceuticals, preclinical to pre-registration
Figure 31: Treatment modalities vary across diseases in the regenerative medicine pipeline
Figure 32: Regenerative medicine financing activity by volume, 2012-16
Figure 33: Regenerative medicine financing activity by total deal value, 2012-16
Figure 34: Regenerative medicine M&A volume and value, 2012-16
Figure 35: Regenerative medicine M&A volume by modality, 2012-16
Figure 36: Biotech companies are the most active acquirers in regenerative medicine, 2012-16
Figure 37: Regenerative medicine partnerships by volume, 2012-16
Figure 38: Regenerative medicine partnerships by total deal value, 2012-16
Figure 39: Biotech-biotech collaborations dominate regenerative medicine partnerships, 2012-16
Figure 40: Active large company partners in regenerative medicine alliances, 2012-16

List of Tables
Table 1: US RMAT designations, June 2017
Table 2: EU regenerative medicine ATMP designations, June 2017
Table 3: Regenerative medicine device portfolios of the most active companies, May 2017
Table 4: Regenerative medicine device pipelines of the most active companies, May 2017
Table 5: Novartis's regenerative medicine pipeline, May 2017
Table 6: Takeda's regenerative medicine pipeline, May 2017
Table 7: Sanofi's regenerative medicine pipeline, May 2017
Table 8: Regenerative medicines awaiting approval worldwide, May 2017
Table 9: Top venture financings in regenerative medicine, 2012-16
Table 10: Top 10 regenerative medicine M&As, 2012-16
Table 11: Regenerative medicine partnerships worth $1bn or higher, 2012-16
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