Cellular Therapy and Cord Blood Market Report 2013 Page 1. Kathy Gray Worldwide Market Reports & Consulting Coordinator Select Biosciences

Transcription

1 Cellular Therapy and Cord Blood Market Report 2013 Kathy Gray Worldwide Market Reports & Consulting Coordinator Select Biosciences Select Biosciences Market Reports Website: SelectBiosciences.com/marketreports/ Report Publication Date: February 2013 Cellular Therapy and Cord Blood Market Report 2013 Page 1

2 Legal Disclaimer and Terms of Use This Market Report is Copyright Protected by Select Biosciences Ltd. All rights reserved. Neither this Market Report nor its contents (in whole or in part) may be reproduced in any form without the expressed written consent of Select Biosciences by its authorized representative. For Questions or Technical Information, Please Contact Select Biosciences Ltd. Telephone: +44 (0) Terms of Use Governing This Market Report Select Biosciences has exercised commercially-reasonable efforts in the preparation of this market report ( Report ), which is based on information available to the public, proprietary technology/market analyses, and information submitted by companies and institutions. This Report is intended solely for internal use by the purchaser ( Purchaser ) for specific informational, research, or other business purposes. The Purchaser shall not reproduce, distribute, or provide to any third-party this Report (in whole or in part) without the prior written permission of Select Biosciences. SELECT BIOSCIENCES MAKES NO REPRESENTATIONS OR WARRANTIES AND EXPRESSLY DISCLAIMS ANY FURTHER REPRESENTATIONS OR WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, REGARDING THE REPORT, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. SELECT BIOSCIENCES SHALL NOT BE LIABLE TO THE PURCHASER FOR ANY CLAIM REGARDING THE ACCURACY OR COMPLETENESS OF THE INFORMATION CONTAINED IN THE REPORT. Under no circumstances shall Select Biosciences be liable for incidental, special, indirect, direct or consequential damages or loss of profits, interruption of business, or related expenses that may arise from use of this Report, including but not limited to those resulting from inaccuracy of the data therein. Due to the content natureofthismarketreport,noreturnsorrefundsofanykindare issued by Select Biosciences after shipment of this Report to the Purchaser. Select Biosciences discloses that it has no conflicts of interest with the subject matter and analysis presented in this market report. For customized qualitative or quantitative market analysis or custom consulting in this domain, please contact Kathy Gray at Select Biosciences for details. Cellular Therapy and Cord Blood Market Report 2013 Page 2

3 Description of Chapter Page Numbers Overall Scope of this Market Report 6 Chapter I. Cellular Therapeutics Market Landscape Stem Cell Market Segmentation and Industry Structure Quantitative Trends in the Cellular Therapy and Regenerative Medicine Marketplace Regenerative Medicine and Stem Cell Research Activity in the US Sales of Commercial Products and Services in Stem Cell/Regenerative Medicine Sectors Breakout of Spending by Companies in the Cellular Therapy/Regenerative Medicine Space Breakout of Spending by Product Platforms in Various Spaces Autologous vs. Allogeneic Business Models in the Cellular Therapy Space Autologous vs. Allogeneic Cellular Therapy: Industry SWOT Market Timeline Adult Stem Cell Therapy Quantitative Market Forecast Stem Cell Research Workflow and Product Development Value Chain Quantitative Scale of Cellular Therapy Market Opportunities in Various Disease Classes Cellular Therapy Product Pipeline Clinical Trials Quantitative Metrics and Detailed Breakout by Phase, Cell Type, Therapeutic Areas Addressed, Geography Companies and Marketed Cellular Therapy Products Currently 7-45 Cellular Therapy and Cord Blood Market Report 2013 Page 3

4 Description of Chapter Chapter II. Cord Blood Market Landscape The HSCT Landscape HSCTs Performed in the EU: Percent Breakout by Disease Classes Addressed Indications for HSCTs in North America: Disease Classes Addressed, Age of Recipients, Types of HSCs Utilized, Classes of Transplant Inoculum Cost Analyses of HSCTs in the EU vs. US Markets Reimbursement Codes and Reimbursed Amounts for Various Procedures Associated with HSCTs The Emerging and Evolving Cord Blood Landscape Cord Blood Banking Quantitative Market Metrics Growth of BM, PBL, and CB Units Worldwide in Public Banks and Registries, Segmented by Country Cord Blood Transplantation Trends: Age of Recipient, Disease Classes Addressed Cord Blood TNCs Landscape and Trends Cord Blood Banking Cost Breakouts EU and US Cord Blood Transplantation Detailed Cost Breakouts Chapter III. Stem Cell Opportunities and Funding Sources in Some of the Top Markets Across the European Union Page Numbers Cellular Therapy and Cord Blood Market Report 2013 Page 4

5 Description of Chapter Page Numbers Chapter IV. ATMP Regulatory Routes for Approval of Cellular Therapies in the European Union Appendix I. Selected Market Opportunities in the Cellular Therapeutics Space Appendix II. Stem Cell Publications Hotspot Mapping Analysis Appendix III. Research Methodology Cellular Therapy and Cord Blood Market Report 2013 Page 5

6 This market report presents the current worldwide market landscape of cellular therapy via several metrics and analyses The following topics are addressed in detail: I. Cellular Therapy Industry Structure and Market Segmentation II. Late-Stage Cellular Therapy Clinical Trials Pipeline III. Approved Cellular Therapy Products IV. Cellular Therapy Market Sizing and Growth [ ] V. Cord Blood Worldwide Market Landscape: Qualitative and Quantitative Market Trends VI. Stem Cell Research Opportunities in Selected EU Markets VII. EU ATMP Regulations for Cellular Therapy Product Approvals Cellular Therapy and Cord Blood Market Report 2013 Page 6

7 Cellular Therapy and Cord Blood Market Report 2013 Page 7

8

9 RMSCR, Combined regenerative medicine and stem cell research categories US NIH-Funded Projects Broken-Out by Area of Specialty Cellular Therapy and Cord Blood Market Report 2013 Page 9

10 EU $0.4 Billion ROW, $0.3 Billion US, $2.9 Billion Total Worldwide Spending=US$3.6 Billion 81% of Spending in Cellular Therapy/Regenerative Medicine is in the US Cellular Therapy and Cord Blood Market Report 2013 Page 10

11 Development al Biology Medical Devices Regenerative Medicine Cell Biology Molecular Biology Biomaterials Organ Construction, Transplants Cellular Therapy and Cord Blood Market Report 2013 Page 11

12 Cellular Therapy and Cord Blood Market Report 2013 Page 12 12

13 In Clinical Development Commercialized

14 Cellular Therapy and Cord Blood Market Report 2013 Page 14

15 Summary of HSCT Utilization Marketplace The use of cord blood as a source of stem cells for cellular therapy is growing The universe of applications for cord blood is expanding in both pediatric and adult patient populations The initial market for cord blood hematologic malignancies and inborn errors of metabolism is expanding and new market opportunities are being added The number of clinical trials utilizing cord blood is increasing Reflects the expanding therapeutic applications for cord blood Cellular Therapy and Cord Blood Market Report 2013 Page 15

16

17

18 Cellular Therapy and Cord Blood Market Report 2013 Page 18

19 Cellular Therapy and Cord Blood Market Report 2013 Page 19

20 ATMP: Advanced Therapy Medicinal Product Cellular Therapeutics are Classified as ATMPs under EU Law EMEA Marketing Authorization is Required Prior to Any ATMP Being Commercialized in the EU

21 Cellular Therapy and Cord Blood Market Report 2013 Page 21

22 Cellular Therapy and Cord Blood Market Report 2013 Page 22

23 Publicly-Available Select Biosciences Conferences Worldwide Cord Blood Forum 2012 San Francisco Conference, June 2012 Webinars Industry Publications Scientific Literature SEC Filings Press Releases Web Sites Research Methodology Sources of Data in the Select Biosciences Cellular Therapy and Cord Blood 2013 Market Report Proprietary Select Biosciences Interviews with Experts Interviews with Company Representatives Meetings with KOLs Company Presentations Algorithm-based parsing and analysis of the scientific literature for research and industry trends Deals Confidential Business Plans Unpublished data Personal Communications Cellular Therapy and Cord Blood Market Report 2013 Page 23