The Business of Cell Therapy
About us
the Cell Therapy Group
- busdev, commercial, marcom, market consultancy
www.celltherapygroup.com www.celltherapyblog.com
Progenitor Cell Therapy
- cell therapy services: clinical/commercial
product/process dev & manufacturing
- 2 US facilities: NJ & CA www.progenitorcelltherapy.com
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Development chief outlines strategy at Genentech
By John Carroll (Fierce Biotech) June 12, 2008 Genentech's Susan Desmond-Hellmann, president of product development, outlined the biotech giant's development strategy to a group at the Goldman Sachs healthcare conference. The research chief also told the group that the blockbuster drugs of the past may never be duplicated. Future drugs will cater to a smaller, better defined group of patients. "The days of big cholesterol-lowering drugs for millions of people may be behind us.“
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Cell Therapy: The “Long Tail” of Regen
Blockbuster products sold to masses Consumers
Customized, personalized products for global micro-markets Products
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Unprecedented Innovation
Out of six biotechnology innovations measured, the study found that four (targeted therapies, monoclonal antibodies, radiotherapy and drug device combinations) advanced significantly in 2007, marking a year of unprecedented progress and commercial impact. Targeted therapies with companion molecular diagnostics have experienced the most profound surge in realization, rising 50 percent in just three years. "As a first step toward more personalized treatments, targeted therapies with companion diagnostics are reaching more patients. However, there remain significant economic, reimbursement and regulatory challenges that could prevent valuable treatments from becoming available to people who need them.“ [1] Monoclonal antibodies - Have achieved widespread clinical acceptance in the past three years after more than 20 years of variable progress. In 2002, monoclonal antibodies were the highest achieving innovative technology in terms of discovery, while RNAi-based gene therapy was the least. By 2007, stem cells moved from the middle of the pack to achieving the highest discovery innovation index among the six technologies; RNAi moved up, and monoclonal antibodies moved down to a lower level of innovation.
Deloitte Center for Health Solutions 2008 Survey of Health Care Consumers can found at www.deloitte.com/us/healthcareconsumersurvey [1] Matthew Hudes, U.S. managing principal, Biotechnology, for Deloitte Consulting LLP's Life Sciences & Health Care practice, and the director of the study.
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The market: size
Jain PharmaBiotech’s “Cell Therapy” market report: ~$25 billion (2008) [1] Michael Lysaght, PhD (Brown University):] $3.4 billion (2008) [2] Bionest Partners projects the global cell therapy market to post a 27% CAGR 2005 to 2015. [3] Proteus Venture Partners cites a 26%39% CAGR 2005-2020. According to a new market research report, the domestic market for stem cell therapies & banking is expected to increase from $112.0 million in 2007 to $423.1 million in 2012, a compound annual growth rate (CAGR) of 30.5%. Stem cell therapeutics generated $46.1 million in 2007 and is expected to generate $267.4 million in 2012, a CAGR of 42.1%.
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The market: companies by phase
Data suggests there are ~700 “stakeholder” companies involved in some material way in the cell therapy space; ~250 therapeutic “cell therapy” companies with approximately 344 products broken down into the following stages:
Phase Pre-clinical Phase I Phase II Phase III Commercial # of companies in 2008 78 77 89 32 68
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The market: commercial
~68 commercial therapeutic products* from ~65 companies
•
Including (a) ~17 stem cell transplantation “products” where clinics are transplanting stem cells in clinic outside the US for a variety of diseases, (b) ~14 skin products in various countries, (c) ~10 cartilage repair products in various countries – many of which are autologous chondrocyte transplant (ACT) products, (d) some multiple inclusions of the same product commercially**, and (e) 3 vetinary products.
Currently ~27 clearly distinguishable types of commercial cell therapies.
* “Products” is defined to include any therapy commercially available from one or more companies in one or more countries in the world ** Sometimes available through different companies in different countries, under different brand names, minor variations of the same product, same product for different indications, and/or second-generation products under a different brand name
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The market: 220+ Investors
~224 investors listed with one or more investments in a cell therapy
~286 investments in ~107 cell therapy companies
~23 pharma, biotech, or device companies listed with an investment in stem cells and/or cell therapy
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2008 to-date (July) summary
~$500+M in deals ~$225M in direct investment
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Hype cycle or Gartner plateau of productivity?
June 2008 May 2000
Tissue Engineering will be the #1 job of the 21st century. “Stem Cells Get Real.” Finally, real businesses, real science, and real hope. Everything you've heard until now is wrong.
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Realizing the Promise of Cell Therapy
Cell Therapies in 2nd Half of Gartner Curve
Phase
2000 Tissue Engineering makes TIME cover 2001: 3300 jobs; 73 firms; >$2.56B market cap 2001 Ortec & Dermagraft FDA Approved
# of Companies 78 77 79 32 68
R&D I II III Commercial
1999 Intercytex Founded
Visibility
1997 First Tissue Therapy FDA Approved (Apligraf) 1997 First Cell Therapy FDA Approved (Carticel) 1997 PCT Formed 2001-2003 ATS & Organogenesis file Chapter 11 Genzymne downsized; 9 leading tissue therapy products fail to win FDA approval; 500 jobs lost; 1M patients treated >$1B in product revenues 800 clinical trials filed with FDA Dendreon files BLA 50 Public companies: $4.7B market cap
1992 Geron Founded
2006 Carticel – 10,000 patients 2005 CIRM Founded
1980 Early Tissue Engineering (MIT)
Time Unrealistic Bust Technology 2.0 Sector Maturation
Technology Trigger
Premature Boom
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Business Models
Products Therapeutics Cells as Tools Platform Techs Devices Reagents
Indirect Services like Publications Conferences Market Reports Info Services
Services Product Support
Cell & Tissue CMOs, CROs Sourcing CTOs Storage Distribution Assays Testing Regulatory
Corporate Support
Investment Finance Sales Business Dev
Reimbursement
Marketing Public Relations Communications
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