Overview

Proceedings of the WTEC Workshop on Tissue Engineering Research in the United States
INTRODUCTION:
OVERVIEW OF THE U.S. TISSUE ENGINEERING ENTERPRISE
Michael J. Lysaght, PhD, Brown University
Although the field of tissue engineering has only recently begun to offer commercial products, and then only
on a modest scale, it nevertheless represents a substantial commercial enterprise. Drawing on data from a
variety of public sources, we have tallied the number of firms and workers in the field and the associated
level of investment. As of the middle of 1999, over 40 companies were involved in developing products
which utilized cells as therapeutic or diagnostic reagents or which combined living cells and biomaterials to
provide a novel medical device or treatment. In aggregate these organizations employed over 2,700 full
time equivalents and annualized cumulative spending was at a rate of just over $500 million per year. Most
of the firms were small, U.S. based, and privately financed. Over 10 tissue engineering startups are NASDQ
listed and have a combined capital value which has recently ranged from one to two billion U.S. dollars. The
annual growth in employees and spending has exceeded 20% per year since 1995; total investment in this
field in the past decade exceeds ~$3 billion. At the present time, U.S. based firms have a commanding lead
over non-U.S. counterparts. These observations provide a strong basis for an optimistic perspective on the
future of tissue engineering, contingent upon the widely recognized need for a few short-term commercial
success stories.
The Growth of Tissue Engineering
CAGR = 20%
Annual Spending in $Millions
$504
$435
$246
95*
98**
*Tiss Eng 1 1995: 221-228
**Tiss Eng 4 1998: 231-238
Mid-99
Cumulative investment
now exceeds $2.7 Billion
Figure 1 Aggregate Annual Spending in the field of tissue engineering has risen from an estimated $250
million in 1995 to over $504 million in 1999. This represents a compound annual growth rate of
over twenty per cent during the past five years
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Proceedings of the WTEC Workshop on Tissue Engineering Research in the United States
Tissue Engineering
Metabolic, Structural, Cellular
750
$167
$283
1650
280
$54
FTE’s
Total = 2680
Figure 2
99 Spending
Total = $504 million
Tissue research and development can be categorized into “structural” prosthesis such as skin,
joint, and bones (approximately 1,650 workers and annual spending of $283 million), “cellular”
including receptor-based extracorporeal cell processing, cell therapy and stem cells (750 workers
and annual spending of $167 million) and “metabolic” such as encapsulation and bioartificial
organs (280 workers and annual spending of $54 million). The total number of full time
equivalents (FTE’s) and spending are shown beneath the pie charts
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Proceedings of the WTEC Workshop on Tissue Engineering Research in the United States
The Business of Tissue Engineering
“First Annual Conference on Tissue Repair,
Replacement, and Regeneration”
Michael J. Lysaght
Brown University
Rhode Island Center for Cellular Medicine
“Science, like the universe, expands most rapidly
at its fringes.”
Ten Millenia ago the development
of agriculture freed humanity from a
reliance on whatever sustenance
nature was kind enough to provide.
The development of tissue
engineering should provide an
analogous freedom from the
limitations of the human body.
-D. Mooney, T. Mikos
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“I’ve thought a lot about this, Charlie, and I
believe that when historians look back at the
twentieth century, the greatest scientific
achievements will not be nuclear energy,
pharmaceuticals, or even space travel, but
will be in the fields of tissue engineering and
genetic medicine.”
Michael Gillian
ABC Science Reporter
28 September 1999 Good Morning America
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Proceedings of the WTEC Workshop on Tissue Engineering Research in the United States
DEFINITIONS & BOUNDARIES
Tissue Engineering
Includes product and processes which:
• combine living cells and biomaterial
•utilize living cells as therapeutic or diagnostic reagents
or which provide related enabling biologics or biomaterials
Excludes:
•whole-organ xenografts, blood substitutes,
conventional marrow/leukocyte transplants
antecedents: blood banking, organ transplantation, artificial organs
SOURCES OF INFORMATION
“It is better to be approximately correct than
exactly wrong.” John Maynard Keynes
Firms active in field:
Bioworld, other trade publications, analysts reports, meeting
participants lists
Company-specific information:
Websites, backgrounders, annual reports, SEC filings (Edgar),
direct contacts
(Data in this presentation referenced to July 31,1999)
Special Thanks to Nancy Nguy
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STRUCTURAL
Skin, Cartilage, Bulk Tissue
>100 FTE’s: ATS, Focal, Genzyme Tissue Repair, Integra,
Lifecell, Organogenesis, Osiris
25-100 FTE’s: Ortec, Reprogenesis, Sulzer, Depuy, Fidia
<25 FTE’s: St. Jude, Tissue Engineering, Regen,
Encelle, PPT
FTE’s =1650
Expenditure = $283 Million
Trend = Upwards
Sales to date of Carticel® and Apligraf® are modest. (~$30 million combined)
mid-1999
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CELLULAR
Stem Cells, Cell Harvesting*, Cell Transplantation*
> 100 FTE’s: Nexell Therapeutics, Systemix (Novartis)
25-100 FTE’s: Aastrom Cell Genysis (1/3) Diacrin, Geron (1/2)
< 25 FTE’s: CBD, Neurospheres, Theracell (Titan),
Cytotherapeutics, SCI, STS
FTE’s =750
Expenditure = $167 Million
Trend = Flat
*Excludes conventional Blood Banking
mid -1999
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METABOLIC
Pancreas, Liver and Immunoisolation
> 100 FTE’s: -25-100 FTE’s: Betagene, Circe, Desmos, Gore Biohybrid,
VitaGen, Hemoclins
< 25 FTE’s:
Algenix, Biohybrid, Encelle, Islet Technologies,
Modex, Milticell, Nephros, Neocell, Novocell,
Theracyte, IsoTis
FTE’s = 280
Expenditure = $54 Million
Trend = Down
mid - 1999
Summary
FTE’s
99 Spending (MM)
Metabolic
280
$54
Structural
1650
$283
750
$167
2680
$504
Cellular
Totals
At the end of Q2 99, the capital value of
publicly traded companies was ~$1.5 Billion
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PUBLIC SECTOR PROGRAMS
~10% of Effort
University Programs*
Brown, Case Western, Duke, Georgia Tech,
Johns Hopkins, MIT, Rice, UCSD, U Penn, Utah
Government/Philanthropic
NIST, NIH, NSF, Whittaker
Centers of Excellence
Rhode Island Center for Cellular Medicine (RICCM)
Pittsburgh Tissue Engineering Initiative
*USA Today 12 August 97
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TAKE HOME MESSAGES
mid -1999 Tissue Engineering Industry Profile
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•
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•
•
•
40 firms
$ 500MM annual burn rate
2700 FTE’s
investment during 90’s of ~$3 Billion
annual growth rate exceeds $1.5 Billion
90% in private sector
“Predictions are difficult, especially about the future”
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D. Quayle
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