MEETING THE CHALLENGE:U.S. INDUSTRY FACES THE 21ST CENTURY
THE U.S. BIOTECHNOLOGY INDUSTRY
Jon PaughProject ManagerandDr. John C. LafranceEditorOffice of Technology PolicyTechnology AdministrationU.S. Department of CommerceOffice of Technology Policy July 1997
3The U.S. Biotechnology Industry
OFFICE OF TECHNOLOGY POLICY
C
ONTENTS
THE U.S. BIOTECHNOLOGY INDUSTRY
P
AGE
F
OREWORD
..................................................................................................5A
CKNOWLEDGMENTS
...................................................................................7E
XECUTIVE
S
UMMARY
..................................................................................9 W
HAT
I
S
B
IOTECHNOLOGY
?......................................................................21
Core Technologies......................................................................................22Biotechnology Materials...........................................................................22Drug Development....................................................................................23Gene Sequencing and Bioinformatics.....................................................24Application of Biotechnology Information to Medicine......................24
I
NDUSTRY
S
TRUCTURE
...............................................................................27
Size of the Industry....................................................................................27Research Intensity and Wage Levels.......................................................30
M
ARKETS
FOR
B
IOTECHNOLOGY
P
RODUCTS
..............................................31
The Medical Market...................................................................................31Market Trends and Potential.............................................................34Diagnostics and New Medical Demands........................................35Biotechnology and the Most Costly Forms of Illness....................38Potential Commercial Applications of Gene Therapy...................43Nonmedical Markets.................................................................................45Agricultural Biotechnology................................................................46Industrial Biotechnology....................................................................58
D
ETERMINANTS
OF
F
UTURE
C
OMPETITIVENESS
.........................................65
Technology Infrastructure and Federal Research Initiatives...............66Capital Formation......................................................................................74Evolving Industry Approaches to Raising Capital........................76Resurgence of Public Market Interest in Biotechnology...............80U.S. Health-Care System...........................................................................82Tax Policies..................................................................................................82Capital Gains Tax Incentives.............................................................83Research and Experimentation Credit.............................................83Orphan Drug Credit............................................................................84
4The U.S. Biotechnology Industry
OFFICE OF TECHNOLOGY POLICY
Regulatory Environment..........................................................................84Food and Drug Administration.........................................................85The Environmental Protection Agency............................................93Department of Agriculture.................................................................96Patent and Trademark Office and IntellectualProperty Rights................................................................................97Foreign Competitors..................................................................................99Trade Issues...............................................................................................102Safety and Environmental Regulations..........................................103Political Barriers to Trade: The Case of BST..................................105Biodiversity Treaty............................................................................106GATT and the TRIPS Agreement....................................................107
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