Chapter 27
Commercial Biotechnology: An Overview Peter Hall
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SRI International, 333 Ravenswood Avenue, Menlo Park, CA 94025
During the past ten years, biotechnology has offered a unifying concept for viewing the commercial bene fits to be derived from life processes. As the term is now used, biotechnology refers to the application of basic scientific disciplines involving the life sciences, chemistry and engineering to develop a range of powerful tools with the ability to provide commercial products and processes encompassing a range of industries. As time has progressed, the term biotechnology has become so broad as to include any life science associated activity with either real or remote commercial potential. While the media and much of the scientific community continue to use biotech nology (or generic engineering) to refer to state-ofthe-art manipulations of genes in prokaryotes and eukaryotes (including plant cells) the definition has become much broader. The term often refers to both established and state-of-the-art endeavors as diverse as aquaculture, production of industrial enzymes, development of microbial agents for cleaning up o i l spills and protecting crops, microbial fermentation to produce specialty chemicals and even the brewing of beer. The scope and interactions of the various compo nents of biotechnology are summarized in Figure 1. The commercialization of biotechnology continues to be driven by: ο the desire of entrepreneurial s c i e n t i s t s to realize a financial return for their laboratory research developments; ο the infusion of investment capital from private and corporate investors; ο the desire of established, market-led pharmaceuti c a l , chemical, agribusiness, food product and
0097-6156/88/0362-0322$06.00/0 © 1988 American Chemical Society
Phillips et al.; The Impact of Chemistry on Biotechnology ACS Symposium Series; American Chemical Society: Washington, DC, 1988.
Phillips et al.; The Impact of Chemistry on Biotechnology ACS Symposium Series; American Chemical Society: Washington, DC, 1988.
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AQUACULTURE
BREEDING
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FORESTRY
HORTICULTURE
FIELD AND PLANTATION CROPS
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AGRICULTURAL CHEMICALS
FOOD CHEMICALS
MEDICAL AND t VETERINARY PRODUCTS f
FOOD/BEVERAGE MANUFACTURE
S C O P E A N D INTERACTIONS O F
BIOTECHNOLOGY
ENERGY AND I FEEDSTOCK CHEMICALS I
FIGURE 1
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LIVESTOCK
PLANTS AND SEEDS
OIL RECOVERY/REFINING
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ANIMAL AGRICULTURE
MAPPING
MISCELLANEOUS I SPECIALTY CHEMICALS j
CONTROL
PESTICIDES
DIAGNOSTIC AND THERAPEUTIC MEDICAL APPLICATIONS
HUMAN GENETICS
GENE
SITE-DIRECTED MUTAGENESIS
FERMENTATION
SEPARATION PURIFICATION
DNA RECOMBINATION
ENGINEERING
ORE RECOVERY/REFINING
POLLUTION
MICROBIAL
H
SYMBIONTS
SOIL
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MICROBIAL SYSTEMS
CELL CULTURE AND FUSION
INSTRUMENTATION AND SOFTWARE DEVELOPMENT
BIOCATALYSIS
CHEMISTRY
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H
COMPUTERIZED INFORMATION AND ANALYSIS SYSTEMS
MISCELLANEOUS INSTRUMENTS
BIOSENSORS
ENGINEERED SYSTEMS
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T H E I M P A C T OF C H E M I S T R Y O N B I O T E C H N O L O G Y
o t h e r d i v e r s i f i e d companies t o p r o t e c t t h e i r e x i s t i n g business and e x p l o i t new, technologyd r i v e n business o p p o r t u n i t i e s ; ο and t h e d e s i r e o f r e g i o n a l , n a t i o n a l and s u p r a n a t i o n a l governmental bodies to s t i m u l a t e i n d u s t r i a l development. Worldwide commitment to biotechnology i s i l l u s t r a t e d by the high l e v e l s of government and corpo rate R&D funding i n v o l v e d — c u r r e n t l y i n the neighbor hood of $4.5 b i l l i o n . T h i s i s shown i n Table 1. L i k e the pharmaceutical i n d u s t r y , with which i t i n t e r s e c t s , the biotechnology i n d u s t r y i s i n c r e a s i n g l y seen as a v a l u a b l e n a t i o n a l asset by c o u n t r i e s around the world. N a t i o n a l and r e g i o n a l governments and development agencies are assuming a greater r o l e i n f o s t e r i n g the t r a n s f e r of technology from academia t o industry. I n d u s t r y / u n i v e r s i t y c o l l a b o r a t i o n s have be come i n c r e a s i n g l y common and i n most cases p r o t e c t the i n t e r e s t s of f a c u l t y members (e.g., freedom t o publish) while p r o v i d i n g i n d u s t r y with ample oppor t u n i t i e s f o r e s t a b l i s h i n g patent p r o t e c t i o n i n the areas they are funding. The b a s i c underpinning technologies i n most cases seem to present no s i g n i f i c a n t b a r r i e r s to biotechnology c o m m e r c i a l i z a t i o n . For i n s t a n c e , the major t h e r a p e u t i c human p r o t e i n s that have been t a r geted by i n d u s t r y have been cloned, with expression l i m i t s i n many cases approaching t h e o r e t i c a l l i m i t s . The present b a r r i e r s to the commercial develop ment of biotechnology are t h r e e f o l d : (1) S e l e c t i o n of v i a b l e product t a r g e t s — w i t h a l l i t s successes, biotechnology i s s t i l l o f t e n "technology looking f o r markets". (2) L i m i t e d market p o t e n t i a l — c r e a t i o n of new markets or s i g n i f i c a n t expansion of e x i s t i n g markets w i l l not occur u n t i l a l a r g e r number of unique and proven compounds have been developed; f o r biotechnology, i t w i l l be d i f f i c u l t to c r e a t e new markets. The g r e a t e s t new market o p p o r t u n i t i e s may be t i s s u e plasminogen a c t i v a t o r (TPA), human and animal growth hormones, a s u c c e s s f u l lymphokine treatment for acquired immune d e f i c i e n c y syndrome (AIDS) and other immunodeficiency-related d i s o r d e r s , d i a g n o s t i c s for screening f o r AIDS and cancer, and environmental monitoring, as w e l l as new instruments and software packages. In the long term, new g e n e t i c a l l y en gineered v a r i e t i e s of higher p l a n t s and m i c r o b i a l p l a n t symbionts w i l l provide unique new market oppor t u n i t i e s . (3) Processing c o s t s — p r o d u c t i o n , separa t i o n , and p u r i f i c a t i o n c o s t s are i n danger of making b i o t e c h n o l o g i e s non-competitive with e x i s t i n g proces ses and products. For most commodity and even spe c i a l t y chemical products, y i e l d improvements using
Phillips et al.; The Impact of Chemistry on Biotechnology ACS Symposium Series; American Chemical Society: Washington, DC, 1988.
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Commercial Biotechnology: An Overview
HALL
Downloaded by CORNELL UNIV on October 2, 2016 | http://pubs.acs.org Publication Date: January 7, 1988 | doi: 10.1021/bk-1988-0362.ch027
Table 1 CURRENT ANNUAL EXPENDITURES ON BIOTECHNOLOGY RESEARCH AND DEVELOPMENT (Millions of U.S. Dollars) SOURCE COUNTRY/REGION United States
Government 525
Japan
55
Europe Belgium Fed. Rep. of Germany France Italy Netherlands Sweden United Kingdom Other Subtotal TOTAL
Industry (est.)
TOTAL
1,500-2,000*
2,000-2,500
1,000
500