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Recombinant protein therapeutics—success rates, market trends and values to 2010

Nature Biotechnology volume 22, pages 1513–1519 (2004)Cite this article

Despite entering its maturation phase, the recombinant protein sector will continue to drive the growth of medical biotechnology over the next six years.

Biotechnology, founded on the principles of recombinant DNA (rDNA) protein production, is and will probably continue to be an R&D-intensive sector. Beginning in the early 1970s, advances in molecular biology and genetic engineering have led to enormous progress in the ability to understand the biomolecular roots of human disease. Stanford University's Paul Berg, the 1980 Nobel Prize winner in chemistry, first produced rDNA in 1972. His lead was followed by a team led by Herbert Boyer (University of California, San Francisco), who in 1973 transformed Escherichia coli cells with recombinant plasmid and later founded Genetic Engineering Technology (Genentech, S. San Francisco, CA, USA). Boyer's team perfected their methods, then developed and later launched, with the help of their licensing partner Eli Lilly (Indianapolis, IN, USA), the first human recombinant protein, recombinant human insulin (Humulin) in 1982. After more than two decades of continuous global expansion, business formation and technological diversification, the rDNA therapeutics sector now represents the core of the human medical biotechnology industry, worth over $32 billion in 2003. The rDNA therapeutics sector includes more than 110 companies that are involved in the discovery, development and marketing of rDNA products. These companies have a pipeline of more than 80 therapeutics in clinical development and a combined portfolio of 73 marketed products1,2.

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Figure 1: US approval success rates for rDNA therapeutics in two periods.

Bob Crimi

Figure 2: Phase transition probabilities by therapeutic category for rDNA products entering clinical study during 1990–1997.

Bob Crimi

Figure 3: Market growth generated by three business waves and recorded between 2001 and 2003.

Bob Crimi

Figure 4: Therapeutic market segmentation from 2001 to 2003.

Bob Crimi

Figure 5: Distribution of market subsegments generated by the industry's leading recombinant protein brands within the 57% total market share in 2010.

Bob Crimi

Figure 6: Market growth from 2004 to 2010.

Bob Crimi

References

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Authors and Affiliations

  1. Datamonitor plc., Charles House 108-110 Finchley Road, London, NW3 5JJ

    Alex K Pavlou

  2. Tufts Center for the Study of Drug Development, 192 South Street, Suite 550, Boston, 02111, Massachusetts, USA

    Janice M Reichert

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  1. Alex K Pavlou
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  2. Janice M Reichert
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Pavlou, A., Reichert, J. Recombinant protein therapeutics—success rates, market trends and values to 2010. Nat Biotechnol 22, 1513–1519 (2004). https://doi.org/10.1038/nbt1204-1513

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