• Wayne R. Gombotz
  • Steven J. Shire
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XI)


Monoclonal antibodies (MAbs) are one of the fastest growing classes of all pharmaceutical products. In 2007, a total of 26 therapeutic MAbs were approved in the U.S. market (Table 1-1), which was valued at more than $12,612 million (Frost & Sullivan 2008). Currently, more than 200 MAbs are in clinical study with more than 600 in preclinical development (Reuters 2008). They play a major role in treating a wide variety of diseases including cancer, infectious disease, allergy, autoimmune disease and inflammation. MAbs now belong to a well-established drug class, that has a high success rate from first in human studies to regulatory approval: Typically 25% (Reichert et al. 2005), which compares favorably with the 11% success rate for small molecule drugs (Kola and Landis 2004).


High Success Rate Antibody Fragment Small Molecule Drug Mouse Protein Humanization Technology 
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Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  1. 1.Omeros CorpSeattleUSA
  2. 2.Late Stage Pharmaceutical and Processing DevelopmentGenentech, Inc.South San FranciscoUSA

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