ABSTRACT
During the last decade, a significant trend in the pharmaceutical industry has been the development of monoclonal antibodies (mAbs) as therapeutic agents. Antibodies are polypeptides that bind to specific antigen targets. A major advantage of mAbs as therapeutic agents is their high target specificity, which results in a low side effect profile. Monoclonal antibodies can also be engineered to have additional biological activity beyond binding of the antibody to its antigen. Antibodies can be conjugated to other therapeutic agents (i.e., for targeted delivery of a cytotoxic or radioactive agent to tumor cells). Antibodies, due to their size (~150 kD for IgG) and glycosylation profile, have a long half-life
in vivo
, resulting in a dosing regimen ranging in scale from a week to months. Monoclonal antibodies have great therapeutic potential and are being pursued both by biotech-
nology companies and by traditional pharmaceutical companies. A recent report
indicates 376 mAb development programs (from preclinical to market), 132 mAbs in clinical development, and 23 approved mAbs (see Table 26.1). The sales figures for 2002 were $5.4 billion (up 37.5% since 2001), and this market share is expected to grow to $16.7 billion by 2008. This growth is fueled by the projected launch of 19 new antibody-based products in the time period 2004 to 2008.
