Monoclonal antibody therapeutics: Leading companies to maximise sales and market share

Karl Ziegelbauer
David R Light

DOI:https://doi.org/10.5912/jcb228

Abstract:

A close look at the biology and pharmacology of monoclonal antibodies reveals both their continuing promise as therapeutic agents to address unmet medical needs, as well as a number of challenges to the future discovery and development of this unique class of biologics. A remarkably consistent experience of reliable clinical efficacy and safety ensures that Biotech and Pharma have strong incentives to accelerate the antibody drug discovery process. Their attractive commercial potential invites consideration of potential challenges to the future expansion of the monoclonal antibody drug market. Four challenges arise from scientific and technical aspects of the antibody drug format: drug target limitations, biodistribution limitations, species specificity issues, and limitations to the route of administration and four challenges are based in the commercial and clinical use of antibody drugs: cost of goods, product differentiation within the antibody market, competition from small molecule drugs, and price sensitivity of clinical acceptance. Despite these challenges and recent setbacks, such as the withdrawal and subsequent relaunch of Tysabri and the TGN1412 Phase I disaster, the prevailing opinion is that monoclonal antibodies will continue to be safe and effective medicines that are worthy of commercialisation.

Keywords:monoclonal antibody ,biologic ,antibody market ,en ,