Antibiotics R&D on the wane

The market for antibacterial drugs is becoming increasingly unattractive to major pharmaceutical companies, despite continued strong worldwide demand for these products and the growing threat of bacterial resistance, according to a report from Datamonitor.

Currently only six marketed drugs have sales of greater than $1 billion and, by 2011, 12 out of 29 key products will face patent expiry, the report noted. Moreover, a relatively sparse R&D pipeline will do little to replace older products. Among the pharma majors, only Pfizer-Pharmacia, Abbott and Aventis appear to be committed to developing new antibiotics.

Companies face a number of key challenges, particularly a reduction in the useful lifecycle of antibacterial products. Concerns over pathogen resistance are causing a general curb on usage, and the increasing prevalence of resistance has also prompted official regulators to place greater demands on manufacturers. For example, approval of Aventis' ketolide antibiotic Ketek (telithromycin) was held up by the US Food and Drug Administration for several months by requests for additional data on resistant strains.

"Only newly developed compounds with superior efficacy and safety profiles will gain approval and the chance to levy premium pricing​", according to Datamonitor.

Traditionally major players have realized antibacterial market dominance through possession of one or two products in the older penicillin, macrolide or cephalosporin classes. Products from these classes are increasingly falling out of favour, with physicians switching to other drugs such as fluoroquinolones for better oral bioavailability and increased efficacy.

New product development focus has now shifted to the carbapenem, ketolide and oxazolidinone classes. Datamonitor has uncovered a strong relationship between companies with a presence in two or more of these classes and market share in 2011.