Flat outlook for antibacterials
antibacterial pipeline, none of them are likely to reach
blockbuster status, according to a new report from Datamonitor.
Most industry activity seems to be focused on second generation compounds, or the reformulation of existing products for new patient groups or therapeutic uses, it notes.
Echoing another report earlier this year which found that R&D into new antibiotics was on the wane, Datamonitor's analysis of the antibacterials pipeline has revealed a relatively small number of new experimental antibiotics.
Of these, only a few are undergoing late-stage clinical evaluation with even fewer expected to reach the market. For this reason, Datamonitor predicts that the entire antibacterials sector, which is currently valued at $27 billion (€22bn), will experience flat growth with a compound annual growth rate of just 0.3 per cent from 2003 to 2011.
Significantly, current antibacterial market leaders - particularly those in western markets such as Bayer and GlaxoSmithKline - have relatively little involvement. Seemingly, most are reducing their investment in this field and leaving innovation to Japan-based firms such as Fujisawa, Shionogi and Taisho and smaller companies such as Cubist, Vircuron and Basiliea.
Current investment within antibacterial R&D differs between the commonly prescribed classes, notes Datamonitor. For example, a number of novel glycopeptides and carbapenems focused on treating drug resistant hospital pathogens such as vancomycin-resistant enterococci and methicillin-resistant Staphylococcus aureus with better dosing profiles.
There are also some enhancements to the cephalosporin and fluoroquinolone classes, although showing added benefit in these markets is more challenging. In addition, existing products such as Pfizer's Zithromax (azithromycin) are in the process of reformulation or combination with novel delivery platforms to fulfil niche applications in the fields of ophthalmology, dermatology and cystic fibrosis.
Of the candidate drugs in development, doripenem, a second-generation carbapenem is expected to have the most revenue potential after launch with estimates of $700-$800 million in sales in 2011. The drug, originally discovered by Shionogi, is a broad spectrum intravenous antibiotic having potent activity against problematic pathogens such as Pseudomonas and the drug resistant pathogens MRSA and penicillin-resistant Streptococcus pneumoniae (PRSP).
Shionogi currently expects to file an application with the Japanese Ministry of Health, Labour and Welfare (MHLW) later this year.
