Big bucks battling super bugs?
SummaryBacterial skin diseases like gangrene can now expect an onslaught of new specialist medications. However, skin infections make up a relatively small proportion of the $20.4 billion annual global antibacterial market, which, says Datamonitor's Amber Gibson, raises questions about why such conditions are the current focus of so much antibacterial product development...
Although skin and skin structure infections represent one of the most common types of bacterial ailments, they are still relatively infrequent when compared to respiratory tract and urinary tract infections. Skin and skin structure infections accounted for only 3% of the $6.5 billion US drugstore sales attributable to antibacterial infections in 2003. However, skin infections are the one sector of the anti-bacterial market where unmet need is growing, and thus the possibility for market expansion exists.
Battling the super bugs
Wyeth recently released the results of its Phase II trial with tigecycline, a broad-spectrum glycylcyline antibiotic, which treats complicated skin and skin structure infections like gangrene. Results show tigecycline led to a cure in 74% of cases and also demonstrated in vitro ability activity against a variety of skin pathogens, including methicillin-resistant and susceptible Staphylococcus aureus (MRSA) and Streptococcus pyogenes.
The increasing incidence of MRSA infections, particularly in the but becoming more common in the , is in part responsible for the increasing clinical demand for skin-specific antibacterial products.
However Wyeth's tigecycline can expect company in the marketplace, with other pharmaceutical and biotechnology companies also responding to the 'carrot' of potential market expansion. Cubist's Cubicin has already been approved by the US Food and Drug Administration, Basilea Pharmaceutica's BAL5788 is in Phase III of its development, while Aventis is currently seeking Japanese approval for Ketek for the treatment of skin diseases.
Targeting skin infections involving drug resistant pathogens also increases the chances of gaining fast-track status, as was the case for Cubicin and BAL5788. This can ultimately reduce time to market and accelerate return on investment. For smaller companies with limited resources this can prove invaluable.
Additionally, targeting these rare infections is often associated with lower R&D costs. This allows the potential involvement of smaller players with limited funds to invest in R&D and marketing campaigns.
Bang for bucks?
However, whether revenue can match this clinical potential is the 'big if'. Limited unmet need in the treatment of most bacterial infections means that establishing a significant market presence can prove difficult, even for companies with recognized marketing power and reputation.
Entry into the antibacterial market, worth a total of $11.5 billion, may be eased by the high level of unmet need in serious skin infections, which will help build awareness of the product among physicians prior to securing additional indications. But the risk still remains that products with efficacy against problematic pathogens such as MRSA will be preserved for such cases, limiting revenue.