London Thursday March 8 2007- The increasing incidence of multi-resistant superbugs is emerging as a major health concern around the world. The best known example is methicillin-resistant Staphylococcus aureus (MRSA), the incidence of which has nearly tripled in some patient groups over the last decade. However, with several candidates for treatment of MRSA infections in late-stage development, other pathogens such as multi-resistant gram negatives including Pseudomonas aeruginosa or Acinetobacter Baumannii are posing as an even larger threat. These infections occur mainly in the hospital setting, which is evolving as the centre of antibacterial therapy fuelled by an ageing population and the higher susceptibility of the elderly towards bacterial infections, according to research* by independent market analyst Datamonitor (DTM.L).

The antibacterials market, valued at approximately $25.5 billion in 2005, is highly mature, growing at a modest average rate of only 5.1% from 2002 to 2005. The community sector is still accounting for the majority of sales with broad range antibiotics such as macrolides, cephalosporins, penicillins and fluoroquinolones dominating sales, each yielding global revenues exceeding $4 billion annually. Most community-acquired infections can be treated well with available drugs, and the level of genericization is very high, leaving little profit opportunities for drug manufacturers.

However, more recently multi-drug resistant bacterial infections such as MRSA have emerged as a major global health concern, refueling Big Pharma’s interest in the sector, says Datamonitor infectious disease analyst Hedwig Kresse. "Sales growth rates reflect this trend with classes mainly indicated for the treatment of resistant infections, such as carbapenems and glycopeptides growing fastest, and former niche antibiotics such as Pfizer’s Zyvox (linezolid) on the verge of blockbuster status."

Over the last decade, MRSA has rapidly developed into a public health concern. The incidence of the so-called ‘superbug’ has been found to nearly triple among US ICU patients, where it accounted for up to 63% of all S. aureus infections in 2004. Across the Atlantic, the situation is nearly as serious with the UK reporting an MRSA incidence of 45%, with approximately 15% of the cases proving fatal.

Because the pathogen is rapidly evolving and acquiring resistances to currently available drugs, new treatment options for MRSA are a crucial unmet need. However, a look at the antibacterial pipeline reveals that there are no less than four candidates for MRSA treatment in late-stage development, indicating that efficacious options will continue to be available. Indeed, the situation is worse for other multi-drug resistant pathogens such as the gram-negatives Pseudomonas or Acinetobacter. The number of antibacterials for the treatment of infections caused by these strains is highly limited, with carbapenems the main and in many cases only efficacious option. With carbapenem-resistant strains starting to emerge and just two new candidates, Johnson & Johnson’s (J&J’s) Doripenem and Ceftobiprole in late-stage development, further treatment alternatives are urgently needed.

The rising incidence of resistant infections will fuel strong growth particularly in the nosocomial antibacterial market, Kresse says. "Although we have seen a worrying increase in MRSA cases in the community setting, most infections with resistant strains occur in the hospital setting. Furthermore, in-hospital treatment of bacterial infections will become more and more common as the number of elderly and immunocompromised patients grows."

Importantly, generic competition is less intense than in the community market. This, in combination with the high clinical need of critically ill patients, eases cost pressure on hospital antibacterials, making the hospital market an attractive target for drugs manufacturers, Kresse says. "With only few branded products left in the relatively well-served and highly genericised community market, the main commercial opportunity in antibacterials lies in the treatment of nosocomial infections."

"Efficacious drugs against MRSA and, in particular, multi-resistant gram-negatives are urgently needed and their significant commercial potential will hopefully drive continued research and development in this area."

Datamonitor’s (DTM.L) report Commercial Insight: Antibacterials - Growth in resistance rates drives niche indications provides detailed forecasts for each antibiotic class and the most important drugs. Discussion of market drivers, threats and lifecycle management strategies in the face of rising resistance and increasing generic incursion.

(8/3/07)