September 15, 2011 (Vol. 31, No. 16)

Unmet Need Slowly Driving Introduction of Novel Types of Branded Products

Treatment of hospital acquired infections (HAIs) has become an increasing focus of healthcare organizations, governments, and news outlets. Infections contracted in hospitals are the fourth largest killer in the U.S. There are approximately 40 million hospital admissions each year, and a nosocomial infection rate of 5%.

For a variety of reasons this hasn’t always translated into a huge market for products. The market for antibiotic pharmaceuticals has suffered due to generic threats and saw declines in the past two years, according to Kalorama Information’s estimates, but it is expected to rebound due to new branded products and should improve in the coming years.

The seriousness of the problem is acknowledged by authorities. The CDC has reported that about one-third of nosocomial infections in the U.S. are preventable, a figure representing nearly 700,000 people. Of these, approximately 94,000 are MRSA infected. Nearly 100,000 people die each year, almost 20,000 of them from MRSA infections.

Nosocomial infections in the European Union are estimated at 4 million with approximately 150,000 deaths reported annually.

Treatment of HAIs involves the careful selection of antibiotics for the specific infection strain. Antibiotic resistance has added a new dimension to treating hospital infections. MRSA infections are of particular concern due to the limited number of treatment options.

Many strains of MRSA are resistant to traditional antistaphylococcal beta-lactam antibiotics, including cephalexin (Keflex). Vancomycin, linezolid, quinupristin, daptomycin, and tigecycline are all common treatments for MRSA. C. difficile is generally treated with Metronidazole.

A staph infection that is not antibiotic resistant can be treated in about one month (depending on severity) using antibiotics. Tuberculosis treatment is difficult and requires long courses of multiple antibiotics. The two antibiotics most commonly used are rifampicin and isoniazid.

In 2010, the HAI treatment market was valued by Kalorama Information at about $8.1 billion, reflecting a decline from the previous year of $8.3 billion. The top four drugs were Floxin, Zosyn, Zyvox, and Avelox. Some of this decline is now being offset by the sales of newer products including Cubicin, Ceftin, Tygacil, and Invanz.

Near-term sales are expected to follow the same trend—declining sales for older, patent-expiring products and steady sales increases for newer, more effective therapies. However, growth from newer products and products entering the market over the next couple years will struggle to offset declines due to a growing generic marketplace.

By 2015, the HAI treatment market will show some signs of increasing once again, reaching $8.5 billion, growth of 1% over 2010. Growth is based on some new market entries, continued demand for launched products, and growing unit sales overall.

Only a handful of top branded products remain in the antibiotic market. In most product segments there is a leading product and in some there are two or three. For example, in the cephalosporin market, few products remain leaders due to the growing number of generic options. The three top products are Omnicef, Ceftin, and Rocephin.

In the carbopenem segment, the newest segment in the antibiotic market, three products dominate sales: Primaxin, Merrem, and Invanx. These are all large players in the HAI treatment segment.

Over the years, there have been over 150 antibiotics introduced, the vast majority of which are no longer in use. The development and later discovery of methicillin-resistant Staphylococcus aureus has placed methicillin on the growing list of discontinued drugs.

Unmet need in the HAI treatment market is expanding. Unfortunately pipelines continue to show a less than adequate response to the growing need for effective therapies.

On average, the FDA approves about 80 to 90 new products per year, of which only two or three per year are for antibiotic therapy. This number has been constant through 2010, showing no improvements over the years despite the growing threat.

Bruce Carlson ([email protected]) is publisher at Kalorama Information.

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