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The World Health Organization has highlighted the lack of available treatments for multi-drug resistant pathogens as a major global health issue in a recent report. Without commercial incentives to develop new antibiotics, however, substantial gaps in the types of infections that pharmaceutical companies are seeking to cover are likely to remain, with potentially fatal repercussions.
To date, pharmaceutical companies' focus on 'superbugs' is largely a result of attempting to capitalize on problematic infections for which there are limited treatment options. Of the totalmarket for hospital antibacterials (valued at $7.9 billion in 2006), some 70% of sales value can be attributed to brand sales which account for a mere 25% of sales volume. This market concentration is further illustrated by the top five players in the sector, which collectively account for 34% of market value, but only 8% of volume sales.
These revenues have been generated by a predominant focus on multi-resistant superbugs such as methicillin resistant Staphylococcus aureus (MRSA), often at the expense of other problematic infections caused by pathogens such as Pseudomonas, Acinetobacter or Klebsiella species on the Gram-negative side of the pathogen spectrum. Similarly, pneumonias and soft tissue infections have received substantial attention, while other types of infections are effectively being neglected with potentially devastating repercussions.
Uptake drivers, and showcase potentials
Bacteremia, endocarditis, obstetric infections, osteomyelitis and prosthetic infections are all examples of infection sites that have seen minimal research interest. This is largely due to the way in which pharmaceutical companies choose infection types in which to study new drugs. The indications sought, and trial structures used can broadly be split into two main streams: 'uptake drivers', and 'showcase potentials'.
Indications such as hospital acquired pneumonia, community acquired pneumonia or skin and skin structure infections represent the most common presentations. Broad and Gram-negative spectrum of activity are also widely publicized areas of need for new products to combat antibiotic resistance. Combined, these sites of infection and pathogen types initially look to offer the potential to drive the total number of instances in which a product can be included in a prescription decision – facilitating early uptake, and driving commercial potential.
Indications such as diabetic foot infection and clinical trial coverage specifically targeted at MRSA, for example, are typically used to showcase potential, or turn prescribing decisions in the candidate's favor and hence drive the realization of commercial potential offered by the core indication.
No denial of MRSA threat, but major gaps lie elsewhere
While MRSA and other resistant Gram-positive bacteria represent an undoubtedly and increasingly problematic menace in the hospital arena, this emphasis has led to the imminent saturation in one part of the market, leaving major gaps in another.
The demand for effective Gram-positive spectrum products is high, but while the next generation of hospital antibiotics (Zeven, Arbelic, oritavancin, ceftaroline and ceftobiprole) compete with already established products (Merrem, Vancomycin, Cubicin, Zyvox etc.), physicians have very few strategies left for the management of infections caused by Pseudomonas or Acinetobacter species.
Pathogens such as Pseudomonas, Acinetobacter and Klebsiella species are causing significant concern amongst physician populations who envisage treatment options thinning significantly in the foreseeable future. The products recommended for Pseudomonas, Acinetobacter and Klebsiella have been on the market for an average of 24 years.
Following the crowd comes at a cost
All of this points towards some very distinct winners and losers in the world of serious bacterial infections. For the pharmaceutical industry, some products are simply going to be crowded out of the market. For the broader population, the superbugs situation is likely to get far worse, and it will be some time until suitable products are available.
As pointed out in the WHO's latest report on Global public health security in the 21st Century: "Fewer new antibiotics are reaching the market with no new class of broad-spectrum antibiotic likely to appear soon". Considering the rate of growth in problematic infections over the past decade, the next decade could be characterized by dramatic increases in mortality resulting from an absence of curative therapies for some pathogens altogether, and a hazy understanding of the best way to use available treatments for an array of increasingly problematic infection types.
There may be hope of a commercial solution to this picture, but to avoid a calamity in the short term, it does require foresight or a more blunt instrument in the form of commercial incentives. The phenomenal costs of increasingly likely treatment failures are likely to put a premium value on problem-solving products, catalyzing a resurgence in R&D interest. Whether national or international bodies decide to offset some of these future costs by investing in commercial incentives, or whether commercial innovators wait until perceived returns are sufficiently high to justify drug development remains to be seen.
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