Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, despite market constraints that include intensified competition, generic erosion and an increasingly stringent regulatory and reimbursement environment, the drug market for key hospital-treated infections that are of high interest to drug developers—most notably nosocomial pneumonia, bloodstream infections, skin and skin structure/surgical site infections and urinary tract infections—will increase from $3.3 billion in 2010 to just over $4 billion in 2020 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. The uptake of eight new therapies, as well as Forest/AstraZeneca/Dainippon Sumitomo's anti-MRSA cephalosporin Teflaro (which launched in the United States in 2011), will help offset sales losses and will account for 30 percent of major-market sales in 2020.
“Additionally, the use of new therapies in the hospital setting will likely be monitored more carefully, owing to the increasing emphasis on antibiotic surveillance and stewardship programs”
The findings from the Pharmacor topic entitled Hospital-Treated Infections reveal that, through 2020, generic erosion of nine key branded products—most notably Pfizer's Zyvox—will be a major constraint to market growth. Additionally, although the market is currently dominated by parenteral agents, drug developers have recognized a long-standing need for agents that are available in an interchangeable intravenous and oral formulation, and several such agents are poised to launch over the next decade. Among these emerging agents is Trius Therapeutics' intravenous and oral oxazolidinone, tedizolid, which is forecasted to garner sales of nearly $400 million by 2020. The uptake of tedizolid will be due to its activity against gram-positive pathogens including MRSA, its reduced toxicity compared with Zyvox and its availability as a step-down therapy.
Other key emerging agents, in addition to Teflaro and tedizolid, include two anti-MRSA quinolones—Rib-X/Sanofi's delafloxacin and Furiex's JNJ-Q2—and two anti-MRSA glycolipopeptides with long-half-lives—Durata Therapeutics' dalbavancin and The Medicines Company's oritavancin. Additionally, two beta lactam/beta lactamase inhibitor combinations, Cubist's CXA-201 and AstraZeneca/Forest's CAZ-AVI, will also launch within the next ten years. These combinations are notable as they are active against multi-drug resistant gram-negative pathogens, including Pseudomonas aeruginosa. Among the emerging therapies, Teflaro is best poised for commercial success owing to its early market entry, significant improvements in spectrum and dosing frequency over currently marketed cephalosporins and its favorable price compared with current anti-MRSA agents such as Cubist's Cubicin, Theravance/Astellas's Vibativ and Zyvox.
The findings also reveal that increasing competition in the already crowded hospital-treated infections therapy market means that emerging agents will face bigger challenges to gain formulary inclusion and will need to demonstrate clear differentiation from their competitors.
"Additionally, the use of new therapies in the hospital setting will likely be monitored more carefully, owing to the increasing emphasis on antibiotic surveillance and stewardship programs," said Decision Resources Analyst David Holman, Ph.D. "Nonetheless, we expect hospital-treated infections to remain a key segment of the overall antibiotics market due to the increasing prevalence of multidrug-resistant infections as well as an aging population who are at increased risk of developing serious infections that require hospital treatment."
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