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Antibacterial Drug Resistance: Expanding Opportunities in the Hospital Market
Decision Resources, Inc., April 2005, Pages: 16


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Antibacterial resistance has always been an important driver of innovation for new antibacterial agents. Over the past 10-15 years, resistance to antibacterials in the hospital setting has risen dramatically. Although they are niche segments with relatively small patient populations, hospital-acquired drug-resistant infections represent the few remaining areas of high unmet medical need within the antibacterial market. With many Big Pharma companies recently choosing to withdraw from active competition in this market, these niche sectors may represent substantial new opportunities for smaller pharmaceutical companies.

In this report, we provide an overview of the mechanisms of resistance and the key pathogens involved in these resistant infections, discuss the impact of antibacterial resistance on outcomes and cost, highlight advantages and challenges of development in this market, outline the ideal characteristics of a novel hospital-based antibacterial, and review the near-term pipeline.

Business Implications
- In the highly mature and competitive antibacterial market, hospital-acquired drug-resistant infections represent the few remaining areas of high unmet medical need and expanding commercial opportunity. The significant morbidity, mortality, and cost associated with drug-resistant infections provide an important clinical incentive for development and allow companies to justify relatively premium pricing in this market. Furthermore, expected growth in the patient population, driven by demographic changes and an expanding population of critically ill patients, will fuel future growth.

- Methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), Enterobacteriaceae, Pseudomonas aeruginosa, and Acinetobacter species represent several of the most important drug-resistant pathogens that have been the focus of antibacterial R&D activity in recent years. With the availability of several products active against MRSA and VRE (e.g., linezolid [Pfizer’s Zyvox], daptomycin [Cubist’s Cubicin]), the most significant emerging threat has shifted to the gram-negative pathogens (Enterobacteriaceae, P. aeruginosa, and Acinetobacter sp.), which in many cases are resistant to most first-line antibacterials.

- Several factors make the hospital antibacterial market a potentially attractive market for small pharmaceutical firms. Its relatively concentrated customer base allows a small company to commercialize a product with a relatively modest sales force. Furthermore, the divestment of many major pharmaceutical companies from antibacterials in recent years provides opportunity for smaller companies that are willing to accept more modest revenue streams within niche segments.

- Many factors will influence the commercial success of an antibacterial agent targeting drug-resistant hospital-acquired infections. Among the most important attributes is activity against all relevant pathogens within a spectrum range (e.g., all staphylococci, streptococci, and enterococci for a product targeting gram-positive infections). Additional features that are important in the hospital setting include the availability of interchangeable oral/parenteral forms, once-daily dosing, and products with an inherently lower propensity to induce resistance in pathogens.




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