Hospital-Acquired Infections

Pharmacor -- May 2008

  Introduction:

Hospital-acquired infections (HAIs) represent a high-value, high-unmet-need segment of the antibacterial market. This space is characterized by an expanding population of at-risk patients and growing prevalence and diversity of antibiotic-resistant pathogens. Over the last two decades, drug development for HAIs has focused on gram-positive pathogens, namely methicillin-resistant Staphylococcus aureus (MRSA). As a result, the pipeline is saturated with agents targeting gram-positive infections. Drug developers seeking commercial success in the HAI market will face stiff competition from established therapies, heightened regulatory scrutiny, and more stringent reimbursement policies. Despite these challenges, commercial success awaits a novel therapy with potent activity against drug-resistant gram-negative pathogens. Since we last reported on HAI, a number of regulatory delays or setbacks have occurred in the approval of products targeting resistant gram-positive infections, including dalbavancin, telavancin, and ceftobiprole.

  Questions Answered in This Report:

Drugs targeting gram-positive infections, namely complicated skin and skin structure infections caused by MRSA, dominate the HAI pipeline. As many as five MRSA therapies, including novel glycopeptides, cephalosporins, and diaminopyrimidines, are poised to enter the market over the next five years. To what degree will these new MRSA agents challenge vancomycin’s dominance in the HAI market? How will they be incorporated into medical practice? Which therapies will have the greatest impact on the HAI market?

Several branded products, including Wyeth’s Zosyn (piperacillin/tazobactam), Johnson & Johnson’s Levaquin (levofloxacin), Pfizer’s Zyvox (linezolid), and Merck’s Primaxin (imipenem/cilastatin), have been key drivers of growth in the HAI market over the past decade. However, these top-selling products will face generic competition during our 2007-2017 forecast period. To what extent will generic erosion affect sales in the HAI market? Will emerging therapies be able to recoup lost sales of leading brands?

Johnson & Johnson/Basilea’s ceftobiprole and Forest Laboratories’ ceftaroline are promising cephalosporins that combine the safety and broad-spectrum coverage of their predecessors with expanded activity against MRSA. How receptive are physicians to these MRSA cephalosporins? Which current therapies are most vulnerable to being replaced by ceftobiprole and ceftaroline? What are the strengths and weaknesses of these agents, and how will these characteristics affect their commercial success?

  Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, and Japan.

Primary research: Thirty-six country-specific interviews with thought leaders, infectious disease specialists, and critical care specialists.

Epidemiology: Estimates of the HAI patient population by indication (urinary tract infections [UTIs], hospital-acquired pneumonia [HAP], bloodstream infections [BSIs], and complicated skin and skin structure infections/surgical site infections [cSSSIs/SSIs]).

Population segments in market forecast: UTIs, HAP, BSIs, and cSSSIs/SSIs.

Emerging therapies: Phase II: 3 drugs; Phase III: 1 drug; preregistration: 5 drugs; registered: 1 drug. Coverage of 2 select preclinical and Phase I products.

Market forecast features: Patient-based sales forecast for the four major HAI indications (UTIs, HAP, BSIs, cSSSI/SSIs) by agent through 2017.