Hospital-Acquired Infections

Pharmacor -- December 2006

  Introduction:

The hospital-acquired infections (HAIs) market is highly fragmented, mature, and competitive.  However, the continual evolution of drug-resistant pathogens, the expanding population of severely ill patients at risk for HAIs, and rising incidence of these infections continue to drive the need for new antibacterial agents. With a pipeline dominated by next-generation antibiotics primarily targeting gram-positive infections, the HAI market offers significant commercial opportunities for agents with novel mechanisms of action and agents that are effective against multidrug-resistant, gram-negative pathogens--a growing clinical concern.

  Questions Answered in This Report:

Vancomycin has dominated the treatment of serious gram-positive infections, including MRSA, for decades. Recently introduced anti-MRSA agents such as linezolid (Pfizer’s Zyvox) and daptomycin (Cubist/Novartis’s Cubicin) have made inroads but have yet to realize their full potential. Three emerging glycopeptides, dalbavancin (Pfizer’s Zeven), Theravance/Astellas’s telavancin, and Targanta’s oritavancin target gram-positive infections, including MRSA. How will these new agents perform in the increasingly crowded gram-positive HAI market?  Are the new agents likely to replace vancomycin in empiric and targeted therapy? What is their commercial potential?

Currently, the cephalosporins are the highest-selling class in the HAI market. Next-generation cephalosporins that have anti-MRSA activity (Johnson & Johnson’s ceftobiprole and Cerexa’s ceftaroline) are expected to launch in the next five years. How receptive are physicians to the new anti-MRSA cephalosporins, a class not traditionally used for treatment of serious gram-positive infections?  Will Johnson & Johnson succeed in positioning ceftobiprole, potentially the first-to-market anti-MRSA cephalosporin, as a broad-spectrum agent suitable for empiric therapy? Is there room for another anti-MRSA cephalosporin? What is the commercial potential for ceftaroline and future competitors?

Several companies have invested substantial resources in the development of therapeutic antibodies that target specific pathogens, but only a few products remain in active development, and even fewer are likely to launch. What do thought leaders believe about the clinical utility and future of antibody-based therapies for the treatment of HAIs? What indications and patient populations will these therapies target? What formulary hurdles must antibody-based therapies overcome to achieve use in clinical practice and commercial success?

The treatment of HAIs is often empiric; product selection is based in part on suspicion of the pathogens that are the likely cause of infection. The distribution of pathogens associated with HAIs varies according to the site of infection. What is the pathogen distribution for each of the most frequently occurring HAI sites? How many incident cases of HAIs are caused by a particular pathogen annually?

  Scope:

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

Primary research: Forty-four 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 surgical site infections and complicated skin and soft tissue infections (SSI/cSSTIs).

Population segments in market forecast: UTIs, HAP, BSIs, SSI/cSSTIs.

Emerging therapies: Phase II, 4 drugs; Phase III, 8 drugs; preregistration, 2 drugs; registered, more than 32 drugs.

Market forecast features:  Patient-based sales forecast for the four major HAI indications (UTIs, HAP, BSIs, and SSI/cSSTIs) by agent through 2015.