Gram-negative infections (GNIs) comprise a large portion of hospital-treated infections (HTIs), which represent a high-value segment of the antibacterial market given the severity of these infections. In the past developers have focused heavily on anti-gram-positive therapies, like those against MRSA, which has allowed the number of antibiotics for GNIs in late-stage pipeline to dwindle. Therefore, the GNI market provides wide market opportunity for developers that can tackle segments of unmet need. In particular, rising multidrug resistance (MDR) in key gram-negative pathogens (GNPs) (e.g., Pseudomonas aeruginosa, Acinetobacter baumannii, Escherichia coli, and Klebsiella pneumoniae) leave physicians with limited therapeutic options. With fewer alternatives, high volume use of a few current agents creates selective pressure for the further development of drug-resistance to therapy. Therefore, opportunity awaits developers who can provide therapies that not only overcome drug-resistance to current therapies, but are safe and tolerable and can stave off emergence of antibiotic-resistance by using novel mechanisms of action.
Questions Answered in This Report:
- Currently available therapies for the treatment of GNIs are experiencing a reduction in efficacy because of the rising prevalence of drug-resistance among GNPs. Which current therapies are most at risk of losing share because of rising drug-resistance rates? Which emerging brands stand to benefit the most from this trend?
- In the past few years, regulatory agencies have developed initiatives and changed regulatory policies in order to entice pharmaceutical companies to re-enter the antibiotics space. How will drug developers take advantage of these programs? How will these programs affect market access for new agents, particularly those that provide significant improvements over standard of care for the treatment of infections caused by MDR GNPs?
- The GNI market will see growth in the older patient population who are at greater risk for contracting GNIs in the healthcare settings (e.g., hospitals, nursing homes, long-term care facilities). How will this shift in patient segment affect medical practices across the major markets? What impact will it have on drug sales?
- A diverse clinical pipeline is poised to deliver up to five new antibiotics in the GNI market during the 2013-2023 forecast period. How will these emerging therapies be positioned in an increasingly crowded GNI market? How will emerging therapies compete with currently marketed products, many of which will be available generically within the 2013-2023 forecast period?
- Antimicrobial stewardship programs are becoming more common in large community hospitals. These programs are aimed at promoting judicious use of antibiotics, namely newer branded agents with activity against drug-resistant GNP strains. How will stewardship programs impact the uptake of emerging therapies across the major markets?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 22 country-specific interviews with thought leaders.
Epidemiology: Estimates of the GNI patient population by indication: nosocomial pneumonia (NP), including hospital-acquired pneumonia, healthcare-associated pneumonia, and ventilator-associated pneumonia, complicated skin and skin structure infections/surgical-site infections (cSSSIs/SSIs), bloodstream infections (BSIs), complicated intra-abdominal infections (cIAIs), and urinary tract infections (UTIs).
Population segments in market forecast: NP, cSSSI/SSIs, BSIs, cIAIs, and UTIs.
Emerging therapies: Phase II: 5 drugs; Phase III: 5 drugs; preregistration: 2 drugs; registered: 0 drugs. Coverage of 7 select preclinical and Phase I products.
Market forecast features: Patient-based annualized sales forecast for the five major indications (NP, cSSSI/SSIs, BSIs, cIAIs, and cUTIs) by agent through 2023.
Kristin Dorfman, M.P.H., M.S.