Introduction:
Gram-negative bacteria cause a wide range of infections in
both the hospital and community settings. However, because of their
pathogenicity and resistance to antibiotics, gram-negative infections (GNIs)
acquired in the hospital setting are the most challenging to treat (and are the
focus of this report). Hospital-acquired gram-negative infections (GNIs)
represent an area of high unmet need and untapped drug development opportunity
in the antibacterial market. This market is characterized by rising antibiotic
resistance in key gram-negative pathogens (
Pseudomonas aeruginosa,
Acinetobacter baumannii, Escherichia coli, and
Klebsiella pneumoniae), a
lean late-stage pipeline, and limited current treatment options. The
greatest near-term opportunity in the hospital-acquired GNI market is in the
development of agents that can rescue the activity of older antibiotics by countering
specific mechanisms of resistance (e.g., beta-lactamase inhibitors). Long-term
opportunity lies in the development of a potent antibiotic with a novel
mechanism of action that is active against multidrug-resistant gram-negative
pathogens.
Questions Answered in This Report:
*
As many as eight new antibiotics from several existing classes,
including cephalosporins, beta-lactam/beta-lactamase inhibitors, carbapenems,
and quinolones, have the potential to launch in the next ten years in the
hospital-acquired GNI market.
What are physicians’ opinions about the
clinical potential of these agents? Which emerging agents are most promising?
How will these agents be incorporated into medical practice to specifically
treat hospital-acquired GNIs? Which of these therapies will have the greatest
impact on the hospital-acquired GNI market?
*
Drug-resistant gram-negative pathogens, such as
carbapenemase-producing
K. pneumoniae, multidrug-resistant (MDR)
Pseudomonas
species, and MDR
Acinetobacter species are becoming more prevalent and
increasingly challenging to treat with the current arsenal of antibiotics.
How is medical practice changing for the treatment of such challenging
hospital-acquired GNIs? How will emerging therapies address these challenges?
What prescribing trends do physicians expect to see in the coming years?
*
A few highly potent, broad-spectrum branded antibiotics—Wyeth’s
Zosyn/Tazocin, Johnson & Johnson’s Levaquin, Merck’s Primaxin, and
Cubist Pharmaceuticals/AstraZeneca’s Merrem/Meronem—have fueled growth
in the GNI market over the past ten years. Expected patent expiries of these
products may allow entry of generics during the 2008-2018 forecast period.
To what extent will generic erosion of these key products affect sales in the
hospital-acquired GNI market? Will emerging therapies be able to recoup lost
sales of leading brands? Which classes will continue to be commercially
successful in the face of generic competition?
*
The pipeline of therapies in early-stage development comprises
a variety of interesting new classes and novel approaches for the treatment of
hospital-acquired GNIs, including antibodies against drug-resistant, nosocomial
gram-negative pathogens (e.g.,
P. aeruginosa).
How receptive are
physicians to such approaches? What are the most promising early-stage
therapies in the pipeline for hospital-acquired GNIs?Scope:
Markets covered: United States, France, Germany, Italy,
Spain, United Kingdom, Japan.
Primary research: 22 country-specific interviews with
thought leaders.
Epidemiology: Diagnosed events of hospital-acquired
infections in the major pharmaceutical markets; estimates of gram-negative
drug-treated populations in the major pharmaceutical markets.
Population segments in market forecast: Urinary tract
infections, nosocomial pneumonia (includes hospital-acquired and
healthcare-associated pneumonia), bloodstream infections, complicated skin and
skin structure infections/surgical site infections.
Emerging therapies: Phase II: 10 drugs; Phase III: 3
drugs; preregistration: 1 drug; registered: 2 drugs. Coverage of 31
select preclinical and Phase I products.
Market forecast features: Using data from the Arlington
Medical Resources, Inc. (AMR; a Decision Resources company), Hospital
Antibiotic Market Guide, we estimate the number of patients currently treated
in a hospital setting with an antibiotic that is active against gram-negative
pathogens. This approach informs our estimates for size of the candidate
population that can be targeted by current and emerging agents in the GNI market.