Last Updated 15 December 2014
Hospital-treated infections (HTIs) constitute a high-value segment of the antibacterial market owing to their severity, which drives the use of potent and branded antibiotics, compared with infections that can be treated solely in the outpatient setting. In addition, common pathogens and antimicrobial resistance in HTIs often necessitate the administration of high-cost, fast-acting intravenous antibiotics with activity against drug-resistant pathogens. However, because this market is already well served with many generically available agents from a range of drug classes, new and emerging therapies will find firm competition from established standard-of-care therapies. In addition, greater implementation of antimicrobial stewardship programs and cost-containment measures will likely further restrict the use of newer agents to later lines of therapy to reduce the risk of drug resistance development and minimize overall healthcare expenditures. Despite these challenges, the expanding population of at-risk patients and the growing rates of multidrug resistance, especially among gram-negative pathogens (GNPs), will provide commercial opportunities for novel agents. With many new therapies launching within the forecast period as well as entry of generic versions of key HTI brands, marketers will need to highlight efficacy and pharmacoeconomic benefits in order to succeed in the increasingly competitive HTI market.
Questions Answered in This Report:
- During the 2013-2023 forecast period, overall growth of the HTI market will be constrained as key branded drugs face patent expiry. Generic launches during the forecast period are anticipated for the following drugs: moxifloxacin (Bayer/Merck’s Avelox); linezolid (Pfizer’s Zyvox/Zyvoxid); doripenem (Johnson & Johnson’s Doribax; Shionogi’s Finibax); ertapenem (Merck’s Invanz); tigecycline (Pfizer’s Tygacil/Taigashiru); daptomycin (Cubist/Novartis/Merck’s Cubicin); and ceftaroline (Actavis/Sumitomo Dainippon’s Teflaro, AstraZeneca’s Zinforo). What impact will generic erosion have on sales in the HTI market? Will the launch of many new, premium-priced therapies offset sales losses from generic erosion of leading brands?
- The changing regulatory landscape in the United States and Europe has created a misalignment between the FDA and EMA clinical trial recommendations, which puts pressure on drug developers to optimize clinical trial design in order to gain favorable assessment from either agency. How are developers navigating the current regulatory environment and accommodating different FDA and EMA primary end points in registration trials? What other regulatory hurdles will developers face in bringing new antibiotics to the HTI market over the forecast period?
- A diverse clinical pipeline is expected to deliver many new antibiotics for HTIs during the 2013-2023 forecast period. Many of these therapies target already well-served indications, such as complicated skin and skin structure infections. How will these therapies be positioned in an increasingly competitive HTI market? To what degree will new agents with MRSA activity challenge vancomycin (generics), the currently preferred therapy for MRSA infections? What key attributes will allow emerging therapies to differentiate themselves from existing products?
- The treatment of gram-negative infections (GNIs), mainly drug-resistant GNIs, is a facet of the HTI market with relatively high unmet need. Emerging therapies that target pan-resistant GNPs such as carbapenem-resistant Enterobacteriaceae or Acinetobacter spp. will gain patient share as physicians encounter an increasing number of these rare yet deadly infections. What are the challenges facing drug developers in this segment of the HTI market? Which therapies will have the greatest commercial success in addressing this area of unmet need? What opportunities remain in the HTI antibiotic market?
- Emergence of pan-resistant GNPs has prompted the FDA to issue guidance for the development of antimicrobial agents for patients with high unmet need. How will this potentially streamlined process affect design and cost of late-stage development of antimicrobial agents with activity against pan-resistant pathogens? Which agents in the late-stage development pipeline are candidates for this new developmental pathway?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 21 country-specific interviews with thought leaders.
Epidemiology: Estimates of the HTI patient population by indication (urinary tract infections [UTIs], complicated skin and skin structure infections/surgical site infections [cSSSIs/SSIs], nosocomial pneumonia [NP]—including hospital-acquired bacterial pneumonia [HABP], healthcare-associated pneumonia [HCAP], and ventilator-associated bacterial pneumonia [VABP]—bloodstream infections [BSIs], and complicated intra-abdominal infections [cIAIs]).
Population segments in market forecast: UTIs, cSSSI/SSIs, NP, BSIs, and cIAIs.
Emerging therapies: Phase III: 3 drugs; preregistration: 2 drugs; registered: 3 drugs. Coverage of other select products, including 2 drugs in Phase I, 6 drugs in Phase II, and 2 drugs in Phase III clinical trials.
Kristin Dorfman, M.P.H., M.S.