Methicillin-resistant Staphylococcus aureus (MRSA) is an important causative pathogen of a range of hospital-treated infections. The steadily increasing severity of infections caused by MRSA that require hospital treatment and the decreasing susceptibility of this pathogen to current antibiotics continue to drive the need for novel therapies. The success of two agents—linezolid (Pfizer’s Zyvox/Zyvoxid) and daptomycin (Cubist/Novartis/Merck’s Cubicin)—has demonstrated the commercial potential that can be achieved in this market and has contributed to continued interest in drug development for novel antibiotics active against MRSA. With up to eight new emerging therapies set to launch by 2022, the competition within the hospital-treated MRSA (HT-MRSA) market will intensify as a growing number of therapies compete for limited patient share. Therefore, new emerging therapies will find uptake in segments of the HT-MRSA market with high unmet need, helping sustain the market even as key branded agents lose patent protection.
Questions Answered in This Report:
- Glycopeptides, particularly vancomycin, are the standard of care for HT- MRSA infections. Despite the availability of numerous efficacious anti-MRSA therapies—linezolid, daptomycin, tigecycline (Pfizer’s Tygacil/Taigashiru), telavancin (Theravance/Clinigen’s Vibativ), and ceftaroline (Forest’s Teflaro, AstraZeneca’s Zinforo, Dainippon Sumitomo)—vancomycin has remained the most widely used antibiotic for HT-MRSA infections. Over the period under study, we forecast that as many as eight new agents could enter the HT-MRSA market, further diversifying treatment options and increasing competition. How will emerging anti-MRSA agents fare against vancomycin and other current therapies? Can any current or emerging agent unseat vancomycin as the patient share leader? What do experts believe will be the leading therapy for HT-MRSA infections in the future, and why?
- Pfizer’s linezolid is the current sales leader in the HT-MRSA market owing to its interchangeable intravenous and oral formulations, premium price, and increasing use across the major pharmaceutical markets that we cover (United States, France, Germany, Italy, Spain, United Kingdom, and Japan). In addition, linezolid has demonstrated superiority to vancomycin in nosocomial pneumonia due to MRSA in a large post-marketing trial. Further, by 2015, following its patent expiry in the United States, linezolid will face generic competition. How will linezolid’s demonstrated superiority to vancomycin in MRSA pneumonia affect the positioning of these two agents in this indication? To what extent will generic erosion affect sales of this blockbuster product in the HT-MRSA market?
- Late-stage drug development includes both broad-spectrum and targeted, narrow-spectrum agents with MRSA activity. Further, several emerging therapies poised to enter the market within the forecast period have the potential to reduce inpatient days (e.g., availability in oral formulations for early step-down therapy, infrequent dosing allowing for outpatient parenteral antibiotic therapy, or shorter course of therapy allowing for early hospital discharge). How receptive are physicians to these agents, and how will they incorporate these novel agents into clinical practice for treatment of MRSA infections in the hospital setting? What is the commercial potential of these novel agents in the HT-MRSA market?
- Regulatory uncertainty over clinical trial design in nosocomial pneumonia has largely prevented drug developers from initiating late-stage trials in this indication. Therefore, the clinical pipeline is dominated by drugs that target complicated skin and skin structure infections caused by MRSA. How will emerging therapies active against MRSA differentiate themselves in this potentially crowded segment of the HT-MRSA market? Which of emerging anti-MRSA agents will find market success in this increasingly competitive segment of the MRSA market? What do thought leaders believe are areas of high unmet need in the HT-MRSA market?
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 35 country-specific interviews with thought leaders.
Epidemiology: Estimation of the diagnosed events of hospital-treated MRSA infections segmented by key indications.
Population segments in market forecast: Complicated skin and skin structure infections, bloodstream infections, nosocomial pneumonia, complicated intra-abdominal infections, urinary tract infections.
Emerging therapies: Phase II: 5 drugs; Phase III: 6 drugs; preregistration: 1 drugs; registered: 0 drugs.
Market forecast features: Bottom-up, patient-based, annualized sales forecast for HT-MRSA infections by population segment by agent through 2022.
Jacqueline Lyons, M.P.H.