Methicillin-resistant Staphylococcus aureus (MRSA) is a clinically important gram-positive pathogen found in both the hospital and outpatient settings. The newly marketed oritavancin (The Medicine Company’s Orbactiv), dalbavancin (Allergan’s Dalvance/Xydalba), and tedizolid (Bayer HealthCare/Merck’s Sivextro) have greatly increased treatment options for MRSA infections, making the hospital-treated MRSA market highly competitive. Within this crowded space, new agents will need to demonstrate improvements over current therapies and justify their premium pricing in light of significant competition, including that coming from generics. This report provides a comprehensive overview and analysis of the epidemiology, patient populations, and current and emerging medical practice and therapies for MRSA infections in the major pharmaceutical markets. The insights presented in this report are derived from primary and secondary research, company presentations and sales data, and detailed interviews with recognized key opinion leaders (KOLs). This report includes a 2016-2026, epidemiology-based, annualized, bottom-up forecast of current and emerging MRSA therapies in the major pharmaceutical markets.

Questions Answered:

  • Because of the many agents in the HT-MRSA therapy market, understanding the positioning of these therapies in the hospital setting is essential for identifying remaining unmet needs. What do experts think about the available therapies for MRSA, and how are these agents currently used in hospital settings?
  • During the forecast period, at least six new antibiotics are expected to launch, and two key MRSA drugs, linezolid and daptomycin, will continue to experience generic erosion across all major markets. Understanding the dynamics of the HT-MRSA market is key to positioning a company’s agent in this highly competitive space. Which currently available and emerging MRSA therapies are poised for commercial success over the 2016-2026 forecast period?
  • The HT-MRSA infection market will be crowded; more than 20 antibiotics are included in the market forecast. Identifying unmet needs among underserved patient populations is critical to developing the appropriate strategies for commercial success. What are the areas of greatest unmet need in the MRSA market, and how will emerging brands address these needs?
  • Public health agencies have always considered controlling and preventing MRSA infection one of their top priorities. As such, these agencies have developed a number of policies to target MRSA infection. Given the recent positive impact of some of these policies on drug-resistance and infection rates, such as the implementation of antimicrobial stewardship, these policies are expected to play a key role in the uptake of new antibiotics. How will changing regulatory policies regarding antibiotic use and antibiotic resistance affect the development and positioning of novel antibiotics for MRSA?

Scope:

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

Primary research: 31 country-specific interviews with infectious disease specialists.

Epidemiology: Diagnosed events of the MRSA population by country and indication, including hospital- and community-acquired MRSA.

Population segments in market forecast: Complicated skin and skin structure infections (cSSSIs) and surgical site infections (SSIs), bloodstream infections (BSIs), complicated intra-abdominal infections (cIAIs), urinary tract infections (UTIs), and nosocomial pneumonia (NP).

Emerging therapies: Phase III: 7 drugs; Phase II: 7 drugs.

Table of contents

  • Methicillin-Resistant Staphylococcus Aureus Infections - Landscape & Forecast - Disease Landscape & Forecast
    • Key Updates
      • September 2017
      • May 2017
    • Executive Summary
      • Key Findings
        • Market Share of MRSA Drug Classes in 2016
        • Market Share of MRSA Drug Classes in 2026
        • Hospital-Treated Methicillin-Resistant Staphylococcus Aureus SWOT Analysis
    • Market Outlook
      • Market Drivers and Constraints
        • What Factors Are Driving the Market for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus?
        • What Factors Are Constraining the Market for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus?
        • Key Market Events for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Major-Market Sales of Key Antibiotic Classes for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections, 2016-2026
        • Patient Share of Vancomycin, Linezolid, and Tedizolid in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Nosocomial Pneumonia, 2016-2026
        • Major-Market Patient Share of Branded and Generic Drugs for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections, 2016-2026
        • Major-Market Share of Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections, by Indication, 2016
      • Drug-Class Specific Trends
        • Major-Market Sales of Glycopeptides/Lipoglycopeptides in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections, 2016-2026
        • Patient Share of Daptomycin in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections, by Region, 2016-2026
        • Major-Market Sales and Treated Patients for Branded and Generic Oxazolidinones in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections, 2016-2026
        • Major-Market Sales and Treated Patients for Branded and Generic Cephalosporins in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections, 2016-2026
    • Forecast
      • Sales of Drugs for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections in the Major Pharmaceutical Markets, 2016-2026
    • Etiology and Pathophysiology
      • Etiology
        • Definitions of Select Antibiotic-Resistant Staphylococcus Aureus
        • Mechanisms of Antibiotic Resistance in Methicillin-Resistant Staphylococcus Aureus
        • Differences Between Hospital-Acquired and Community-Acquired Methicillin-Resistant Staphylococcus Aureus
      • Pathophysiology
        • Virulence Factors of Methicillin-Resistant Staphylococcus Aureus
        • Risk Factors for Methicillin-Resistant Staphylococcus Aureus Carriage and Infection in the Hospital Setting
        • Risk Factors for Methicillin-Resistant Staphylococcus Aureus Carriage and Infection in the Community Setting
        • Major Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Strategies for the Prevention and Control of Methicillin-Resistant Staphylococcus Aureus
      • Key Pathways and Drug Targets
        • Key Drug Targets for Methicillin-Resistant Staphylococcus Aureus Infections
    • Current Treatment Overview
      • Key Findings
        • Expert Insight
        • Disease Overview
      • Treatment Goals
        • Key End Points Used in Clinical Trials for MRSA Infections
        • Key Physician Insights on Clinical End Points
      • Key Current Therapies
        • Overview
        • Mechanism of Action of Key Current Drug Classes Used for HT-MRSA Infections
        • Current Therapies Used for HT-MRSA Infections
        • Market Events Impacting the Use of Key Current Therapies for MRSA Infections
        • Vancomycin
        • Teicoplanin
        • Telavancin
        • Dalbavancin
        • Oritavancin
        • Advantages and Disadvantages of Glycopeptides/Lipoglycopeptides
        • Expert Insight: Glycopeptides/Lipoglycopeptides
        • Ongoing Clinical Development
        • Key Ongoing Clinical Trials of Glycopeptides/Lipoglycopeptides in the Treatment of MRSA
        • Advantages and Disadvantages of Lipopeptides
        • Expert Insight: Lipopeptides
        • Linezolid
        • Tedizolid
        • Advantages and Disadvantages of Oxazolidinones
        • Expert Insight: Oxazolidinones
        • Ongoing Clinical Development
        • Key Ongoing Clinical Trials of Oxazolidinones in the Treatment of MRSA
        • Ceftaroline
        • Ceftobiprole
        • Advantages and Disadvantages of Cephalosporins
        • Expert Insight: Cephalosporins
        • Ongoing Clinical Development
        • Key Ongoing Clinical Trials of Cephalosporins in the Treatment of MRSA
        • Tigecycline
        • Advantages and Disadvantages of Tetracyclines and Tetracycline Derivatives
        • Expert Insight: Tetracyclines and Tetracycline Derivatives
      • Medical Practice
        • Overview
        • Treatment Guidelines
        • Treatment Guidelines for HT-MRSA Infections by Market
        • Drug Selection
        • Treatment Decision Tree for Infections Suspected of Being Caused by MRSA
        • Treatment Decision Tree for UTIs: Major Markets
        • Treatment Decision Tree for BSIs: Major Markets
        • Treatment Decision Tree for NP: Major Markets
        • Treatment Decision Tree for cIAIs: Major Markets
        • Treatment Decision Tree for cSSSIs and SSIs: Major Markets
        • Factors Influencing Drug Selection in HT-MRSA Infections
    • Epidemiology Overview
      • Introduction
        • Key Findings
        • Expert Insight
      • Epidemiology Populations
        • Disease Definition
        • Methods
        • Sources Used for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infection Events by Infection Site
        • Number of Diagnosed Events of Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infection in the Major Pharmaceutical Markets by Infection Site, 2018-2028
        • Number of Diagnosed Events of Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infection in the Major Pharmaceutical Markets by Type of Nosocomial Pneumonia, 2018-2028
        • Diagnosed and Drug-Treated Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infection Events
    • Unmet Need Overview
      • Key Findings
        • Expert Insight
      • Attainment of Unmet Needs
        • Current Attainment of Unmet Needs in MRSA
        • Future Attainment of Unmet Needs
        • Top Unmet Needs in Methicillin-Resistant Staphylococcus Aureus Infections—Current and Future Attainment
    • Emerging Therapies Overview
      • Key Findings
        • Expert Insight
        • Pipeline Trends for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
      • Notable Developments Among Key Emerging Therapies for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Key Emerging Therapies in Development for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Estimated Launch Dates of Key Emerging Therapies for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Delafloxacin Profile
        • Delafloxacin Clinical Development
        • Key Development Milestones for Delafloxacin in the Treatment of Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Expert Insight: Use of Delafloxacin in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Expert Insight: Delafloxacin
        • Expectations for Sales Opportunity of Delafloxacin in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Lascufloxacin Profile
        • Lascufloxacin Clinical Development
        • Key Development Milestones for Lascufloxacin in the Treatment of Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Expert Insight: Use of Lascufloxacin in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Expectations for Sales Opportunity of Lascufloxacin in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Solithromycin Profile
        • Solithromycin Clinical Development
        • Expert Insight: Use of Solithromycin in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Expert Insight: Solithromycin
        • Expectations for Sales Opportunity of Solithromycin in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Omadacycline Profile
        • Omadacycline Clinical Development
        • Key Development Milestones for Omadacycline in the Treatment of Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Expert Insight: Use of Omadacycline in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Expert Insight: Omadacycline
        • Expectations for Sales Opportunity of Omadacycline in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Fusidic Acid (Taksta) Profile
        • Fusidic Acid (Taksta) Clinical Development
        • Key Development Milestones for Fusidic Acid (Taksta) in the Treatment of Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Expert Insight: Use of Fusidic Acid (Taksta) in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Expert Insight: Fusidic Acid (Taksta)
        • Expectations for Launch and Sales Opportunity of Fusidic Acid (Taksta) in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Lefamulin Profile
        • Lefamulin Clinical Development
        • Key Development Milestones for Lefamulin in the Treatment of Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Expert Insight: Use of Lefamulin in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Expert Insight: Lefamulin
        • Expectations for Sales Opportunity of Lefamulin in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infection
        • Iclaprim Profile
        • Iclaprim Clinical Development
        • Key Development Milestones for Iclaprim in the Treatment of Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Expert Insight: Use of Iclaprim in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Expert Insight: Iclaprim
        • Expectations for Launch and Sales Opportunity of Iclaprim in Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
      • Notable Developments in the Early-Phase Pipeline for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections
        • Select Compounds in Early-Phase Development for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus
    • Access and Reimbursement Overview
      • Region-Specific Reimbursement Practices
        • Reimbursement Environment for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections in the United States
        • Reimbursement Environment for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections in France
        • Reimbursement Environment for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infections in Germany
        • Reimbursement Environment for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infection Therapies in Italy
        • Reimbursement Environment for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infection Therapies in Spain
        • Reimbursement Environment for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infection Therapies in the United Kingdom
        • Reimbursement Environment for Hospital-Treated Methicillin-Resistant Staphylococcus Aureus Infection Therapies in Japan
    • Methodology
      • Appendix
        • Key Abbreviations Related to MRSA
        • Brands, Marketers, and Generic Availability of Current Therapies Used for HT-MRSA Infections by Market
        • MRSA Bibliography
        • Supplemental Epidemiology Bibliography

    Author(s): Jiamin Zhuo, PhD

    Jiamin Zhuo, Ph.D., is a business insights analyst on the infectious, niche, and rare diseases team at Decision Resources Group. He provides expert insight into the commercial aspects of drug development and market dynamics in bacterial infections, including gram-negative infections and Methicillin-resistant Staphylococcus aureus.

    He attained his Ph.D. at the Mayo Graduate School, Mayo Clinic, in Minnesota and his B.Sc. in physiology from Peking University in China. Prior to joining DRG, Dr. Zhuo was a postdoctoral fellow at Boston University and MIT, where he gained extensive experience in quantitative research methods.