Methicillin-Resistant Staphylococcus aureus (MRSA) - 5EU Drug Forecast and Market Analysis to 2024 Summary With the discovery of penicillin, the first naturally-occurring antibiotic, in 1928, and its mass production in the early 1940s, infections with Staphylococcus aureus were mostly treatable, without any major complications. However, clinicians soon observed the emergence of penicillin-resistant strains of S. aureus, which was largely driven by bacterial expression of beta-lactamases. Methicillin, a novel penicillin analogue that was resistant to beta-lactamases, was introduced in 1959, and was initially effective against penicillin-resistant S. aureus strains. However, this success was short-lived, as the first methicillin-resistant S. aureus (MRSA) strain had been identified in the lab by 1961, and cases of MRSA were first observed in the clinic in 1968. Initially, MRSA strains only occurred in small and local outbreaks across the US and Europe, but they can now be found around the world. For the purposes of this report, GlobalData defines the 5EU MRSA market as encompassing the sales of antimicrobial agents prescribed for the treatment of hospitalized MRSA skin infections, pneumonia, and bacteremia in France, Germany, Italy, Spain, and the UK. Importantly, revenues generated by these products outside of the aforementioned countries, patient populations, and clinical scenarios are beyond the Scope of this analysis. *This is an on-demand report and will be delivered within 24 hrs. (excluding weekends) of the purchase. Scope - Overview of MRSA including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape. - Detailed information on the key drugs in 5EU including product description, safety and efficacy profiles as well as a SWOT analysis. - Sales forecast for the top drugs in 5EU from 2014-2024. - Analysis of the impact of key events as well the drivers and restraints affecting 5EU MRSA market. Reasons To Buy - Understand and capitalize by identifying products that are most likely to ensure a robust return - Stay ahead of the competition by understanding the changing competitive landscape for MRSA. - Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential - Make more informed business decisions from insightful and in-depth analysis of drug performance - Obtain sales forecast for drugs from 2014-2024 in 5EU.
Table of Contents
1.1 List of Tables 1.2 List of Figures 2 Introduction 2.1 Catalyst 2.2 Related Reports 2.3 Upcoming Related Reports 3 Disease Overview 3.1 Etiology 3.1.1 MRSA Strains 3.1.2 VISA Strains 3.1.3 VRSA Strains 3.2 Pathophysiology 3.2.1 Infection Sites 3.2.2 Expression of Virulence Factors 3.2.3 Mechanisms of Antibiotic Resistance 3.2.4 Biofilm Formation 3.3 Symptoms 3.4 Prognosis 3.4.1 Skin and Soft Tissue Infections 3.4.2 Pneumonia 3.4.3 Bacteremia 3.4.4 Chronic MRSA Infection 4 Disease Management 4.1 Diagnosis and Treatment Overview 4.1.1 Diagnosis 4.1.2 Treatment Guidelines 4.1.3 Clinical Practice 4.2 5EU 4.2.1 Forecast 4.2.2 Key Events 4.2.3 Drivers and Barriers 5 Competitive Assessment 5.1 Overview 5.2 Product Profiles - Glycopeptides and Lipoglycopeptides 5.2.1 Vancomycin 5.2.2 Dalvance (dalbavancin) 5.2.3 Orbactiv (oritavancin) 5.2.4 Vibativ (telavancin) 5.2.5 Targocid (teicoplanin) 5.3 Product Profiles - Lipopeptides 5.3.1 Cubicin (daptomycin) 5.4 Product Profiles - Oxazolidinones 5.4.1 Zyvox (linezolid) 5.4.2 Sivextro (tedizolid phosphate) 5.5 Product Profiles - Cephalosporins 5.5.1 Teflaro (ceftaroline fosamil) 5.5.2 Zevtera (ceftobiprole medocaril) 5.6 Product Profiles - Glycylcyclines 5.6.1 Tygacil (tigecycline) 5.7 Other Antimicrobial Agents 6 Unmet Need and Opportunity 6.1 Overview 6.2 Drugs with Demonstrated Efficacy in Difficult-to-Treat Patient Populations 6.2.1 Unmet Need 6.2.2 Gap Analysis 6.2.3 Opportunity 6.3 Expand Breadth of Clinical Data Outside of Skin Infections 6.3.1 Unmet Need 6.3.2 Gap Analysis 6.3.3 Opportunity 6.4 Physician Education 6.4.1 Unmet Need 6.4.2 Gap Analysis 6.4.3 Opportunity 6.5 Antibiotics with More Convenient Formulations and Dosing Schedules 6.5.1 Unmet Need 6.5.2 Gap Analysis 6.5.3 Opportunity 6.6 Innovative Approaches to Clinical Trial Design 6.6.1 Unmet Need 6.6.2 Gap Analysis 6.6.3 Opportunity 6.7 Drugs with Novel Mechanisms of Action 6.7.1 Unmet Need 6.7.2 Gap Analysis 6.7.3 Opportunity 6.8 More Affordable Therapies 6.8.1 Unmet Need 6.8.2 Gap Analysis 6.8.3 Opportunity 7 Pipeline Assessment 7.1 Overview 7.2 Promising Drugs in Late-Stage Clinical Development 7.2.1 Delafloxacin (RX-3341) 7.2.2 Solithromycin (CEM-101) 7.2.3 Omadacycline (PTK-0796) 7.2.4 KRP-AM1977X 7.2.5 Taksta (fusidic acid, oral tablets) 7.2.6 Lefamulin (BC-3781) 7.2.7 Debio1450 (Debio1452 prodrug) 7.2.8 Brilacidin 7.3 Other Promising Products in Clinical Development 8 Market Outlook 8.1 5EU 8.1.1 Forecast 8.1.2 Key Events 8.1.3 Drivers and Barriers 9 Appendix 9.1 Bibliography 9.2 Abbreviations 9.3 Methodology 9.4 Forecasting Methodology 9.4.1 Hospitalized MRSA Patients 9.4.2 Percentage of Drug-Treated MRSA Patients 9.4.3 Drugs Included in Each Therapeutic Class 9.4.4 Launch, Label Expansion, and Patent Expiry Dates 9.4.5 General Pricing Assumptions 9.4.6 Individual Drug Assumptions 9.4.7 Generic Erosion 9.4.8 Pricing of Pipeline Agents 9.5 Primary Research - KOLs Interviewed for This Report 9.6 Primary Research - Prescriber Survey 9.7 About the Authors 9.7.1 Author and Therapy Area Director 9.7.2 Author 9.7.3 Epidemiologist 9.7.4 Global Director of Therapy Analysis and Epidemiology 9.7.5 Global Head of Healthcare 9.8 About GlobalData 9.9 Disclaimer
List of Tables
Table 1: Symptoms of MRSA-Associated Infections Table 2: National and International Treatment Guidelines for MRSA Infections Table 3: Sales Forecasts ($m) for MRSA in the 5EU, 2014-2024 Table 4: Key Events Impacting Sales for MRSA in the 5EU, 2014-2024 Table 5: MRSA Therapeutics Market - Drivers and Barriers in the 5EU, 2014-2024 Table 6: National Healthcare Authorities and Government Drug Pricing Authorities in the 5EU Nations Table 7: Leading Branded Treatments for MRSA, 2015 Table 8: Product Profile - Vancomycin Table 9: Vancomycin SWOT Analysis, 2015 Table 10: Global Sales Forecasts ($m) for Vancomycin, 2014-2024 Table 11: Product Profile - Dalvance Table 12: Efficacy of Dalvance - Primary and Secondary Endpoints, DISCOVER 1 and DISCOVER 2 Table 13: Safety of Dalvance - Frequency of AEs, DISCOVER 1 and DISCOVER 2 Table 14: Dalvance SWOT Analysis, 2015 Table 15: Global Sales Forecasts ($m) for Dalvance, 2014-2024 Table 16: Product Profile - Orbactiv Table 17: Efficacy of Orbactiv - Primary and Secondary Endpoints, SOLO I and SOLO II Table 18: Safety of Orbactiv - Frequency of AEs, SOLO I and SOLO II Table 19: Orbactiv SWOT Analysis, 2015 Table 20: Global Sales Forecasts ($m) for Orbactiv, 2014-2024 Table 21: Product Profile - Vibativ Table 22: Efficacy of Vibativ - Pooled Primary and Secondary Endpoints, ATLAS 1 and ATLAS 2 Table 23: Safety of Vibativ - Frequency of AEs, ATLAS and ATTAIN Phase III Programs Table 24: Vibativ SWOT Analysis, 2015 Table 25: Global Sales Forecasts ($m) for Vibativ, 2014-2024 Table 26: Product Profile - Targocid Table 27: Targocid SWOT Analysis, 2015 Table 28: Global Sales Forecasts ($m) for Targocid, 2014-2024 Table 29: Product Profile - Cubicin Table 30: Efficacy of Cubicin - Pooled Clinical Success Rates by Causative Pathogen, cSSSI Trials Table 31: Safety of Cubicin - Frequency of AEs and SAEs Table 32: Cubicin SWOT Analysis, 2015 Table 33: Global Sales Forecasts ($m) for Cubicin, 2014-2024 Table 34: Product Profile - Zyvox Table 35: Efficacy of Zyvox - Primary and Secondary Endpoints, cSSSI Study in Adults Table 36: Safety of Zyvox - Frequency of Treatment-Emergent AEs Table 37: Zyvox SWOT Analysis, 2015 Table 38: Global Sales Forecasts ($m) for Zyvox, 2014-2024 Table 39: Product Profile - Sivextro Table 40: Efficacy of Sivextro - Primary and Secondary Endpoints, ESTABLISH Phase III Program Table 41: Safety of Sivextro - Frequency of Treatment-Emergent AEs, ESTABLISH-1 and ESTABLISH-2 Table 42: Sivextro SWOT Analysis, 2015 Table 43: Global Sales Forecasts ($m) for Sivextro, 2014-2024 Table 44: Product Profile - Teflaro Table 45: Efficacy of Teflaro - Pooled Primary and Secondary Endpoints, FOCUS 1 and FOCUS 2 Table 46: Safety of Teflaro - Frequency of AEs, FOCUS and CANVAS Phase III Programs Table 47: Teflaro SWOT Analysis, 2015 Table 48: Global Sales Forecasts ($m) for Teflaro, 2014-2024 Table 49: Product Profile - Zevtera Table 50: Efficacy of Zevtera - Primary and Endpoints, HABP and CABP Phase III Studies Table 51: Safety of Zevtera - Frequency of AEs, HABP and CABP Phase III Studies Table 52: Zevtera SWOT Analysis, 2015 Table 53: Global Sales Forecasts ($m) for Zevtera, 2014-2024 Table 54: Product Profile - Tygacil Table 55: Tygacil SWOT Analysis, 2015 Table 56: Global Sales Forecasts ($m) for Tygacil, 2014-2024 Table 57: Summary of Other Antimicrobial Agents Used for S. aureus and MRSA, 2015 Table 58: Unmet Need and Opportunity in MRSA, 2015 Table 59: Key Late-Stage Pipeline Agents for MRSA, 2015 Table 60: Product Profile - Delafloxacin Table 61: Delafloxacin SWOT Analysis, 2015 Table 62: Global Sales Forecasts ($m) for Delafloxacin, 2014-2024 Table 63: Product Profile - Solithromycin Table 64: Solithromycin SWOT Analysis, 2015 Table 65: Global Sales Forecasts ($m) for Solithromycin, 2014-2024 Table 66: Product Profile - Omadacycline Table 67: Omadacycline SWOT Analysis, 2015 Table 68: Global Sales Forecasts ($m) for Omadacycline, 2014-2024 Table 69: Product Profile - KRP-AM1977X Table 70: KRP-AM1977X SWOT Analysis, 2015 Table 71: Global Sales Forecasts ($m) for KRP-AM1977X, 2014-2024 Table 72: Product Profile - Taksta Table 73: Taksta SWOT Analysis, 2015 Table 74: Global Sales Forecasts ($m) for Taksta, 2014-2024 Table 75: Product Profile - Lefamulin Table 76: Lefamulin SWOT Analysis, 2015 Table 77: Global Sales Forecasts ($m) for Lefamulin, 2014-2024 Table 78: Product Profile - Debio1450 Table 79: Debio1450 SWOT Analysis, 2015 Table 80: Global Sales Forecasts ($m) for Debio1450, 2014-2024 Table 81: Product Profile - Brilacidin Table 82: Brilacidin SWOT Analysis, 2015 Table 83: Global Sales Forecasts ($m) for Brilacidin, 2014-2024 Table 84: Other Promising Pipeline Products for MRSA, 2015 Table 85: Sales Forecasts ($m) for MRSA in the 5EU, 2014-2024 Table 86: Key Events Impacting Sales for MRSA in the 5EU, 2014-2024 Table 87: MRSA Therapeutics Market - Drivers and Barriers in the 5EU, 2014-2024 Table 88: National Healthcare Authorities and Government Drug Pricing Authorities in the 5EU Nations Table 89: Key Historical and Projected Launch Dates for MRSA Across the 7MM Table 90: Key Historical and Projected Label Expansion Dates for MRSA Across the 7MM Table 91: Key Historical and Projected Patent Expiry Dates for MRSA Across the 7MM Table 92: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
List of Figures
Figure 1: The MRSA SCCmec Gene Cluster Figure 2: Sites of S. aureus Infection Figure 3: Cartoon Depicting the Key Mechanisms of Antibiotic Resistance Observed in S. aureus Figure 4: Sales for MRSA Therapeutics by Drug Class in the 5EU, 2014 and 2024 Figure 5: Sales for MRSA Therapeutics by Country in the 5EU, 2014-2024 Figure 6: MRSA Therapeutics - Phase III/Phase II Pipeline, 2015 Figure 7: Competitive Assessment of the Recently Approved and Late-Stage Pipeline Agents in MRSA, 2014-2024 Figure 8: Sales for MRSA Therapeutics by Drug Class in the 5EU, 2014 and 2024 Figure 9: Sales for MRSA Therapeutics by Country in the 5EU, 2014-2024
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