Methicillin-Resistant Staphylococcus aureus (MRSA) - Japan 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 Japanese MRSA market as encompassing the sales of antimicrobial agents prescribed for the treatment of hospitalized MRSA skin infections, pneumonia, and bacteremia. Importantly, revenues generated by these products outside of the aforementioned 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 Japan including product description, safety and efficacy profiles as well as a SWOT analysis. - Sales forecast for the top drugs in Japan from 2014-2024. - Analysis of the impact of key events as well the drivers and restraints affecting Japan 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 Japan.
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 Japan 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 Japan 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: MRSA Disease Management, Country Profile - Japan Table 4: Leading Branded Treatments for MRSA, 2015 Table 5: Product Profile - Vancomycin Table 6: Vancomycin SWOT Analysis, 2015 Table 7: Global Sales Forecasts ($m) for Vancomycin, 2014-2024 Table 8: Product Profile - Dalvance Table 9: Efficacy of Dalvance - Primary and Secondary Endpoints, DISCOVER 1 and DISCOVER 2 Table 10: Safety of Dalvance - Frequency of AEs, DISCOVER 1 and DISCOVER 2 Table 11: Dalvance SWOT Analysis, 2015 Table 12: Global Sales Forecasts ($m) for Dalvance, 2014-2024 Table 13: Product Profile - Orbactiv Table 14: Efficacy of Orbactiv - Primary and Secondary Endpoints, SOLO I and SOLO II Table 15: Safety of Orbactiv - Frequency of AEs, SOLO I and SOLO II Table 16: Orbactiv SWOT Analysis, 2015 Table 17: Global Sales Forecasts ($m) for Orbactiv, 2014-2024 Table 18: Product Profile - Vibativ Table 19: Efficacy of Vibativ - Pooled Primary and Secondary Endpoints, ATLAS 1 and ATLAS 2 Table 20: Safety of Vibativ - Frequency of AEs, ATLAS and ATTAIN Phase III Programs Table 21: Vibativ SWOT Analysis, 2015 Table 22: Global Sales Forecasts ($m) for Vibativ, 2014-2024 Table 23: Product Profile - Targocid Table 24: Targocid SWOT Analysis, 2015 Table 25: Global Sales Forecasts ($m) for Targocid, 2014-2024 Table 26: Product Profile - Cubicin Table 27: Efficacy of Cubicin - Pooled Clinical Success Rates by Causative Pathogen, cSSSI Trials Table 28: Safety of Cubicin - Frequency of AEs and SAEs Table 29: Cubicin SWOT Analysis, 2015 Table 30: Global Sales Forecasts ($m) for Cubicin, 2014-2024 Table 31: Product Profile - Zyvox Table 32: Efficacy of Zyvox - Primary and Secondary Endpoints, cSSSI Study in Adults Table 33: Safety of Zyvox - Frequency of Treatment-Emergent AEs Table 34: Zyvox SWOT Analysis, 2015 Table 35: Global Sales Forecasts ($m) for Zyvox, 2014-2024 Table 36: Product Profile - Sivextro Table 37: Efficacy of Sivextro - Primary and Secondary Endpoints, ESTABLISH Phase III Program Table 38: Safety of Sivextro - Frequency of Treatment-Emergent AEs, ESTABLISH-1 and ESTABLISH-2 Table 39: Sivextro SWOT Analysis, 2015 Table 40: Global Sales Forecasts ($m) for Sivextro, 2014-2024 Table 41: Product Profile - Teflaro Table 42: Efficacy of Teflaro - Pooled Primary and Secondary Endpoints, FOCUS 1 and FOCUS 2 Table 43: Safety of Teflaro - Frequency of AEs, FOCUS and CANVAS Phase III Programs Table 44: Teflaro SWOT Analysis, 2015 Table 45: Global Sales Forecasts ($m) for Teflaro, 2014-2024 Table 46: Product Profile - Zevtera Table 47: Efficacy of Zevtera - Primary and Endpoints, HABP and CABP Phase III Studies Table 48: Safety of Zevtera - Frequency of AEs, HABP and CABP Phase III Studies Table 49: Zevtera SWOT Analysis, 2015 Table 50: Global Sales Forecasts ($m) for Zevtera, 2014-2024 Table 51: Product Profile - Tygacil Table 52: Tygacil SWOT Analysis, 2015 Table 53: Global Sales Forecasts ($m) for Tygacil, 2014-2024 Table 54: Summary of Other Antimicrobial Agents Used for S. aureus and MRSA, 2015 Table 55: Unmet Need and Opportunity in MRSA, 2015 Table 56: Key Late-Stage Pipeline Agents for MRSA, 2015 Table 57: Product Profile - Delafloxacin Table 58: Delafloxacin SWOT Analysis, 2015 Table 59: Global Sales Forecasts ($m) for Delafloxacin, 2014-2024 Table 60: Product Profile - Solithromycin Table 61: Solithromycin SWOT Analysis, 2015 Table 62: Global Sales Forecasts ($m) for Solithromycin, 2014-2024 Table 63: Product Profile - Omadacycline Table 64: Omadacycline SWOT Analysis, 2015 Table 65: Global Sales Forecasts ($m) for Omadacycline, 2014-2024 Table 66: Product Profile - KRP-AM1977X Table 67: KRP-AM1977X SWOT Analysis, 2015 Table 68: Global Sales Forecasts ($m) for KRP-AM1977X, 2014-2024 Table 69: Product Profile - Taksta Table 70: Taksta SWOT Analysis, 2015 Table 71: Global Sales Forecasts ($m) for Taksta, 2014-2024 Table 72: Product Profile - Lefamulin Table 73: Lefamulin SWOT Analysis, 2015 Table 74: Global Sales Forecasts ($m) for Lefamulin, 2014-2024 Table 75: Product Profile - Debio1450 Table 76: Debio1450 SWOT Analysis, 2015 Table 77: Global Sales Forecasts ($m) for Debio1450, 2014-2024 Table 78: Product Profile - Brilacidin Table 79: Brilacidin SWOT Analysis, 2015 Table 80: Global Sales Forecasts ($m) for Brilacidin, 2014-2024 Table 81: Other Promising Pipeline Products for MRSA, 2015 Table 82: Sales Forecasts ($m) for MRSA in Japan, 2014-2024 Table 83: Key Events Impacting Sales for MRSA in Japan, 2014-2024 Table 84: MRSA Therapeutics Market - Drivers and Barriers in Japan, 2014-2024 Table 85: Key Historical and Projected Launch Dates for MRSA Across the 7MM Table 86: Key Historical and Projected Label Expansion Dates for MRSA Across the 7MM Table 87: Key Historical and Projected Patent Expiry Dates for MRSA Across the 7MM Table 88: 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: MRSA Therapeutics - Phase III/Phase II Pipeline, 2015 Figure 5: Competitive Assessment of the Recently Approved and Late-Stage Pipeline Agents in MRSA, 2014-2024 Figure 6: Sales for MRSA Therapeutics by Drug Class in Japan, 2014 and 2024
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