Methicillin-Resistant Staphylococcus aureus (MRSA) — US Drug Forecast and Market Analysis to 2024

Pages: 320 Published: December 01, 2015 Report Code: GDHC285CFR

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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 US 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 the US including product description, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in the US from 2014-2024.

Analysis of the impact of key events as well the drivers and restraints affecting the US 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 US.

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology

3.1.1MRSA Strains

3.1.2VISA Strains

3.1.3VRSA Strains

3.2Pathophysiology

3.2.1Infection Sites

3.2.2Expression of Virulence Factors

3.2.3Mechanisms of Antibiotic Resistance

3.2.4Biofilm Formation

3.3Symptoms

3.4Prognosis

3.4.1Skin and Soft Tissue Infections

3.4.2Pneumonia

3.4.3Bacteremia

3.4.4Chronic MRSA Infection

4Disease Management

4.1Diagnosis and Treatment Overview

4.1.1Diagnosis

4.1.2Treatment Guidelines

4.1.3Clinical Practice

4.2US

5Competitive Assessment

5.1Overview

5.2Product Profiles – Glycopeptides and Lipoglycopeptides

5.2.1Vancomycin

5.2.2Dalvance (dalbavancin)

5.2.3Orbactiv (oritavancin)

5.2.4Vibativ (telavancin)

5.2.5Targocid (teicoplanin)

5.3Product Profiles – Lipopeptides

5.3.1Cubicin (daptomycin)

5.4Product Profiles – Oxazolidinones

5.4.1Zyvox (linezolid)

5.4.2Sivextro (tedizolid phosphate)

5.5Product Profiles – Cephalosporins

5.5.1Teflaro (ceftaroline fosamil)

5.5.2Zevtera (ceftobiprole medocaril)

5.6Product Profiles – Glycylcyclines

5.6.1Tygacil (tigecycline)

5.7Other Antimicrobial Agents

6Unmet Need and Opportunity

6.1Overview

6.2Drugs with Demonstrated Efficacy in Difficult-to-Treat Patient Populations

6.2.1Unmet Need

6.2.2Gap Analysis

6.2.3Opportunity

6.3Expand Breadth of Clinical Data Outside of Skin Infections

6.3.1Unmet Need

6.3.2Gap Analysis

6.3.3Opportunity

6.4Physician Education

6.4.1Unmet Need

6.4.2Gap Analysis

6.4.3Opportunity

6.5Antibiotics with More Convenient Formulations and Dosing Schedules

6.5.1Unmet Need

6.5.2Gap Analysis

6.5.3Opportunity

6.6Innovative Approaches to Clinical Trial Design

6.6.1Unmet Need

6.6.2Gap Analysis

6.6.3Opportunity

6.7Drugs with Novel Mechanisms of Action

6.7.1Unmet Need

6.7.2Gap Analysis

6.7.3Opportunity

6.8More Affordable Therapies

6.8.1Unmet Need

6.8.2Gap Analysis

6.8.3Opportunity

7Pipeline Assessment

7.1Overview

7.2Promising Drugs in Late-Stage Clinical Development

7.2.1Delafloxacin (RX-3341)

7.2.2Solithromycin (CEM-101)

7.2.3Omadacycline (PTK-0796)

7.2.4KRP-AM1977X

7.2.5Taksta (fusidic acid, oral tablets)

7.2.6Lefamulin (BC-3781)

7.2.7Debio1450 (Debio1452 prodrug)

7.2.8Brilacidin

7.3Other Promising Products in Clinical Development

8Market Outlook

8.1US

8.1.1Forecast

8.1.2Key Events

8.1.3Drivers and Barriers

9Appendix

9.1Bibliography

9.2Abbreviations

9.3Methodology

9.4Forecasting Methodology

9.4.1Hospitalized MRSA Patients

9.4.2Percentage of Drug-Treated MRSA Patients

9.4.3Drugs Included in Each Therapeutic Class

9.4.4Launch, Label Expansion, and Patent Expiry Dates

9.4.5General Pricing Assumptions

9.4.6Individual Drug Assumptions

9.4.7Generic Erosion

9.4.8Pricing of Pipeline Agents

9.5Primary Research – KOLs Interviewed for This Report

9.6Primary Research – Prescriber Survey

9.7About the Authors

9.7.1Author and Therapy Area Director

9.7.2Author

9.7.3Epidemiologist

9.7.4Global Director of Therapy Analysis and Epidemiology

9.7.5Global Head of Healthcare

9.8About GlobalData

9.9Disclaimer

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 – US

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 Therapeutics in the US, 2014–2024

Table 83: Key Events Impacting Sales for MRSA in the US, 2014–2024

Table 84: MRSA Therapeutics Market — Drivers and Barriers in the US, 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 the US, 2014 and 2024

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