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PharmaPoint: Methicillin-Resistant Staphylococcus Aureus (MRSA) - Global 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.

Today, the MRSA market is highly competitive, as physicians have a myriad of antimicrobial agents at their disposal that are approved to treat these severe and often life-threatening infections. There are currently over 10 marketed antibiotics that have demonstrated potent activity against MRSA, which are frequently used to treat invasive infections in the hospital setting. GlobalData projects the global MRSA marketplace - which, for the purposes of this report, includes patients hospitalized with MRSA skin infections, pneumonia, or bacteremia in the seven major pharmaceutical markets (7MM; US, France, Germany, Italy, Spain, UK, Japan) - to experience limited growth from 2014-2024.

Highlights

Key Questions Answered

- How will the MRSA therapeutics market landscape in the 7MM (US, France, Germany, Italy, Spain, UK, Japan) change from 2014-2024?
- What are the most promising late-stage pipeline drugs for MRSA?
- How do the clinical and commercial attributes of late-stage pipeline therapies compare with one another, and against existing treatment options?
- What are the key unmet needs in MRSA treatment landscape?
- What drivers and barriers will influence MRSA therapeutics sales in the 7MM over the forecast period?

Key Findings

- The global MRSA marketplace, which, for the purposes of this report, includes patients hospitalized with MRSA skin infections, pneumonia, or bacteremia in the 7MM, was worth approximately $1.40 billion in 2014. GlobalData projects the market to exceed $1.45 billion in sales by 2024, at a Compound Annual Growth Rate (CAGR) of 0.4% from 2014-2024. These sales are projected to originate predominantly from the US (with a 71% market share), followed distantly by Japan (with a 16% market share).
- The recent and expected launches of novel antimicrobial agents with potent activity against MRSA, led by Allergan’s Dalvance (dalbavancin), Merck’s Sivextro (tedizolid phosphate), The Medicines Company’s Orbactiv (oritavancin), Debiopharm’s Debio1450, and Nabriva’s lefamulin, will be a principal driver of MRSA drug sales growth across the 7MM from 2014-2014.
- Competition from generics manufacturers, spurred on by the anticipated loss of patent protection for the market leaders Zyvox (linezolid) and Cubicin (daptomycin), will serve as a formidable barrier to growth for the duration of the forecast period.

Scope

- Overview of MRSA infections, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
- Topline MRSA market revenue from 2014-2024. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.
- Key topics covered include current treatment options, unmet needs and opportunities, and the drivers and barriers affecting MRSA therapeutics sales in the 7MM.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
- Analysis of the current and future market competition in the global MRSA therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global MRSA therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the MRSA therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

Table Of Contents

PharmaPoint: Methicillin-Resistant Staphylococcus Aureus (MRSA) - Global Drug Forecast and Market Analysis to 2024
1 Table of Contents
1 Table of Contents 11
1.1 List of Tables 17
1.2 List of Figures 23
2 Introduction 25
2.1 Catalyst 25
2.2 Related Reports 26
2.3 Upcoming Related Reports 27
3 Disease Overview 28
3.1 Etiology 28
3.1.1 MRSA Strains 31
3.1.2 VISA Strains 33
3.1.3 VRSA Strains 33
3.2 Pathophysiology 34
3.2.1 Infection Sites 34
3.2.2 Expression of Virulence Factors 36
3.2.3 Mechanisms of Antibiotic Resistance 38
3.2.4 Biofilm Formation 42
3.3 Symptoms 43
3.4 Prognosis 44
3.4.1 Skin and Soft Tissue Infections 45
3.4.2 Pneumonia 45
3.4.3 Bacteremia 45
3.4.4 Chronic MRSA Infection 46
4 Epidemiology 47
4.1 Disease Background 47
4.2 Risk Factors and Comorbidities 48
4.3 Global Trends 50
4.3.1 US 50
4.3.2 5EU 51
4.3.3 Japan 51
4.4 Forecast Methodology 52
4.4.1 Sources Used 54
4.4.2 Sources Not Used 67
4.4.3 Forecast Assumptions and Methods 68
4.5 Epidemiological Forecast for MRSA (2014-2024) 74
4.5.1 Hospitalized Incident Cases of MRSA 74
4.5.2 Sex-Specific Hospitalized Incident Cases of MRSA 76
4.5.3 Age-Specific Hospitalized Incident Cases of MRSA 78
4.5.4 Age-Standardized Hospitalized Incidence Rate of MRSA 80
4.5.5 Proportion of Hospitalized Incident MRSA Cases by Infection Site 82
4.5.6 Proportion of Hospitalized Incident MRSA Cases by Case Definition 83
4.6 Discussion 84
4.6.1 Epidemiological Forecast Insight 84
4.6.2 Limitations of the Analysis 85
4.6.3 Strengths of the Analysis 86
5 Disease Management 87
5.1 Diagnosis and Treatment Overview 87
5.1.1 Diagnosis 87
5.1.2 Treatment Guidelines 88
5.1.3 Clinical Practice 89
5.2 US 91
5.3 5EU 95
5.4 Japan 98
6 Competitive Assessment 102
6.1 Overview 102
6.2 Product Profiles - Glycopeptides and Lipoglycopeptides 107
6.2.1 Vancomycin 107
6.2.2 Dalvance (dalbavancin) 115
6.2.3 Orbactiv (oritavancin) 124
6.2.4 Vibativ (telavancin) 132
6.2.5 Targocid (teicoplanin) 142
6.3 Product Profiles - Lipopeptides 148
6.3.1 Cubicin (daptomycin) 148
6.4 Product Profiles - Oxazolidinones 157
6.4.1 Zyvox (linezolid) 157
6.4.2 Sivextro (tedizolid phosphate) 169
6.5 Product Profiles - Cephalosporins 178
6.5.1 Teflaro (ceftaroline fosamil) 178
6.5.2 Zevtera (ceftobiprole medocaril) 188
6.6 Product Profiles - Glycylcyclines 197
6.6.1 Tygacil (tigecycline) 197
6.7 Other Antimicrobial Agents 204
7 Unmet Need and Opportunity Analysis 206
7.1 Overview 206
7.2 Drugs with Demonstrated Efficacy in Difficult-to-Treat Patient Populations 209
7.2.1 Unmet Need 209
7.2.2 Gap Analysis 211
7.2.3 Opportunity 212
7.3 Expand Breadth of Clinical Data Outside of Skin Infections 213
7.3.1 Unmet Need 213
7.3.2 Gap Analysis 214
7.3.3 Opportunity 215
7.4 Physician Education 215
7.4.1 Unmet Need 215
7.4.2 Gap Analysis 216
7.4.3 Opportunity 217
7.5 Antibiotics with More Convenient Formulations and Dosing Schedules 218
7.5.1 Unmet Need 218
7.5.2 Gap Analysis 220
7.5.3 Opportunity 221
7.6 Innovative Approaches to Clinical Trial Design 222
7.6.1 Unmet Need 222
7.6.2 Gap Analysis 223
7.6.3 Opportunity 224
7.7 Drugs with Novel Mechanisms of Action 227
7.7.1 Unmet Need 227
7.7.2 Gap Analysis 228
7.7.3 Opportunity 228
7.8 More Affordable Therapies 229
7.8.1 Unmet Need 229
7.8.2 Gap Analysis 230
7.8.3 Opportunity 230
8 Pipeline Assessment 233
8.1 Overview 233
8.2 Promising Drugs in Late-Stage Clinical Development 233
8.2.1 Delafloxacin (RX-3341) 236
8.2.2 Solithromycin (CEM-101) 243
8.2.3 Omadacycline (PTK-0796) 250
8.2.4 KRP-AM1977X 257
8.2.5 Taksta (fusidic acid, oral tablets) 263
8.2.6 Lefamulin (BC-3781) 268
8.2.7 Debio1450 (Debio1452 prodrug) 276
8.2.8 Brilacidin 282
8.3 Other Promising Products in Clinical Development 289
9 Current and Future Players 291
9.1 Overview 291
9.2 Trends in Corporate Strategy 294
9.3 Company Profiles - Current Players 296
9.3.1 Pfizer 296
9.3.2 Merck 298
9.3.3 Allergan 299
9.3.4 The Medicines Company 301
9.3.5 Theravance Biopharma 303
9.3.6 Basilea Pharmaceutica 305
9.3.7 Sanofi 306
9.4 Additional Companies with Promising Pipeline Products 307
9.4.1 Melinta Therapeutics 307
9.4.2 Cempra Pharmaceuticals 308
9.4.3 Paratek Pharmaceuticals 309
9.4.4 Kyorin Pharmaceutical 310
9.4.5 Nabriva Therapeutics 310
9.4.6 Debiopharm International 311
9.4.7 Cellceutix Corporation 311
10 Market Outlook 313
10.1 Global Markets 313
10.1.1 Forecast 313
10.1.2 Drivers and Barriers - Global Issues 321
10.2 US 322
10.2.1 Forecast 322
10.2.2 Key Events 327
10.2.3 Drivers and Barriers 328
10.3 5EU 329
10.3.1 Forecast 329
10.3.2 Key Events 334
10.3.3 Drivers and Barriers 335
10.4 Japan 336
10.4.1 Forecast 336
10.4.2 Key Events 341
10.4.3 Drivers and Barriers 342
11 Appendix 343
11.1 Bibliography 343
11.2 Abbreviations 394
11.3 Methodology 400
11.4 Forecasting Methodology 400
11.4.1 Hospitalized MRSA Patients 400
11.4.2 Percentage of Drug-Treated MRSA Patients 400
11.4.3 Drugs Included in Each Therapeutic Class 401
11.4.4 Launch, Label Expansion, and Patent Expiry Dates 402
11.4.5 General Pricing Assumptions 404
11.4.6 Individual Drug Assumptions 406
11.4.7 Generic Erosion 418
11.4.8 Pricing of Pipeline Agents 418
11.5 Primary Research - KOLs Interviewed for This Report 420
11.6 Primary Research - Prescriber Survey 422
11.7 About the Authors 423
11.7.1 Author and Therapy Area Director 423
11.7.2 Author 423
11.7.3 Epidemiologist 424
11.7.4 Global Director of Therapy Analysis and Epidemiology 424
11.7.5 Global Head of Healthcare 425
11.8 About GlobalData 426
11.9 Disclaimer 426

1.1 List of Tables
Table 1: Symptoms of MRSA-Associated Infections 44
Table 2: Risk Factors and Comorbidities for MRSA 49
Table 3: Definitions of HA-MRSA and CA-MRSA 53
Table 4: US, Sources Used to Calculate the MRSA Incident Cases Arising from Pneumonias, SSTIs, and BSIs 55
Table 5: France, Sources Used to Calculate the MRSA Incident Cases Arising from Pneumonias, SSTIs, and BSIs 57
Table 6: Germany, Sources Used to Calculate the MRSA Incident Cases Arising from Pneumonias, SSTIs, and BSIs 59
Table 7: Italy, Sources Used to Calculate the MRSA Incident Cases Arising from Pneumonias, SSTIs, and BSIs 61
Table 8: Spain, Sources Used to Calculate the MRSA Incident Cases Arising from Pneumonias, SSTIs, and BSIs 63
Table 9: UK, Sources Used to Calculate the MRSA Incident Cases Arising from Pneumonias, SSTIs, and BSIs 65
Table 10: Japan, Sources Used to Calculate the MRSA Incident Cases Arising from Pneumonias, SSTIs, and BSIs 67
Table 11: 7MM, Hospitalized Incident Cases of MRSA, Men and Women, All Ages, N, 2014-2024 75
Table 12: 7MM, Sex-Specific Hospitalized Incident Cases of MRSA, All Ages, N, 2014 77
Table 13: 7MM, Age-Specific Hospitalized Incident Cases of MRSA, Men and Women, N, 2014 79
Table 14: National and International Treatment Guidelines for MRSA Infections 89
Table 15: MRSA Disease Management, Country Profile - US 94
Table 16: MRSA Disease Management, Region Profile - 5EU 97
Table 17: MRSA Disease Management, Country Profile - Japan 100
Table 18: Leading Branded Treatments for MRSA, 2015 106
Table 19: Product Profile - Vancomycin 110
Table 20: Vancomycin SWOT Analysis, 2015 113
Table 21: Global Sales Forecasts ($m) for Vancomycin, 2014-2024 115
Table 22: Product Profile - Dalvance 118
Table 23: Efficacy of Dalvance - Primary and Secondary Endpoints, DISCOVER 1 and DISCOVER 2 119
Table 24: Safety of Dalvance - Frequency of AEs, DISCOVER 1 and DISCOVER 2 121
Table 25: Dalvance SWOT Analysis, 2015 122
Table 26: Global Sales Forecasts ($m) for Dalvance, 2014-2024 124
Table 27: Product Profile - Orbactiv 127
Table 28: Efficacy of Orbactiv - Primary and Secondary Endpoints, SOLO I and SOLO II 128
Table 29: Safety of Orbactiv - Frequency of AEs, SOLO I and SOLO II 129
Table 30: Orbactiv SWOT Analysis, 2015 130
Table 31: Global Sales Forecasts ($m) for Orbactiv, 2014-2024 132
Table 32: Product Profile - Vibativ 135
Table 33: Efficacy of Vibativ - Pooled Primary and Secondary Endpoints, ATLAS 1 and ATLAS 2 136
Table 34: Safety of Vibativ - Frequency of AEs, ATLAS and ATTAIN Phase III Programs 139
Table 35: Vibativ SWOT Analysis, 2015 140
Table 36: Global Sales Forecasts ($m) for Vibativ, 2014-2024 142
Table 37: Product Profile - Targocid 144
Table 38: Targocid SWOT Analysis, 2015 146
Table 39: Global Sales Forecasts ($m) for Targocid, 2014-2024 148
Table 40: Product Profile - Cubicin 151
Table 41: Efficacy of Cubicin - Pooled Clinical Success Rates by Causative Pathogen, cSSSI Trials 152
Table 42: Safety of Cubicin - Frequency of AEs and SAEs 154
Table 43: Cubicin SWOT Analysis, 2015 155
Table 44: Global Sales Forecasts ($m) for Cubicin, 2014-2024 157
Table 45: Product Profile - Zyvox 161
Table 46: Efficacy of Zyvox - Primary and Secondary Endpoints, cSSSI Study in Adults 163
Table 47: Safety of Zyvox - Frequency of Treatment-Emergent AEs 165
Table 48: Zyvox SWOT Analysis, 2015 167
Table 49: Global Sales Forecasts ($m) for Zyvox, 2014-2024 169
Table 50: Product Profile - Sivextro 172
Table 51: Efficacy of Sivextro - Primary and Secondary Endpoints, ESTABLISH Phase III Program 174
Table 52: Safety of Sivextro - Frequency of Treatment-Emergent AEs, ESTABLISH-1 and ESTABLISH-2 175
Table 53: Sivextro SWOT Analysis, 2015 176
Table 54: Global Sales Forecasts ($m) for Sivextro, 2014-2024 178
Table 55: Product Profile - Teflaro 181
Table 56: Efficacy of Teflaro - Pooled Primary and Secondary Endpoints, FOCUS 1 and FOCUS 2 183
Table 57: Safety of Teflaro - Frequency of AEs, FOCUS and CANVAS Phase III Programs 185
Table 58: Teflaro SWOT Analysis, 2015 186
Table 59: Global Sales Forecasts ($m) for Teflaro, 2014-2024 188
Table 60: Product Profile - Zevtera 191
Table 61: Efficacy of Zevtera - Primary and Endpoints, HABP and CABP Phase III Studies 193
Table 62: Safety of Zevtera - Frequency of AEs, HABP and CABP Phase III Studies 194
Table 63: Zevtera SWOT Analysis, 2015 195
Table 64: Global Sales Forecasts ($m) for Zevtera, 2014-2024 197
Table 65: Product Profile - Tygacil 199
Table 66: Tygacil SWOT Analysis, 2015 202
Table 67: Global Sales Forecasts ($m) for Tygacil, 2014-2024 203
Table 68: Summary of Other Antimicrobial Agents Used for S. aureus and MRSA, 2015 205
Table 69: Unmet Need and Opportunity in MRSA, 2015 208
Table 70: Key Late-Stage Pipeline Agents for MRSA, 2015 234
Table 71: Product Profile - Delafloxacin 238
Table 72: Delafloxacin SWOT Analysis, 2015 241
Table 73: Global Sales Forecasts ($m) for Delafloxacin, 2014-2024 243
Table 74: Product Profile - Solithromycin 245
Table 75: Solithromycin SWOT Analysis, 2015 248
Table 76: Global Sales Forecasts ($m) for Solithromycin, 2014-2024 250
Table 77: Product Profile - Omadacycline 252
Table 78: Omadacycline SWOT Analysis, 2015 255
Table 79: Global Sales Forecasts ($m) for Omadacycline, 2014-2024 257
Table 80: Product Profile - KRP-AM1977X 259
Table 81: KRP-AM1977X SWOT Analysis, 2015 261
Table 82: Global Sales Forecasts ($m) for KRP-AM1977X, 2014-2024 262
Table 83: Product Profile - Taksta 264
Table 84: Taksta SWOT Analysis, 2015 266
Table 85: Global Sales Forecasts ($m) for Taksta, 2014-2024 268
Table 86: Product Profile - Lefamulin 271
Table 87: Lefamulin SWOT Analysis, 2015 274
Table 88: Global Sales Forecasts ($m) for Lefamulin, 2014-2024 275
Table 89: Product Profile - Debio1450 278
Table 90: Debio1450 SWOT Analysis, 2015 280
Table 91: Global Sales Forecasts ($m) for Debio1450, 2014-2024 282
Table 92: Product Profile - Brilacidin 284
Table 93: Brilacidin SWOT Analysis, 2015 287
Table 94: Global Sales Forecasts ($m) for Brilacidin, 2014-2024 288
Table 95: Other Promising Pipeline Products for MRSA, 2015 290
Table 96: Key Companies in the MRSA Marketplace in the 7MM, 2015 292
Table 97: Pfizer's MRSA Portfolio Assessment, 2015 297
Table 98: Merck's MRSA Portfolio Assessment, 2015 299
Table 99: Allergan's MRSA Portfolio Assessment, 2015 301
Table 100: The Medicines Company's MRSA Portfolio Assessment, 2015 303
Table 101: Theravance Biopharma's MRSA Portfolio Assessment, 2015 304
Table 102: Basilea Pharmaceutica's MRSA Portfolio Assessment, 2015 306
Table 103: Sanofi's MRSA Portfolio Assessment, 2015 307
Table 104: Companies with Promising Pipeline Candidates for MRSA in the 7MM, 2015 307
Table 105: Global Sales Forecasts ($m) for MRSA Therapeutics, 2014-2024 315
Table 106: MRSA Therapeutics Market - Global Drivers and Barriers, 2014-2024 321
Table 107: Sales Forecasts ($m) for MRSA Therapeutics in the US, 2014-2024 325
Table 108: Key Events Impacting Sales for MRSA in the US, 2014-2024 327
Table 109: MRSA Therapeutics Market - Drivers and Barriers in the US, 2014-2024 328
Table 110: Sales Forecasts ($m) for MRSA in the 5EU, 2014-2024 331
Table 111: Key Events Impacting Sales for MRSA in the 5EU, 2014-2024 334
Table 112: MRSA Therapeutics Market - Drivers and Barriers in the 5EU, 2014-2024 335
Table 113: National Healthcare Authorities and Government Drug Pricing Authorities in the 5EU Nations 336
Table 114: Sales Forecasts ($m) for MRSA in Japan, 2014-2024 339
Table 115: Key Events Impacting Sales for MRSA in Japan, 2014-2024 341
Table 116: MRSA Therapeutics Market - Drivers and Barriers in Japan, 2014-2024 342
Table 117: Key Historical and Projected Launch Dates for MRSA Across the 7MM 402
Table 118: Key Historical and Projected Label Expansion Dates for MRSA Across the 7MM 403
Table 119: Key Historical and Projected Patent Expiry Dates for MRSA Across the 7MM 404
Table 120: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 422

1.2 List of Figures
Figure 1: The MRSA SCCmec Gene Cluster 30
Figure 2: Sites of S. aureus Infection 34
Figure 3: Cartoon Depicting the Key Mechanisms of Antibiotic Resistance Observed in S. aureus 39
Figure 4: US, Methodology for Calculation of MRSA Hospitalized Incident Cases 70
Figure 5: 5EU, Methodology Used to Calculate the MRSA Hospitalized Incident Cases by Infection Type 73
Figure 6: 7MM, Hospitalized Incident Cases of MRSA, Men and Women, All Ages, N, 2014-2024 76
Figure 7: 7MM, Sex-Specific Hospitalized Incident Cases of MRSA, All Ages, N, 2014 78
Figure 8: 7MM, Age-Specific Hospitalized Incident Cases of MRSA, Men and Women, N, 2014 80
Figure 9: 7MM, Age-Standardized Hospitalized Incidence Rate of MRSA, 2014 82
Figure 10: 7MM, Proportion of Hospitalized Incident MRSA Cases by Infection Site, Men and Women, All Ages 83
Figure 11: 7MM, Proportion of Hospitalized Incident MRSA Cases by Case Definition, Men and Women, All Ages 84
Figure 12: MRSA Therapeutics - Phase III/Phase II Pipeline, 2015 235
Figure 13: Competitive Assessment of the Recently Approved and Late-Stage Pipeline Agents in MRSA, 2014-2024 236
Figure 14: Global Sales for Branded MRSA Products by Company, 2014 and 2024 293
Figure 15: Company Portfolio Gap Analysis in MRSA, 2014-2024 294
Figure 16: Global Sales for MRSA Therapeutics by Country, 2014 and 2024 317
Figure 17: Global Sales for MRSA Therapeutics by Region, 2014-2024 318
Figure 18: Global Sales for MRSA Therapeutics by Drug Class, 2014 and 2024 319
Figure 19: Global Sales for MRSA Therapeutics by Infection Site, 2014-2024 320
Figure 20: Sales for MRSA Therapeutics by Drug Class in the US, 2014 and 2024 326
Figure 21: Sales for MRSA Therapeutics by Drug Class in the 5EU, 2014 and 2024 332
Figure 22: Sales for MRSA Therapeutics by Country in the 5EU, 2014-2024 333
Figure 23: Sales for MRSA Therapeutics by Drug Class in Japan, 2014 and 2024 340

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