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PharmaPoint: Atrial Fibrillation - Global Drug Forecast and Market Analysis to 2025

Summary

Atrial fibrillation (AF) is the most common cardiac arrhythmia and is a heart condition that causes an irregular and often abnormally fast heart rate. Various therapeutic options are available to treat patients with AF, and most patients will receive some form of antithrombotic therapy, a heart rate control agent, and potentially an antiarrhythmic drug for rhythm control.

All sectors of the AF market have historically been saturated with generics, with the vitamin K antagonists such as warfarin playing an important role in stroke prevention in AF. However, since 2010, and the launch of the first of the new oral anticoagulants (NOACs), a shift in the treatment of patients with AF has occurred. The NOACs offer a significant advancement in anticoagulation and their continued uptake will be the main driver of growth in the AF market over the next 10 years.

In contrast, despite a great unmet need for safer antiarrhythmic drugs, developments in this field are expected to be much slower and there are presently no late-stage drug candidates that are expected to address this unmet need during the forecast period.

Highlights

Key Questions Answered

- The anticoagulant market for stroke prevention in AF has become increasingly crowded. How will the drug treatment landscape for AF change? Which of the NOACs will become the market leader over the next ten years? What are the key drivers and barriers to this change?
- The AF market is marked by the presence of a number of unmet needs. What are the main unmet needs in the treatment of AF? Will the drugs under development fulfil the unmet needs of the AF market?
- Will any late-stage anticoagulants drugs make a significant impact on the AF market? What subgroups of the AF population will they target?

Scope

- Overview of AF, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized AF therapeutics market revenue, annual cost of therapy, and treatment usage pattern data from 2015, forecast for ten years to 2025.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications for the AF therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
- Analysis of the current and future market competition in the global AF 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. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global AF therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global AF therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global AF therapeutics market from 2015-2025.
- 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: Atrial Fibrillation - Global Drug Forecast and Market Analysis to 2025
1 Table of Contents
1 Table of Contents 12
1.1 List of Tables 18
1.2 List of Figures 23
2 Introduction 25
2.1 Catalyst 25
2.2 Related Reports 26
2.3 Upcoming Related Reports 26
3 Disease Overview 27
3.1 Etiology and Pathophysiology 27
3.1.1 Etiology 27
3.1.2 Pathophysiology 28
3.2 Symptoms 29
3.3 Classification of Atrial Fibrillation 30
3.4 Prognosis 30
4 Epidemiology 32
4.1 Disease Background 32
4.2 Risk Factors and Comorbidities 33
4.3 Global Trends 35
4.4 Forecast Methodology 37
4.4.1 Sources Used 37
4.4.2 Forecast Assumptions and Methods 40
4.4.3 Sources Not Used 47
4.5 Epidemiological Forecast for AF (2015-2025) 49
4.5.1 Diagnosed Prevalent Cases 49
4.6 Discussion 57
4.6.1 Epidemiological Forecast Insight 57
4.6.2 Limitations of the Analysis 58
4.6.3 Strengths of the Analysis 59
5 Disease Management 60
5.1 Diagnosis and Treatment Overview 60
5.1.1 Diagnosis 60
5.1.2 Treatment Guidelines and Leading Prescribed Drugs 62
5.1.3 Clinical Practice 64
5.2 US 77
5.3 France 79
5.4 Germany 81
5.5 Italy 83
5.6 Spain 85
5.7 UK 87
5.8 Japan 89
5.9 Canada 92
6 Competitive Assessment 94
6.1 Overview 94
6.2 Product Profiles - Major Brands, Anticoagulant Agents 99
6.2.1 Warfarin (Widely Genericized) 99
6.2.2 Pradaxa (dabigatran) 111
6.2.3 Xarelto (rivaroxaban) 125
6.2.4 Eliquis (apixaban) 138
6.2.5 Savaysa (edoxaban) 151
6.3 Product Profiles - Major Brands, Antiarrhythmic Drugs 164
6.3.1 Multaq (dronedarone) 164
6.3.2 Brinavess (vernakalant) 176
6.4 Other Therapeutic Classes 188
6.4.1 Vitamin K Antagonists Other than Warfarin (Widely Genericized) 189
6.4.2 Antiplatelets - Aspirin (Widely Genericized) 190
6.4.3 Beta-Blockers - Atenolol, Metoprolol, Propranolol (Widely Genericized) 192
6.4.4 Calcium Channel Blockers - Diltiazem, Verapamil (Widely Genericized) 193
6.4.5 Cardiac Glycosides ? Digoxin (Widely Genericized) 194
6.4.6 Potassium Channel Blockers - Amiodarone, Sotalol, Dofetilide (Widely Genericized) 195
6.4.7 Sodium Channel Blockers - Flecainide, Propafenone (Widely Genericized) 197
7 Unmet Need and Opportunity 199
7.1 Overview 199
7.2 Target Opportunity Profiles in Specific Patient Segments 201
7.2.1 Atrial Fibrillation Patients with Valvular AF and Mechanical Heart Valves 201
7.2.2 Atrial Fibrillation Patients with Severe Chronic Kidney Disease or Renal Failure 202
7.3 Safer Antiarrhythmic Drugs for the Maintenance of Sinus Rhythm 203
7.3.1 Unmet Need 203
7.3.2 Gap Analysis 204
7.3.3 Opportunity 205
7.4 Effective and Rapid-Acting Cardioversion Drugs 206
7.4.1 Unmet Need 206
7.4.2 Gap Analysis 207
7.4.3 Opportunity 208
7.5 Therapies for Valvular Atrial Fibrillation Patients 209
7.5.1 Unmet Need 209
7.5.2 Gap Analysis 211
7.5.3 Opportunity 212
7.6 Therapies for Atrial Fibrillation Patients with Severe Chronic Kidney Disease or Renal Failure 212
7.6.1 Unmet Need 212
7.6.2 Gap Analysis 214
7.6.3 Opportunity 214
7.7 Improved Access to and Reimbursement of the New Oral Anticoagulants 216
7.7.1 Unmet Need 216
7.7.2 Gap Analysis 220
7.7.3 Opportunity 223
7.8 Increased Physician Education on the Clinical Benefits of the NOACs 224
7.8.1 Unmet Need 224
7.8.2 Gap Analysis 225
7.8.3 Opportunity 226
7.9 Increased Patient Awareness of the Clinical Benefits and Proper Use of the NOACs 227
7.9.1 Unmet Need 227
7.9.2 Gap Analysis 228
7.9.3 Opportunity 229
7.10 Reversal agents for the New Oral Anticoagulants 230
7.10.1 Unmet Need 230
7.10.2 Gap Analysis 232
7.10.3 Opportunity 234
8 Pipeline Assessment 235
8.1 Overview 235
8.2 Promising Drugs in Clinical Development 236
8.2.1 Tecarfarin 237
8.3 Other Drugs in Development 251
8.3.1 Early-Stage Anticoagulant Pipeline 251
8.3.2 Early-Stage Antiarrhythmia Pipeline 256
9 Current and Future Players 264
9.1 Overview 264
9.2 Trends in Corporate Strategy 266
9.3 Company Profiles 268
9.3.1 Boehringer Ingelheim 268
9.3.2 Bayer 271
9.3.3 Janssen (Johnson and Johnson) 274
9.3.4 Bristol-Myers Squibb 277
9.3.5 Pfizer 280
9.3.6 Daiichi-Sankyo 283
9.3.7 Armetheon 286
10 Market Outlook 289
10.1 Global Markets 289
10.1.1 Forecast 289
10.1.2 Drivers and Barriers - Global Issues 298
10.2 US 303
10.2.1 Forecast 303
10.2.2 Key Events 308
10.2.3 Drivers and Barriers 308
10.3 France 310
10.3.1 Forecast 310
10.3.2 Key Events 315
10.3.3 Drivers and Barriers 315
10.4 Germany 319
10.4.1 Forecast 319
10.4.2 Key Events 324
10.4.3 Drivers and Barriers 324
10.5 Italy 326
10.5.1 Forecast 326
10.5.2 Key Events 331
10.5.3 Drivers and Barriers 331
10.6 Spain 334
10.6.1 Forecast 334
10.6.2 Key Events 338
10.6.3 Drivers and Barriers 338
10.7 UK 340
10.7.1 Forecast 340
10.7.2 Key Events 345
10.7.3 Drivers and Barriers 345
10.8 Japan 348
10.8.1 Forecast 348
10.8.2 Key Events 352
10.8.3 Drivers and Barriers 352
10.9 Canada 356
10.9.1 Forecast 356
10.9.2 Key Events 360
10.9.3 Drivers and Barriers 360
11 Appendix 363
11.1 Bibliography 363
11.2 Abbreviations 385
11.3 Methodology 390
11.4 Forecasting Methodology 390
11.4.1 Diagnosed Atrial Fibrillation Patients 390
11.4.2 Percent Drug-Treated Patients 391
11.4.3 Drugs Included in Each Therapeutic Class 391
11.4.4 Launch and Patent Expiry Dates 392
11.4.5 General Pricing Assumptions 392
11.4.6 Individual Drug Assumptions 394
11.4.7 Generic Erosion 402
11.4.8 Pricing of Pipeline Agents 402
11.5 Physicians and Specialists Included in this Study 403
11.6 About the Authors 407
11.6.1 Analyst 407
11.6.2 Senior Analyst 407
11.6.3 Therapy Director 407
11.6.4 Epidemiologist 408
11.6.5 Global Director of Therapy Analysis and Epidemiology 408
11.7 About GlobalData 410
11.8 Disclaimer 41

1.1 List of Tables
Table 1: Common Cardiac and Non-cardiac Causes of AF 28
Table 2: Classification of AF 30
Table 3: Clinical Subtypes of AF 32
Table 4: Risk Factors and Comorbidities for AF 34
Table 5: Prevalence (%) of AF as Reported in Epidemiological Studies 36
Table 6: 8MM, Sources Used to Forecast the Diagnosed Prevalent Cases of AF 38
Table 7: 8MM, Sources Used to Forecast Clinical Subtypes of Diagnosed Prevalent Cases of AF 39
Table 8: 8MM, Sources Not Used in the Epidemiological Analysis of AF 48
Table 9: 8MM, Diagnosed Prevalent Cases of AF, Ages ?40 Years, Both Sexes, N, Selected Years 2015-2025 50
Table 10: 8MM, Age-Specific Diagnosed Prevalent Cases of AF, Both Sexes, N (Row %), 2015 52
Table 11: 8MM, Sex-Specific Diagnosed Prevalent Cases of AF, Ages ?40 Years, N (Row %), 2015 54
Table 12: CHADS2 Index for Stroke Risk Assessment 62
Table 13: CHA2DS2-VASc Index for Stroke Risk Assessment 62
Table 14: Treatment Guidelines for AF by Country 63
Table 15: Most Prescribed Drugs or Drug Classes for AF by Country, 2015 64
Table 16: Country Profile ? US 78
Table 17: Country Profile ? France 80
Table 18: Country Profile - Germany 82
Table 19: Country Profile ? Italy 84
Table 20: Country Profile ? Spain 86
Table 21: Country Profile ? UK 88
Table 22: Country Profile ? Japan 91
Table 23: Country Profile ? Canada 93
Table 24: Leading Treatments and Branded Drugs for AF, 2016 99
Table 25: Product Profile - Warfarin (Widely Genericized) 103
Table 26: Warfarin (Widely Genericized) SWOT Analysis, 2016 109
Table 27: Global Sales Forecasts ($m) for Warfarin, 2015-2025 111
Table 28: Product Profile - Pradaxa (dabigatran) 115
Table 29: Pradaxa (dabigatran) SWOT Analysis, 2016 122
Table 30: Global Sales Forecasts ($m) for Pradaxa, 2015-2025 125
Table 31: Product Profile - Xarelto (rivaroxaban) 129
Table 32: Xarelto (rivaroxaban) SWOT Analysis, 2016 135
Table 33: Global Sales Forecasts ($m) for Xarelto, 2015-2025 137
Table 34: Product Profile - Eliquis (apixaban) 142
Table 35: Eliquis (apixaban) SWOT Analysis, 2016 148
Table 36: Global Sales Forecasts ($m) for Eliquis, 2015-2025 150
Table 37: Product Profile - Savaysa (edoxaban) 154
Table 38: Savaysa (edoxaban) SWOT Analysis, 2016 161
Table 39: Global Sales Forecasts ($m) for Savaysa, 2015-2025 163
Table 40: Product Profile - Multaq (dronedarone) 167
Table 41: Overview of the Pivotal Clinical Trials for Multaq 168
Table 42: Efficacy of Multaq in Patients with Paroxysmal or Persistent AF/AFL in the ATHENA Study 170
Table 43: Efficacy of Multaq in Patients with Permanent AF in the PALLAS Study 171
Table 44: Multaq (dronedarone) SWOT Analysis, 2016 174
Table 45: Global Sales Forecasts ($m) for Multaq, 2015-2025 175
Table 46: Product Profile - Brinavess (vernakalant) 181
Table 47: Efficacy of Intravenous Brinavess in Pivotal Late-Stage Clinical Trials 182
Table 48: Brinavess (vernakalant) SWOT Analysis, 2016 186
Table 49: Global Sales Forecasts ($m) for Brinavess, 2015-2025 188
Table 50: Summary of Widely Genericized Therapeutic Classes, 2014 189
Table 51: Commonly Used Genericized Vitamin K Antagonists (Excluding Warfarin), by Region 190
Table 52: Unmet Need and Opportunity in AF 200
Table 53: Target Opportunity Profile for AF Patients with Valvular AF and Mechanical Heart Valves 201
Table 54: Target Opportunity Profile for AF Patients with Severe Chronic Kidney Disease or Renal Failure 202
Table 55: Late-Stage Pipeline for AF, 2016 236
Table 56: Therapeutic Classes in Late-Stage Development for AF, 2016 236
Table 57: Product Profile - Tecarfarin 243
Table 58: Treatment-Emergent Adverse Events Reported for >2 Patients in Phase IIa Tecarfarin Study 246
Table 59: Tecarfarin SWOT Analysis, 2016 249
Table 60: Global Sales Forecasts ($m) for Tecarfarin, 2015-2025 251
Table 61: Early-Stage Pipeline Products for AF - Anticoagulant Agents 252
Table 62: Early-Stage Pipeline Products for AF - Antiarrhythmic Drugs 257
Table 63: Key Companies in the AF Market, 2016 265
Table 64: Boehringer Ingelheim's AF Portfolio Assessment, 2016 270
Table 65: Boehringer Ingelheim SWOT Analysis, 2016 270
Table 66: Bayer's AF Portfolio Assessment, 2016 273
Table 67: Bayer SWOT Analysis, 2016 274
Table 68: Janssen's AF Portfolio Assessment, 2016 276
Table 69: Janssen SWOT Analysis, 2016 277
Table 70: Bristol-Myers Squibb's AF Portfolio Assessment, 2016 279
Table 71: Bristol-Myers Squibb SWOT Analysis, 2016 280
Table 72: Pfizer's AF Portfolio Assessment, 2016 282
Table 73: Pfizer SWOT Analysis, 2016 283
Table 74: Daiichi-Sankyo's AF Portfolio Assessment, 2016 285
Table 75: Daiichi-Sankyo SWOT Analysis, 2016 286
Table 76: Armetheon's AF Portfolio Assessment, 2016 288
Table 77: Armetheon SWOT Analysis, 2016 288
Table 78: Global* Sales Forecasts ($m) for AF, 2015-2025 291
Table 79: Global AF Market - Drivers and Barriers, 2016 298
Table 80: Sales Forecasts ($m) for AF in the US, 2015-2025 305
Table 81: Key Events Impacting Sales for AF in the US, 2016 308
Table 82: AF Market - Drivers and Barriers in the US, 2015-2025 308
Table 83: Sales Forecasts ($m) for AF in France, 2015-2025 312
Table 84: Key Events Impacting Sales for AF in France, 2016 315
Table 85: AF Market - Drivers and Barriers in France, 2015-2025 315
Table 86: Sales Forecasts ($m) for AF in Germany, 2015-2025 321
Table 87: Key Events Impacting Sales for AF in Germany, 2016 324
Table 88: AF Market - Drivers and Barriers in Germany, 2015-2025 324
Table 89: Sales Forecasts ($m) for AF in Italy, 2015-2025 328
Table 90: Key Events Impacting Sales for AF in Italy, 2016 331
Table 91: AF Market - Drivers and Barriers in Italy, 2015-2025 331
Table 92: Sales Forecasts ($m) for AF in Spain, 2015-2025 335
Table 93: Key Events Impacting Sales for AF in Spain, 2016 338
Table 94: AF Market - Drivers and Barriers in Spain, 2015-2025 338
Table 95: Sales Forecasts ($m) for AF in the UK, 2015-2025 342
Table 96: Key Events Impacting Sales for AF in the UK, 2016 345
Table 97: AF Market - Drivers and Barriers in the UK, 2015-2025 345
Table 98: Sales Forecasts ($m) for AF in Japan, 2015-2025 349
Table 99: Key Events Impacting Sales for AF in Japan, 2016 352
Table 100: AF Market - Drivers and Barriers in Japan, 2015-2025 352
Table 101: Sales Forecasts ($m) for AF in Canada 2015-2025 357
Table 102: Key Events Impacting Sales for AF in Canada, 2016 360
Table 103: AF Market - Drivers and Barriers in Canada, 2015-2025 360
Table 104: Key Launch Dates 392
Table 105: Key Patent Expiries 392
Table 106: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 406

1.2 List of Figures
Figure 1: 8MM, Diagnosed Prevalent Cases of AF, Ages ?40 Years, Both Sexes, N, 2015-2025 51
Figure 2: 8MM, Age-Specific Diagnosed Prevalent Cases of AF, Both Sexes, N, 2015 53
Figure 3: 8MM, Sex-Specific Diagnosed Prevalent Cases of AF, Ages ?40 Years, 2015 55
Figure 4: 8MM, Age-Standardized Diagnosed Prevalence of AF, Ages ?40 Years, N, 2015 56
Figure 5: 8MM, Diagnosed Prevalent Cases of AF by Clinical Subtypes, Both Sexes, Ages ?40 Years, 2015 57
Figure 6: ESC Guideline Recommendations for Choosing an Anticoagulant 67
Figure 7: JCS Guideline Recommendations for Choosing an Anticoagulant 69
Figure 8: CCS Guideline Recommendations for Choosing an Anticoagulant 70
Figure 9: AHA Guideline Recommendations for Drug Therapy for Ventricular Rate Control 72
Figure 10: AHA Guideline Recommendations for Rhythm Control in Patients with Paroxysmal and Persistent AF 75
Figure 11: ESC Guideline Recommendations for Rhythm Control According to Underlying Pathology 76
Figure 12: JCS Guideline Recommendations for Rhythm Control 77
Figure 13: Site of Action of the New Oral Anticoagulants in the Anticoagulation Cascade 95
Figure 14: Competitive Assessment of Late-Stage Pipeline Agents for AF, 2015-2025 237
Figure 15: Company Portfolio Gap Analysis in AF, 2015-2025 266
Figure 16: Global Sales for AF by Country, 2015-2025 293
Figure 17: Annual Global Sales for AF by Region, 2015-2025 294
Figure 18: Global* AF Sales by Drug Class, 2015-2025 295
Figure 19: Annual Global* Sales for AF by Drug Class, 2015-2025 296
Figure 20: Annual Global* Sales for the Novel Oral Anticoagulants, 2015-2025 297
Figure 21: Sales for AF in the US by Drug Class, 2015-2025 307
Figure 22: Sales for AF in France by Drug Class, 2015-2025 314
Figure 23: Sales for AF in Germany by Drug Class, 2015-2025 323
Figure 24: Sales for AF in Italy by Drug Class, 2015-2025 330
Figure 25: Sales for AF in Spain by Drug Class, 2015-2025 337
Figure 26: Sales for AF in the UK by Drug Class, 2015-2025 344
Figure 27: Sales for AF in Japan by Drug Class, 2015-2025 351
Figure 28: Sales for AF in Canada by Drug Class, 2015-2025 359

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