PharmaPoint: Atrial Fibrillation - Global Drug Forecast and Market Analysis to 2023

Publisher Name :
Date: 27-Feb-2015
No. of pages: 406

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. Two potential antiarrhythmic drugs are in late-stage development and are forecast to enter the market within the next decade: Gilead's ranolazine/dronedarone and ChanRx's vanoxerine.

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 of the late-stage antiarrhythmic drugs make a significant impact on the AF market? Which of these drugs will have the highest peak sales at the end of the forecast period, and why?


Key Findings

  • The major driver for the growth of the AF market will be the continued uptake of the NOACs for the prevention of stroke in patients with AF. Due to the advances that the NOACs provide in terms of improved safety and the lack of a need for routine monitoring, NOAC uptake will continue to increase, taking market share away from vitamin K antagonists, such as warfarin.

  • The second major driver will be the approval and launch of the first antidotes for the NOACs, which will alleviate physician and patient concerns regarding a lack of a reversal agent in the event of uncontrolled bleeding, and will increase overall uptake.

  • Despite a great unmet need for safer antiarrhythmic drugs, developments in this field are expected to be much slower due to the high risk involved in developing these drugs. Barriers to growth include the requirement for large, costly, and comprehensive clinical trials to support regulatory approval of cardiovascular drugs, which will deter drug developers wanting to enter the AF market. Widely available generic antiarrhythmic drugs will also make it difficult for any novel rhythm control agents to gain reimbursement and wider uptake.


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 2013, forecast for ten years to 2023.

  • 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

  • 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 2013-2023.

  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

PharmaPoint: Atrial Fibrillation - Global Drug Forecast and Market Analysis to 2023

Table of Contents

1 Table of Contents 12
1.1 List of Tables 19
1.2 List of Figures 24

2 Introduction 26
2.1 Catalyst 26
2.2 Related Reports 27
2.3 Upcoming Related Reports 27

3 Disease Overview 28
3.1 Etiology and Pathophysiology 28
3.1.1 Etiology 28
3.1.2 Pathophysiology 29
3.2 Symptoms 30
3.3 Classification of Atrial Fibrillation 31
3.4 Prognosis 32

4 Epidemiology 33
4.1 Disease Background 33
4.2 Risk Factors and Comorbidities 34
4.3 Global Trends 36
4.4 Forecast Methodology 38
4.4.1 Sources Used 40
4.4.2 Forecast Assumptions and Methods 46
4.4.3 Sources Not Used 51
4.5 Epidemiological Forecast for Atrial Fibrillation (2013-2023) 52
4.5.1 Diagnosed Prevalent Cases of Atrial Fibrillation 52
4.5.2 Age-Specific Diagnosed Prevalent Cases of Atrial Fibrillation 53
4.5.3 Sex-Specific Diagnosed Prevalent Cases of Atrial Fibrillation 55
4.5.4 Age-Standardized Diagnosed Prevalence of Atrial Fibrillation 57
4.5.5 Diagnosed Prevalent Cases of Atrial Fibrillation by Clinical Subtypes 59
4.6 Discussion 60
4.6.1 Epidemiological Forecast Insight 60
4.6.2 Limitations of the Analysis 62
4.6.3 Strengths of the Analysis 63

5 Disease Management 64
5.1 Diagnosis and Treatment Overview 64
5.1.1 Diagnosis 64
5.1.2 Treatment Guidelines and Leading Prescribed Drugs 66
5.1.3 Clinical Practice 68
5.2 US 82
5.3 France 84
5.4 Germany 86
5.5 Italy 88
5.6 Spain 90
5.7 UK 92
5.8 Japan 94
5.9 Canada 97

6 Competitive Assessment 99
6.1 Overview 99
6.2 Product Profiles - Major Brands, Anticoagulant Agents 104
6.2.1 Warfarin (Widely Genericized) 104
6.2.2 Pradaxa (dabigatran) 114
6.2.3 Xarelto (rivaroxaban) 128
6.2.4 Eliquis (apixaban) 141
6.2.5 Savaysa (edoxaban) 154
6.3 Product Profiles - Major Brands, Antiarrhythmic Drugs 166
6.3.1 Multaq (dronedarone) 166
6.3.2 Brinavess (vernakalant) 178
6.4 Other Therapeutic Classes 190
6.4.1 Vitamin K Antagonists Other than Warfarin (Widely Genericized) 191
6.4.2 Antiplatelets - Aspirin (Widely Genericized) 193
6.4.3 Beta-Blockers - Atenolol, Metoprolol, Propranolol (Widely Genericized) 194
6.4.4 Calcium Channel Blockers - Diltiazem, Verapamil (Widely Genericized) 195
6.4.5 Cardiac Glycosides ? Digoxin (Widely Genericized) 196
6.4.6 Potassium Channel Blockers - Amiodarone, Sotalol, Dofetilide (Widely Genericized) 197
6.4.7 Sodium Channel Blockers - Flecainide, Propafenone (Widely Genericized) 199

7 Unmet Need and Opportunity 201
7.1 Overview 201
7.2 Safer Antiarrhythmic Drugs for the Maintenance of Sinus Rhythm 202
7.2.1 Unmet Need 202
7.2.2 Gap Analysis 203
7.2.3 Opportunity 204
7.3 Effective and Rapid Acting Cardioversion Drugs 205
7.3.1 Unmet Need 205
7.3.2 Gap Analysis 206
7.3.3 Opportunity 207
7.4 Antidotes for the New Oral Anticoagulants 208
7.4.1 Unmet Need 208
7.4.2 Gap Analysis 209
7.4.3 Opportunity 211
7.5 Improved Access to and Reimbursement of the New Oral Anticoagulants 212
7.5.1 Unmet Need 212
7.5.2 Gap Analysis 215
7.5.3 Opportunity 217
7.6 Increased Physician Education on the Clinical Benefits of the NOACs 218
7.6.1 Unmet Need 218
7.6.2 Gap Analysis 219
7.6.3 Opportunity 220
7.7 Increased Patient Awareness on the Clinical Benefits of the NOACs 221
7.7.1 Unmet Need 221
7.7.2 Gap Analysis 222
7.7.3 Opportunity 222

8 Pipeline Assessment 224
8.1 Overview 224
8.2 Clinical Trial Mapping 225
8.2.1 Clinical Trials by Country 225
8.2.2 Clinical Trials by Phase and Trial Status 226
8.3 Promising Drugs in Clinical Development 227
8.3.1 Ranolazine/Dronedarone 229
8.3.2 Vanoxerine 239
8.4 Other Drugs in Development 249
8.4.1 Early-Stage Anticoagulant Pipeline 249
8.4.2 Early-Stage Antiarrhythmia Pipeline 255

9 Current and Future Players 260
9.1 Overview 260
9.2 Trends in Corporate Strategy 262
9.3 Company Profiles 264
9.3.1 Boehringer Ingelheim 264
9.3.2 Bayer 267
9.3.3 Janssen (Johnson & Johnson) 270
9.3.4 Bristol-Myers Squibb 273
9.3.5 Pfizer 276
9.3.6 Daiichi-Sankyo 280
9.3.7 Gilead 283

10 Market Outlook 286
10.1 Global Markets 286
10.1.1 Forecast 286
10.1.2 Drivers and Barriers - Global Issues 295
10.2 United States 300
10.2.1 Forecast 300
10.2.2 Key Events 306
10.2.3 Drivers and Barriers 306
10.3 France 309
10.3.1 Forecast 309
10.3.2 Key Events 313
10.3.3 Drivers and Barriers 313
10.4 Germany 317
10.4.1 Forecast 317
10.4.2 Key Events 322
10.4.3 Drivers and Barriers 322
10.5 Italy 324
10.5.1 Forecast 324
10.5.2 Key Events 329
10.5.3 Drivers and Barriers 329
10.6 Spain 332
10.6.1 Forecast 332
10.6.2 Key Events 336
10.6.3 Drivers and Barriers 336
10.7 United Kingdom 338
10.7.1 Forecast 338
10.7.2 Key Events 343
10.7.3 Drivers and Barriers 343
10.8 Japan 346
10.8.1 Forecast 346
10.8.2 Key Events 351
10.8.3 Drivers and Barriers 351
10.9 Canada 354
10.9.1 Forecast 354
10.9.2 Key Events 358
10.9.3 Drivers and Barriers 358

11 Appendix 361
11.1 Bibliography 361
11.2 Abbreviations 382
11.3 Methodology 387
11.4 Forecasting Methodology 387
11.4.1 Diagnosed Atrial Fibrillation Patients 387
11.4.2 Percent Drug-Treated Patients 388
11.4.3 Drugs Included in Each Therapeutic Class 388
11.4.4 Launch and Patent Expiry Dates 389
11.4.5 General Pricing Assumptions 390
11.4.6 Individual Drug Assumptions 391
11.4.7 Generic Erosion 400
11.4.8 Pricing of Pipeline Agents 400
11.5 Physicians and Specialists Included in this Study 401
11.6 About the Authors 403
11.6.1 Analyst 403
11.6.2 Therapy Area Director 403
11.6.3 Epidemiologist 404
11.6.4 Global Head of Healthcare 404
11.7 About GlobalData 405
11.8 Disclaimer 405

List of Tables

Table 1: Common Cardiac and Non-Cardiac Causes of AF 29
Table 2: Classification of AF 31
Table 3: Clinical Subtypes of AF 33
Table 4: Risk Factors and Comorbidities for AF 35
Table 5: Diagnosed Prevalence (%) of AF in the 6MM,* as Reported in Epidemiological Studies 36
Table 6: Total Prevalence (%) of AF in the 7MM,* as Reported in Epidemiological Studies 37
Table 7: 8MM, Sources of Prevalence Data Used to Forecast the Diagnosed Prevalent Cases of AF 39
Table 8: 8MM, Sources of AF Subtype Data Used to Forecast the Diagnosed Prevalent Cases of AF by Subtypes 40
Table 9: 8MM, Diagnosed Prevalent Cases of AF, Ages ?40 Years, Both Sexes, N, 2013-2023 52
Table 10: 8MM, Diagnosed Prevalent Cases of AF, by Age, Both Sexes, N (Row %), 2013 54
Table 11: 8MM, Diagnosed Prevalent Cases of AF, by Sex, Ages ?40 Years, N (Row %), 2013 56
Table 12: 8MM, Diagnosed Prevalent Cases of AF, by Clinical Subtypes, Both Sexes, N (Row %), 2013 59
Table 13: CHADS2 Index for Stroke Risk Assessment 66
Table 14: CHA2DS2-VASc Index for Stroke Risk Assessment 66
Table 15: Treatment Guidelines for Atrial Fibrillation by Country 67
Table 16: Most Prescribed Drugs or Drug Classes for AF by Country, 2014 68
Table 17: Country Profile ? US 83
Table 18: Country Profile ? France 85
Table 19: Country Profile - Germany 87
Table 20: Country Profile ? Italy 89
Table 21: Country Profile ? Spain 91
Table 22: Country Profile ? UK 93
Table 23: Country Profile ? Japan 96
Table 24: Country Profile ? Canada 98
Table 25: Leading Treatments and Branded Drugs for AF, 2014 103
Table 26: Product Profile - Warfarin (Widely Genericized) 107
Table 27: Warfarin (Widely Genericized) SWOT Analysis, 2014 112
Table 28: Global Sales Forecasts ($m) for Warfarin, 2013-2023 114
Table 29: Product Profile - Pradaxa (dabigatran) 118
Table 30: Pradaxa (dabigatran) SWOT Analysis, 2014 125
Table 31: Global Sales Forecasts ($m) for Pradaxa, 2013-2023 128
Table 32: Product Profile - Xarelto (rivaroxaban) 132
Table 33: Xarelto (rivaroxaban) SWOT Analysis, 2013 138
Table 34: Global Sales Forecasts ($m) for Xarelto, 2013-2023 140
Table 35: Product Profile - Eliquis (apixaban) 145
Table 36: Eliquis (apixaban) SWOT Analysis, 2014 151
Table 37: Global Sales Forecasts ($m) for Eliquis, 2013-2023 153
Table 38: Product Profile - Savaysa (edoxaban) 157
Table 39: Savaysa (edoxaban) SWOT Analysis, 2014 163
Table 40: Global Sales Forecasts ($m) for Savaysa, 2013-2023 166
Table 41: Product Profile - Multaq (dronedarone) 169
Table 42: Overview of the Pivotal Clinical Trials for Multaq 170
Table 43: Efficacy of Multaq in Patients with Paroxysmal or Persistent AF/AFL in the ATHENA Study 172
Table 44: Efficacy of Multaq in Patients with Permanent AF in the PALLAS Study 174
Table 45: Multaq (dronedarone) SWOT Analysis, 2014 176
Table 46: Global Sales Forecasts ($m) for Multaq, 2013-2023 178
Table 47: Product Profile - Brinavess (vernakalant) 183
Table 48: Efficacy of Intravenous Brinavess in Pivotal Late-Stage Clinical Trials 184
Table 49: Brinavess (vernakalant) SWOT Analysis, 2014 188
Table 50: Global Sales Forecasts ($m) for Brinavess, 2013-2023 190
Table 51: Summary of Widely Genericized Therapeutic Classes, 2014 191
Table 52: Commonly Used Genericized Vitamin K Antagonists (Excluding Warfarin), by Region* 192
Table 53: Unmet Need and Opportunity in Atrial Fibrillation 201
Table 54: AF - Clinical Trials by Phase and Status, 2014 227
Table 55: Late-Stage Pipeline for AF, 2014 227
Table 56: Therapeutic Classes in Late-Stage Development for AF, 2014 228
Table 57: Product Profile - Ranolazine/Dronedarone 232
Table 58: Ranolazine/Dronedarone SWOT Analysis, 2014 237
Table 59: Global Sales Forecasts ($m) for Ranolazine/Dronedarone, 2013-2023 239
Table 60: Product Profile - Vanoxerine 242
Table 61: Efficacy of Vanoxerine in Patients with AF/AFL in the Phase IIb COR-ART Study 243
Table 62: Safety of Vanoxerine in Patients with AF/AFL in the Phase IIb COR-ART Study 245
Table 63: Vanoxerine SWOT Analysis, 2014 247
Table 64: Global Sales Forecasts ($m) for Vanoxerine, 2013-2023 249
Table 65: Early-Stage Pipeline Products for Atrial Fibrillation - Anticoagulant Agents 250
Table 66: Early-Stage Pipeline Products for Atrial Fibrillation - Antiarrhythmic Drugs 256
Table 67: Key Companies in the AF Market, 2014 261
Table 68: Boehringer Ingelheim's AF Portfolio Assessment, 2014 266
Table 69: Boehringer Ingelheim SWOT Analysis, 2014 267
Table 70: Bayer's AF Portfolio Assessment, 2014 269
Table 71: Bayer SWOT Analysis, 2014 270
Table 72: Janssen's AF Portfolio Assessment, 2014 272
Table 73: Janssen SWOT Analysis, 2014 273
Table 74: Bristol-Myers Squibb's AF Portfolio Assessment, 2014 275
Table 75: Bristol-Myers Squibb SWOT Analysis, 2014 276
Table 76: Pfizer's AF Portfolio Assessment, 2014 278
Table 77: Pfizer SWOT Analysis, 2014 279
Table 78: Daiichi-Sankyo's AF Portfolio Assessment, 2014 281
Table 79: Daiichi-Sankyo SWOT Analysis, 2014 282
Table 80: Gilead's AF Portfolio Assessment, 2014 284
Table 81: Gilead SWOT Analysis, 2014 285
Table 82: Global* Sales Forecasts ($m) for AF, 2013-2023 288
Table 83: Global AF Market - Drivers and Barriers, 2014 295
Table 84: Sales Forecasts ($m) for AF in the US, 2013-2023 303
Table 85: Key Events Impacting Sales for AF in the US, 2014 306
Table 86: AF Market - Drivers and Barriers in the US, 2013-2023 306
Table 87: Sales Forecasts ($m) for AF in France, 2013-2023 311
Table 88: Key Events Impacting Sales for AF in France, 2014 313
Table 89: AF Market - Drivers and Barriers in France, 2013-2023 313
Table 90: Sales Forecasts ($m) for AF in Germany, 2013-2023 319
Table 91: Key Events Impacting Sales for AF in Germany, 2014 322
Table 92: AF Market - Drivers and Barriers in Germany, 2013-2023 322
Table 93: Sales Forecasts ($m) for AF in Italy, 2013-2023 326
Table 94: Key Events Impacting Sales for AF in Italy, 2014 329
Table 95: AF Market - Drivers and Barriers in Italy, 2013-2023 329
Table 96: Sales Forecasts ($m) for AF in Spain, 2013-2023 333
Table 97: Key Events Impacting Sales for AF in Spain, 2014 336
Table 98: AF Market - Drivers and Barriers in Spain, 2013-2023 336
Table 99: Sales Forecasts ($m) for AF in UK, 2013-2023 340
Table 100: Key Events Impacting Sales for AF in the UK, 2014 343
Table 101: Asthma Market - Drivers and Barriers in the UK, 2013-2023 343
Table 102: Sales Forecasts ($m) for AF in Japan, 2013-2023 348
Table 103: Key Events Impacting Sales for AF in Japan, 2014 351
Table 104: AF Market - Drivers and Barriers in Japan, 2013-2023 351
Table 105: Sales Forecasts ($m) for AF in Canada, 2013-2023 356
Table 106: Key Events Impacting Sales for AF in Canada, 2014 358
Table 107: AF Market - Drivers and Barriers in Canada, 2013-2023 358
Table 108: Key Launch Dates 389
Table 109: Key Patent Expiries 389
Table 110: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 40

List of Figures

Figure 1: 8MM, Diagnosed Prevalent Cases of AF, Ages ?40 Years, Both Sexes, N, 2013-2023 53
Figure 2: 8MM, Diagnosed Prevalent Cases of AF, by Age, Both Sexes, N, 2013 55
Figure 3: 8MM, Diagnosed Prevalent Cases of AF, by Sex, Ages ?40 Years, N, 2013 57
Figure 4: 8MM, Age-Standardized Diagnosed Prevalence (%) of AF, by Sex, Ages ?40 Years, 2013 58
Figure 5: 8MM, Diagnosed Prevalent Cases of AF, by Clinical Subtypes, Both Sexes, N, 2013 60
Figure 6: ESC Guideline Recommendations for Choosing an Anticoagulant 71
Figure 7: JCS Guideline Recommendations for Choosing an Anticoagulant 73
Figure 8: CCS Guideline Recommendations for Choosing an Anticoagulant 74
Figure 9: AHA Guideline Recommendations for Drug Therapy for Ventricular Rate Control 76
Figure 10: AHA Guideline Recommendations for Rhythm Control in Patients with Paroxysmal and Persistent AF 78
Figure 11: ESC Guideline Recommendations for Rhythm Control According to Underlying Pathology 80
Figure 12: JCS Guideline Recommendations for Rhythm Control 81
Figure 13: Site of Action of the New Oral Anticoagulants in the Anticoagulation Cascade 100
Figure 14: AF Therapeutics - Clinical Trials by Country, 2014 225
Figure 15: Competitive Assessment of Late-Stage Pipeline Agents for AF, 2013-2023 228
Figure 16: Company Portfolio Gap Analysis in AF, 2013-2023 262
Figure 17: Global Sales for AF by Country, 2013-2023 290
Figure 18: Annual Global Sales for AF by Region, 2013-2023 291
Figure 19: Global* AF Sales by Drug Class, 2013-2023 292
Figure 20: Annual Global* Sales for AF by Drug Class, 2013-2023 293
Figure 21: Annual Global* Sales for the Novel Oral Anticoagulants, 2013-2023 294
Figure 22: Sales for AF in the US by Drug Class, 2013-2023 305
Figure 23: Sales for AF in France by Drug Class, 2013-2023 312
Figure 24: Sales for AF in Germany by Drug Class, 2013-2023 321
Figure 25: Sales for AF in Italy by Drug Class, 2013-2023 328
Figure 26: Sales for AF in Spain by Drug Class, 2013-2023 335
Figure 27: Sales for AF in the UK by Drug Class, 2013-2023 342
Figure 28: Sales for AF in Japan by Drug Class, 2013-2023 350
Figure 29: Sales for AF in Canada by Drug Class, 2013-2023 357

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