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

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 and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Symptoms

3.3Classification of Atrial Fibrillation

3.4Prognosis

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Forecast Assumptions and Methods

4.4.3Sources Not Used

4.5Epidemiological Forecast for AF (2015–2025)

4.5.1Diagnosed Prevalent Cases

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Disease Management

5.1Diagnosis and Treatment Overview

5.1.1Diagnosis

5.1.2Treatment Guidelines and Leading Prescribed Drugs

5.1.3Clinical Practice

5.2US

5.3France

5.4Germany

5.5Italy

5.6Spain

5.7UK

5.8Japan

5.9Canada

6Competitive Assessment

6.1Overview

6.2Product Profiles – Major Brands, Anticoagulant Agents

6.2.1Warfarin (Widely Genericized)

6.2.2Pradaxa (dabigatran)

6.2.3Xarelto (rivaroxaban)

6.2.4Eliquis (apixaban)

6.2.5Savaysa (edoxaban)

6.3Product Profiles – Major Brands, Antiarrhythmic Drugs

6.3.1Multaq (dronedarone)

6.3.2Brinavess (vernakalant)

6.4Other Therapeutic Classes

6.4.1Vitamin K Antagonists Other than Warfarin (Widely Genericized)

6.4.2Antiplatelets – Aspirin (Widely Genericized)

6.4.3Beta-Blockers – Atenolol, Metoprolol, Propranolol (Widely Genericized)

6.4.4Calcium Channel Blockers – Diltiazem, Verapamil (Widely Genericized)

6.4.5Cardiac Glycosides – Digoxin (Widely Genericized)

6.4.6Potassium Channel Blockers – Amiodarone, Sotalol, Dofetilide (Widely Genericized)

6.4.7Sodium Channel Blockers – Flecainide, Propafenone (Widely Genericized)

7Unmet Need and Opportunity

7.1Overview

7.2Target Opportunity Profiles in Specific Patient Segments

7.2.1Atrial Fibrillation Patients with Valvular AF and Mechanical Heart Valves

7.2.2Atrial Fibrillation Patients with Severe Chronic Kidney Disease or Renal Failure

7.3Safer Antiarrhythmic Drugs for the Maintenance of Sinus Rhythm

7.3.1Unmet Need

7.3.2Gap Analysis

7.3.3Opportunity

7.4Effective and Rapid-Acting Cardioversion Drugs

7.4.1Unmet Need

7.4.2Gap Analysis

7.4.3Opportunity

7.5Therapies for Valvular Atrial Fibrillation Patients

7.5.1Unmet Need

7.5.2Gap Analysis

7.5.3Opportunity

7.6Therapies for Atrial Fibrillation Patients with Severe Chronic Kidney Disease or Renal Failure

7.6.1Unmet Need

7.6.2Gap Analysis

7.6.3Opportunity

7.7Improved Access to and Reimbursement of the New Oral Anticoagulants

7.7.1Unmet Need

7.7.2Gap Analysis

7.7.3Opportunity

7.8Increased Physician Education on the Clinical Benefits of the NOACs

7.8.1Unmet Need

7.8.2Gap Analysis

7.8.3Opportunity

7.9Increased Patient Awareness of the Clinical Benefits and Proper Use of the NOACs

7.9.1Unmet Need

7.9.2Gap Analysis

7.9.3Opportunity

7.10Reversal agents for the New Oral Anticoagulants

7.10.1Unmet Need

7.10.2Gap Analysis

7.10.3Opportunity

8Pipeline Assessment

8.1Overview

8.2Promising Drugs in Clinical Development

8.2.1Tecarfarin

8.3Other Drugs in Development

8.3.1Early-Stage Anticoagulant Pipeline

8.3.2Early-Stage Antiarrhythmia Pipeline

9Current and Future Players

9.1Overview

9.2Trends in Corporate Strategy

9.3Company Profiles

9.3.1Boehringer Ingelheim

9.3.2Bayer

9.3.3Janssen (Johnson & Johnson)

9.3.4Bristol-Myers Squibb

9.3.5Pfizer

9.3.6Daiichi-Sankyo

9.3.7Armetheon

10Market Outlook

10.1Global Markets

10.1.1Forecast

10.1.2Drivers and Barriers – Global Issues

10.2US

10.2.1Forecast

10.2.2Key Events

10.2.3Drivers and Barriers

10.3France

10.3.1Forecast

10.3.2Key Events

10.3.3Drivers and Barriers

10.4Germany

10.4.1Forecast

10.4.2Key Events

10.4.3Drivers and Barriers

10.5Italy

10.5.1Forecast

10.5.2Key Events

10.5.3Drivers and Barriers

10.6Spain

10.6.1Forecast

10.6.2Key Events

10.6.3Drivers and Barriers

10.7UK

10.7.1Forecast

10.7.2Key Events

10.7.3Drivers and Barriers

10.8Japan

10.8.1Forecast

10.8.2Key Events

10.8.3Drivers and Barriers

10.9Canada

10.9.1Forecast

10.9.2Key Events

10.9.3Drivers and Barriers

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1Diagnosed Atrial Fibrillation Patients

11.4.2Percent Drug-Treated Patients

11.4.3Drugs Included in Each Therapeutic Class

11.4.4Launch and Patent Expiry Dates

11.4.5General Pricing Assumptions

11.4.6Individual Drug Assumptions

11.4.7Generic Erosion

11.4.8Pricing of Pipeline Agents

11.5Physicians and Specialists Included in this Study

11.6About the Authors

11.6.1Analyst

11.6.2Senior Analyst

11.6.3Therapy Director

11.6.4Epidemiologist

11.6.5Global Director of Therapy Analysis and Epidemiology

11.7About GlobalData

11.8Disclaimer

Table 1: Common Cardiac and Non-cardiac Causes of AF

Table 2: Classification of AF

Table 3: Clinical Subtypes of AF

Table 4: Risk Factors and Comorbidities for AF

Table 5: Prevalence (%) of AF as Reported in Epidemiological Studies

Table 6: 8MM, Sources Used to Forecast the Diagnosed Prevalent Cases of AF

Table 7: 8MM, Sources Used to Forecast Clinical Subtypes of Diagnosed Prevalent Cases of AF

Table 8: 8MM, Sources Not Used in the Epidemiological Analysis of AF

Table 9: 8MM, Diagnosed Prevalent Cases of AF, Ages =40 Years, Both Sexes, N, Selected Years 2015–2025

Table 10: 8MM, Age-Specific Diagnosed Prevalent Cases of AF, Both Sexes, N (Row %), 2015

Table 11: 8MM, Sex-Specific Diagnosed Prevalent Cases of AF, Ages =40 Years, N (Row %), 2015

Table 12: CHADS2 Index for Stroke Risk Assessment

Table 13: CHA2DS2-VASc Index for Stroke Risk Assessment

Table 14: Treatment Guidelines for AF by Country

Table 15: Most Prescribed Drugs or Drug Classes for AF by Country, 2015

Table 16: Country Profile – US

Table 17: Country Profile – France

Table 18: Country Profile – Germany

Table 19: Country Profile – Italy

Table 20: Country Profile – Spain

Table 21: Country Profile – UK

Table 22: Country Profile – Japan

Table 23: Country Profile – Canada

Table 24: Leading Treatments and Branded Drugs for AF, 2016

Table 25: Product Profile – Warfarin (Widely Genericized)

Table 26: Warfarin (Widely Genericized) SWOT Analysis, 2016

Table 27: Global Sales Forecasts ($m) for Warfarin, 2015–2025

Table 28: Product Profile – Pradaxa (dabigatran)

Table 29: Pradaxa (dabigatran) SWOT Analysis, 2016

Table 30: Global Sales Forecasts ($m) for Pradaxa, 2015–2025

Table 31: Product Profile – Xarelto (rivaroxaban)

Table 32: Xarelto (rivaroxaban) SWOT Analysis, 2016

Table 33: Global Sales Forecasts ($m) for Xarelto, 2015–2025

Table 34: Product Profile – Eliquis (apixaban)

Table 35: Eliquis (apixaban) SWOT Analysis, 2016

Table 36: Global Sales Forecasts ($m) for Eliquis, 2015–2025

Table 37: Product Profile – Savaysa (edoxaban)

Table 38: Savaysa (edoxaban) SWOT Analysis, 2016

Table 39: Global Sales Forecasts ($m) for Savaysa, 2015–2025

Table 40: Product Profile – Multaq (dronedarone)

Table 41: Overview of the Pivotal Clinical Trials for Multaq

Table 42: Efficacy of Multaq in Patients with Paroxysmal or Persistent AF/AFL in the ATHENA Study

Table 43: Efficacy of Multaq in Patients with Permanent AF in the PALLAS Study

Table 44: Multaq (dronedarone) SWOT Analysis, 2016

Table 45: Global Sales Forecasts ($m) for Multaq, 2015–2025

Table 46: Product Profile – Brinavess (vernakalant)

Table 47: Efficacy of Intravenous Brinavess in Pivotal Late-Stage Clinical Trials

Table 48: Brinavess (vernakalant) SWOT Analysis, 2016

Table 49: Global Sales Forecasts ($m) for Brinavess, 2015–2025

Table 50: Summary of Widely Genericized Therapeutic Classes, 2014

Table 51: Commonly Used Genericized Vitamin K Antagonists (Excluding Warfarin), by Region

Table 52: Unmet Need and Opportunity in AF

Table 53: Target Opportunity Profile for AF Patients with Valvular AF and Mechanical Heart Valves

Table 54: Target Opportunity Profile for AF Patients with Severe Chronic Kidney Disease or Renal Failure

Table 55: Late-Stage Pipeline for AF, 2016

Table 56: Therapeutic Classes in Late-Stage Development for AF, 2016

Table 57: Product Profile – Tecarfarin

Table 58: Treatment-Emergent Adverse Events Reported for >2 Patients in Phase IIa Tecarfarin Study

Table 59: Tecarfarin SWOT Analysis, 2016

Table 60: Global Sales Forecasts ($m) for Tecarfarin, 2015–2025

Table 61: Early-Stage Pipeline Products for AF – Anticoagulant Agents

Table 62: Early-Stage Pipeline Products for AF – Antiarrhythmic Drugs

Table 63: Key Companies in the AF Market, 2016

Table 64: Boehringer Ingelheim’s AF Portfolio Assessment, 2016

Table 65: Boehringer Ingelheim SWOT Analysis, 2016

Table 66: Bayer’s AF Portfolio Assessment, 2016

Table 67: Bayer SWOT Analysis, 2016

Table 68: Janssen’s AF Portfolio Assessment, 2016

Table 69: Janssen SWOT Analysis, 2016

Table 70: Bristol-Myers Squibb’s AF Portfolio Assessment, 2016

Table 71: Bristol-Myers Squibb SWOT Analysis, 2016

Table 72: Pfizer’s AF Portfolio Assessment, 2016

Table 73: Pfizer SWOT Analysis, 2016

Table 74: Daiichi-Sankyo’s AF Portfolio Assessment, 2016

Table 75: Daiichi-Sankyo SWOT Analysis, 2016

Table 76: Armetheon’s AF Portfolio Assessment, 2016

Table 77: Armetheon SWOT Analysis, 2016

Table 78: Global* Sales Forecasts ($m) for AF, 2015–2025

Table 79: Global AF Market – Drivers and Barriers, 2016

Table 80: Sales Forecasts ($m) for AF in the US, 2015–2025

Table 81: Key Events Impacting Sales for AF in the US, 2016

Table 82: AF Market – Drivers and Barriers in the US, 2015–2025

Table 83: Sales Forecasts ($m) for AF in France, 2015–2025

Table 84: Key Events Impacting Sales for AF in France, 2016

Table 85: AF Market – Drivers and Barriers in France, 2015–2025

Table 86: Sales Forecasts ($m) for AF in Germany, 2015–2025

Table 87: Key Events Impacting Sales for AF in Germany, 2016

Table 88: AF Market – Drivers and Barriers in Germany, 2015–2025

Table 89: Sales Forecasts ($m) for AF in Italy, 2015–2025

Table 90: Key Events Impacting Sales for AF in Italy, 2016

Table 91: AF Market – Drivers and Barriers in Italy, 2015–2025

Table 92: Sales Forecasts ($m) for AF in Spain, 2015–2025

Table 93: Key Events Impacting Sales for AF in Spain, 2016

Table 94: AF Market – Drivers and Barriers in Spain, 2015–2025

Table 95: Sales Forecasts ($m) for AF in the UK, 2015–2025

Table 96: Key Events Impacting Sales for AF in the UK, 2016

Table 97: AF Market – Drivers and Barriers in the UK, 2015–2025

Table 98: Sales Forecasts ($m) for AF in Japan, 2015–2025

Table 99: Key Events Impacting Sales for AF in Japan, 2016

Table 100: AF Market – Drivers and Barriers in Japan, 2015–2025

Table 101: Sales Forecasts ($m) for AF in Canada 2015–2025

Table 102: Key Events Impacting Sales for AF in Canada, 2016

Table 103: AF Market – Drivers and Barriers in Canada, 2015–2025

Table 104: Key Launch Dates

Table 105: Key Patent Expiries

Table 106: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figure 1: 8MM, Diagnosed Prevalent Cases of AF, Ages =40 Years, Both Sexes, N, 2015–2025

Figure 2: 8MM, Age-Specific Diagnosed Prevalent Cases of AF, Both Sexes, N, 2015

Figure 3: 8MM, Sex-Specific Diagnosed Prevalent Cases of AF, Ages =40 Years, 2015

Figure 4: 8MM, Age-Standardized Diagnosed Prevalence of AF, Ages =40 Years, N, 2015

Figure 5: 8MM, Diagnosed Prevalent Cases of AF by Clinical Subtypes, Both Sexes, Ages =40 Years, 2015

Figure 6: ESC Guideline Recommendations for Choosing an Anticoagulant

Figure 7: JCS Guideline Recommendations for Choosing an Anticoagulant

Figure 8: CCS Guideline Recommendations for Choosing an Anticoagulant

Figure 9: AHA Guideline Recommendations for Drug Therapy for Ventricular Rate Control

Figure 10: AHA Guideline Recommendations for Rhythm Control in Patients with Paroxysmal and Persistent AF

Figure 11: ESC Guideline Recommendations for Rhythm Control According to Underlying Pathology

Figure 12: JCS Guideline Recommendations for Rhythm Control

Figure 13: Site of Action of the New Oral Anticoagulants in the Anticoagulation Cascade

Figure 14: Competitive Assessment of Late-Stage Pipeline Agents for AF, 2015–2025

Figure 15: Company Portfolio Gap Analysis in AF, 2015–2025

Figure 16: Global Sales for AF by Country, 2015–2025

Figure 17: Annual Global Sales for AF by Region, 2015–2025

Figure 18: Global* AF Sales by Drug Class, 2015–2025

Figure 19: Annual Global* Sales for AF by Drug Class, 2015–2025

Figure 20: Annual Global* Sales for the Novel Oral Anticoagulants, 2015–2025

Figure 21: Sales for AF in the US by Drug Class, 2015–2025

Figure 22: Sales for AF in France by Drug Class, 2015–2025

Figure 23: Sales for AF in Germany by Drug Class, 2015–2025

Figure 24: Sales for AF in Italy by Drug Class, 2015–2025

Figure 25: Sales for AF in Spain by Drug Class, 2015–2025

Figure 26: Sales for AF in the UK by Drug Class, 2015–2025

Figure 27: Sales for AF in Japan by Drug Class, 2015–2025

Figure 28: Sales for AF in Canada by Drug Class, 2015–2025