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

  • ID: 3942784
  • Report
  • Region: Global
  • 411 pages
  • GlobalData
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FEATURED COMPANIES

  • ARCA Biopharma
  • Bayer
  • Bristol-Myers Squibb
  • Daiichi-Sankyo
  • Janssen Pharmaceuticals
  • Otsuka Pharmaceutical
  • MORE
Various therapeutic options are available to treat patients with atrial fibrillation (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.

It is estimated that 2015 sales for AF at approximately $8.0 Billion across the 8MM. The US dominates the overall size of the AF market, generating an estimated $5.7 Billion in 2015 and accounting for 70.6% of the overall size of the market. This is mainly due to the large prevalent AF population in the US, early adoption of the new oral anticoagulants (NOACs), and higher prices for AF medications in this market.

As per Jesus Cuaron, Analyst: “Since the launch of the first NOACs in 2010, this drug class has experienced substantial uptake, accounting for $6.8 billion, approximately 85% of all atrial fibrillation sales revenue across the 8MM in 2015. This uptake will continue to increase, and will be the main driver of growth in the atrial fibrillation space through 2022.

Major drivers for the growth of the AF market over the forecast period will include:
  • 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 the vitamin K antagonists, such as warfarin.
  • A shift in AF treatment guidelines to using the CHA2DS2-VASc score instead of the CHADS2 score for assessing stroke risk, which will cause a larger proportion of lower-risk patients to receive anticoagulant treatment.
  • The approval and launch of the first reversal agents for the NOACs, which will alleviate physician and patient concerns regarding a lack of a reversal agent in the event of uncontrolled bleeding, thereby increasing overall uptake.
Companies attempting to penetrate the AF market and differentiate their products, particularly those companies that market NOACs, are doing so with two main strategies: label expansion to increase physician brand familiarity, and intensive marketing to disseminate clinical trial results. Gaining approval for additional cardiovascular indications has been a strategy that has worked very well for Bayer and Janssen, the two companies that jointly developed and market Xarelto

The report “PharmaPoint: Atrial Fibrillation - Global Drug Forecast and Market Analysis to 2025” provides overview of AF, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Specially, this report provides the following analysis:
  • 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.
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2 of 5

FEATURED COMPANIES

  • ARCA Biopharma
  • Bayer
  • Bristol-Myers Squibb
  • Daiichi-Sankyo
  • Janssen Pharmaceuticals
  • Otsuka Pharmaceutical
  • MORE
1.1 List of Tables

1.2 List of Figures

2 Introduction

2.1 Catalyst

2.2 Related Reports

2.3 Upcoming Related Reports

3 Disease Overview

3.1 Etiology and Pathophysiology

3.1.1 Etiology

3.1.2 Pathophysiology

3.2 Symptoms

3.3 Classification of Atrial Fibrillation

3.4 Prognosis

4 Epidemiology

4.1 Disease Background

4.2 Risk Factors and Comorbidities

4.3 Global Trends

4.4 Forecast Methodology

4.4.1 Sources Used

4.4.2 Forecast Assumptions and Methods

4.4.3 Sources Not Used

4.5 Epidemiological Forecast for AF (2015-2025)

4.5.1 Diagnosed Prevalent Cases

4.6 Discussion

4.6.1 Epidemiological Forecast Insight

4.6.2 Limitations of the Analysis

4.6.3 Strengths of the Analysis

5 Disease Management

5.1 Diagnosis and Treatment Overview

5.1.1 Diagnosis

5.1.2 Treatment Guidelines and Leading Prescribed Drugs

5.1.3 Clinical Practice

5.2 US

5.3 France

5.4 Germany

5.5 Italy

5.6 Spain

5.7 UK

5.8 Japan

5.9 Canada

6 Competitive Assessment

6.1 Overview

6.2 Product Profiles - Major Brands, Anticoagulant Agents

6.2.1 Warfarin (Widely Genericized)

6.2.2 Pradaxa (dabigatran)

6.2.3 Xarelto (rivaroxaban)

6.2.4 Eliquis (apixaban)

6.2.5 Savaysa (edoxaban)

6.3 Product Profiles - Major Brands, Antiarrhythmic Drugs

6.3.1 Multaq (dronedarone)

6.3.2 Brinavess (vernakalant)

6.4 Other Therapeutic Classes

6.4.1 Vitamin K Antagonists Other than Warfarin (Widely Genericized)

6.4.2 Antiplatelets - Aspirin (Widely Genericized)

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

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

6.4.5 Cardiac Glycosides - Digoxin (Widely Genericized)

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

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

7 Unmet Need and Opportunity

7.1 Overview

7.2 Target Opportunity Profiles in Specific Patient Segments

7.2.1 Atrial Fibrillation Patients with Valvular AF and Mechanical Heart Valves

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

7.3 Safer Antiarrhythmic Drugs for the Maintenance of Sinus Rhythm

7.3.1 Unmet Need

7.3.2 Gap Analysis

7.3.3 Opportunity

7.4 Effective and Rapid-Acting Cardioversion Drugs

7.4.1 Unmet Need

7.4.2 Gap Analysis

7.4.3 Opportunity

7.5 Therapies for Valvular Atrial Fibrillation Patients

7.5.1 Unmet Need

7.5.2 Gap Analysis

7.5.3 Opportunity

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

7.6.1 Unmet Need

7.6.2 Gap Analysis

7.6.3 Opportunity

7.7 Improved Access to and Reimbursement of the New Oral Anticoagulants

7.7.1 Unmet Need

7.7.2 Gap Analysis

7.7.3 Opportunity

7.8 Increased Physician Education on the Clinical Benefits of the NOACs

7.8.1 Unmet Need

7.8.2 Gap Analysis

7.8.3 Opportunity

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

7.9.1 Unmet Need

7.9.2 Gap Analysis

7.9.3 Opportunity

7.10 Reversal agents for the New Oral Anticoagulants

7.10.1 Unmet Need

7.10.2 Gap Analysis

7.10.3 Opportunity

8 Pipeline Assessment

8.1 Overview

8.2 Promising Drugs in Clinical Development

8.2.1 Tecarfarin

8.3 Other Drugs in Development

8.3.1 Early-Stage Anticoagulant Pipeline

8.3.2 Early-Stage Antiarrhythmia Pipeline

9 Current and Future Players

9.1 Overview

9.2 Trends in Corporate Strategy

9.3 Company Profiles

9.3.1 Boehringer Ingelheim

9.3.2 Bayer

9.3.3 Janssen (Johnson & Johnson)

9.3.4 Bristol-Myers Squibb

9.3.5 Pfizer

9.3.6 Daiichi-Sankyo

9.3.7 Armetheon

10 Market Outlook

10.1 Global Markets

10.1.1 Forecast

10.1.2 Drivers and Barriers - Global Issues

10.2 US

10.2.1 Forecast

10.2.2 Key Events

10.2.3 Drivers and Barriers

10.3 France

10.3.1 Forecast

10.3.2 Key Events

10.3.3 Drivers and Barriers

10.4 Germany

10.4.1 Forecast

10.4.2 Key Events

10.4.3 Drivers and Barriers

10.5 Italy

10.5.1 Forecast

10.5.2 Key Events

10.5.3 Drivers and Barriers

10.6 Spain

10.6.1 Forecast

10.6.2 Key Events

10.6.3 Drivers and Barriers

10.7 UK

10.7.1 Forecast

10.7.2 Key Events

10.7.3 Drivers and Barriers

10.8 Japan

10.8.1 Forecast

10.8.2 Key Events

10.8.3 Drivers and Barriers

10.9 Canada

10.9.1 Forecast

10.9.2 Key Events

10.9.3 Drivers and Barriers

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.4 Forecasting Methodology

11.4.1 Diagnosed Atrial Fibrillation Patients

11.4.2 Percent Drug-Treated Patients

11.4.3 Drugs Included in Each Therapeutic Class

11.4.4 Launch and Patent Expiry Dates

11.4.5 General Pricing Assumptions

11.4.6 Individual Drug Assumptions

11.4.7 Generic Erosion

11.4.8 Pricing of Pipeline Agents

11.5 Physicians and Specialists Included in this Study

11.6 About the Authors

11.6.1 Analyst

11.6.2 Senior Analyst

11.6.3 Therapy Director

11.6.4 Epidemiologist

11.6.5 Global Director of Therapy Analysis and Epidemiology

11.7 About us

11.8 Disclaimer

1.1 List of Tables

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

1.2 List of Figures

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
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  • ARCA Biopharma
  • Armetheon Inc.
  • Bayer
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Cardiome Pharma
  • Daiichi-Sankyo
  • Isis Pharmaceuticals
  • Janssen Pharmaceuticals
  • Laboratoires Pierre Fabre
  • Otsuka Pharmaceutical
  • Pfizer
  • Portola Pharmaceuticals
  • Sanofi
  • Servier
  • Xention
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