Atrial Fibrillation Market Size, Drug Analysis, Epidemiology, Disease Management, Pipeline Assessment, Unmet Needs and Forecast to 2032

About GlobalData 2

1 Atrial Fibrillation: Executive Summary 9

1.1 AF market will decline at a negative CAGR of

1.3% 10

1.2 Bayer and Bristol Myers Squibb will continue to lead the AF market over the forecast period 11

1.3 While outlook in AF improves, opportunities remain to improve patient outcomes 13

1.4 Bayer’s FXIa inhibitor asundexian will be a key driver of growth 14

1.5 What do physicians think? 15

2 Introduction 17

2.1 Catalyst 17

2.2 Related reports 17

2.3 Upcoming reports 18

3 Disease Overview 19

3.1 Etiology and pathophysiology 19

3.1.1 Etiology 19

3.1.2 Pathophysiology 20

3.2 Classification 21

4 Epidemiology 22

4.1 Disease Background 22

4.2 Risk Factors and Comorbidities 25

4.3 Global and Historical Trends 27

4.4 8MM Forecast Methodology 28

4.4.1 Sources 28

4.4.2 Forecast Assumptions and Methods 37

4.4.3 Forecast assumptions and methods: total prevalent cases of AF – 8MM 37

4.4.4 Forecast assumptions and methods: diagnosed prevalent cases of AF 39

4.4.5 Forecast assumptions and methods: diagnosed prevalent cases of AF by temporal patterns of arrhythmia 40

4.4.6 Forecast assumptions and methods: diagnosed prevalent cases of AF by CHADS2 stroke risk score 43

4.4.7 Forecast assumptions and methods: diagnosed prevalent cases of AF by CHA2DS2 – VASc stroke risk score in men 46

4.4.8 Forecast assumptions and methods: diagnosed prevalent cases of AF by CHA2DS2 – VASc stroke risk score in women 48

4.4.9 Forecast assumptions and methods: diagnosed prevalent cases of AF with/without moderate-to-severe mitral stenosis and/or an artificial (mechanical) heart valve 50

4.4.10 Forecast assumptions and methods: diagnosed prevalent cases of AF with CKD by stage 52

4.4.11 Forecast assumptions and methods: diagnosed prevalent cases of AF with major bleeding risk by HAS‐BLED score 52

4.4.12 Forecast assumptions and methods: diagnosed prevalent cases of AF admitted to ED 54

4.5 Epidemiological Forecast for atrial fibrillation 56

4.5.1 Total prevalent cases of AF 56

4.5.2 Diagnosed prevalent cases of AF 57

4.5.3 Age-specific diagnosed prevalent cases of AF 58

4.5.4 Sex-specific diagnosed prevalent cases of AF 59

4.5.5 Diagnosed prevalent cases of AF by temporal pattern of arrhythmia 60

4.5.6 Diagnosed prevalent cases of AF by CHADS2 stroke risk score 61

4.5.7 Diagnosed prevalent cases of AF by CHA2DS2 – VASc stroke risk score in men 62

4.5.8 Diagnosed prevalent cases of AF by CHA2DS2 – VASc stroke risk score in women 63

4.5.9 Diagnosed prevalent cases of AF with or without moderate-to-severe mitral stenosis and/or an artificial (mechanical) heart valve 64

4.5.10 Diagnosed prevalent cases of AF with CKD by stage 65

4.5.11 Diagnosed prevalent cases of AF with major bleeding risk by HAS‐BLED score 66

4.5.12 Diagnosed prevalent cases of AF admitted to ED 67

4.6 Discussion 67

4.6.1 Epidemiological Forecast Insight 67

4.6.2 COVID-19 impact 69

4.6.3 Limitations of the analysis 70

4.6.4 Strengths of the analysis 71

5 Disease Management 72

5.1 Diagnosis and treatment overview 72

5.1.1 Diagnosis 72

5.1.2 Treatment 73

5.2 KOL insights on disease management 77

6 Competitive Assessment 82

6.1 Overview 82

7 Unmet Needs and Opportunity Assessment 84

7.1 Overview 84

7.2 Development of anticoagulants with reduced risk of bleeding 85

7.3 Therapies for atrial fibrillation patients with ESRD 90

7.4 Safer antiarrhythmic drugs for the maintenance of sinus rhythm 94

7.5 Effective and rapid-acting cardioversion drugs 97

8 R&D Strategies 100

8.1 Overview 100

8.1.1 Development of anticoagulants with novel MOAs to reduce bleeding risk 100

8.1.2 Targeting AF patients with ESRD 101

8.1.3 Development of non-invasive and fast-acting cardioversion agents 102

8.2 Clinical trials design 103

8.2.1 Exclusion criteria for AF clinical trials 103

9 Pipeline Assessment 106

9.1 Overview 106

9.2 Promising drugs in clinical development 107

10 Pipeline Valuation Analysis 110

10.1 Overview 110

10.2 Competitive assessment 111

10.2.1 Anticoagulant agents 111

10.2.2 Pharmacological cardioversion agents 114

11 Current and Future Players 117

11.1 Overview 117

11.2 Deal-making trends 118

12 Market Outlook 120

12.1 Global markets 120

12.1.1 Forecast 120

12.1.2 Drivers and barriers – global issues 122

12.2 US 122

12.2.1 Forecast 122

12.2.2 Key events 124

12.2.3 Drivers and barriers 124

12.3 5EU 125

12.3.1 Forecast 125

12.3.2 Key events 126

12.3.3 Drivers and barriers 126

12.4 Japan 127

12.4.1 Forecast 127

12.4.2 Key events 128

12.4.3 Drivers and barriers 128

12.5 Canada 129

12.5.1 Forecast 129

12.5.2 Key events 130

12.5.3 Drivers and barriers 130

13 Appendix 131

13.1 Bibliography 131

13.2 Abbreviations 142

13.3 Methodology 144

13.3.1 Forecasting methodology 144

13.4 Primary research – KOLs interviewed for this report 145

13.4.1 KOLs 145

13.5 Primary research – prescriber survey 146

13.6 About the Authors 147

13.6.1 Analyst 147

13.6.2 Therapy Area Director 147

13.6.3 Epidemiologist 147

13.6.4 Epidemiologist reviewers 148

13.6.5 Vice President of Disease Analysis and Intelligence 149

13.6.6 Global Head and EVP of Healthcare Operations and Strategy 149

Contact Us 150

List of Tables

Table 1: Atrial fibrillation: key metrics in the 8MM 9

Table 2: Common cardiac and non-cardiac causes of AF 19

Table 3: Classification of AF 21

Table 4: Risk factors and comorbidities for AF 26

Table 5: CHADS2 index for stroke risk assessment 72

Table 6: CHA₂DS₂-VASc index for stroke risk assessment 73

Table 7: Treatment guidelines for atrial fibrillation 73

Table 8: Atrial fibrillation market – global drivers and barriers, 2022–32 122

Table 9: Key events impacting sales for atrial fibrillation in the US, 2022–32 124

Table 10: Atrial fibrillation market – drivers and barriers in the US, 2022–32 124

Table 11: Key events impacting sales for atrial fibrillation in the 5EU, 2022–32 126

Table 12: Atrial fibrillation market – drivers and barriers in the 5EU, 2022–32 126

Table 13: Key events impacting sales for atrial fibrillation in Japan, 2022–32 128

Table 14: Atrial fibrillation market – drivers and barriers in Japan, 2022–32 128

Table 15: Key events impacting sales for atrial fibrillation in Canada, 2022–32 130

Table 16: Atrial fibrillation market – drivers and barriers in Canada, 2022–32 130

Table 17: High-prescribing physicians (non-KOLs) surveyed, by country 146

List of Figures

Figure 1: Global sales forecast by country for atrial fibrillation in 2022 and 2032 11

Figure 2: Analysis of the company portfolio gap in atrial fibrillation during the forecast period 12

Figure 3: Competitive assessment of the pipeline anticoagulant drugs benchmarked against the current SOC 14

Figure 4: Competitive assessment of the pipeline drugs for pharmacological cardioversion benchmarked against the SOC 15

Figure 5: 8MM, diagnosed prevalence of AF (%), men and women, ages ≥40 years, 2022 27

Figure 6: 8MM, sources used and not used to forecast the diagnosed prevalent cases of AF 29

Figure 7: 8MM, sources used to forecast the diagnosed prevalent cases of AF by temporal pattern of arrhythmia 30

Figure 8: 8MM, sources used to forecast the diagnosed prevalent cases of AF by CHADS2 stroke risk score 31

Figure 9: 8MM, sources used to forecast the diagnosed prevalent cases of AF by CHA2DS2 – VASc score in men 32

Figure 10: 8MM, sources used to forecast the diagnosed prevalent cases of AF by CHA2DS2 – VASc score in women 33

Figure 11: 8MM, sources used to forecast the diagnosed prevalent cases of AF with/without moderate-to-severe mitral stenosis and/or an artificial (mechanical) heart valve 34

Figure 12: 8MM, sources used to forecast the diagnosed prevalent cases of AF with CKD 35

Figure 13: 8MM, sources used to forecast the diagnosed prevalent cases of AF with major bleeding risk by HAS‐BLED score 35

Figure 14: 8MM, sources used to forecast the diagnosed prevalent cases of AF admitted to the ED 36

Figure 15: 8MM, sources used to forecast the diagnosis rate of AF 36

Figure 16: 8MM, total prevalent cases of AF, N, both sexes, ages ≥40 years, 2022 56

Figure 17: 8MM, diagnosed prevalent cases of AF, N, both sexes, ages ≥40 years, 2022 57

Figure 18: 8MM, diagnosed prevalent cases of AF by age, N, both sexes, 2022 58

Figure 19: 8MM, diagnosed prevalent cases of AF by sex, N, ages ≥40 years, 2022 59

Figure 20: 8MM, diagnosed prevalent cases of AF by temporal pattern of arrhythmia, N, both sexes, ages ≥40 years, 2022 60

Figure 21: 8MM, diagnosed prevalent cases of AF by CHADS2 stroke risk score, N, both sexes, ages ≥40 years, 2022 61

Figure 22: 8MM, diagnosed prevalent cases of AF by CHA2DS2 – VASc stroke risk score in men, N, men, ages ≥40 years, 2022 62

Figure 23: 8MM, diagnosed prevalent cases of AF by CHA2DS2 – VASc stroke risk score in women, N, women, ages ≥40 years, 2022 63

Figure 24: 8MM, diagnosed prevalent cases of AF with and without moderate-to-severe mitral stenosis and/or an artificial (mechanical) heart valve, N, both sexes, ≥40 years, 2022 64

Figure 25: 8MM, diagnosed prevalent cases of AF with CKD by stage, N, both sexes, ages ≥40 years, 2022 65

Figure 26: 8MM, diagnosed prevalent cases of AF by HAS‐BLED score, N, both sexes, ages ≥40 years, 2022 66

Figure 27: 8MM, diagnosed prevalent cases of AF admitted to ED, N, both sexes, ages ≥40 years, 2022 67

Figure 28: General treatment algorithm for stroke prevention in AF 74

Figure 29: CCS guideline recommendations for choosing an anticoagulant 75

Figure 30: General treatment algorithm for long-term ventricular rate control in AF patients 76

Figure 31: Treatment algorithm for the maintenance of sinus rhythm in AF patients 77

Figure 32: Unmet needs and opportunities in AF 85

Figure 33: Overview of the development pipeline in atrial fibrillation 107

Figure 34: Key late-stage trials for the promising pipeline agents that GlobalData expects to be licensed for atrial fibrillation in the 8MM during the forecast period 108

Figure 35: Competitive assessment of the marketed and pipeline drugs for anticoagulation benchmarked against the SOC 114

Figure 36: Competitive assessment of the marketed and pipeline drugs for pharmacological cardioversion benchmarked against the SOC 116

Figure 37: Analysis of the company portfolio gap in AF during the forecast period 118

Figure 38: Global (8MM) sales forecast by country for atrial fibrillation in 2022 and 2032 121

Figure 39: Sales forecast by class for atrial fibrillation in the US in 2022 and 2032 123

Figure 40: Sales forecast by class for atrial fibrillation in the 5EU in 2022 and 2032 125

Figure 41: Sales forecast by class for atrial fibrillation in Japan in 2022 and 2032 127

Figure 42: Sales forecast by class for atrial fibrillation in Canada in 2022 and 2032 129