Published : Jun-2017
No. of Pages : 203
1 Table of Contents 2
1.1 List of Tables 8
1.2 List of Figures 9
2 Executive Summary 11
2.1 Sales for Venous Thromboembolism by Region, 2016-2026 12
2.2 VTE Primary Prophylaxis Treatments Will Promote Market Growth 13
2.3 Big Pharma Fuels Confidence in VTE Treatments via CV Label Expansions 14
2.4 Betrixaban to Acquire Critical Market Position by Addressing Unmet Needs 15
2.5 Opportunities Remain: The VTE Market Requires a Transformational Therapy 15
2.6 What Do Physicians Think? 16
3 Introduction 18
3.1 Catalyst 18
3.2 Related Reports 19
4 Disease Overview 20
4.1 Etiology and Pathophysiology 20
4.1.1 Etiology 20
4.1.2 Pathophysiology 20
4.2 Symptoms 21
4.3 Prognosis 22
4.4 Quality of Life 23
5 Epidemiology 24
5.1 Disease Background 24
5.2 Risk Factors and Comorbidities 25
5.3 Global and Historical Trends 26
5.4 Forecast Methodology 29
5.4.1 Sources 29
5.4.2 Forecast Assumptions and Methods 32
5.5 Epidemiological Forecast for VTE (2016-2026) 45
5.5.1 Diagnosed Incident Cases of Pulmonary Embolism 45
5.5.2 Diagnosed Incident Cases of Deep Vein Thrombosis 46
5.5.3 Diagnosed Incident Cases of VTE 47
5.5.4 Age-Specific Diagnosed Incident Cases of VTE 48
5.5.5 Sex-Specific Diagnosed Incident Cases of VTE 49
5.5.6 One- and 10-Year First Time Recurrent Cases of VTE 50
5.5.7 Number of VTE Cases with Cancer as Comorbidity 51
5.5.8 Number of VTE Attacks 52
5.5.9 Number of Hospital Discharges Meeting Criteria for Medically Ill and Those at Risk for VTE 53
5.5.10 Number of Primary Total Knee Replacements and Revisions 54
5.5.11 Number of Hip Replacements 55
5.6 Discussion 56
5.6.1 Epidemiological Forecast Insight 56
5.6.2 Limitations of the Analysis 57
5.6.3 Strengths of the Analysis 58
6 Disease Management 59
6.1 Diagnosis Overview 59
6.2 Treatment Overview 60
6.2.1 Treatment Guidelines and Leading Prescribed Drugs 60
6.2.2 Clinical Practice 63
6.3 US 66
6.4 5EU 67
6.5 Japan 69
7 Competitive Assessment 71
7.1 Overview 71
7.2 Warfarin 74
7.2.1 Overview 74
7.2.2 Efficacy and Safety 77
7.2.3 SWOT Analysis 78
7.2.4 Forecast 78
7.3 Pradaxa (dabigatran) 79
7.3.1 Overview 79
7.3.2 Efficacy and Safety 82
7.3.3 SWOT Analysis 84
7.3.4 Forecast 85
7.4 Xarelto (rivaroxaban) 85
7.4.1 Overview 85
7.4.2 Efficacy and Safety 88
7.4.3 SWOT Analysis 91
7.4.4 Forecast 91
7.5 Eliquis (apixaban) 92
7.5.1 Overview 92
7.5.2 Efficacy and Safety 94
7.5.3 SWOT Analysis 97
7.5.4 Forecast 97
7.6 Savaysa (edoxaban) 98
7.6.1 Overview 98
7.6.2 Efficacy and Safety 100
7.6.3 SWOT Analysis 101
7.6.4 Forecast 101
7.7 Other Therapeutic Classes 102
7.7.1 Heparins 102
7.7.2 Arixtra (fondaparinux) 103
7.7.3 Antiplatelets - Aspirin 104
8 Unmet Needs and Opportunity Assessment 105
8.1 Overview 105
8.2 Unmet Needs 106
8.2.1 Inadequate Prophylaxis in Acute Medically Ill Patients 106
8.2.2 Anticoagulation with Significantly Reduced Bleeding Risk 108
8.2.3 Optimal Therapy for Cancer Patients 110
8.2.4 Optimal Therapy for Patients with Moderate and Severe Renal Failure 113
8.2.5 Physician Education on Clinical Benefits of New Oral Anticoagulants among Orthopedic Surgeons in the US 115
8.2.6 Reversal Agents for New Oral Anticoagulants 116
8.3 Opportunity Assessment 118
8.3.1 Target Opportunity Profile - VTE Prophylaxis in Acute Medically Ill Patients 119
8.3.2 Target Opportunity Profile - VTE Patients with Cancer 120
8.3.3 Target Opportunity Profile - VTE Patients with Renal Impairment 121
8.3.4 Target Opportunity Profile - VTE Prophylaxis in THR and TKR Patients 122
9 Pipeline Assessment 123
9.1 Overview 123
9.2 Promising Drugs in Clinical Development 124
9.3 Betrixaban 125
9.3.1 Overview 125
9.3.2 Efficacy 127
9.3.3 Safety 128
9.3.4 Dosing and Formulation 128
9.3.5 Potential Clinical and Commercial Positioning 128
9.3.6 SWOT Analysis 130
9.3.7 Forecast 130
9.4 Xarelto (rivaroxaban) 131
9.4.1 Overview 131
9.4.2 Efficacy and Safety 132
9.4.3 Dosing and Formulation 132
9.4.4 Potential Clinical and Commercial Positioning 133
9.4.5 SWOT Analysis 133
9.4.6 Forecast 133
9.5 IONIS-FXIRX 134
9.5.1 Overview 134
9.5.2 Efficacy 136
9.5.3 Safety 137
9.5.4 Dosing and Formulation 137
9.5.5 Potential Clinical and Commercial Positioning 137
9.5.6 SWOT Analysis 139
9.5.7 Forecast 139
9.6 Tecarfarin 140
9.6.1 Overview 140
9.6.2 Efficacy 142
9.6.3 Safety 143
9.6.4 Dosing and Formulation 143
9.6.5 Potential Clinical and Commercial Positioning 143
9.6.6 SWOT Analysis 145
9.6.7 Forecast 146
9.7 Promising Drugs in Early-Stage Development 146
9.7.1 DS-1040 147
9.7.2 BAY-1213790 147
9.7.3 BMS-262084 148
9.7.4 GMI-1271 148
9.7.5 EP-7041 148
9.7.6 GC2107 149
9.7.7 Ichorcumab (JNJ-375) 149
9.7.8 CSL-312 149
9.8 Other Drugs in Development 150
10 Current and Future Players 151
10.1 Overview 151
10.2 Trends in Corporate Strategy 153
10.3 Boehringer Ingelheim 153
10.3.1 Overview 153
10.3.2 Portfolio Assessment 154
10.4 Bayer 155
10.4.1 Overview 155
10.4.2 Portfolio Assessment 156
10.5 Janssen 157
10.5.1 Overview 157
10.5.2 Portfolio Assessment 157
10.6 Bristol-Myers Squibb 158
10.6.1 Overview 158
10.6.2 Portfolio Assessment 159
10.7 Pfizer 160
10.7.1 Overview 160
10.7.2 Portfolio Assessment 160
10.8 Daiichi-Sankyo 161
10.8.1 Overview 161
10.8.2 Portfolio Assessment 162
10.9 Portola Pharmaceuticals 162
10.9.1 Overview 162
10.9.2 Portfolio Assessment 162
10.10 Ionis Therapeutics 163
10.10.1 Overview 163
10.10.2 Portfolio Assessment 164
10.11 Armetheon 164
10.11.1 Overview 164
10.11.2 Portfolio Assessment 165
11 Market Outlook 166
11.1 Global Markets 166
11.1.1 Forecast 166
11.1.2 Drivers and Barriers - Global Issues 171
11.2 US 174
11.2.1 Forecast 174
11.2.2 Key Events 175
11.2.3 Drivers and Barriers 175
11.3 5EU 175
11.3.1 Forecast 175
11.3.2 Key Events 177
11.3.3 Drivers and Barriers 177
11.4 Japan 178
11.4.1 Forecast 178
11.4.2 Key Events 179
11.4.3 Drivers and Barriers 179
12 Appendix 180
12.1 Bibliography 180
12.2 Abbreviations 188
12.3 Methodology 191
12.3.1 Forecasting Methodology 191
12.3.2 Diagnosed Patients 191
12.3.3 Percent Drug-Treated Patients 191
12.3.4 Drugs Included in Each Therapeutic Class 192
12.3.5 Launch and Patent Expiry Dates 192
12.3.6 General Pricing Assumptions 193
12.3.7 Individual Drug Assumptions 194
12.3.8 Generic Erosion 196
12.3.9 Pricing of Pipeline Agents 196
12.4 Primary Research - KOLs Interviewed for this Report 197
12.5 Primary Research - Prescriber Survey 199
12.6 About the Authors 200
12.6.1 Analyst 200
12.6.2 Managing Analyst 200
12.6.3 Therapy Area Director 200
12.6.4 Epidemiologist 201
12.6.5 Global Director of Therapy Analysis and Epidemiology 201
12.6.6 Global Head and EVP of Healthcare Operations and Strategy 202
12.7 About GlobalData 203
12.8 Contact Us 203
12.9 Disclaimer 203
1.1 List of Tables
Table 1: VTE: Key Metrics in the 7MM 11
Table 2: Symptoms of VTE 22
Table 3: Risk Factors and Comorbidities for Venous Thromboembolism 26
Table 4: 7MM, Diagnosed Incident Cases of PE, Men and Women, All Ages, N, Select Years, 2016-2026 46
Table 5: 7MM, Diagnosed Incident Cases of DVT, Men and Women, All Ages, N, Select Years, 2016-2026 47
Table 6: 7MM, Diagnosed Incident Cases of VTE, Men and Women, All Ages, N, Select Years, 2016-2026 48
Table 7: 7MM, One- and 10-Year Recurrent VTE Cases, Men and Women, All Ages, N, 2016 51
Table 8: Number of VTE Cases With Cancer Comorbidity, Men and Women, All Ages, N, 2016 and 2026 52
Table 9: 7MM, Number of VTE Attacks, Men and Women, All Ages, N, Select Years, 2016-2026 53
Table 10: 7MM, Number of Hospital Discharges Meeting Criteria for Medically Ill; Those at risk for VTE, Men and Women, Ages ?40 Years, N, 2016 54
Table 11: 7MM, Number of Primary Total Knee Replacements and Revisions, Men and Women, Ages ?15 Years, N, Select Years, 2016-2026 55
Table 12: 7MM, Number of Hip Replacements, Men and Women, Ages ?15 Years, N, Select Years, 2016-2026 56
Table 13: Treatment Guidelines for VTE by Country 60
Table 14: Duration of Anticoagulation Therapy for Different VTE Types 62
Table 15: Most Prescribed Drugs or Drug Classes for VTE by Country, 2016 63
Table 16: Factors Influencing Anticoagulant Choice in Different Treatment Settings for VTE 64
Table 17: Country Profile ? US 67
Table 18: Country Profile - 5EU 68
Table 19: Country Profile ? Japan 70
Table 20: Leading Drugs for VTE Treatment and Prophylaxis, 2016 74
Table 21: Product Profile - Warfarin 76
Table 22: Warfarin SWOT Analysis, 2016 78
Table 23: Product Profile - Pradaxa 81
Table 24: Efficacy and Safety of Pradaxa in VTE Treatment 82
Table 25: Efficacy and Safety of Pradaxa in Long-Term Secondary VTE Prevention 83
Table 26: Efficacy and Safety of Pradaxa in Primary Prophylaxis for THR 84
Table 27: Pradaxa SWOT Analysis, 2016 84
Table 28: Product Profile - Xarelto 88
Table 29: Efficacy and Safety of Xarelto in VTE Treatment 89
Table 30: Efficacy and Safety of Xarelto in Long-Term Secondary VTE Prevention 90
Table 31: Efficacy and Safety of Xarelto in Primary Prophylaxis for TKR and THR 90
Table 32: Xarelto SWOT Analysis, 2016 91
Table 33: Product Profile - Eliquis 94
Table 34: Efficacy and Safety of Eliquis in VTE Treatment 95
Table 35: Efficacy and Safety of Eliquis in Long-Term Secondary VTE Prevention 96
Table 36: Efficacy and Safety of Eliquis in Primary Prophylaxis for TKR and THR 96
Table 37: Eliquis SWOT Analysis, 2016 97
Table 38: Product Profile - Savaysa 99
Table 39: Efficacy and Safety of Savaysa in VTE Treatment 100
Table 40: Savaysa SWOT Analysis, 2016 101
Table 41: Commonly Used LMWHs 103
Table 42: Unmet Need and Opportunity in VTE, 2016 106
Table 43: Target Opportunity Profile - VTE Prophylaxis in Acute Medically Ill Patients 119
Table 44: Target Opportunity Profile - VTE Patients with Cancer 120
Table 45: Target Opportunity Profile - VTE Patients with Renal Impairment 121
Table 46: Target Opportunity Profile - VTE Prophylaxis in THR and TKR 122
Table 47: Late-Stage Pipeline for VTE, 2016 124
Table 48: Product Profile - Betrixaban 127
Table 49: Betrixaban SWOT Analysis, 2016 130
Table 50: Product Profile - Xarelto 132
Table 51: Product Profile - IONIS-FXIRX 136
Table 52: IONIS-FXIRX SWOT Analysis, 2016 139
Table 53: Product Profile - Tecarfarin 142
Table 54: Tecarfarin SWOT Analysis, 2016 145
Table 55: Early-Stage Pipeline Products for VTE 147
Table 56: Ongoing Late-Stage Clinical Trials of the NOACs in VTE 150
Table 57: Key players in the VTE market 152
Table 58: Boehringer Ingelheim's VTE Portfolio Assessment, 2016 155
Table 59: Bayer's VTE Portfolio Assessment, 2016 156
Table 60: Janssen's VTE Portfolio Assessment, 2016 158
Table 61: BMS' VTE Portfolio Assessment, 2016 159
Table 62: Pfizer's VTE Portfolio Assessment, 2016 161
Table 63: Daiichi Sankyo's VTE Portfolio Assessment, 2016 162
Table 64: Portola's VTE Portfolio Assessment, 2016 163
Table 65: Ionis' VTE Portfolio Assessment, 2016 164
Table 66: Armetheon's VTE Portfolio Assessment, 2016 165
Table 67: VTE - Global Drivers and Barriers, 2016-2026 171
Table 68: Key Events Impacting Sales for VTE in the US, 2016-2026 175
Table 69: VTE - Global Drivers and Barriers in the US, 2016-2026 175
Table 70: Key Events Impacting Sales for VTE in the 5EU, 2016-2026 177
Table 71: VTE - Global Drivers and Barriers in the 5EU, 2016-2026 177
Table 72: Key Events Impacting Sales for VTE in Japan, 2016-2026 179
Table 73: VTE - Global Drivers and Barriers in Japan, 2016-2026 179
Table 74: Key Projected Launch Dates for VTE 192
Table 75: Key Historical and Projected Patent Expiry Dates for VTE 193
Table 76: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 199
1.2 List of Figures
Figure 1: Global Sales for VTE by Country, 2016 and 2026 13
Figure 2: Etiology of VTE: Virchow's Triad 20
Figure 3: 7MM, Age-Standardized Diagnosed Incidence of PE, All Ages, Cases per 100,000 Population, 2016 28
Figure 4: 7MM, Age-Standardized Diagnosed Incidence of DVT, All Ages, Cases per 100,000, 2016 29
Figure 5: 7MM, Sources Used to Forecast Diagnosed Incident Cases of PE and DVT, 2016 30
Figure 6: 7MM, Sources Used to Forecast the Number of Hospital Discharges that Meet the Criteria for Medically Ill. 2016 31
Figure 7: 7MM, Sources Used to Forecast Primary Total Knee Replacements and Hip Replacements. 2016 32
Figure 8: 7MM, Age-Specific Diagnosed Incident Cases of VTE, Men and Women, N 49
Figure 9: 7MM, Sex-Specific Diagnosed Incident Cases of VTE, All Ages, N, 2016 50
Figure 10: Treatment Algorithm for VTE 61
Figure 11: Site of Action of Current and Pipeline Treatments in VTE 72
Figure 12: Competitive Assessment of Late-Stage Pipeline Agents in VTE, 2016-2026 124
Figure 13: Clinical and Commercial Positioning of Betrixaban 129
Figure 14: Clinical and Commercial Positioning of Xarelto 133
Figure 15: Clinical and Commercial Positioning of IONIS-FXIRX 138
Figure 16: Clinical and Commercial Positioning of Tecarfarin 144
Figure 17: Company Portfolio Gap Analysis in VTE, 2016-2026 152
Figure 18: Global Sales for VTE by Country, 2016 and 2026 167
Figure 19: Global Sales for VTE Treatment by Drug Class, 2016 and 2026 168
Figure 20: Global Sales for VTE Prophylaxis by Drug Class, 2016 and 2026 169
Figure 21: Global Sales for NOACs, 2016-2026 170
Figure 22: Global Sales for VTE, 2016-2026 171
