PharmaPoint: Venous Thromboembolism-Global Drug Forecast and Market Analysis to 2026

PharmaPoint: Venous Thromboembolism-Global Drug Forecast and Market Analysis to 2026


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Executive Summary

PharmaPoint: Venous Thromboembolism-Global Drug Forecast and Market Analysis to 2026

Summary

Venous thromboembolism (VTE) is a disease that includes a myriad of life-threatening disorders ranging from pulmonary embolism (PE) to deep vein thrombosis (DVT. The condition is relatively prevalent and is associated with long-term mortality and morbidity. VTE occurs when a thrombus (blood clot) forms in an individual's deep vein, owing to either changes in the components of their blood, damage to the endothelium in the vasculature, and/or changes in the flow of blood). When a thrombus materializes in the veins of the lower extremities, it can embolize, potentially occluding blood vessels in the lungs. Consequently, the vast majority of patients presenting with symptomatic pulmonary embolism also suffer from deep vein thrombosis, and many individuals diagnosed with deep vein thrombosis display pulmonary embolism that is asymptomatic. VTE can arise in both non-hospitalized and hospitalized individuals, repeatedly returns, and can cause chronic complications, such as post-thrombotic syndrome (PTS) or chronic thromboembolic pulmonary hypertension (CTEPH).

Key Questions Answered

The NOACs will see a significant increase in patient shares for the treatment of VTE and VTE primary prophylaxis against the established vitamin K antagonists and heparins. However, there are considerably high unmet needs within the indication. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the VTE market?

The current late-stage VTE pipeline consists of betrixaban and Xarelto for thromboprophylaxis in acute medically ill patients, as well as first in class Factor XI inhibitor, IONIS-FXIRX and vitamin K antagonist, tecarfarin. Will the late-stage drugs make a significant impact on the VTE market? Which of these drugs will have the highest peak sales at the highest CAGR, and why?

We have seen a significant increase in the VTE population, in terms of diagnosed incidence and recurrent attacks, as well as an increase in the prophylaxis population. How will epidemiological changes impact the growth of the future market?

Scope

Overview of VTE, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Annualized VTE therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the VTE 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 VTE 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

The report will enable you to-

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 VTE therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global VTE therapeutics market in 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 VTE therapeutics market from 2016-2026.

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



Read More



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Ken Research
Ankur Gupta, Head Marketing & Communications

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1 Table of Contents

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

1.2 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

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

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