PharmaPoint: Venous Thromboembolism – Global Drug Forecast and Market Analysis to 2025

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).

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.

Key Highlights

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, in particular, which is vying for entry into the VTE market as the first NOAC approved for extended prophylaxis in acute medically ill patients- a significant unmet need in VTE space. Xarelto is also contending for entry in this space through an additional label expansion for the established therapy. 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?

Companies mentioned

Boehringer Ingelheim

Bayer

Janssen

BMS

Pfizer

Sanofi

Daiichi-Sankyo

Portola Pharmaceuticals

Boehringer Ingelheim

Bayer

Janssen

BMS

Pfizer

Sanofi

Daiichi-Sankyo

Portola Pharmaceuticals

Table of Contents

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 ...

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

3.3Prognosis

3.4Quality of Life

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 VTE, 2015–2025

4.5.1Pulmonary Embolism

4.5.2Deep Vein Thrombosis

4.5.3VTE

4.5.4Number of Hospital Discharges Meeting Criteria for Medically Ill and Those at Risk for VTE

4.5.5Number of Primary Total Knee Replacements and Revisions

4.5.6Number of Total Hip Replacements

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

6Competitive Assessment

6.1Overview

6.2Product Profiles – Oral Anticoagulants

6.2.1Warfarin (Widely Genericized)

6.2.2Pradaxa (dabigatran)

6.2.3Xarelto (rivaroxaban)

6.2.4Eliquis (apixaban)

6.2.5Savaysa (edoxaban)

6.3Product Profiles – Other Treatments

6.3.1Heparins

6.3.2Arixtra (fondaparinux)

6.3.3Antiplatelets – Aspirin (Widely Genericized)

7Unmet Needs and Opportunities

7.1Overview

7.2Unmet Needs and Opportunities

7.2.1Inadequate Prophylaxis in Acute Medically Ill Patients

7.2.2Complicated Dose Adjustments with New Oral Anticoagulants

7.2.3Optimal Therapy for Cancer Patients

7.2.4Optimal Therapy for Patients with Moderate and Severe Renal Failure

7.2.5Physician Education on Clinical Benefits of New Oral Anticoagulants among Orthopedic Surgeons in the US

7.2.6Reversal Agents for New Oral Anticoagulants

7.3Opportunities for Drug Development in the VTE Market

7.3.1Target Opportunity Profile – VTE Prophylaxis in Acute Medically Ill Patients

7.3.2Target Opportunity Profile – VTE Patients with Cancer

7.3.3Target Opportunity Profile – VTE Patients with Renal Impairment

7.3.4Target Opportunity Profile – VTE Prophylaxis in THR and TKR Patients

7.3.5Target Opportunity Profile – VTE Prophylaxis in Hip Fracture Surgery Patients

8Pipeline Assessment

8.1Overview

8.2Clinical Trial Mapping

8.2.1Clinical Trials by Country

8.2.2Clinical Trials by Phase and Trial Status

8.3Promising Drugs in Clinical Development

8.3.1Betrixaban (betrixaban)

8.3.2Xarelto (rivaroxaban)

8.4Other Drugs in Development

8.4.1Early-Stage Anticoagulant Pipeline

8.4.2Other Late-Stage Clinical Trials of the NOACs in VTE

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

9.3.7Portola Pharmaceuticals

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

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1Diagnosed VTE 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 Payers Included in this Study

11.6About the Authors

11.6.1Analyst

11.6.2Therapy Area Director

11.6.3Epidemiologist

11.6.4Global Head of Healthcare

11.7About GlobalData

11.8Disclaimer

List of Tables

Table 1: Symptoms of VTE

Table 2: Mean SF-36 Subscale and Summary Scores for Patients With and Without PTS

Table 3: Risk Factors and Comorbidities ...

Table 1: Symptoms of VTE

Table 2: Mean SF-36 Subscale and Summary Scores for Patients With and Without PTS

Table 3: Risk Factors and Comorbidities for VTE

Table 4: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of PE

Table 5: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of DVT

Table 6: 8MM, Sources Used to Forecast the Number of Hospital Discharges that Meet the Criteria for Medically Ill

Table 7: 6MM, Sources Used to Forecast Primary TKRs

Table 8: 6MM, Sources Used to Forecast the Rate of Primary TKR Requiring Revisions

Table 9: Japan and China, Sources Used to Forecast Primary TKRs and Revisions

Table 10: 8MM, Sources Used to Forecast THRs

Table 11: 8MM, Diagnosed Incident Cases of PE, All Ages, Both Sexes, Select Years 2015–2025

Table 12: 8MM, Diagnosed Incident Cases of DVT, All Ages, Both Sexes, Select Years 2015–2025

Table 13: 8MM, Diagnosed Incident Cases of VTE, All Ages, Both Sexes, Select Years 2015–2025

Table 14: 8MM, Age-Specific Diagnosed Incident Cases of VTE, Both Sexes, N (Row %), 2015

Table 15: 8MM, Sex-Specific Diagnosed Incident Cases of VTE, Both Sexes, N (Row %), 2015

Table 16: 8MM, Number of Recurrent VTE Cases One and 10 Years After Incident VTE Event, Both Sexes, All Ages, N, 2015

Table 17: 8MM, Number of VTE Cases With Cancer Comorbidity, Both Sexes, All Ages, N, 2015 and 2025

Table 18: 8MM, Number of VTE Attacks, Both Sexes, All Ages, N, 2015–2025

Table 19: 8MM, Number of Hospital Discharges Meeting Criteria for Medically Ill; Those at risk for VTE, Both Sexes, Ages =40 Years, N, 2015

Table 20: 8MM, Number of Primary TKRs and Revisions, Both Sexes, Ages =15 Years

Table 21: 8MM, Number of THRs, Both Sexes, Ages =15 Years

Table 22: Treatment Guidelines for VTE by Country

Table 23: Duration of Anticoagulation Therapy for Different VTE Types

Table 24: Most Prescribed Drugs or Drug Classes for VTE by Country, 2016

Table 25: Factors Influencing Anticoagulant Choice in Different Treatment Settings for VTE

Table 26: Country Profile - US

Table 27: Country Profile - France

Table 28: Country Profile – Germany

Table 29: Country Profile - Italy

Table 30: Country Profile - Spain

Table 31: Country Profile - UK

Table 32: Country Profile - Japan

Table 33: Leading Drugs for VTE Treatment and Prophylaxis, 2016

Table 34: Product Profile – Warfarin

Table 35: Warfarin SWOT Analysis, 2016

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

Table 37: Product Profile – Pradaxa (dabigatran)

Table 38: Efficacy and Safety of Pradaxa in VTE Treatment

Table 39: Efficacy and Safety of Pradaxa in Long-term Secondary VTE Prevention

Table 40: Efficacy and Safety of Pradaxa in Primary Prophylaxis for THR

Table 41: Pradaxa SWOT Analysis, 2016

Table 42: Global VTE Sales Forecasts ($m) for Pradaxa, 2015–2025

Table 43: Product Profile – Xarelto (rivaroxaban)

Table 44: Efficacy and Safety of Xarelto in VTE Treatment

Table 45: Efficacy and Safety of Xarelto in Long-term Secondary VTE Prevention

Table 46: Efficacy and Safety of Xarelto in Primary Prophylaxis for TKR and THR

Table 47: Xarelto SWOT Analysis, 2016

Table 48: Global VTE Sales Forecasts ($m) for Xarelto, 2015–2025

Table 49: Product Profile – Eliquis (apixaban)

Table 50: Efficacy and Safety of Eliquis in VTE Treatment

Table 51: Efficacy and Safety of Eliquis in Long-term Secondary VTE Prevention

Table 52: Efficacy and Safety of Eliquis in Primary Prophylaxis for TKR and THR

Table 53: Eliquis SWOT Analysis, 2016

Table 54: Global VTE Sales Forecasts ($m) for Eliquis, 2015–2025

Table 55: Product Profile – Savaysa (edoxaban)

Table 56: Efficacy and Safety of Savaysa in VTE Treatment

Table 57: Savaysa (edoxaban) SWOT Analysis, 2016

Table 58: Global VTE Sales Forecasts ($m) for Savaysa, 2015–2025

Table 59: Commonly Used LMWHs

Table 60: Unmet Needs in VTE

Table 61: Target Opportunity Profile – VTE Prophylaxis in Acute Medically Ill Patients

Table 62 : Target Opportunity Profile – VTE Patients with Cancer

Table 63: Target Opportunity Profile – VTE Patients with Renal Impairment

Table 64: Target Opportunity Profile – VTE prophylaxis in THR and TKR

Table 65: Target Opportunity Profile – VTE prophylaxis in Hip Fracture Surgery

Table 66: VTE – Company-sponsored Clinical Trials by Phase and Status, 2016

Table 67: Late-Stage Pipeline for VTE, 2016

Table 68: Product Profile – Betrixaban

Table 69: Betrixaban SWOT Analysis, 2016

Table 70: Global Sales Forecasts ($) for Betrixaban, 2015-2025

Table 71: Product Profile – Xarelto

Table 72: Global Sales Forecasts ($) for Xarelto of Acute Medically Ill VTE Patients, 2015-2025

Table 73: Early-Stage Pipeline Products for VTE

Table 74: Ongoing Late-Stage Clinical Trials of the NOACs in VTE

Table 75: Key Companies in the VTE Market, 2016

Table 76: Boehringer Ingelheim’s VTE Portfolio Assessment, 2016

Table 77: Boehringer Ingelheim SWOT Analysis, 2016

Table 78: Bayer’s VTE Portfolio Assessment, 2016

Table 79: Bayer SWOT Analysis, 2016

Table 80: Janssen’s VTE Portfolio Assessment, 2016

Table 81: Janssen SWOT Analysis, 2016

Table 82: BMS’ VTE Portfolio Assessment, 2016

Table 83: BMS SWOT Analysis, 2016

Table 84: Pfizer’s VTE Portfolio Assessment, 2016

Table 85: Pfizer SWOT Analysis, 2016

Table 86: Daiichi-Sankyo’s VTE Portfolio Assessment, 2016

Table 87: Daiichi-Sankyo SWOT Analysis, 2016

Table 88: Portola Pharmaceutical’s VTE Portfolio Assessment, 2016

Table 89: Portola SWOT Analysis, 2016

Table 90: 7MM Total Sales Forecasts ($m) for VTE, 2015–2025

Table 91: Global VTE Market – Drivers and Barriers, 2016

Table 92: US Sales Forecasts ($m) for VTE, 2015–2025

Table 93: Key Events Impacting Sales for VTE in the US, 2016

Table 94: VTE Market – Drivers and Barriers in the US, 2015–2025

Table 95: France Sales Forecasts ($m) for VTE, 2015–2025

Table 96: Key Events Impacting Sales for VTE in France, 2016

Table 97: VTE Market – Drivers and Barriers in France, 2015–2025

Table 98: Germany Sales Forecasts ($m) for VTE, 2015–2025

Table 99: Key Events Impacting Sales for VTE in Germany, 2016

Table 100: VTE Market – Drivers and Barriers in Germany, 2015–2025

Table 101: Italy Sales Forecasts ($m) for VTE, 2015–2025

Table 102: Key Events Impacting Sales for VTE in Italy, 2016

Table 103: VTE Market – Drivers and Barriers in Italy, 2015–2025

Table 104: Spain Sales Forecasts ($m) for VTE, 2015–2025

Table 105: Key Events Impacting Sales for VTE in Spain, 2016

Table 106: VTE Market – Drivers and Barriers in Spain, 2015–2025

Table 107: UK Sales Forecasts ($m) for VTE, 2015–2025

Table 108: Key Events Impacting Sales for VTE in the UK, 2016

Table 109: VTE Market ?? Drivers and Barriers in the UK, 2015–2025

Table 110: Japan Sales Forecasts ($m) for VTE, 2015–2025

Table 111: Key Events Impacting Sales for VTE in Japan, 2016

Table 112: VTE Market – Drivers and Barriers in Japan, 2015–2025

Table 113: Key Launch Dates

Table 114: Key Patent Expiries

Table 115: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Etiology of VTE: Virchow’s Triad

Figure 2: 8MM, Diagnosed Incident Cases of PE, All Ages, Both Sexes, Select Years 2015–2025

Figure ...

Figure 1: Etiology of VTE: Virchow’s Triad

Figure 2: 8MM, Diagnosed Incident Cases of PE, All Ages, Both Sexes, Select Years 2015–2025

Figure 3: Age-Standardized Diagnosed Incidence of PE, All Ages, Cases Per 100,000, 2015

Figure 4: 8MM, Diagnosed Incident Cases of DVT, All Ages, Both Sexes, Select Years 2015–2025

Figure 5: Age-Standardized Diagnosed Incidence of DVT, All Ages, Cases Per 100,000 Population, 2015

Figure 6: 8MM, Diagnosed Incident Cases of VTE, All Ages, Both Sexes, Select Years 2015–2025

Figure 7: 8MM, Age-Specific Diagnosed Incident Cases of VTE, Both Sexes, N (Row %), 2015

Figure 8: 8MM, Sex-Specific Diagnosed Incident Cases of VTE, Both Sexes, N, 2015

Figure 9: 8MM, Number of VTE Attacks, Both Sexes, All Ages, N, 2015–2025

Figure 10: 8MM, Number of Primary TKRs and Revisions, Both Sexes, Ages =15 Years

Figure 11: 8MM, Number THRs, Both Sexes, Ages =15 Years

Figure 12: Treatment Algorithm for VTE

Figure 13: Site of Action of Current and Pipeline Treatments in VTE

Figure 14: VTE Therapeutics – Ongoing Company-sponsored Clinical Trials by Country, 2016

Figure 15: Competitive Assessment of Late-Stage Pipeline Agents in VTE, 2015–2025

Figure 16: Company Portfolio Gap Analysis in VTE, 2015–2025

Figure 17: Global Sales for VTE by Country, 2015 and 2025

Figure 18: Annual Global Sales for VTE Treatment by Drug Class, 2015 and 2025

Figure 19: Annual Global Sales for VTE Primary Prophylaxis by Drug Class, 2015 and 2025

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

Figure 21: Sales for VTE in the US by Drug Class, 2015 and 2025

Figure 22: Sales for VTE Treatment in France by Drug Class, 2015 and 2025

Figure 23: Sales for VTE in Germany by Drug Class, 2015 and 2025

Figure 24: Sales for VTE in Italy by Drug Class, 2015 and 2025

Figure 25: Sales for VTE in Spain by Drug Class, 2015 and 2025

Figure 26: Sales for VTE in the UK by Drug Class, 2015 and 2025

Figure 27: Sales for VTE in Japan by Drug Class, 2015 and 2025

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