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Xarelto (Acute Coronary Syndrome) - Forecast and Market Analysis to 2023

Summary

GlobalData has released its new PharmaPoint Drug Evaluation report, “Xarelto (Acute Coronary Syndrome) - Forecast and Market Analysis to 2023”. The current ACS market - primarily comprised of antithrombotics, antihypertensives, and statins - is flush with well-established standard-of-care therapies, many of which are generic. Therefore, the pipeline therapies that show the most promise exploit novel mechanisms of action and target orphan biochemical pathways. The ACS market will be driven by an aging population with a preponderance of lifestyle-based diseases, such as obesity, and the growing prevalence of metabolic disorders such as diabetes. The expansion of biologics into the ACS mainstream during the ten year forecast period is expected to significantly and fundamentally alter the ACS market, both medically and financially.

Xarelto was approved in the EU for the prevention of non-valvular atrial fibrillation (AF)-related stroke and systemic embolism, and for the treatment of deep vein thrombosis (DVT). On July 1, 2011, Xarelto was approved in the US to reduce the risk of blood clots, DVT, and pulmonary embolism (PE) following hip or knee replacement surgery, and in November of the same year, it was approved for stroke prevention in patients with non-valvular AF.

Scope

- Overview of ACS, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on Aricept including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Aricept for the top seven countries from 2013 to 2023.
- Sales information covered for the US, France, Germany, Italy, Spain, the UK and Japan.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for ACS
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of Aricept performance
- Obtain sales forecast for Aricept from 2013-2023 in top seven countries (the US, France, Germany, Italy, Spain, the UK and Japan)

Table Of Contents

Xarelto (Acute Coronary Syndrome) - Forecast and Market Analysis to 2023
1 Table of Contents

2 Introduction 12
2.1 Catalyst 12
2.2 Related Reports 13
2.3 Upcoming Related Reports 15
3 Disease Overview 16
3.1 Etiology and Pathophysiology 17
3.1.1 Etiology 17
3.1.2 Pathophysiology 21
3.1.3 Prognosis 22
3.1.4 Quality of Life 23
3.2 Symptoms 23
4 Disease Management 25
4.1 Treatment Overview 25
5 Competitive Assessment 31
5.1 Overview 31
5.2 Strategic Competitor Assessment 32
6 Unmet Need and Opportunity 37
6.1 Overview 37
6.2 Therapies that Directly Treat Thrombogenic Atherosclerotic Plaques 38
6.2.1 Unmet Need 38
6.2.2 Gap Analysis 39
6.2.3 Opportunity 39
6.3 Therapies that Treat Fibrotic Myocardium and Associated Comorbidities 40
6.3.1 Unmet Need 40
6.3.2 Gap Analysis 41
6.3.3 Opportunity 41
6.4 LDL-C-Lowering Drugs for Statin-Intolerant, Refractory, or Non-Compliant Patients 42
6.4.1 Unmet Need 42
6.4.2 Gap Analysis 44
6.4.3 Opportunity 46
6.5 Antidotes for New Oral Anticoagulants (NOACs) 46
6.5.1 Unmet Need 46
6.5.2 Gap Analysis 47
6.5.3 Opportunity 47
6.6 Blood-Thinning Agents with Significantly Reduced Bleeding Risks 48
6.6.1 Unmet Need 48
6.6.2 Gap Analysis 49
6.6.3 Opportunity 49
7 Pipeline Assessment 51
7.1 Overview 51
7.2 Clinical Trials by Phase and Trial Status 53
7.3 Promising Drugs in Clinical Development 55
8 Xarelto (rivaroxaban) 60
8.1 Overview 60
8.2 Efficacy 63
8.3 Safety 65
8.4 Dosing and Formulation 65
8.5 Potential Clinical Positioning 65
8.6 Potential Commercial Positioning 66
8.7 Pricing and Reimbursement 66
8.8 SWOT Analysis 67
8.9 Forecast 67
9 Appendix 70
9.1 Bibliography 70
9.2 Abbreviations 76
9.3 Methodology 80
9.4 Forecasting Methodology 80
9.4.1 Methodology for Forecasting Selected Portions of the Diagnosed Prevalent ACS Population 80
9.4.2 Diagnosed Acute Coronary Syndrome Patients 81
9.4.3 Percent Drug-Treated Patients 82
9.4.4 General Pricing Assumptions 82
9.4.5 Generic Erosion 84
9.4.6 Pricing of Pipeline Agents 84
9.5 Physicians and Specialists Included in this Study 85
9.6 About the Authors 88
9.6.1 Author 88
9.6.2 Reviewer 88
9.6.3 Global Head of Healthcare 89
9.7 About GlobalData 90
9.8 Disclaimer 90

1.1 List of Tables

Table 1: Antiplatelet Agents that Inhibit Platelet Activation 19
Table 2: Anticoagulants that Inhibit the Coagulatory Cascade 19
Table 3: Symptoms of Acute Coronary Syndrome 24
Table 4: Treatment Guidelines for Acute Coronary Syndromes (UA, NSTEMI, and STEMI) 28
Table 5: Most Prescribed Drugs for ACS by Class in the Global Markets, 2014 30
Table 6: Leading Treatments for Acute Coronary Syndrome, 2014 36
Table 7: Unmet Need and Opportunity in Acute Coronary Syndrome 38
Table 8: Acute Coronary Syndrome - Clinical Trials by Phase and Status, 2014 54
Table 9: Acute Coronary Syndrome - Late-Stage Pipeline, 2014 57
Table 10: Comparison of Therapeutic Classes in Development for ACS, 2014 58
Table 11: Product Profile - Xarelto (rivaroxaban) 63
Table 12: Xarelto (rivaroxaban) SWOT Analysis, 2014 67
Table 13: Global Sales Forecasts ($m) for Xarelto, 2013-2023 69
Table 14: Price Sources and Calculations, by Country 83
Table 15: Physicians Surveyed, By Country 87

1.2 List of Figures

Figure 1: The ACS Timeline and the Scope of GlobalData's ACS Report and Forecast 17
Figure 2: Progression of Coronary Artery Disease, Atherosclerotic Plaque Rupture, Thrombosis, and Acute Coronary Syndrome 18
Figure 3: Platelet and Coagulatory Factors Implicated in Thrombosis 20
Figure 4: Electrocardiography in the Diagnosis of ACS 21
Figure 5: Acute Coronary Syndrome Therapeutics - Clinical Trials by Phase in the 7MM, 2014 55
Figure 6: Competitive Assessment of Late-Stage Pipeline Agents for ACS, 2013-2023 59

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