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PharmaPoint: Acute Coronary Syndrome - Japan Drug Forecast and Market Analysis to 2023

Summary

GlobalData estimates that the total market size for the 7MM in 2013 was $12.3bn, comprised of $5.0bn in branded drug sales (40%) and $7.3bn in generic sales (60%). GlobalData expects that the ACS drug market will grow at a CAGR of 13.4% over the ten year forecast period, resulting in a market value of $43.4bn by 2023, of which 64% will be attributed to branded drug sales ($27.7bn) and 36% to generic drug sales ($15.7bn). 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.

By the end of the forecast period, GlobalData projects that the Japanese market will overtake the Italian market in size, becoming the fourth largest market behind the US, Germany, and the UK. The Japanese antiplatelet market in 2013 was the smallest of all 7MM due to the pending product launches of Brilinta and Effient.

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 the key drugs in Japan including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in Japan from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the Japan ACS market.

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 drug performance
- Obtain sales forecast for drugs from 2013-2023 in Japan.

Table Of Contents

PharmaPoint: Acute Coronary Syndrome - Japan Drug Forecast and Market Analysis to 2023
1 Table of Contents

2 Introduction 13
2.1 Catalyst 13
2.2 Related Reports 14
2.3 Upcoming Related Reports 16
3 Disease Overview 17
3.1 Etiology and Pathophysiology 18
3.1.1 Etiology 18
3.1.2 Pathophysiology 22
3.1.3 Prognosis 23
3.1.4 Quality of Life 24
3.2 Symptoms 24
4 Disease Management 26
4.1 Treatment Overview 26
4.2 Japan 30
4.2.1 Diagnosis 30
4.2.2 Clinical Practice 30
5 Competitive Assessment 31
5.1 Overview 31
5.2 Strategic Competitor Assessment 32
5.3 Product Profiles 37
5.3.1 Fibrinolytic (Thrombolytic) Drugs - Tissue Plasminogen Activator (tPA) 37
5.3.2 Clopidogrel 41
5.3.3 Brilinta (ticagrelor) 45
5.3.4 Effient (prasugrel) 49
5.3.5 Warfarin 53
5.3.6 Statins - HMG-CoA Reductase Inhibitors 57
5.3.7 Beta-Adrenergic Receptor Antagonists (Beta Blockers) 69
5.3.8 Renin-Angiotensin-Aldosterone System (RAAS) Inhibitors 72
6 Unmet Need and Opportunity 85
6.1 Overview 85
6.2 Therapies that Directly Treat Thrombogenic Atherosclerotic Plaques 86
6.2.1 Unmet Need 86
6.2.2 Gap Analysis 87
6.2.3 Opportunity 87
6.3 Therapies that Treat Fibrotic Myocardium and Associated Comorbidities 88
6.3.1 Unmet Need 88
6.3.2 Gap Analysis 89
6.3.3 Opportunity 89
6.4 LDL-C-Lowering Drugs for Statin-Intolerant, Refractory, or Non-Compliant Patients 90
6.4.1 Unmet Need 90
6.4.2 Gap Analysis 92
6.4.3 Opportunity 94
6.5 Antidotes for New Oral Anticoagulants (NOACs) 94
6.5.1 Unmet Need 94
6.5.2 Gap Analysis 95
6.5.3 Opportunity 95
6.6 Blood-Thinning Agents with Significantly Reduced Bleeding Risks 96
6.6.1 Unmet Need 96
6.6.2 Gap Analysis 97
6.6.3 Opportunity 97
7 Pipeline Assessment 99
7.1 Overview 99
7.2 Clinical Trials by Phase and Trial Status 101
7.3 Promising Drugs in Clinical Development 103
7.3.1 Xarelto (rivaroxaban) 107
7.3.2 Cangrelor 115
7.3.3 Zontivity (vorapaxar) 121
7.3.4 Alirocumab (RGN727) 127
7.3.5 Evolocumab (AMG 145) 135
7.3.6 Bococizumab (PF-04950615) 144
7.3.7 Anacetrapib 149
7.3.8 Evacetrapib 156
7.3.9 Darapladib 160
8 Market Outlook 166
8.1 Japan 166
8.1.1 Forecast 166
8.1.2 Key Events 171
8.1.3 Drivers and Barriers - Global Issues 172
8.1.4 Japan - Drivers and Barriers 178
9 Appendix 181
9.1 Bibliography 181
9.2 Abbreviations 194
9.3 Methodology 199
9.4 Forecasting Methodology 199
9.4.1 Methodology for Forecasting Selected Portions of the Diagnosed Prevalent ACS Population 199
9.4.2 Diagnosed Acute Coronary Syndrome Patients 200
9.4.3 Percent Drug-Treated Patients 201
9.4.4 Drugs Included in Each Therapeutic Class 201
9.4.5 Launch and Patent Expiry Dates 202
9.4.6 General Pricing Assumptions 203
9.4.7 Individual Drug Assumptions 203
9.4.8 Generic Erosion 211
9.4.9 Pricing of Pipeline Agents 211
9.5 Physicians and Specialists Included in this Study 212
9.6 About the Authors 215
9.6.1 Author 215
9.6.2 Reviewer 215
9.6.3 Global Head of Healthcare 216
9.7 About GlobalData 217
9.8 Disclaimer 217

1.1 List of Tables

Table 1: Antiplatelet Agents that Inhibit Platelet Activation 20
Table 2: Anticoagulants that Inhibit the Coagulatory Cascade 20
Table 3: Symptoms of Acute Coronary Syndrome 25
Table 4: Treatment Guidelines for Acute Coronary Syndromes (UA, NSTEMI, and STEMI) 29
Table 5: Most Prescribed Drugs for ACS by Class in Japan, 2014 29
Table 6: Leading Treatments for Acute Coronary Syndrome, 2014 36
Table 7: Commonly Used tPAs 39
Table 8: Product Profile - Tissue Plasminogen Activator (tPA) 39
Table 9: Fibrinolytics?SWOT Analysis, 2014 41
Table 10: Product Profile - Plavix (clopidogrel) 43
Table 11: Clopidogrel SWOT Analysis, 2014 45
Table 12: Product Profile - Brilinta (ticagrelor) 47
Table 13: Brilinta (ticagrelor) SWOT Analysis, 2014 48
Table 14: Product Profile - Effient (prasugrel) 51
Table 15: Effient (prasugrel) SWOT Analysis, 2014 53
Table 16: Product Profile - Warfarin 55
Table 17: Warfarin SWOT Analysis, 2014 57
Table 18: Product Profile - Lipitor 59
Table 19: Lipitor (atorvastatin) SWOT Analysis, 2014 61
Table 20: Product Profile - Crestor (rosuvastatin) 63
Table 21: Crestor (rosuvastatin) SWOT Analysis, 2014 65
Table 22: Product Profile - Zocor (simvastatin) 66
Table 23: Zocor (simvastatin) SWOT Analysis, 2014 68
Table 24: Commonly Used Beta Blockers 69
Table 25: Product Profile - Beta Blockers 70
Table 26: Beta Blockers SWOT Analysis, 2014 71
Table 27: Product Profile - Tekturna (aliskiren) 73
Table 28: Tekturna (aliskiren) SWOT Analysis, 2014 75
Table 29: Commonly Used ACE Inhibitors 76
Table 30: Product Profile - ACE Inhibitors 76
Table 31: ACE Inhibitor?SWOT Analysis, 2014 78
Table 32: Commonly Used ARBs 79
Table 33: Product Profile - Angiotensin Receptor Blockers (ARBs) 79
Table 34: ARB SWOT Analysis, 2014 81
Table 35: Product Profile - Mineralocorticoid Receptor Antagonists (MRAs) 82
Table 36: MRA SWOT Analysis, 2014 84
Table 37: Unmet Need and Opportunity in Acute Coronary Syndrome 86
Table 38: Acute Coronary Syndrome - Clinical Trials by Phase and Status, 2014 102
Table 39: Acute Coronary Syndrome - Late-Stage Pipeline, 2014 105
Table 40: Comparison of Therapeutic Classes in Development for ACS, 2014 106
Table 41: Product Profile - Xarelto (rivaroxaban) 110
Table 42: Xarelto (rivaroxaban) SWOT Analysis, 2014 114
Table 43: Product Profile - Cangrelor 117
Table 44: Cangrelor SWOT Analysis, 2014 121
Table 45: Product Profile - Zontivity (vorapaxar) 123
Table 46: Vorapaxar SWOT Analysis, 2014 127
Table 47: Product Profile - Alirocumab (RGN727) 130
Table 48: Alirocumab SWOT Analysis, 2014 135
Table 49: Product Profile - Evolocumab (AMG 145) 138
Table 50: Phase III Clinical Trials of Evolocumab Reported by Amgen from Q4 2013 - Q1 2014 140
Table 51: Evolocumab SWOT Analysis, 2013 144
Table 52: Product Profile - Bococizumab (PF-04950615) 146
Table 53: Bococizumab (PF-04950615) SWOT Analysis, 2014 148
Table 54: Product Profile - Anacetrapib 151
Table 55: Anacetrapib SWOT Analysis, 2014 155
Table 56: Product Profile - Evacetrapib 157
Table 57: Evacetrapib SWOT Analysis, 2013 160
Table 58: Product Profile - Darapladib 162
Table 59: Darapladib SWOT Analysis, 2014 165
Table 60: Sales Forecasts ($m) for ACS in Japan, 2013-2023 168
Table 61: Key Events Impacting Sales for Acute Coronary Syndrome in Japan, 2014 171
Table 62: Acute Coronary Syndrome Market - Drivers and Barriers, 2014 172
Table 63: Acute Coronary Syndrome Market - Drivers and Barriers in Japan, 2014 178
Table 64: Key Launch Dates 202
Table 65: Key Patent Expiries 202
Table 66: Price Sources and Calculations, in US 203
Table 67: Physicians Surveyed, By Country 214

1.2 List of Figures

Figure 1: The ACS Timeline and the Scope of GlobalData's ACS Report and Forecast 18
Figure 2: Progression of Coronary Artery Disease, Atherosclerotic Plaque Rupture, Thrombosis, and Acute Coronary Syndrome 19
Figure 3: Platelet and Coagulatory Factors Implicated in Thrombosis 21
Figure 4: Electrocardiography in the Diagnosis of ACS 22
Figure 5: Acute Coronary Syndrome Therapeutics - Clinical Trials by Phase in the 7MM, 2014 103
Figure 6: Competitive Assessment of Late-Stage Pipeline Agents for ACS, 2013-2023 107
Figure 7: Sales for Acute Coronary Syndrome in Japan by Drug Class, 2013-2023 170

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