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PharmaPoint: Acute Coronary Syndrome - 5EU 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.

France represents one of the smallest in terms of overall ACS drug sales. Next to the US market, Germany commands the largest global market share for the sale of ACS drugs. Italy’s contribution to global sales in both 2013 and 2023 falls in the middle of the sales distribution for the 7MM covered in this forecast. Of the 7MMs that were forecast in this report, Spain’s share of global sales is the smallest for both the 2013 base year and the final forecast year of 2023. Of the markets forecast here, the UK commands the third largest market share in both the 2013 base year and in 2023.

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 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in 5EU (the UK, France, Italy, Spain, Germany) from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the 5EU 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 5EU (the UK, France, Italy, Spain, Germany).

Table Of Contents

PharmaPoint: Acute Coronary Syndrome - 5EU Drug Forecast and Market Analysis to 2023
1 Table of Contents

2 Introduction 16
2.1 Catalyst 16
2.2 Related Reports 17
2.3 Upcoming Related Reports 19
3 Disease Overview 20
3.1 Etiology and Pathophysiology 21
3.1.1 Etiology 21
3.1.2 Pathophysiology 25
3.1.3 Prognosis 26
3.1.4 Quality of Life 27
3.2 Symptoms 27
4 Disease Management 29
4.1 Treatment Overview 29
4.2 France 34
4.2.1 Diagnosis 34
4.2.2 Clinical Practice 34
4.3 Germany 35
4.3.1 Diagnosis 35
4.3.2 Clinical Practice 35
4.4 Italy 36
4.4.1 Diagnosis 36
4.4.2 Clinical Practice 36
4.5 Spain 37
4.5.1 Diagnosis 37
4.5.2 Clinical Practice 37
4.6 UK 39
4.6.1 Diagnosis 39
4.6.2 Clinical Practice 40
5 Competitive Assessment 42
5.1 Overview 42
5.2 Strategic Competitor Assessment 43
5.3 Product Profiles 48
5.3.1 Fibrinolytic (Thrombolytic) Drugs - Tissue Plasminogen Activator (tPA) 48
5.3.2 Clopidogrel 52
5.3.3 Brilinta (ticagrelor) 56
5.3.4 Effient (prasugrel) 60
5.3.5 Integrilin (eptifibatide) 64
5.3.6 Warfarin 67
5.3.7 Angiomax (bivalirudin) 71
5.3.8 Arixtra (fondaparinux) and the Heparins 74
5.3.9 Statins - HMG-CoA Reductase Inhibitors 78
5.3.10 Beta-Adrenergic Receptor Antagonists (Beta Blockers) 90
5.3.11 Renin-Angiotensin-Aldosterone System (RAAS) Inhibitors 93
6 Unmet Need and Opportunity 106
6.1 Overview 106
6.2 Therapies that Directly Treat Thrombogenic Atherosclerotic Plaques 107
6.2.1 Unmet Need 107
6.2.2 Gap Analysis 108
6.2.3 Opportunity 108
6.3 Therapies that Treat Fibrotic Myocardium and Associated Comorbidities 109
6.3.1 Unmet Need 109
6.3.2 Gap Analysis 110
6.3.3 Opportunity 110
6.4 LDL-C-Lowering Drugs for Statin-Intolerant, Refractory, or Non-Compliant Patients 111
6.4.1 Unmet Need 111
6.4.2 Gap Analysis 113
6.4.3 Opportunity 115
6.5 Antidotes for New Oral Anticoagulants (NOACs) 115
6.5.1 Unmet Need 115
6.5.2 Gap Analysis 116
6.5.3 Opportunity 116
6.6 Blood-Thinning Agents with Significantly Reduced Bleeding Risks 117
6.6.1 Unmet Need 117
6.6.2 Gap Analysis 118
6.6.3 Opportunity 118
7 Pipeline Assessment 120
7.1 Overview 120
7.2 Clinical Trials by Phase and Trial Status 122
7.3 Promising Drugs in Clinical Development 124
7.3.1 Xarelto (rivaroxaban) 128
7.3.2 Cangrelor 136
7.3.3 Zontivity (vorapaxar) 142
7.3.4 Alirocumab (RGN727) 148
7.3.5 Evolocumab (AMG 145) 156
7.3.6 Bococizumab (PF-04950615) 165
7.3.7 Anacetrapib 170
7.3.8 Evacetrapib 177
7.3.9 Darapladib 181
8 Market Outlook 187
8.1 Global 187
8.1.1 Drivers and Barriers - Global Issues 187
8.2 France 193
8.2.1 Forecast 193
8.2.2 Key Events 198
8.2.3 Drivers and Barriers 198
8.3 Germany 201
8.3.1 Forecast 201
8.3.2 Key Events 206
8.3.3 Drivers and Barriers 206
8.4 Italy 209
8.4.1 Forecast 209
8.4.2 Key Events 215
8.4.3 Drivers and Barriers 216
8.5 Spain 218
8.5.1 Forecast 218
8.5.2 Key Events 224
8.5.3 Drivers and Barriers 224
8.6 United Kingdom 226
8.6.1 Forecast 226
8.6.2 Key Events 232
8.6.3 Drivers and Barriers 232
9 Appendix 235
9.1 Bibliography 235
9.2 Abbreviations 249
9.3 Methodology 255
9.4 Forecasting Methodology 255
9.4.1 Methodology for Forecasting Selected Portions of the Diagnosed Prevalent ACS Population 255
9.4.2 Diagnosed Acute Coronary Syndrome Patients 256
9.4.3 Percent Drug-Treated Patients 257
9.4.4 Drugs Included in Each Therapeutic Class 257
9.4.5 Launch and Patent Expiry Dates 258
9.4.6 General Pricing Assumptions 259
9.4.7 Individual Drug Assumptions 260
9.4.8 Generic Erosion 269
9.4.9 Pricing of Pipeline Agents 270
9.5 Physicians and Specialists Included in this Study 271
9.6 About the Authors 274
9.6.1 Author 274
9.6.2 Reviewer 274
9.6.3 Global Head of Healthcare 275
9.7 About GlobalData 276
9.8 Disclaimer 276

1.1 List of Tables

Table 1: Antiplatelet Agents that Inhibit Platelet Activation 23
Table 2: Anticoagulants that Inhibit the Coagulatory Cascade 23
Table 3: Symptoms of Acute Coronary Syndrome 28
Table 4: Treatment Guidelines for Acute Coronary Syndrome in the 5EU 32
Table 5: Most Prescribed Drugs for ACS by Class in the Global Markets, 2014 33
Table 6: Leading Treatments for Acute Coronary Syndrome, 2014 47
Table 7: Commonly Used tPAs 50
Table 8: Product Profile - Tissue Plasminogen Activator (tPA) 50
Table 9: Fibrinolytics?SWOT Analysis, 2014 52
Table 10: Product Profile - Plavix (clopidogrel) 54
Table 11: Clopidogrel SWOT Analysis, 2014 56
Table 12: Product Profile - Brilinta (ticagrelor) 58
Table 13: Brilinta (ticagrelor) SWOT Analysis, 2014 59
Table 14: Product Profile - Effient (prasugrel) 62
Table 15: Effient (prasugrel) SWOT Analysis, 2014 64
Table 16: Product Profile - Integrilin (eptifibatide) 65
Table 17: Integrilin (eptifibatide) SWOT Analysis, 2014 67
Table 18: Product Profile - Warfarin 69
Table 19: Warfarin SWOT Analysis, 2014 71
Table 20: Product Profile - Angiomax 72
Table 21: Angiomax (bivalirudin) SWOT Analysis, 2014 73
Table 22: Product Profile - Arixtra (fondaparinux) 75
Table 23: Arixtra (fondaparinux sodium) SWOT Analysis, 2014 78
Table 24: Product Profile - Lipitor 80
Table 25: Lipitor (atorvastatin) SWOT Analysis, 2014 82
Table 26: Product Profile - Crestor (rosuvastatin) 84
Table 27: Crestor (rosuvastatin) SWOT Analysis, 2014 86
Table 28: Product Profile - Zocor (simvastatin) 87
Table 29: Zocor (simvastatin) SWOT Analysis, 2014 89
Table 30: Commonly Used Beta Blockers 90
Table 31: Product Profile - Beta Blockers 91
Table 32: Beta Blockers SWOT Analysis, 2014 92
Table 33: Product Profile - Tekturna (aliskiren) 94
Table 34: Tekturna (aliskiren) SWOT Analysis, 2014 96
Table 35: Commonly Used ACE Inhibitors 97
Table 36: Product Profile - ACE Inhibitors 97
Table 37: ACE Inhibitor?SWOT Analysis, 2014 99
Table 38: Commonly Used ARBs 100
Table 39: Product Profile - Angiotensin Receptor Blockers (ARBs) 100
Table 40: ARB SWOT Analysis, 2014 102
Table 41: Product Profile - Mineralocorticoid Receptor Antagonists (MRAs) 103
Table 42: MRA SWOT Analysis, 2014 105
Table 43: Unmet Need and Opportunity in Acute Coronary Syndrome 107
Table 44: Acute Coronary Syndrome - Clinical Trials by Phase and Status, 2014 123
Table 45: Acute Coronary Syndrome - Late-Stage Pipeline, 2014 126
Table 46: Comparison of Therapeutic Classes in Development for ACS, 2014 127
Table 47: Product Profile - Xarelto (rivaroxaban) 131
Table 48: Xarelto (rivaroxaban) SWOT Analysis, 2014 135
Table 49: Product Profile - Cangrelor 138
Table 50: Cangrelor SWOT Analysis, 2014 142
Table 51: Product Profile - Zontivity (vorapaxar) 144
Table 52: Vorapaxar SWOT Analysis, 2014 148
Table 53: Product Profile - Alirocumab (RGN727) 151
Table 54: Alirocumab SWOT Analysis, 2014 156
Table 55: Product Profile - Evolocumab (AMG 145) 159
Table 56: Phase III Clinical Trials of Evolocumab Reported by Amgen from Q4 2013 - Q1 2014 161
Table 57: Evolocumab SWOT Analysis, 2013 165
Table 58: Product Profile - Bococizumab (PF-04950615) 167
Table 59: Bococizumab (PF-04950615) SWOT Analysis, 2014 169
Table 60: Product Profile - Anacetrapib 172
Table 61: Anacetrapib SWOT Analysis, 2014 176
Table 62: Product Profile - Evacetrapib 178
Table 63: Evacetrapib SWOT Analysis, 2013 181
Table 64: Product Profile - Darapladib 183
Table 65: Darapladib SWOT Analysis, 2014 186
Table 66: Acute Coronary Syndrome Market - Drivers and Barriers, 2014 187
Table 67: Sales Forecasts ($m) for ACS in France, 2013-2023 195
Table 68: Key Events Impacting Sales for Acute Coronary Syndrome in France, 2014 198
Table 69: Acute Coronary Syndrome Market - Drivers and Barriers in France, 2014 198
Table 70: Sales Forecasts ($m) for ACS in Germany, 2013-2023 203
Table 71: Key Events Impacting Sales for Acute Coronary Syndrome in Germany, 2014 206
Table 72: Acute Coronary Syndrome Market - Drivers and Barriers in Germany, 2014 206
Table 73: Sales Forecasts ($m) for ACS in Italy, 2013-2023 212
Table 74: Key Events Impacting Sales for Acute Coronary Syndrome in Italy, 2014 215
Table 75: Acute Coronary Syndrome Market - Drivers and Barriers in Italy, 2014 216
Table 76: Sales Forecasts ($m) for ACS in Spain, 2013-2023 221
Table 77: Key Events Impacting Sales for Acute Coronary Syndrome in Spain, 2014 224
Table 78: Acute Coronary Syndrome Market - Drivers and Barriers in Spain, 2014 224
Table 79: Sales Forecasts ($m) for ACS in UK, 2013-2023 229
Table 80: Key Events Impacting Sales for Acute Coronary Syndrome in the UK, 2014 232
Table 81: Acute Coronary Syndrome Market - Drivers and Barriers in the UK, 2014 232
Table 82: Key Launch Dates 258
Table 83: Key Patent Expiries 258
Table 84: Price Sources and Calculations, by Country 259
Table 85: Physicians Surveyed, By Country 273

1.2 List of Figures
Figure 1: The ACS Timeline and the Scope of GlobalData's ACS Report and Forecast 21
Figure 2: Progression of Coronary Artery Disease, Atherosclerotic Plaque Rupture, Thrombosis, and Acute Coronary Syndrome 22
Figure 3: Platelet and Coagulatory Factors Implicated in Thrombosis 24
Figure 4: Electrocardiography in the Diagnosis of ACS 25
Figure 5: Acute Coronary Syndrome Therapeutics - Clinical Trials by Phase in the 7MM, 2014 124
Figure 6: Competitive Assessment of Late-Stage Pipeline Agents for ACS, 2013-2023 128
Figure 7: Sales for Acute Coronary Syndrome in France by Drug Class, 2013-2023 197
Figure 8: Sales for Acute Coronary Syndrome in Germany by Drug Class, 2013-2023 205
Figure 9: Sales for Acute Coronary Syndrome in Italy by Drug Class, 2013-2023 214
Figure 10: Sales for Acute Coronary Syndrome in Spain by Drug Class, 2013-2023 223
Figure 11: Sales for Acute Coronary Syndrome in the UK by Drug Class, 2013-2023 231

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