PharmaPoint: Acute Coronary Syndrome – US Drug Forecast and Market Analysis to 2023

Publisher Name:
Published Date: 31-Jul-2014
No. of pages: 233

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.

Of the 7MM forecast for acute coronary syndrome, the US market dominates the other six countries in sales for every class and brand of drug, by a very large margin. The statin share can predominantly be attributed to sales volume as most statins, with the exception of Crestor, are available as inexpensive generics. Contrarily, the large market share from the ARBs is due to the relatively high cost of therapy and the presence of branded options still on the market.

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

Table of Contents For This Report

Table of Contents

1 Table of Contents 1

1.1 List of Tables 5

1.2 List of Figures 8

2 Esecutive Summary 9

2.1 Sales for Acute Coronary Syndrome (ACS) in the US 9

2.2 What Do the Physicians Think? 10

3 Introduction 13

3.1 Catalyst 13

3.2 Related Reports 14

3.3 Upcoming Related Reports 16

4 Disease Overview 16

4.1 Etiology and Pathophysiology 18

4.1.1 Etiology 18

4.1.2 Pathophysiology 22

4.1.3 Prognosis 24

4.1.4 Quality of Life 24

4.2 Symptoms 25

5 Disease Management 26

5.1 Treatment Overview 26

5.2 US 31

5.2.1 Diagnosis 31

5.2.2 Clinical Practice 32

6 Competitive Assessment 33

6.1 Overview 33

6.2 Strategic Competitor Assessment 34

6.3 Product Profiles 39

6.3.1 Fibrinolytic (Thrombolytic) Drugs – Tissue Plasminogen Activator (tPA) 39

6.3.2 Clopidogrel 43

6.3.3 Brilinta (ticagrelor) 47

6.3.4 Effient (prasugrel) 51

6.3.5 Integrilin (eptifibatide) 55

6.3.6 Warfarin 58

6.3.7 Angiomax (bivalirudin) 62

6.3.8 Arixtra (fondaparinux) and the Heparins 64

6.3.9 Statins – HMG-CoA Reductase Inhibitors 69

6.3.10 Beta-Adrenergic Receptor Antagonists (Beta Blockers) 80

6.3.11 Renin-Angiotensin-Aldosterone System (RAAS) Inhibitors 83

7 Unmet Need and Opportunity 96

7.1 Overview 96

7.2 Therapies that Directly Treat Thrombogenic Atherosclerotic Plaques 98

7.2.1 Unmet Need 98

7.2.2 Gap Analysis 98

7.2.3 Opportunity 99

7.3 Therapies that Treat Fibrotic Myocardium and Associated Comorbidities 99

7.3.1 Unmet Need 99

7.3.2 Gap Analysis 100

7.3.3 Opportunity 101

7.4 LDL-C-Lowering Drugs for Statin-Intolerant, Refractory, or Non-Compliant Patients 101

7.4.1 Unmet Need 101

7.4.2 Gap Analysis 104

7.4.3 Opportunity 105

7.5 Antidotes for New Oral Anticoagulants (NOACs) 106

7.5.1 Unmet Need 106

7.5.2 Gap Analysis 107

7.5.3 Opportunity 107

7.6 Blood-Thinning Agents with Significantly Reduced Bleeding Risks 108

7.6.1 Unmet Need 108

7.6.2 Gap Analysis 109

7.6.3 Opportunity 109

8 Pipeline Assessment 110

8.1 Overview 110

8.2 Clinical Trials by Phase and Trial Status 112

8.3 Promising Drugs in Clinical Development 114

8.3.1 Xarelto (rivaroxaban) 118

8.3.2 Cangrelor 125

8.3.3 Zontivity (vorapaxar) 132

8.3.4 Alirocumab (RGN727) 138

8.3.5 Evolocumab (AMG 145) 145

8.3.6 Bococizumab (PF-04950615) 154

8.3.7 Anacetrapib 159

8.3.8 Evacetrapib 165

8.3.9 Darapladib 170

9 Market Outlook 175

9.1 United States 175

9.1.1 Forecast 175

9.1.2 Key Events 180

9.1.3 Drivers and Barriers – Global Issues 181

9.1.4 United States – Drivers and Barriers 186

10 Appendix 189

10.1 Bibliography 189

10.2 Abbreviations 202

10.3 Methodology 207

10.4 Forecasting Methodology 207

10.4.1 Methodology for Forecasting Selected Portions of the Diagnosed Prevalent ACS Population 207

10.4.2 Diagnosed Acute Coronary Syndrome Patients 208

10.4.3 Percent Drug-Treated Patients 209

10.4.4 Drugs Included in Each Therapeutic Class 209

10.4.5 Launch and Patent Expiry Dates 210

10.4.6 General Pricing Assumptions 211

10.4.7 Individual Drug Assumptions 211

10.4.8 Generic Erosion 220

10.4.9 Pricing of Pipeline Agents 220

10.5 Physicians and Specialists Included in this Study 221

10.6 About the Authors 224

10.6.1 Author 224

10.6.2 Reviewer 224

10.6.3 Global Head of Healthcare 225

10.7 About GlobalData 226

10.8 Contact Us 226

10.9 Disclaimer 226

List of Tables

Table 1: Antiplatelet Agents that Inhibit Platelet Activation 19

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) 30

Table 5: Most Prescribed Drugs for ACS by Class in the US, 2014 30

Table 6: Leading Treatments for Acute Coronary Syndrome, 2014 37

Table 7: Commonly Used tPAs 41

Table 8: Product Profile – Tissue Plasminogen Activator (tPA) 41

Table 9: Fibrinolytics?SWOT Analysis, 2014 43

Table 10: Product Profile – Plavix (clopidogrel) 45

Table 11: Clopidogrel SWOT Analysis, 2014 47

Table 12: Product Profile – Brilinta (ticagrelor) 49

Table 13: Brilinta (ticagrelor) SWOT Analysis, 2014 50

Table 14: Product Profile – Effient (prasugrel) 53

Table 15: Effient (prasugrel) SWOT Analysis, 2014 55

Table 16: Product Profile – Integrilin (eptifibatide) 56

Table 17: Integrilin (eptifibatide) SWOT Analysis, 2014 57

Table 18: Product Profile – Warfarin 60

Table 19: Warfarin SWOT Analysis, 2014 62

Table 20: Product Profile – Angiomax 63

Table 21: Angiomax (bivalirudin) SWOT Analysis, 2014 64

Table 22: Product Profile – Arixtra (fondaparinux) 66

Table 23: Arixtra (fondaparinux sodium) SWOT Analysis, 2014 69

Table 24: Product Profile – Lipitor 71

Table 25: Lipitor (atorvastatin) SWOT Analysis, 2014 73

Table 26: Product Profile – Crestor (rosuvastatin) 75

Table 27: Crestor (rosuvastatin) SWOT Analysis, 2014 77

Table 28: Product Profile – Zocor (simvastatin) 78

Table 29: Zocor (simvastatin) SWOT Analysis, 2014 80

Table 30: Commonly Used Beta Blockers 81

Table 31: Product Profile – Beta Blockers 82

Table 32: Beta Blockers SWOT Analysis, 2014 83

Table 33: Product Profile – Tekturna (aliskiren) 85

Table 34: Tekturna (aliskiren) SWOT Analysis, 2014 87

Table 35: Commonly Used ACE Inhibitors 88

Table 36: Product Profile – ACE Inhibitors 88

Table 37: ACE Inhibitor?SWOT Analysis, 2014 90

Table 38: Commonly Used ARBs 91

Table 39: Product Profile – Angiotensin Receptor Blockers (ARBs) 91

Table 40: ARB SWOT Analysis, 2014 93

Table 41: Product Profile – Mineralocorticoid Receptor Antagonists (MRAs) 94

Table 42: MRA SWOT Analysis, 2014 96

Table 43: Unmet Need and Opportunity in Acute Coronary Syndrome 97

Table 44: Acute Coronary Syndrome – Clinical Trials by Phase and Status, 2014 113

Table 45: Acute Coronary Syndrome – Late-Stage Pipeline, 2014 116

Table 46: Comparison of Therapeutic Classes in Development for ACS, 2014 117

Table 47: Product Profile – Xarelto (rivaroxaban) 121

Table 48: Xarelto (rivaroxaban) SWOT Analysis, 2014 125

Table 49: Product Profile – Cangrelor 127

Table 50: Cangrelor SWOT Analysis, 2014 132

Table 51: Product Profile – Zontivity (vorapaxar) 134

Table 52: Vorapaxar SWOT Analysis, 2014 138

Table 53: Product Profile – Alirocumab (RGN727) 140

Table 54: Alirocumab SWOT Analysis, 2014 145

Table 55: Product Profile – Evolocumab (AMG 145) 148

Table 56: Phase III Clinical Trials of Evolocumab Reported by Amgen from Q4 2013 – Q1 2014 149

Table 57: Evolocumab SWOT Analysis, 2013 154

Table 58: Product Profile – Bococizumab (PF-04950615) 156

Table 59: Bococizumab (PF-04950615) SWOT Analysis, 2014 158

Table 60: Product Profile – Anacetrapib 161

Table 61: Anacetrapib SWOT Analysis, 2014 165

Table 62: Product Profile – Evacetrapib 167

Table 63: Evacetrapib SWOT Analysis, 2013 169

Table 64: Product Profile – Darapladib 172

Table 65: Darapladib SWOT Analysis, 2014 175

Table 66: Sales Forecasts ($m) for ACS in US, 2013–2023 177

Table 67: Key Events Impacting Sales for Acute Coronary Syndrome in the US, 2014 180

Table 68: Acute Coronary Syndrome Market – Drivers and Barriers, 2014 181

Table 69: Acute Coronary Syndrome Market – Drivers and Barriers in the US, 2014 186

Table 70: Key Launch Dates 210

Table 71: Key Patent Expiries 210

Table 72: Price Sources and Calculations, in US 211

Table 73: Physicians Surveyed, By Country 223

List of Figures

Figure 1: Sales for ACS in the US by Therapeutic class, 2013–2023 10

Figure 2: T he ACS Timeline and the Scope of GlobalData’s ACS Report and Forecast 18

Figure 3: Progression of Coronary Artery Disease, Atherosclerotic Plaque Rupture, Thrombosis, and Acute Coronary Syndrome 19

Figure 4: Platelet and Coagulatory Factors Implicated in Thrombosis 21

Figure 5: Electrocardiography in the Diagnosis of ACS 23

Figure 6: Acute Coronary Syndrome Therapeutics – Clinical Trials by Phase in the 7MM, 2014 114

Figure 7: Competitive Assessment of Late-Stage Pipeline Agents for ACS, 2013–2023 118

Figure 8: Sales for Acute Coronary Syndrome in US by Drug Class, 2013–2023 179

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