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

Pages: 233 Published: August 29, 2014 Report Code: GDHC246CFR

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

1Table of Contents1

1.1List of Tables5

1.2List of Figures8

2Esecutive Summary9

2.1Sales for Acute Coronary Syndrome (ACS) in the US9

2.2What Do the Physicians Think?10

3Introduction13

3.1Catalyst13

3.2Related Reports14

3.3Upcoming Related Reports16

4Disease Overview16

4.1Etiology and Pathophysiology18

4.1.1Etiology18

4.1.2Pathophysiology22

4.1.3Prognosis24

4.1.4Quality of Life24

4.2Symptoms25

5Disease Management26

5.1Treatment Overview26

5.2US31

5.2.1Diagnosis31

5.2.2Clinical Practice32

6Competitive Assessment33

6.1Overview33

6.2Strategic Competitor Assessment34

6.3Product Profiles39

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

6.3.2Clopidogrel43

6.3.3Brilinta (ticagrelor)47

6.3.4Effient (prasugrel)51

6.3.5Integrilin (eptifibatide)55

6.3.6Warfarin58

6.3.7Angiomax (bivalirudin)62

6.3.8Arixtra (fondaparinux) and the Heparins64

6.3.9Statins – HMG-CoA Reductase Inhibitors69

6.3.10Beta-Adrenergic Receptor Antagonists (Beta Blockers)80

6.3.11Renin-Angiotensin-Aldosterone System (RAAS) Inhibitors83

7Unmet Need and Opportunity96

7.1Overview96

7.2Therapies that Directly Treat Thrombogenic Atherosclerotic Plaques98

7.2.1Unmet Need98

7.2.2Gap Analysis98

7.2.3Opportunity99

7.3Therapies that Treat Fibrotic Myocardium and Associated Comorbidities99

7.3.1Unmet Need99

7.3.2Gap Analysis100

7.3.3Opportunity101

7.4LDL-C-Lowering Drugs for Statin-Intolerant, Refractory, or Non-Compliant Patients101

7.4.1Unmet Need101

7.4.2Gap Analysis104

7.4.3Opportunity105

7.5Antidotes for New Oral Anticoagulants (NOACs)106

7.5.1Unmet Need106

7.5.2Gap Analysis107

7.5.3Opportunity107

7.6Blood-Thinning Agents with Significantly Reduced Bleeding Risks108

7.6.1Unmet Need108

7.6.2Gap Analysis109

7.6.3Opportunity109

8Pipeline Assessment110

8.1Overview110

8.2Clinical Trials by Phase and Trial Status112

8.3Promising Drugs in Clinical Development114

8.3.1Xarelto (rivaroxaban)118

8.3.2Cangrelor125

8.3.3Zontivity (vorapaxar)132

8.3.4Alirocumab (RGN727)138

8.3.5Evolocumab (AMG 145)145

8.3.6Bococizumab (PF-04950615)154

8.3.7Anacetrapib159

8.3.8Evacetrapib165

8.3.9Darapladib170

9Market Outlook175

9.1United States175

9.1.1Forecast175

9.1.2Key Events180

9.1.3Drivers and Barriers – Global Issues181

9.1.4United States – Drivers and Barriers186

10Appendix189

10.1Bibliography189

10.2Abbreviations202

10.3Methodology207

10.4Forecasting Methodology207

10.4.1Methodology for Forecasting Selected Portions of the Diagnosed Prevalent ACS Population207

10.4.2Diagnosed Acute Coronary Syndrome Patients208

10.4.3Percent Drug-Treated Patients209

10.4.4Drugs Included in Each Therapeutic Class209

10.4.5Launch and Patent Expiry Dates210

10.4.6General Pricing Assumptions211

10.4.7Individual Drug Assumptions211

10.4.8Generic Erosion220

10.4.9Pricing of Pipeline Agents220

10.5Physicians and Specialists Included in this Study221

10.6About the Authors224

10.6.1Author224

10.6.2Reviewer224

10.6.3Global Head of Healthcare225

10.7About GlobalData226

10.8Contact Us226

10.9Disclaimer226

List of Tables

Table 1: Antiplatelet Agents that Inhibit Platelet Activation19

Table 2: Anticoagulants that Inhibit the Coagulatory Cascade20

Table 3: Symptoms of Acute Coronary Syndrome25

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, 201430

Table 6: Leading Treatments for Acute Coronary Syndrome, 201437

Table 7: Commonly Used tPAs41

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

Table 9: Fibrinolytics?SWOT Analysis, 201443

Table 10: Product Profile – Plavix (clopidogrel)45

Table 11: Clopidogrel SWOT Analysis, 201447

Table 12: Product Profile – Brilinta (ticagrelor)49

Table 13: Brilinta (ticagrelor) SWOT Analysis, 201450

Table 14: Product Profile – Effient (prasugrel)53

Table 15: Effient (prasugrel) SWOT Analysis, 201455

Table 16: Product Profile – Integrilin (eptifibatide)56

Table 17: Integrilin (eptifibatide) SWOT Analysis, 201457

Table 18: Product Profile – Warfarin60

Table 19: Warfarin SWOT Analysis, 201462

Table 20: Product Profile – Angiomax63

Table 21: Angiomax (bivalirudin) SWOT Analysis, 201464

Table 22: Product Profile – Arixtra (fondaparinux)66

Table 23: Arixtra (fondaparinux sodium) SWOT Analysis, 201469

Table 24: Product Profile – Lipitor71

Table 25: Lipitor (atorvastatin) SWOT Analysis, 201473

Table 26: Product Profile – Crestor (rosuvastatin)75

Table 27: Crestor (rosuvastatin) SWOT Analysis, 201477

Table 28: Product Profile – Zocor (simvastatin)78

Table 29: Zocor (simvastatin) SWOT Analysis, 201480

Table 30: Commonly Used Beta Blockers81

Table 31: Product Profile – Beta Blockers82

Table 32: Beta Blockers SWOT Analysis, 201483

Table 33: Product Profile – Tekturna (aliskiren)85

Table 34: Tekturna (aliskiren) SWOT Analysis, 201487

Table 35: Commonly Used ACE Inhibitors88

Table 36: Product Profile – ACE Inhibitors88

Table 37: ACE Inhibitor?SWOT Analysis, 201490

Table 38: Commonly Used ARBs91

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

Table 40: ARB SWOT Analysis, 201493

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

Table 42: MRA SWOT Analysis, 201496

Table 43: Unmet Need and Opportunity in Acute Coronary Syndrome97

Table 44: Acute Coronary Syndrome – Clinical Trials by Phase and Status, 2014113

Table 45: Acute Coronary Syndrome – Late-Stage Pipeline, 2014116

Table 46: Comparison of Therapeutic Classes in Development for ACS, 2014117

Table 47: Product Profile – Xarelto (rivaroxaban)121

Table 48: Xarelto (rivaroxaban) SWOT Analysis, 2014125

Table 49: Product Profile – Cangrelor127

Table 50: Cangrelor SWOT Analysis, 2014132

Table 51: Product Profile – Zontivity (vorapaxar)134

Table 52: Vorapaxar SWOT Analysis, 2014138

Table 53: Product Profile – Alirocumab (RGN727)140

Table 54: Alirocumab SWOT Analysis, 2014145

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

Table 56: Phase III Clinical Trials of Evolocumab Reported by Amgen from Q4 2013 – Q1 2014149

Table 57: Evolocumab SWOT Analysis, 2013154

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

Table 59: Bococizumab (PF-04950615) SWOT Analysis, 2014158

Table 60: Product Profile – Anacetrapib161

Table 61: Anacetrapib SWOT Analysis, 2014165

Table 62: Product Profile – Evacetrapib167

Table 63: Evacetrapib SWOT Analysis, 2013169

Table 64: Product Profile – Darapladib172

Table 65: Darapladib SWOT Analysis, 2014175

Table 66: Sales Forecasts ($m) for ACS in US, 2013–2023177

Table 67: Key Events Impacting Sales for Acute Coronary Syndrome in the US, 2014180

Table 68: Acute Coronary Syndrome Market – Drivers and Barriers, 2014181

Table 69: Acute Coronary Syndrome Market – Drivers and Barriers in the US, 2014186

Table 70: Key Launch Dates210

Table 71: Key Patent Expiries210

Table 72: Price Sources and Calculations, in US211

Table 73: Physicians Surveyed, By Country223

List of Figures

Figure 1: Sales for ACS in the US by Therapeutic class, 2013–202310

Figure 2: The ACS Timeline and the Scope of GlobalData’s ACS Report and Forecast18

Figure 3: Progression of Coronary Artery Disease, Atherosclerotic Plaque Rupture, Thrombosis, and Acute Coronary Syndrome19

Figure 4: Platelet and Coagulatory Factors Implicated in Thrombosis21

Figure 5: Electrocardiography in the Diagnosis of ACS23

Figure 6: Acute Coronary Syndrome Therapeutics – Clinical Trials by Phase in the 7MM, 2014114

Figure 7: Competitive Assessment of Late-Stage Pipeline Agents for ACS, 2013–2023118

Figure 8: Sales for Acute Coronary Syndrome in US by Drug Class, 2013–2023179

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