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Dyslipidemia-5EU Drug Forecast and Market Analysis to 2023

Dyslipidemia-5EU Drug Forecast and Market Analysis to 2023


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Executive Summary

Dyslipidemia-5EU Drug Forecast and Market Analysis to 2023

Summary

GlobalData estimates that the total market size for the 8MM in 2013 was USD 15.4bn, comprised of USD 11.0bn in branded drug sales (72%) and USD 4.4bn in generic sales (28%). GlobalData expects that the dyslipidemia drug market will grow at a CAGR of 9.4% over the ten year forecast period, resulting in a market value of USD 37.9bn by 2023, of which 71% will be attributed to branded drug sales (USD 26.9bn) and 29% to generic drug sales (USD 11.0bn). The current dyslipidemia market is dominated by the statins, the revolutionary drugs that reduce low-density lipoprotein cholesterol (LDL-C) and that have been proven to reduce the risk of cardiovascular events such as heart attack and stroke. Other major lipid-modulating drugs, such as Zetia (ezetimibe), the fibrates, bile acid sequestrants, omega-3 fish oil agents, and rare-disease therapies comprise the remainder of the current dyslipidemia space. The launch of the proprotein convertase subtilisin/kexin type 9 (PCSK9) biologics and the cholesteryl ester transfer protein (CETP) inhibitors will reshape the sales landscape of the dyslipidemia market moving forward.

As with the other markets examined in this forecast, dyslipidemia sales in the 5EU in the 2013 base year were dominated by the statins and ezetimibe. In 2013, statin sales contributed 64% (USD 1.5 billion) towards the dyslipidemia market share in the 5EU.

*This is an on-demand report and will be delivered within 24 hrs. (excluding weekends) of the purchase.

Scope

Overview of Dyslipidemia 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 from 2013-2023.

Analysis of the impact of key events as well the drivers and restraints affecting 5EU Dyslipidemia 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 Dyslipidemia.

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.

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 6

1.2 List of Figures 10

2 Introduction 11

2.1 Catalyst 11

2.2 Related Reports 12

2.3 Upcoming Related Reports 13

3 Disease Overview 14

3.1 Etiology and Pathophysiology 14

3.1.1 Etiology 14

3.1.2 Pathophysiology 16

3.2 Symptoms 20

3.3 Prognosis 20

3.4 Quality of Life 20

4 Disease Management 21

4.1 Diagnosis and Treatment Overview 21

4.1.1 Diagnosis 21

4.1.2 Treatment Guidelines and Leading Prescribed Drugs 23

4.1.3 Clinical Practice 26

4.2 France 28

4.3 Germany 30

4.4 Italy 33

4.5 Spain 35

4.6 UK 37

5 Competitive Assessment 40

5.1 Overview 40

5.2 Product Profiles-Major Brands 44

5.2.1 Statins 44

5.2.2 Zetia (ezetimibe) 64

5.2.3 Vytorin (simvastatin/ezetimibe) 73

5.2.4 Liptruzet (atorvastatin/ezetimibe) 77

5.2.5 Niaspan (niacin extended-release) 81

5.2.6 Kynamro (mipomersen sodium) 87

5.2.7 Juxtapid (lomitapide) 94

5.2.8 TriCor/Trilipix (fenofibrate/fenfibric acid) 99

5.2.9 Omega-3 Fatty Acids 104

5.2.10 Welchol (colesevelam HCl) and the Bile Acid Sequestrants 119

6 Unmet Need and Opportunity 125

6.1 Overview 125

6.2 LDL-C-Lowering Drugs for Statin-Intolerant and Statin-Refractory Patients 126

6.2.1 Unmet Need 126

6.2.2 Gap Analysis 127

6.2.3 Opportunity 128

6.3 Improved Diagnosis, Patient Education, and Long-term Compliance 129

6.3.1 Unmet Need 129

6.3.2 Gap Analysis 130

6.3.3 Opportunity 132

6.4 Therapies that Prevent or Reverse the Build-Up of Atherosclerotic Plaque 133

6.4.1 Unmet Need 133

6.4.2 Gap Analysis 134

6.4.3 Opportunity 135

6.5 Therapies for Patients with HoFH with Improved Side Effect Profiles 136

6.5.1 Unmet Need 136

6.5.2 Gap Analysis 137

6.5.3 Opportunity 138

7 Pipeline Assessment 139

7.1 Overview 139

7.2 Clinical Trial Mapping 143

7.2.1 Clinical Trials by Patient Population 143

7.3 Promising Drugs in Clinical Development 143

7.3.1 Alirocumab 143

7.3.2 Bococizumab 152

7.3.3 Evolocumab 157

7.3.4 Anacetrapib 166

7.3.5 Evacetrapib 174

7.3.6 TA-8995 (DEZ-001) 180

7.3.7 CER-001 186

7.3.8 ETC-1002 192

7.4 Other Drugs in Development 200

8 Market Outlook 201

8.1 5EU 201

8.1.1 Forecast 201

8.1.2 Key Events 209

8.1.3 Drivers and Barriers 210

9 Appendix 213

9.1 Bibliography 213

9.2 Abbreviations 241

9.3 Methodology 249

9.4 Forecasting Methodology 249

9.4.1 Diagnosed Dyslipidemia Patients 249

9.4.2 Percent Drug-Treated Patients 250

9.4.3 Drugs Included in Each Therapeutic Class 250

9.4.4 Launch and Patent Expiry Dates 251

9.4.5 General Pricing Assumptions 252

9.4.6 Individual Drug Assumptions 253

9.4.7 Generic Erosion 260

9.4.8 Pricing of Pipeline Agents 260

9.5 Physicians and Specialists Included in this Study 262

9.6 About the Authors 264

9.6.1 Analyst 264

9.6.2 Therapy Area Director 264

9.6.3 Epidemiologist 265

9.6.4 Global Head of Healthcare 265

9.7 About GlobalData 266

9.8 Disclaimer 266

1.2 List of Figures

Figure 1: Competitive Assessment of Late-Stage Pipeline Agents in Dyslipidemia, 2013-2023 142

Figure 2: Dyslipidemia Therapeutics-Clinical Trials by Indication and Lipid Biomarker, 2014 143

Figure 3: Composite Sales for Dyslipidemia in the 5EU by Drug Class, 2013-2023 204

Figure 4: Sales Breakdown for the 5EU Markets, 2013-2023 205

Figure 5: 5EU Country Sales, Segmented by Drug Class, 2013-2023 206

Figure 6: High-Selling* Drug Classes in the 5EU, Segmented by Country, 2013-2023 207

Figure 7: Low-Selling* Drug Classes in the 5EU, Segmented by Country, 2013-2023 208

1.1 List of Tables

Table 1: Dyslipidemia: Key Metrics in Eight Major Pharmaceutical Markets 14

Table 2: Common Secondary Causes of Dyslipidemia 16

Table 3: Treatment Guidelines for Dyslipidemia 24

Table 4: Most Commonly Prescribed Drugs for Dyslipidemia by Class in the Global Markets, 2014 26

Table 5: Country Profile-France 30

Table 6: Country Profile-Germany 33

Table 7: Country Profile-Italy 35

Table 8: Country Profile-Spain 37

Table 9: Country Profile-UK 39

Table 10: Leading Treatments for Dyslipidemia, 2014 44

Table 11: Statin Combination Therapies 46

Table 12: Product Profile-Lipitor 47

Table 13: Lipitor (atorvastatin) SWOT Analysis, 2014 49

Table 14: Global Sales Forecasts (USD m) for Lipitor (atorvastatin), 2013-2023 50

Table 15: Product Profile-Crestor (rosuvastatin) 52

Table 16: Crestor (rosuvastatin) SWOT Analysis, 2014 54

Table 17: Global Sales Forecasts (USD m) for Crestor (rosuvastatin), 2013-2023 55

Table 18: Product Profile-Zocor (simvastatin) 56

Table 19: Zocor (simvastatin) SWOT Analysis, 2014 58

Table 20: Global Sales Forecasts (USD m) for Zocor (simvastatin), 2013-2023 59

Table 21: Product Profile-Livalo (pitavastatin) 60

Table 22: Livalo (pitavastatin) SWOT Analysis, 2014 63

Table 23: Product Profile-Zetia (ezetimibe) 66

Table 24: Zetia (ezetimibe) SWOT Analysis, 2014 72

Table 25: Global Sales Forecasts (USD m) for Zetia (ezetimibe), 2013-2023 73

Table 26: Product Profile-Vytorin (simvastatin/ezetimibe) 74

Table 27: Vytorin (simvastatin/ezetimibe) SWOT Analysis, 2014 76

Table 28: Global Sales Forecasts (USD m) for Vytorin (simvastatin/ezetimibe), 2013-2023 77

Table 29: Product Profile-Liptruzet (atorvastatin/ezetimibe) 78

Table 30: Liptruzet (atorvastatin/ezetimibe) SWOT Analysis, 2014 80

Table 31: Global Sales Forecasts (USD m) for Liptruzet (atorvastatin/ezetimibe), 2013-2023 81

Table 32: Product Profile-Niaspan (niacin extended-release) 83

Table 33: Niaspan (niacin extended-release) SWOT Analysis, 2014 86

Table 34: Global Sales Forecasts (USD m) for Niaspan (niacin extended-release), 2013-2023 87

Table 35: Product Profile-Kynamro (mipomersen sodium) 89

Table 36: Kynamro-Induced Changes in Lipid Parameters from Akdim et al., 2010 90

Table 37: Kynamro-Induced Changes in Lipid Parameters from Raal et al., 2010 91

Table 38: Kynamro (mipomersen) SWOT Analysis, 2014 92

Table 39: Global Sales Forecasts (USD m) for Kynamro (mipomersen), 2013-2023 93

Table 40: Product Profile-Juxtapid (lomitapide) 95

Table 41: Juxtapid-Induced Dose-Responsive Changes in Lipid Parameters from Cuchel et al., 2007 96

Table 42: Juxtapid-Induced Changes in Lipid Parameters from Cuchel et al., 2013 97

Table 43: Juxtapid (lomitapide) SWOT Analysis, 2014 98

Table 44: Global Sales Forecasts (USD m) for Juxtapid (lomitapide), 2013-2023 99

Table 45: A Summary of the Therapeutic Properties of Fibrates* 100

Table 46: Product Profile-TriCor (fenofibrate) and Trilipix (fenofibric acid) 101

Table 47: TriCor/Trilipix (fenofibrate/fenofibric acid) SWOT Analysis, 2014 103

Table 48: Global Sales Forecasts (USD m) for TriCor/Trilipix (fenofibrate/fenofibric acid), 2013-2023 104

Table 49: Product Profile-Lovaza (omega-3 acid ethyl esters) 106

Table 50: Lovaza (omega-3 acid ethyl esters) SWOT Analysis, 2014 108

Table 51: Global Sales Forecasts (USD m) for Lovaza (omega-3 acid ethyl esters), 2013-2023 109

Table 52: Product Profile-Vascepa (icosapent ethyl) 111

Table 53: Vascepa (icosapent ethyl) SWOT Analysis, 2014 113

Table 54: Global Sales Forecasts (USD m) for Vascepa (icosapent ethyl), 2013-2023 114

Table 55: Product Profile-Epanova (omega-3 carboxylic acids) 115

Table 56: Epanova-Induced Changes in Blood Lipid Parameters from Kastelein et al., 2012 117

Table 57: Epanova-Induced Changes in Blood Lipid Parameters from Maki et al., 2013 117

Table 58: Epanova (omega-3 carboxylic acids) SWOT Analysis, 2014 118

Table 59: Global Sales Forecasts (USD m) for Epanova (omega-3 carboxylic acids), 2013-2023 119

Table 60: Product Profile-Welchol (colesevelam HCl) 121

Table 61: Welchol-Induced Changes in Blood Glucose and Lipid Parameters from Zieve et al., 2007 122

Table 62: Welchol (colesevelam HCl) SWOT Analysis, 2014 123

Table 63: Global Sales Forecasts (USD m) for Welchol (colesevelam HCl), 2013-2023 124

Table 64: Unmet Need and Opportunity in Dyslipidemia 126

Table 65: Comparison of Therapeutic Classes in Development for Dyslipidemia, 2014 142

Table 66: Product Profile-Alirocumab 146

Table 67: Alirocumab SWOT Analysis, 2014 151

Table 68: Global Sales Forecasts (USD m) for Alirocumab, 2013-2023 152

Table 69: Product Profile-Bococizumab 153

Table 70: Bococizumab SWOT Analysis, 2014 156

Table 71: Global Sales Forecasts (USD m) for Bococizumab, 2013-2023 157

Table 72: Product Profile-Evolocumab 159

Table 73: Phase III Clinical Trials of Evolocumab Reported by Amgen from Q4 2013-Q1 2014 161

Table 74: Evolocumab SWOT Analysis, 2014 165

Table 75: Global Sales Forecasts (USD ) for Evolocumab, 2013-2023 166

Table 76: Product Profile-Anacetrapib 168

Table 77: Anacetrapib SWOT Analysis, 2014 172

Table 78: Global Sales Forecasts (USD ) for Anacetrapib, 2013-2023 173

Table 79: Product Profile-Evacetrapib 175

Table 80: Evacetrapib SWOT Analysis, 2014 179

Table 81: Global Sales Forecasts (USD ) for Evacetrapib, 2013-2023 180

Table 82: Product Profile-TA-8995 (DEZ-001) 181

Table 83: Impact of Steady-State TA-8995 on CETP and Lipid Parameters from Ford et al., 2014 182

Table 84: TA-8995 SWOT Analysis, 2014 185

Table 85: Global Sales Forecasts (USD ) for TA-8995, 2013-2023 186

Table 86: Product Profile-CER-001 188

Table 87: CER-001 SWOT Analysis, 2014 191

Table 88: Global Sales Forecasts (USD ) for CER-001, 2013-2023 192

Table 89: Product Profile-ETC-1002 194

Table 90: ETC-1002/Ezetimibe Active Comparator Trial Results 196

Table 91: ETC-1002 SWOT Analysis, 2014 198

Table 92: Global Sales Forecasts (USD ) for ETC-1002, 2013-2023 199

Table 93: Dyslipidemia Drugs in Development, 2014 200

Table 94: Sales Forecast (USD m) for Dyslipidemia in the 5EU, 2013-2023 202

Table 95: Key Events Impacting Sales for Dyslipidemia in the 5EU, 2014 209

Table 96: Dyslipidemia Market-5EU Drivers and Barriers, 2014 210

Table 97: National Healthcare Authorities in the 5EU Nations 210

Table 98: National Public Health Initiatives in the 5EU Nations 211

Table 99: Governmental Drug Pricing Authorities in the 5EU Nations 212

Table 100: Key Launch Dates 251

Table 101: Key Patent Expiries 251

Table 102: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 263

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