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Dyslipidemia-China Drug Forecast and Market Analysis to 2023

Dyslipidemia-China Drug Forecast and Market Analysis to 2023


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Executive Summary

Dyslipidemia-China 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.

More so than in any other market, the statins dominated Chinese dyslipidemia drugs sales in the 2013 base year, contributing 84% to the total market share, reflecting sales of USD 1.7 billion in total sales.

*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 China including product description, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in China from 2013-2023.

Analysis of the impact of key events as well the drivers and restraints affecting China 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 China.

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 5

1.2 List of Figures 9

2 Introduction 10

2.1 Catalyst 10

2.2 Related Reports 11

2.3 Upcoming Related Reports 12

3 Disease Overview 13

3.1 Etiology and Pathophysiology 13

3.1.1 Etiology 13

3.1.2 Pathophysiology 15

3.2 Symptoms 19

3.3 Prognosis 19

3.4 Quality of Life 19

4 Disease Management 20

4.1 Diagnosis and Treatment Overview 20

4.1.1 Diagnosis 20

4.1.2 Treatment Guidelines and Leading Prescribed Drugs 22

4.1.3 Clinical Practice 25

4.2 China 27

5 Competitive Assessment 30

5.1 Overview 30

5.2 Product Profiles-Major Brands 34

5.2.1 Statins 34

5.2.2 Zetia (ezetimibe) 54

5.2.3 Vytorin (simvastatin/ezetimibe) 63

5.2.4 Liptruzet (atorvastatin/ezetimibe) 67

5.2.5 Niaspan (niacin extended-release) 71

5.2.6 Kynamro (mipomersen sodium) 77

5.2.7 Juxtapid (lomitapide) 84

5.2.8 TriCor/Trilipix (fenofibrate/fenfibric acid) 89

5.2.9 Omega-3 Fatty Acids 94

5.2.10 Welchol (colesevelam HCl) and the Bile Acid Sequestrants 109

6 Unmet Need and Opportunity 115

6.1 Overview 115

6.2 LDL-C-Lowering Drugs for Statin-Intolerant and Statin-Refractory Patients 116

6.2.1 Unmet Need 116

6.2.2 Gap Analysis 117

6.2.3 Opportunity 118

6.3 Improved Diagnosis, Patient Education, and Long-term Compliance 119

6.3.1 Unmet Need 119

6.3.2 Gap Analysis 120

6.3.3 Opportunity 122

6.4 Therapies that Prevent or Reverse the Build-Up of Atherosclerotic Plaque 123

6.4.1 Unmet Need 123

6.4.2 Gap Analysis 124

6.4.3 Opportunity 125

6.5 Therapies for Patients with HoFH with Improved Side Effect Profiles 126

6.5.1 Unmet Need 126

6.5.2 Gap Analysis 127

6.5.3 Opportunity 128

7 Pipeline Assessment 129

7.1 Overview 129

7.2 Clinical Trial Mapping 133

7.2.1 Clinical Trials by Patient Population 133

7.3 Promising Drugs in Clinical Development 133

7.3.1 Alirocumab 133

7.3.2 Bococizumab 142

7.3.3 Evolocumab 147

7.3.4 Anacetrapib 156

7.3.5 Evacetrapib 164

7.3.6 TA-8995 (DEZ-001) 170

7.3.7 CER-001 176

7.3.8 ETC-1002 182

7.4 Other Drugs in Development 190

8 Market Outlook 191

8.1 China 191

8.1.1 Forecast 191

8.1.2 Key Events 195

8.1.3 Drivers and Barriers 195

9 Appendix 198

9.1 Bibliography 198

9.2 Abbreviations 226

9.3 Methodology 234

9.4 Forecasting Methodology 234

9.4.1 Diagnosed Dyslipidemia Patients 234

9.4.2 Percent Drug-Treated Patients 235

9.4.3 Drugs Included in Each Therapeutic Class 235

9.4.4 Launch and Patent Expiry Dates 236

9.4.5 General Pricing Assumptions 237

9.4.6 Individual Drug Assumptions 238

9.4.7 Generic Erosion 245

9.4.8 Pricing of Pipeline Agents 245

9.5 Physicians and Specialists Included in this Study 247

9.6 About the Authors 249

9.6.1 Analyst 249

9.6.2 Therapy Area Director 249

9.6.3 Epidemiologist 250

9.6.4 Global Head of Healthcare 250

9.7 About GlobalData 251

9.8 Disclaimer 251

1.2 List of Figures

Figure 1: Competitive Assessment of Late-Stage Pipeline Agents in Dyslipidemia, 2013-2023 132

Figure 2: Dyslipidemia Therapeutics-Clinical Trials by Indication and Lipid Biomarker, 2014 133

Figure 3: Sales for Dyslipidemia in China by Drug Class, 2013-2023 194

1.1 List of Tables

Table 1: Dyslipidemia: Key Metrics in Eight Major Pharmaceutical Markets 13

Table 2: Common Secondary Causes of Dyslipidemia 15

Table 3: Treatment Guidelines for Dyslipidemia 23

Table 4: Most Commonly Prescribed Drugs for Dyslipidemia by Class in the Global Markets, 2014 25

Table 5: Country Profile-China 29

Table 6: Leading Treatments for Dyslipidemia, 2014 34

Table 7: Statin Combination Therapies 36

Table 8: Product Profile-Lipitor 37

Table 9: Lipitor (atorvastatin) SWOT Analysis, 2014 39

Table 10: Global Sales Forecasts (USD m) for Lipitor (atorvastatin), 2013-2023 40

Table 11: Product Profile-Crestor (rosuvastatin) 42

Table 12: Crestor (rosuvastatin) SWOT Analysis, 2014 44

Table 13: Global Sales Forecasts (USD m) for Crestor (rosuvastatin), 2013-2023 45

Table 14: Product Profile-Zocor (simvastatin) 46

Table 15: Zocor (simvastatin) SWOT Analysis, 2014 48

Table 16: Global Sales Forecasts (USD m) for Zocor (simvastatin), 2013-2023 49

Table 17: Product Profile-Livalo (pitavastatin) 50

Table 18: Livalo (pitavastatin) SWOT Analysis, 2014 53

Table 19: Product Profile-Zetia (ezetimibe) 56

Table 20: Zetia (ezetimibe) SWOT Analysis, 2014 62

Table 21: Global Sales Forecasts (USD m) for Zetia (ezetimibe), 2013-2023 63

Table 22: Product Profile-Vytorin (simvastatin/ezetimibe) 64

Table 23: Vytorin (simvastatin/ezetimibe) SWOT Analysis, 2014 66

Table 24: Global Sales Forecasts (USD m) for Vytorin (simvastatin/ezetimibe), 2013-2023 67

Table 25: Product Profile-Liptruzet (atorvastatin/ezetimibe) 68

Table 26: Liptruzet (atorvastatin/ezetimibe) SWOT Analysis, 2014 70

Table 27: Global Sales Forecasts (USD m) for Liptruzet (atorvastatin/ezetimibe), 2013-2023 71

Table 28: Product Profile-Niaspan (niacin extended-release) 73

Table 29: Niaspan (niacin extended-release) SWOT Analysis, 2014 76

Table 30: Global Sales Forecasts (USD m) for Niaspan (niacin extended-release), 2013-2023 77

Table 31: Product Profile-Kynamro (mipomersen sodium) 79

Table 32: Kynamro-Induced Changes in Lipid Parameters from Akdim et al., 2010 80

Table 33: Kynamro-Induced Changes in Lipid Parameters from Raal et al., 2010 81

Table 34: Kynamro (mipomersen) SWOT Analysis, 2014 82

Table 35: Global Sales Forecasts (USD m) for Kynamro (mipomersen), 2013-2023 83

Table 36: Product Profile-Juxtapid (lomitapide) 85

Table 37: Juxtapid-Induced Dose-Responsive Changes in Lipid Parameters from Cuchel et al., 2007 86

Table 38: Juxtapid-Induced Changes in Lipid Parameters from Cuchel et al., 2013 87

Table 39: Juxtapid (lomitapide) SWOT Analysis, 2014 88

Table 40: Global Sales Forecasts (USD m) for Juxtapid (lomitapide), 2013-2023 89

Table 41: A Summary of the Therapeutic Properties of Fibrates* 90

Table 42: Product Profile-TriCor (fenofibrate) and Trilipix (fenofibric acid) 91

Table 43: TriCor/Trilipix (fenofibrate/fenofibric acid) SWOT Analysis, 2014 93

Table 44: Global Sales Forecasts (USD m) for TriCor/Trilipix (fenofibrate/fenofibric acid), 2013-2023 94

Table 45: Product Profile-Lovaza (omega-3 acid ethyl esters) 96

Table 46: Lovaza (omega-3 acid ethyl esters) SWOT Analysis, 2014 98

Table 47: Global Sales Forecasts (USD m) for Lovaza (omega-3 acid ethyl esters), 2013-2023 99

Table 48: Product Profile-Vascepa (icosapent ethyl) 101

Table 49: Vascepa (icosapent ethyl) SWOT Analysis, 2014 103

Table 50: Global Sales Forecasts (USD m) for Vascepa (icosapent ethyl), 2013-2023 104

Table 51: Product Profile-Epanova (omega-3 carboxylic acids) 105

Table 52: Epanova-Induced Changes in Blood Lipid Parameters from Kastelein et al., 2012 107

Table 53: Epanova-Induced Changes in Blood Lipid Parameters from Maki et al., 2013 107

Table 54: Epanova (omega-3 carboxylic acids) SWOT Analysis, 2014 108

Table 55: Global Sales Forecasts (USD m) for Epanova (omega-3 carboxylic acids), 2013-2023 109

Table 56: Product Profile-Welchol (colesevelam HCl) 111

Table 57: Welchol-Induced Changes in Blood Glucose and Lipid Parameters from Zieve et al., 2007 112

Table 58: Welchol (colesevelam HCl) SWOT Analysis, 2014 113

Table 59: Global Sales Forecasts (USD m) for Welchol (colesevelam HCl), 2013-2023 114

Table 60: Unmet Need and Opportunity in Dyslipidemia 116

Table 61: Comparison of Therapeutic Classes in Development for Dyslipidemia, 2014 132

Table 62: Product Profile-Alirocumab 136

Table 63: Alirocumab SWOT Analysis, 2014 141

Table 64: Global Sales Forecasts (USD m) for Alirocumab, 2013-2023 142

Table 65: Product Profile-Bococizumab 143

Table 66: Bococizumab SWOT Analysis, 2014 146

Table 67: Global Sales Forecasts (USD m) for Bococizumab, 2013-2023 147

Table 68: Product Profile-Evolocumab 149

Table 69: Phase III Clinical Trials of Evolocumab Reported by Amgen from Q4 2013-Q1 2014 151

Table 70: Evolocumab SWOT Analysis, 2014 155

Table 71: Global Sales Forecasts (USD ) for Evolocumab, 2013-2023 156

Table 72: Product Profile-Anacetrapib 158

Table 73: Anacetrapib SWOT Analysis, 2014 162

Table 74: Global Sales Forecasts (USD ) for Anacetrapib, 2013-2023 163

Table 75: Product Profile-Evacetrapib 165

Table 76: Evacetrapib SWOT Analysis, 2014 169

Table 77: Global Sales Forecasts (USD ) for Evacetrapib, 2013-2023 170

Table 78: Product Profile-TA-8995 (DEZ-001) 171

Table 79: Impact of Steady-State TA-8995 on CETP and Lipid Parameters from Ford et al., 2014 172

Table 80: TA-8995 SWOT Analysis, 2014 175

Table 81: Global Sales Forecasts (USD ) for TA-8995, 2013-2023 176

Table 82: Product Profile-CER-001 178

Table 83: CER-001 SWOT Analysis, 2014 181

Table 84: Global Sales Forecasts (USD ) for CER-001, 2013-2023 182

Table 85: Product Profile-ETC-1002 184

Table 86: ETC-1002/Ezetimibe Active Comparator Trial Results 186

Table 87: ETC-1002 SWOT Analysis, 2014 188

Table 88: Global Sales Forecasts (USD ) for ETC-1002, 2013-2023 189

Table 89: Dyslipidemia Drugs in Development, 2014 190

Table 90: Sales Forecasts (USD ) for Dyslipidemia in China, 2013-2023 192

Table 91: Key Events Impacting Sales for Dyslipidemia in China, 2014 195

Table 92: Dyslipidemia Market-China Drivers and Barriers, 2014 195

Table 93: Key Launch Dates 236

Table 94: Key Patent Expiries 236

Table 95: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 248

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