Global Cardiovascular Disease Drugs Market to 2023 – Expiries, Acquisitions and New Products for Deep Vein Thrombosis, Pulmonary Arterial Hypertension and Dyslipidemia to Shake-Up the Competitive Landscape

The cardiovascular disease (CVD) therapy area encompasses a range of different diseases and conditions affecting the heart and/or blood vessels. The most crucial risk factors for CVD are hypertension and dyslipidemia, which accelerate the development of atherosclerotic plaque build up within blood vessels. As atheroma develops it causes the affected blood vessels to narrow, restricting blood flow to the body, brain or heart, depending on its locale.

It is also possible for the fibrous cap of this plaque to break off, triggering the coagulation cascade and causing a thrombus to form locally, which can completely occlude blood flow.

The treatments of CVD typically focus on prevention by controlling risk factors. As such, the treatments usually fall within three categories: Anti-hypertensives, which aim to maintain blood pressure within a normal range; anti-dyslipidemic drugs, which aim to modify lipid levels to a normal range; and anti-thrombotic drugs, which aim to prevent thrombi formation by inhibiting the coagulation cascade or platelet aggregation.

There has been vast scientific innovation in the CVD therapeutics market in recent decades, particularly within the anti-dyslipidemia market. This was seen first with the introduction of statins such as Lipitor (atorvastatin), and more recently with the introduction of protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. However, other areas such as the heart failure market remain poorly treated. Dyslipidemia and hypertension have continuing high levels of development within the current pipeline and, despite high levels of generic development, there is also a large degree of innovation, with targets such as apolipoproteins and elements of the reverse lipid transport pathway. In addition, the current pipeline includes nearly 200 products for the treatment of heart failure, suggesting an increase in interest in treating the disease.

Scope

– With over 1,400 products in active development, the pipeline for CVD is extensive. Does current pipeline innovation hold the potential to change the CVD market in the near future?

– The clinical trials process for CVD drugs is complex. What is the risk of a CVD drug failing to reach the market? What is the risk of a drug failing at a specific Phase?

– The CVD market landscape is forecast to undergo a period of substantial change following key approvals, patent expiries and acquisitions. Which of the leading companies will have the highest market share by 2023? What strategies have these companies adopted to achieve market growth?

– There has been a moderately high level of deal activity in recent years. How do deal frequency and value compare between target families and molecule types?

Reasons to buy

- Understand the current clinical and commercial landscape through a comprehensive analysis of disease symptoms, diagnostic methods, etiology, pathophysiology, comorbidities and complications, epidemiology, prognosis and treatment.

- Recognize the leading therapeutics, as well as gaps in the market, with portfolios of key marketed products, including historical and forecast sales revenue patterns.

- Identify trends and developments, in terms of molecule type and molecular target, within the overall CVD pipeline, as well as for key CVD indications: hypertension, heart failure, dyslipidemia and thrombotic events.

- Consider market opportunities and potential risks by examining trends in clinical trial duration and size, as well as clinical trial failure rates, by stage of development, key indication, molecule type and molecular target.

- Predict how the evolving treatment landscape will drive market growth to 2023 and understand the contributions that different products and companies will make to this growth.

- Understand how strategic consolidations have shaped the current pipeline and marketed products landscape.

Table of Contents

1 Table of Contents

1 Table of Contents 5

1.1 List of Tables 7

1.2 List of Figures 8

2 Introduction 11

2.1 Therapy Area Introduction 11

2.2 Symptoms 12

2.3 Diagnosis 13

2.3.1 Hypertension 13

2.3.2 Dyslipidemia 14

2.3.3 Imaging Tests 15

2.3.4 Stress Testing 15

2.4 Etiology, Pathophysiology, Comorbidities and Complications 16

2.4.1 Hypertension 17

2.4.2 Dyslipidemia 19

2.4.3 Heart Failure 21

2.4.4 Thrombosis 21

2.5 Epidemiology Patterns and Forecasts - Prevalence and Patient Segmentation 23

2.5.1 Hypertension 23

2.5.2 Dyslipidemia 24

2.5.3 Heart failure 25

2.5.4 Thrombotic events 26

2.6 Prognosis 26

2.7 Management and Treatment of Cardiovascular Disease 27

2.7.1 Pharmacological Intervention 27

2.7.2 Non-pharmacological Intervention 35

2.7.3 Unmet Need 35

3 Key Marketed Products 37

3.1 Overview 37

3.2 Lipitor (atorvastatin) - Pfizer 38

3.3 Crestor (rosuvastatin) - AstraZeneca 39

3.4 Zetia (ezetimibe) - Merck & Co. 40

3.5 Praluent (alirocumab) - Sanofi 42

3.6 Repatha (evolocumab) - Amgen 43

3.7 Plavix (clopidogrel) - Sanofi 44

3.8 Xarelto (rivaroxaban) - Bayer 45

3.9 Eliquis (apixaban) - Bristol Myers Squibb and Pfizer 47

3.10 Brilinta (ticagrelor) - AstraZeneca 48

3.11 Entresto (valsartan plus sacubitril) - Novartis 50

3.12 Benicar (olmesartan medoxomil) - Daiichi Sankyo 51

3.13 Bevyxxa (betrixaban) - Portola 52

3.14 Uptravi (selexipag) - Johnson & Johnson 53

3.15 Opsumit (macitentan) - Johnson & Johnson 55

3.16 Conclusion 56

4 Pipeline Landscape Assessment 59

4.1 Overview 59

4.2 Pipeline Development Landscape 60

4.3 Molecular Targets in the Pipeline 63

4.4 Clinical Trials 67

4.4.1 Failure Rate by Stage of Development, Indication, Molecule Type and Molecular Target 68

4.4.2 Clinical Trial Duration by Stage of Development, Indication, Molecule Type and Molecular Target 72

4.4.3 Clinical Trial Size by Stage of Development, Indication, Molecule Type and Molecular Target 76

4.4.4 Aggregate Clinical Program Size by Stage of Development, Indication, Molecule Type and Molecular Target 80

4.4.5 Assessment of Key Pipeline Products 84

4.5 Conclusion 93

5 Multi-Scenario Market Forecast to 2023 95

5.1 Overall Market Size 95

5.2 Generic Penetration 99

5.3 Revenue Forecast by Molecular Target 102

5.3.1 Coagulation Cascade 103

5.3.2 Renin angiotensin system 104

5.3.3 P2Y12 Receptors 105

5.3.4 HMG-CoA Reductase Inhibitors (statins) 106

5.3.5 PCSK9 Inhibitors 107

5.3.6 Beta 1 Adrenergic Receptors 108

5.3.7 Prostaglandin Receptors 109

5.3.8 Endothelin Receptors 110

6 Company Analysis and Positioning 111

6.1 Revenue and Market Share Analysis by Company 113

6.2 Company Landscape 125

6.3 Marketed and Pipeline Portfolio Analysis 125

7 Strategic Consolidations 128

7.1 Licensing Deals 128

7.1.1 Deals by Region, Value and Year 128

7.1.2 Deals by Indication 130

7.1.3 Deals by Stage of Development and Value 131

7.1.4 Deals by Molecule Type, Molecular Target and Value 132

7.1.5 List of Deals with Disclosed Deal Values 133

7.2 Co-development Deals 134

7.2.1 Deals by Region, Year and Value 134

7.2.2 Deals by Indication 136

7.2.3 Deals by Stage of Development and Value 137

7.2.4 Deals by Molecule Type, Molecular Target and Value 138

7.2.5 List of Deals with Disclosed Deal Values 139

8 Appendix 140

8.1 References 140

8.2 Tables of All Pipeline Products 146

8.3 Abbreviations 224

8.4 Disease List 225

8.4.1 Hypertension 225

8.4.2 Dyslipidemia 225

8.4.3 Heart failure 225

8.4.4 Thrombotic events 225

8.4.5 Other 225

8.5 Methodology 226

8.5.1 Coverage 226

8.5.2 Secondary Research 226

8.5.3 Market Size and Revenue Forecasts 227

8.5.4 Pipeline Analysis 227

8.5.5 Competitive Landscape 227

8.6 Contact Us 228

8.7 Disclaimer 228

List of Tables

1.1 List of Tables

Table 1: Cardiovascular Disease Drugs Market, US, Systolic and Diastolic Blood Pressure Level and Corresponding Category, 2017 13

Table 2: Cardiovascular Disease Drugs Market, Global, Total Cholesterol, LDL and HDL Levels and Corresponding Category, 2017 14

Table 3: Cardiovascular Disease Drugs Market, Global, Approved Indications for Lipitor, 2017 38

Table 4: Cardiovascular Disease Drugs Market, Global, Approved Indications for Crestor, 2017 39

Table 5: Cardiovascular Disease Drugs Market, Global, Approved Indications for Zetia, 2017 41

Table 6: Cardiovascular Disease Drugs Market, Global, Approved Indications for Praluent, 2017 42

Table 7: Cardiovascular Disease Drugs Market, Global, Approved Indications for Repatha, 2017 43

Table 8: Cardiovascular Disease Drugs Market, Global, Approved Indications for Plavix, 2017 44

Table 9: Cardiovascular Disease Drugs Market, Global, Approved Indications for Xarelto, 2017 46

Table 10: Cardiovascular Disease Drugs Market, Global, Approved Indications for Eliquis, 2017 47

Table 11: Cardiovascular Disease Drugs Market, Global, Approved Indications for Brilinta, 2017 49

Table 12: Cardiovascular Disease Drugs Market, Global, Approved Indications for Entresto, 2017 50

Table 13: Cardiovascular Disease Drugs Market, Global, Approved Indications for Benicar, 2017 51

Table 14: Cardiovascular Disease Drugs Market, Global, Approved Indications for Bevyxxa, 2017 52

Table 15: Cardiovascular Disease Drugs Market, Global, Approved Indications for Uptravi, 2017 54

Table 16: Cardiovascular Disease Drugs Market, Global, Approved Indications for Opsumit, 2017 55

Table 17: Cardiovascular Disease Drugs Market, Global, Clinical Evidence for Inclisiran, 2017 84

Table 18: Cardiovascular Disease Drugs Market, Global, Clinical Evidence for MEDI-6012, 2017 86

Table 19: Cardiovascular Disease Drugs Market, Global, Clinical Evidence for Volanesorsen Sodium, 2017 88

Table 20: Cardiovascular Disease Drugs Market, Global, Clinical Evidence for Vericiguat, 2017 90

Table 21: Cardiovascular Disease Drugs Market, Global, Clinical Evidence for Bempedoic Acid, 2017 92

Table 22: Cardiovascular Disease Drugs Market, Global, Annual Revenue Forecast for Key Products ($m), 2016-2023 (part 1) 96

Table 23: Cardiovascular Disease Drugs Market, Global, Annual Revenue Forecast for Key Products ($m), 2016-2023 (part 2) 97

Table 24: Cardiovascular Disease Drugs Market, Global, Usage of Generics Across Key Indications, 2017 101

Table 25: Cardiovascular Disease Drugs Market, Global, Forecast Revenues by Company, 2016-2023 113

Table 26: Cardiovascular Disease Therapeutics Market, Global, Pipeline Products, Discovery, 2017 146

Table 27: Cardiovascular Disease Therapeutics Market, Global, Pipeline Products, Preclinical, 2017 157

Table 28: Cardiovascular Disease Therapeutics Market, Global, Pipeline Products, IND/CTA-filed, 2017 200

Table 29: Cardiovascular Disease Therapeutics Market, Global, Pipeline Products, Phase I, 2017 201

Table 30: Cardiovascular Disease Therapeutics Market, Global, Pipeline Products, Phase II, 2017 206

Table 31: Cardiovascular Disease Therapeutics Market, Global, Pipeline Products, Phase III, 2017 214

Table 32: Cardiovascular Disease Therapeutics Market, Global, Pipeline Products, Pre-registration, 2017 221

Table 33: Cardiovascular Disease Therapeutics Market, Global, Pipeline Products, Unknown, 2017 223

Table 34: Abbreviations 224

List of Figures

1.2 List of Figures

Figure 1: Cardiovascular Disease Drugs Market, Global, Epidemiology Patterns for Hypertension, 2016-2023 24

Figure 2: Cardiovascular Disease Drugs Market, Global, Epidemiology Patterns for Dyslipidemia, 2016-2023 25

Figure 3: Cardiovascular Disease Drugs Market, Global, Epidemiology Patterns for Heart Failure, 2016-2023 26

Figure 4: Cardiovascular Disease Drugs Market, Global, Key Marketed Products and Approved Indications, 2017 37

Figure 5: Cardiovascular Disease Drugs Market, Global, Annual Revenue for Lipitor ($bn), 2006-2023 39

Figure 6: Cardiovascular Disease Drugs Market, Global, Annual Revenue for Crestor ($bn), 2006-2023 40

Figure 7: Cardiovascular Disease Drugs Market, Global, Annual Revenue for Zetia ($bn), 2006-2023 41

Figure 8: Cardiovascular Disease Drugs Market, Global, Annual Revenue for Praluent ($bn), 2015-2023 43

Figure 9: Cardiovascular Disease Drugs Market, Global, Annual Revenue for Repatha ($bn), 2016-2023 44

Figure 10: Cardiovascular Disease Drugs Market, Global, Annual Revenue for Plavix ($bn), 2006-2023 45

Figure 11: Cardiovascular Disease Drugs Market, Global, Annual Revenue for Xarelto ($bn), 2011-2023 47

Figure 12: Cardiovascular Disease Drugs Market, Global, Annual Revenue for Eliquis ($bn), 2012-2023 48

Figure 13: Cardiovascular Disease Drugs Market, Global, Annual Revenue for Brilinta ($bn), 2011-2023 49

Figure 14: Cardiovascular Disease Drugs Market, Global, Annual Revenue for Entresto ($bn), 2015-2023 51

Figure 15: Cardiovascular Disease Drugs Market, Global, Annual Revenue for Benicar ($bn), 2006-2023 52

Figure 16: Cardiovascular Disease Drugs Market, Global, Annual Revenue for Bevyxxa ($m), 2017-2023 53

Figure 17: Cardiovascular Disease Drugs Market, Global, Annual Revenue for Uptravi ($bn), 2016-2023 54

Figure 18: Cardiovascular Disease Drugs Market, Global, Annual Revenue for Opsumit ($bn), 2013-2023 56

Figure 19: Cardiovascular Disease Drugs Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2017 59

Figure 20: Cardiovascular Disease Drugs Market, Global, Pipeline by Stage of Development and Molecule Type, 2017 60

Figure 21: Cardiovascular Disease Drugs Market, Global, Pipeline for Key Cardiovascular Disease Indications by Stage of Development, 2017 62

Figure 22: Cardiovascular Disease Drugs Market, Global, Pipeline for Key Cardiovascular Disease Indications by Molecule Type, 2017 63

Figure 23: Cardiovascular Disease Drugs Market, Global, Pipeline by Molecular Target and Stage of Development, 2017 65

Figure 24: Cardiovascular Disease Drugs Market, Global, Pipeline by Molecular Target Breakdown, 2017 66

Figure 25: Cardiovascular Drugs Market, Global, Pipeline for Key Cardiovascular Disease Indications by Molecular Target, 2017 67

Figure 26: Cardiovascular Disease Drugs Market, Global, Clinical Program Attrition Rates by Stage of Development (%), 2006-2017 68

Figure 27: Cardiovascular Disease Drugs Market, Global, Clinical Trial Failure Rates (Phases I-III) and Overall Clinical Trial Attrition Rates by Indication (%), 2006-2017 69

Figure 28: Cardiovascular Disease Drugs Market, Global, Clinical Trial Failure Rates (Phases I-III) and Overall Clinical Trial Attrition Rates by Molecule Type (%), 2006-2017 70

Figure 29: Cardiovascular Disease Drugs Market, Global, Clinical Trial Failure Rates (Phases I-III) and Overall Clinical Trial Attrition Rates by Molecular Target (%), 2006-2017 71

Figure 30: Cardiovascular Disease Drugs Market, Global, Clinical Trial Duration by Stage of Development (months), 2006-2017 72

Figure 31: Cardiovascular Disease Drugs Market, Global, Clinical Trial Duration by Stage of Development and Indication (months), 2006-2017 73

Figure 32: Cardiovascular Disease Drugs, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2017 74

Figure 33: Cardiovascular Disease Drugs Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2017 75

Figure 34: Cardiovascular Disease Drugs Market, Global, Clinical Trial Size by Stage of Development (participants), 2006-2017 76

Figure 35: Cardiovascular Disease Drugs Market, Global, Clinical Trial Size by Stage of Development and Indication (participants), 2006-2017 77

Figure 36: Cardiovascular Disease Drugs Market, Global, Clinical Trial Size by Stage of Development and Molecule Type (participants), 2006-2017 78

Figure 37: Cardiovascular Disease Drugs Market, Global, Clinical Trial Size by Stage of Development and Molecular Target (participants), 2006-2017 79

Figure 38: Cardiovascular Disease Drugs Market, Global, Aggregate Clinical Program Size by Stage of Development (participants), 2006-2017 80

Figure 39: Cardiovascular Disease Drugs Market, Global, Aggregate Clinical Program Size by Stage of Development and Indication (participants), 2006-2017 81

Figure 40: Cardiovascular Disease Drugs Market, Global, Aggregate Clinical Program Size by Stage of Development and Molecule Type (participants), 2006-2017 82

Figure 41: Cardiovascular Disease Drugs Market, Global, Aggregate Clinical Program Size by Stage of Development and Molecular Target (participants), 2006-2017 83

Figure 42: Cardiovascular Disease Drugs Market, Global, Revenue Forecast for Inclisiran ($bn), 2020-2023 85

Figure 43: Cardiovascular Disease Drugs Market, Global, Revenue Forecast for MEDI-6012 ($m), 2020-2023 86

Figure 44: Cardiovascular Disease Drugs Market, Global, Revenue Forecast for Volanesorsen ($m), 2018-2023 89

Figure 45: Cardiovascular Disease Drugs Market, Global, Revenue Forecast for Vericiguat ($m), 2019-2023 91

Figure 46: Cardiovascular Disease Drugs Market, Global, Revenue Forecast for Bempedoic acid ($m), 2019-2023 93

Figure 47: Cardiovascular Disease Drugs Market, Global, Market Size ($bn), 2016-2023 95

Figure 48: Cardiovascular Disease Drugs Market, Global, Key Products Market Share, 2016-2023 99

Figure 49: Cardiovascular Drugs Market, Global, Annual Revenue by Premium and Generic Products ($bn), 2016-2023 100

Figure 50: Cardiovascular Disease Drugs Market, Global, Annual Revenue Forecast for Drugs Targeting Elements of the Coagulation Cascade ($bn), 2016-2023 103

Figure 51: Cardiovascular Disease Drugs Market, Global, Annual Revenue Forecast for Drugs Acting on RAS ($bn), 2016-2023 104

Figure 52: Cardiovascular Disease Drugs Market, Global, Annual Revenue Forecast for P2Y12 Inhibitors ($bn), 2016-2023 105

Figure 53: Cardiovascular Disease Drugs Market, Global, Annual Revenue Forecast for HMG-CoA Inhibitors ($bn), 2016-2023 106

Figure 54: Cardiovascular Disease Drugs Market, Global, Annual Revenue Forecast for PCSK9 Inhibitors ($bn), 2016-2023 107

Figure 55: Cardiovascular Disease Drugs Market, Global, Annual Revenue Forecast for Beta Blockers ($bn), 2016-2023 108

Figure 56: Cardiovascular Disease Drugs Market, Global, Annual Revenue Forecast for Drugs Acting on Prostaglandin Receptors ($bn), 2016-2023 109

Figure 57: Cardiovascular Disease Drugs Market, Global, Annual Revenue Forecast for Drugs Acting on Endothelin Receptors ($bn), 2016-2023 110

Figure 58: Cardiovascular Disease Drugs Market, Global, Cluster by Growth and Market Share, 2016-2023 111

Figure 59: Cardiovascular Disease Drugs Market, Global, Company Analysis Matrix, 2017 112

Figure 60: Cardiovascular Disease Drugs Market, Global, Forecast Market Share by Company (%), 2016-2023 115

Figure 61: Cardiovascular Diseasse Drugs Market, Global, Companies by Compound Annual Growth Rate (%), 2016-2023 116

Figure 62: Cardiovascular Disease Drugs Market, Global, Sanofi Annual Revenue Forecast, 2016-2023 117

Figure 63: Cardiovascular Disease Drugs Market, Global, AstraZeneca Annual Revenue Forecast, 2016-2023 118

Figure 64: Cardiovascular Disease Drugs Market, Global, Novartis Annual Revenue Forecast, 2016-2023 119

Figure 65: Cardiovascular Disease Drugs Market, Global, Bayer Annual Revenue Forecast, 2016-2023 120

Figure 66: Cardiovascular Disease Drugs Market, Global, Pfizer Annual Revenue Forecast, 2016-2023 121

Figure 67: Cardiovascular Disease Drugs Market, Global, Johnson and Johnson, Annual Revenue Forecast, 2016-2023 122

Figure 68: Cardiovascular Disease Drugs Market, Global, Bristol-Myers Squibb, Annual Revenue Forecast, 2016-2023 123

Figure 69: Cardiovascular Disease Drugs Market, Global, Merck & Co, Annual Revenue Forecast, 2016-2023 124

Figure 70: Cardiovascular Disease Drugs Market, Global, High-Activity and Late-Stage Pipeline Developers by Type, 2017 125

Figure 71: Cardiovascular Disease Drugs Market, Global, Pipeline, Overall, High-Activity and Late-Stage Developers by Level of Cardiovascular Specialization, 2017 126

Figure 72: Cardiovascular Disease Drugs Market, Global, Proportion of Total Company Revenue Attributed to Cardiovascular Disease, 2016-2023 127

Figure 73: Cardiovascular Disease Drugs, Global, Licensing Deals by Region, Value and Year, 200`6-2017 129

Figure 74: Cardiovascular Disease Drugs Market, Global, Licensing Deals by Indication, 2006-2017 130

Figure 75: Cardiovascular Disease Drugs, Global, Licensing Deals by Deal Value, Upfront Payment Value and Stage of Development, 2006-2017 131

Figure 76: Cardiovascular Disease Drugs Market, Global, Number and Aggregate Deal Value of Licensing Deals by Molecule Type and Molecular Target, 2006-2017 132

Figure 77: Cardiovascular Disease Drugs Market, Global, Licensing Deals with Disclosed Deal Values, 2006-2017 133

Figure 78: Cardiovascular Disease Drugs, Global, Co-development Deals by Region, Value and Year, 2006-2017 135

Figure 79: Cardiovascular Drugs Market, Global, Co-development Deals by Indication, 2006-2017 136

Figure 80: Cardiovascular Disease Drugs Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2017 137

Figure 81: Cardiovascular Disease Drugs Market, Global, Number and Aggregate Deal Value of Co-development Deals by Molecule Type and Molecular Target, 2006-2017 138

Figure 82: Cardiovascular Disease Drugs Market, Global, Co-development Deals with Disclosed Deal Values, 2006-2017 139

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