MediPoint: Diagnostic Cardiac Biomarkers for Acute Coronary Syndromes - EU Analysis and Market Forecasts

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MediPoint: Diagnostic Cardiac Biomarkers for Acute Coronary Syndromes - EU Analysis and Market Forecasts

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MediPoint: Diagnostic Cardiac Biomarkers for Acute Coronary Syndromes - EU Analysis and Market Forecasts

Summary

In Europe, the ACS in vitro diagnostics market is dominated by a single biomarker test, cardiac troponins. However, this market remains of high interest due to advancements in assay sensitivity both on laboratory and point-of-care platforms. GlobalData expects these advancements to have an impact on other diagnostic tests such as creatine kinase-MB isoenzyme and myoglobin. Furthermore, the emergence of pipeline biomarker tests will change the landscape of ACS in vitro diagnostic testing and is expected to provide enhancements in the early diagnosis of the disease.

Acute coronary syndrome (ACS) consists of two major diseases, myocardial infarction (MI) and unstable angina, with the former being one of the major killers in the mature markets. Though the incidence of ACS is either in decline or steady across the US and European countries, millions of ACS and suspected ACS patients still visit emergency rooms every year with symptoms such as chest pain, and these patients are typically assessed with in vitro diagnostic cardiac biomarker tests. The ACS diagnostic cardiac biomarker reagents market is dominated by the cardiac troponins, the gold-standard biomarkers for the diagnosis of MI.

Scope

- An overview of ACS, which includes epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines.

- Annualized EU ACS in vitro diagnostic testing reagents market revenue and future forecasts from 2009 to 2011, forecast for 7 years to 2018.

- Investigation of current and future market competition for diagnostic cardiac biomarkers for ACS

- Insightful review of the key industry drivers, restraints and challenges as well as predicted impact of key events.

- Competitor assessment including device approval analysis and device sales forecasts.

- Marketed and pipeline product profiles covering efficiency, safety, clinical study details, device approvals, product positioning and device sales forecast.

- Analysis of unmet needs within the market and opportunities for future players.

- Technology trends evaluation to assess strength of pipeline.

- An overview of all devices in development including clinical study details, design and material selection considerations, efficacy reports, and device approval timelines.

- Company profiles including business description, financial overview and SWOT analysis.

- Coverage of key market players.

- Strategic assessment of the diagnostic cardiac biomarkers for ACS sector through market impact analysis, future market scenario and company analysis.

- Direct quotes from Key Opinion Leaders (KOL) as well as cardiologists

Reasons to buy

- Understand the trends shaping and driving EU diagnostic cardiac biomarkers for ACS.

- Realize device preferences of physicians who have performed the tests already.

- Access market sizing, forecasts and quantified growth opportunities in EU diagnostic cardiac biomarkers for ACS Market through 2018.

- Quantify candidate patient populations to better design product pricing & launch plans.

- Drive revenues, formulate effective sales and marketing strategies and gain in-depth understanding of the competitive landscape.

- Perform benchmarking analysis of growth opportunities against currently marketed products.

- Assess competitiveness of products in market by understanding the strengths and weaknesses of current competition.

- Take a comprehensive look at the market's device pipeline and identify promising, paradigm-shifting products.

- Create an effective counter-strategy to gain a competitive advantage against those currently in the market.

- Organize your sales and marketing efforts by identifying the market categories and segments that present the best opportunities for growth.

- What's the next big thing in EU diagnostic cardiac biomarkers for ACS market landscape? Identify, understand and capitalize.

1 Table of Contents

1 Table of Contents 6

1.1 List of Tables 12

1.2 List of Figures 14

2 Introduction 16

2.1 Catalyst 16

3 Disease Overview 17

3.1 Acute Coronary Syndromes 17

3.2 Anatomy and Physiology 18

3.3 Pathophysiology 19

3.4 Clinical Presentation 20

3.4.1 Symptoms 20

3.4.2 Diagnosis 20

3.5 Clinical Outcomes 25

3.5.1 Treatment Options 25

3.5.2 Treatment Paradigm 28

3.6 Epidemiology 29

3.7 Economic Impact 30

4 Competitive Assessment 32

4.1 Overview 32

4.2 Cardiac Troponins 33

4.2.1 Overview 33

4.2.2 Clinical Application and Utility 34

4.2.3 Market Penetration 38

4.2.4 SWOT Analysis 39

4.3 Creatine Kinase-MB 39

4.3.1 Overview 39

4.3.2 Clinical Application and Utility 40

4.3.3 Market Penetration 42

4.3.4 SWOT Analysis 42

4.4 Myoglobin 42

4.4.1 Overview 42

4.4.2 Clinical Application and Utility 43

4.4.3 Market Penetration 45

4.4.4 SWOT Analysis 45

4.5 Point-of-Care 45

4.5.1 Overview 45

4.5.2 Clinical Application and Utility 47

4.5.3 Market Penetration 50

4.5.4 SWOT Analysis 51

5 Unmet Needs 52

5.1 Overview 52

5.2 Earlier Diagnosis 53

5.3 Specificity and False Positives 55

5.4 Interpretation of Biochemical Assay Results 56

5.5 Markers for Myocardial Ischemia 58

6 Pipeline Products 59

6.1 Overview 59

6.2 BAG3 (Biouniversia) 60

6.2.1 Overview 60

6.2.2 SWOT Analysis 60

6.3 CAVARISK (Cavadis) 60

6.3.1 Overview 60

6.3.2 SWOT Analysis 60

6.4 CardioScore (BG Medicine) 61

6.4.1 Overview 61

6.4.2 SWOT Analysis 61

6.5 Circulating Endothelial Cells 62

6.5.1 Overview 62

6.5.2 SWOT Analysis 63

6.6 Copeptin (Thermo Scientific) 63

6.6.1 Overview 63

6.6.2 SWOT Analysis 66

6.7 Heart-Type Fatty Acid Binding Protein 66

6.7.1 Overview 66

6.7.2 SWOT Analysis 68

6.8 MIRISK VP Assessment (Aviir) 69

6.8.1 Overview 69

6.8.2 SWOT Analysis 69

6.9 Early Emerging Tests 70

6.9.1 Heart Diagnostic Assay (Prevencio/University of Pittsburgh) 70

6.9.2 Sentinel CVD (GeneNews) 70

6.9.3 SomaScan Cardiovascular Assay (SomaLogic) 70

7 Industry Overview 71

7.1 ACS Diagnostic Biomarker Testing Trends 71

7.2 Market Access 73

7.3 Reimbursement Trends 76

7.4 Regulatory Environment 78

7.4.1 Approval of New Tests 78

7.4.2 Product Recalls 79

8 Current and Future Players 81

8.1 Overview 81

8.2 Trends in Corporate Strategy 81

8.3 Abbott Diagnostics 82

8.3.1 Overview 82

8.3.2 Portfolio Assessment 82

8.4 Alere 84

8.4.1 Overview 84

8.4.2 Portfolio Assessment 85

8.5 Beckman Coulter 86

8.5.1 Overview 86

8.5.2 Portfolio Assessment 87

8.6 bioMérieux 88

8.6.1 Overview 88

8.6.2 Portfolio Assessment 89

8.7 Mitsubishi Chemical Medience Corporation 90

8.7.1 Overview 90

8.7.2 Portfolio Assessment 91

8.8 Ortho-Clinical Diagnostics 92

8.8.1 Overview 92

8.8.2 Portfolio Assessment 93

8.9 Radiometer Medical 94

8.9.1 Overview 94

8.9.2 Portfolio Assessment 95

8.10 Randox Laboratories 96

8.10.1 Overview 96

8.10.2 Portfolio Assessment 97

8.11 Response Biomedical 98

8.11.1 Overview 98

8.11.2 Portfolio Assessment 99

8.12 Roche Diagnostics 100

8.12.1 Overview 100

8.12.2 Portfolio Assessment 101

8.13 Siemens Healthcare 102

8.13.1 Overview 102

8.13.2 Portfolio Assessment 103

8.14 Thermo Scientific 104

8.14.1 Overview 104

8.14.2 Portfolio Assessment 105

9 Market Drivers and Opportunities and Barriers 106

9.1 Market Drivers 106

9.1.1 Uptake of Pipeline Biomarker Tests 106

9.1.2 Increasing Adoption of POC Testing 107

9.2 Market Opportunities 108

9.2.1 High-Sensitivity Troponin Assays 108

9.2.2 Enhancement in Sensitivity of Troponin POC Assays 110

9.2.3 New Pipeline Tests for Early Diagnosis of ACS 110

9.3 Market Barriers 111

9.3.1 Saturation of Troponin Testing in the European Markets 111

9.3.2 Removal of CK-MB and Myoglobin from Testing Panels 111

9.3.3 Reimbursement 111

10 Country Outlooks and Forecasts 112

10.1 European Markets Overview 112

10.2 France 114

10.3 Germany 117

10.4 Italy 118

10.5 Spain 119

10.6 UK 122

11 Appendix 125

11.1 Bibliography 125

11.2 Abbreviations 137

11.3 Research Methodology 139

11.3.1 Overview 139

11.3.2 Coverage 139

11.3.3 Secondary Research 139

11.3.4 Forecast Methodology 140

11.4 Primary Research 141

11.5 Physicians and Specialists Included in this Study 142

11.6 About the Authors 143

11.6.1 Analysts 143

11.6.2 Global Head of Healthcare 144

11.7 About MediPoint 144

11.8 About GlobalData 144

11.9 Contact Us 145

11.10 Disclaimer 145

List of Tables

Table 1: Risk Factors Associated with ACS 21

Table 2: Properties of Common ACS and MI Diagnostic Biomarkers 24

Table 3: Diagnosis and Risk Stratification of ACS 24

Table 4: Common PCI Periprocedural Antithrombotic Drugs 25

Table 5: Common Drugs for Fibrinolysis 26

Table 6: Common Drugs for the Treatment of NSTEMI and UA 27

Table 7: Description of Direct and Indirect Economic Costs 30

Table 8: Economic Impact ($bn) of CAD in Europe, 2009 to 2018 30

Table 9: Product Profile – Cardiac Troponins 34

Table 10: Cardiac Troponin Concentrations of Selected Current Troponin Assays 35

Table 11: Cardiac Troponin Concentrations of Selected High-Sensitivity Troponin Assays 36

Table 12: Cardiac Troponins SWOT Analysis 39

Table 13: Product Profile – Creatine Kinase-MB 40

Table 14: Creatine Kinase-MB SWOT Analysis 42

Table 15: Product Profile – Myoglobin 43

Table 16: Myoglobin SWOT Analysis 45

Table 17: Product Profile – Point-of-Care Testing 46

Table 18: Cardiac Troponin Concentrations of POC Troponin Assays 48

Table 19: Point-of-Care Cardiac Panel SWOT Analysis 51

Table 20: ACS Cardiac Biomarker Product Pipeline 59

Table 21: BAG3 SWOT Analysis 60

Table 22: CAVARISK SWOT Analysis 60

Table 23: CardioScore SWOT Analysis 61

Table 24: Circulating Endothelial Cells SWOT Analysis 63

Table 25: Copeptin SWOT Analysis 66

Table 26: Heart-Type Fatty Acid Binding Protein SWOT Analysis 68

Table 27: MIRISK VP SWOT Analysis 69

Table 28: Company Profile – Abbott Diagnostics 82

Table 29: Abbott Diagnostics SWOT Analysis, 2013 83

Table 30: Company Profile – Alere 84

Table 31: Alere SWOT Analysis, 2013 85

Table 32: Company Profile – Beckman Coulter 86

Table 33: Beckman Coulter SWOT Analysis, 2013 87

Table 34: Company Profile – bioMérieux 88

Table 35: bioMérieux SWOT Analysis, 2013 89

Table 36: Company Profile – Mitsubishi Chemical Medience Corporation 90

Table 37: Mitsubishi Chemical Medience Corporation SWOT Analysis, 2013 91

Table 38: Company Profile – Ortho-Clinical Diagnostics 92

Table 39: Ortho-Clinical Diagnostics SWOT Analysis, 2013 93

Table 40: Company Profile – Radiometer Medical 94

Table 41: Radiometer Medical SWOT Analysis, 2013 95

Table 42: Company Profile – Randox Laboratories 96

Table 43: Randox Laboratories SWOT Analysis, 2013 97

Table 44: Company Profile – Response Biomedical 98

Table 45: Response Biomedical SWOT Analysis, 2013 99

Table 46: Company Profile – Roche Diagnostics 100

Table 47: Roche Diagnostics SWOT Analysis, 2013 102

Table 48: Company Profile – Siemens Healthcare 103

Table 49: Siemens Healthcare SWOT Analysis, 2013 103

Table 50: Company Profile – Thermo Scientific 104

Table 51: Thermo Scientific SWOT Analysis, 2013 105

Table 52: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in the European Markets, ($m), 2009–2018 112

Table 53: Major Events Affecting the European ACS In Vitro Diagnostics Market 113

Table 54: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in France, ($m), 2009–2018 114

Table 55: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in Germany, ($m), 2009–2018 117

Table 56: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in Italy, ($m), 2009–2018 118

Table 57: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in Spain, ($m), 2009–2018 119

Table 58: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in the UK, ($m) 2009–2018 122

List of Figures

Figure 1: Anatomy of the Human Heart 18

Figure 2: Heart Muscle Damage, Atherosclerosis and Thrombosis 19

Figure 3: Strategy for Evaluating ACS 21

Figure 4: Treatment and Management of ACS 28

Figure 5: Annual Number of ACS Cases Across Europe, 2009?2018 29

Figure 6: Direct and Indirect Costs ($bn) of CAD in Europe, 2011 to 2018 31

Figure 7: Europe Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents, 2012 32

Figure 8: Estimated European ACS Diagnostic Biomarker Testing Volumes, 2009 to 2018 72

Figure 9: European Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009–2018 112

Figure 10: European Market Share for ACS In Vitro Diagnostic Testing Reagents, 2012 and 2018 113

Figure 11: France Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009–2018 114

Figure 12: France Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents, 2012 and 2018 116

Figure 13: Germany Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009–2018 117

Figure 14: Italy Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009–2018 118

Figure 15: Spain Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009–2018 119

Figure 16: Spain Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents, 2012 and 2018 121

Figure 17: UK Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m) 2009–2018 122

Figure 18: UK Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents, 2012 and 2018 124

Companies mentioned

Abbott Diagnostics

Alere

Beckman Coulter

bioMérieux

Mitsubishi Chemical Medience Corporation

Ortho-Clinical Diagnostics

Radiometer Medical

Randox Laboratories

Response Biomedical

Roche Diagnostics

Siemens Healthcare

Thermo Scientific

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In_Vitro_Diagnostic Industry: MediPoint: Diagnostic Cardiac Biomarkers for Acute Coronary Syndromes - EU Analysis and Market Forecasts

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