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

Summary

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. In the US and Europe, the troponin market has reached saturation, therefore growth for these tests will be driven by increased uptake in the emerging markets of Brazil, China, and India. Uptake of two pipeline biomarker tests, Thermo Scientific’s copeptin, and heart-type fatty acid binding protein (H-FABP), will arrest the decline in the mature markets, and will drive the growth of the overall market. Though premium-priced point-of-care (POC) tests will be increasingly adopted as POC troponin tests become more sensitive, the overall market will remain dominated by laboratory-based tests at the end of the study period.

Highlights

Key Questions Answered

- The number of cases of ACS are in decline or steady in the mature markets of the US and 5EU. However, the number of cases in the emerging markets is increasing. (Q). What impact is this likely to have on the ACS diagnostic cardiac biomarker testing reagents markets in these countries? (Q). What are the true drivers for volumes of these tests?(Q). How do the major markets differ in their diagnostic testing protocols?
- The cardiac troponins are the most utilized cardiac biomarker tests for ACS, and manufacturers are continuing to develop improved sensitivity assays. (Q). What is the uptake of other biomarker tests, such as creatine kinase-MB (CK-MB) and myoglobin, across the major markets? (Q). How will troponin, CK-MB, and myoglobin tests fare once the pipeline biomarkers copeptin and H-FABP gain uptake? (Q). What are the opinions of interviewed experts regarding the next-generation of high-sensitivity troponin assays?
- POC testing is a small component of the overall ACS in vitro diagnostic market. However, manufacturers are continuing to develop more sensitive POC troponin tests. (Q). What are the opinions of interviewed experts regarding POC testing? (Q). What do they perceive as the advantages of this approach? (Q). What are the growth opportunities for POC testing in this market?
- The ACS diagnostic cardiac biomarkers market is served by several major players. Many of these manufacturers develop both laboratory and POC testing platforms and reagents. (Q). Who are the current and future players in this market?(Q). What determines the choice of brand for a laboratory? (Q). What are the key attributes key opinion leaders are looking for?

Key Findings

- The ACS Diagnostic Cardiac Biomarker market is dominated by cardiac troponin laboratory testing, however, opportunities still remain for manufacturers of both novel pipeline biomarkers and POC tests
- The number of cases of ACS are increasing in the emerging markets of Brazil, China, and India. GlobalData expects these markets to grow due to increasing uptake of troponin and emerging biomarker testing
- New market entrants will increase competitiveness in the areas of test reliability and specificity and will provide clinicians with more options for the early diagnosis of ACS

Scope

- Overview of ACS and ACS diagnostic cardiac biomarker testing, including epidemiology, etiology, diagnosis, pathology, treatment guidelines, and evolving regulatory structures
- Annualized ACS in vitro diagnostic testing reagents market revenue, annual cost of ACS cardiac biomarker testing and testing volume data from 2009-2012 and forecast for six years to 2018
- Key topics covered include strategic competitor assessment, market characterization, identification of unmet needs, reimbursement considerations, and implications for the ACS diagnostic cardiac biomarker testing market
- Pipeline analysis: Emerging ACS cardiac biomarker tests, both diagnostic tests and risk predication tests, emerging biomarkers, and in depth key opinion leader insight
- Analysis of the current and future market competition in the global ACS diagnostic cardiac biomarker testing reagents market. Insightful review of the key industry drivers, opportunities, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications

Reasons to buy

- “What Physicians Think” quotes provide a unique insight into how healthcare professionals are reacting to events within the industry, and what their responses could mean for industry strategists. This information is essential for all strategic decision makers in every organization allowing them to act on high quality information.

Table Of Contents

Table of Contents

1 Table of Contents 6
1.1 List of Tables 12
1.2 List of Figures 15
2 Introduction 17
2.1 Catalyst 17
2.2 Related Reports 18
2.3 Upcoming Related Reports 18
3 Disease Overview 19
3.1 Acute Coronary Syndromes 19
3.2 Anatomy and Physiology 20
3.3 Pathophysiology 21
3.4 Clinical Presentation 22
3.4.1 Symptoms 22
3.4.2 Diagnosis 22
3.5 Clinical Outcomes 27
3.5.1 Treatment Options 27
3.5.2 Treatment Paradigm 30
3.6 Epidemiology 31
3.7 Economic Impact 32
4 Competitive Assessment 35
4.1 Overview 35
4.2 Cardiac Troponins 36
4.2.1 Overview 36
4.2.2 Clinical Application and Utility 37
4.2.3 Market Penetration 42
4.2.4 SWOT Analysis 43
4.3 Creatine Kinase-MB 43
4.3.1 Overview 43
4.3.2 Clinical Application and Utility 44
4.3.3 Market Penetration 46
4.3.4 SWOT Analysis 46
4.4 Myoglobin 46
4.4.1 Overview 46
4.4.2 Clinical Application and Utility 47
4.4.3 Market Penetration 49
4.4.4 SWOT Analysis 49
4.5 Point-of-Care 49
4.5.1 Overview 49
4.5.2 Clinical Application and Utility 51
4.5.3 Market Penetration 54
4.5.4 SWOT Analysis 55
5 Unmet Needs 56
5.1 Overview 56
5.2 Earlier Diagnosis 57
5.3 Specificity and False Positives 59
5.4 Interpretation of Biochemical Assay Results 60
5.5 Markers for Myocardial Ischemia 62
5.6 Troponin Assay Sensitivity 63
6 Pipeline Products 64
6.1 Overview 64
6.2 BAG3 (Biouniversia) 65
6.2.1 Overview 65
6.2.2 SWOT Analysis 65
6.3 CAVARISK (Cavadis) 65
6.3.1 Overview 65
6.3.2 SWOT Analysis 65
6.4 CardioScore (BG Medicine) 66
6.4.1 Overview 66
6.4.2 SWOT Analysis 66
6.5 Circulating Endothelial Cells 67
6.5.1 Overview 67
6.5.2 SWOT Analysis 68
6.6 Copeptin (Thermo Scientific) 68
6.6.1 Overview 68
6.6.2 SWOT Analysis 71
6.7 Heart-Type Fatty Acid Binding Protein 71
6.7.1 Overview 71
6.7.2 SWOT Analysis 73
6.8 MIRISK VP Assessment (Aviir) 74
6.8.1 Overview 74
6.8.2 SWOT Analysis 74
6.9 Early Emerging Tests 75
6.9.1 Heart Diagnostic Assay (Prevencio/University of Pittsburgh) 75
6.9.2 Sentinel CVD (GeneNews) 75
6.9.3 SomaScan Cardiovascular Assay (SomaLogic) 75
7 Industry Overview 76
7.1 ACS Diagnostic Biomarker Testing Trends 76
7.1.1 US 76
7.1.2 Europe 78
7.1.3 APAC 80
7.1.4 Brazil 81
7.2 Market Access 82
7.3 Reimbursement Trends 85
7.3.1 US 85
7.3.2 Europe 86
7.3.3 APAC 88
7.3.4 Brazil 89
7.4 Regulatory Environment 90
7.4.1 Approval of New Tests 90
7.4.2 Product Recalls 93
8 Current and Future Players 95
8.1 Overview 95
8.2 Trends in Corporate Strategy 95
8.3 Abbott Diagnostics 96
8.3.1 Overview 96
8.3.2 Portfolio Assessment 96
8.4 Alere 98
8.4.1 Overview 98
8.4.2 Portfolio Assessment 99
8.5 Beckman Coulter 100
8.5.1 Overview 100
8.5.2 Portfolio Assessment 101
8.6 bioMerieux 102
8.6.1 Overview 102
8.6.2 Portfolio Assessment 103
8.7 Mitsubishi Chemical Medience Corporation 104
8.7.1 Overview 104
8.7.2 Portfolio Assessment 105
8.8 Ortho-Clinical Diagnostics 106
8.8.1 Overview 106
8.8.2 Portfolio Assessment 107
8.9 Radiometer Medical 108
8.9.1 Overview 108
8.9.2 Portfolio Assessment 109
8.10 Randox Laboratories 110
8.10.1 Overview 110
8.10.2 Portfolio Assessment 111
8.11 Response Biomedical 112
8.11.1 Overview 112
8.11.2 Portfolio Assessment 113
8.12 Roche Diagnostics 114
8.12.1 Overview 114
8.12.2 Portfolio Assessment 115
8.13 Siemens Healthcare 116
8.13.1 Overview 116
8.13.2 Portfolio Assessment 117
8.14 Thermo Scientific 118
8.14.1 Overview 118
8.14.2 Portfolio Assessment 119
9 Market Drivers and Opportunities and Barriers 120
9.1 Market Drivers 120
9.1.1 Uptake of Pipeline Biomarker Tests 120
9.1.2 Increasing Adoption of POC Testing 121
9.1.3 Increasing Volume of Tests in the Emerging Markets 122
9.2 Market Opportunities 123
9.2.1 High-Sensitivity Troponin Assays 123
9.2.2 Enhancement in Sensitivity of Troponin POC Assays 125
9.2.3 New Pipeline Tests for Early Diagnosis of ACS 125
9.2.4 Emerging Markets 126
9.3 Market Barriers 126
9.3.1 Decreasing Numbers of ACS Cases in the US 126
9.3.2 Saturation of Troponin Testing in the Mature Markets 127
9.3.3 Removal of CK-MB and Myoglobin from Testing Panels 127
9.3.4 Reimbursement 127
10 Country Outlooks and Forecasts 128
10.1 Major Markets Overview 128
10.2 US 131
10.3 France 134
10.4 Germany 137
10.5 Italy 138
10.6 Spain 139
10.7 UK 142
10.8 Japan 145
10.9 Brazil 146
10.10 China 149
10.11 India 150
11 Appendix 151
11.1 Bibliography 151
11.2 Abbreviations 163
11.3 Research Methodology 165
11.3.1 Overview 165
11.3.2 Coverage 165
11.3.3 Secondary Research 165
11.3.4 Forecast Methodology 166
11.4 Primary Research 167
11.5 Physicians and Specialists Included in this Study 167
11.6 About the Authors 169
11.6.1 Analysts 169
11.6.2 Global Head of Healthcare 170
11.7 About MediPoint 170
11.8 About GlobalData 170
11.9 Contact Us 171
11.10 Disclaimer 171



List of Tables


Table 1: Risk Factors Associated with ACS 23
Table 2: Properties of Common ACS and MI Diagnostic Biomarkers 26
Table 3: Diagnosis and Risk Stratification of ACS 26
Table 4: Common PCI Periprocedural Antithrombotic Drugs 27
Table 5: Common Drugs for Fibrinolysis 28
Table 6: Common Drugs for the Treatment of NSTEMI and UA 29
Table 7: Description of Direct and Indirect Economic Costs 32
Table 8: Economic Impact ($bn) of CAD in the US and Europe, 2009 to 2018 33
Table 9: Product Profile - Cardiac Troponins 37
Table 10: Cardiac Troponin Concentrations of Selected Current Troponin Assays 39
Table 11: Cardiac Troponin Concentrations of Selected High-Sensitivity Troponin Assays 40
Table 12: Cardiac Troponins SWOT Analysis 43
Table 13: Product Profile - Creatine Kinase-MB 44
Table 14: Creatine Kinase-MB SWOT Analysis 46
Table 15: Product Profile - Myoglobin 47
Table 16: Myoglobin SWOT Analysis 49
Table 17: Product Profile - Point-of-Care Testing 50
Table 18: Cardiac Troponin Concentrations of POC Troponin Assays 52
Table 19: Point-of-Care Cardiac Panel SWOT Analysis 55
Table 20: ACS Cardiac Biomarker Global Product Pipeline 64
Table 21: BAG3 SWOT Analysis 65
Table 22: CAVARISK SWOT Analysis 65
Table 23: CardioScore SWOT Analysis 66
Table 24: Circulating Endothelial Cells SWOT Analysis 68
Table 25: Copeptin SWOT Analysis 71
Table 26: Heart-Type Fatty Acid Binding Protein SWOT Analysis 73
Table 27: MIRISK VP SWOT Analysis 74
Table 28: Company Profile - Abbott Diagnostics 96
Table 29: Abbott Diagnostics SWOT Analysis, 2013 97
Table 30: Company Profile - Alere 98
Table 31: Alere SWOT Analysis, 2013 99
Table 32: Company Profile - Beckman Coulter 100
Table 33: Beckman Coulter SWOT Analysis, 2013 101
Table 34: Company Profile - bioMerieux 102
Table 35: bioMerieux SWOT Analysis, 2013 103
Table 36: Company Profile - Mitsubishi Chemical Medience Corporation 104
Table 37: Mitsubishi Chemical Medience Corporation SWOT Analysis, 2013 105
Table 38: Company Profile - Ortho-Clinical Diagnostics 106
Table 39: Ortho-Clinical Diagnostics SWOT Analysis, 2013 107
Table 40: Company Profile - Radiometer Medical 108
Table 41: Radiometer Medical SWOT Analysis, 2013 109
Table 42: Company Profile - Randox Laboratories 110
Table 43: Randox Laboratories SWOT Analysis, 2013 111
Table 44: Company Profile - Response Biomedical 112
Table 45: Response Biomedical SWOT Analysis, 2013 113
Table 46: Company Profile - Roche Diagnostics 114
Table 47: Roche Diagnostics SWOT Analysis, 2013 116
Table 48: Company Profile - Siemens Healthcare 117
Table 49: Siemens Healthcare SWOT Analysis, 2013 117
Table 50: Company Profile - Thermo Scientific 118
Table 51: Thermo Scientific SWOT Analysis, 2013 119
Table 52: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in the 10 Major Markets, ($m), 2009-2018 129
Table 53: Major Events Affecting the Global ACS In Vitro Diagnostics Market 129
Table 54: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in the US, ($m), 2009-2018 131
Table 55: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in France, ($m), 2009-2018 134
Table 56: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in Germany, ($m), 2009-2018 137
Table 57: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in Italy, ($m), 2009-2018 138
Table 58: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in Spain, ($m), 2009-2018 139
Table 59: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in the UK, ($m) 2009-2018 142
Table 60: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in Japan, ($m), 2009-2018 145
Table 61: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in Brazil, ($m), 2009-2018 146
Table 62: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in China, ($m), 2009-2018 149
Table 63: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in India, ($m), 2009-2018 150

1.2 List of Figures

Figure 1: Anatomy of the Human Heart 20
Figure 2: Heart Muscle Damage, Atherosclerosis and Thrombosis 21
Figure 3: Strategy for Evaluating ACS 23
Figure 4: Treatment and Management of ACS 30
Figure 5: Annual Number of ACS Cases Across the Major Markets, 2009?2018 31
Figure 6: Direct and Indirect Costs ($bn) of CAD in the US and Europe, 2011 to 2018 33
Figure 7: Major Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents, 2012 35
Figure 8: Estimated US ACS Diagnostic Biomarker Testing Volumes, 2009 to 2018 78
Figure 9: Estimated European ACS Diagnostic Biomarker Testing Volumes, 2009 to 2018 79
Figure 10: Estimated APAC ACS Diagnostic Biomarker Testing Volumes, 2009 to 2018 81
Figure 11: Estimated Brazil ACS Diagnostic Biomarker Testing Volumes, 2009 to 2018 82
Figure 12: Global Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009-2018 128
Figure 13: Global Market Share for ACS In Vitro Diagnostic Testing Reagents, 2012 and 2018 130
Figure 14: US Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009-2018 131
Figure 15: US Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents, 2012 and 2018 133
Figure 16: France Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009-2018 134
Figure 17: France Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents, 2012 and 2018 136
Figure 18: Germany Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009-2018 137
Figure 19: Italy Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009-2018 138
Figure 20: Spain Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009-2018 139
Figure 21: Spain Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents, 2012 and 2018 141
Figure 22: UK Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m) 2009-2018 142
Figure 23: UK Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents, 2012 and 2018 144
Figure 24: Japan Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009-2018 145
Figure 25: Brazil Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009-2018 146
Figure 26: Brazil Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents, 2012 and 2018 148
Figure 27: China Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009-2018 149
Figure 28: India Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009-2018 150



Companies Mentioned

Abbott Diagnostics
Alere
Beckman Coulter
bioMerieux
Mitsubishi Chemical Medience Corporation
Ortho-Clinical Diagnostics
Radiometer Medical
Randox Laboratories
Response Biomedical
Roche Diagnostics
Siemens Healthcare
Thermo Scientific

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