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





Published: April 2013 | Pages: 143 | Format: PDF

 Summary 

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 APAC 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 APAC 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 APAC 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 APAC diagnostic cardiac biomarkers for ACS market landscape? Identify, understand and capitalize. 

 

  1 Table of Contents 

 1 Table of Contents 7 

 1.1 List of Tables 13 

 1.2 List of Figures 15 

 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 26 

 3.5.1 Treatment Options 26 

 3.5.2 Treatment Paradigm 29 

 3.6 Epidemiology 30 

 3.7 Economic Impact 31 

 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 38 

 4.3 Creatine Kinase-MB 39 

 4.3.1 Overview 39 

 4.3.2 Clinical Application and Utility 40 

 4.3.3 Market Penetration 41 

 4.3.4 SWOT Analysis 41 

 4.4 Myoglobin 42 

 4.4.1 Overview 42 

 4.4.2 Clinical Application and Utility 43 

 4.4.3 Market Penetration 44 

 4.4.4 SWOT Analysis 44 

 4.5 Point-of-Care 45 

 4.5.1 Overview 45 

 4.5.2 Clinical Application and Utility 46 

 4.5.3 Market Penetration 49 

 4.5.4 SWOT Analysis 50 

 5 Unmet Needs 51 

 5.1 Overview 51 

 5.2 Earlier Diagnosis 52 

 5.3 Specificity and False Positives 54 

 5.4 Interpretation of Biochemical Assay Results 56 

 5.5 Markers for Myocardial Ischemia 58 

 5.6 Troponin Assay Sensitivity 59 

 6 Pipeline Products 60 

 6.1 Overview 60 

 6.2 BAG3 (Biouniversia) 61 

 6.2.1 Overview 61 

 6.2.2 SWOT Analysis 61 

 6.3 CAVARISK (Cavadis) 62 

 6.3.1 Overview 62 

 6.3.2 SWOT Analysis 62 

 6.4 CardioScore (BG Medicine) 63 

 6.4.1 Overview 63 

 6.4.2 SWOT Analysis 63 

 6.5 Circulating Endothelial Cells 64 

 6.5.1 Overview 64 

 6.5.2 SWOT Analysis 65 

 6.6 Copeptin (Thermo Scientific) 66 

 6.6.1 Overview 66 

 6.6.2 SWOT Analysis 69 

 6.7 Heart-Type Fatty Acid Binding Protein 70 

 6.7.1 Overview 70 

 6.7.2 SWOT Analysis 72 

 6.8 MIRISK VP Assessment (Aviir) 73 

 6.8.1 Overview 73 

 6.8.2 SWOT Analysis 73 

 6.9 Early Emerging Tests 74 

 6.9.1 Heart Diagnostic Assay (Prevencio/University of Pittsburgh) 74 

 6.9.2 Sentinel CVD (GeneNews) 74 

 6.9.3 SomaScan Cardiovascular Assay (SomaLogic) 74 

 7 Industry Overview 75 

 7.1 ACS Diagnostic Biomarker Testing Trends 75 

 7.2 Market Access 77 

 7.3 Reimbursement Trends 79 

 7.3.1 Japan 79 

 7.3.2 China 79 

 7.3.3 India 80 

 7.4 Regulatory Environment 81 

 7.4.1 Product Recalls 81 

 8 Current and Future Players 82 

 8.1 Overview 82 

 8.2 Trends in Corporate Strategy 82 

 8.3 Abbott Diagnostics 83 

 8.3.1 Overview 83 

 8.3.2 Portfolio Assessment 84 

 8.4 Alere 85 

 8.4.1 Overview 85 

 8.4.2 Portfolio Assessment 86 

 8.5 Beckman Coulter 87 

 8.5.1 Overview 87 

 8.5.2 Portfolio Assessment 88 

 8.6 bioMérieux 89 

 8.6.1 Overview 89 

 8.6.2 Portfolio Assessment 90 

 8.7 Mitsubishi Chemical Medience Corporation 91 

 8.7.1 Overview 91 

 8.7.2 Portfolio Assessment 92 

 8.8 Ortho-Clinical Diagnostics 93 

 8.8.1 Overview 93 

 8.8.2 Portfolio Assessment 94 

 8.9 Radiometer Medical 95 

 8.9.1 Overview 95 

 8.9.2 Portfolio Assessment 96 

 8.10 Randox Laboratories 97 

 8.10.1 Overview 97 

 8.10.2 Portfolio Assessment 98 

 8.11 Response Biomedical 99 

 8.11.1 Overview 99 

 8.11.2 Portfolio Assessment 100 

 8.12 Roche Diagnostics 101 

 8.12.1 Overview 101 

 8.12.2 Portfolio Assessment 101 

 8.13 Siemens Healthcare 103 

 8.13.1 Overview 103 

 8.13.2 Portfolio Assessment 104 

 8.14 Thermo Scientific 105 

 8.14.1 Overview 105 

 8.14.2 Portfolio Assessment 106 

 9 Market Drivers and Opportunities and Barriers 107 

 9.1 Market Drivers 107 

 9.1.1 Uptake of Pipeline Biomarker Tests 107 

 9.1.2 Increasing Adoption of POC Testing 108 

 9.1.3 Increasing Volume of Tests in the Emerging Markets 109 

 9.2 Market Opportunities 110 

 9.2.1 High-Sensitivity Troponin Assays 110 

 9.2.2 Enhancement in Sensitivity of Troponin POC Assays 112 

 9.2.3 New Pipeline Tests for Early Diagnosis of ACS 113 

 9.2.4 Emerging Markets 114 

 9.3 Market Barriers 115 

 9.3.1 Saturation of Troponin Testing in Japan 115 

 9.3.2 Removal of CK-MB and Myoglobin from Testing Panels 115 

 9.3.3 Reimbursement 115 

 10 Country Outlooks and Forecasts 116 

 10.1 APAC Region Markets Overview 116 

 10.2 Japan 118 

 10.3 China 119 

 10.4 India 120 

 11 Appendix 121 

 11.1 Bibliography 121 

 11.2 Abbreviations 133 

 11.3 Research Methodology 135 

 11.3.1 Overview 135 

 11.3.2 Coverage 135 

 11.3.3 Secondary Research 135 

 11.3.4 Forecast Methodology 136 

 11.4 Primary Research 137 

 11.5 Physicians and Specialists Included in this Study 138 

 11.6 About the Authors 140 

 11.6.1 Analysts 140 

 11.6.2 Global Head of Healthcare 141 

 11.7 About MediPoint 142 

 11.8 About GlobalData 142 

 11.9 Contact Us 142 

 11.10 Disclaimer 143 

  

 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 25 

 Table 4: Common PCI Periprocedural Antithrombotic Drugs 26 

 Table 5: Common Drugs for Fibrinolysis 27 

 Table 6: Common Drugs for the Treatment of NSTEMI and UA 28 

 Table 7: Description of Direct and Indirect Economic Costs 31 

 Table 8: Product Profile – Cardiac Troponins 34 

 Table 9: Cardiac Troponin Concentrations of Selected Current Troponin Assays 35 

 Table 10: Cardiac Troponin Concentrations of Selected High-Sensitivity Troponin Assays 36 

 Table 11: Cardiac Troponins SWOT Analysis 38 

 Table 12: Product Profile – Creatine Kinase-MB 39 

 Table 13: Creatine Kinase-MB SWOT Analysis 41 

 Table 14: Product Profile – Myoglobin 42 

 Table 15: Myoglobin SWOT Analysis 44 

 Table 16: Product Profile – Point-of-Care Testing 45 

 Table 17: Cardiac Troponin Concentrations of POC Troponin Assays 47 

 Table 18: Point-of-Care Cardiac Panel SWOT Analysis 50 

 Table 19: ACS Cardiac Biomarker Product Pipeline 60 

 Table 20: BAG3 SWOT Analysis 61 

 Table 21: CAVARISK SWOT Analysis 62 

 Table 22: CardioScore SWOT Analysis 63 

 Table 23: Circulating Endothelial Cells SWOT Analysis 65 

 Table 24: Copeptin SWOT Analysis 69 

 Table 25: Heart-Type Fatty Acid Binding Protein SWOT Analysis 72 

 Table 26: MIRISK VP SWOT Analysis 73 

 Table 27: Company Profile – Abbott Diagnostics 83 

 Table 28: Abbott Diagnostics SWOT Analysis, 2013 84 

 Table 29: Company Profile – Alere 85 

 Table 30: Alere SWOT Analysis, 2013 86 

 Table 31: Company Profile – Beckman Coulter 87 

 Table 32: Beckman Coulter SWOT Analysis, 2013 88 

 Table 33: Company Profile – bioMérieux 89 

 Table 34: bioMérieux SWOT Analysis, 2013 90 

 Table 35: Company Profile – Mitsubishi Chemical Medience Corporation 91 

 Table 36: Mitsubishi Chemical Medience Corporation SWOT Analysis, 2013 92 

 Table 37: Company Profile – Ortho-Clinical Diagnostics 93 

 Table 38: Ortho-Clinical Diagnostics SWOT Analysis, 2013 94 

 Table 39: Company Profile – Radiometer Medical 95 

 Table 40: Radiometer Medical SWOT Analysis, 2013 96 

 Table 41: Company Profile – Randox Laboratories 97 

 Table 42: Randox Laboratories SWOT Analysis, 2013 98 

 Table 43: Company Profile – Response Biomedical 99 

 Table 44: Response Biomedical SWOT Analysis, 2013 100 

 Table 45: Company Profile – Roche Diagnostics 101 

 Table 46: Roche Diagnostics SWOT Analysis, 2013 102 

 Table 47: Company Profile – Siemens Healthcare 103 

 Table 48: Siemens Healthcare SWOT Analysis, 2013 104 

 Table 49: Company Profile – Thermo Scientific 105 

 Table 50: Thermo Scientific SWOT Analysis, 2013 106 

 Table 51: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in the APAC Region Markets, ($m), 2009–2018 116 

 Table 52: Major Events Affecting the ACS In Vitro Diagnostics Market 117 

 Table 53: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in Japan, ($m), 2009–2018 118 

 Table 54: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in China, ($m), 2009–2018 119 

 Table 55: Sales Forecasts for ACS In Vitro Diagnostic Testing Reagents in India, ($m), 2009–2018 120 

  

 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 29 

 Figure 5: Annual Number of ACS Cases Across APAC, 2009?2018 30 

 Figure 6: APAC Region Market Share by Test Type for ACS In Vitro Diagnostic Testing Reagents, 2012 32 

 Figure 7: Estimated APAC ACS Diagnostic Biomarker Testing Volumes, 2009 to 2018 76 

 Figure 8: APAC Region Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009–2018 116 

 Figure 9: APAC Region Market Share for ACS In Vitro Diagnostic Testing Reagents, 2012 and 2018 117 

 Figure 10: Japan Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009–2018 118 

 Figure 11: China Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009–2018 119 

 Figure 12: India Sales Forecast for ACS In Vitro Diagnostic Testing Reagents, ($m), 2009–2018 120 

  

 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