Cardiac Marker Sample - TriMark Publications

1 TTrreennddss,, IInndduussttrryy PPaarrttiicciippaannttss,, PPrroodduucctt OOvveerrvviieewwss aanndd MMaarrkkeett DDrriivveerrss Cardiac Marker DIAGNOSTIC TESTING MARKETS ( Sample COPY, NOT FOR RESALE) TriMark Publications April 2017 Volume: TMRCMARK17-0401 Cardiac Marker Diagnostic Testing Markets April 2017 2017 TriMark Publications , LLC. All rights reserved. 210 TABLE OF CONTENTS 1. Overview 8 Statement of Report 8 Objectives of This Report 8 Scope of This Report 10 Methodology 10 Executive Summary 12 2. The Basics of Biomarkers 14 3. Cardiac Marker Testing Markets: Market Segment Analysis: Size, Growth and Share 21 Global Cardiac Marker Diagnostic Testing Markets 21 Clinical Utility of Cardiac Markers 23 Market Drivers in the Cardiac Marker Diagnostics Testing Sector 24 Market Restraints in Cardiac Marker Testing Segment 24 Principal Market Segments for Cardiac Marker Testing 25 Key Players in the Cardiac Marker Diagnostics Testing Segment 25 Cardiac Marker Testing Sector Analysis 26 Cardiac Marker Testing Market 27 Market Overview 27 Cardiac Diagnostic Test Segments 28 Hospital POC Cardiac Markers 29 European Cardiac Marker Diagnostic Test Market 31 German Diagnostic Markets 33 Diagnostic Testing Market 35 Market Statistics 35 Italy 36

2 France 37 Spain 38 Benelux 38 Scandinavia 39 Switzerland 39 Barriers to Entry to European Market 40 Japanese Diagnostic Testing Market 40 Chinese Diagnostic Testing Market 41 Canadian Diagnostic Market 42 Cardiac Marker Testing Individual Markets 43 Clinical Overview 43 Cardiac Acute Disease Markers 44 Market Overview 44 Troponins 47 Market Size and Growth Projections 49 Clinical Use of Cardiac Troponins 52 TnI and TnT Market Drivers 55 TnI and TnT Market Restraints 55 CK-MB and Cardiac Enzymes 56 Creatine Kinase (CK) Enzymes 56 Market Size and Growth Projections 57 CK-MB: Market Drivers 58 CK-MB: Market Restraints 58 Myoglobin 58 Market Size and Growth Projections 58 Clinical Use of Myoglobin 59 Myoglobin Market Drivers 60 Myoglobin Market Restraints 60 Natriuretic Peptides 60 Market Overview 60 Cardiac Marker Diagnostic Testing Markets April 2017 2017 TriMark Publications , LLC.

3 All rights reserved 3 Market Size and Growth Projections 62 Commercial Assays for BNP and NT-proBNP 63 Competitive Landscape 65 BNP Test Market Share 65 Clinical Applications of BNP/NT-proBNP 68 BNP NT-proBNP Market Drivers 71 BNP NT-proBNP Market Restraints 71 Future Projections and Trends of BNP Testing 71 Future Use of BNP 72 Albumin 72 Ischemic Modified Albumin (IMA) 72 Microalbuminuria 74 Key Players in Cardiac Markers 75 Evaluation of Cardiac Markers 83 Cardiac Markers Use in Clinical Decisions 84 Status of Cardiac Markers in the ER 85 Cardiac Markers in Renal Failure 85 Troponins in Non-Ischemic Heart Disease 85 Market Restraints 86 Market Drivers 86 POC Cardiac Markers 86 Market Restraints 87 The Next Wave 89 4.

4 Cardiovascular Disease Markers 93 Cholesterol, HDL and LDL 93 Cholesterol Testing Market Forecasts 95 Cholesterol Testing Market Growth Drivers 95 Market Outlook: Market Analysis 95 Trends and Issues 97 Key Players in the Cholesterol Kit Market 98 Review of Cholesterol Kit Company Products 99 Alere 99 PTS Diagnostics CardioChek 99 Miraculins PreVu POC Skin Cholesterol Test 100 Abaxis Piccolo Xpress 100 Product Comparison of Leading Suppliers 101 Homocysteine 103 Fibrinogen 103 C-Reactive Protein 103 Lipoprotein Fractions 106 Oxidized LDL and HDL 107 5.

5 Cardiac Marker Testing Development Issues 108 Genetic Testing and Personalized Medicine 108 Preventive Medicine 108 Patient Safety and Quality Measures 109 Reimbursement 109 Cardiovascular Screening Codes 111 Cardiovascular Disease Risk Panels 112 Other Reimbursement Concerns 113 Reimbursement for Cardiovascular Disease Risk Factors 113 Rapid Near-Patient Testing in Hospitals 114 Satellite Facilities 114 Regionalization of Laboratory Care 115 POCT: Current Market Trends and Drivers 116 Effectiveness of POCT 117 New Growth Areas for POCT 118 Cardiac Marker Diagnostic Testing Markets April 2017 2017 TriMark Publications , LLC.

6 All rights reserved 4 Advantages of POCT in a Clinical Setting 118 Shifts from Central Lab Testing to POCT 119 Turnaround Time for POCT 119 Clinical Laboratory Improvement Amendments (CLIA) 120 Regulatory Requirements 122 Record-Keeping and Data Management 122 Effectiveness of Clinical Outcomes 122 6. Business Trends in the Industry 124 Sector Consolidation 124 Diagnostic Testing Growth Trends 124 Acquisition, License Agreements, Internal Development and Partnerships 124 Industry Leaders and New Entrants 126 Product Testing Depth in Cardiac Marker Testing 126 Government Regulation 126 Regulation 126 CLIA Regulations 127 Clinical Laboratory Improvement Act 128 State Licensing for Service Laboratories 129 IVDMIAs 130 FDA Draft Guidance on In Vitro Companion Diagnostic Devices 130 510(k)

7 Clearance 131 Pre-Market Approval 131 Pre-Market Approval Application 132 Importing Medical Devices into the 133 Exporting Medical Devices from the 133 Regulations 134 Japanese Regulations 138 Chinese Regulations 142 Barriers to Growth 146 Drivers of Growth 147 7. Important Technology Trends 150 Trends in Cardiac Marker Diagnostic Testing 150 Free Fatty Acids and Fatty Acid Binding Proteins 150 Glycogen Phosphorylase Isoenzyme BB 151 S-100 Protein 151 Cobalt-Binding Albumin 151 Myosin Light Chains 152 ST2 152 Galectin-3 152 Emerging POCT Cardiac Marker Testing 153 Cardiac Biomarker Research 153 Glutathione Peroxidase 153 Antioxidant Biomarkers 153 Oxidative Biomarkers 153 Inflammatory Biomarkers 154 Nitrosative Biomarkers 155 Hemostatic Biomarkers 155

8 Potential Stroke Markers 155 Pharmacogenomics: Cardiovascular Drugs and Proteomic Markers 156 Cardiac Proteomics 156 Drivers for Cardiovascular Proteomic Markers 156 Barriers to Cardiovascular Proteomic Markers 156 Future Developments for Cardiovascular Markers 157 Research Questions 157 Biomarker Development Strategies 160 Biomarkers for Unstable Angina 161 Cardiac Marker Diagnostic Testing Markets April 2017 2017 TriMark Publications , LLC. All rights reserved 5 Lp-PLA2 162 Urotensin 162 INDEX OF FIGURES Figure : Market Share of Cardiac Marker Segment 27 Figure : Cardiac Marker Diagnostic Testing Market Segments, 2016 29 Figure : POC Cardiac Marker Sales, 2011-2021 30 Figure : Cardiac Marker Market for Diagnostic Testing in Europe, 2011-2021 32 Figure : Cardiac Marker POCT Troponin Market Share by Product Type 87 Figure : Cardiac Marker POCT BNP Market Share by Product Type 87 Figure : Prevalence of Total Cholesterol Among Adults Aged 20 and Over, by Sex and Age in the , 2011-2014 94 Figure.

9 Age-Adjusted Trends in Prevalence of High total and low HDL Cholesterol Among Adults Aged over 20 in the , 1999-2014 95 Figure : Prevalence of Cholesterol Screening in Adults Ages 20, 96 Figure : CLIA Laboratories by Certificate Types, 2016 120 Figure : Current Conformity Assessment Route, Annexes and Quality System Standards by IVD Device Category 135 Figure : The Chinese Healthcare System 143 INDEX OF TABLES Table : Biomarkers in Heart Failure 15 Table : Cardiac Biomarkers of Inflammation and Atherogenesis 16 Table : Cardiac Biomarkers of Endothelial Function 17 Table : Cardiac Biomarkers of Thrombosis 17 Table : Cardiac Biomarkers of Ischemia/Necrosis 17 Table : Cardiac Biomarkers of Hemodynamic Stress 19 Table : Cardiac Biomarkers of Heart Failure Mortality 19 Table : Cardiac Biomarkers of Renal Dysfunction 19 Table : Cardiac Biomarkers of Metabolic/Lipid Dysregulation 20 Table : Cardiac Biomarkers of Brain Damage 20 Table : Cardiac Marker Markets by Country and Region, 2010-2020 22 Table : Cardiac Marker Markets by Country and Region, 2010-2020 22 Table : Total Global Cardiac Marker Market, 2010-2021 22 Table : Cardiac Markers in Clinical Use 23 Table : Market Share of Cardiac Marker Segment 26 Table : Cardiac Marker Market, 2011-2021 28 Table : Cardiac Marker Diagnostic Testing Market Segments, 2016 28 Table : POC Cardiac Marker Sales, 2015-2021 29 Table.

10 Spectrum of Patient Care Testing 30 Table : Cardiac Marker Market for Diagnostic Testing in Europe, 2015-2021 31 Table : Regional Comparison of Healthcare and IVD Expenditures 32 Table : German IVD Diagnostics Products Market Sales, 2010-2020 34 Table : German Cardiac Marker Test Market, 2010-2020 34 Table : IVD Diagnostics Products Market Sales, 2010-2020 36 Table : Cardiac Marker Market, 2010-2020 36 Table : Italian Cardiac Marker Market, 2010-2020 37 Table : French Cardiac Marker Market, 2010-2020 38 Table : Spanish Cardiac Marker Market, 2010-2020 38 Table : Benelux Cardiac Marker Market, 2010-2020 39 Table : Scandinavian Cardiac Marker Market, 2010-2020 39 Table : Swiss Cardiac Marker Market, 2010-2020 40 Cardiac Marker Diagnostic Testing Markets April 2017 2017 TriMark Publications , LLC.