Cardiac Marker Diagnostic Testing Markets
1. Overview 6
1.1 Statement of Report 6
1.2 Objectives of This Report 6
1.3 Scope of This Report 8
1.4 Methodology 8
1.5 Executive Summary 8
2. Introduction 11
2.1 Global Diagnostic Products Industry 11
2.2 Barriers to Entry 14
2.3 Company Evaluation Overview 15
2.4 Market Outlook 16
2.5 Technologies and Products that are the Most Successful in the New IVD Environment 16
3. Cardiac Marker Testing Markets: Market Segment Analysis: Size, Growth and Share 18
3.1 Global Cardiac Marker Diagnostic Testing Markets 18
3.1.1 Clinical Utility of Cardiac Markers 22
3.1.2 Market Drivers in the Cardiac Marker Diagnostics Testing Sector 24
3.1.3 Market Restraints in Cardiac Marker Testing Segment 24
3.1.4 Principal Market Segments for Cardiac Marker Testing 24
3.1.5 Key Players in the Cardiac Marker Diagnostics Testing Segment 25
3.1.6 Cardiac Marker Testing Sector Analysis 26
3.1.7 Cardiac Marker Market Share 26
3.2 U.S. Cardiac Marker Testing Market 26
3.2.1 Market Overview 26
3.2.2 Diagnostic Test Categories 27
3.2.3 U.S. Hospital POC Cardiac Markers 28
3.3 European Cardiac Marker Diagnostic Test Market 29
3.3.1 German Diagnostic Markets 32
3.3.2 U.K. Diagnostic Testing Market 33
3.3.2.1 U.K. Market Statistics 33
3.3.2.2 U.K. Competitive Analysis 34
3.3.2.3 U.K. Market Access 35
3.3.3 Italy 35
3.3.4 France 36
3.3.5 Spain 36
3.3.6 Belgium 36
3.3.7 Switzerland 37
3.3.8 Barriers to Entry to European Market 37
3.4 Japanese Diagnostic Testing Market 37
3.5 Chinese Diagnostic Testing Market 37
3.6 Canadian Diagnostic Market 40
3.7 Cardiac Marker Testing Individual Markets 40
3.7.1 Clinical Overview 40
3.7.2 Cardiac Acute Disease Markers 41
3.7.3 Market Overview 42
3.7.3.1 AMI and Troponins 44
3.7.3.2 Market Size and Growth Projections 47
3.7.3.3 Clinical Use of Cardiac Troponins 48
3.7.3.4 TnI and TnT Market Drivers 51
3.7.3.5 TnI and TnT Market Restraints 51
3.7.3.6 New Tests for Troponin 52
3.7.4 CK-MB and Cardiac Enzymes 52
3.7.4.1 CK Enzymes 52
3.7.4.2 Market Size and Growth Projections 53
3.7.4.3 CK-MB: Market Drivers 54
3.7.4.4 CK-MB: Market Restraints 54
3.7.5 Myoglobin 54
3.7.5.1 Market Size and Growth Projections 54
3.7.5.2 Clinical Use of Myoglobin 55
3.7.5.3 Myoglobin Market Drivers 56
3.7.5.4 Myoglobin Market Restraints 56
3.7.6 BNP 56
3.7.6.1 Market Overview 56
3.7.6.2 Market Size and Growth Projections 58
3.7.6.3 Commercial Assays for BNP and NT-proBNP 58
3.7.6.4 Competitive Landscape 60
3.7.6.5 BNP Test Market Share 60
3.7.6.6 Clinical Applications of BNP 62
3.7.6.7 BNP Market Drivers 64
3.7.6.8 BNP Market Restraints 65
3.7.7 Albumin 65
3.7.7.1 Intact Albumin 65
3.7.7.2 Albumin Cobalt Binding Test 65
3.7.7.3 Ischemic Modified Albumin 66
3.7.7.4 Microalbuminuria 68
3.7.8 Key Players in Cardiac Markers 68
3.7.9 Cardiac Marker Controls 77
3.7.10 Evaluation of Cardiac Markers 77
3.7.11 Cardiac Markers Use in Clinical Decisions 78
3.7.12 Status of Cardiac Markers in the ER 78
3.7.13 Cardiac Markers in Renal Failure 78
3.7.14 Troponins in Non-Ischemic Heart Disease 79
3.7.15 Market Restraints 79
3.7.16 Market Drivers 80
3.7.17 Cardiac Panels 80
3.7.18 POC Cardiac Markers 80
3.7.18.1 Market Size and Growth Rate 80
3.7.18.2 Market Restraints 81
3.7.18.3 The Next Wave 82
4. Cardiovascular Disease Markers 86
4.1 Cholesterol, HDL and LDL 86
4.1.1 Cholesterol Testing Market Forecasts 87
4.1.2 Cholesterol Market Growth Drivers 87
4.1.3 Market Outlook: U.S. Market Analysis 87
4.1.4 Trends and Issues 88
4.1.5 Key Players in the Cholesterol OTC Kit Market 88
4.2 Homocysteine 88
4.3 Fibrinogen 89
4.4 C-Reactive Protein 89
4.5 Lipoprotein Fractions 91
4.6 Pulmonary Embolism (D-Dimer Test) 92
4.7 Oxidized LDL and HDL 92
4.8 Stroke 92
5. Cardiac Marker Testing Development Issues 94
5.1 Genetic Testing and Personalized Medicine 94
5.2 Preventive Medicine 94
5.3 Patient Safety and Quality Measures 94
5.4 Reimbursement 95
5.5 Cardiovascular 97
5.6 Screening for Diabetes 97
5.7 Other Reimbursement Concerns 98
5.7.1 Reimbursement for Routine Venipuncture 98
5.7.2 Japanese Reimbursements for Medical Devices 98
5.8 CPT Test Codes and Payment Amounts 98
5.9 Rapid Near-Patient Testing in Hospitals 99
5.10 Satellite Facilities 99
5.11 Regionalization of Laboratory Care 100
5.12 Requirements for POCT 101
5.12.1 Benefits of POCT 102
5.12.2 Turnaround Time for POCT 103
5.13 Clinical Laboratory Improvement Amendments (CLIA) 103
5.14 Quality Assurance Issues 104
5.15 Political Control 105
5.16 Regulatory Requirements 105
5.17 Recordkeeping and Data Management 105
5.17.1 Effectiveness of Clinical Outcomes 105
6. Business Trends in the Industry 106
6.1 Sector Consolidation 106
6.2 Diagnostic Testing Growth Trends 106
6.3 Acquisition, License Agreements, Internal Development and Partnerships 108
6.4 Product Testing Depth in Cardiac Marker Testing 111
6.5 Government Regulation 111
6.5.1 U.S. Regulation 111
6.5.1.1 Importing Medical Devices into the U.S. 112
6.5.1.2 Exporting Medical Devices from the U.S. 113
6.5.2 U.K. Regulations 113
6.5.3 E.U. Regulations 114
6.5.4 Japanese Regulations 115
6.5.5 Chinese Regulations 116
6.6 Barriers to Growth 117
6.7 Drivers of Growth 117
6.8 Product Launches and Developments 117
7. Important Technology Trends 119
7.1 Trends in Cardiac Marker Diagnostic Testing 119
7.1.1 Fatty Acid Binding Protein 120
7.1.2 Glycogen Phosphorylase Isoenzyme BB 120
7.1.3 S-100 Protein 120
7.1.4 Cobalt-Binding Albumin 120
7.1.5 Myosin Light Chains 121
7.2 Cardiac Biomarker Research 121
7.2.1 Myeloperoxidase 121
7.2.2 Glutathione Peroxidase 122
7.2.3 Antioxidant Biomarkers 122
7.2.4 Oxidative Biomarkers 122
7.2.5 Inflammatory Biomarkers 123
7.2.6 Nitrosative Biomarkers 123
7.2.7 Hemostatic Biomarkers 124
7.3 Potential Stroke Markers 124
7.3.1 Pharmacogenomics: Cardiovascular Drugs and Proteomic Markers 125
7.3.2 Cardiac Proteomics 125
7.3.3 Drivers for Cardiovascular Proteomic Markers 125
7.3.4 Barriers to Cardiovascular Proteomic Markers 126
7.4 Future Developments for Cardiovascular Markers 126
7.5 Research Questions 126
7.5.1 Roche’s Biomarker Strategy 129
7.5.2 Biomarkers for Unstable Angina 130
7.6 Lp-PLA2 130
7.7 Urotensin 131
8. Company Profiles 132
8.1 Abbott Laboratories 132
8.2 Ani Biotech 136
8.3 Axis-Shield 137
8.4 Bayer Corporation 138
8.5 Beckman Coulter 139
8.6 Biosite, Inc. (now a brand of Inverness Medical Innovations) 141
8.7 Inverness Medical Innovations 144
8.8 Johnson & Johnson 146
8.9 LifeSign 146
8.10 Olympus America 146
8.11 PreMD, Inc. 147
8.12 Randox Laboratories 147
8.13 Response Biomedical 147
8.14 Roche Diagnostics 148
8.16 Sierra Resources International 152
8.17 Spectral Diagnostics, Inc. 152
LIST OF FIGURES
Figure 2.1: Lab Industry Market Share 13
Figure 2.2: Market Share of Major Lab Testing Segments 14
LIST OF TABLES
Table 2.1: World Population and Growth, 2000-2024 11
Table 2.2: Worldwide Market Share IVD Companies 12
Table 2.3: U.S. In Vitro Central Lab Diagnostic Testing, 2001-2007 13
Table 2.4: Worldwide Near-Patient Diagnostic Testing, 2001-2007 13
Table 3.1: Cardiac Marker Markets by Country, 2002-2010 18
Table 3.2: Total Global Cardiac Marker Market, 2002-2010 18
Table 3.3: Overall IVD Testing Market Worldwide, 2007 20
Table 3.4: Worldwide Distribution of IVD Testing, 2007 20
Table 3.5: Top 12 Countries for IVD Testing Markets, 2007 20
Table 3.6: Eight Largest Diagnostic Companies Worldwide, 2007 21
Table 3.7: Cardiac Markers 23
Table 3.8: Market Share of Cardiac Marker Segment 26
Table 3.9: U.S. Cardiac Marker Market, 2001-2010 27
Table 3.10: U.S. Cardiac Marker Diagnostic Testing Market Segments, 2007 27
Table 3.11: U.S. POC Cardiac Marker Sales, 2001-2010 28
Table 3.12: The Cardiac Marker Market for Diagnostic Testing in Europe, 2001-2010 30
Table 3.13: Regional Comparison of Healthcare and IVD Expenditures 31
Table 3.14: German Diagnostics Products Market Sales, 1997-2008 32
Table 3.15: The German Cardiac Marker Test Market, 2000-2010 32
Table 3.16: U.K. Cardiac Marker Market, 2001-2010 34
Table 3.17: Major U.K. IVD Manufacturers 34
Table 3.18: U.S. IVD Manufacturers Doing Business in the U.K. 34
Table 3.19: Other European Companies that Manufacture IVD Products in the U.K. 35
Table 3.20: Italian Cardiac Marker Market, 2001-2010 35
Table 3.21: French Cardiac Marker Market, 2001-2010 36
Table 3.22: Spanish Cardiac Marker Market, 2001-2010 36
Table 3.23: Japanese Cardiac Marker Diagnostic Testing Market, 2001-2010 37
Table 3.24: Chinese Diagnostics Products Market, 2000-2010 38
Table 3.25: ER Admissions in the U.S., 1997-2005 43
Table 3.26: Common Causes of Chest Pain 43
Table 3.27: Rate of Inappropriate Discharge from the ER for Patients with AMI 44
Table 3.28: Continuing Analytical Issues for Implementation of Cardiac Troponin 46
Table 3.29: Global Cardiac Troponin Marker Market, 2001-2010 47
Table 3.30: U.S. Cardiac Troponin Marker Market, 2001-2010 48
Table 3.31: Trends in U.S. Sales of POC Cardiac Marker Tests, 1998-2007 48
Table 3.32: World Revenue from CK-MB Markets, 2001-2010 53
Table 3.33: U.S. Revenue from CK-MB Markets, 2001-2010 53
Table 3.34: World Myoglobin Market Revenues, 2001-2010 54
Table 3.35: U.S. Myoglobin Market Revenues, 2001-2010 55
Table 3.36: BNP Clinical Characteristics 57
Table 3.37: Worldwide Sales of BNP Diagnostic Tests, 2004-2010 58
Table 3.38: U.S. Sales of BNP Diagnostic Tests, 2004-2010 58
Table 3.39: Commercial BNP Assays in the U.S. 61
Table 3.40: Market Share of BNP Assays in the U.S. 61
Table 3.41: Market Share of NT-proBNP Assays in the U.S. 61
Table 3.42: Siemens Healthcare Diagnostics Cardiac Marker Assays 76
Table 3.43: Cardiac Markers: Sampling Frequency 77
Table 3.44: Cardiac Marker Products by LifeSign 80
Table 4.1: HDL Levels in Adults 86
Table 4.2: LDL Levels in Adults 87
Table 4.3: LDL Screening Management Rates—Percent of Patient Population 87
Table 4.4: Number of U.S. Cholesterol Tests, 2000-2010 88
Table 4.5: World CRP Market Revenue, 2001-2010 90
Table 4.6: U.S. CRP Market Revenue, 2001-2010 91
Table 4.7: Clinical Characteristics of D-Dimer 92
Table 5.1: POCT in Two Hospitals Cost Analysis with Labor Included 102
Table 5.2: Cost Analysis for Glucose Testing: POCT vs. Central Lab 102
Table 5.3: Financial Comparison for Moderate and Waived CLIA Labs 103
Table 5.4: POCT Clinical Outcomes in AMI 105
Table 7.1: Oxidative Biomarker Research Assay Market Size 123
Table 7.2: Non-Lipid Markers of CVD 127
Table 8.1: Products Marketed by Abbott in the Diagnostic Market 135
Table 8.2: Products Marketed by Biosite in the Diagnostic Market 143
