Cardiac Marker Diagnostic Testing Markets

Table of Contents:


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 23
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 25
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 27
3.2.1 Market Overview 27
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 30
3.3.1 German Diagnostic Markets 33
3.3.2 U.K. Diagnostic Testing Market 34
3.3.2.1 U.K. Market Statistics 35
3.3.2.2 U.K. Competitive Analysis 35
3.3.2.3 U.K. Market Access 36
3.3.3 Italy 37
3.3.4 France 37
3.3.5 Spain 38
3.3.6 Belgium 38
3.3.7 Switzerland 38
3.3.8 Barriers to Entry to European Market 38
3.4 Japanese Diagnostic Testing Market 38
3.5 Chinese Diagnostic Testing Market 39
3.6 Canadian Diagnostic Market 42
3.7 Cardiac Marker Testing Individual Markets 42
3.7.1 Clinical Overview 42
3.7.2 Cardiac Acute Disease Markers 43
3.7.3 Market Overview 43
3.7.3.1 AMI and Troponins 46
3.7.3.2 Market Size and Growth Projections 49
3.7.3.3 Clinical Use of Cardiac Troponins 50
3.7.3.4 TnI and TnT Market Drivers 53
3.7.3.5 TnI and TnT Market Restraints 53
3.7.3.6 New Tests for Troponin 54
3.7.4 CK-MB and Cardiac Enzymes 54
3.7.4.1 CK Enzymes 54
3.7.4.2 Market Size and Growth Projections 55
3.7.4.3 CK-MB: Market Drivers 55
3.7.4.4 CK-MB: Market Restraints 56
3.7.5 Myoglobin 56
3.7.5.1 Market Size and Growth Projections 56
3.7.5.2 Clinical Use of Myoglobin 57
3.7.5.3 Myoglobin Market Drivers 57
3.7.5.4 Myoglobin Market Restraints 58
3.7.6 BNP 58
3.7.6.1 Market Overview 58
3.7.6.2 Market Size and Growth Projections 59
3.7.6.3 Commercial Assays for BNP and NT-proBNP 60
3.7.6.4 Competitive Landscape 62
3.7.6.5 BNP Test Market Share 63
3.7.6.6 Clinical Applications of BNP 64
3.7.6.7 BNP Market Drivers 67
3.7.6.8 BNP Market Restraints 67
3.7.7 Albumin 68
3.7.7.1 Intact Albumin 68
3.7.7.2 Albumin Cobalt Binding Test 68
3.7.7.3 Ischemic Modified Albumin 68
3.7.7.4 Microalbuminuria 70
3.7.8 Key Players in Cardiac Markers 71
3.7.9 Cardiac Marker Controls 80
3.7.10 Evaluation of Cardiac Markers 80
3.7.11 Cardiac Markers Use in Clinical Decisions 81
3.7.12 Status of Cardiac Markers in the ER 81
3.7.13 Cardiac Markers in Renal Failure 82
3.7.14 Troponins in Non-Ischemic Heart Disease 82
3.7.15 Market Restraints 82
3.7.16 Market Drivers 83
3.7.17 Cardiac Panels 83
3.7.18 POC Cardiac Markers 84
3.7.18.1 Market Size and Growth Rate 84
3.7.18.2 Market Restraints 85
3.7.18.3 The Next Wave 86

4. Cardiovascular Disease Markers 90
4.1 Cholesterol, HDL and LDL 90
4.1.1 Cholesterol Testing Market Forecasts 91
4.1.2 Cholesterol Market Growth Drivers 91
4.1.3 Market Outlook: U.S. Market Analysis 91
4.1.4 Trends and Issues 92
4.1.5 Key Players in the Cholesterol OTC Kit Market 92
4.2 Homocysteine 93
4.3 Fibrinogen 93
4.4 C-Reactive Protein 93
4.5 Lipoprotein Fractions 95
4.6 Pulmonary Embolism (D-Dimer Test) 96
4.7 Oxidized LDL and HDL 97
4.8 Stroke 97

5. Cardiac Marker Testing Development Issues 99
5.1 Genetic Testing and Personalized Medicine 99
5.2 Preventive Medicine 99
5.3 Patient Safety and Quality Measures 99
5.4 Reimbursement 100
5.5 Cardiovascular 102
5.6 Screening for Diabetes 102
5.7 Other Reimbursement Concerns 103
5.7.1 Reimbursement for Routine Venipuncture 103
5.7.2 Japanese Reimbursements for Medical Devices 103
5.8 CPT Test Codes and Payment Amounts 103
5.9 Rapid Near-Patient Testing in Hospitals 104
5.10 Satellite Facilities 104
5.11 Regionalization of Laboratory Care 105
5.12 Requirements for POCT 106
5.12.1 Benefits of POCT 107
5.12.2 Turnaround Time for POCT 108
5.13 Clinical Laboratory Improvement Amendments (CLIA) 108
5.14 Quality Assurance Issues 109
5.15 Political Control 110
5.16 Regulatory Requirements 110
5.17 Recordkeeping and Data Management 110
5.17.1 Effectiveness of Clinical Outcomes 110

6. Business Trends in the Industry 111
6.1 Sector Consolidation 111
6.2 Diagnostic Testing Growth Trends 111
6.3 Acquisition, License Agreements, Internal Development and Partnerships 113
6.4 Product Testing Depth in Cardiac Marker Testing 116
6.5 Government Regulation 116
6.5.1 U.S. Regulation 116
6.5.1.1 Importing Medical Devices into the U.S. 117
6.5.1.2 Exporting Medical Devices from the U.S. 118
6.5.2 U.K. Regulations 118
6.5.3 E.U. Regulations 120
6.5.4 Japanese Regulations 121
6.5.5 Chinese Regulations 121
6.6 Barriers to Growth 122
6.7 Drivers of Growth 122
6.8 Product Launches and Developments 123

7. Important Technology Trends 124
7.1 Trends in Cardiac Marker Diagnostic Testing 124
7.1.1 Fatty Acid Binding Protein 125
7.1.2 Glycogen Phosphorylase Isoenzyme BB 125
7.1.3 S-100 Protein 125
7.1.4 Cobalt-Binding Albumin 125
7.1.5 Myosin Light Chains 126
7.2 Cardiac Biomarker Research 126
7.2.1 Myeloperoxidase 126
7.2.2 Glutathione Peroxidase 127
7.2.3 Antioxidant Biomarkers 127
7.2.4 Oxidative Biomarkers 127
7.2.5 Inflammatory Biomarkers 128
7.2.6 Nitrosative Biomarkers 129
7.2.7 Hemostatic Biomarkers 129
7.3 Potential Stroke Markers 129
7.3.1 Pharmacogenomics: Cardiovascular Drugs and Proteomic Markers 130
7.3.2 Cardiac Proteomics 130
7.3.3 Drivers for Cardiovascular Proteomic Markers 131
7.3.4 Barriers to Cardiovascular Proteomic Markers 131
7.4 Future Developments for Cardiovascular Markers 131
7.5 Research Questions 131
7.5.1 Roche's Biomarker Strategy 134
7.5.2 Biomarkers for Unstable Angina 135
7.6 Lp-PLA2 135
7.7 Urotensin 136

8. Company Profiles 137
8.1 Abbott Laboratories 137
8.2 Ani Biotech 141
8.3 Axis-Shield 142
8.4 Bayer Corporation 143
8.5 Beckman Coulter 144
8.6 Biosite, Inc. 147
8.7 Dade Behring 149
8.8 Diagnostic Products Corp. 150
8.9 Inverness Medical Innovations 151
8.10 Johnson & Johnson 153
8.11 LifeSign 154
8.12 Olympus America 154
8.13 PreMD, Inc. 154
8.14 Randox Laboratories 155
8.15 Response Biomedical 155
8.16 Roche Diagnostics 156
8.17 Sierra Resources International 157
8.18 Spectral Diagnostics, Inc. 158