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Cardiac Marker Diagnostic Testing Markets


Description: The purpose of this report is to describe the specific market segment of the in vitro diagnostics (IVD) market devoted to cardiac marker testing. This study examines clinical measurement devices and their reagents and supplies as used in hospitals, clinics and doctors offices. This examination is arranged to provide the reader with an overview of the outstanding diagnostic test market segments of cardiac care, with evidence that these segments are poised for high future growth.

An overview of the diagnostic testing cardiac marker market is presented with the latest information regarding emerging new products and industry trends. It will not only quantify but also qualify the cardiac marker market segments as an area of research, product development and investment. Forecasts of the cardiac marker market and an analysis of products in the worldwide diagnostics market will provide a basis for understanding the significance of past developments and future possibilities within this diagnostic category.


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 Roches 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


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, 2004 20
Table 3.4: Worldwide Distribution of IVD Testing, 2004 20
Table 3.5: Top 12 Countries for IVD Testing Markets, 2004 20
Table 3.6: Ten Largest Diagnostic Companies Worldwide 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, 2004 28
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 31
Table 3.13: Regional Comparison of Healthcare and IVD Expenditures 32
Table 3.14: German Diagnostics Products Market Sales, 1997-2007 33
Table 3.15: The German Cardiac Marker Test Market, 2000-2010 34
Table 3.16: U.K. Cardiac Marker Market, 2001-2010 35
Table 3.17: Major U.K. IVD Manufacturers 35
Table 3.18: U.S. IVD Manufacturers Doing Business in the U.K. 36
Table 3.19: Other European Companies that Manufacture IVD Products in the U.K. 36
Table 3.20: Italian Cardiac Marker Market, 2001-2010 37
Table 3.21: French Cardiac Marker Market, 2001-2010 37
Table 3.22: Spanish Cardiac Marker Market, 2001-2010 38
Table 3.23: Japanese Cardiac Marker Diagnostic Testing Market, 2001-2010 39
Table 3.24: Chinese Diagnostics Products Market, 2000-2010 40
Table 3.25: ER Admissions in the U.S., 1997-2004 44
Table 3.26: Common Causes of Chest Pain 45
Table 3.27: Rate of Inappropriate Discharge from the ER for Patients with AMI 45
Table 3.28: Continuing Analytical Issues for Implementation of Cardiac Troponin 48
Table 3.29: Global Cardiac Troponin Marker Market, 2001-2010 49
Table 3.30: U.S. Cardiac Troponin Marker Market, 2001-2010 49
Table 3.31: Trends in U.S. Sales of POC Cardiac Marker Tests, 1998-2005 50
Table 3.32: World Revenue from CK-MB Markets, 2001-2010 55
Table 3.33: U.S. Revenue from CK-MB Markets, 2001-2010 55
Table 3.34: World Myoglobin Market Revenues, 2001-2010 56
Table 3.35: U.S. Myoglobin Market Revenues, 2001-2010 56
Table 3.36: BNP Clinical Characteristics 59
Table 3.37: Worldwide Sales of BNP Diagnostic Tests, 2004-2010 60
Table 3.38: U.S. Sales of BNP Diagnostic Tests, 2004-2010 60
Table 3.39: Commercial BNP Assays in the U.S. 63
Table 3.40: Market Share of BNP Assays in the U.S. 64
Table 3.41: Market Share of NT-proBNP Assays in the U.S. 64
Table 3.42: Diagnostic Products Cardiac Marker Diagnostic Assays 79
Table 3.43: Cardiac Markers: Sampling Frequency 81
Table 3.44: Products Marketed by LifeSign 84
Table 4.1: HDL Levels in Adults 90
Table 4.2: LDL Levels in Adults 91
Table 4.3: LDL Screening Management Rates-Percent of Patient Population 91
Table 4.4: Number of U.S. Cholesterol Tests, 2000-2010 92
Table 4.5: World CRP Market Revenue, 2001-2010 95
Table 4.6: U.S. CRP Market Revenue, 2001-2010 95
Table 4.7: Clinical Characteristics of D-Dimer 96
Table 5.1: POCT in Two Hospitals Cost Analysis with Labor Included 107
Table 5.2: Cost Analysis for Glucose Testing: POCT vs. Central Lab 107
Table 5.3: Financial Comparison for Moderate and Waived CLIA Labs 108
Table 5.4: POCT Clinical Outcomes in AMI 110
Table 7.1: Oxidative Biomarker Research Assay Market Size 128
Table 7.2: Non-Lipid Markers of CVD 132
Table 8.1: Products Marketed by Abbott in the Diagnostic Market 140
Table 8.2: Products Marketed by Biosite in the Diagnostic Market 149


Summary: The purpose of this report is to describe the specific market segment of the in vitro diagnostics (IVD) market called cardiac marker testing. It examines these clinical measurement devices and their reagents and supplies as utilized used in hospitals, clinics, and doctors’ offices. This report is arranged to provide the reader with an overview of the outstanding diagnostic test market segments of cardiac care, and with evidence that these segments are poised for high future growth. Each segment is accompanied by analysis and forecasts by product type and application.




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