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Reportlinker Adds Cardiac Marker Diagnostic Testing Markets
Date:3/31/2011

NEW YORK, March 31, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Cardiac Marker Diagnostic Testing Markets

http://www.reportlinker.com/p089570/Cardiac-Marker-Diagnostic-Testing-Markets.html

The purpose of this TriMark Publications 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 doctor's 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.

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 9

2. Introduction 12

2.1 Global Diagnostic Products Industry 12

2.2 Barriers to Entry 16

2.3 Company Evaluation Overview 16

2.4 Market Outlook 17

2.5 Technologies and Products that are the Most Successful in the New IVD

Environment 17

3. Cardiac Marker Testing Markets: Market Segment Analysis: Size, Growth and

Share 19

3.1 Global Cardiac Marker Diagnostic Testing Markets 19

3.1.1 Clinical Utility of Cardiac Markers 24

3.1.2 Market Drivers in the Cardiac Marker Diagnostics Testing Sector 25

3.1.3 Market Restraints in Cardiac Marker Testing Segment 26

3.1.4 Principal Market Segments for Cardiac Marker Testing 26

3.1.5 Key Players in the Cardiac Marker Diagnostics Testing Segment 26

3.1.6 Cardiac Marker Testing Sector Analysis 27

3.2 U.S. Cardiac Marker Testing Market 28

3.2.1 Market Overview 28

3.2.2 Diagnostic Test Categories 29

3.2.3 U.S. Hospital POC Cardiac Markers 29

3.3 European Cardiac Marker Diagnostic Test Market 31

3.3.1 German Diagnostic Markets 33

3.3.2 U.K. Diagnostic Testing Market 35

3.3.2.1 U.K. Market Statistics 35

3.3.2.2 U.K. Competitive Analysis 36

3.3.2.3 U.K. Market Access 37

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 39

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 44

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 56

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 58

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 60

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 62

3.7.6.6 Clinical Applications of BNP 64

3.7.6.7 BNP Market Drivers 66

3.7.6.8 BNP Market Restraints 67

3.7.7 Albumin 67

3.7.7.1 Intact Albumin 67

3.7.7.2 Albumin Cobalt Binding Test 67

3.7.7.3 Ischemic Modified Albumin 68

3.7.7.4 Microalbuminuria 70

3.7.8 Key Players in Cardiac Markers 70

3.7.9 Cardiac Marker Controls 78

3.7.10 Evaluation of Cardiac Markers 78

3.7.11 Cardiac Markers Use in Clinical Decisions 79

3.7.12 Status of Cardiac Markers in the ER 79

3.7.13 Cardiac Markers in Renal Failure 80

3.7.14 Troponins in Non-Ischemic Heart Disease 80

3.7.15 Market Restraints 80

3.7.16 Market Drivers 81

3.7.17 Cardiac Panels 81

3.7.18 POC Cardiac Markers 81

3.7.18.1 Market Size and Growth Rate 82

3.7.18.2 Market Restraints 83

3.7.18.3 The Next Wave 84

4. Cardiovascular Disease Markers 87

4.1 Cholesterol, HDL and LDL 87

4.1.1 Cholesterol Testing Market Forecasts 88

4.1.2 Cholesterol Market Growth Drivers 88

4.1.3 Market Outlook: U.S. Market Analysis 88

4.1.4 Trends and Issues 89

4.1.5 Key Players in the Cholesterol OTC Kit Market 89

4.2 Homocysteine 89

4.3 Fibrinogen 90

4.4 C-Reactive Protein 90

4.5 Lipoprotein Fractions 92

4.6 Pulmonary Embolism (D-Dimer Test) 93

4.7 Oxidized LDL and HDL 93

4.8 Stroke 93

5. Cardiac Marker Testing Development Issues 95

5.1 Genetic Testing and Personalized Medicine 95

5.2 Preventive Medicine 95

5.3 Patient Safety and Quality Measures 95

5.4 Reimbursement 96

5.5 Cardiovascular 98

5.6 Screening for Diabetes 98

5.7 Other Reimbursement Concerns 99

5.7.1 Reimbursement for Routine Venipuncture 99

5.7.2 Japanese Reimbursements for Medical Devices 99

5.8 CPT Test Codes and Payment Amounts 99

5.9 Rapid Near-Patient Testing in Hospitals 100

5.10 Satellite Facilities 100

5.11 Regionalization of Laboratory Care 101

5.12 Requirements for POCT 102

5.12.1 Benefits of POCT 103

5.12.2 Turnaround Time for POCT 104

5.13 Clinical Laboratory Improvement Amendments (CLIA) 104

5.14 Quality Assurance Issues 105

5.15 Political Control 106

5.16 Regulatory Requirements 106

5.17 Recordkeeping and Data Management 106

5.17.1 Effectiveness of Clinical Outcomes 106

6. Business Trends in the Industry 107

6.1 Sector Consolidation 107

6.2 Diagnostic Testing Growth Trends 107

6.3 Acquisition, License Agreements, Internal Development and Partnerships 109

6.4 Product Testing Depth in Cardiac Marker Testing 112

6.5 Government Regulation 112

6.5.1 U.S. Regulation 112

6.5.1.1 Importing Medical Devices into the U.S. 113

6.5.1.2 Exporting Medical Devices from the U.S. 114

6.5.2 U.K. Regulations 114

6.5.3 E.U. Regulations 115

6.5.4 Japanese Regulations 116

6.5.5 Chinese Regulations 117

6.6 Barriers to Growth 118

6.7 Drivers of Growth 118

6.8 Product Launches and Developments 118

7. Important Technology Trends 120

7.1 Trends in Cardiac Marker Diagnostic Testing 120

7.1.1 Fatty Acid Binding Protein 121

7.1.2 Glycogen Phosphorylase Isoenzyme BB 121

7.1.3 S-100 Protein 121

7.1.4 Cobalt-Binding Albumin 121

7.1.5 Myosin Light Chains 122

7.2 Cardiac Biomarker Research 122

7.2.1 Myeloperoxidase 122

7.2.2 Glutathione Peroxidase 123

7.2.3 Antioxidant Biomarkers 123

7.2.4 Oxidative Biomarkers 123

7.2.5 Inflammatory Biomarkers 124

7.2.6 Nitrosative Biomarkers 124

7.2.7 Hemostatic Biomarkers 125

7.3 Potential Stroke Markers 125

7.3.1 Pharmacogenomics: Cardiovascular Drugs and Proteomic Markers 126

7.3.2 Cardiac Proteomics 126

7.3.3 Drivers for Cardiovascular Proteomic Markers 126

7.3.4 Barriers to Cardiovascular Proteomic Markers 127

7.4 Future Developments for Cardiovascular Markers 127

7.5 Research Questions 127

7.5.1 Roche's Biomarker Strategy 130

7.5.2 Biomarkers for Unstable Angina 131

7.6 Lp-PLA2 131

7.7 Urotensin 132

8. Company Profiles 133

8.1 Abbott Laboratories 133

8.2 Ani Biotech 137

8.3 Axis-Shield 138

8.4 Bayer Corporation 138

8.5 Beckman Coulter 140

8.6 Biosite, Inc. (now a brand of Inverness Medical Innovations) 142

8.7 Inverness Medical Innovations 144

8.8 Johnson & Johnson 146

8.9 LifeSign 147

8.10 PreMD, Inc. 147

8.11 Randox Laboratories 147

8.12 Response Biomedical 147

8.13 Roche Diagnostics 148

8.14 Sierra Resources International 152

8.15 Spectral Diagnostics, Inc. 152

LIST OF FIGURES

Figure 2.1: Lab Industry Market Share 15

Figure 2.2: Market Share of Major Lab Testing Segments 15

Figure 3.1: Worldwide Distribution of IVD Testing, 2010 21

LIST OF TABLES

Table 2.1: World Population and Growth, 2000-2024 12

Table 2.2: Worldwide Market Share IVD Companies 13

Table 2.3: Global Clinical Laboratory Market Sales, 1998-2011 14

Table 2.4: U.S. In Vitro Central Lab Diagnostic Testing, 2003-2012 14

Table 2.5: Global Point of Care Revenues, 2005-2012 14

Table 3.1: Cardiac Marker Markets by Country, 2002-2010 19

Table 3.2: Total Global Cardiac Marker Market, 2002-2010 19

Table 3.3: Overall IVD Testing Market Worldwide, 2010 21

Table 3.4: Worldwide Distribution of IVD Testing, 2010 21

Table 3.5: Top 12 Countries for IVD Testing Markets, 2010 22

Table 3.6: Eight Largest Diagnostic Companies Worldwide, 2010 22

Table 3.7: Cardiac Markers 24

Table 3.8: Market Share of Cardiac Marker Segment 28

Table 3.9: U.S. Cardiac Marker Market, 2001-2010 28

Table 3.10: U.S. Cardiac Marker Diagnostic Testing Market Segments, 2010 29

Table 3.11: U.S. POC Cardiac Marker Sales, 2001-2010 30

Table 3.12: Cardiac Marker Market for Diagnostic Testing in Europe, 2001-2010 31

Table 3.13: Regional Comparison of Healthcare and IVD Expenditures 33

Table 3.14: German Diagnostics Products Market Sales, 1997-2008 34

Table 3.15: 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 36

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 38

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: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2010 45

Table 3.26: Common Causes of Chest Pain 45

Table 3.27: Rate of Inappropriate Discharge from the ER for Patients with AMI 46

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 50

Table 3.31: Trends in U.S. Sales of POC Cardiac Marker Tests, 1998-2010 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 57

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. 63

Table 3.41: Market Share of NT-proBNP Assays in the U.S. 63

Table 3.42: Siemens Healthcare Diagnostics Cardiac Marker Assays 77

Table 3.43: Cardiac Markers: Sampling Frequency 79

Table 3.44: Cardiac Marker Products by LifeSign 81

Table 4.1: HDL Levels in Adults 87

Table 4.2: LDL Levels in Adults 88

Table 4.3: LDL Screening Management Rates-Percent of Patient Population 88

Table 4.4: Number of U.S. Cholesterol Tests, 2000-2010 89

Table 4.5: World CRP Market Revenue, 2001-2010 91

Table 4.6: U.S. CRP Market Revenue, 2001-2010 92

Table 4.7: Clinical Characteristics of D-Dimer 93

Table 5.1: POCT in Two Hospitals Cost Analysis with Labor Included 103

Table 5.2: Cost Analysis for Glucose Testing: POCT vs. Central Lab 103

Table 5.3: Financial Comparison for Moderate and Waived CLIA Labs 104

Table 5.4: POCT Clinical Outcomes in AMI 106

Table 7.1: Oxidative Biomarker Research Assay Market Size 124

Table 7.2: Non-Lipid Markers of CVD 128

Table 8.1: Products Marketed by Abbott in the Diagnostic Market 136

Table 8.2: Products Marketed by Biosite in the Diagnostic Market 144

To order this report:

: Cardiac Marker Diagnostic Testing Markets

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Nicolas Bombourg

Reportlinker

Email: nbo@reportlinker.com

US: (805)652-2626

Intl: +1 805-652-2626


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