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Cardiac Marker Diagnostic Testing Markets

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 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.Overview6
  • 1.1Statement of Report6
  • 1.2Objectives of This Report6
  • 1.3Scope of This Report8
  • 1.4Methodology8
  • 1.5Executive Summary8
  
  
• 2.Introduction11
  • 2.1Global Diagnostic Products Industry11
  • 2.2Barriers to Entry14
  • 2.3Company Evaluation Overview15
  • 2.4Market Outlook16
  • 2.5Technologies and Products that are the Most Successful in the New IVD Environment16
  
  
• 3.Cardiac Marker Testing Markets: Market Segment Analysis: Size, Growth and Share18
  • 3.1Global Cardiac Marker Diagnostic Testing Markets18
    • 3.1.1Clinical Utility of Cardiac Markers22
    • 3.1.2Market Drivers in the Cardiac Marker Diagnostics Testing Sector24
    • 3.1.3Market Restraints in Cardiac Marker Testing Segment24
    • 3.1.4Principal Market Segments for Cardiac Marker Testing24
    • 3.1.5Key Players in the Cardiac Marker Diagnostics Testing Segment25
    • 3.1.6Cardiac Marker Testing Sector Analysis26
    • 3.1.7Cardiac Marker Market Share26
  • 3.2U.S. Cardiac Marker Testing Market26
    • 3.2.1Market Overview26
    • 3.2.2Diagnostic Test Categories27
    • 3.2.3U.S. Hospital POC Cardiac Markers28
  • 3.3European Cardiac Marker Diagnostic Test Market29
    • 3.3.1German Diagnostic Markets32
    • 3.3.2U.K. Diagnostic Testing Market33
      • 3.3.2.1U.K. Market Statistics33
      • 3.3.2.2U.K. Competitive Analysis34
      • 3.3.2.3U.K. Market Access35
    • 3.3.3Italy35
    • 3.3.4France36
    • 3.3.5Spain36
    • 3.3.6Belgium36
    • 3.3.7Switzerland37
    • 3.3.8Barriers to Entry to European Market37
  • 3.4Japanese Diagnostic Testing Market37
  • 3.5Chinese Diagnostic Testing Market37
  • 3.6Canadian Diagnostic Market40
  • 3.7Cardiac Marker Testing Individual Markets40
    • 3.7.1Clinical Overview40
    • 3.7.2Cardiac Acute Disease Markers41
    • 3.7.3Market Overview42
      • 3.7.3.1AMI and Troponins44
      • 3.7.3.2Market Size and Growth Projections47
      • 3.7.3.3Clinical Use of Cardiac Troponins48
      • 3.7.3.4TnI and TnT Market Drivers51
      • 3.7.3.5TnI and TnT Market Restraints51
      • 3.7.3.6New Tests for Troponin52
    • 3.7.4CK-MB and Cardiac Enzymes52
      • 3.7.4.1CK Enzymes52
      • 3.7.4.2Market Size and Growth Projections53
      • 3.7.4.3CK-MB: Market Drivers54
      • 3.7.4.4CK-MB: Market Restraints54
    • 3.7.5Myoglobin54
      • 3.7.5.1Market Size and Growth Projections54
      • 3.7.5.2Clinical Use of Myoglobin55
      • 3.7.5.3Myoglobin Market Drivers56
      • 3.7.5.4Myoglobin Market Restraints56
    • 3.7.6BNP56
      • 3.7.6.1Market Overview56
      • 3.7.6.2Market Size and Growth Projections58
      • 3.7.6.3Commercial Assays for BNP and NT-proBNP58
      • 3.7.6.4Competitive Landscape60
      • 3.7.6.5BNP Test Market Share60
      • 3.7.6.6Clinical Applications of BNP62
      • 3.7.6.7BNP Market Drivers64
      • 3.7.6.8BNP Market Restraints65
    • 3.7.7Albumin65
      • 3.7.7.1Intact Albumin65
      • 3.7.7.2Albumin Cobalt Binding Test65
      • 3.7.7.3Ischemic Modified Albumin66
      • 3.7.7.4Microalbuminuria68
    • 3.7.8Key Players in Cardiac Markers68
    • 3.7.9Cardiac Marker Controls77
    • 3.7.10Evaluation of Cardiac Markers77
    • 3.7.11Cardiac Markers Use in Clinical Decisions78
    • 3.7.12Status of Cardiac Markers in the ER78
    • 3.7.13Cardiac Markers in Renal Failure78
    • 3.7.14Troponins in Non-Ischemic Heart Disease79
    • 3.7.15Market Restraints79
    • 3.7.16Market Drivers80
    • 3.7.17Cardiac Panels80
    • 3.7.18POC Cardiac Markers80
      • 3.7.18.1Market Size and Growth Rate80
      • 3.7.18.2Market Restraints81
      • 3.7.18.3The Next Wave82
      
      
• 4.Cardiovascular Disease Markers86
  • 4.1Cholesterol, HDL and LDL86
    • 4.1.1Cholesterol Testing Market Forecasts87
    • 4.1.2Cholesterol Market Growth Drivers87
    • 4.1.3Market Outlook: U.S. Market Analysis87
    • 4.1.4Trends and Issues88
    • 4.1.5Key Players in the Cholesterol OTC Kit Market88
  • 4.2Homocysteine88
  • 4.3Fibrinogen89
  • 4.4C-Reactive Protein89
  • 4.5Lipoprotein Fractions91
  • 4.6Pulmonary Embolism (D-Dimer Test)92
  • 4.7Oxidized LDL and HDL92
  • 4.8Stroke92
  
  
• 5.Cardiac Marker Testing Development Issues94
  • 5.1Genetic Testing and Personalized Medicine94
  • 5.2Preventive Medicine94
  • 5.3Patient Safety and Quality Measures94
  • 5.4Reimbursement95
  • 5.5Cardiovascular97
  • 5.6Screening for Diabetes97
  • 5.7Other Reimbursement Concerns98
    • 5.7.1Reimbursement for Routine Venipuncture98
    • 5.7.2Japanese Reimbursements for Medical Devices98
  • 5.8CPT Test Codes and Payment Amounts98
  • 5.9Rapid Near-Patient Testing in Hospitals99
  • 5.10Satellite Facilities99
  • 5.11Regionalization of Laboratory Care100
  • 5.12Requirements for POCT101
    • 5.12.1Benefits of POCT102
    • 5.12.2Turnaround Time for POCT103
  • 5.13Clinical Laboratory Improvement Amendments (CLIA)103
  • 5.14Quality Assurance Issues104
  • 5.15Political Control105
  • 5.16Regulatory Requirements105
  • 5.17Recordkeeping and Data Management105
    • 5.17.1Effectiveness of Clinical Outcomes105
    
    
• 6.Business Trends in the Industry106
  • 6.1Sector Consolidation106
  • 6.2Diagnostic Testing Growth Trends106
  • 6.3Acquisition, License Agreements, Internal Development and Partnerships108
  • 6.4Product Testing Depth in Cardiac Marker Testing111
  • 6.5Government Regulation111
    • 6.5.1U.S. Regulation111
      • 6.5.1.1Importing Medical Devices into the U.S.112
      • 6.5.1.2Exporting Medical Devices from the U.S.113
    • 6.5.2U.K. Regulations113
    • 6.5.3E.U. Regulations114
    • 6.5.4Japanese Regulations115
    • 6.5.5Chinese Regulations116
  • 6.6Barriers to Growth117
  • 6.7Drivers of Growth117
  • 6.8Product Launches and Developments117
  
  
• 7.Important Technology Trends119
  • 7.1Trends in Cardiac Marker Diagnostic Testing119
    • 7.1.1Fatty Acid Binding Protein120
    • 7.1.2Glycogen Phosphorylase Isoenzyme BB120
    • 7.1.3S-100 Protein120
    • 7.1.4Cobalt-Binding Albumin120
    • 7.1.5Myosin Light Chains121
  • 7.2Cardiac Biomarker Research121
    • 7.2.1Myeloperoxidase121
    • 7.2.2Glutathione Peroxidase122
    • 7.2.3Antioxidant Biomarkers122
    • 7.2.4Oxidative Biomarkers122
    • 7.2.5Inflammatory Biomarkers123
    • 7.2.6Nitrosative Biomarkers123
    • 7.2.7Hemostatic Biomarkers124
  • 7.3Potential Stroke Markers124
    • 7.3.1Pharmacogenomics: Cardiovascular Drugs and Proteomic Markers125
    • 7.3.2Cardiac Proteomics125
    • 7.3.3Drivers for Cardiovascular Proteomic Markers125
    • 7.3.4Barriers to Cardiovascular Proteomic Markers126
  • 7.4Future Developments for Cardiovascular Markers126
  • 7.5Research Questions126
    • 7.5.1Roche\'s Biomarker Strategy129
    • 7.5.2Biomarkers for Unstable Angina130
  • 7.6Lp-PLA2130
  • 7.7Urotensin131
  
  
• 8.Company Profiles132
  • 8.1Abbott Laboratories132
  • 8.2Ani Biotech136
  • 8.3Axis-Shield137
  • 8.4Bayer Corporation138
  • 8.5Beckman Coulter139
  • 8.6Biosite, Inc. (now a brand of Inverness Medical Innovations)141
  • 8.7Inverness Medical Innovations144
  • 8.8Johnson & Johnson146
  • 8.9LifeSign146
  • 8.10Olympus America146
  • 8.11PreMD, Inc.147
  • 8.12Randox Laboratories147
  • 8.13Response Biomedical147
  • 8.14Roche Diagnostics148
  • 8.16Sierra Resources International152
  • 8.17Spectral Diagnostics, Inc.152
  
  
  

 

LIST OF FIGURES

Figure 2.1: Lab Industry Market Share13

Figure 2.2: Market Share of Major Lab Testing Segments14

LIST OF TABLES

Table 2.1: World Population and Growth, 2000-202411

Table 2.2: Worldwide Market Share IVD Companies12

Table 2.3: U.S. In Vitro Central Lab Diagnostic Testing, 2001-200713

Table 2.4: Worldwide Near-Patient Diagnostic Testing, 2001-200713

Table 3.1: Cardiac Marker Markets by Country, 2002-201018

Table 3.2: Total Global Cardiac Marker Market, 2002-201018

Table 3.3: Overall IVD Testing Market Worldwide, 200720

Table 3.4: Worldwide Distribution of IVD Testing, 200720

Table 3.5: Top 12 Countries for IVD Testing Markets, 200720

Table 3.6: Eight Largest Diagnostic Companies Worldwide, 200721

Table 3.7: Cardiac Markers23

Table 3.8: Market Share of Cardiac Marker Segment26

Table 3.9: U.S. Cardiac Marker Market, 2001-201027

Table 3.10: U.S. Cardiac Marker Diagnostic Testing Market Segments, 200727

Table 3.11: U.S. POC Cardiac Marker Sales, 2001-201028

Table 3.12: The Cardiac Marker Market for Diagnostic Testing in Europe, 2001-201030

Table 3.13: Regional Comparison of Healthcare and IVD Expenditures31

Table 3.14: German Diagnostics Products Market Sales, 1997-200832

Table 3.15: The German Cardiac Marker Test Market, 2000-201032

Table 3.16: U.K. Cardiac Marker Market, 2001-201034

Table 3.17: Major U.K. IVD Manufacturers34

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, 2001-201035

Table 3.21: French Cardiac Marker Market, 2001-201036

Table 3.22: Spanish Cardiac Marker Market, 2001-201036

Table 3.23: Japanese Cardiac Marker Diagnostic Testing Market, 2001-201037

Table 3.24: Chinese Diagnostics Products Market, 2000-201038

Table 3.25: ER Admissions in the U.S., 1997-200543

Table 3.26: Common Causes of Chest Pain43

Table 3.27: Rate of Inappropriate Discharge from the ER for Patients with AMI44

Table 3.28: Continuing Analytical Issues for Implementation of Cardiac Troponin46

Table 3.29: Global Cardiac Troponin Marker Market, 2001-201047

Table 3.30: U.S. Cardiac Troponin Marker Market, 2001-201048

Table 3.31: Trends in U.S. Sales of POC Cardiac Marker Tests, 1998-200748

Table 3.32: World Revenue from CK-MB Markets, 2001-201053

Table 3.33: U.S. Revenue from CK-MB Markets, 2001-201053

Table 3.34: World Myoglobin Market Revenues, 2001-201054

Table 3.35: U.S. Myoglobin Market Revenues, 2001-201055

Table 3.36: BNP Clinical Characteristics57

Table 3.37: Worldwide Sales of BNP Diagnostic Tests, 2004-201058

Table 3.38: U.S. Sales of BNP Diagnostic Tests, 2004-201058

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 Assays76

Table 3.43: Cardiac Markers: Sampling Frequency77

Table 3.44: Cardiac Marker Products by LifeSign80

Table 4.1: HDL Levels in Adults86

Table 4.2: LDL Levels in Adults87

Table 4.3: LDL Screening Management Rates-Percent of Patient Population87

Table 4.4: Number of U.S. Cholesterol Tests, 2000-201088

Table 4.5: World CRP Market Revenue, 2001-201090

Table 4.6: U.S. CRP Market Revenue, 2001-201091

Table 4.7: Clinical Characteristics of D-Dimer92

Table 5.1: POCT in Two Hospitals Cost Analysis with Labor Included102

Table 5.2: Cost Analysis for Glucose Testing: POCT vs. Central Lab102

Table 5.3: Financial Comparison for Moderate and Waived CLIA Labs103

Table 5.4: POCT Clinical Outcomes in AMI105

Table 7.1: Oxidative Biomarker Research Assay Market Size123

Table 7.2: Non-Lipid Markers of CVD127

Table 8.1: Products Marketed by Abbott in the Diagnostic Market135

Table 8.2: Products Marketed by Biosite in the Diagnostic Market143

 

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