Cardiac Marker Diagnostic Testing Markets - Market Research Reports

Contents:

1. Overview
1.1 Statement of Report
1.2 Objectives of This Report
1.3 Scope of This Report
1.4 Methodology
1.5 Executive Summary

2. Introduction
2.1 Global Diagnostic Products Industry
2.2 Barriers to Entry
2.3 Company Evaluation Overview
2.4 Market Outlook
2.5 Technologies and Products that are the Most Successful in the New IVD Environment

3. Cardiac Marker Testing Markets: Market Segment Analysis: Size, Growth and Share
3.1 Global Cardiac Marker Diagnostic Testing Markets
3.1.1 Clinical Utility of Cardiac Markers
3.1.2 Market Drivers in the Cardiac Marker Diagnostics Testing Sector
3.1.3 Market Restraints in Cardiac Marker Testing Segment
3.1.4 Principal Market Segments for Cardiac Marker Testing
3.1.5 Key Players in the Cardiac Marker Diagnostics Testing Segment
3.1.6 Cardiac Marker Testing Sector Analysis
3.2 U.S. Cardiac Marker Testing Market
3.2.1 Market Overview
3.2.2 Diagnostic Test Categories
3.2.3 U.S. Hospital POC Cardiac Markers
3.3 European Cardiac Marker Diagnostic Test Market
3.3.1 German Diagnostic Markets
3.3.2 U.K. Diagnostic Testing Market
3.3.2.1 U.K. Market Statistics
3.3.2.2 U.K. Competitive Analysis
3.3.2.3 U.K. Market Access
3.3.3 Italy
3.3.4 France
3.3.5 Spain
3.3.6 Belgium
3.3.7 Switzerland
3.3.8 Barriers to Entry to European Market
3.4 Japanese Diagnostic Testing Market
3.5 Chinese Diagnostic Testing Market
3.6 Canadian Diagnostic Market
3.7 Cardiac Marker Testing Individual Markets
3.7.1 Clinical Overview
3.7.2 Cardiac Acute Disease Markers
3.7.3 Market Overview
3.7.3.1 AMI and Troponins
3.7.3.2 Market Size and Growth Projections
3.7.3.3 Clinical Use of Cardiac Troponins
3.7.3.4 TnI and TnT Market Drivers
3.7.3.5 TnI and TnT Market Restraints
3.7.4 CK-MB and Cardiac Enzymes
3.7.4.1 CK Enzymes
3.7.4.2 Market Size and Growth Projections
3.7.4.3 CK-MB: Market Drivers
3.7.4.4 CK-MB: Market Restraints
3.7.5 Myoglobin
3.7.5.1 Market Size and Growth Projections
3.7.5.2 Clinical Use of Myoglobin
3.7.5.3 Myoglobin Market Drivers
3.7.5.4 Myoglobin Market Restraints
3.7.6 Natriuretic Peptides
3.7.6.1 Market Overview
3.7.6.2 Market Size and Growth Projections
3.7.6.3 Commercial Assays for BNP and NT-proBNP
3.7.6.4 Competitive Landscape
3.7.6.5 BNP Test Market Share
3.7.6.6 Clinical Applications of BNP/NT-proBNP
3.7.6.7 BNP NT-proBNP Market Drivers
3.7.6.8 BNP NT-proBNP Market Restraints
3.7.6.9 Future Projections and Trends of NP testing
3.7.7 Albumin
3.7.7.1 Intact Albumin
3.7.7.2 Albumin Cobalt Binding Test
3.7.7.3 Ischemic Modified Albumin
3.7.7.4 Microalbuminuria
3.7.8 Key Players in Cardiac Markers
3.7.9 Evaluation of Cardiac Markers
3.7.10 Cardiac Markers Use in Clinical Decisions
3.7.11 Status of Cardiac Markers in the ER
3.7.12 Cardiac Markers in Renal Failure
3.7.13 Troponins in Non-Ischemic Heart Disease
3.7.14 Market Restraints
3.7.15 Market Drivers
3.7.16 Cardiac Panels
3.7.17 POC Cardiac Markers
3.7.17.1 Market Size and Growth Rate
3.7.17.2 Market Restraints
3.7.17.3 The Next Wave

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

5. Cardiac Marker Testing Development Issues
5.1 Genetic Testing and Personalized Medicine
5.2 Preventive Medicine
5.3 Patient Safety and Quality Measures
5.4 Reimbursement
5.5 Cardiovascular
5.6 Screening for Diabetes
5.7 Other Reimbursement Concerns
5.7.1 Reimbursement for Routine Venipuncture
5.7.2 Japanese Reimbursements for Medical Devices
5.8 CPT Test Codes and Payment Amounts
5.9 Rapid Near-Patient Testing in Hospitals
5.10 Satellite Facilities
5.11 Regionalization of Laboratory Care
5.12 Requirements for POCT
5.12.1 Benefits of POCT
5.12.2 Turnaround Time for POCT
5.13 Clinical Laboratory Improvement Amendments (CLIA)
5.14 Regulatory Requirements
5.15 Record-keeping and Data Management
5.15.1 Effectiveness of Clinical Outcomes

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

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

8. Company Profiles
8.1 Abbott Laboratories
8.2 Alere
8.3 Ani Biotech
8.4 Axis-Shield
8.5 Bayer Corporation
8.6 Beckman Coulter (now part of Danaher)
8.7 Biosite, Inc. (now a brand of Alere)
8.8 Johnson & Johnson
8.9 LifeSign
8.10 PreMD, Inc.
8.11 Randox Laboratories
8.12 Response Biomedical
8.13 Roche Diagnostics
8.14 Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics, Diagnostic Products Corporation, and Dade Behring)
8.15 Sierra Resources International
8.16 Spectral Diagnostics, Inc.

INDEX OF FIGURES

Figure 2.1: Lab Industry Market Share 16
Figure 2.2: Market Share of Major Lab Testing Segments 16
Figure 3.1: Worldwide Distribution of IVD Testing, 2010 22

INDEX OF TABLES

Table 2.1: World Population and Growth, 2000-2024 13
Table 2.2: Worldwide Market Share IVD Companies 14
Table 2.3: Global Clinical Laboratory Market Sales, 1998-2011 15
Table 2.4: U.S. In Vitro Central Lab Diagnostic Testing, 2003-2012 15
Table 2.5: Global Point of Care Revenues, 2005-2012 15
Table 3.1: Cardiac Marker Markets by Country, 2002-2010 20
Table 3.2: Total Global Cardiac Marker Market, 2002-2010 20
Table 3.3: Overall IVD Testing Market Worldwide, 2010 22
Table 3.4: Worldwide Distribution of IVD Testing, 2010 22
Table 3.5: Top 12 Countries for IVD Testing Markets, 2010 23
Table 3.6: Eight Largest Diagnostic Companies Worldwide, 2010 23
Table 3.7: Cardiac Markers 25
Table 3.8: Market Share of Cardiac Marker Segment 29
Table 3.9: U.S. Cardiac Marker Market, 2001-2010 29
Table 3.10: U.S. Cardiac Marker Diagnostic Testing Market Segments, 2010 30
Table 3.11: U.S. POC Cardiac Marker Sales, 2001-2010 31
Table 3.12: Cardiac Marker Market for Diagnostic Testing in Europe, 2001-2010 32
Table 3.13: Regional Comparison of Healthcare and IVD Expenditures 34
Table 3.14: German Diagnostics Products Market Sales, 1997-2008 35
Table 3.15: German Cardiac Marker Test Market, 2000-2010 35
Table 3.16: U.K. Cardiac Marker Market, 2001-2010 36
Table 3.17: Major U.K. IVD Manufacturers 37
Table 3.18: U.S. IVD Manufacturers Doing Business in the U.K. 37
Table 3.19: Other European Companies that Manufacture IVD Products in the U.K. 37
Table 3.20: Italian Cardiac Marker Market, 2001-2010 38
Table 3.21: French Cardiac Marker Market, 2001-2010 38
Table 3.22: Spanish Cardiac Marker Market, 2001-2010 39
Table 3.23: Japanese Cardiac Marker Diagnostic Testing Market, 2001-2010 40
Table 3.24: Chinese Diagnostics Products Market, 2000-2010 41
Table 3.25: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2010 46
Table 3.26: Common Causes of Chest Pain 46
Table 3.27: Rate of Inappropriate Discharge from the ER for Patients with AMI 47
Table 3.28: Continuing Analytical Issues for Implementation of Cardiac Troponin 49
Table 3.29: Global Cardiac Troponin Marker Market, 2001-2010 50
Table 3.30: U.S. Cardiac Troponin Marker Market, 2001-2010 51
Table 3.31: Trends in U.S. Sales of POC Cardiac Marker Tests, 1998-2010 51
Table 3.32: World Revenue from CK-MB Markets, 2001-2010 56
Table 3.33: U.S. Revenue from CK-MB Markets, 2001-2010 56
Table 3.34: World Myoglobin Market Revenues, 2001-2010 57
Table 3.35: U.S. Myoglobin Market Revenues, 2001-2010 58
Table 3.36: BNP Clinical Characteristics 60
Table 3.37: Worldwide Sales of BNP Diagnostic Tests, 2004-2010 61
Table 3.38: U.S. Sales of BNP Diagnostic Tests, 2004-2010 61
Table 3.39: Analytical Characteristics of Commercial BNP Assays per Manufacturer 63
Table 3.40: Analytical Characteristics of Commercial NT-proBNP Assays per Manufacturer 64
Table 3.41: Market Share of BNP Assays in the U.S. 65
Table 3.42: Market Share of NT-proBNP Assays in the U.S. 65
Table 3.43: U.S. Hospital Share Estimates of NP Usage 66
Table 4.1: HDL Levels in Adults 85
Table 4.2: LDL Levels in Adults 86
Table 4.3: LDL Screening Management Rates-Percent of Patient Population, 2004 86
Table 4.4: LDL Screening Management Rates-Percent of Patient Population, 2009 86
Table 4.5: Number of U.S. Cholesterol Tests, 2000-2010 87
Table 4.6: World CRP Market Revenue, 2001-2010 90
Table 4.7: U.S. CRP Market Revenue, 2001-2010 90
Table 4.8: Clinical Characteristics of D-Dimer 91
Table 5.1: POCT in Two Hospitals Cost Analysis with Labor Included 101
Table 5.2: Cost Analysis for Glucose Testing: POCT vs. Central Lab 101
Table 5.3: POCT Clinical Outcomes in AMI 104
Table 7.1: Oxidative Biomarker Research Assay Market Size 118
Table 7.2: Non-Lipid Markers of CVD 123
Table 8.1: Products Marketed by Abbott in the Diagnostic Market 129
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