Cardiac Marker Diagnostic Testing Markets

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
  • 3.1.7 Cardiac Marker Market Share
• 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
    • 3.7.3.6 New Tests for Troponin
  • 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 BNP
    • 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
    • 3.7.6.7 BNP Market Drivers
    • 3.7.6.8 BNP Market Restraints
  • 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 Cardiac Marker Controls
  • 3.7.10 Evaluation of Cardiac Markers
  • 3.7.11 Cardiac Markers Use in Clinical Decisions
  • 3.7.12 Status of Cardiac Markers in the ER
  • 3.7.13 Cardiac Markers in Renal Failure
  • 3.7.14 Troponins in Non-Ischemic Heart Disease
  • 3.7.15 Market Restraints
  • 3.7.16 Market Drivers
  • 3.7.17 Cardiac Panels
  • 3.7.18 POC Cardiac Markers
    • 3.7.18.1 Market Size and Growth Rate
    • 3.7.18.2 Market Restraints
    • 3.7.18.3 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 OTC 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 Quality Assurance Issues
• 5.15 Political Control
• 5.16 Regulatory Requirements
• 5.17 Recordkeeping and Data Management
  • 5.17.1 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
• 6.8 Product Launches and Developments

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

• 8.1 Abbott Laboratories
• 8.2 Ani Biotech
• 8.3 Axis-Shield
• 8.4 Bayer Corporation
• 8.5 Beckman Coulter
• 8.6 Biosite, Inc. (now a brand of Inverness Medical Innovations)
• 8.7 Inverness Medical Innovations
• 8.8 Johnson & Johnson
• 8.9 LifeSign
• 8.10 Olympus America
• 8.11 PreMD, Inc.
• 8.12 Randox Laboratories
• 8.13 Response Biomedical
• 8.14 Roche Diagnostics
• 8.16 Sierra Resources International
• 8.17 Spectral Diagnostics, Inc.

• Figure 2.1: Lab Industry Market Share
• Figure 2.2: Market Share of Major Lab Testing Segments

• Table 2.1: World Population and Growth, 2000-2024
• Table 2.2: Worldwide Market Share IVD Companies
• Table 2.3: U.S. In Vitro Central Lab Diagnostic Testing, 2001-2007
• Table 2.4: Worldwide Near-Patient Diagnostic Testing, 2001-2007
• Table 3.1: Cardiac Marker Markets by Country, 2002-2010
• Table 3.2: Total Global Cardiac Marker Market, 2002-2010
• Table 3.3: Overall IVD Testing Market Worldwide, 2007
• Table 3.4: Worldwide Distribution of IVD Testing, 2007
• Table 3.5: Top 12 Countries for IVD Testing Markets, 2007
• Table 3.6: Eight Largest Diagnostic Companies Worldwide, 2007
• Table 3.7: Cardiac Markers
• Table 3.8: Market Share of Cardiac Marker Segment
• Table 3.9: U.S. Cardiac Marker Market, 2001-2010
• Table 3.10: U.S. Cardiac Marker Diagnostic Testing Market Segments, 2007
• Table 3.11: U.S. POC Cardiac Marker Sales, 2001-2010
• Table 3.12: The Cardiac Marker Market for Diagnostic Testing in Europe, 2001-2010
• Table 3.13: Regional Comparison of Healthcare and IVD Expenditures
• Table 3.14: German Diagnostics Products Market Sales, 1997-2008
• Table 3.15: The German Cardiac Marker Test Market, 2000-2010
• Table 3.16: U.K. Cardiac Marker Market, 2001-2010
• Table 3.17: Major U.K. IVD Manufacturers
• Table 3.18: U.S. IVD Manufacturers Doing Business in the U.K.
• Table 3.19: Other European Companies that Manufacture IVD Products in the U.K.
• Table 3.20: Italian Cardiac Marker Market, 2001-2010
• Table 3.21: French Cardiac Marker Market, 2001-2010
• Table 3.22: Spanish Cardiac Marker Market, 2001-2010
• Table 3.23: Japanese Cardiac Marker Diagnostic Testing Market, 2001-2010
• Table 3.24: Chinese Diagnostics Products Market, 2000-2010
• Table 3.25: ER Admissions in the U.S., 1997-2005
• Table 3.26: Common Causes of Chest Pain
• Table 3.27: Rate of Inappropriate Discharge from the ER for Patients with AMI
• Table 3.28: Continuing Analytical Issues for Implementation of Cardiac Troponin
• Table 3.29: Global Cardiac Troponin Marker Market, 2001-2010
• Table 3.30: U.S. Cardiac Troponin Marker Market, 2001-2010
• Table 3.31: Trends in U.S. Sales of POC Cardiac Marker Tests, 1998-2007
• Table 3.32: World Revenue from CK-MB Markets, 2001-2010
• Table 3.33: U.S. Revenue from CK-MB Markets, 2001-2010
• Table 3.34: World Myoglobin Market Revenues, 2001-2010
• Table 3.35: U.S. Myoglobin Market Revenues, 2001-2010
• Table 3.36: BNP Clinical Characteristics
• Table 3.37: Worldwide Sales of BNP Diagnostic Tests, 2004-2010
• Table 3.38: U.S. Sales of BNP Diagnostic Tests, 2004-2010
• Table 3.39: Commercial BNP Assays in the U.S.
• Table 3.40: Market Share of BNP Assays in the U.S.
• Table 3.41: Market Share of NT-proBNP Assays in the U.S.
• Table 3.42: Siemens Healthcare Diagnostics Cardiac Marker Assays
• Table 3.43: Cardiac Markers: Sampling Frequency
• Table 3.44: Cardiac Marker Products by LifeSign
• Table 4.1: HDL Levels in Adults
• Table 4.2: LDL Levels in Adults
• Table 4.3: LDL Screening Management Rates-Percent of Patient Population
• Table 4.4: Number of U.S. Cholesterol Tests, 2000-2010
• Table 4.5: World CRP Market Revenue, 2001-2010
• Table 4.6: U.S. CRP Market Revenue, 2001-2010
• Table 4.7: Clinical Characteristics of D-Dimer
• Table 5.1: POCT in Two Hospitals Cost Analysis with Labor Included
• Table 5.2: Cost Analysis for Glucose Testing: POCT vs. Central Lab
• Table 5.3: Financial Comparison for Moderate and Waived CLIA Labs
• Table 5.4: POCT Clinical Outcomes in AMI
• Table 7.1: Oxidative Biomarker Research Assay Market Size
• Table 7.2: Non-Lipid Markers of CVD
• Table 8.1: Products Marketed by Abbott in the Diagnostic Market
• Table 8.2: Products Marketed by Biosite in the Diagnostic Market