Market Report Source

Overview

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
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. Company Profiles
8.1 Abbott Laboratories
8.2 Ani Biotech
8.3 Axis-Shield
8.4 Bayer Corporation
8.5 Beckman Coulter
8.6 Biosite, Inc.
8.7 Dade Behring
8.8 Diagnostic Products Corp.
8.9 Inverness Medical Innovations
8.10 Johnson & Johnson
8.11 LifeSign
8.12 Olympus America
8.13 PreMD, Inc.
8.14 Randox Laboratories
8.15 Response Biomedical
8.16 Roche Diagnostics
8.17 Sierra Resources International
8.18 Spectral Diagnostics, Inc.

LIST OF FIGURES

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

LIST OF TABLES

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, 2004
Table 3.4: Worldwide Distribution of IVD Testing, 2004
Table 3.5: Top 12 Countries for IVD Testing Markets, 2004
Table 3.6: Ten Largest Diagnostic Companies Worldwide
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, 2004
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, 1997-2007
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., 1997-2004
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, 1998-2005
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: Diagnostic Products Cardiac Marker Diagnostic Assays
Table 3.43: Cardiac Markers: Sampling Frequency
Table 3.44: Products Marketed 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