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Cardiac Marker Diagnostic Testing Markets

  • ID: 3093610
  • January 2015
  • Region: Global
  • 194 Pages
  • TriMark Publications

FEATURED COMPANIES

  • Alere and SWOT Analysis
  • CardioGenics
  • LifeSign, LLC
  • PTS Diagnostics
  • Randox Laboratories Ltd.
  • Roche Diagnostics
  • MORE

Cardiac marker diagnostic testing measures the concentration of certain proteins, i.e., biomarkers, which indicate the presence or severity of cardiovascular disease (CVD). Among the most prevalent CVDs are sudden cardiac arrest (SCA), acute myocardial infarction (AMI), congestive heart failure (CHF) and atherosclerosis. Every year, an estimated 17 million people worldwide die from a CVD.

This report describes the specific market segment of the in vitro diagnostics (IVD) market devoted to cardiac marker testing, including size; growth; industry trends; product development and investment; and clinical measurement devices, reagents and supplies. Highly-attractive cardiac marker areas of growth covered in this review include: the cardiac rapid assay market, troponins, Creatine kinase-myocardial band (CK-MB) and brain natriuretic peptide (BNP) testing.

Also examined are heart failure, myoglobin, homocysteine (Hcy), C-reactive protein (CRP), pulmonary embolism (PE) (D-dimer test), low-density and high-density lipoproteins (LDL and HDL), stroke, cardiac enzymes, albumin, cardiac markers used in clinical decisions, cardiac markers in renal failure, cardiac panels and point of care (POC) cardiac markers.

This study also provides a thorough analysis of the companies known to be marketing, manufacturing or developing cardiac marker products in the U.S. and worldwide, as well as detailed tables, charts and figures covering the U.S., Europe and Asia markets.

Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • Alere and SWOT Analysis
  • CardioGenics
  • LifeSign, LLC
  • PTS Diagnostics
  • Randox Laboratories Ltd.
  • Roche Diagnostics
  • MORE

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. The Basics of Biomarkers

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 Cardiac Diagnostic Test Segments
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
3.3.3 Italy
3.3.4 France
3.3.5 Spain
3.3.6 Benelux
3.3.7 Scandinavia
3.3.8 Switzerland
3.3.9 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 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 Creatine Kinase (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
3.7.6.10 Future Use of BNP
3.7.7 Albumin
3.7.7.1 Ischemic Modified Albumin (IMA)
3.7.7.2 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 Testing 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
4.1.5.1 Review of Cholesterol Kit Company Products
4.1.5.1.1 Cholestech (Now Alere)
4.1.5.1.2 PTS Diagnostics CardioChek
4.1.5.1.3 Miraculins PREVUE POC Skin Cholesterol Test
4.1.5.1.4 Abaxis Piccolo Express
4.1.5.2 Product Comparison of Leading Suppliers
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 Screening Codes
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 POCT: Current Market Trends and Drivers
5.12.1 Effectiveness of POCT
5.12.2 New Growth Areas for POCT
5.12.3 Advantages of POCT in a Clinical Setting
5.12.4 Shifts from Central Lab Testing to POCT
5.12.5 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
6.5.2 CLIA Regulations
6.5.3 Clinical Laboratory Improvement Act
6.5.4 State Licensing for Service Laboratories
6.5.5 IVDMIAs
6.5.6 FDA Draft Guidance on In Vitro Companion Diagnostic Devices
6.5.7 510(k) Clearance
6.5.8 Pre-Market Approval
6.5.8.1 Pre-Market Approval Application
6.5.8.2 Importing Medical Devices into the U.S.
6.5.8.3 Exporting Medical Devices from the U.S.
6.5.9 E.U. Regulations
6.5.10 Japanese Regulations
6.5.11 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 Free Fatty Acids and Fatty Acid Binding Proteins
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
7.1.6 Emerging POCT Cardiac Marker Testing
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 Biomarker Development Strategies
7.5.2 Biomarkers for Unstable Angina
7.6 Lp-PLA2
7.7 Urotensin

8. Company Profiles
8.1 Abbott Laboratories and SWOT Analysis
8.2 Alere and SWOT Analysis
8.3 Beckman Coulter (now part of Danaher)
8.4 bioMérieux
8.5 Biosite, Inc. (now a brand of Alere)
8.6 CardioGenics
8.7 Chek Diagnostics
8.8 diaDexus and SWOT Analysis
8.9 Health-Chem Diagnostics (HCD)
8.10 Ortho-Clinical Diagnostics, Inc. and SWOT Analysis
8.11 LifeSign, LLC
8.12 PreMD, Inc.
8.13 PTS Diagnostics
8.14 Randox Laboratories Ltd.
8.15 Response Biomedical
8.16 Radiometer Medical
8.17 Roche Diagnostics
8.18 Sanyo Chemical Industries Ltd.
8.19 Siemens Healthcare Diagnostics
8.20 Sierra Resources International
8.21 Spectral Diagnostics, Inc.
8.22 Shionogi & Co., Ltd.

List of Figures:
Figure 3.1: Market Share of Cardiac Marker Segment
Figure 3.2: U.S. Cardiac Marker Diagnostic Testing Market Segments, 2014
Figure 3.3: U.S. POC Cardiac Marker Sales, 2010-2020
Figure 3.4: Cardiac Marker Market for Diagnostic Testing in Europe, 2010-2020
Figure 3.5: Cardiac Marker POCT Troponin Market Share by Product Type
Figure 3.6: Cardiac Marker POCT BNP Market Share by Product Type
Figure 4.1: Age-Adjusted Prevalence of High LDL Cholesterol Among Adults Aged 40-74, by Sex and Age in the U.S., 1976-2010
Figure 4.2: Age-Adjusted Trends in Prevalence of High LDL Cholesterol, Use of Cholesterol-Lowering Medications, and Low Saturated-Fat Intake Among Adults Aged 40-74 in the U.S.,1976-2010
Figure 5.1: CLIA Laboratories by Certificate Types
Figure 6.1: Current Conformity Assessment Route, Annexes and Quality System Standards by IVD Device Category
Figure 6.2: The Chinese Healthcare System

List of Tables:
Table 2.1: Cardiac Biomarkers of Inflammation and Atherogenesis
Table 2.2: Cardiac Biomarkers of Endothelial Function
Table 2.3: Cardiac Biomarkers of Thrombosis
Table 2.4: Cardiac Biomarkers of Ischemia/Necrosis
Table 2.5: Cardiac Biomarkers of Hemodynamic Stress
Table 2.6: Cardiac Biomarkers of Heart Failure Mortality
Table 2.7: Cardiac Biomarkers of Renal Dysfunction
Table 2.8: Cardiac Biomarkers of Metabolic/Lipid Dysregulation
Table 2.9: Cardiac Biomarkers of Brain Damage
Table 3.1: Cardiac Marker Markets by Country and Region, 2010-2020
Table 3.2: Cardiac Marker Markets by Country and Region, 2010-2020
Table 3.3: Total Global Cardiac Marker Market, 2010-2020
Table 3.4: Most Clinically Used Cardiac Markers
Table 3.5: Market Share of Cardiac Marker Segment
Table 3.6: U.S. Cardiac Marker Market, 2010-2020
Table 3.7: U.S. Cardiac Marker Diagnostic Testing Market Segments, 2014
Table 3.8: U.S. POC Cardiac Marker Sales, 2010-2020
Table 3.9: Cardiac Marker Market for Diagnostic Testing in Europe, 2010-2020
Table 3.10: Regional Comparison of Healthcare and IVD Expenditures
Table 3.11: German IVD Diagnostics Products Market Sales, 2010-2020
Table 3.12: German Cardiac Marker Test Market, 2010-2020
Table 3.13: U.K. IVD Diagnostics Products Market Sales, 2010-2020
Table 3.14: U.K. Cardiac Marker Market, 2010-2020
Table 3.15: Italian Cardiac Marker Market, 2010-2020
Table 3.16: French Cardiac Marker Market, 2010-2020
Table 3.17: Spanish Cardiac Marker Market, 2010-2020
Table 3.18: Benelux Cardiac Marker Market, 2010-2020
Table 3.19: Scandinavian Cardiac Marker Market, 2010-2020
Table 3.20: Swiss Cardiac Marker Market, 2010-2020
Table 3.21: Japanese Cardiac Marker Diagnostic Testing Market, 2010-2020
Table 3.22: Chinese Cardiac Marker Market, 2010-2020
Table 3.23: Canadian Cardiac Marker Market, 2010-2020
Table 3.24: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2014
Table 3.25: Common Causes of Chest Pain
Table 3.26: Rate of Inappropriate Discharge from the ER for Patients with AMI, 1984-2014
Table 3.27: Continuing Analytical Issues for Implementation of Cardiac Troponin
Table 3.28: Global Cardiac Troponin Marker Market, 2010-2020
Table 3.29: U.S. Cardiac Troponin Marker Market, 2010-2020
Table 3.30: Selected POC Cardiac Biomarkers, 2014
Table 3.31: Projections in U.S. Sales of POC Cardiac Marker Tests, 2010-2020
Table 3.32: Causes of Troponin Elevations
Table 3.33: World Revenue from CK-MB Markets, 2010-2020
Table 3.34: U.S. Revenue from CK-MB Markets, 2010-2020
Table 3.35: World Myoglobin Market Revenues, 2010-2020
Table 3.36: U.S. Myoglobin Market Revenues, 2010-2020
Table 3.37: BNP Clinical Characteristics
Table 3.38: Global Sales of BNP and NT-proBNP assays, 2010-2020
Table 3.39: U.S. Sales of BNP and NT-proBNP assays, 2010-2020
Table 3.40: FDA Approved BNP Assays
Table 3.41: FDA Approved NT-proBNP Assays
Table 3.42: Analytical Characteristics of Commercial BNP Assays per Manufacturer
Table 3.43: Analytical Characteristics of Commercial NT-proBNP Assays per Manufacturer
Table 3.44: Market Share of BNP Assays in the U.S. by Instrument
Table 3.45: Market Share of NT-proBNP Assays in the U.S. by Instrument
Table 3.46: U.S. Hospital Share Estimates of NP Usage
Table 3.47: CHF National Hospital Discharge Survey, 2000-2010
Table 3.48: BNP NT-pro BNP Market Drivers
Table 3.49: BNP NT-pro BNP Market Restraints
Table 3.50: Trends in Cardiovascular Testing in Primary Care, U.S. and Globally
Table 3.51: The Clinical Advantages of Ischemia Modified Albumin
Table 3.52: Analytical Advantages of IMA
Table 3.53: Analytical Disadvantages of IMA
Table 4.1: HDL Levels in Adults
Table 4.2: LDL Levels in Adults
Table 4.3: Number of U.S. Cholesterol Tests, 2000-2014
Table 4.4: Selected POC Cholesterol Testing Devices, 2014
Table 4.5: World CRP Market Revenue, 2010-2020
Table 4.6: U.S. CRP Market Revenue, 2010-2020
Table 4.7: Clinical Characteristics of CRP
Table 4.8: Clinical Characteristics of D-Dimer
Table 5.1: CPT Codes Lipid Profile and Cholesterol Testing
Table 5.2: Financial Comparison for Moderate and Waived CLIA Labs
Table 5.3: POCT Clinical Outcomes in AMI
Table 6.1: Regulatory Rules that Affect the Ability of a Diagnostic Testing Reagent Company to Conduct Business
Table 6.2: Strengths of the 510k Process
Table 6.3: Drawbacks of the 510k Process
Table 6.4: Number of Healthcare Institutions According to Ownership China, 2010
Table 6.5: Total Number of Hospitals by Ranking China, 2010
Table 6.6: POC Cardiac Marker Testing Market: Market Restraints Ranked in Order of Impact
Table 6.7: Cardiac Marker Testing Market: Market Drivers Ranked in Order of Impact
Table 7.1: Oxidative Biomarker Research Assay Market Size
Table 7.2: Potential New Stroke Markers
Table 7.3: Non-Lipid Markers of CVD
Table 8.1: Alere Professional Diagnostics
Table 8.2: Alere, Inc. Financial Figures—Net Sales by Business Sector, 2011-2013
Table 8.3: Alere, Inc. Financial Figures—Net Sales by Geographic Region, 2011-2013
Table 8.4: Roche Group Financial Figures—Net Sales by Business Sector, 2009-2013
Table 8.5: Roche Group Financial Figures—Net Sales by Geographic Region, 2012 and 2013 for the Diagnostics Division
Table 8.6: Roche Group Financial Figures—Net Sales by Sub-Division, 2011-2013

Note: Product cover images may vary from those shown

- Abbott Laboratories and SWOT Analysis
- Alere and SWOT Analysis
- Beckman Coulter (now part of Danaher)
- Biosite, Inc. (now a brand of Alere)
- bioMérieux
- CardioGenics
- Chek Diagnostics
- diaDexus and SWOT Analysis
- Health-Chem Diagnostics (HCD)
- LifeSign, LLC
- Ortho-Clinical Diagnostics, Inc. and SWOT Analysis
- PTS Diagnostics
- PreMD, Inc.
- Radiometer Medical
- Randox Laboratories Ltd.
- Response Biomedical
- Roche Diagnostics
- Sanyo Chemical Industries Ltd.
- Shionogi & Co., Ltd.
- Siemens Healthcare Diagnostics
- Sierra Resources International
- Spectral Diagnostics, Inc.

Note: Product cover images may vary from those shown
Note: Product cover images may vary from those shown

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