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Cardiac Marker Diagnostic Testing Markets

  • August 2016
  • -
  • TriMark Publications
  • -
  • 161 pages

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 TriMark Publications 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.

Table Of Contents

Cardiac Marker Diagnostic Testing Markets











TABLE OF CONTENTS



1. Overview 8

1.1 Statement of Report 8

1.2 Objectives of This Report 8

1.3 Scope of This Report 10

1.4 Methodology 10

1.5 Executive Summary 12

2. The Basics of Biomarkers 14

3. Cardiac Marker Testing Markets: Market Segment Analysis: Size, Growth and
Share 21

3.1 Global Cardiac Marker Diagnostic Testing Markets 21

3.1.1 Clinical Utility of Cardiac Markers 23

3.1.2 Market Drivers in the Cardiac Marker Diagnostics Testing Sector 24

3.1.3 Market Restraints in Cardiac Marker Testing Segment 24

3.1.4 Principal Market Segments for Cardiac Marker Testing 25

3.1.5 Key Players in the Cardiac Marker Diagnostics Testing Segment 25

3.1.6 Cardiac Marker Testing Sector Analysis 26

3.2 U.S. Cardiac Marker Testing Market 27

3.2.1 Market Overview 27

3.2.2 Cardiac Diagnostic Test Segments 28

3.2.3 U.S. Hospital POC Cardiac Markers 29

3.3 European Cardiac Marker Diagnostic Test Market 31

3.3.1 German Diagnostic Markets 33

3.3.2 U.K. Diagnostic Testing Market 35

3.3.2.1 U.K. Market Statistics 35

3.3.3 Italy 36

3.3.4 France 37

3.3.5 Spain 38

3.3.6 Benelux 38

3.3.7 Scandinavia 39

3.3.8 Switzerland 39

3.3.9 Barriers to Entry to European Market 40

3.4 Japanese Diagnostic Testing Market 40

3.5 Chinese Diagnostic Testing Market 41

3.6 Canadian Diagnostic Market 42

3.7 Cardiac Marker Testing Individual Markets 43

3.7.1 Clinical Overview 43

3.7.2 Cardiac Acute Disease Markers 44

3.7.3 Market Overview 44

3.7.3.1 Troponins 47

3.7.3.2 Market Size and Growth Projections 49

3.7.3.3 Clinical Use of Cardiac Troponins 52

3.7.3.4 TnI and TnT Market Drivers 55

3.7.3.5 TnI and TnT Market Restraints 55

3.7.4 CK-MB and Cardiac Enzymes 56

3.7.4.1 Creatine Kinase (CK) Enzymes 56

3.7.4.2 Market Size and Growth Projections 57

3.7.4.3 CK-MB: Market Drivers 58

3.7.4.4 CK-MB: Market Restraints 58

3.7.5 Myoglobin 58

3.7.5.1 Market Size and Growth Projections 58

3.7.5.2 Clinical Use of Myoglobin 59

3.7.5.3 Myoglobin Market Drivers 60

3.7.5.4 Myoglobin Market Restraints 60

3.7.6 Natriuretic Peptides 60

3.7.6.1 Market Overview 60

3.7.6.2 Market Size and Growth Projections 62

3.7.6.3 Commercial Assays for BNP and NT-proBNP 63

3.7.6.4 Competitive Landscape 65

3.7.6.5 BNP Test Market Share 65

3.7.6.6 Clinical Applications of BNP/NT-proBNP 68

3.7.6.7 BNP NT-proBNP Market Drivers 71

3.7.6.8 BNP NT-proBNP Market Restraints 71

3.7.6.9 Future Projections and Trends of BNP Testing 71

3.7.6.10 Future Use of BNP 72

3.7.7 Albumin 72

3.7.7.1 Ischemic Modified Albumin (IMA) 72

3.7.7.2 Microalbuminuria 74

3.7.8 Key Players in Cardiac Markers 75

3.7.9 Evaluation of Cardiac Markers 83

3.7.10 Cardiac Markers Use in Clinical Decisions 84

3.7.11 Status of Cardiac Markers in the ER 85

3.7.12 Cardiac Markers in Renal Failure 85

3.7.13 Troponins in Non-Ischemic Heart Disease 85

3.7.14 Market Restraints 86

3.7.15 Market Drivers 86

3.7.16 POC Cardiac Markers 86

3.7.17.2 Market Restraints 87

3.7.17.3 The Next Wave 89

4. Cardiovascular Disease Markers 93

4.1 Cholesterol, HDL and LDL 93

4.1.1 Cholesterol Testing Market Forecasts 95

4.1.2 Cholesterol Testing Market Growth Drivers 95

4.1.3 Market Outlook: U.S. Market Analysis 95

4.1.4 Trends and Issues 97

4.1.5 Key Players in the Cholesterol Kit Market 98

4.1.5.1 Review of Cholesterol Kit Company Products 99

4.1.5.1.1 Alere 99

4.1.5.1.2 PTS Diagnostics CardioChek 99

4.1.5.1.3 Miraculins PreVu POC Skin Cholesterol Test 100

4.1.5.1.4 Abaxis Piccolo Xpress 100

4.1.5.2 Product Comparison of Leading Suppliers 101

4.2 Homocysteine 103

4.3 Fibrinogen 103

4.4 C-Reactive Protein 103

4.5 Lipoprotein Fractions 106

4.6 Oxidized LDL and HDL 107

5. Cardiac Marker Testing Development Issues 108

5.1 Genetic Testing and Personalized Medicine 108

5.2 Preventive Medicine 108

5.3 Patient Safety and Quality Measures 109

5.4 Reimbursement 109

5.5 Cardiovascular Screening Codes 111

5.6 Cardiovascular Disease Risk Panels 112

5.7 Other Reimbursement Concerns 113

5.7.1 Reimbursement for Cardiovascular Disease Risk Factors 113

5.9 Rapid Near-Patient Testing in Hospitals 114

5.10 Satellite Facilities 114

5.11 Regionalization of Laboratory Care 115

5.12 POCT: Current Market Trends and Drivers 116

5.12.1 Effectiveness of POCT 117

5.12.2 New Growth Areas for POCT 118

5.12.3 Advantages of POCT in a Clinical Setting 118

5.12.4 Shifts from Central Lab Testing to POCT 119

5.12.5 Turnaround Time for POCT 119

5.13 Clinical Laboratory Improvement Amendments (CLIA) 120

5.14 Regulatory Requirements 122

5.15 Record-Keeping and Data Management 122

5.15.1 Effectiveness of Clinical Outcomes 122

6. Business Trends in the Industry 124

6.1 Sector Consolidation 124

6.2 Diagnostic Testing Growth Trends 124

6.3 Acquisition, License Agreements, Internal Development and Partnerships 124

6.4 Industry Leaders and New Entrants 126

6.4 Product Testing Depth in Cardiac Marker Testing 126

6.5 Government Regulation 126

6.5.1 U.S. Regulation 126

6.5.2 CLIA Regulations 127

6.5.3 Clinical Laboratory Improvement Act 128

6.5.4 State Licensing for Service Laboratories 129

6.5.5 IVDMIAs 130

6.5.6 FDA Draft Guidance on In Vitro Companion Diagnostic Devices 130

6.5.7 510(k) Clearance 131

6.5.8 Pre-Market Approval 131

6.5.8.1 Pre-Market Approval Application 132

6.5.8.2 Importing Medical Devices into the U.S. 133

6.5.8.3 Exporting Medical Devices from the U.S. 133

6.5.9 E.U. Regulations 134

6.5.10 Japanese Regulations 138

6.5.11 Chinese Regulations 142

6.6 Barriers to Growth 146

6.7 Drivers of Growth 147

7. Important Technology Trends 150

7.1 Trends in Cardiac Marker Diagnostic Testing 150

7.1.1 Free Fatty Acids and Fatty Acid Binding Proteins 150

7.1.2 Glycogen Phosphorylase Isoenzyme BB 151

7.1.3 S-100 Protein 151

7.1.4 Cobalt-Binding Albumin 151

7.1.5 Myosin Light Chains 152

7.1.6 ST2 152

7.1.7 Galectin-3 152

7.1.6 Emerging POCT Cardiac Marker Testing 153

7.2 Cardiac Biomarker Research 153

7.2.1 Glutathione Peroxidase 153

7.2.2 Antioxidant Biomarkers 153

7.2.3 Oxidative Biomarkers 153

7.2.4 Inflammatory Biomarkers 154

7.2.5 Nitrosative Biomarkers 155

7.2.6 Hemostatic Biomarkers 155

7.3 Potential Stroke Markers 155

7.3.1 Pharmacogenomics: Cardiovascular Drugs and Proteomic Markers 156

7.3.2 Cardiac Proteomics 156

7.3.3 Drivers for Cardiovascular Proteomic Markers 156

7.3.4 Barriers to Cardiovascular Proteomic Markers 156

7.4 Future Developments for Cardiovascular Markers 157

7.5 Research Questions 157

7.5.1 Biomarker Development Strategies 160

7.5.2 Biomarkers for Unstable Angina 161

7.6 Lp-PLA2 162

7.7 Urotensin 162





INDEX OF FIGURES



Figure 3.1: Market Share of Cardiac Marker Segment 27

Figure 3.2: U.S. Cardiac Marker Diagnostic Testing Market Segments, 2016 29

Figure 3.3: U.S. POC Cardiac Marker Sales, 2011-2021 30

Figure 3.4: Cardiac Marker Market for Diagnostic Testing in Europe, 2011-2021 32

Figure 3.5: Cardiac Marker POCT Troponin Market Share by Product Type 87

Figure 3.6: Cardiac Marker POCT BNP Market Share by Product Type 87

Figure 4.1: Prevalence of Total Cholesterol Among Adults Aged 20 and Over, by
Sex and Age in the U.S., 2011-2014 94

Figure 4.2: Age-Adjusted Trends in Prevalence of High total and low HDL
Cholesterol Among Adults Aged over 20 in the U.S., 1999-2014 95

Figure 4.3: Prevalence of Cholesterol Screening in Adults Ages =20, U.S. 96

Figure 5.1: CLIA Laboratories by Certificate Types, 2016 120

Figure 6.1: Current Conformity Assessment Route, Annexes and Quality System
Standards by IVD Device Category 135

Figure 6.2: The Chinese Healthcare System 143





INDEX OF TABLES



Table 2.1: Biomarkers in Heart Failure 15

Table 2.2: Cardiac Biomarkers of Inflammation and Atherogenesis 16

Table 2.3: Cardiac Biomarkers of Endothelial Function 17

Table 2.4: Cardiac Biomarkers of Thrombosis 17

Table 2.5: Cardiac Biomarkers of Ischemia/Necrosis 17

Table 2.6: Cardiac Biomarkers of Hemodynamic Stress 19

Table 2.7: Cardiac Biomarkers of Heart Failure Mortality 19

Table 2.8: Cardiac Biomarkers of Renal Dysfunction 19

Table 2.9: Cardiac Biomarkers of Metabolic/Lipid Dysregulation 20

Table 2.10: Cardiac Biomarkers of Brain Damage 20

Table 3.1: Cardiac Marker Markets by Country and Region, 2010-2020 22

Table 3.2: Cardiac Marker Markets by Country and Region, 2010-2020 22

Table 3.3: Total Global Cardiac Marker Market, 2010-2021 22

Table 3.4: Cardiac Markers in Clinical Use 23

Table 3.5: Market Share of Cardiac Marker Segment 26

Table 3.6: U.S. Cardiac Marker Market, 2011-2021 28

Table 3.7: U.S. Cardiac Marker Diagnostic Testing Market Segments, 2016 28

Table 3.8: U.S. POC Cardiac Marker Sales, 2015-2021 29

Table 3.9: Spectrum of Patient Care Testing 30

Table 3.9: Cardiac Marker Market for Diagnostic Testing in Europe, 2015-2021 31

Table 3.10: Regional Comparison of Healthcare and IVD Expenditures 32

Table 3.11: German IVD Diagnostics Products Market Sales, 2010-2020 34

Table 3.12: German Cardiac Marker Test Market, 2010-2020 34

Table 3.13: U.K. IVD Diagnostics Products Market Sales, 2010-2020 36

Table 3.14: U.K. Cardiac Marker Market, 2010-2020 36

Table 3.15: Italian Cardiac Marker Market, 2010-2020 37

Table 3.16: French Cardiac Marker Market, 2010-2020 38

Table 3.17: Spanish Cardiac Marker Market, 2010-2020 38

Table 3.18: Benelux Cardiac Marker Market, 2010-2020 39

Table 3.19: Scandinavian Cardiac Marker Market, 2010-2020 39

Table 3.20: Swiss Cardiac Marker Market, 2010-2020 40

Table 3.21: Japanese Cardiac Marker Diagnostic Testing Market, 2011-2021 40

Table 3.22: Chinese Cardiac Marker Market, 2011-2021 41

Table 3.23: Canadian Cardiac Marker Market, 2010-2020 42

Table 3.24: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2015 45

Table 3.25: Common Causes of Chest Pain 46

Table 3.26: Rate of Inappropriate Discharge from the ER for Patients with AMI,
1984-2014 46

Table 3.27: Continuing Analytical Issues for Implementation of Cardiac Troponin
48

Table 3.28: Global Cardiac Troponin Marker Market, 2011-2021 50

Table 3.29: U.S. Cardiac Troponin Marker Market, 2011-2021 50

Table 3.30: Selected POC Cardiac Biomarkers, 2016 51

Table 3.31: Projections in U.S. Sales of POC Cardiac Marker Tests, 2011-2021 52

Table 3.32: Causes of Troponin Elevations 54

Table 3.33: World Revenue from CK-MB Markets, 2011-2021 57

Table 3.34: U.S. Revenue from CK-MB Markets, 2011-2021 58

Table 3.35: World Myoglobin Market Revenues, 2011-2021 59

Table 3.36: U.S. Myoglobin Market Revenues, 2011-2021 59

Table 3.37: BNP Clinical Characteristics 61

Table 3.38: Global Sales of BNP and NT-proBNP assays, 2011-2021 62

Table 3.39: U.S. Sales of BNP and NT-proBNP assays, 2011-2021 63

Table 3.40: FDA Approved BNP Assays 64

Table 3.41: FDA Approved NT-proBNP Assays 64

Table 3.42: Analytical Characteristics of Commercial BNP Assays per Manufacturer
66

Table 3.43: Analytical Characteristics of Commercial NT-proBNP Assays per
Manufacturer 66

Table 3.44: Market Share of BNP Assays in the U.S. by Instrument 67

Table 3.45: Market Share of NT-proBNP Assays in the U.S. by Instrument 67

Table 3.46: U.S. Hospital Share Estimates of NP Usage 68

Table 3.47: CHF National Hospital Discharge Survey, 2000-2010 68

Table 3.48: BNP NT-pro BNP Market Drivers 71

Table 3.49: BNP NT-pro BNP Market Restraints 71

Table 3.50: Trends in Cardiovascular Testing in Primary Care, U.S. and Globally
71

Table 3.51: The Clinical Advantages of Ischemia Modified Albumin 73

Table 3.52: Analytical Advantages of IMA 74

Table 3.53: Analytical Disadvantages of IMA 74

Table 4.1: Cholesterol Levels in Adults 93

Table 4.3: Number of U.S. Cholesterol Tests, 2000-2014 97

Table 4.4: Selected POC Cholesterol Testing Devices, 2016 98

Table 4.5: World CRP Market Revenue, 2010-2020 104

Table 4.6: U.S. CRP Market Revenue, 2010-2020 106

Table 4.7: Clinical Characteristics of CRP 106

Table 5.1: CPT Codes Lipid Profile and Cholesterol Testing 112

Table 5.2: Financial Comparison for Moderate and Waived CLIA Labs 121

Table 6.1: Regulatory Rules that Affect the Ability of a Diagnostic Testing
Reagent Company to Conduct Business 126

Table 6.2: Strengths of the 510k Process 131

Table 6.3: Drawbacks of the 510k Process 131

Table 6.4: Number of Healthcare Institutions According to Ownership China, 2010
144

Table 6.5: Total Number of Hospitals by Ranking China, 2010 145

Table 6.6: POC Cardiac Marker Testing Market: Market Restraints Ranked in Order
of Impact 147

Table 6.7: Cardiac Marker Testing Market: Market Drivers Ranked in Order of
Impact 148

Table 7.1: CRP Levels associated with Risk for Cardiovascular Disease 154

Table 7.2: Potential New Stroke Markers 155

Table 7.3: Non-Lipid Markers of CVD 158






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