Cardiac Biomarkers: Technologies and Global Markets

Table of Contents

Chapter 1 Introduction
1.1 Overview
1.2 Study Goals and Objectives
1.3 Reasons for Doing this Study
1.4 Scope of the Report
1.5 What's New in this Update?
1.6 Methodology and Information Sources
1.6.1 Primary Data and Information Gathering
1.6.2 Secondary Data and Information Gathering
1.6.3 Market Share Analysis and Market Forecast Prediction
1.7 Geographic Breakdown
1.8 Analyst's Credentials
1.9 Custom Research
1.10 Related Research Reports

Chapter 2 Summary and Highlights

Chapter 3 Cardiovascular Disease and Its Associated Burden
3.1 Overview of Cardiovascular Disease
3.1.1 Coronary Artery Disease
3.2 Atherosclerosis
3.3 Angina (Angina Pectoris)
3.4 Acute Myocardial Infarction (Ami)
3.5 Disease Management
3.6 Medical Management
3.7 Lifestyle Changes
3.8 Diet Modification
3.9 Smoking Cessation
3.10 Pharmaceuticals
3.11 Anticoagulants and Antiplatelet Drugs
3.12 Lipid-Lowering Drugs
3.13 Anti-Hypertensive Drugs
3.14 Nitroglycerin Preparations
3.15 Surgical Intervention
3.15.1 Coronary Artery Bypass Graft Surgery
3.15.2 Transmyocardial Revascularization
3.15.3 Percutaneous Coronary Interventions
3.16 Global Burden of Cardiovascular Disease
3.16.1 Cvd and Its Associated Burden, 2030
3.16.2 Economic Burden of Cvd

Chapter 4 Introduction to Cardiac Biomarkers
4.1 Types of Biomarkers
4.1.1 Antecedent Biomarker Tests
4.1.2 Screening Biomarker Tests
4.1.3 Diagnostic Biomarker Tests
4.1.4 Staging Biomarkers
4.1.5 Prognostic Biomarker Tests
4.2 Role of Biomarkers in the Prevention, Assessment and Management of Heart Failure
4.2.1 Myocardial Stress/Injury
4.2.2 Neurohormonal Activation
4.2.3 Remodeling
4.2.4 Comorbidities
4.2.5 Other Biomarkers of Cardiac Activity
4.2.6 Role of Biomarkers in Heart Failure Clinical Trials
4.3 Biomarker Discovery and Validation
4.3.1 Biomarker Candidate Screening
4.3.2 Biomarker Candidate Validation
4.4 Omic Technologies for Biomarker Discovery
4.4.1 Genomics
4.4.2 Proteomics
4.4.3 Metabolomics
4.4.4 Lipidomics
4.5 Considerations When Developing a Cardiac Biomarker
4.6 Defining Abnormal Biomarker Values
4.6.1 Reference Limits
4.6.2 Discrimination Limits
4.6.3 Threshold Defining Risk
4.7 Receiver Operating Characteristic Curve Analysis of Biomarker Accuracy

Chapter 5 Review of Key Individual Cardiac Biomarkers
5.1 Gold Standard of Cardiac Biomarkers
5.2 Troponin Complex
5.2.1 Troponin C
5.2.2 Troponin T
5.2.3 Troponin I
5.2.4 Troponin as the Preferred Biomarker
5.2.5 High Sensitivity Troponin Assays
5.2.6 Emergence of Point-Of-Care Troponin Testing
5.3 Pro-Bnp And/Or Nt-Probnp
5.4 Creatine Kinase Test
5.5 Myoglobin (Mb)
5.6 C-Reactive Protein
5.7 Other Key Cardiac Biomarkers
5.7.1 Copeptin
5.7.2 D-Dimer
5.7.3 Galectin-3
5.7.4 Fatty Acid Binding Proteins
5.7.5 St2
5.8 Emerging Cardiac Biomarkers
5.8.1 Choline
5.8.2 Ischemia-Modified Albumin
5.8.3 Myeloperoxidase
5.8.4 S100-Beta
5.9 Recent Technological Advances and Key Developments in Cardiac Biomarker Measurement
5.9.1 Drivers
5.9.2 Barriers
5.9.3 Validation Hurdles
5.9.4 Notable Technological Advancements

Chapter 6 Global Market for Cardiac Biomarkers
6.1 Introduction
6.2 Global Market for Cardiac Biomarkers, by Type of Biomarker
6.2.1 Regional Overview
6.3 North American Market
6.3.1 Selected Market Drivers
6.3.2 Selected Market Restraints
6.3.3 North American Market, by Country
6.4 European Market
6.4.1 Selected Market Drivers
6.4.2 Selected Market Restraints
6.4.3 European Market, by Country
6.5 Asia-Pacific Market
6.5.1 Selected Market Drivers
6.5.2 Selected Market Restraints
6.5.3 Asia-Pacific Market, by Country
6.6 Rest of World Market
6.6.1 Selected Market Drivers
6.6.2 Selected Market Restraints

Chapter 7 Impact of the Covid-19 Pandemic
7.1 Overview
7.2 Impact of Covid-19 on the Market for Cardiac Biomarkers

Chapter 8 Regulatory and Legislative Requirements for Cardiac Biomarkers
8.1 North America
8.1.1 U.S.
8.1.2 Recent Developments
8.1.3 Canada
8.2 Europe
8.2.1 (General) Medical Device Directive, Mdd (93/42/Eec)
8.2.2 Active Implantable Medical Device Directive, Aimdd (90/383/Eec)
8.2.3 in Vitro Diagnostic Medical Device Directive, Ivdmdd (98/79/Ec)
8.2.4 Proposed Changes to the Medical Device Directive, Mdd (93/42/Eec)
8.2.5 Notified Bodies
8.2.6 German Reimbursement Structure and Schedules for Diagnostic Procedures
8.2.7 French Reimbursement Structure and Schedules for Diagnostic Procedures
8.2.8 Italian Reimbursement Structure and Schedules for Diagnostic Procedures
8.3 Japan
8.3.1 Marketing Authorization System
8.4 China
8.4.1 Overview of the Healthcare System
8.4.2 Healthcare Reforms
8.4.3 Healthcare Institutions
8.5 India
8.5.1 Overview of the Healthcare System
8.5.2 Hospital Resources
8.5.3 Population Statistics
8.6 South Korea
8.7 Brazil
8.7.1 Background
8.7.2 Regulatory and Legislative Requirements
8.7.3 Market Entry and Reimbursement of Medical Devices
8.8 Argentina
8.8.1 Background
8.9 Mexico
8.9.1 Legislation and Regulations Governing Medical Devices in Mexico
8.9.2 Health Insurance Structure

Chapter 9 Patent Review and New Developments in Cardiac Biomarkers
9.1 Introduction
9.2 Cardiac Biomarker Patents, by Region and Country

Chapter 10 Competitive Landscape
10.1 Company Market Share Analysis
10.2 Recent News

Chapter 11 Company Profiles

• Abbott Laboratories
• Acs Biomarker Bv
• Beckman Coulter (Subsidiary of Danaher Corp.)
• Bg Medicine Inc.
• Biomerieux S.A.
• Bio-Rad Laboratories, Inc.
• Cardiogenics
• Creative Diagnostics
• Critical Diagnostics
• Life Diagnostics Inc.
• Lifesign
• Lsi Medience Corp.
• Meridian Life Science Inc.
• Metanomics Health GmbH
• Ortho-Clinical Diagnostics Inc.
• Perkinelmer Inc.
• Pts Diagnostics
• Quidel Corp.
• Radiometer Medical Aps
• Randox Laboratories Ltd.
• Response Biomedical Corp.
• Roche Diagnostics
• Sanyo Chemical Industries Ltd.
• Siemens AG
• Singulex Inc.
• Spectral Medical Inc.
• Thermo Fisher Scientific, Inc.
• Tosoh Bioscience Inc.
• Trinity Biotech plc

Chapter 12 Appendix A: Company Addresses and Contact Details
12.1 Company Addresses and Contact Details

Chapter 13 Appendix B: Government Regulatory Agencies and Professional Organizations
13.1 Government Regulatory Agencies and Professional Organizations

Chapter 14 Appendix C: Commonly Used Acronyms Associated With Cardiac Biomarkers

List of Tables
Summary Table B: Global Market Shares of Cardiac Biomarkers, by Region, 2021
Summary Table A: Global Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 1: Standard Angina Pectoris Classification
Table 2: Top 20 Leading Causes of Deaths Globally, 2019
Table 3: Estimated Deaths Due to Noncommunicable Diseases, by Gender and Disease, 2019
Table 4: Estimated Deaths Due to Cardiovascular Disease, by Gender and Disease, 2019
Table 5: Global Health Estimates, by Gender and WHO Region, 2019
Table 6: Global Distribution of Male Deaths Caused by Cardiovascular Disease, by Age, 2019
Table 7: Global Distribution of Female Deaths Caused by Cardiovascular Disease, by Age Group, 2019
Table 8: Estimated Deaths Due to Cardiovascular Disease, by Gender and Disease, 2030
Table 9: Estimated Deaths Due to Cardiovascular Disease, by Gender and WHO Region, 2030
Table 10: Global Distribution of Male Deaths Caused by Cardiovascular Disease, by Age Group, 2030
Table 11: Global Distribution of Female Deaths Caused by Cardiovascular Disease, by Age, 2030
Table 12: Economic Burden of NCDs in India, 2012-2030
Table 13: Summary of Heart Failure Biomarkers
Table 14: Cardiac Biomarkers of Myocyte Stretch
Table 15: Cardiac Biomarkers of Myocyte Injury
Table 16: Cardiac Biomarkers of Oxidative Stress
Table 17: Cardiac Biomarkers of Neurohormonal Activation
Table 18: Prognostic and Diagnostic Values and Analytical Performance of Inflammatory Markers in Coronary Artery Disease
Table 19: Cardiac Biomarkers of Inflammation and Atherogenesis
Table 20: Cardiac Biomarkers of Renal Dysfunction
Table 21: Soluble Cell Adhesion Molecules
Table 22: Cardiac Biomarkers of Thrombosis
Table 23: Cardiac Biomarkers of Metabolic/Lipid Dysregulation
Table 24: Cardiac Biomarkers of Brain Damage
Table 25: Techniques Available for Biomarker Development
Table 26: Desirable Features of Cardiac Biomarkers
Table 27: Common Cardiac Biomarkers
Table 28: Contemporary Cardiac Troponin I and T Assay Analytical Characteristics as Designated by the Manufacturer
Table 29: High Sensitivity* Cardiac Troponin I and T Assay Analytical Characteristics Designated by Manufacturer
Table 30: Point-of-Care Cardiac Troponin I and T Assay Analytical Characteristics Designated by Manufacturer
Table 31: BNP, NT-proBNP and MR-proANP Assays: Analytical Characteristics Designated by Manufacturer
Table 32: Profile of Biomarker Myoglobin
Table 33: Profile of Biomarker ST2
Table 34: Global Market for Cardiac Biomarkers, Through 2027
Table 35: Global Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 36: Global Market Shares of Cardiac Biomarkers, by Type of Biomarker, 2021
Table 37: Global Market Shares of Cardiac Biomarkers, by Region, 2021
Table 38: Global Market for Cardiac Biomarkers, by Region, 2027
Table 39: Global Market for Cardiac Biomarkers, by Instrument Category, Through 2027
Table 40: North American Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 41: North American Market for Cardiac Biomarkers, by Instrument Category, Through 2027
Table 42: Number of Persons Aged 65 Years or Over, Globally, by Region, 2019 and 2050
Table 43: Rough Projections of CVD Prevalence in the U.S., 2010-2030
Table 44: North American Market Shares of Cardiac Biomarkers , by Country, 2021
Table 45: U.S. Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 46: Canadian Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 47: European Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 48: European Market for Cardiac Biomarkers, by Instrument Category, Through 2027
Table 49: European Market Shares of Cardiac Biomarkers, by Country, 2021
Table 50: French Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 51: German Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 52: Italian Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 53: Spanish Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 54: U.K. Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 55: Rest of the European Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 56: Asia-Pacific Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 57: Asia-Pacific Market for Cardiac Biomarkers, by Instrument Category, Through 2027
Table 58: Asia-Pacific Market Shares of Cardiac Biomarkers, by Country, 2021
Table 59: Japanese Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 60: Chinese Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 61: Indian Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 62: South Korean Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 63: Australian Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 64: Rest of Asia-Pacific Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 65: RoW Market for Cardiac Biomarkers, by Type of Biomarker, Through 2027
Table 66: RoW Market for Cardiac Biomarkers, by Instrument Category, Through 2027
Table 67: ICD-9 and ICD 10 CM Diagnosis Codes Commonly Used to Report Cardiac Conditions
Table 68: Clinical Diagnostic Laboratory Fee Schedule, 2021
Table 69: Comparison of Pharmaceutical Affair Law and Japanese Medical Device Nomenclature and Related Codes with the EU MDD
Table 70: Number of Different Types of Medical Institutions and Beds Provided in Each Institution Type in China, 2018-2019
Table 71: Total Number of Hospitals, by Ranking in China, 2019
Table 72: Overview of Healthcare in India
Table 73: Recent Asia-Pacific Patent Publications Related to Cardiac Biomarkers
Table 74: Recent Chinese Patent Publications Related to Cardiac Biomarkers
Table 75: Recent European Patent Publications Related to Cardiac Biomarkers
Table 76: Recent U.S. Patent Publications Related to Cardiac Biomarkers
Table 77: Recent Canadian Patent Publications Related to Cardiac Biomarkers
Table 78: Recent Global Patent Publications Related to Cardiac Biomarkers
Table 79: Abbott Laboratories: Annual Revenue, by Business Segment, 2019-2021
Table 80: Abbott Laboratories: Diagnostics Revenue, by Segment, 2019-2021
Table 81: Danaher Corp.: Revenue, by Business Segment, 2019-2021
Table 82: bioMérieux S.A.: Recent Financial Performance, FY 2019-FY 2021
Table 83: Bio-Rad Laboratories, Inc.: Annual Revenue, by Business Segment, 2019-2021
Table 84: Meridian Life Science Inc.: Annual Revenue, by Business Segment, 2019-2021
Table 85: Meridian Life Science Inc.: Revenue, by Life Sciences Segment, 2019-2021
Table 86: PerkinElmer Inc.: Recent Financial Performance, FY 2019-FY 2021
Table 87: PerkinElmer Inc.: Annual Revenue, by Business Segment, FY 2019-FY 2021
Table 88: Quidel Corp.: Recent Financial Performance, FY 2019-FY 2021
Table 89: Roche Group: Annual Revenue, by Business Segment, 2019-2021
Table 90: Roche Group: Annual Revenue, by Diagnostics Segment, 2019-2021
Table 91: Siemens Healthineers: Annual Revenue, by Business Segment, 2019-2021
Table 92: Siemens Healthineers' Cardiovascular Assay Menu
Table 93: Thermo Fisher Scientific, Inc.: Annual Revenue, by Business Segment, 2019-2021
Table 94: Thermo Fisher Scientific, Inc.: Results of Operations, by Region, 2019-2021
Table 95: Tosoh Biosciences Inc.: Recent Financial Performance, FY 2019-FY 2021
Table 96: Tosoh Biosciences Inc.: Cardiac Biomarkers Product Portfolio
Table 97: Trinity Biotech Plc.: Annual Revenue, by Business Segment, 2019-2021
Table 98: Company Addresses and Contact Details
Table 99: Government Regulatory Agencies and Professional Organizations Associated with Cardiac Biomarkers
Table 100: Commonly Used Acronyms Associated with Cardiac Biomarkers

List of Figures
Summary Figure A: Global Market Shares of Cardiac Biomarkers, by Type of Biomarker, 2021
Summary Figure B: Global Market Shares of Cardiac Biomarkers, by Region, 2021
Figure 1: Global Distribution of Male Deaths Caused by Cardiovascular Disease, by Age Group, 2019
Figure 2: Global Distribution of Male Deaths Caused by Cardiovascular Disease, 2019
Figure 3: Global Distribution of Female Deaths Caused by Cardiovascular Disease, by Age Group, 2019
Figure 4: Global Distribution of Female Deaths Caused, by Cardiovascular Disease, 2019
Figure 5: Global Distribution of Male Deaths Caused by Cardiovascular Disease, by Age, 2030
Figure 6: Global Distribution of Male Deaths Caused, by Cardiovascular Disease, 2030
Figure 7: Global Distribution of Female Deaths Caused by Cardiovascular Disease, by Age Group, 2030
Figure 8: Global Distribution of Female Deaths Caused, by Cardiovascular Disease, 2030
Figure 9: Projected Total Costs of Cardiovascular Disease in the U.S., 2015-2030
Figure 10: Classes of Biomarkers Contributing to the HF Biomarker Profile
Figure 11: Possible Roles of C-Reactive Protein in the Pathogenesis of Metabolic Syndrome and Cardiovascular Disorders
Figure 12: Biomarker Use in Heart Failure Trials
Figure 13: Approaches to Defining Abnormal Biomarker Values
Figure 14: Receiver Operating Characteristic Curve in Different Cardiac Biomarkers
Figure 15: Interpreting Elevated Levels of Cardiac Troponin
Figure 16: Comparison of 19 Cardiac Troponin Assays
Figure 17: Schematic Diagram of the Synthesis of NT-proBNP and BNP from the Pre-proBNP Protein by Cardiomyocytes
Figure 18: Interpretation of NT-proBNP Values as a Predictor of Heart Failure
Figure 19: Global Market Shares of Cardiac Biomarkers, by Type of Biomarker, 2021
Figure 20: Global Market Shares of Cardiac Biomarkers, by Region, 2021
Figure 21: North American Market for Cardiac Biomarkers, by Type of Biomarker, 2021
Figure 22: North American Market Shares of Cardiac Biomarkers Market, by Country, 2021
Figure 23: U.S. Market for Cardiac Biomarkers, by Type of Biomarker, 2021
Figure 24: European Market for Cardiac Biomarkers, by Type of Biomarker, 2021
Figure 25: European Market Shares of Cardiac Biomarkers, by Country, 2021
Figure 26: Asia-Pacific Market for Cardiac Biomarkers, by Type of Biomarker, 2021
Figure 27: Asia-Pacific Market Shares of Cardiac Biomarkers, by Country, 2021
Figure 28: RoW Market for Cardiac Biomarkers, by Type of Biomarker, 2021
Figure 29: U.S. General Population with Private Health Insurance Coverage, 2013-2021
Figure 30: Illustration of Medicare Payment Process in the U.S.
Figure 31: French Pricing and Reimbursement Process for Medical Devices
Figure 32: Market Access Pathway for Inpatient Medical Devices in Italy
Figure 33: Market Access Pathway for Outpatient Medical Devices in Italy
Figure 34: The Chinese Healthcare System
Figure 35: Global Market Shares of Cardiac Biomarkers, by Manufacturer, 2021
Figure 36: bioMérieux S.A.: Sales Share, by Application, 2021
Figure 37: Quidel Corp.: Revenue Share, by Product Segment, FY 2021

Samples

Executive Summary

This chapter summarizes the global market value, market growth rates and key market drivers and restraints for the cardiac biomarkers market, and it identifies the key suppliers of both centralized laboratory and point-of-care testing.

Over the past 40 years, blood cardiac biomarkers have improved in accuracy in term of evaluating cardiac problems. Creatinine kinase-MB (CK-MB) utilization, first in 1972, was a significant advancement in the creation of a highly specific biomarker with an initial focus on myocardial infarction (MI). The next significant development was the advent of Cardiac Troponin (cTn) assays in 1989, and the modern definition of Acute Myocardial Infarction (AMI) is based on later improvements to these assays. Ironically, this process created significant challenges for critical care doctors who treat patients with multiorgan failure as opposed to those patients who visit the emergency room complaining of chest pain or single-organ pathology.

Reasons for Doing This Study:

• Cardiac biomarkers are substances that are released into the blood when the heart is damaged or stressed. Measurements of these biomarkers are used to help diagnose acute coronary syndrome (ACS) and cardiac ischemia; conditions associated with insufficient blood flow to the heart. Tests for cardiac biomarkers can also be used to help determine a person’s risk of having these conditions or to help monitor and manage someone with suspected ACS and cardiac ischemia.
• Cardiovascular diseases (CVDs) are the leading cause of death globally, taking an estimated 17.9 million lives per year, representing 32% of all global deaths. Of these deaths, 85% were due to heart attack and stroke. Coronary heart disease, cerebrovascular disease, rheumatic heart disease and other diseases are among the category of heart and blood vessel disorders known as CVDs.
• The increased hospitalization of patients in ICUs during the COVID-19 pandemic led to a surge in demand for clinical biomarkers like D-dimer and CRP, as well as blood gas testing. Several cardiac biomarkers, most notably High-Sensitive Cardiac Troponin (hs-cTn) and N-terminal pro-B-type Natriuretic Peptide (NT-proBNP), have emerged as valuable predictors of prognosis in patients with COVID-19.
• There is a need for new and more rapid techniques to monitor cardiovascular diseases. Because the current techniques used are not sufficient, there has been continuous R&D to find new cardiac biomarkers. The above reasons are compelling enough to research and analyze the cardiac biomarkers market, which has tremendous growth potential.

Companies Mentioned

• Abbott Laboratories
• Acs Biomarker Bv
• Beckman Coulter (Subsidiary of Danaher Corp.)
• Bg Medicine Inc.
• Biomerieux S.A.
• Bio-Rad Laboratories, Inc.
• Cardiogenics
• Creative Diagnostics
• Critical Diagnostics
• Life Diagnostics Inc.
• Lifesign
• Lsi Medience Corp.
• Meridian Life Science Inc.
• Metanomics Health GmbH
• Ortho-Clinical Diagnostics Inc.
• Perkinelmer Inc.
• Pts Diagnostics
• Quidel Corp.
• Radiometer Medical Aps
• Randox Laboratories Ltd.
• Response Biomedical Corp.
• Roche Diagnostics
• Sanyo Chemical Industries Ltd.
• Siemens AG
• Singulex Inc.
• Spectral Medical Inc.
• Thermo Fisher Scientific, Inc.
• Tosoh Bioscience Inc.
• Trinity Biotech plc