Cardiac Biomarkers - Global Strategic Business Report

This report analyzes the worldwide markets for Cardiac Biomarkers in US$ Million. The market is analyzed by Location-wise (Clinical Laboratory Testing, and Point-of-Care Testing) and by Assay types (Acute Myocardial Infarction (AMI) Tests (Creatine Kinase-MB (CK-MB), Cardiac Troponin, & Myoglobin), and Congestive Heart Failure (CHF) Tests (BNP &NT-proBNP)). The report provides separate omprehensive analytics for the US, Europe, and Rest of the World. Annual estimates and forecasts are provided for the period 2009 through 2017. A six-year historic analysis is also provided for these markets. The report profiles 58 companies including many key and niche players such as Abbott Diagnostics, Alere, Inc., Ani Biotech Oy, Axis-Shield PoC, Beckman Coulter, Inc., BG Medicine, biomérieux, LifeSign LLC, Nanogen Inc., Ortho-Clinical Diagnostics, Inc., Prognostix, Inc., Response Biomedical Corp., Roche Diagnostics Corp., and Siemens Healthcare Diagnostics, Inc..Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

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1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS 1
Study Reliability and Reporting Limitations 1
Disclaimers 2
Data Interpretation & Reporting Level 2
Quantitative Techniques & Analytics 3
Product Definitions and Scope of Study 3

2. INDUSTRY OVERVIEW 4
Cardiovascular Diseases: Leading cause of Mortality Worldwide 4
Table 1: A Review of Region-Wise Incidence and Prevalence of
Cardiovascular Diseases: 2006 4
Basic Topologies of Cardiovascular Diseases 5
Table 2: Leading Causes of Death in Low Income Nations
(includes corresponding Graph/Chart) 6
Table 3: Leading Causes of Death in Middle Income Nations
(includes corresponding Graph/Chart) 7
Table 4: Leading Causes of Death in High Income Nations
(includes corresponding Graph/Chart) 8
Cardiac Biomarkers: A Snapshot 8
Fast and Accurate Diagnosis - Reduce Unnecessary Healthcare Costs 9
Cardiac Biomarkers - Making Diagnosis Easier and Quicker 9
What is a Cardiac BioMarker 9
Necessity of a Cardiac Marker Assay Test 10
How it works? 10
Major Cardiac Markers and their Properties 11
Market Analysis 11
Market Trends 12
Strong Demand for Risk Assessment Markers 12
Intense Competition among Players in the Cardiac Diagnostics
Market 12
Siemens Healthcare: World's Largest Fully Integrated
Diagnostics Company 12
Product Portfolio of Bayer and Dade Behring 13
The Future of Cardiac Marker POCT Segment 14
Need for Early Detection Markers 14
Rapid Turnaround time: A Crucial Parameter for POC Testing Kits 15
Stroke Biomarkers: A Review 15
Player Initiatives in the Recent Years 15

3. TRENDS IN RESEARCH AND DEVELOPMENT 17
Increasing Health Burden Drives Research Efforts 17
High-Performance Techniques Drive Biomarker Discovery in
Cardiology 17
Effective Phenotyping Takes Precedence for Successful
Genotyping Studies 17
Biomarkers of ACS: A Leading Segment 18
Biomarkers - A Promising Diagnostic Tool for ACS 18
New Diagnostic Biomarkers for ACS on the Anvil 19
Biomarker Discovery in Cardiovascular Diseases to Undergo
Significant Changes 19
Genomic Biomarkers for Detecting Cardiovascular Diseases 20
Growing Demand for Stroke Biomarkers 20
Rising Incidence of the Disease - A Major Driver for Stroke
Biomarkers 20

4. CARDIAC MARKERS AND MYOCARDIAL INFARCTION 21
Chain Reaction after an Event of MI 21
Action Plan after an Event of MI 21
Protocol for Conducting AMI Markers Tests 22
Myocardial Infarction Cardiac Biomarkers - Benefits and
Limitations 22
Creatine Kinase - The Traditional Gold Standard, Loosing Sheen 22
Market and Forecasts: 23
Isomers 23
Kinetics 23
Purpose of Test and When to Order 23
Evaluation 23
Points to remember 23
Cardiac Troponin - Taking Over from CK-MB 24
Market and Forecast 24
Overview 24
Troponin Tissue-Specific Subtypes 24
Other Diseases 25
Uses of Troponin Tests 25
New Advanced High-sensitivity (Hs) Cardiac Troponin Tests 25
Myoglobin 26
Purpose of Test and When to Order 26
Testing and Evaluation 26
Points to Remember 26
Market and Forecast 27

5. CARDIAC MARKERS AND CONGESTIVE HEART FAILURE (CHF) 28
Key Facts 28
BNP (B-type Natriuretic Peptide) 28
NT-proBNP (N-terminal proBNP) 29
Purpose of Tests and When to Order 29
Testing and Evaluation 29
Points to Remember 30
Market and Forecast 30
Introduction of BNP Test and the Changing Market Scenario in
the Segment: A Review 30
Player Strategies in the BNP and NT-proBNP Testing Market: A
Review 31
Choosing the Right BNP and NT proBNP Assay Kit in the Market 31
Evolution of BNP and NT proBNP Market 31
NT-proBNP is superior to BNP in Predicting Mortality in Heart
Failure Patients, with Reduced Kidney Function 32

6. OTHER IMPORTANT CARDIAC BIOMARKERS 33
Homocysteine 33
C-Reactive Protein 33
Plasminogen Activator Inhibitor-1 34
D-Dimer 34
Thrombus Precursor Protein 34
Galectin-3 Biomarker 34
Galectin-3: An Overview of Clinical Studies 35
Galectin-3: Overview of Clinical Studies in Cardiovascular
Disease Diagnosis 35
Potential Future Cardiac Biomarkers 35

7. CARDIAC BIOMARKER TESTING IN CLINICAL LABORATORIES 38
Market and Forecast 38

8. CARDIAC BIOMARKERS AT POINT-OF- CARE TESTING 39
Market and Forecast 39
Major Players Operating in the Cardiac Markers POCT Segment 40
Cardiac Markers Point-of-Care testing (POCT) Segment: Major
Players & Their Operating Brands. 40

9. STRATEGIC CORPORATE DEVELOPMENTS 41
BG Medicine and Boston Scientific Partner for Collaborative
Research 41
HDL and Gamma Therapeutics to Offer Biomarker Assay Tests for
Risk Assessment of Stroke and Heart attack 41
Pacific Biomarkers Enters into Research Deals with Two
Multinational Firms 41
Roche Enters into Cross-Licensing Agreement with Alere 42
ACC and Roche Diagnostics Initiate Collaboration 42
Aushon BioSystems Enters into Partnership with LightArray Biotech 42
Inverness Medical Innovations Changes Name to Alere 43
BG Medicine Inks Agreement with LabCorp 43
Siemens and Eko Diagnostics to Establish a PET Biomarkers
Manufacturing 43
Caprion Takes over PPD's Biomarker Business 43
Corgenix Medical Inks Supply Agreement with BG Medicine 43
ELITech Buys Out Nanogen Assets 44
Cordex and BG Medicine to join Forces for Clinical
Investigation of Biomarkers for Cardiac Failure 44
Asbach and Oxford Biosystems Ink Distribution Agreements with
Athera 44
GCIC Grants Funds to Prognostix to Further Product Development 45
Thermo Fisher Scientific Takes over B.R.A.H.M.S 45
Response Biomedical Signs Partnership Agreement with Roche 45
Compugen Announces Discovery of Troponin I Biomarker Variant,
Inks Agreement with Biosite 46
Inverness Acquires Biosite 46
Siemens Acquires Diagnostic Division of Bayer Healthcare 46
Siemens Announces Acquisition of Dade Behring 46
Beckman Collaborates in CVD Related Research Projects 47
Dade Behring Receives Sublicense to New Cardiac Marker 47
Inverness Acquires Cholestech 47
Response Biomedical Secures Clearance to Market RAMP®
NT-proBNP Test 48
Acrongenomics Collaborates with Molecular Vision and Pearson
Matthews 48
BG Medicine Obtains Rights to Develop Tests for Congestive
Heart Failure 48
Nanogen Gains US Reissue Patent for Combined Use of Biomarkers
for CHF Diagnosis 48
Nanogen Secures FDA Approval for CHF NT-proBNP EDTA Plasma Test 49
Roche Diagnostics Secures FDA Approval for Roche Elecsys®
proBNP Test 49
Nanogen Acquires Rapid Cardiac Immunoassay Test Businesses of SDI 49
Response Biomedical Starts Clinical Trials of the RAMP
NT-proBNP Test 50
Procter and Gamble, Inverness to Form JV for Consumer Diagnostics 50
Roche Diagnostics Grants Rights for NT- proBNP to Mitsubishi
Kagaku Latron 50
Bayer Healthcare Receives FDA Approval for Troponin-I-Test
Tnl-Ultra 50
MKI Obtains EU Approval and CE Mark for Four Cardiac Markers 51
Dade Behring Grants PIGF Rights to Abbott 51
Siemens and PETNET Pharmaceuticals Acquire PETNET's New
England Operations 51
OXIS International Acquires Biocheck 51
Wampole, Roche collaborate on Ischemia Modified Albumin Test 52
Nanogen Extends Point-of-Care Diagnostic Tests Distribution in
Europe 52
Abbott, Cleveland Clinic Agrees to Develop MPO Cardiac Test 52
Roche Diagnostics Grants Rights to Response Biomedical for
Troponin T and NT- proBNP 52
Inverness Acquires Ischemia Technologies 53
Roche Diagnostics Grants Rights for NT- proBNP to bioMerieux 53
Roche Confers Rights of NT-proBNP to Ortho-Clinical Diagnostics 54
Dade Behring Grants CRP Sublicense to Roche Diagnostics 54
Roche Awards Non Exclusive Rights of NT-proBNP marker to DPC 54
Abbott Gains Approval for CK-MB Test in the US 54
i-STAT Gains Approval for Troponin I Test from US FDA 55

10. PRODUCT LAUNCHES/DEVELOPMENTS/ APPROVALS 56
Eisai and Sanko to Unveil Cobas h 232 Series 56
bioMerieux and Philips Co-Develop an Advanced Rapid POCT
Solution for Emergency Testing 56
Singulex Secures US patent for use of Erenna Technology in
Diagnosing Low Troponin-I Levels 56
BG Medicine Receives FDA Clearance for Galactin-3 Assay 57
Roche Launches STAT Immunoassays Module 57
Alere International Launches New Triage® NT-proBNP Test 57
Abbott Laboratories and BG Medicine Ink Agreement 58
PGxHealth Unveils Familion DCM Genetic Test 58
Roche Diagnostics Launches Cardiac 200 58
Thermo Fisher Scientific Introduces Biomarker based
Diagnostics for Heart Attack in Europe 58
Alere Introduces Triage® NT-proBNP Test 59
Celera Inks Non-Exclusive License Agreement with Perlegen
Sciences 59
Maine Standards Launches VALIDATE CM2 Test Set 59
Response Bags FDA Clearance for RAMP® NT-proBNP Test 60
bioMérieux Rolls out VIDAS® NT-proBNP 60
Roche Diagnostics Introduces Cobas-H-232 Handheld Cardiac
Marker System 60
OXIS Discovers a Unique Diagnostic Biomarker for
Cardiovascular Disease 60
Ortho-Clinical Presents Sensitivity Troponin I Test, VITROS
Troponin I ES 61
bioMerieux Unveils ‘VIDAS® Troponin I Ultra' 61
Roche Elecsys proBNP Assay Secures FDA Clearance 61
Bayer Launches New Tnl-Ultra™ Troponin Assay on ADVIA Centaur®
CP Immunoassay system 62
Ortho-Clinical Diagnostics Receives FDA Clearance for VITROS
NT-proBNP Assay 62
Dade Behring Launches CardioPhase® hsCRP Test 63
Diagnostic Products Corporation to Market NT-proBNP Outside US 63
Dade Behring Introduces Homocysteine Assay for BN™ System 63
Biosite Develops Triage® Cardio ProfilER™ Panel 63
A Breakthrough Biochip Array System for MI 64
FDA Approves Emergency Department Diagnostic Test from Biosite 64
Response Biomedical Obtains Regulatory Clearance for RAMP® 64
Response Biomedical Gains US FDA Approval for 3rd RAMP® Test 64
CLINIQA Rolls Out Liquid Stable Cardiac Marker Controls 65
Abbott Releases AxSYM® Troponin-I ADV Assay in World Markets 65

11. FOCUS ON SELECT GLOBAL PLAYERS 66
Abbott Diagnostics (USA) 66
Alere, Inc. (USA) 66
Ani Biotech Oy (Finland) 66
Axis-Shield PoC (UK) 67
Beckman Coulter, Inc. (USA) 67
BG Medicine (USA) 67
biomérieux (France) 68
LifeSign LLC (USA) 68
Ortho-Clinical Diagnostics, Inc. (USA) 69
Prognostix, Inc. (USA) 69
Response Biomedical Corp. (Canada) 69
Roche Diagnostics Corp. (USA) 70
Siemens Healthcare Diagnostics, Inc. (USA) 70

12. GLOBAL MARKET PERSPECTIVE 71
Table 5: World Recent Past, Current and Future Analysis for
Cardiac Biomarkers by Geographic Region - US, Europe, and Rest
of the World Markets Independently Analyzed with Annual Sales
Figures in US$ million for Years 2009 through 2017 (includes
corresponding Graph/Chart) 71

Table 6: World Historic Review Analysis for Cardiac Biomarkers
by Geographic Region - US, Europe, and Rest of the World
Markets Independently Analyzed with Annual Sales Figures in
US$ million for Years 2003 through 2008 (includes
corresponding Graph/Chart) 72

Table 7: World 15-Year Perspective for Cardiac Biomarkers by
Geographic Region - US, Europe, and Rest of the World Markets
Independently Analyzed with Annual Sales Figures in US$
million for Years 2003, 2010, and 2017 (includes corresponding
Graph/Chart) 73

Table 8: World Recent Past, Current and Future Analysis for
Cardiac Biomarkers in Laboratory Testing Sector by Geographic
Region - US, Europe, and Rest of the World Markets
Independently Analyzed with Annual Sales Figures in US$
million for Years 2009 through 2017 (includes corresponding
Graph/Chart) 74

Table 9: World Historic Review Analysis for Cardiac Biomarkers
in Laboratory Testing Sector by Geographic Region - US,
Europe, and Rest of the World Markets Independently Analyzed
with Annual Sales Figures in US$ million for Years 2003
through 2008 (includes corresponding Graph/Chart) 75

Table 10: World 15-Year Perspective for Cardiac Biomarkers in
Laboratory Testing Sector by Geographic Region - US, Europe,
and Rest of the World Markets Independently Analyzed with
Annual Sales Figures in US$ million for Years 2003, 2010, and
2017 (includes corresponding Graph/Chart) 76

Table 11: World Recent Past, Current and Future Analysis for
Cardiac Biomarkers in Point-of-Care Testing Sector by
Geographic Region - US, Europe, and Rest of the World Markets
Independently Analyzed with Annual Sales Figures in US$
million for Years 2009 through 2017 (includes corresponding
Graph/Chart) 77

Table 12: World Historic Review Analysis for Cardiac
Biomarkers in Point-of-Care Testing Sector by Geographic
Region - US, Europe, and Rest of the World Markets
Independently Analyzed with Annual Sales Figures in US$
million for Years 2003 through 2008 (includes corresponding
Graph/Chart) 78

Table 13: World 15-Year Perspective for Cardiac Biomarkers in
Point-of-Care Testing Sector by Geographic Region - US,
Europe, and Rest of the World Markets Independently Analyzed
with Annual Sales Figures in US$ million for Years 2003, 2010,
and 2017 (includes corresponding Graph/Chart) 79

Table 14: World Recent Past, Current & Future Analysis for
CK-MB Assay Test by Geographic Region - US, Europe and Rest of
the World Markets. Independently Analyzed with Annual Sales
Figures in US$ million for Years 2006 through 2017 (includes
corresponding Graph/Chart) 80

Table 15: World Historic Review Analysis for CK-MB Assay Test
by Geographic Region - US, Europe and Rest of the World
Markets. Independently Analyzed with Annual Sales Figures in
US$ million for Years 2003 through 2008 (includes
corresponding Graph/Chart) 81

Table 16: World 15-Year Perspective for CK-MB Assay Test by
Geographic Region - US, Europe and Rest of the World Markets
Independently Analyzed with Annual Sales Figures in US$
million for Years 2003, 2010, and 2017 (includes corresponding
Graph/Chart) 82

Table 17: World Recent Past, Current & Future Analysis for
Cardiac Troponin Assay Test by Geographic Region - US, Europe
and Rest of the World Markets. Independently Analyzed with
Annual Sales Figures in US$ million for Years 2009 through
2017 (includes corresponding Graph/Chart) 83

Table 18: World Historic Review Analysis for Cardiac Troponin
Assay Test by Geographic Region - US, Europe and Rest of the
World Markets. Independently Analyzed with Annual Sales
Figures in US$ million for Years 2001 through 2005 (includes
corresponding Graph/Chart) 84

Table 19: World 15-Year Perspective for Cardiac Troponin Assay
Test by Geographic Region - USA, Europe and Rest of the World
Markets. Independently Analyzed with Annual Sales Figures in
US$ million for Years 2006, 2009, and 2017 (includes
corresponding Graph/Chart) 85

Table 20: World Recent Past, Current & Future Analysis for
Myoglobin Assay Test by Geographic Region - US, Europe and
Rest of the World Markets. Independently Analyzed with Annual
Sales Figures in US$ million for Years 2009 through 2017
(includes corresponding Graph/Chart) 86

Table 21: World Historic Review Analysis for Myoglobin Assay
Test by Geographic Region - US, Europe and Rest of the World
Markets. Independently Analyzed with Annual Sales Figures in
US$ million for Years 2003 through 2008 (includes
corresponding Graph/Chart) 87

Table 22: World 15-Year Perspective for Myoglobin Assay Test
by Geographic Region - US, Europe and Rest of the World
Markets. Independently Analyzed with Annual Sales Figures in
US$ million for Years 2003, 2010, and 2017 (includes
corresponding Graph/Chart) 88

Table 23: World Recent Past, Current & Future Analysis for BNP
& NT-proBNP Assay Test by Geographic Region - US, Europe and
Rest of the World Markets. Independently Analyzed with Annual
Sales Figures in US$ million for Years 2009 through 2017
(includes corresponding Graph/Chart) 89

Table 24: World Historic Review Analysis for BNP & NT-proBNP
Assay Test by Geographic Region - US, Europe and Rest of the
World Markets. Independently Analyzed with Annual Sales
Figures in US$ million for Years 2003 through 2008 (includes
corresponding Graph/Chart) 90

Table 25: World 15-Year Perspective for BNP & NT- proBNP Assay
Test by Geographic Region - US, Europe and Rest of the World
Markets. Independently Analyzed with Annual Sales Figures in
US$ million for Years 2003, 2010, and 2017 (includes
corresponding Graph/Chart) 91

13. THE UNITED STATES 92
A.Market Analysis 92
Cardiovascular Diseases in the US: A Review 92
Heart Facts 92
Table 26: The US Disease Statistics for Coronary Heart
Disease (CHD) & Myocardial Infarction (MI) 93

Table 27: Prevalence of Cardiovascular Diseases in the US
by Type (2007-2009) (includes corresponding Graph/Chart) 93

Table 28: The US Prevalence of Coronary Heart Disease (CHD)
as a Percentage of Total Population by Age-group & Sex, in
2005 - 06. (includes corresponding Graph/Chart) 94

Table 29: The US Annual Number of New & Recurrent Adults
diagnosed with Heart Attack by Age & Sex in the Recent Past
(includes corresponding Graph/Chart) 94

Table 30: The US Disease Statistics for Heart Failure 95

Table 31: The Annual Number of Americans Diagnosed with
Heart Failure as per 1000 persons by Age & Sex, in the
Recent Past (includes corresponding Graph/Chart) 95
Number of Deaths due to Heart Diseases & Strokes: A Historic
Review 95
Senior Citizens at High Risk for Heart Failure 96
CHF Biomarkers to Spearhead the US market 96
US Cardiac Markers POCT Segment 96
Table 32: US AMI (Acute Myocardial Infarction) Diagnostics
Market: Market Share by Revenue held by Major Players
(Siemens, Beckman Coulter, and Others) in 2010(E) (includes
corresponding Graph/Chart) 97

Table 33: US CHF (Congestive Heart Failure) Diagnostics
Market: Market Share by Revenue held by Major Players
(Siemens, Alere, Beckman Coulter, and Others) in 2010(E)
(includes corresponding Graph/Chart) 97
Product Launches/Approvals/Developments 98
Strategic Corporate Developments 103
Focus on Select Key Players 115
Abbott Diagnostics 115
Beckman Coulter, Inc. 115
BG Medicine (USA) 115
diaDexus, Inc. 116
Inverness Medical Innovations, Inc. 116
LifeSign LLC 117
Ortho-Clinical Diagnostics, Inc. 117
Prognostix, Inc. 117
Roche Diagnostics Corp. 117
Siemens Healthcare Diagnostics, Inc. 118
B.Market Analytics 119
Table 34: The US Recent Past, Current and Future Analysis
for Cardiac Markers by Segment - Clinical Laboratory testing
and Point-of-Care Testing (POCT) Markets: Independently
Analyzed with Annual Sales in US$ million for Years 2009
through 2017 (includes corresponding Graph/Chart) 119

Table 35: The US Historic Review Analysis for Cardiac
Markers by Segment - Clinical Laboratory testing and
Point-of-Care Testing (POCT) Markets: Independently Analyzed
with Annual Sales in US$ million for Years 2003 through 2008
(includes corresponding Graph/Chart) 120

Table 36: The US 15-Year Perspective for Cardiac Markers by
Segment - Clinical Laboratory testing and Point-of- Care
Testing (POCT) Markets: Independently Analyzed with Annual
Sales in US$ million for 2003, 2010 and 2017 (includes
corresponding Graph/Chart) 121

Table 37: The US Recent Past, Current and Future Analysis
for Cardiac Markers by Test Type - AMI (CK-MB, Cardiac
Troponin and Myoglobin), and CHF (BNP and NT proBNP)
Markets: Independently Analyzed with Annual Sales in US$
million for Years 2009 through 2017 (includes corresponding
Graph/Chart) 122

Table 38: The US Historic Review Analysis for Cardiac
Markers by Test Type - AMI (CK-MB, Cardiac Troponin and
Myoglobin), and CHF (BNP and NT proBNP) Markets:
Independently Analyzed with Annual Sales in US$ million for
Years 2003 through 2008 (includes corresponding Graph/Chart) 123

Table 39: The US 15-Year Perspective for Cardiac Markers by
Test Type - AMI (CK-MB, Cardiac Troponin and Myoglobin), and
CHF (BNP and NT proBNP) Markets: Independently Analyzed with
Annual Sales in US$ million for 2003, 2010 and 2017
(includes corresponding Graph/Chart) 124

14. EUROPE 125
A.Market Analysis 125
European Cardiovascular Diseases Fact Sheet 125
Evolution of the European Cardiac Risk Markers Market 125
Cardiac Markers in Primary Care Sector 126
Product Launches/Approvals/Developments 126
Strategic Corporate Developments 127
B.Market Analytics 128
Table 40: European Recent Past, Current and Future Analysis
for Cardiac Markers by Region - France, Germany, Italy, UK,
and ‘Rest of Europe' Markets: Independently Analyzed with
Annual Sales in US$ million for Years 2009 through 2017
(includes corresponding Graph/Chart) 128

Table 41: European Historic Review Analysis for Cardiac
Markers by Region - France, Germany, Italy, UK, and ‘Rest of
Europe' Markets: Independently Analyzed with Annual Sales in
US$ million for Years 2003 through 2008 (includes
corresponding Graph/Chart) 129

Table 42: European 15-Year Perspective for Cardiac Markers
by Region - France, Germany, Italy, UK, and ‘Rest of Europe'
Markets: Independently Analyzed with Annual Sales in US$
million for 2003, 2010 and 2017 (includes corresponding
Graph/Chart) 130

Table 43: European Recent Past, Current and Future Analysis
for Cardiac Markers by Segment - Clinical Laboratory testing
and Point-of-Care Testing (POCT) Markets: Independently
Analyzed with Annual Sales in US$ million for Years 2009
through 2017 (includes corresponding Graph/Chart) 131

Table 44: European Historic Review Analysis for Cardiac
Markers by Segment - Clinical Laboratory testing and
Point-of-Care Testing (POCT) Markets: Independently Analyzed
with Annual Sales in US$ million for Years 2003 through 2008
(includes corresponding Graph/Chart) 132

Table 45: European 15-Year Perspective for Cardiac Markers
by Segment - Clinical Laboratory testing and Point-of-Care
Testing (POCT) Markets: Independently Analyzed with Annual
Sales in US$ million for 2003, 2010 and 2017 133

Table 46: European Recent Past, Current and Future Analysis
for Cardiac Markers by Assay Test Type - AMI (CK-MB, Cardiac
Troponin and Myoglobin), and CHF (BNP and NT proBNP)
Markets: Independently Analyzed with Annual Sales in US$
million for Years 2009 through 2017 (includes corresponding
Graph/Chart) 134

Table 47: European Historic Review Analysis for Cardiac
Markers by Assay Test Type - AMI (CK-MB, Cardiac Troponin
and Myoglobin), and CHF (BNP and NT proBNP) Markets:
Independently Analyzed with Annual Sales in US$ million for
Years 2003 through 2008 (includes corresponding Graph/Chart) 135

Table 48: European 15-Year Perspective for Cardiac Markers
by Assay Test Type - AMI (CK-MB, Cardiac Troponin and
Myoglobin), and CHF (BNP and NT proBNP) Markets:
Independently Analyzed with Annual Sales in US$ million for
2003, 2010 and 2017 (includes corresponding Graph/Chart) 136

14a. FRANCE 137
A.Market Analysis 137
Product Launches/Approvals/Developments 137
Strategic Corporate Developments 138
BioMérieux - A Key Player 138
B.Market Analytics 139
Table 49: French Recent Past, Current and Future Analysis
for Cardiac Markers by Segment - Clinical Laboratory testing
and Point-of- Care Testing (POCT) Markets: Independently
Analyzed with Annual Sales in US$ million for Years 2009
through 2017 (includes corresponding Graph/Chart) 139

Table 50: French Historic Review Analysis for Cardiac
Markers by Segment - Clinical Laboratory testing and
Point-of-Care Testing (POCT) Markets: Independently Analyzed
with Annual Sales in US$ million for Years 2003 through 2008
(includes corresponding Graph/Chart) 140

Table 51: French 15-Year Perspective for Cardiac Markers by
Segment - Clinical Laboratory testing and Point-of-Care
Testing (POCT) Markets: Independently Analyzed with Annual
Sales in US$ million for 2003, 2010 and 2017 (includes
corresponding Graph/Chart) 141

14b. GERMANY 142
A.Market Analysis 142
Rennesens GmbH 142
Strategic Corporate development 142
B.Market Analytics 143
Table 52: German Recent Past, Current and Future Analysis
for Cardiac Markers by Segment - Clinical Laboratory testing
and Point-of-Care Testing (POCT) Markets: Independently
Analyzed with Annual Sales in US$ million for Years 2009
through 2017 (includes corresponding Graph/Chart) 143

Table 53: German Historic Review Analysis for Cardiac
Markers by Segment - Clinical Laboratory testing and
Point-of-Care Testing (POCT) Markets: Independently Analyzed
with Annual Sales in US$ million for Years 2003 through 2008
(includes corresponding Graph/Chart) 144

Table 54: German 15-Year Perspective for Cardiac Markers by
Segment - Clinical Laboratory testing and Point-of-Care
Testing (POCT) Markets: Independently Analyzed with Annual
Sales in US$ million for 2003, 2010 and 2017 (includes
corresponding Graph/Chart) 145

14c. ITALY 146
Market Analysis 146
Table 55: Italian Recent Past, Current and Future Analysis
for Cardiac Markers by Segment - Clinical Laboratory testing
and Point-of- Care Testing (POCT) Markets: Independently
Analyzed with Annual Sales in US$ million for Years 2009
through 2017 (includes corresponding Graph/Chart) 146

Table 56: Italian Historic Review Analysis for Cardiac
Markers by Segment - Clinical Laboratory testing and
Point-of-Care Testing (POCT) Markets: Independently Analyzed
with Annual Sales in US$ million for Years 2003 through 2008
(includes corresponding Graph/Chart) 147

Table 57: Italian 15-Year Perspective for Cardiac Markers by
Segment - Clinical Laboratory testing and Point-of- Care
Testing (POCT) Markets: Independently Analyzed with Annual
Sales in US$ million for 2003, 2010 and 2017 (includes
corresponding Graph/Chart) 148

14d. THE UNITED KINGDOM 149
A.Market Analysis 149
UK Cardiovascular Diseases Fact Sheet 149
Table 58: The UK's Healthcare Costs of Cardio Vascular
Diseases (CVD), Coronary Heart Diseases (CHD) & Strokes in
2006 (includes corresponding Graph/Chart) 150
Strategic Corporate Development 150
Product Launch 151
Axis-Shield PoC: A Key Player 151
B.Market Analytics 152
Table 59: The UK Recent Past, Current and Future Analysis
for Cardiac Markers by Segment - Clinical Laboratory testing
and Point-of-Care Testing (POCT) Markets: Independently
Analyzed with Annual Sales in US$ million for Years 2009
through 2017 (includes corresponding Graph/Chart) 152

Table 60: The UK Recent Past, Current and Future Analysis
for Cardiac Markers by Segment - Clinical Laboratory testing
and Point-of-Care Testing (POCT) Markets: Independently
Analyzed with Annual Sales in US$ million for Years 2003
through 2008 (includes corresponding Graph/Chart) 153

Table 61: The UK 15-Year Perspective for Cardiac Markers by
Segment - Clinical Laboratory testing and Point-of- Care
Testing (POCT) Markets: Independently Analyzed with Annual
Sales in US$ million for 2003, 2010 and 2017 (includes
corresponding Graph/Chart) 154

14e. REST OF EUROPE 155
A.Market Analysis 155
Ani Biotech Oy: A Key Player 155
B.Market Analytics 156
Table 62: Rest of Europe Recent Past, Current and Future
Analysis for Cardiac Markers by Segment - Clinical
Laboratory testing and Point-of-Care Testing (POCT) Markets:
Independently Analyzed with Annual Sales in US$ million for
Years 2009 through 2017 (includes corresponding Graph/Chart) 156

Table 63: Rest of Europe Recent Past, Current and Future
Analysis for Cardiac Markers by Segment - Clinical
Laboratory testing and Point-of-Care Testing (POCT) Markets:
Independently Analyzed with Annual Sales in US$ million for
Years 2001 through 2005 (includes corresponding Graph/Chart) 157

Table 64: Rest of Europe 15-Year Perspective for Cardiac
Markers by Segment - Clinical Laboratory testing and
Point-of-Care Testing (POCT) Markets: Independently Analyzed
with Annual Sales in US$ million for 2003, 2010 and 2017
(includes corresponding Graph/Chart) 158

15. REST OF WORLD 159
A.Market Analysis 159
Evolution of BNP Test market in Japan 159
Canada: cardiovascular disease facts 159
Table 65: Heart Disease in Canada by Province: an Overview
(includes corresponding Graph/Chart) 160
Heart Attacks 160
Cardiac Arrest 160
Heart Failure 160
Stroke 161
Congenital Heart Disease 161
Product Launches/Approvals/Developments 161
Strategic Corporate Developments 163
Focus on Select Key Players 165
Response Biomedical Corporation 165
Sekisui Medical Co. Ltd. 165
Shionogi and Co. Ltd. 165
B.Market Analytics 166
Table 66: Rest of the World Recent Past, Current and Future
Analysis for Cardiac Markers by Segment - Clinical
Laboratory testing and Point-of-Care Testing (POCT) Markets:
Independently Analyzed with Annual Sales in US$ million for
Years 2006 through 2017 (includes corresponding Graph/Chart) 166

Table 67: Rest of the World Historic Review Analysis for
Cardiac Markers by Segment - Clinical Laboratory testing and
Point-of- Care Testing (POCT) Markets: Independently
Analyzed with Annual Sales in US$ million for Years 2003
through 2008 (includes corresponding Graph/Chart) 167

Table 68: Rest of the World 15-Year Perspective for Cardiac
Markers by Segment - Clinical Laboratory testing and
Point-of-Care Testing (POCT) Markets: Independently Analyzed
with Annual Sales in US$ million for 2003, 2010 and 2017
(includes corresponding Graph/Chart) 168

Table 69: Rest of the World Recent Past, Current and Future
Analysis for Cardiac Markers by Assay Test Type - AMI
(CK-MB, Cardiac Troponin and Myoglobin), and CHF (BNP and NT
proBNP) Markets: Independently Analyzed with Annual Sales in
US$ million for Years 2009 through 2017 (includes
corresponding Graph/Chart) 169

Table 70: Rest of the World Historic Review Analysis for
Cardiac Markers by Assay Test Type - AMI (CK-MB, Cardiac
Troponin and Myoglobin), and CHF (BNP and NT proBNP)
Markets: Independently Analyzed with Annual Sales in US$
million for Years 2003 through 2008 (includes corresponding
Graph/Chart) 170

Table 71: Rest of the World 15-Year Perspective for Cardiac
Markers by Test Type - AMI (CK-MB, Cardiac Troponin and
Myoglobin), and CHF (BNP and NT proBNP) Markets:
Independently Analyzed with Annual Sales in US$ million for
2003, 2010 and 2017 (includes corresponding Graph/Chart) 171

COMPETITIVE LANDSCAPE

Total Companies Profiled: 58 (including Divisions/Subsidiaries - 75)

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Region/Country Players
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The United States 32
Canada 4
Japan 3
Europe 20
France 3
Germany 1
The United Kingdom 6
Spain 1
Rest of Europe 9
Asia-Pacific (Excluding Japan) 13
Latin America 1
Middle-East 2
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Cardiovascular Disease (CVD) continues to be the leading cause of mortality worldwide, accounting for a whopping 17 million deaths annually. An estimated 30 million people worldwide get afflicted with one or the other form of cardiovascular diseases every year. Heart failure results in the death of over 5 million people every year. Heart Diseases constitute one of the 10 leading causes of death in the lower, middle and high income groups across the globe. Biomarkers provide tremendous support in effective clinical decision making, which is mainly dependent on diagnosing the health status of a patient. Owing to their precision in the early detection of risks associated with cardiac diseases, biomarkers emerged as an invaluable tool in detecting cardiovascular diseases that constitute a leading cause of mortality in several developed nations, including the US. Increasing technological advancements in the area of biomarkers have enabled their use in unconventional applications.

Cardiac biomarkers, used in the diagnosis and prognosis of myocardial infarction and heart failure, are one of the fastest growing segments of the clinical immunoassay diagnostics market. Cardiovascular biomarkers have taken cardiovascular and metabolic disease diagnosis and management to a new level, by enhancing the efficiency of these processes. Inflammatory and lipid biomarkers have been validated as indicators for assessing potential risks of cardiovascular diseases in patients. Their use has been proven to be effective in establishing the cardiovascular disease onset, thus enabling the prevention of conditions, such as coronary thrombosis and stroke. Besides, these biomarkers are capable of accurately assessing risks of Acute Coronary Syndrome (ACS), stroke and other cardiovascular events in the home as well as primary care settings.

The cardiac biomarkers currently available in the market cater to the needs of physicians for the prognosis, diagnosis, and risk assessment of cardiovascular diseases, such as heart failure and myocardial infarction. Researchers are looking out for additional markers that can help in detecting earlier events in the myocardial infarction disease progression, such as markers for plaque instability and myocardial ischemia.

The US represents the single largest market for Cardiac Biomarkers, as stated by the Global Industry Analysts research report on Cardiac Biomarkers. Rest of World is likely to emerge as the fastest growing market for Cardiac Biomarkers with a compounded annual growth rate (CAGR) of 11.6% over the analysis period. Cardiac Troponin assay market constitutes the largest cardiac biomarkers test segment. BNP and NT-pro BNP assay test market is likely to emerge as the fastest growing segment reflecting a compounded annual growth rate (CAGR) of 15.6% over the analysis period.

Traditionally, clinicians preferred clinical laboratories for performing cardiac biomarkers tests for myocardial infarction, and to a limited extent, point-of-care. However, the POCT market for cardiac biomarkers showed dramatically upward trend with the introduction of the BNP test by Biosite in 2001. Clinical laboratory testing segment dominates the global cardiac biomarkers market, while Point-of-Care testing is poised to register the fastest CAGR of 12.9% during the analysis period.

Global Industry Analysts ©

- Abbott Diagnostics
- Alere Inc.
- Ani Biotech Oy
- Axis-Shield PoC
- Beckman Coulter Inc.
- BG Medicine
- biomérieux
- LifeSign LLC
- Nanogen Inc.
- Ortho-Clinical Diagnostics Inc.
- Prognostix Inc.
- Response Biomedical Corp.
- Roche Diagnostics Corp.
- Siemens Healthcare Diagnostics Inc