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Cardiovascular Biomarkers: Players, Products and Prospects (Volume III)


Description: Part of our new 3-volume report on Cancer, CNS and Cardiovascular Biomarkers, this volume provides a comprehensive analysis of the cardiovascular biomarker sector, along with a critical assessment of the companies involved.

In 2007, the cardiovascular biomarker market accounted for an estimated 23% of biomarker revenues to generate over US$1.3 billion with the majority of revenues derived from biomarker discovery and molecular diagnostics. The market has yet to reach the maturity of the oncology biomarker market, but over the coming years the importance of genetic markers and companion diagnostics will grow. By 2015, the estimated market value will be US$6.6 billion, with biomarker discovery being the largest component.

One of the largest markets for cardiovascular biomarkers lies in the diagnosis of acute coronary syndromes in patients presenting with acute signs and symptoms, such as shortness of breath or chest pain.

For example, Troponin is well established as a diagnostic marker of myocardial infarction and has been described as the cornerstone of diagnosis for the condition. However, the marker has a major limitation: troponin levels only rise six to eight hours after a myocardial ischaemia. The search for new diagnostic biomarkers for use in the acute setting has focused on the identification of earlier markers of infarction. These include ischaemia modified albumin (IMA) as well as potential markers, heart fatty acid binding protein and glycogen phosphorylase isoenzyme BB (GPBB). In addition, some of the leading providers are suggesting that panels of cardiac markers are most useful for diagnosis in acute settings. Examples include Biosite’s (now part of Inverness Medical Innovations) CardioProfiler Triage panel. This is a PoC diagnostic that measures a number of markers including Troponin I, CK-MB, myoglobin and BNP. New multi-marker panels are also under development. These include an index score panel for the diagnosis of peripheral artery disease (VASCLIR, Vermillion). The panel evaluates ß-2-microglobulin, cystatin C, hsCRP and glucose to create an index score and is currently in clinical trials.

Screening patients for prediction of future cardiovascular disease is currently the second major market for cardiovascular biomarkers. These markers include lipid biomarkers (e.g. LDL, HDL, triglycerides, LDL particle number and lipoprotein concentrations) or inflammatory biomarkers (e.g. CRP or Lp-PLA2). Lipid profiles are well-established as indicators of future cardiovascular risk that can be reduced through the use of lipid-lowering therapies such as statins.

Questions, Questions
- What clinical studies are CardioDx currently engaged in?
- What approach is deCODE Genetics taking in its research?
- Which pharmaceutical companies are utilising Entelos predictive biostimulation technology?

Focus on...market potential
In 2007, the cardiovascular biomarker market accounted for and estimated 23% of biomarker revenues generating over US$1.3 billion, with the majority of revenues derived from biomarker discovery and molecular diagnostics. The market has yet to reach the maturity of the oncology biomarker market, but will grow in the short term with the introduction of new, proprietary markers for acute coronary syndromes. Over the coming years, the importance of genetic markers and companion diagnostics will grow.

By 2015, we estimate the global cardiovascular biomarker market will account for around one third of global biomarker sales and will be worth up to US$6.6 billion as it becomes more mature; driven by growth in clinical biomarkers, the development of targeted therapies and associated companion diagnostics, discovery and validation of genetic markers of cardiovascular risk and reimbursement of pharmacogenomic and prognostic tests.


Contents: EXECUTIVE SUMMARY 1
Figure1: Growth in biomarker market 2007-2015 1
What are biomarkers? 2
Why are they important? 2
Figure 2: Potential impact of biomarkers on disease pathways 2
What technologies are involved? 3
What impact will biomarkers have on R&D? 3
Figure 3: Potential impact of biomarkers on R&D 3
Who are the major biomarker players and in what research area? 4
Cancer biomarker companies 5
Cardiovascular biomarker companies 6
CNS biomarkers companies 7
Company Analysis Criteria 7
Biomarker technology & platforms 7
Association/clinical studies 8
Management strategy 8
Application & potential 8

CARDIOVASCULAR MARKET & REVENUES 9
Market revenues - global 9
Figure 1: Global cardiovascular disease drug sales 2007 9
Market revenues – leading brands 10
Figure 2: Leading Cardiovascular brands (2007) 10
Market revenues – leading players 11
Figure 3: Top 10 cardiovascular players (2007 revenues) 11

CARDIOVASCULAR EPIDEMIOLOGY, DIAGNOSIS, SCREENING & TREATMENT 12
Epidemiology 12
Figure 4: Breakdown of deaths from cardiovascular diseases in the US (2004) 13
Diagnosis 13
Screening 14
Table 1: Screening for cardiovascular disease 14
Current treatments 14
Table 2: Cardiovascular therapeutic drug categories and their indications 15
Future treatments 15
Figure 5: Drugs in clinical development for heart disease 16

CARDIOVASCULAR BIOMARKERS 17
Cardiovascular biomarker R&D 17
Figure 6: Impact of biomarkers on the drug R&D process 18
Table 3: Types of biomarker 19
Known cardiovascular biomarkers 19
Table 4: Commercially available cardiovascular diagnostics 19
Probable and possible valid cardiovascular biomarkers 21
Table 5: Probable cardiovascular biomarkers 22
Table 6: Possible cardiovascular biomarkers 23

CARDIOVASCULAR BIOMARKER OPPORTUNITIES & CHALLENGES 26
Opportunities 26
Figure 7: Cardiovascular biomarker opportunities 26
Challenges 27
Figure 8: Cardiovascular biomarker challenges 27

BIOMARKER MARKET 29
Biomarker market revenues – global 29
Figure 9: Global biomarker sales in 2007 29
Cardiovascular biomarker market revenues – global 30
Figure 10: Global cardiovascular biomarker sales in 2007 30
Future biomarker market revenues – global 30
Figure 11: Global biomarker sales in 2015 31
Future cardiovascular biomarker market revenues – global 31
Figure 12: Global cardiovascular biomarker sales in 2015 31

CARDIOVASCULAR BIOMARKER TRENDS 32
Table 7: Recent deals in cardiovascular biomarkers 32
Pharma and specialty pharma deals 33
Collaborations with service providers 33
Collaborations with academics and consortia 33
BIOMARKER ANALYSIS 34
Assays for circulating biomarkers 34
DNA and RNA biomarkers 34
Proteomic, metabolomic biomarkers 34
Systems biology for biomarker discovery 34
Imaging biomarkers 35

KEY BIOMARKER COMPANIES ANALYSED 36
KEY BIOMARKER EVALUATION CRITERIA 37
CARDIOVASCULAR BIOMARKERS - COMPANY ANALYSIS 38
Abbott Diagnostics 38
Biomarker novelty & technology platform 38
Association studies/clinical data 38
Management strategy 38
Application & market potential 38
Biomarker analysis 39
Atherotech 40
Biomarker novelty & technology platform 40
Association studies/clinical data 40
Management strategy 40
Application & market potential 40
Biomarker analysis 40
Affymetrix 41
Biomarker novelty & technology platform 41
Figure 13: Affymetrix’ approach to biomarker discovery, validation and clinical utility applications 41
Association studies/clinical data 41
Management strategy 42
Application & market potential 42
Biomarker analysis 43
Beckman Coulter 44
Biomarker novelty & technology platform 44
Association studies/clinical data 44
Management strategy 44
Application & market potential 45
Biomarker analysis 45
Berkeley HeartLab 46
Biomarker novelty & technology platform 46
Figure 14: Markers of cardiovascular disease measured at Berkeley HeartLab 46
Association studies/clinical data 46
Management strategy 47
Application & market potential 47
Biomarker analysis 47
BG Medicine 48
Biomarker novelty & technology platform 48
Association studies/clinical data 48
Management strategy 48
Figure 15: BG Medicine’s Biomarker Programme 49
Application & market potential 49
Biomarker analysis 50
CardioDx 51
Biomarker novelty & technology platform 51
Association studies/clinical data 51
Management strategy 51
Application & market potential 51
Biomarker analysis 52
Competitor Ratio Analysis Score = 9/40 52
Celera 53
Biomarker novelty & technology platform 53
Association studies/clinical data 53
Management strategy 54
Application & market potential 54
Biomarker analysis 54
CIS Biotech 55
Biomarker novelty & technology platform 55
Association studies/clinical data 55
Management strategy 55
Application & market potential 55
Biomarker analysis 56
Clinical Data 57
Biomarker novelty & technology platform 57
Association studies/clinical data 57
Management strategy 58
Application & market potential 58
Biomarker analysis 58
Compugen 59
Biomarker novelty & technology platform 59
Association studies/clinical data 59
Management strategy 59
Application & market potential 60
Biomarker analysis 60
Critical Diagnostics 61
Biomarker novelty & technology platform 61
Association studies/clinical data 61
Management strategy 61
Application & market potential 61
Biomarker analysis 62
deCODE Genetics 63
Biomarker novelty & technology platform 63
Association studies/clinical data 63
Management strategy 63
Figure 16: deCODE’s approach to target discovery and development 64
Application & market potential 64
Biomarker analysis 64
diaDexus 65
Biomarker novelty & technology platform 65
Association studies/clinical data 65
Management strategy 65
Application & market potential 65
Biomarker analysis 66
Entelos 67
Biomarker novelty & technology platform 67
Association studies/clinical data 67
Management strategy 67
Application & market potential 67
Biomarker analysis 68
FoxHollow Technologies 69
Biomarker novelty & technology platform 69
Association studies/clinical data 69
Management strategy 69
Application & market potential 69
Biomarker analysis 70
GE Healthcare 71
Biomarker novelty & technology platform 71
Figure 17: Cardiology focus at GE Healthcare 71
Association studies/clinical data 72
Management strategy 72
Application & market potential 72
Biomarker analysis 72
Genomas 73
Biomarker novelty & technology platform 73
Figure 18: PhysioGenomics Technology from Genomas 73
Association studies/clinical data 73
Management strategy 74
Application & market potential 74
Biomarker analysis 74
Inverness Medical Innovations 75
Biomarker novelty & technology platform 75
Association studies/clinical data 75
Management strategy 75
Application & market potential 76
Biomarker analysis 76
Jurilab 77
Biomarker novelty & technology platform 77
Figure 19: Jurilab’s Genetic Discovery Method 78
Association studies/clinical data 78
Management strategy 79
Application & market potential 79
Biomarker analysis 79
Competitor Ratio Analysis Score = 12/40 79
Laboratory Corporation of America 80
Biomarker novelty & technology platform 80
Association studies/clinical data 80
Management strategy 80
Application & market potential 80
Biomarker analysis 81
Lipomics Technologies 82
Biomarker novelty & technology platform 82
Association studies/clinical data 82
Management strategy 82
Application & market potential 82
Biomarker analysis 83
LipoScience 84
Biomarker novelty & technology platform 84
Association studies/clinical data 84
Management strategy 84
Application & market potential 84
Biomarker analysis 85
Competitor Ratio Analysis Score = 15/40 85
Nanosphere Inc 86
Biomarker novelty & technology platform 86
Association studies/clinical data 86
Management strategy 86
Application & market potential 86
Biomarker analysis 87
Osmetech Molecular Diagnostics 88
Biomarker novelty & technology platform 88
Association studies/clinical data 88
Management strategy 88
Application & market potential 88
Biomarker analysis 89
Competitor Ratio Analysis Score = 12/40 89
PrognostiX 90
Biomarker novelty & technology platform 90
Association studies/clinical data 90
Management strategy 90
Application & market potential 90
Biomarker analysis 90
Quest Diagnostics 91
Biomarker novelty & technology platform 91
Association studies/clinical data 91
Management strategy 91
Application & market potential 91
Biomarker analysis 92
Competitor Ratio Analysis Score = 27/40 92
Roche Diagnostics 93
Biomarker novelty & technology platform 93
Figure 20: Roche’s technologies for biomarker discovery and development 93
Association studies/clinical data 93
Figure 21: Roche’s clinical trial programme for cardiac biomarker NT-proBNP 94
Management strategy 94
Application & market potential 94
Biomarker analysis 95
Siemens Medical Solutions 96
Biomarker novelty & technology platform 96
Figure 22: Siemens Integrated in vivo & in vitro diagnostic suites 96
Association studies/clinical data 96
Management strategy 97
Application & market potential 97
Biomarker analysis 97
Singulex 98
Biomarker novelty & technology platform 98
Figure 23: Sensitivity of Singulex’s Erenna system compared to ELISA and bead-based fluorescence readout systems 98
Association studies/clinical data 98
Management strategy 99
Application & market potential 99
Biomarker analysis 99
SuperArray Bioscience Corporation 100
Biomarker novelty & technology platform 100
Association studies/clinical data 100
Management strategy 100
Application & market potential 100
Biomarker analysis 101
Vermillion 102
Biomarker novelty & technology platform 102
Association studies/clinical data 102
Management strategy 102
Application & market potential 103
Biomarker analysis 103
Zora Biosciences OY 104
Biomarker novelty & technology platform 104
Table 8: Zora metabolite profiling platform 104
Association studies/clinical data 104
Management strategy 104
Application & market potential 104
Biomarker analysis 105

Cardiovascular biomarker APPENDIX 1 106
Table 9: Global biomarker sales 2007-20015E 106
Cardiovascular biomarker APPENDIX 2 107
Table 10: Global cardiovascular biomarker sales 2007-20015E 107
Cardiovascular biomarker APPENDIX 3 108
Company Analysis Criteria 108
Biomarker technology & platforms 108
Association studies 108
Management strategy 108
Application & potential 108
Table 9: Key cardiovascular biomarker companies 109
Figure 26: Leading Cardiovascular Biomarker Companies – Service providers, Technology Providers, Biomarker Discovery & Diagnostic Developers 111

GLOSSARY 112
ACRONYMS 114
BIBLIOGRAPHY & end NOTES 118


Companies Mentioned - Abbott Diagnostics - Atherotech - Affymetrix - Beckman Coulter - Berkeley HeartLab - BG Medicine - CardioDx - Celera - CIS Biotech - Clinical Data - Compugen - Critical Diagnostics - deCODE Genetics - diaDexus - Entelos - FoxHollow Technologies - GE Healthcare - Genomas - Inverness Medical Innovations - Jurilab - Laboratory Corporation of America - Lipomics Technologies - LipoScience - Nanosphere Inc - Osmetech Molecular Diagnostics - PrognostiX - Quest Diagnostics - Roche Diagnostics - Siemens Medical Solutions - Singulex - SuperArray Bioscience Corporation - Vermillion - Zora Biosciences OY


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