The Future of Cardiovascular Diagnostics: Impact of technological advances on growth opportunities and future market outlook

Cardiovascular disease (CVD) is one of the leading causes of death in the developed world, accounting for around a third of all deaths. It remains a tremendous medical and cost burden on society. The identification and application of novel cardio biomarkers has helped cardiologists to stratify high risk patients whilst the advances in diagnostic imaging has lead to improvements in the speed and resolution of images, increasing its clinical utility in the detection, diagnosis and treatment of CVD whilst minimizing the need for invasive procedures. In addition, diagnostic imaging provides cardiologists with detailed anatomical (CT, MRI, US), metabolic and functional (nuclear imaging, fMRI) information upon which an accurate diagnosis an be made. Currently no single imaging test is superior to all the others and a variety of imaging modalities may be used to diagnose CVD.
A variety of cardiac biomarkers are now available including those to determine cholesterol & lipoproteins levels, cardiac necrosis, thrombosis, inflammation and genetic variants - to aid in patient risk stratification and the diagnosis of a range of cardiovascular conditions – acute coronary syndrome (ACS), coronary artery disease (CAD), heart failure (HF), stroke and pulmonary embolism (PE). A raft of possible and probable cardiac biomarkers are currently under evaluation that if successful, may provide cardiologist with a more comprehensive assessment of cardiovascular risk and prognosis. Meanwhile in vitro diagnostic (IVD) companies have launched a range of assay platforms including laboratory bases ultra high through systems to point of care (PoC) bench top and hand held devices. Enabling rapid and cost-effective testing and migrating CV testing from the hospital to the clinic and bedside.


Key features of this report


• Highlight some of the key technologies which IVD and healthcare companies are developing to maximize the using of medical imaging in the detection and diagnosis of cardiovascular diseases
• Analysis the recent advances in cardiac biomarker discovery and validation and their potential application as single or multimarket tests in the clinic and emergency department.
• Discuss the shift in the decentralization of cardiac diagnostics from the laboratory based testing to PoC testing in the emergency room due to advances in biosensor and the adoption of wireless technology and leading to improvements in the speed and cost of cardiac testing
• Identify the novel imaging technologies and instruments that may revolutionize cardiovascular imaging, including the development of 124 and 245 multislice CT, hybrid systems (PET-CT, SPECT-CT and the development of highly portable and miniaturized ECG and US equipment.


Scope of this report


• Identify key technologies for IVD and diagnostic imaging and their applications in early diagnosis, treatment and patient monitoring of a range of cardiovascular diseases
• Identify the companies leading the field in developing novel technologies for IVD and diagnostic imaging
• Discover the approaches being adopted by the leading IVD and healthcare companies
• Discover the potential of these products and technologies for improving diagnosis and guiding treatment decisions earlier during the course of cardiovascular disease process to help to reduce long-term healthcare costs


Key Market Issues


• Improving diagnosis: Increasingly, IVD testing is being used by cardiologist in conjunction with diagnostic imaging to stratify patient risk, to improve diagnosis, minimize the use of invasive procedures, and improve patient management.
• IVD testing to identify patient predisposed to disease and to determine prognosis: Several tests are now available that can indentify asymptomatic patients that are at high risk of CV disease allowing for early dietary and lifestyle interventions and the prescription of preventative medicine if necessary, in addition prognostic tests following MI are available to help guide cardiologist for the most appropriate long-term therapeutic or surgical intervention helping to minimizing future risk.
• Innovative opportunities: Molecular imaging is one of the most rapidly evolving areas of medical imaging and has application in drug R&D and clinical diagnostics. Molecular imaging can be applied in the clinical setting molecular imaging probes may be used as surrogate endpoints to assess new treatments or monitor the effect of therapy for a variety of diseased states, leading to developmental cost-savings through the rapid accumulation of clinical evidence to support drug approval and usage.

Key findings from this report


• Diagnostic screening using both IVD and diagnostic imaging technologies can lead to the early detection of disease to minimize the use of invasive procedures, and improve patient management.
• New biomarkers test could provide a more comprehensive assessment from which to stratify patient treatment and escalate additional diagnostic aids or treatment.
• New technologies that replace the need for X-rays and radioactivity are under development such as magnetic particle imaging (MPI) could revolutionize the way cardiovascular imaging modalities are used in the future for diagnosis, treatment and maintenance therapy.

Key questions answered


• What has driven the increasing usage of IVD and diagnostic imaging modalities in recent years?
• Which technologies are at the forefront of cardiovascular IVD and diagnostic imaging and where are they most appropriate for clinical diagnosis and treatment of disease?
• What are the key technologies and areas of innovation in cardiovascular diagnostics?
• What strategies are the leading IVD and healthcare companies using in order to remain at the forefront of CV diagnostics and responding to consumer needs for safe, more efficient, portable/PoC and cost effective diagnostics.



Report Highlights
Companies mentioned in the report: Atherotech VAP test , Philips Healthcare: Magnetic Particle imaging , Abbott , Beckman Coulter , Becton Dickinson & Company , bioMérieux , GE Healthcare , Hitachi Medical Corporation , Inverness Medical Imaging
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Table of Contents
Cardiovascular Diagnostics
Executive Summary 10
Cardiovascular disease & diagnostics 10
Current cardiac diagnostic modalities 11
Novel cardiac diagnostic modalities 12
The market, trends & future directions 13
Chapter 1 Cardiovascular disease & diagnostics 16
Introduction 17
Cardiovascular disease 20
Cardiovascular risk factors 23
Diagnosis of cardiovascular diseases 25
Cardiovascular screening 25
Conclusions on CVD diagnosis and screening 27
Cardiovascular diagnostics 28
Cardiovascular in vitro diagnostics: biomarkers and tests 28
Cholesterol testing 28
Lipoprotein & apolipoprotein profiling 30
Cholesterol guidelines 31
Case study: Atherotech VAP technology 32
Cardiac biomarkers 34
In vivo cardiovascular diagnostics: options & applications 36
Diagnostic imaging for coronary artery disease 38
Diagnostic imaging for stroke 40
Diagnostic imaging for pulmonary embolism 40
Conclusions on diagnostic imaging modalities 41
Report outline 41
Chapter 2 Current cardiac diagnostic modalities 44
Introduction 45
Coronary artery disease diagnostic tests 46
In vitro diagnosis of CAD 46
In vivo diagnosis of CAD 49
Conclusions on diagnostic tests for CAD 54
Acute coronary syndromes diagnostics 55
In vitro diagnosis for ACS 56
In vivo diagnosis of ACS 59
Conclusions on diagnostic tests for heart attack patients 62
Heart failure 62
In vitro diagnosis of heart failure 64
In vivo diagnosis of heart failure 65
Conclusion on diagnostic tests for CHF 68
Stroke 68
In vivo diagnosis of stroke 69
In vitro diagnosis of stroke 71
Conclusion on diagnostic tests for stroke 73
Deep vein thrombosis & pulmonary embolism 73
In vitro tests for PE 74
In vivo diagnosis of PE 76
Conclusion on diagnostic tests for DVT & PE 78
Coagulation diagnostics 78
Genotyping in cardiovascular disease 80
Cytochrome P450 80
ApoE genotyping 80
Cardiac channelopathies 81
Thrombophilia genotyping 81
Overall conclusions 82
Chapter 3 Novel cardiac diagnostic modalities 86
Introduction 87
Challenges 87
Tough economic environment 87
Healthcare coverage & regulation 89
Payment & reimbursement 89
Emerging markets 90
Conclusions on challenges 92
Opportunities 92
New cardiac biomarkers 93
Pharmacogenomics 99
Genetic biomarkers to guide treatment decisions 100
Genetic biomarkers of cardiovascular risk 101
Point of care testing 104
Novel imaging agents 107
Cardiovascular molecular imaging 109
Novel imaging modalities 110
Case study: Magnetic Particle Imaging (Philips Healthcare) 110
Hybrid imaging systems 111
PET-MRI 112
PET-CT 112
SPECT-CT 113
Computer assisted diagnosis & artificial intelligence 113
Conclusions 114
Overall conclusions 114
Chapter 4 The market, trends & future directions 118
Market analysis 119
The IVD market 119
The cardiovascular IVD market 123
The diagnostic imaging market 128
Leading IVD & imaging companies 132
Abbott, Illinois, US 132
Beckman Coulter, California, US 132
Becton Dickinson & Company, NJ, US 133
bioMérieux, Marcy L’Etoile, France 133
GE Healthcare, New York, US 134
Hitachi Medical Corporation, Tokyo, Japan 135
Inverness Medical Innovations, Inc., MA, US 135
Johnson & Johnson, NJ, US 136
Philips Healthcare, Amsterdam, the Netherlands 137
Roche, Basel, Switzerland 137
Siemens Healthcare, Berlin & Munich, Germany 138
Toshiba Medical Systems Corporation, Tokyo, Japan 139
M&A activity 140
Recent collaborations & agreements 145
Recent product launches & trends 148
Cardiovascular in vitro diagnostics 148
Cardiovascular diagnostic imaging 149
Future directions 152
Summary & overall conclusions 153
Chapter 5 Appendices 158
Primary research methodology 158
Glossary 159
Acknowledgements 163
Index 164
Bibliography & Endnotes 166

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List of Figures
Figure 1.1: Cardiovascular diagnostic platforms 18
Figure 1.2: CVD – breakdown of deaths in the US (2006) 22
Figure 1.3: Increased use of medicine reduces the risk of death after stroke and heart attack 26
Figure 1.4: Increased use of medicine reduces the risk of death after stroke and heart attack 27
Figure 1.5: VAP test – treatment guideline 33
Figure 2.6: Conventional coronary angiography 50
Figure 2.7: EBCT angiogram of heart and pulmonary arteries 52
Figure 2.8: Principals of MSCT angiography scan of heart and pulmonary arteries 53
Figure 2.9: Diagnosis & risk stratification of ACS patients 56
Figure 2.10: Profile of cardiac necrosis markers after acute MI 57
Figure 2.11: Typical electrocardiogram from a healthy adult heart 59
Figure 2.12: Typical electrogram observed during ACS patient with US/NSTEMI 60
Figure 2.13: Typical electrogram observed during ACS patient with STEMI 61
Figure 2.14: Diagnosis & risk stratification of HF patients 63
Figure 2.15: Echocardiogram 66
Figure 2.16: MUGA scan of the heart 67
Figure 2.17: Doppler Ultrasound in a) normal & b) stroke 69
Figure 2.18: MRI scan of brain following a stroke 70
Figure 2.19: Commercial MRI Units 71
Figure 2.20: Increased risk of stroke with elevated Lp-PLA2 (ARIC Study) 72
Figure 2.21: Roche’s PoC CARDIAC D-Dimer test 75
Figure 2.22: Ventilation-perfusion scan for detecting PEs 76
Figure 2.23: Contrast enhanced CT image of PE 77
Figure 3.24: Global Population (2008) 91
Figure 3.25: Schematic of MPI technology 111
Figure 4.26: The IVD market – geographic split (2008) 119
Figure 4.27: The IVD market – segments (2008) 120
Figure 4.28: The IVD market – market leaders (2008) 121
Figure 4.29: Cardiovascular Diagnostics – Market Segments (2008) 124
Figure 4.30: Leading diagnostic imaging companies (2008) 129
Figure 4.31: Leading diagnostic imaging – market segments (2008) 130
List of Tables
Table 1.1: CVD – conditions & associated risk factors 20
Table 1.2: CVD – conditions & associated risk factors (continued) 21
Table 1.3: Uncontrollable cardiovascular risk factors 23
Table 1.4: Protective cardiovascular risk factors 23
Table 1.5: Controllable / treatable cardiovascular risk factors 24
Table 1.6: ATPIII Classification of TC, LDL-C & HDL-C 32
Table 1.7: Commercially available cardiovascular diagnostics to assess acute coronary syndromes 34
Table 1.8: Commercially available diagnostics to assess cardiovascular risk, stroke & thrombosis 35
Table 1.9: Anatomical - In vivo imaging modalities 36
Table 1.10: Functional - In vivo imaging modalities 37
Table 1.11: Advantages & disadvantages of cardiac imaging modalities 38
Table 1.12: In vivo imaging tests to assess cardiac anatomy & function 39
Table 2.13: Diagnostic tests - CAD 46
Table 2.14: Diagnostics for ACS 55
Table 2.15: Diagnostic tests for heart failure 64
Table 2.16: Properties of BNP 64
Table 2.17: Leading diagnostics for stroke 68
Table 2.18: Leading thrombotic diagnostic tests 74
Table 3.19: COACH trial data on Galectin-3 95
Table 3.20: Commercially available POC cardiac tests 106
Table 4.21: Medical Device Manufacturers & Suppliers in IVD 122
Table 4.22: Medical Device Manufacturers & Suppliers in IVD (continued) 123
Table 4.23: Cardiovascular focused IVD companies 126
Table 4.24 Cardiovascular focused IVD companies (continued): 127
Table 4.25: Medical device manufacturers & suppliers in imaging 131
Table 4.26: Recent M&A activity in the cardiovascular diagnostic arena 142
Table 4.27: Recent M&A activity in the cardiovascular diagnostic arena (continued) 143
Table 4.28: Recent M&A activity in the cardiovascular diagnostic arena (continued) 144
Table 4.29: Recent collaborations in the cardiovascular arena 146
Table 4.30: Recent collaborations in the cardiovascular diagnostic arena (continued) 147
Table 4.31: Recent product launches in cardiovascular IVDs 148
Table 4.32: Recent product launches in diagnostic imaging 151

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