The Future of Cardiovascular Diagnostics: Impact of Technological Advances on Growth Opportunities and Future Market Outlook

NEW YORK, July 7 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

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

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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 identify 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.

Companies mentioned

Atherotech VAP test , Philips Healthcare: Magnetic Particle imaging , Abbott , Beckman Coulter , Becton Dickinson & Company , bioMerieux , GE Healthcare , Hitachi Medical Corporation , Inverness Medical Imaging

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

bioMerieux, 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

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

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