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

Date: March 22, 2010
Pages: 180
US$ 3,835.00
Publisher: Business Insights
Report type: Strategic Report
Delivery: E-mail Delivery (PDF), Hard Copy Mail Delivery, CD-ROM Mail Delivery

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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.

  • 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


    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


    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


    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


    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


    Primary research methodology 158
    Glossary 159
    Acknowledgements 163
    Index 164
    Bibliography & Endnotes 166


    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


    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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