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Trends in the Early Diagnosis of Cardiovascular Disease: Worldwide Market Opportunities

Despite dramatic improvements in both diagnosis and therapy, cardiovascular disease remains the leading cause of mortality in the developed world. Worldwide more than $54 billion was spent on cardiac care therapeutics in 1999, with an expected 10% annual increase for the next 10 to 15 years. Furthermore, U.S. government statistics indicate that approximately $4 billion of unnecessary medical costs are spent each year on the assessment of non-cardiac cases in hospital emergency departments. As the population ages, this unnecessary expenditure is expected to double.

Because of these vast utilization costs, there is a move to use resources in the early diagnosis of disease risk that will allow for prevention, early intervention with therapeutics and lifestyle changes, and proactive disease management. The laboratory and imaging diagnostics industries will have substantial impact on the early selection of heart disease candidates.

On the in vitro diagnostics front, a menu of lipid tests, hypercoagulation factors, enzyme and protein markers, genetic markers, and even exposure to viral infections all contribute to the risk assessment initiative. The world cardiac rapid assay market is expected to achieve an average annual growth rate of 20% to 25% for the near future, driven by a host of new markers (ultra sensitive CRP, homocystein, plasminogen-activator inhibitors, s100 protein, p-selectin, soluble fibrin, glycogen phosphorylase-BB, thrombus precursor protein, and recently discovered genetic factors). In addition, the possible involvement of infectious agents in heart disease offers another opportunity for in vitro diagnostics.

Emerging in vivo testing, including imaging techniques such as ultrasound, MRI, PET, and CT, are now capable of uncovering plaque build up and heart function irregularities long before patients show clinical symptoms. The world market for functional cardiac imaging will see an annual average growth of 20% over the next 5 years.

Combining the information from biochemical markers, imaging, clinical parameters, ECG, and other parameters via information technology will enhance and help develop better intervention strategies. In the United States alone, cardiovascular telemedicine generated approximately $75 million in 2000.

Trends in the Early Diagnosis of Cardiovascular Disease examines these emerging markets and opportunities in-depth, including market size and potential. It contains a comprehensive listing of companies and organizations involved in the various market segments along with detailed company profiles of the largest and most important companies active in these market segments:

  • cardiac in vitro diagnostics (coagulation, proteins, genes, lipids)
  • proactive diagnostic imaging systems
  • cardiac risk assessment information technology
  • home cardiovascular monitoring systems


Scope and Methodology

This report presents diagnostic modalities for the early detection of CVD throughout the continuum of the disease progression including: congestive heart failure, unstable angina, myocardial infarction, stroke, and other manifestations of CVD. The emphasis is on in vitro diagnostic tests, primarily because this is where the major market opportunities lie. With the incidence of cardiac disease on a constant growth curve, a test modality that can provide specific, inexpensive screening tools for CVD before the onset of symptoms, is like the proverbial “license to print money.” In vivo tests such as stress tests, ultrasound, etc., are too labor intensive and too capital cost intensive to be used in screening programs. Even with the poor correlation of lipid profiling with CVD risk, cholesterol and blood pressure test programs (combined with blood glucose testing) are offered everywhere: physicians' offices, community clinics, and even pharmacy retail chains. Perhaps in 10 to 15 years from now imaging technologies will have reached a level of miniaturization that will permit their use for routine screening. But for the immediate future, the search is on for blood tests that can solve the problem of early CVD diagnosis.

For this report, the market for CVD diagnostics has been divided into three segments based on the stage of CVD:

  • Early detection of CVD risk in asymptomatic individuals
  • Effective diagnosis of individuals presenting with CVD at a healthcare provider—physician's office, community clinic, hospital emergency department, ambulance
  • Preventative management of people with cardiac disease

For each of these stages, the report includes breakthroughs in in vitro and in vivo testing procedures. It also discusses the role that the Internet, ehealth, and telemetry play in CVD patient management.

The market for the early diagnosis of CVD by in vitro diagnostics is provided in U.S. dollars for the years 2000 to 2005. In vivo tests are presented primarily as the number of procedures performed in the years 2000 to 2005, because in vivo testing equipment—ultrasound, CT, MR, and X-ray instrumentation—has generally reached a steady-state installation rate. Therefore, sales of these devices do not provide an accurate assessment of the market for CVD diagnostics using these test modes. Where appropriate, the dollar values for in vivo instrument placement is provided. No adjustments have been made to the market data for the effects of currency exchange fluctuations or inflation.

The report will cover trends and issues concerning:

  • in vivo diagnostics
  • point-of-care testing
  • bioinformatics
  • diagnostic biomarkers and genetic indicators

For in vivo tests, the report focuses on innovation in current technologies and trends in new technology development. As such, it is far from comprehensive and does NOT discuss the following areas in significant detail:

  • blood pressure analysis
  • electrocardiology (ECG equipment and supplies)
  • traditional stress testing
  • angiography and angiograms

The various diagnostic techniques and trends are discussed from the point of view of their present and potential market impact. Therefore, the report does not provide an in depth discussion of the etiology, physiology, and clinical manifestations of CVD except where an understanding of these areas is required to understand the impact of new and early diagnostics on patient care. Similarly, the report does not describe the technical aspects of test modalities, such as molecular assays, immunoassays, MR imaging, ultrasound, CT, etc.

Market analysis in this report covers world markets for in vitro and in vivo CVD diagnostics; however, the reader will find a bias toward the developed areas of the globe: North America, Japan, and Western Europe. That said, CVD is a growing global problem, and the report covers CVD testing in the more industrialized developing countries of Latin America and Asia Pacific where possible.

All market data are based on factory sales to the end user and do not reflect retail pricing or reimbursement payments. Data for the in vitro diagnostic market are presented in dollar market size for categories of tests, and for specific analytes where possible. Here the dollar value of a market segment is directly proportional to the number of tests performed, because the cost of the instrumentation is generally buried in the per test price. In vivo diagnostics is driven by placement of expensive capital equipment, the value of which does not necessarily reflect the market penetration of a technology. Therefore, market data for imaging diagnostics are provided in both dollars and the number of procedures performed on an annual basis.

The report discusses tests and technologies that are currently available and those that are expected to take their place. Generally, current products and technologies establish the standard of care and its value to payers. Many of the assays and imaging techniques presented in the report are expected to replace the standard of care in 2001, but with healthcare systems' emphasis on cost/benefit analysis for new technologies adoption, the market value and thus penetration capabilities of newer approaches may be limited. The information presented in this report is derived from publicly available information sources such as company, government, and medical organization reports. The analysis is based on the author's industry knowledge combined with literature searches and interviews with industry professionals and experts in the areas of in vitro diagnostics, imaging industries, and cardiologists.

The developments reported are as current as possible and represent events through June 2001. Some events of note from July and August 2001 are included, but coverage beyond June 2001 is by necessity incomplete.

Press Release

Emphasis on Early Detection to Push Cardiovascular IVD Market to $3 Billion

New York, September 14, 2001 /PR Newswire — Several emerging in vitro diagnostic tests for cardiovascular disease (CVD) are expected to show explosive growth in the next five years, leading to a nearly $3 billion market in 2005. According to a new study released today from Kalorama Information, 9 of 11 categories of cardiovascular in vitro diagnostics will post double-digit growth, with some as high as 80%.

The new study, Trends in the Early Diagnosis of Cardiovascular Disease: Worldwide Market Opportunities, now available from MarketResearch.com, reveals that emerging approaches to CVD assessment are opening great opportunities for in vitro diagnostic companies. A menu of lipid tests, hypercoagulation factors, enzyme and protein markers, and genetic markers all contribute to risk assessment. Rapid cardiac assays and the possible involvement of infectious agents offer yet more opportunities for the in vitro segment.

Driven by the recognition of CVD’s costs in terms of mortality and utilization, interest in early detection of the disease process is growing, according to the study. Statistics indicate that approximately $4 billion of unnecessary medical costs are spent each year on the assessment of non-cardiac cases in hospital emergency departments, and costs associated with CVD generally are expected to show 10% growth for the next 10 to 15 years.

“Because of these vast utilization costs, there is a move to use resources in the early identification of disease risk to allow for early intervention and proactive disease management,” states Steven Heffner, Acquisition Editor for Kalorama Information. “Both the laboratory diagnostics and imaging industries will have substantial impact on the early selection of candidates.”

The study, which also covers the in vivo diagnostic segment’s role in early assessment and monitoring, discusses disease management, telehealth, and reimbursement trends and lists more than 100 products on the market and in development.

Press Release

Newer Imaging Techniques Drive 70% Increase in Cardiovascular In Vivo Diagnostics

New York, September 18, 2001 /PR Newswire — Emerging imaging techniques, such as artery calcium scoring, and new twists on existing modalities, such as electron beam computed tomography (EBT) and contrast-enhanced magnetic resonance and ultrasound, are pushing the cardiovascular in vivo diagnostics segment to stronger growth than in general radiology. According to a new study released today from Kalorama Information, the next 5 years will see a 70% increase in the use of in vivo cardiac testing.

Driven by the recognition of CVD’s costs in terms of mortality and utilization, interest in early detection of the disease process is growing, according to the study entitled Trends in the Early Diagnosis of Cardiovascular Disease: Worldwide Market Opportunities, now available from MarketResearch.com. Due in part to this increased interest in early assessment, the number of cardiac in vivo tests performed will increase across the board, with 7 of 11 modalities experiencing double-digit growth. EBT, for example, is expected to increase at a 60% annual rate through 2005.

“The imaging sector is often considered mature, with little growth opportunity,” notes Steven Heffner, Acquisition Editor for Kalorama Information. “However, emphasis on cost-effective early diagnosis has given new life to imaging in the cardiovascular area, especially for noninvasive and portable techniques.”

According to the study, EBT, magnetic resonance, computed tomography, ultrasound, stress ultrasound, and remote heart rate monitors are expected to displace more expensive, invasive procedures, such as the nuclear stress tests, X-ray angiography, and nuclear perfusion tests. However, the tried and true electrocardiogram and its partner, the Holter monitor, will retain their importance as a first pass screen for CVD.

The study, which also covers the explosive in vitro diagnostic segment’s role in early assessment and monitoring, discusses disease management, telehealth, and reimbursement trends and lists products on the market and in development.

Chapter 1: Executive Summary

  • Scope and Methodology
  • In Vitro and In Vivo Tests for Early CVD
  • Size and Growth of the Market
  • Market Trends

Chapter 2: Introduction

  • 21st Century Disease Management Paradigm: Cardiovascular Tests, Genes, Imaging, and Bioinformatics
  • The Pros and Cons of Early Diagnosis
  • Point of View

Chapter 3: Trends and Issues

  • Background and Epidemiology
    • Market Population Trends in Major World Markets
    • World Cardiac Disease Demographics
    • North America
    • Africa and Asia
    • Latin America
    • Europe
  • Specific Disease Statistics
    • Deep Vein Thrombosis
    • Coronary Artery Disease
    • Hypertension
    • Congestive Heart Failure
    • Stroke
  • Human Genomics in Early CVD Assessment
  • Home Telemedicine Initiatives
  • Bioinformatics and Risk Assessment
  • Technology, Patient Outcomes, and Reimbursement Issues

Chapter 4: In Vitro Tests for Early CVD Diagnosis

  • Market Overview
    • Total Market
    • Geographic Analysis
    • Market Penetration
    • Cell Necrosis Enzymes
    • Coagulation Factors
    • Homocysteine
    • D-Dimer
    • High-Sensitivity C-Reactive Protein and Inflammation Markers
    • Lipids
    • Specific Enzymes and Proteins
    • Genes
    • Viral Infections
  • Commercial Outlook

Chapter 5: In Vitro Company Profiles

  • Agen Biomedical Ltd
  • American Biogenetic Sciences Inc
  • Axis-Shield Diagnostics Ltd
  • Biopool International Inc (see Xtrana Inc)
  • Biosite Diagnostics Inc
  • Cholestech Corp
  • Competitive Technologies Inc
  • CompuCyte Corp
  • Corgenix Medical Corp
  • CV Technologies Inc
  • Dade Behring Inc
  • diaDexus Inc
  • Ischemia Technologies Inc
  • LipoMed Inc
  • Myriad Genetics Inc
  • Sigma Diagnostics
  • Spectral Diagnostics
  • SYN X Pharma Inc
  • Third Wave Technologies Inc
  • Xtrana Inc

Chapter 6: In Vivo Diagnostics—Imaging and Assessment DEVICES

  • Background
    • Coronary Artery Disease
    • Peripheral Vascular Disease
  • Market Overview
  • Electrocardiography, Stress Tests, and Holter Monitors
  • Heart Rate, Blood Flow, Hemodynamics, and Electrophysiology
  • Nuclear Cardiology—X-ray Angiograph
  • Ultrasound
  • Magnetic Resonance Imaging
  • Computed Tomography
  • Positron Emission Tomography
  • Three-Dimensional Imaging
  • Contrast Agents
  • Commercial Outlook

Chapter 7: In Vivo Company Profiles

  • ATL Ultrasound—Advanced Technology Laboratories Inc
  • Boston Medical Technologies Inc
  • Boston Scientific (see Cardiac Pathways Corp)
  • Cambridge Heart Inc
  • Cardiac Mariners Inc (see NexRay Inc)
  • Cardiac Pathways Corp
  • CardioDynamics International Corp
  • Deltex Medical, Ltd
  • EP MedSystems Inc
  • FONAR Corp
  • Hypertension Diagnostics Inc
  • Imatron Inc
  • Itamar Medical Ltd
  • NexRay Inc
  • Royal Philips Electronics (see ATL Ultrasound—Advanced Technology
  • Laboratories Inc)
  • SonoSite Inc
  • Vital Images Inc
  • Volumetrics Medical Imaging

Chapter 8: Conclusions and Strategic Implications

  • Early Detection and Cost Savings
    • Conclusion
    • Implication
  • In Vitro Panels Remain Imperative
    • Conclusion
    • Implication
  • The Role of In Vivo Testing
    • Conclusion
    • Implication
  • Telehealth
    • Conclusion
    • Implication
  • Nature of Competitors
    • Conclusion
    • Implication
  • Cost-Benefit Analyses
    • Conclusion
    • Implication
  • Consumerism
    • Conclusion
    • Implication

Appendix A: Selected Cardiac In Vitro Diagnostic Products Available and in Development

Appendix B: Selected Cardiac In Vivo Diagnostic Products Available and in Development

Appendix C: Company Directory

List of Exhibits
Chapter One: Executive Summary
Table 1-1: Worldwide Market for Selected Cardiac In Vitro Diagnostics: 2000-2005
Table 1-2: Worldwide In Vivo Cardiac Diagnostic Procedures by Type: 2000-2005
Chapter Three: Trends and Issues
Table 3-1: Selected Genetic Tests and Therapeutic Targets
Table 3-2: Selected Companies Developing Cardiovascualar Genomic
Chapter Four: In Vitro Tests for Early CVD Diagnosis
Table 4-1: Selected In Vitro Diagnostic Markers for CVD
Table 4-2: Selected CVD Drug Targets
Table 4-3: Worldwide Market for Selected Cardic In Vitro Diagnostics: 2000-2005
Figure 4-1: Worldwide Market for Cardiac In Vitro Diagnostics, Market Share by Test Type: 2000
Figure 4-2: Worldwide Market for Cardiac In Vitro Diagonistics, Market Share by Test Type: 2005
Figure 4-3: Worldwide Market for Cardiac In Vitro Diagnostics, Revenue Distribution by Region: 2005
Figure 4-4: Technology Penetration Forecast for Cardiac In Vitro Diagnostics: 2000-2010
Table 4-4: Reported Serum Marker Cut-Off Values
Table 4-5: Cut-off, Percentile, and Coefficient of Variation for Leading Troponin Assays
Chapter Six: In Vivo Diagnostics—Imaging and Assessment Devices
Table 6-1: In Vivo CVD Test Techniques
Table 6-2: Worldwide In Vivo Cardiac Diagnostic Procedures by Type: 2000-2005
Figure 6-1: Worldwide Market for Cardiac In Vivo Diagnostics, Market Share by Test Type: 2000
Figure 6-2: Worldwide Market for Cardiac In Vivo Diagnostics, Market Share by Test Type: 2005
Figure 6-3: Technology Penetration Forecast for Cardiac In Vivo Diagnostics 2000-2010

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