"""EXECUTIVE SUMMARY
Although a wide variety of in vivo diagnostic (IVD) tests and tools are available for probing cardiovascular function, these conventional techniques are costly and time consuming, and have very limited predictive potential. Smarter ways of assessing cardiovascular function rely on in vitro measurements of various biomarkers. Often the smarter approach is also to perform these tests at point-of-care (POC) sites, rather than in a central laboratory.
The cardiovascular IVD market represents one of the largest sectors within the IVD industry, chiefly due to the high prevalence rate and mortality of cardiovascular disease. The cardiovascular IVD market is creating growth opportunities both for established suppliers as well as new entrants into the market. Growth in this market is also being accelerated by the availability of new therapies.
Cardiovascular IVDs currently account for around 10% ($2.1 billion) of the global IVD market. We predict that the cardiovascular IVD market will grow considerably faster than the industry average, at an annual growth rate of 19.6%, reaching a value of $6.2 billion in 2007.
Since the mid-1990s, sales of cholesterol and lipid profile testing for cardiovascular disease risk have continued to increase and will continue to do so throughout 2002-2007. Developments in this area, including non-invasive cholesterol tests are discussed. These tests are increasingly aimed at the POC market. Although total cholesterol and high- and low- density cholesterol levels have long served as the primary indicators of risk for coronary artery disease, they miss 50% of people who ultimately suffer myocardial infarction (MI).
It is now known that several biomolecules and processes are involved in the formation of an atherosclerotic plaque, its transformation into unstable plaque, thrombus formation and plaque expansion. To detect more persons with an elevated risk, test developers have been turning to newer risk factors. Recently launched tests in this segment include: lipoprotein fractions, apolipoproteins B and A-1; lipoprotein (a); C-reactive protein; fibrinogen; homocysteine and activated factor XII. A number of tests are currently making a successful transition from clinical research to the clinical setting. Many other potential risk assessment markers are under active evaluation. There is likely to be considerable scope for manufacturers to introduce products based on panels of different biomarkers.
Rupture of an atherosclerotic plaque can lead to MI. IVD tests for the diagnosis of MI on the market are based on cardiac markers of necrosis. One of these markers, troponin, is rapidly becoming the new gold standard for the diagnosis of MI. Current development efforts in the industry focus on portable POC systems for the detection of multiple cardiac markers of necrosis which are capable of providing rapid qualitative results. Other markers of necrosis are under investigation. The industry has also been seeking earlier markers of MI, including markers of active thrombosis and of ischaemia. New biomarkers, which may aid the diagnosis of congestive heart failure and stroke, are also discussed.
Haemostasis is a critical component of cardiovascular disease. Several D-dimer immunoassays are now commercially available for exclusion of deep vein thrombosis or pulmonary embolism. Anticoagulants and anti-platelet agents play an increasingly important role in the management of cardiac patients and treatment with these drugs must be closely monitored. Recently introduced tests can detect the earliest stages of clot formation or quantify the level of platelet function, and these tests are increasingly aimed at the POC market.
This report also reviews current attempts to identify genetic markers that could form the basis of viable commercial products. Rapid progress is being made in the discovery and validation of single nucleotide polymorphisms associated with cardiovascular disease. Nucleic acid testing products for the determination of susceptibility to cardiovascular disease and responsiveness to cardiovascular drugs have begun to make an appearance on the market.
A world population that is getting richer and older faces an increased cardiovascular disease burden. Demographic data and incidences of cardiovascular disease throughout the world are tabulated and their implications discussed in this report. Established and expanding geographic markets for cardiovascular IVDs are profiled. Growth forecasts to 2007 are given for all the major cardiovascular IVD product segments within each geographic market. """
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