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Variations in the cost of troponins across Europe are set to narrow in the next few years according to a recently published report on 'End-user Trends in the European Cardiac Markers Markets' by growth consultants, Frost & Sullivan (http://biotech.frost.com). Among its other key conclusions - point of care testing (POCt) is still at a nascent stage while the two novel natriuretic peptides (NP) markers are poised to make an immediate impact.
Nearly 300 clinical pathologists, consultant biochemists and opinion leaders at over 290 hospitals across Europe were interviewed for the study. Penetration and usage levels of troponins, CKMB and myoglobin as well as POC cardiac testing within hospitals were assessed. Also evaluated were awareness and uptake levels of new cardiac markers such as NP, Homocysteine, C reactive protein (high sensitivity) (hs-CRP) and modified LDL (mLDL).
Overall, the report confirms that across Europe, the number of new end-users is dramatically reducing. Dr. Sohail Sheikh, Programme Manager at Frost & Sullivan and author of the report, says: " It seems troponin testing has reached the upper-strata of the product life cycle. Many regions are now embracing a replacement market."
With the usage of troponin averaging around 600 tests per month per site, the report is also critical of regions which have restricted use. "We've come across too many end-users who through flawed practices, fail to recognise the benefits of troponin testing," says Dr Sheikh. The report identifies regions such as Sweden and Spain having the greatest usage per site, in contrast to the UK and Germany which fall below the European average.
With cost being such an issue for end-users it was important to gauge the level of variations in the price of troponin. Although the average was in the region of EUR four per test, the report indicated that a vast number of end-users although using significant volumes were still paying in excess of EUR five per test. But with the dynamics shifting to a replacement market such discrepancies are likely to diminish.
The report also highlights the barriers end-users face in deploying decentralised testing. "Although physicians are keen to perform point of care tests - the benefits are still outweighed by the drawbacks, namely staff training, overall costs and data handling," adds Dr Sheikh.
To overcome some of these barriers many hospitals are developing decentralised testing suites, annexes of the central laboratory which are specifically geared at catering for high performance STAT diagnostics testing. With only one-in-five sites reporting any sort of decentralised testing, the Frost & Sullivan report found the concept of POCt to be still at a developmental juncture.
Reflective of this trend was the growing number of STAT labs in several large hospitals in the UK and particularly Spain. Here, high performance, lower throughput platforms were expected to reduce turn around times, while minimizing the price differential between central and decentralised testing.
Clinical awareness was significantly high for all novel markers, with only mLDL falling below 50 per cent. Awareness of Homocysteine was nearly saturated at an average of 88 per cent with usage at 50 per cent across Europe. Brain natriuretic peptide (BNP), pro-brain natriuretic peptide (pro-BNP) and hs-CRP also registered high levels of recognition.
Two developments were identified as key to building central guidelines and workflow programmes for the NP tests, thereby boosting their uptake. These include the European Heart Failure meeting in Strasbourg in June 2003 and the publication of research results linking BNP test to the management of acute presentations.
Among the other novel cardiac markers, CRP (hs-CRP) was viewed as having a more long-term effect on the European market. "The absence of an appropriate and efficient framework for screening 'at risk' populations and the slow uptake of early diagnosis practices will mean that the market for hs-CRP will be slow in gathering pace. However, there remain a number of high profile advocates of this test and this will mean that significant volumes will be sold, albeit mainly for research applications," concludes Dr. Sheikh.
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