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Numerology and other forms of prognostication
IVD manufacturers who do business in Europe have long been aware of the limited growth in that market, so perhaps a few more dismal numbers about it will do no harm. This group of numbers comes from the annual summary on the sale of laboratory testing products, which was released last month by the European Diagnostic Manufacturers Association (EDMA; Brussels). The summary covers products sold during 1998.
Now the bad news: 1998 sales growth in Europe's total laboratory market (which includes laboratory reagents and instrumentation as well as rapid tests) remained flat at 1.9%. The number is hardly a surprise. EDMA notes that "on average over the last five years the corrected growth rate for the IVD market was 1.1% per year—not even enough to cover inflation." Segments that represent a drag on the European market include instrumentation (down 3.9%) and laboratory reagents (up only 0.9%).
But EDMA's report also includes some good news, especially for manufacturers of new generations of IVD products. For instance, in 1998 the market for rapid tests increased by 10.7%, which is hardly a growth figure to be overlooked. And the market for patient self-testing devices (including over-the-counter pregnancy tests and glucose test strips) jumped a whopping 13.8%—a respectable figure anywhere, but especially impressive for Europe. EDMA notes that self-testing products now represent about 15% of the total European market, and that health authorities in some countries are actively promoting the use of such products, especially in relation to diabetes management.
Despite the doom and gloom that EDMA's report would seem to convey, the lesson of Europe's numbers is really not different from that of nearly every IVD market analyst—as I discovered in doing research for this issue's feature story. Analysts agree that growth in some segments of the worldwide IVD market is flat (perhaps even permanently so). But they are equally in agreement over the exciting prospects being offered by new technologies, including increased automation, point-of-care tests, and molecular diagnostics.
All of which just goes to show that numbers, by themselves, are pretty poor predictors. No matter how many data points one accumulates, there is no guarantee that the next point to fall will carry on the trend established by previous points.
To understand the patterns of the IVD marketplace—whether in the United States, Europe, or the ROW countries—what observers really need is a good understanding of the technologies in play and the context in which they exist. In this issue, for example, Emery Stephans offers a commentary on industry's efforts to create a connectivity standard to meet the needs of the burgeoning point-of-care marketplace; and Maurizio Suppo provides an update on progress of the IVD Directive, with advice about what manufacturers should be doing during the directive's transposition period. These are real issues that will affect the way IVD products are designed and manufactured for years to come—and therefore will also influence their acceptance in the marketplace.
It's unfortunate that market reports are so often thought of as merely a set of numbers, because what counts (so to speak) is the analysis that underlies those numbers. Predicting the future may be impossible, but manufacturers will make better guesstimates if they focus more on the trends in technology than on the numbers.
Steven Halasey
steve.halasey@cancom.com
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