Medical Device Link.

Originally Published IVD Technology September 2004

INDUSTRY NEWS

Figure 1. Total European point-of-care test market revenue forecasts. Source: Frost & Sullivan (San Antonio, TX) (click to enlarge).

The competitive nature of the European point-of-care (POC) test market has resulted in extensive technological advances to gain product differentiation. This market is expected to grow as IVD manufacturers meet end-user needs for greater accessibility, speed, and accuracy of results.

According to a report released by Frost & Sullivan (San Antonio, TX), the POC test market in Europe grew by 9.7% in 2003 and generated $635.3 million in revenues (see Figure 1). The report projected that this market will continue to expand at a compound annual growth rate of 12%, and will eventually reach $1.4 billion in 2010.

This growth will be fueled by certain technology trends and developments in POC testing, which are expected to occur in several areas. For example, many of today’s POC tests already offer wireless connectivity that is suitable for interfacing with a hospital or laboratory information system and allows improved data flow and storage of results. Increasingly, computerized billing capabilities will be engineered into POC systems.

Another growing trend is miniaturization. Benchtop POC test systems are expected to have minimized footprints and require smaller sample volumes. Other POC systems are also likely to allow noninvasive testing. This improves healthcare workers’ safety by avoiding exposure to blood samples.

The various types of POC testing included in this report are at different stages of market development. While the fertility and hematology sectors are well established, the markets for infectious diseases and cardiac POC tests are still underdeveloped. In terms of revenues, the coagulation, diabetes, and fertility POC test segments were the most important markets in 2003.

Coagulation POC testing is being driven by innovative instruments. These devices need to integrate coagulation, blood gas, electrolyte, and immunoassay diagnostics into the same platform. The introduction of direct thrombin inhibitors and low-molecular-weight heparins can help increase use of coagulation monitoring further. Such factors will contribute to the double-digit growth projected for the $131 million coagulation POC test sector.

Diabetes POC testing is another booming sector with double-digit growth. With diabetes POC testing now well established all over Europe, this sector is poised for steady growth, especially with irregular HbA1c measurements driving users to POC testing. Recommended frequent diabetes testing is also expected to improve adherence to treatments and drive POC test usage.

Fertility POC testing has become popular, with home testing becoming more common. Even though an influx of less-expensive products from India and China has reduced margins, IVD manufacturers can make up lost ground with both ovulation and pregnancy tests. Manufacturers of these tests have also added marketable features to such tests such as splashguards on result windows, and covers for wick ends
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New markers are likely to find eager takers in the cardiac POC test sector once their clinical utility is thoroughly proven. This sector can be particularly lucrative to IVD manufacturers due to the increasing prevalence of heart disease across Western Europe.

On the other hand, there have not been many groundbreaking technological developments in the hematology market. However, the costlier complete blood count (CBC) and differential assays replacing stand-alone tests are likely to generate greater revenues. Infectious-disease POC test systems will also be challenged to prove their merits as few have achieved waived status in Europe under the Clinical Laboratory Improvement Amendmentx.

The POC test market in Europe has the potential to develop into a highly lucrative market. Although the practicality of POC testing has never been in question, the concept of POC testing is still taking longer than expected to become fully adopted by the European healthcare community. Nonetheless, the European POC test market is anticipated to expand in the future, albeit in a more gradual rather than explosive manner.

For more information about this report, visit Frost & Sullivan’s Web site at www.frost.com.  

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