Glycated Hemoglobin Tests See Increasing Use

Glycated hemoglobin (HbA1c) testing is one of the success stories of point-of-care (POC) diagnostics, and an area that will experience higher growth rates than other POC tests because of expert recommendations, new cases, and thriving mail-in test sales, according to a new market report.

The test measures glucose attached to the blood protein hemoglobin, a well-established analyte related to the long-term evaluation of blood sugar control. Ideally, every insulin dependent diabetic should be tested for HbA1c every three months. The test will show its fastest growth in the United States, and Kalorama Information (New York, NY, USA), a market research company and publisher of the report, estimates some 87% of diabetic patients aged 65 and over have been monitored with an HbA1c test.

"HbA1c tests offer a picture of the patient's blood sugar control over the past two or three months, which can be useful in consulting with the patient,” said Shara Rosen, an analyst for Kalorama Information. "It can be conducted at any time of day without fasting, and the value of hemoglobin glucose varies less than fasting plasma glucose [FPG] values.”

Kalorama estimates the global market for POC HbA1c tests was US$230 million in 2009, but should increase to $350 million by 2013. This growth rate is 50% faster than the average POC testing product, according to the report. The self-testing portion, performed chiefly by mail-in lab services, is only a small percentage of those revenues now, but it is showing faster sales growth than lab-based tests. Kalorama expects mail-in testing to grow at 25% for the next five years.

HbA1c testing products have been available for 20 years and there are several competitors in the market. At least 30 companies now offer HbA1c assays for automated systems--Bio-Rad, Abbott Laboratories, Bayer/Siemens, Beckman Coulter, Siemens, and Roche Diagnostics among them. The market is growing in the United States, but faces challenges worldwide, including high device costs for some diabetic world populations, inadequate consumer education, psychologic and physical discomfort, and patient inconvenience.

In 2009, a committee of experts from the American Diabetes Association, the European Association for the Study of Diabetes, and the International Diabetes Association concluded that the A1C test should be the primary test used to diagnose prediabetes, type 1, and type 2 diabetes. "These recommendations won't impact the use of the established FPG tests immediately, but long-term they have the potential to make a major change in the way diabetes is diagnosed,” according to Rosen.

Kalorama Information supplies independent market research in the life sciences, as well as a full range of custom research services. We routinely assist the media with healthcare topics.

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