As Kalorama Information's lead diagnostic analyst finds, the point of care concept is at a crossroads: the technologies needed to make rapid testing a reality have arrived. But is healthcare ready?
Kalorama believes that the drive for wellness and the attention surrounding healthcare reform will focus attention on rapid diagnostics. However, according to Shara Rosen, RT, M.B.A., there are many challenges which must be overcome for point of care solutions to be fully utilized, and those companies willing to pivot strategies and best adjust to tomorrow’s healthcare marketplace may be rewarded.
This report, Point of Care Diagnostics 2010: Rapid Testing at a Crossroads represents the most current analysis of the role POC Diagnostics in today's in vitro industry. Other reports have looked at products, companies and revenue numbers, as this report does. But in her analysis Shara Rosen takes a bold look into the markets, technologies, and trends in decentralized testing with a special focus on the economics of rapid test use in critical care and emergency medicine. The report includes:
All countries are feeling the brunt of aging populations and an increased burden of chronic disease management. Employers and insurance companies are interested in improving the health of customers, and there are some innovative tactics developing in this area. The report is conservative in its predictions and offers a calculated look into the future, based on events currently taking place.
The report offers a quantitative assessment of specific markets in US dollars for 2008 and forecasted out to 2013. These data are provided in order to set the status quo of tests and technologies. However the report concentrates on how these will impact the economics of healthcare over the near term and longer when possible.
As part of Kalorama Information's comprehensive coverage, the following companies are discussed:
New York, March 10, 2010 — Glycated hemoglobin (HbA1c) testing is one of the success stories of point-of-care diagnostics, and an area that will experience higher growth rates than other POC tests as a result of expert recommendations, new cases and booming mail-in test sales, according to the new report Point-of-care Diagnostics 2010 and Beyond: Rapid Testing at a Crossroads, by healthcare market research publisher Kalorama Information.
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 U.S., and Kalorama estimates some 87% of diabetics 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, 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 $230 million in 2009, but should rise to $350 million by 2013. This growth rate is fifty percent faster than the average POC testing product, according to the report. The self-testing portion, performed primarily 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 two decades and there are several competitors in the market. At least thirty 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, psychological 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 pre-diabetes, type 1, and type 2 diabetes. The recommendations were reported at a symposium at the ADA 69th Scientific Sessions, held in New Orleans last year.
“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‘s Point-of-care Diagnostics 2010 and Beyond: Rapid Testing at a Crossroads has forecasts of every significant area of point-of-care diagnostics, a discussion of industry trends, and extensive profiles of companies in the market.
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