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TRENDS & PERSPECTIVES

Lateral-flow POC tests to grow

Richard Park

Table I. (click to enlarge) Combined worldwide sales of over-the-counter and professional
lateral-flow point-of-care tests by category: 2005 (actual), 2010 (projected). Source: Kalorama Information (New York City).

The lateral-flow point-of-care (POC) test market is expected to grow steadily and increase by more than 40% in five years. According to a report by Kalorama Information (New York City), titled “Lateral-Flow Technology and the Future of Point-of-Care Diagnostics,” the combined over-the-counter (OTC) and professional lateral-flow POC tests generated global revenues of $1.88 billion in 2005 (see Table I). Of this total, self-testing accounted for $635 million, while professional POC testing brought in $1.245 billion. With an average annual growth rate of 8%, this market is projected to reach $2.725 billion by 2010.

The United States and Europe dominate the market for clinical lateral-flow POC tests. In 2005, the U.S. and European markets accounted for $940 million, or 50%, and $752 million, or 40%, respectively. Japan and Asia generated $94 million, or 5%, while the rest of the world took up the remaining 5% of the market.

The report stated that the use of clinical lateral-flow POC tests has been continually growing since the early 1990s. Such growth in lateral-flow testing has been driven primarily by expanded test menus and increased use of current test menus. This expansion was in response to increased interest in public health issues and the prevalence of chronic diseases.

Continued growth in lateral-flow POC testing will mainly come from the professional sector’s investment in POC testing for cardiac markers, cholesterol, and infectious diseases. The compound annual growth rate for professional POC tests is projected to be 12%. Meanwhile, aside from pregnancy tests, the OTC test market has stalled. However, some future growth can be expected in self-testing for infectious diseases such as sexually transmitted diseases and urinary tract infections.

As the trend toward expanding decentralized testing went beyond glucose, many healthcare providers felt that lateral-flow POC testing devices added technology and training costs. Since reimbursement for POC tests has not been automatic, POC testing has been used mostly in acute-care situations. However, in 2006, more healthcare professionals began to realize the positive effects of POC testing on patient care such as shortened length of stay, more appropriate and timely use of therapeutics, and less patient morbidity.

Hospital-based lateral-flow POC testing still faces many barriers. For example, there is a perception that POC tests are more expensive than lab-based tests and that patient test results are not included in the patient’s records. In addition, the baseline testing done in an acute-care area is useless because either the test results from POC devices do not correlate with lab-based systems or an algorithm to establish correlation has not been developed.

One key to effective lateral-flow POC testing programs is developing the ability to link POC devices with centralized management stations and a healthcare system’s primary information system. By doing so, the POC test can be easily included in the patient’s medical records. With such POC information systems, physicians can determine the significance of a lab result. Even though very few lateral-flow test devices currently provide digital results to a receiving network, this value-added component of lateral-flow POC testing is being developed.

Despite the slowdown in OTC lateral-flow POC tests, there are projections that patient self-testing could skyrocket because of rising consumer expectations, technological innovations, and the surge of consumer activism in healthcare. Pharmacies, retail outlets, and physician offices have been establishing their position for patient wellness screening.

One of the latest trends to overcome the reluctance for lateral-flow POC self-testing is the emergence of direct-to-consumer marketing of lab tests in malls, supermarkets, and via the Internet. Practically every test offered through traditional channels is now available without a prescription on the Internet. With more people becoming involved in managing their health and willing to pay out-of-pocket, self-testing may become a multi-billion-dollar market.

Additional information about this report can be accessed via the Kalorama Information Web site at www.kaloramainformation.com.

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