CEO SUMMARY: It will be no surprise to lab directors and pathologists that Kalorama Information, in its latest report on point-of-care (POC) testing, estimates that glucose testing comprises 67% of this market segment. What is notable is Kalorama’s prediction that worldwide POC testing will grow by 30% during the next four years. Because of new portable and handheld instruments, POC testing is migrating from hospitals to workplaces, homes, disaster sites, and convenience clinics.
IS POINT-OF-CARE (POC) TESTING poised to draw off specimens that currently flow into high-volume core laboratories? While the answer to this question is “not likely anytime soon,” POC testing nevertheless is projected to grow by 30% in the next four years!
This estimate comes from a new report by Kalorama Information, a publisher and market researcher in New York City that specializes in reporting on biotechnology, diagnostics, healthcare, medical devices, and pharmaceuticals. Kalorama defines point-of-care testing as diagnostic testing at or near the site of patient care.
Last year, the worldwide market for POC in vitro diagnostic (IVD) tests totaled an estimated $13.3 billion. According to Kalorama, this means POC is about 28% of the overall $44 billion in vitro diagnostic testing market. Self-testing POC accounts for $8.525 billion, and professional POC testing accounts for $4.78 billion.
Kalorama estimates that, in the next four years, the market for POC in vitro diagnostic testing will grow by over 30%, reaching a total of $17.8 billion by 2013. “At that point it is anticipated that point- of-care testing will represent a bit larger share of the total IVD market, nearly 31%,” said the report, Point of Care Diagnostics, April 2009.
Glucose, Critical Care Tests
It will be no surprise to lab directors and pathologists that glucose testing represents 67% of all POC testing, making it the undisputed leader in the field. Critical care testing represents the second-largest POC segment at 8%, and pregnancy testing is third at 5%.
Other POC testing segments and their share of total volume are: Infectious diseases–3%; cardiac markers–3%; fecal occult blood–3%; cholesterol/lipids–2%; HbA1c–2%; hemoglobin–2%; and other coagulation–2%.
Kalorama believes that several factors are driving the growth in POC testing. Notably, it considers managed care in the United States as a main growth driver, stating that “managed care’s obsession with cost reductions is pushing the need for testing nearer the patient, as well as decentralized testing in the home, at the bedside, and in the physician’s office.” THE DARK REPORT observes that Kalorama is predicting that managed care recognizes that a point-of-care test—even if more expensive than the same assay done in a high volume core laboratory—can often improve patient outcomes while reducing the total cost of that patient encounter. If this proves true during the next few years, clinical labs will need a strategy that allows them to participate in POC testing done in patient settings.
Innovation From Technology
Second, technology is driving innovation in the field of POC testing. Kalorama points out how increasingly smaller and more sophisticated transportable, portable, and handheld instruments have played a significant role in helping this form of diagnostic testing migrate from hospitals out to other settings, such as workplaces, homes, disaster sites, and most recently, convenience clinics in retail outlets. The third factor encouraging more POC testing is the increase in wellness testing.
Another interesting development is the use of different specimen types. Kalorama reported that “manufacturers are increasingly introducing minimally invasive [POC] tests that can be easily performed on a patient’s saliva, urine, breath, or other bodily by-products.
Demographics Fuels Demand
“The new technologies and distribution channels enabling this shift have occurred in response to ongoing demographic changes that are creating a larger market for the [POC] products,” the report said. “As the U.S. population continues to age, while at the same time living longer, it is becoming increasingly susceptible to a range of medical conditions that require identification.”
Kalorama further noted that increased utilization of point-of-care testing is the result of healthcare professionals—in their search for faster, easier, and cheaper ways of diagnosing illness. POC diagnostics are finding ready acceptance as the most appropriate approach in decision-sensitive situations, including emergency departments and operating rooms.
The report listed the spectrum of diseases where POC testing now plays a role. These include: patients with diabetes; cancer; strep throat, influenza, and pneumonia; sexually transmitted diseases; and high cholesterol and other cardiovascular disorders.
Infectious Disease Testing
In the field of infectious disease, rapid tests are available for a wide range of conditions, such as: HIV, gonorrhea, syphilis, chlamydia, herpes, hepatitis, strep A, strep B, tuberculosis, RSV, influenza, legionella, mononucleosis, mycoplasma pneumonia, E. coli, H. pylori, cryptosporidium, giardia, C. difficile, rotavirus, fungal disease, and bacterial meningitis.
Another interesting insight for lab managers and pathologists is Kalorama’s conclusion that physician office laboratories (POLs) are eager users of point-of-care tests for screening, diagnosis, and patient monitoring. It says that POL demand is a major source of increased utilization of POC testing. Also, as POC tests become more reliable and easier to perform, that encourages office-based physicians to expand the menu of POC tests they regularly use within their practice—and that in turn further increases demand for these tests.
Home Monitoring Growth
For laboratory professionals interested in home-based POC testing, Kalorama has big expectations for this segment. It predicts that glucose monitoring will continue to be the largest sector of POC testing. In particular, the growing incidence of chronic diseases, particularly diabetes, means that the volumes of these tests will increase strongly in the coming years.
Kalorama doesn’t overlook the trend of walk-in rapid clinics in retail outlets. Pharmacy chains and such retailers as Wal-Mart have built thousands of these “rapid clinics” over the past five years. “If present trends continue, and assuming that the retail clinic model remains viable and is not hampered by regulation or professional resistance, retail clinics could see, conservatively, three times the sales of POC diagnostics as this segment is producing today,” declared the report.
Kalorama observes that one problem with offering laboratory tests in these retail-based medical clinics is that the majority of individuals seen in such clinics do not return to receive the results of their lab tests. That means if the test results are positive, the patient is likely to remain untreated.
Point-of-care testing provides a solution to that situation. It means the clinic can give the patient an answer during that same visit, and treatment can be started immediately. This is why Kalorama believes that retail walk-in clinics will be an important source of demand for new POC tests in the coming years.
Home Monitoring Growth
With its prediction that point-of-care will experience 30% growth during the next four years, Kalorama is bullish on the prospects for POC testing. However, that statistic hides the fact that the lion’s share of this testing is glucose self-testing by patients.
Thus, the market segment of point-of-care tests that could divert specimens currently going to clinical laboratories represents a smaller fraction of the overall lab testing pie. It is likely that these types of point-of-care tests won’t be a disruptive threat to clinical labs during the next four years that Kalorama covers in its report.
However, most lab managers and pathologists recognize that POC tests will continually improve because of new innovative technologies. Increased accuracy and reliability, combined with smaller, faster test kits and analyzers, will encourage providers to make greater use of these POC tests in their medical practices. Over time, this means point-of-care testing will be competing for specimens with centralized clinical laboratories.
Infectious Disease Testing Is Fueling POC Demand
LAST MONTH’S OUTBREAK of A/H1N1 influenza demonstrated once again why there is a need for in vitro diagnostic IVD) technology than can test great numbers of patients quickly and accurately for infectious disease.
In its report titled “Point of Care Diagnostics,” Kalorama Information estimated that the world market for rapid infectious disease tests was estimated at $424 million in 2007. The infectious disease tests performed most often are for influenza, hepatitis, HIV, Strep A, and respiratory viruses (such as influenza).
Kalorama predicts that miniaturized molecular assays will be increasingly competitive with rapid immunoassays. The need for higher levels of sensitivity and specificity are likely to encourage faster adoption of miniaturized molecular assays that offer clinicians more accuracy, reliability, and reproducibility than competing rapid immunoassays.
Even though at least 75 vendors world-wide market POC test kits for infectious disease, these tests have not been used widely in physicians’ offices for two reasons, the report said. First, many of these tests do not fit the current physician office routine. Second, many of these tests are not as sensitive as lab-based tests. Recognizing that these tests lack the sensitivity of lab-based tests, physicians still need confirmation with a lab-based assay. “Therefore it is more efficient to send samples to a central lab,” the report concluded.