I have been blogging about direct access testing (DAT) for almost a decade but have never known with any degree of certainty the size of this market. However, I have always suggested that it was very small in relation to total clinical lab testing which was estimated to be $163B in 2012 (see: Clinical Laboratory Services Market Size 2013 - 2019). This point is very relevant to the future prospects of a company like Theranos which has emphasized the business opportunity of allowing consumers to order their own lab tests. Here's an excerpt from an article about the DAT market (see: Direct patient access to routine tests on rise):
Revenues for routine direct-to-consumer laboratory tests were estimated to be worth $33.1 million in 2015, according to Kalorama Information. The market research firm said that routine DTC laboratory testing is expected to grow by an average 30 percent annually over the next five years. The aging population, uninsured patients, disease monitoring, and treatment monitoring will be key factors for growth....Some of the most commonly ordered routine laboratory tests are CBC with differential, comprehensive metabolic panel, lipid panel, prothrombin time, and TSH. Kalorama says that HealthCheckUSA, Any Lab Test Now, and Walk-in Lab are among the companies offering testing services to consumers. But the large testing firms are also involved and, in some cases, perform the tests for the smaller outlets as well as offer their own online services. LabCorp has partnered with Walk-In Lab to provide blood test services across the country. Quest offers Blueprint for Wellness Direct Pay for consumers to monitor their personal health and wellness. The tests can be ordered directly online without a physician’s order. Patient direct pay is the most common payment structure for DTC lab testing.
So, it appears that the routine direct-to-consumer market is almost a rounding error compared to the total lab testing market in the U.S. One key question to then ask is whether DAT testing will grow rapidly if it becomes more convenient for healthcare consumers in walk-in drug store clinics. My personal opinion on this question is that the DAT market will remain, for the foreseeable future, as only a small fraction of the total clinical lab market. The reason for this is that I think we are on the cusp of the emergence of more sophisticated home lab testing that consumers can perform on themselves. Pregnancy tests, urine test strips, and home blood glucose testing with glucometers have been with us for decades. The next major leap will be the appearance of more sophisticated home analyzers that can be plugged into our smart phones. Needle-free home blood sampling from the finger is also on the horizon (see: New sampling device promises to make blood tests needle-free). Such home testing apps will partly take the place of DAT testing for consumers who are vitally interested in actively monitoring their health status.