Physician Office IVD Sector Nears USD 2.5 Billion

The physician office laboratory (POL) in vitro diagnostic (IVD) market grew to USD 2.44 billion in 2013, from just over USD 2 billion four years ago, according to the 2014 market study report “Physician Office Laboratory Markets, 3rd Edition” from Kalorama Information (New York, NY, USA). Considered in its POL analysis are tests physically performed in a physician office setting or lab located on the premises of the clinic or practice (not an associated hospital), and performed at the time of a consultation with a physician or other healthcare professional for screening, diagnosis, or monitoring purposes.

Physician Office Laboratory Markets reveals that unlike laboratory medicine (or lab pathology), there is no settled role for professional point-of-care (POC) or “near-patient” testing (NPT) in modern healthcare systems. The use of decentralized IVD testing in primary and outpatient care, most often in POLs, is not uniform worldwide nor is it universally supported. Nonetheless, payers, regulators, and administrators are forced to address POL testing as capabilities of benchtop and portable IVD instruments and assays improve and present clinicians with more in-house testing options.

"Gone are the days when professional POC diagnostics markets could aspire to above-average annual revenue on the basis of market penetration and the rising profile of decentralized testing," said Emil Salazar, analyst for Kalorama Information and author of the report, "The overall POL market is instead projected over the next 5 years to average growth near equal with the overall global IVD market."

The POL market features numerous in-office tests that have been widely implemented due to the low hurdles presented by CLIA-waived testing and the value of core lab tests performed in-office at large practices and with specialists. Some POL test segments are expected to see average annual growth through 2019 of only 0%–1%. POL test segments projected to attract more growth (rates of 5% and over) are related to diabetes care, cardiovascular disease, and actionable infectious disease markers. Routine infectious disease testing has also invited the first forays of molecular diagnostics into the POL space.

The prospects of POL market growth also vary widely by geography. Kalorama Information has profiled the traditionally core country markets for POL tests and determined their future potential in light of recent regulatory tightening of fee schedules and reimbursement eligibility as well as other factors. In some cases, recent regulation threatens to tip competitive balance even more towards higher-volume labs, typically reference or commercial labs, across from smaller labs including POLs.

Physician Office Laboratory Markets not only presents leading opportunities for IVD sales growth in the POL channel, but is also a valuable resource for determining competitive positioning within the channel vis-à-vis its leading players.

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