• by esalazar@marketresearch.com
  • September 5 2014
  • POL

How and Where IVD Will Find Growth in the Global POL Market

How and Where IVD Will Find Growth in the Global POL Market

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 physician office laboratories (POLs), is not uniform worldwide nor is it universally supported. Nonetheless, payers, regulators and administrators are forced to address POL testing as the capabilities of benchtop and portable IVD instruments and assays are ever-improving and present clinicians with more in-house testing options. The resultant complexity of the global POL market - its variable reception across national and regional markets by payers and regulators; the solid penetration to emergent POL channel adoption of different tests - invites guidance and prompted Kalorama Information’s latest 2014 edition of its physician office laboratory market study, Physician Office Laboratory Markets.

Gone are the days when professional POC diagnostics markets could aspire to above average annual growth (5%+) on the basis of market penetration and the rising profile of decentralized testing. The overall POL market is instead projected over the next five years to average growth near equal with the overall global IVD market. As reviewed in the blog series on the highest-volume POL tests, 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%.

The 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. Several molecular platforms already support ease-of-use, moderately complex flu assays that can be performed outside of central labs. While CLIA waivers for such molecular assays would assuredly boost their market potential, regulators’ concerns over CLIA-waived test QA/QC measures among POC users will likely delay the first such milestone waiver for molecular POC. Moderate-complexity molecular systems’ penetration among CLIA-certified POLs is expected to represent only a minor paradigm of growth for the overall POL market.

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. Global POL market growth is consequently projected to predominate in select markets.

Kalorama Information’s Physician Office Laboratory Markets presents readers not only the 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.