April 9, 2019 -- Introducing accurate in vitro diagnostic (IVD) test results to the location where patient care is occurring is a compelling concept for improved care. And that is reflected in the growing year-over-year revenues for point-of-care (POC) diagnostic testing products that are successful in getting that done.
POC has not taken over every category of testing, and it's not for everything. Indeed, lab-based tests remain stalwart in clinical diagnosis in major-market hospitals, where they offer superior sensitivity and specificity, as well as volume advantages.
Yet the POC market is growing larger every year, and 2018 was no exception. This is according to Kalorama Information's latest point-of-care market study.
There are cost concerns around POC testing, and there are adoption challenges. There are also technology limitations. But Kalorama found that each year these boundaries are being pushed.
POC markets are growing faster than non-POC markets, and faster than the average of the in vitro diagnostics industry. In 2018, sales of POC testing reached $22.3 billion, increasing 7.5% from $20.7 billion in 2017. That's fast -- more than twice as fast as the growth of the whole market.
New technologies and increased demand are contributing to the growth. Slowing the revenue growth trend, on the other hand, are pricing strategies that continue to discount the cost of POC diagnostic testing in some segments, as well as higher costs in other segments of testing. In 2023, the total global POC diagnostic testing market is expected to reach $30 billion, displaying growth of 6.1% over the forecast period of 2018 to 2023.
Diagnostic tests performed outside the central laboratory or decentralized testing generally fall into the category of POC. Over the years, the increasing introduction of transportable, portable, and handheld instruments has resulted in the migration of POC testing from the hospital environment to a range of medical environments including the workplace, home, disaster care, and, most recently, convenience clinics.
The menu for POC diagnostic testing continues to expand. In the past five to 10 years, POC products were developed in the following categories: hemoglobin A1c (HbA1c), B-type natriuretic peptide (BNP), whole-blood lactate, D-dimer, and C-reactive protein (CRP).
Moreover, POC test devices have contributed significantly to the growth of the overall diagnostics market over the past 10 years. More diagnostic manufacturers have pursued Clinical Laboratory Improvement Amendments (CLIA) waiver status for their POC devices and the CE Mark for POC or self-use. At the same time, more decentralized test venues are investing in nonwaived rapid tests and instruments.
POC testing appears to be headed for an even bigger role in diagnosing patients and monitoring their care. New technologies are allowing POC devices to produce quantitative lab-quality test results that can be transferred automatically to an information system, a remote caregiver service for consultation, or an electronic medical record.
Molecular POC tests in physician offices are already available for conditions such as respiratory infections and more. The capacity to provide precise answers for time-sensitive tests such as sexually transmissible diseases and other infections will drive the market for POC molecular test devices.
Ease of use is a plus for hospital labs. Worldwide, lab budgets are being cut for test send-outs, and there are not enough trained technologists to run molecular tests in their present configuration.
Diagnostics are generally a market of focus -- the new pharmaceutical development model calls for tailoring therapy to the individual's particular disease physiology, which is often determined by the results of a diagnostic test. So, more tests -- molecular and immunoassays -- will come to market; some will have a high price tag and some will not.
But price will not be the deciding factor. Test adoption in this scenario is based on performance data, contribution to patient outcomes, and cost-benefit analysis.
A major factor in achieving this goal of more precise and personalized therapeutic options is the use of advanced algorithm-driven information technologies that can turn test data into actionable medical decision-making information. This trend is driven by the involvement of major information technology companies and payors that are tired of paying for drugs that often have limited positive patient outcomes.
Information about diseases, therapies, and tests is readily available via the internet and a growing number of apps on mobile devices. Wearable devices participate in this area by collecting vital-sign data that are then analyzed by IT tools to provide healthcare improvement instructions.
Bruce Carlson is the publisher of Kalorama Information, part of Science and Medicine Group. More information is available in Kalorama's "Worldwide Market for Point-of-Care (POC) Testing" report.
Disclosure: LabPulse.com is a sister company of Kalorama Information.