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6 Trends to Watch in Point-of-Care IVD, according to Kalorama Information
Friday, May 5, 2023
Kalorama Information's new report features key trends driving growth in the global POC diagnostic testing market through 2027.
ARLINGTON, Va., April 27, 2023 /PRNewswire-PRWeb/ -- Point-of-care (POC) in vitro diagnostic (IVD) sales reached $45 billion in 2022. This includes instruments - permanent and disposable, and associated reagents and supplies. Kalorama Information's latest report, The Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 10th Edition, details this and more.
Point-of-care covers a variety of tests - some performed in a lab, some in a doctor's office, some in a patient's home that can inform a patient directly or in the space of a provider-patient visit. Colon cancer, cardiac disease, diabetes, are among the conditions where point-of-care tests prove useful.
The following trends are present in the market, according to the report:
-- Infectious disease is a leading category. COVID-19 was a significant
game changer in 2020-2021 and is still had some influence in 2022. The
number of new tests for POC COVID-19 was stunning. In addition, new
technologies and increased demand contributed to growth in the markets.
-- Technological progress is expanding the domain of rapid and
point-of-care tests. Led by the U.S. population, the global client base
for POC products and tests (including physician offices and other
primary care settings such as clinics and mobile labs) will endure
through episodes of healthcare expansion and reform found worldwide.
However, the role of POC tests remains contentious due to questions
regarding quality control or accuracy and added costs. In the United
States, results of the GPA Waived Project have vindicated regulatory
concerns regarding the quality of CLIA-waived testing that have also
stalled the introduction of additional test waivers. Skepticism
regarding POC test accuracy is significantly stronger abroad, with much
more limited test menus for reimbursement or outright bans on testing at
unaudited or uncertified office labs.
-- Molecular POC diagnostics is at the nexus of low-complexity rapid
testing performed near the patient and high-technology clinical
molecular diagnostics. The emergent molecular POC test space seeks to
leverage the key strengths of both segments - rapid results with
ease-of-use operation and high sensitivity and specificity results - to
address critical testing areas relating to emergency care, rapid
clinical intervention, effective field screening, and the control of
high-burden diseases in the developing world. COVID-19 tests
significantly opened the door for new POC molecular testing.
-- The downside continues to be cost. Test cost will continue to weigh more
heavily upon the trajectory of POC testing in many markets. In Europe,
fee schedules have significantly dampened or led to the contraction of
national POC markets; Switzerland is an exception through its preserved
(though repeatedly contested) premiums paid to POC tests over scheduled
base fees. In the United States, future changes to Medicare's CLFS will
place significant pressure on some POC tests performed in large volumes
on automated systems in centralized and commercial labs. For this
reason, Kalorama Information expects slower growth in the U.S. POC
markets for core hematology and chemistry tests as fee schedules used by
CMS and private payers move closer to averages from the largest lab
competitors. Reform in the United States has also targeted overpayments
and inflated volumes from office labs through self-referral, which is
allowed through an exemption from the Stark Rule.
-- The push to discover rapid testing for the COVID-19 pandemic has had a
positive effect on POC testing in general. Point-of-care tests were
growing before the COVID -19 pandemic but test manufacturers have
stepped up the development of dependable POC tests to answer the call
for rapid and easy to use devices to facilitate testing outside the
laboratory. This has helped to spotlight the ease and quality of all FDA
cleared POC tests.
-- Multiplex POC is a growth area. The future of multiplexed POC testing
(xPOCT) devices is being driven by novel technologies such as aptamers
or targets such as circulating RNAs or tumor cells, exosomes, and
miRNAs, as well as applications such as personalized medicine, homecare
monitoring and wearables. Advances in technology are driving this
lucrative area of POC testing. (xPOCT is a more complex form of POC
testing. It allows the simultaneous POC measurement of different
substances from a single sample. POC testing uses the concentrations of
analytes to provide information about the patient. xPOCT systems are
developed to provide multiplexing capability of up to 10 analytes for
different applications. xPOCT has become increasingly important in
resource-limited settings such as developing countries, doctor's offices
and home settings.
These trends will combine for a growing market. In 2027, the total global POC diagnostic testing market is expected to reach $53 billion, displaying growth of 3.3% over the forecast period 2022-2027.
For more information or to purchase the market research report The Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 10th Edition, visit: https://kaloramainformation.com/product/the-worldwide-market-for-point-of-care-poc-diagnostic-tests-10th-edition/.
ABOUT KALORAMA INFORMATION
Kalorama Information, part of Science and Medicine Group, is the leading publisher of market research in healthcare areas, including in vitro diagnostics (IVD), biotechnology, medical devices, and pharmaceuticals. Science and Medicine Group supports companies seeking to commercialize the rapidly changing marketplace at the intersection of science, medicine, and technology. Comprised of industry-leading brands, Science and Medicine Group serves analytical instrument, life science, imaging, and clinical diagnostic companies by helping them create strategies and products to win markets and provide platforms to digitally engage their markets through a variety of innovative solutions. Kalorama Information produces 30 reports a year. The firm offers a Knowledge Center, which provides access to all published reports.
Media Contact
Daniel Granderson, Kalorama Information, (703) 783-1721, daniel.granderson@scienceandmedicinegroup.com
SOURCE Kalorama Information
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