Point-of-care IVD sales rose to $45 billion in 2022

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Point-of-care (POC) IVD sales, including permanent instruments, disposable instruments, and associated reagents and supplies, reached $45 billion in 2022, according to Kalorama Information, a sister brand to LabPulse.

The point-of-care IVD segment covers a variety of tests -- performed in a lab, doctor's office, or a patient's home -- that can provide results directly or during a provider-patient visit. These tests prove useful in detecting colon cancer, cardiac disease, and diabetes, among many other medical conditions.

Infectious disease testing also represents a leading category; COVID-19 was a significant game-changer in 2020 and 2021 and still had some influence in 2022. The number of new tests for POC COVID-19 was stunning, with new technologies and increased demand contributing to growth.

Numerous trends will combine to enable a growing market. In 2027, the total global POC diagnostic testing market is expected to grow to almost $53.06 billion. According to the Kalorama report, growth of 3.3% per year is expected over the forecast period from 2022 to 2027.

Certainly, technological progress is expanding the domain of rapid and point-of-care tests. Led by the growing U.S. population, the global client base for POC products and tests (including tests done in physicians' 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 future for POC testing is not all upside, according to Kalorama. The role of such tests remains contentious due to questions regarding quality control or accuracy and added costs. In the U.S., results of the GPRA (Government Performance and Results Act) Waived Project have vindicated concerns regarding the quality of CLIA-waived testing that have also stalled the introduction of additional test waivers. The GPRA Waived Project is a 2014 survey program overseen by the Centers for Medicare & Medicaid Services (CMS) with the aim of increasing the percentage of labs receiving a certificate of waiver that are in full compliance with CLIA regulations. The survey showed labs had very high rates of compliance with the regulations.

Skepticism regarding POC test accuracy is significantly stronger outside the U.S., with the availability of more-limited test menus for reimbursement or outright bans on testing at unaudited or uncertified office labs.

POC molecular diagnostic tests are at the nexus of low-complexity rapid testing performed near the patient and high-technology clinical molecular diagnostic testing. The emergent molecular POC testing space seeks to leverage the key strengths of both types of settings -- rapid results with ease-of-use operation and high sensitivity and specificity results -- to address critical testing for 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 development of smaller devices and Bluetooth communication has dramatically changed patient/physician roles. Patients are more interested in playing a bigger role in their healthcare, which will lead to an increase in personalized healthcare with interventions tailored to specific patients.

Test cost will continue to weigh more heavily on 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 use of preserved (although repeatedly contested) premiums paid for POC tests in addition to scheduled base fees. In the U.S., future changes to Medicare’s Clinical Laboratory Fee Schedule (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 test markets for core hematology and chemistry tests for which fee schedules -- a listing of fees used by CMS and private payors to pay providers -- more closely match average fee schedules from the largest lab competitors.

Reform in the U.S. has also targeted overpayments and inflated volumes from office labs generated through self-referral, which have been allowed through an exemption from the Stark Law (unless an exception applies, the Stark Law prohibits physicians from referring patients to receive designated health services payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship.)

The push to develop rapid testing during the COVID-19 pandemic has had a positive effect on POC testing in general. Point-of-care testing markets were already growing, but during the pandemic,  test manufacturers stepped up the development of reliable tests to answer the call for rapid and easy-to-use devices that facilitate testing outside the laboratory. Such development has, overall, served to highlight the ease of use and quality of FDA-cleared POC tests.

For more information, see Kalorama's report, The Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 10th Edition.

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