Six Trends to Watch in POC-IVD

Point of care IVD sales reached 45 billion dollars in 2022.  This includes instruments – permanent and disposable, and associated reagents and supplies.   Kalorama Information’s latest report details this:

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 reliable 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 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. Multiplexed 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 $53,059 million, displaying growth of 3.3% over the forecast period 2022-2027.  For more information, see Kalorama’s report