Pune, India, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Point-of-care testing (POCT) is essential for the rapid detection of analytes near to the patient, which facilitates in disease diagnosis, monitoring, and management. It enables quick medical decisions, as the diseases can be diagnosed at a very early stage, and is an important criterion in preventing advanced disease types. This primarily leads to improved health outcomes for patients by enabling the early start of treatment. Recent advancements in biosensors, which is a critical component for point of care diagnostics is directly responsible for the bioanalytical performance of assay.
According to our new research study on “Point-of-Care Diagnostics Market Forecast to 2028 – COVID-19 Impact and Global Analysis – by Product, Prescription Mode, End User, and Geography” the point of care diagnostics market size is expected to grow from $36 billion in 2021 to $82.95 billion by 2028; it is estimated to grow at a CAGR of 12.7% from 2021 to 2028. Factors driving the point of care diagnostics market growth are increasing number of COVID-19 cases in the recent past, increasing prevalence of infectious diseases, and rising number of CLIA-waived point of care tests.
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North America Point of Care Diagnostics market accounted for the largest share in 2020 and is expected to continue a similar trend during the forecast period followed by Europe. North America has been segmented into the United States of America (USA), Canada, and Mexico. The United States captured the largest share in 2020 and is expected to continue a similar trend during the forecast period. Technological advancements is one of the reasons for the regional growth. For instance, Abbott’s i-STAT 1 POC blood analyzer can run multiple tests on one cartridge, including tests for cardiac markers, coagulation, blood gases, chemistries, electrolytes, and hematology. Roche Diagnostics’ cobas Liat PCR System also performs multiple tests, using polymerase chain reaction technology to test for influenza A/B, respiratory syncytial virus, and group A strep in about 20 minutes. Also on the infectious diseases front, the COVID-19 pandemic has spurred development of POC tests for SARS-CoV-2. In the United States, Cepheid was first to market a rapid, near-patient test that gave results in 45 minutes. The Food and Drug Administration (FDA) on March 21, 2020, issued an emergency use authorization (EUA) for Cepheid’s Xpert Xpress SARS-CoV-2 test for use in high- and moderate-complexity CLIA labs. Another company named Mesa Biotech (San Diego) received an EUA in 2020 for a test that gives results in 30 minutes, and Abbott Labs received an EUA in 2020 for a POC test that can deliver positive results in five minutes.
Other market participants that recently got FDA approval for POC COVID-19 tests include Becton Dickinson, bioMerieux, Integrated DNA Technologies, LabCorp and Quest Diagnostics.
Global Point of Care Diagnostics Market: Competitive Landscape and Key Developments
Companies such as Roche, Bio-Rad, bioMérieux, Siemens Healthineers, Nova Biomedical, Danaher, PTS Diagnostics, and Abbott are some of the major companies operating in global Point of Care Diagnostics market. Some of the key development initiatives undertaken by company participants in recent years are provided below:
On March 5, 2021, Cue Health took an important step when the Cue COVID-19 Test for home and over the counter (OTC) use was approved for nonprescription home use, thus becoming the nation’s first molecular diagnostic test available without a prescription to consumers for home use and to enterprise users and healthcare professionals without CLIA certification.
In December 2020, the Ellume COVID-19 Home Test (Ellume Limited, EUA approved) became the first antigen test to be authorized for nonprescription, OTC home use.
On March 31, 2021, tests from the BinaxNOW family were authorized for nonprescription home use with self-collected samples from individuals aged 15 years and older or adult-collected anterior nasal swab samples from individuals aged 2 plus years old (BinaxNOW COVID-19 Antigen Self-Test
Impact of COVID-19 on Global Point of Care Diagnostics Market:
In the recent past, it has been reported that rapid point-of-care (PoC) diagnostics was critical in the COVID-19 pandemic. Successful examples of EUA-approved RT-PCR-based POC devices are the Xpert Xpress SARS-CoV-2, Xpert Xpress SARS-CoV-2/Flu/RSV, Xpert Xpress SARS-CoV-2 DoD (all the three products from Cepheid), Accula SARS-CoV-2 Test (Mesa Biotech Inc.), cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test (Roche Molecular Systems, Inc.), BioFire Respiratory Panel 2.1-EZ (BioFire Diagnostics, LLC), and Visby Medical COVID-19 Point-of-Care Test (Visby Medical, Inc.). One example, the Visby Medical test, is a single-use (disposable), fully integrated test, where anterior nasal or midturbinate swabs samples can be self-collected by individuals 18 years of age or older, under the supervision of a health care provider. All of these EUA-approved tests are authorized for use at the POC (i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation).
Isothermal amplification-based approaches have recently generated attention for detection of SARS-CoV-2 virus due to the simplicity of this technology (typically one-step) and the ease of translation to a point-of-use device, as these technologies eliminate the need for precise thermal cycles to achieve RNA amplification. Shortly after the pandemic started, Abbott Diagnostics Scarborough, Inc. released the ID NOW COVID-19 test which uses RT-LAMP. This was the first isothermal technology to receive EUA authorization for COVID-19 testing. Cue COVID-19 Test (Cue Health, EUA approved) utilizes isothermal amplification (20 min) in a single-use cartridge that detects the virus from direct nasal swabs with a limit of detection of 20 genome copies per sample using an electrochemical detection method.
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Global Point of Care Diagnostics Market: Segmentation Overview
Global Point of Care Diagnosticss market based on prescription mode has been segmented into prescription based and OTC based. In 2020, the prescription-based testing segment held the largest share and the is anticipated to register the highest CAGR of 13.0% in the market during the forecast period. For instance, the Assure COVID-19 IgG/IgM Rapid Test Device is currently the only FDA authorized COVID-19 POC serology test and is available by prescription only.
Based on product, the Point of Care Diagnostics market is segmented into glucose monitoring, infectious disease testing, cardiometabolic testing, pregnancy and fertility testing, coagulation testing, tumor/cancer marker, cholesterol testing, urinalysis testing, hematology testing, and other testing products. In 2020, the glucose monitoring product segment held the largest share, whereas, the infectious disease testing segment is anticipated to register the highest CAGR of 14.1% during the forecast period. POC testing is a widely used tool to enable immediate determination of glucose levels in hospitalized patients and facilitate rapid treatment decisions in response to fluctuations in glycemia. This essentially aids the hospital Point of Care Diagnosticss market. Accurate POC glucose testing requires attention to various factors during, before, and after performance of tests. In POCT glucose meters, glucose measurement methods involve an enzymatic reaction. After adding the sample, the reaction occurs, and the final response is measured using photometric (colorimetric) or amperometric (electrochemical) methods.
Go through further research published by The Insight Partners:
Point-of-Care Testing Devices Market - Global Analysis and Forecast to 2030
Point of Care Test Market - Global Analysis and Forecast to 2030
Point of Care Molecular Diagnostics Market - Global Analysis and Forecast to 2030
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