While market demand for self-testing kits and other test kits is on the rise, testing protocols and result tracking needs to be more stringent
A new dynamic market is emerging for COVID-19-based diagnostics. Testing is moving into physicians’ offices and even into the home. The increase in COVID testing capacity is the outcome of expansion in the network of testing labs in the country and fast track availability of self-testing kits in the market.
A rapid surge in Omicron cases, led to a rise in at-home or self-testing kits recently. The Indian Council of Medical Research has approved multiple at-home COVID test kits so far most of which are nasal swab-based tests. They are affordable and easy to perform and handle but comes with certain risks that can’t be ignored (See story: COVID-19 diagnostics: Testing times)
Talking about the rising market of self-testing COVID testing kits, Chandra Ganjoo, Executive Director & Head-Corporate Communications, Trivitron Healthcare said, “The scenario of the pandemic has accelerated an entire paradigm shift in the diagnostics industry and has brought phenomenal revolution concerning its scope and capacity. The pandemic has impacted the level of health awareness and the need for quality preventive healthcare. The market trends due to pandemic demands for new consumer-friendly models of care, point-of-care testing, self-testing kits, genome testing, application of artificial intelligence based diagnostic solutions, affordable life-saving devices and advanced critical care solutions to cope-up with the anticipated increase of test volume.
Sharing her views on rising demand for self-test kits, she added, “Self-test kits are a valuable tool that can be used to assess and monitor for COVID-19 infection. Individuals who are symptomatic and who have a known COVID-19 exposure risk can go for this test to prevent the spread and start with the initial treatment and self-isolation. Self-test kits are affordable, reliable and are easy to perform, making testing possible as faster and economical option than laboratory based tests. The lack of any mechanism to capture positive cases through home tests, unless individuals report the result themselves on the ICMR site, is a cause for concern. All such tests must have an inbuilt system of data capture through mobile phone-based application software. Manufacturers of self-test must advise the suppliers to ensure compatibility of data flow into the ICMR COVID-19 testing portal.”
Data Bridge Market Research analyses that at-home testing kits market is growing with the CAGR of 5.3 per cent in the forecast period of 2021 to 2028 and expected to reach USD 8,154.74 million by 2028. Increasing health awareness among people is helping the at-home testing kits market to grow at significant rate.
The analysis also states, “The rising adoption of self-help and do-it-yourself (DIY) test kits due to convenience and rapid results is a major factor which is driving the growth of the at-home testing kits market. There are doubts among end-users related to the reliability of the rapid home testing kits which might hinder the growth of the at-home testing kits market. It has become an urgent need of the companies to bring the rapid testing kits for COVID-19 to lower the death rate and increase the detection rate of patients and this is creating huge opportunity for the at-home testing kits market. The high competition in the market is a major challenge for the at-home testing kits market growth.”
Talking about the COVID-19 diagnostics market, Jatin Mahajan, Managing Director, J Mitra & Co said, “Various research reports are trying to predict the future of COVID-19 diagnostics worldwide, and all of them differ in their outlook. Unfortunately, the coronavirus has constantly been mutating, and we can all, at best, guesstimate what the future has in store for us. As per the Fortune Business Insights report, the global COVID-19 diagnostics market will decrease from USD 20.05 billion in 2021 to USD 9.20 billion in 2028 at a CAGR of -10.5 per cent. This means that the COVID-19 diagnostics business is currently probably at its peak. This is a bad sign for the COVID-19 diagnostics players (like us), but we welcome this downslide in business which means mental peace and health relief for the population.”
“We are continuously moving closer to point-of-care testing and diagnostics as an industry. For COVID-19, there are self-test kits. POCT uses rapid diagnostic tests that which can be performed in various settings. These point-of-care tests can diagnose SARS-CoV-2 infections in multiple environments based on antigen, antibody, or NAAT technology”, he added.
As per ICMR recent data, among 3236 government laboratories, 2120 have been approved to test for Real-Time PCR (RT PCR) tests, 952 for TrueNat screening tests, 131 for CBNAAT testing, and 33 for other Molecular-Nucleic Acid (M-NA) testing platforms.
Stressing on the road ahead, Dr Nilesh Shah, President and Chief of Science & Innovation Metropolis Healthcare said, “The COVID diagnostics market is moving towards rapid RT PCR, POC, RAT and home RAT. This is because turnaround time is becoming increasingly critical. Regular RT PCR will become only a confirmatory test. The largest market would be home RAT followed by CLIA or AI based RAT and then POC. Antibody test has low future while neutralising antibody test has no good future.”
Anand K., CEO – SRL Diagnostics believes that RTPCR test will remain the gold standard for COVID-19 diagnosis. Talking about the same, he said, “We have witnessed some level of usage of home based self-tests during this omicron induced surge. The home-based test kits are unregulated, has no guidelines or a mechanism for data collation, contact tracing or recording new cases. The RAT testing method has lower sensitivity and specificity and hence chances of a false negative results are high. At-Home COVID-19 testing is based on the RAT method.”
“A negative result on a Rapid Antigen Test still needs confirmation by RTPCR if the patient is symptomatic or if the person is a primary contact of an infected person. RTPCR will remain the gold standard for COVID-19 diagnosis and especially more so for hospitalisation, monitoring of patients, traveling mandates and back-to-work testing needs”, he added.