The COVID-19 pandemic in India has increased the demand for its diagnosis in the country, which in turn, is anticipated to drive the growth of the Indian COVID-19 diagnostics market. In India, the COVID-19 cases initially peaked during April-May 2020 and in the second wave, more cases have been observed in the country that was more than the first wave. The growth in COVID-19 cases had increased the demand associated with quick diagnostic test kits to detect the COVID-19. As more time the diagnosis takes, it increases the concern about further infection in the community. As a result, the country is inclined towards the development of quick diagnostic kits.
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The Indian COVID-19 diagnostics market is mainly driven by the rapid increase in the number of COVID-19 cases coupled with the increasing government initiatives for the proper detection of the virus. As per the Worldometer, in India, from 27th January 2020 to 23rd June 2021, there have been around 30 million confirmed cases of COVID-19 with 392,014 fatalities. India has been one of the adversely impacted economies across the globe from the COVID-19 pandemic. According to the Indian Council of Medical Research (ICMR), till 23rd June 2021, a total of around 397.8 million COVID-19 tests were conducted. In May 2021, the Indian Government announced the expansion of the COVID-19 testing program along with at least 40% of RT-PCR testing to be conducted. The Indian Government has offered significant funds to support the manufacturers of kits, reagents, and equipment for COVID-19 diagnostics through several contracts. For instance, in June 2021, with one of the vendors named CEPHEID, a contract was signed amounting to $192,500 for COVID-19 diagnostics by the government. Now, the country has around 2,675 working laboratories for COVID-19 diagnosis including government laboratories and private laboratories. Such rapid increment in the facility creation to serve a huge population with governmental support had significantly driven the market of the Indian COVID-19 diagnostics market.
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FDA and Indian Council of Medical Research
In November 2020, the ICMR had approved the use of swab collection methods concerning RT-PCR tests that are considered economical and more convenient. ICMR had given the approval for three batches of COVID Kavach ELISA IgG kits for testing the blood samples for IgG antibodies using the ELISA method. ELISA is an enzyme-based laboratory test that supports detecting and quantifying antibodies in the blood. Saliva test based on Rapid Antigen Test (RAT) has received clearance and approval in the US from the FDA. However, this test is not approved by the ICMR and still, the council is actively exploring this test method.
Government Schemes and Initiatives
- In May 2021, the Indian Government set the target to increase rapid antigen test capacity to 4.5 million per day by June end; however, the shortage of the production of COVID-19 test kit in reference to the specified target due to delayed payments by states has led to overlooking the target.
- In April 2020, for COVID-19 testing and treatment, the Government of India had notified a specific package of 64 testing kits under AB-PMJAY.
- In April 2020, the guideline was stated by the Ministry of Home Affairs to enable inter-state movement of the person in which states will screen the people, quarantine them and do periodic health checkups.KEY PLAYERS IN THE INDIAN COVID-19 DIAGNOSTICS MARKETThe Indian COVID-19 diagnostics market has various players contributing majorly to the overall growth. Some of the key players operating in the Indian COVID-19 diagnostics market include ADT Biotech Sdnbhd, Cepheid Inc., Ltd., Thermo Fisher Scientific Inc., Mylab Discovery Solutions Pvt Ltd., J Mitra & Co. Pvt Ltd. among others.
Recent Trends and Strategies
- In May 2021, Mylab Discovery Solutions Pvt. Ltd. launched COVID-19 Rapid Antigen Self-Test Kit. The test is approved by ICMR. It is one of the first Indian COVID-19 test kits for self-use. The kit provides a result within 15 min.
- In April 2021, J Mitra & Co. Pvt. Ltd. launched India’s one of the first COVID-19 Neutralizing Antibody Microlisa Elisa Test in its current fight against the COVID-19 pandemic. The test kit has cleared all government parameters and has received approvals, including from the Drug Controller General of India (DCGI). Besides, COVID-19 Neutralizing Antibody Microlisa Elisa Test is the first commercial laboratory test to detect neutralizing antibodies against SARS-CoV-2.
- In March 2020, Abbott obtained approval for the supply of its LyteStar 2019-nCoV RT-PCR test kit by the health ministry. The kits were meant to be supplied to MoH facilities that had been tasked to run tests for the coronavirus.
- In June 2020, Cephied, Inc. announced that it has developed next-generation tests for the detection of COVID-19 to assist the global efforts in fighting the pandemic. Cepheid’s Xpert Xpress SARS-CoV-2/Flu/RSV four-in-one test delivers detection of Flu A, Flu B, COVID-19, and RSV (Respiratory syncytial virus) from a single patient sample with results expected in about 35 minutes.
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