Major players in the COVID-19 rapid test kits market are Thermo Fisher Scientific, Abbott Laboratories, BioMedomics, CTK Biotech, F. Hoffmann-La Roche AG, Cepheid Inc., Cellex Inc., Acumen Research Laboratories, Biolidics, and LabCorp.
The global COVID-19 rapid test kits market is expected to decline from $14.94 billion in 2020 to $8.81 billion in 2021 at a compound annual growth rate (CAGR) of -41%. The change in growth trend is mainly due to the companies stabilizing their output after catering to the demand that grew exponentially during the COVID-19 pandemic in 2020. The market is expected to reach $0.27 billion in 2025 at a CAGR of -58%.
The COVID-19 rapid test kits market consists of sales of rapid test kits used for COVID-19 diagnosis and detection.The COVID-19 rapid test kits are either rapid antigen test kits or rapid antibody test kits manufactured by the entities that manufacture in-vitro rapid diagnostic tests in the medical equipment industry.
The companies involved in manufacturing these rapid test kits are primarily engaged in designing, research and production of the rapid test kits which are used in hospitals and clinics, home care, diagnostic laboratories and more.
The COVID-19 rapid test kits market covered in this report is segmented by test type into rapid antigen test, rapid antibody test, others. It is also segmented by kit type into equipment and extraction kits, reagents, by specimen type into nasopharyngeal swab, oropharyngeal swab, nasal swab, blood sample, others, and by end-users into hospitals and clinics, diagnostic laboratories, home care, others.
The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
Product recalls due to quality control issues are expected to hinder the market growth during the forecast period.Rapid medical device approval due to present COVID-19 scenario paves ways to challenges such as product recalls due to safety, efficacy and quality issues.
In May 2020, Spartan Bioscience’s rapid COVID-19 diagnostic kits which were approved with fast track designation in April 2020 were recalled due to efficacy concerns posed by Health Canada regarding its proprietary swab.Health Canada paused the regulatory approval of the test kit and till then permitted Spartan rapid test kit to be used for research purposes only.
In April 2020, India recalled rapid-antibody testing kits imported from China due to efficacy issues, and all the procurement orders from China have also been cancelled. The lack of proper screening and quality assurance along with fast track approval is expected to increase the product recalls which will hinder the market growth.
In April 2020, Hememics Biotechnologies Inc., a US-based research and development company announced a partnership with Biomedical Research and Development Authority (BARDA) to develop a rapid antigen and antibody diagnostic tool which is Bluetooth-enabled. Under the partnership, BARDA will contribute $638,000 to Hememics for the manufacturing and scaling up production of the immune biosensor platform, which is a Bluetooth-enabled rapid diagnostic kit that screens people within 60 seconds with a single drop of blood or mucus. Biomedical Advanced Research and Development Authority (BARDA) is an office of US HHS, which takes measures against bioterrorism, epidemic and pandemic diseases.
Government regulations and steps to provide diversified diagnostic approaches are expected to boost the market growth during the forecast period.Better diagnostics facilities are required to overcome the increasing spread of COVID-19 cases globally, particularly in the rising geriatric population.
In March 2020, the FDA has approved decentralized testing platforms to enlarge the testing capabilities across healthcare centres in the US.FDA issued a policy, under which, states can set up their platforms for authorizing the tests developed and the laboratories developing these tests need not engage with the FDA instead will engage with the respective state authorities.
National Institutes of Health (NIH) has announced a Rapid Acceleration of Diagnostics (RADx), which is a fast track program for COVID-19 test development and distribution procedure under which it will be funding up to $500 million for the development of innovative SARS-CoV-2 diagnostic tests. Robust funding and investments by the public as well as private agencies for the rapid and innovative development of diagnostics for COVID-19 are expected to further boost the market.
The incorporation of Artificial Intelligence (AI) algorithms with the rapid diagnostic test kits is expected to boost market growth during the forecast period. In March 2020, Surgisphere announced the availability of a rapid diagnostic intelligent tool for COVID-19 that it developed to utilize three laboratory tests with a sensitivity of 93.7% and specificity of 99.9% to identify patients who are likely to be infected with Coronavirus. Surgisphere created a decision tree analysis to identify patients who are likely to be infected with Coronavirus, using clinical lab data of patients in the QuartzClinical platform which is a cloud-based healthcare data analytics platform. Early detection of patients results in faster treatment and thus saving more lives which can be achieved through the use of artificial intelligence along with the rapid diagnosis test.
The countries covered in the market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.