The coronavirus (COVID-19) outbreak was first reported on December 31, 2019, in Wuhan, China. The World Health Organization declared COVID-19 as a pandemic on March 11, 2020. COVID-19 infection is caused by the novel SARS-CoV-2, which is a member of single stranded RNA coronavirus family. Some of the common symptoms observed in COVID-19 patients include dry cough, fever, and fatigue while some less common symptoms include muscle pain, nausea, diarrhea, loss of smell, vomiting, chills, and conjunctivitis. Sometimes, severe symptoms such as shortness of breath, loss of appetite, and others may be observed in the COVID-19 patients. The COVID-19 rapid test kits are either rapid antigen test kits or rapid antibody test kits.
The global COVID-19 rapid diagnostic test market is estimated to be valued at US$ 3,846.9 Mn in 2021 and is expected to exhibit a CAGR of 8.8% during the forecast period (2021-2028).
Figure 1.Global COVID-19 Rapid Diagnostic Test Market Share (%) in Terms of Value, by Sample Type, 2021
Increasing acquisition and collaboration among the key players is expected to drive the market growth during the forecast period
The increasing acquisition and collaboration among the key players is expected to drive the global COVID-19 rapid diagnostic test market growth during the forecast period. For instance, in February 2021, BD, a U.S.-based medical device company, collaborated with Scanwell Health, a California-based smartphone-enabled at-home medical tests manufacturer, to create an at-home lateral flow rapid antigen test for SARS-CoV-2 using a BD antigen test and the Scanwell Health mobile app.
|Base Year:||2020||Market Size in 2021:||US$ 3,846.9 Mn|
|Historical Data for:||2017 to 2020||Forecast Period:||2021 to 2028|
|Forecast Period 2021 to 2028 CAGR:||8.8%||2028 Value Projection:||US$ 6,952.3 Mn|
Abbott Laboratories, F. Hoffmann-La Roche AG, Cardinal Health, Inc., Alfa Scientific Designs, Inc., Acon Laboratories, Inc., Thermo Fisher Scientific Inc., Danaher Corporation, PerkinElmer, Inc., Bio-Rad Laboratories, Inc., and Creative Diagnostics
|Restraints & Challenges:||
Figure 2.Global COVID-19 Rapid Diagnostic Test Market Share (%), by Test Type, 2021
Increasing product launches and regulatory approvals is expected to drive the COVID-19 rapid diagnostic test market growth
Increasing product launches and regulatory approvals is expected to drive the COVID-19 rapid diagnostic test market growth during the forecast period. For instance, in September 2020, Laboratory Corporation of America Holdings, a U.S.-based testing laboratory company, launched a combined diagnostic test for flu, respiratory syncytial virus (RSV), and COVID-19.
Moreover, in September 2020, Mammoth Biosciences, a U.S.-based biotechnology company, received emergency use authorization from the U.S. FDA for its SARS-CoV-2 DETECTR Reagent Kit, which is based on CRISPR technology.
Global COVID-19 Rapid Diagnostic Test Market– Impact of Coronavirus (COVID-19) Pandemic
According to the Coronavirus (COVID-19) Weekly Epidemiological Update by the World Health Organization, over 245,403,909 cases and 4,981,395 deaths due to coronavirus (COVID-19) were reported till October 27, 2021, across the globe. During the COVID-19 pandemic, pharmaceutical business, and likewise biotechnology firms are facing difficulties due to the interruption in supply chains.
The global incidence of coronavirus is escalating demand for advanced diagnostic test kits, which is expected to boost growth of the COVID-19 rapid diagnostic test market.
Increasing demand of product launches for the diagnosis of COVID-19 is expected to drive the COVID-19 rapid diagnostic test market growth. For instance, in October 2020, Cipla Inc., an Indian pharmaceutical company, launched its new COVID-19 diagnostic test called ELIFast. ELIFast is based on ELISA (Enzyme linked immunosorbent assay), which detects the antibodies against SARS-CoV-2.
Global COVID-19 Rapid Diagnostic Test Market: Restraint
Product recalls, lack of skilled healthcare professionals, and less efficacy of rapid COVID-19 diagnostic tests as compared to laboratory setting are the factors that are expected to hinder growth of the global COVID-19 rapid diagnostic test market over the forecast period. For instance, in May 2020, India recalled rapid-antibody COVID-19 testing kits from two Chinese in-vitro diagnostics companies, namely Guangzhou Wondfo Biotech Co. and Zhuhai Livzon Diagnostics, Inc. due to low accuracy and inconsistent results delivered by the COVID-19 test kits.
Moreover, on October 1, 2021, Ellume Limited, an Australia-based digital diagnostics company, issued a recall of approximately 427,000 of its COVID-19 home tests. In total, approximately 42,000 affected tests were used and produced false positive results.
Major players operating in the global COVID-19 rapid diagnostic test market include Abbott Laboratories, F. Hoffmann-La Roche AG, Cardinal Health, Inc., Alfa Scientific Designs, Inc., Acon Laboratories, Inc., Thermo Fisher Scientific Inc., Danaher Corporation, PerkinElmer, Inc., Bio-Rad Laboratories, Inc., and Creative Diagnostics.
A rapid diagnostic test of a sample of a person helps to detect the presence of viral proteins (antigens) related to the COVID-19 virus. This ensures an accurate and a speedy diagnosis, and its usage is Centers for Disease Control and Prevention CDC-approved. This test is a rapid diagnostic test based on antigen detection. The other test is rapid diagnostic test based on antibody detection. This test is used to detect the presence of antibodies in the blood of COVID-19 infected people. The strength of the antibody response depends on several factors like medications, age, infections, and the severity of disease, etc.
Molecular and antigen tests are types of diagnostic tests that can detect the infection if you have an active COVID-19 infection. Samples for diagnostic tests are normally collected with a throat or nasal swab, or saliva collected by spitting into a tube. Antibody tests look for antibodies in your immune system produced in response to SARS-CoV-2, the virus that is responsible for causing COVID-19. Antibody tests cannot be used to diagnose an active COVID-19 infection. Antibodies can take several days or weeks to develop after you get infected by the infection and may stay in your blood for several weeks or even after recovery from the infection. Samples for antibody tests are typically blood drawn by your doctor or other medical personnel.
The increasing number of approvals for new and advanced COVID-19 rapid diagnostic test kits by regulatory authorities is expected to propel the market growth over the forecast period. For instance, on May 12, 2020, Fujirebio Europe received CE mark for the molecular IVD assay iAMP COVID-19 detection kit, developed in partnership with Atila Biosystems, Inc., a U.S.-based company focused on developing products for nucleic acid amplification and detection of clinical diagnostic applications. Moreover, in September 2020, the U.S. FDA granted emergency use status to MiraDx, a U.S.-based molecular genetics company, for its SARS-CoV-2 RT-PCR assay used for detection of COVID-19.
Furthermore, development of cheaper COVID-19 detection kits is expected to drive the global COVID-19 rapid diagnostic test market growth over the forecast period. For instance, in January 2021, the World Health Organization approved a rapid antigen test developed by UNICEF (United Nations International Children’s Emergency Fund) for diagnosis of COVID-19 under emergency use. This COVID-19 diagnostic test is a low cost alternative to other more expensive COVID-19 test and is priced at US$ 2.55 per test. With the development of such low cost COVID-19 rapid diagnostic tests, low and middle income countries such as Bangladesh, Indonesia, and others would have more access to the COVID-19 diagnostic tests.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.