Updated: Sep 22
RT-PCR kits are one of the mostly used molecular diagnostic process to identify the COVID-19 virus. Many RT-PCR assays have already been developed by many companies & researchers to deal with the pandemic. One of the most prominent RT PCR rapid test was developed by Cepheid, USA i.e. Xpert® Xpress SARS-CoV-2 test which provided results in 45 min with use of GenXpert benchtop system. It was also approved by FDA under EUA. It is a rapid and automated point-of-care (POC) molecular diagnostic test that enables the qualitative detection of SARS-CoV-2 in nasopharyngeal swab, nasal wash, or aspirate specimens from suspects.
As of 30th July 2020, there were 17,300,933 corona virus cases reported on Worldometer, in which North America (31.12%) reported the highest number of cases followed by Asia-Pacific (24.37%) and Europe (16.47%). As the number of covid-19 cases are increasing, its the number of tests per unit of population is required to control the spread. As faster the test is done, the corona positive patients can get initial treatments and get recovered. As of August 16th the recovery rate of covid-19 patients were more than 70% for at-least 10 countries. The awareness and initial treatment for such patients have helped to recover faster in these countries.
As of 10th Aug, 2020, Quest Diagnostics reported results of approx 11.2 million COVID-19 molecular diagnostic tests. Helix has also received EUA from the U.S. FDA for the COVID-19 NGS test which is a real time RT-PCR test. LabCorp has performed more than 8.5 million molecular tests since March. Companies like Bosch in collaboration with Randox Laboratories, UK has developed Vivalytic COVID-19 test, which is fully automated and rapid POC molecular diagnostic test that can simultaneously detect SARS-CoV-2 and nine other respiratory viruses, including influenza A and B. Abbott ID Now™ COVID-19 test is the other most used IVD assay that detects SARS-CoV-2 in just 5 min. It is a molecular POC test that utilizes the isothermal nucleic acid amplification technology (INAAT) for the qualitative detection of viral RNA from SARS-CoV-2. The test can be used in any location, such as clinics, hospitals, physicians’ offices, or in outbreak hotspots of COVID-19. It requires a portable touchscreen-operated instrument, i.e., ID Now, which is lightweight (6.6 pounds) and compact. It employs a molecular diagnostics for the RdRp gene, and can take throat, nasal, nasopharyngeal and oropharyngeal swabs as samples. The kit contains 24 tests, positive and negative controls, swabs for sample collection, and pipettes. It has also received the FDA EUA and is being used worldwide.
Currently, the molecular diagnostics market has seen more growth rate in applications for infectious diseases (mainly because of Covid-19 tests), other segments has relatively negative growth rate due to pandemic and less accommodation in hospitals and labs for testing until its urgent in case of cancer patients and other critical issues. In future, the molecular diagnostics tests will become a key diagnostics method with increasing number of point to care facilities, and increased investments by people & governments for health safety purposes.
By technology, the PCR technology contributes the highest market size for molecular diagnostics purposes. During the current pandemic of COVID-19, the PCR is the most widely used technological process to diagnose the COVID-19 virus in human. There are different PCR test available for different applications. For example: Assessment of bacterial and viral loads and absolute pathogen counts, detection of cancer in body fluid and stool DNA, quantification of NGS libraries, diagnosis of inherited disease & infectious diseases (HIV, tuberculosis, malaria, hepatitis, and Staph-related diseases, and genetic disorders such as cancer and syndromes., etc.). By Region, North America dominates the PCR technology market with more than 28%, followed by Europe, Asia-Pacific, South America and Middle-East & Africa respectively. Owing to the growth in new technologies and modern facilities (point of care), the demand for PCR technologies in molecular diagnostics has also seen significant growth over the last 5 years. In North America, there is high amount of expenditure on healthcare, increased adoption of the point of care facilities, availability of R&D grants, and commercialisation of the RT PCR kits in current pandemic to diagnose COVID-19.
By region, North America dominates the molecular diagnostics market with the largest market share. The increasing trend in adoption of molecular diagnostics for infectious diseases (HIV, HCV, HBV, chlamydia, gonorrhea, trichomonas, B. pertussis, methicillin-resistant Staphylococcus aureus (MRSA), Sexually Transmitted Diseases (STD) tests and Healthcare Acquired Infections (HAIs), etc.) by mass population, coupled with advent of new cancer diagnostic solutions, is driving the market in the region. The Asia Pacific region is estimated to register the highest growth during the forecast period 2020-25. The increased healthcare spending in the region in different countries like India, China, South Korea, ASEAN, and modernisation of healthcare infrastructure and implementation of clinical laboratory technologies (especially in rural areas) are some of the key factors driving the growth of the molecular diagnostics market in the region.
India is one of the fastest growing market for the molecular diagnostics market in Asia-pacific region. The country has very high potential market due to large population and the molecular diagnostics market in large number of rural areas are yet to penetrate. By Application, the infectitious disease contributes the largest market share i.e. more than 84% of the overll market in the country. The diagnostics of infectitous diseases like TB, HIV, HBV (Hepatitis B virus) and HCV ares the major driver of the market. For TB testing, the key players, Danaher, Molbio, Qiagen, Roche, and Bio-Rad provides the major contribution by advancing technology and improving the testing products to easily diagnose the TB disease.
In current pandemic scenario, the molecular diagnostics test for COVID-19 is being done at a large number through majorly RT PCR process to directly detect the presence of the virus rather than antibodies. The other tests conducted includes Rapid antigen tests, which also detect the virus rather than the antibodies produced by the body. In india, ICMR has approved rapid antigen tests to use it in high contaminated zone and healthcare settings. This test is a point of care test and the results are obtained quickly. TrueNat test developed by Molbio Diagnostics Pvt. Ltd. is the other test which is approved by ICMR for diagnosis of COVID-19 virus in India.
In 2019, the company Roche had the highest market share in the molecular diagnostics market in global region, followed by Cepheid (Danaher Corporation), Hologic Corporation, etc. In the current pandemic where every industry has been affected much including overall Healthcare industry, the COVID-19 related healthcare business has supported the overall estimated growth to be positive(~2% only) for Healthcare industry for the year 2020. In molecular diagnostics market, the key players for the year 2020 will majorly stand out based on the COVID-19 tests as these tests will generate revenue more than 40% of the overall molecular diagnostics market.