Molecular Diagnostics Market and COVID-19 Virus
RT-PCR kits are one of the most used molecular diagnostic processes 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 tests was developed by Cepheid, USA i.e. Xpert® Xpress SARS-CoV-2 test, which provided results in 45 min using GenXpert benchtop system. FDA also approved it 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 the nasopharyngeal swab, nasal wash, or aspirate specimens from suspects.
As of 10th August 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, a real RT-PCR test. LabCorp has performed more than 8.5 million molecular tests since March. Bosch, in collaboration with Randox Laboratories, UK, has developed the Vivalytic COVID-19 test, a 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 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 have relatively negative growth rates due to the pandemic and less accommodation in hospitals and labs for testing until it’s urgent in cancer patients and other critical issues. In future, the molecular diagnostics tests will become a key diagnostics method with the increasing number of point-to-care facilities and increased investments by people & governments for health safety purposes.
PCR technology contributes the highest market size for molecular diagnostics purposes by technology. During the current pandemic of COVID-19, the PCR is the most widely used technological process to diagnose the COVID-19 virus in humans. There are different PCR tests available for various 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 a high amount of expenditure on healthcare, increased adoption of the point of care facilities, availability of R&D grants, and commercialization of the RT PCR kits in the current pandemic to diagnose COVID-19.
North America dominates the molecular diagnostics market with the largest market share by region. 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 the mass population, coupled with the 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 modernization 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 markets for the molecular diagnostics market in the Asia-pacific region. The country has a very high potential market due to its large population and the molecular diagnostics market in a large number of rural areas is yet to penetrate. By application, the infectious disease contributes the largest market share, i.e., more than 84% of the overall market in the country. The diagnostics of infectious diseases like TB, HIV, HBV (Hepatitis B virus), and HCV are the market’s major drivers. For TB testing, the key players, Danaher, Molbio, Qiagen, Roche, and Bio-Rad, provide the major contribution by advancing technology and improving testing products to diagnose TB easily.
In the 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 include 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 that ICMR approves for diagnosing the COVID-19 virus in India.