Impact of COVID-19 on the Global Molecular Diagnostics Market
The spread of COVID-19 worldwide has dramatically increased the number of suspected cases and the geographic areas where laboratory testing must be implemented and intensified. The molecular testing for COVID-19 has led to shortages of molecular testing reagents worldwide for COVID-19. Beyond supply issues, there are limitations of absorption capacity in several regions, especially in low- and middle-income countries.
Testing remains a crucial step to control the rapid spread of the virus. With an increasing number of cases, governments across the world are exploring the opportunities of allowing private laboratories to ramp up testing. The wide availability of diagnostics will be required for the immediate detection of COVID-19 cases. The World Health Organization (WHO) has developed testing strategy recommendations as a part of the strategic preparedness and response plan. The foundation of this strategy includes:
Testing in regions with community transmission and in settings where the testing capacity cannot meet needs must be prioritized. It should focus on the early detection and protection of vulnerable patients and healthcare workers.
Focused testing in healthcare facilities helps ensure that infection prevention and control measures are effectively implemented so that vulnerable patients who do not have COVID-19 are safeguarded from nosocomial COVID-19 infection.
Testing among vulnerable populations and risk groups will be important for early treatment to minimize progression to severe disease.
On February 4th, 2020, the Food and Drug Administration (US FDA) issued a new policy to accelerate the availability of diagnostic services. A public health emergency was announced, justifying the authorization of the emergency use of in-vitro diagnostics (IVDs) for the diagnosis of COVID-19.
The US FDA has approved 20 manufacturers and kits for diagnostic testing for COVID-19. For instance, on March 12th, 2020, Roche Diagnostics received the EUA (Emergency Use Authorization) for its novel coronavirus diagnostic test and cobasSARS-CoV-2 Test from the US FDA, which will be soon made available in India.
In India, the Indian Council of Medical Research (ICMR) has approved 176 labs, including 47 private labs, to conduct the necessary tests.
The European Commission decided to postpone the changes from Medical Device Directive (MDD) to Medical Device Regulation (MDR), which was expected to be implemented on May 26th, 2020, by a year. This enabled the medical device market and Notified Bodies (NBs) to focus on combating COVID-19.
Australia issued an exemption for devices involved in the diagnosis, confirmatory testing, prevention, monitoring, treatment, or alleviation of COVID-19.
Currently Available Testing Kits: Molecular assays and immunoassays are the most widely adopted diagnostics tests for COVID-19. Furthermore, digital solutions are being developed to monitor and track the development of COVID-19. For instance, InferRead CT Pneumonia is being developed by Beijing-based Infervision Technology, which detects lesions from symptoms of pneumonia. Breath biomarkers that can detect and track the virus are currently being developed.
In conclusion, the molecular diagnostics market must keep up with demand, despite the factories of suppliers shutting down production, reduced factory working hours, limited workforce, and, often, the shutdown of research & development. It is certainly a challenge to introduce innovative new products in the market during these times. Several molecular assays and immunoassays are currently available to identify COVID-19. However, quality diagnostics, which provide faster and accurate test results, is the need of the hour.