Resulting in reagent shortages, new product launches, new pipeline products entering development
The coronavirus (COVID-19) pandemic has had a dramatic impact on the in vitro diagnostics (IVD) testing market resulting in reagent shortages, new product launches and a host of new pipeline products entering development, says GlobalData.
The current test used to diagnose COVID-19 is an RT-PCR based assay. In recent months, the pandemic has led to overwhelming demands for RT-PCR reagents causing shortages in reagents required for key steps in the testing process, such as RNA extraction kits.
Companies such as Thermo Fisher Scientific, Abbott Laboratories, Hologic, Quidel Corp, and Roche Diagnostics have now all received emergency use authorisation from the Food and Drug Administration (FDA) for their COVID-19 diagnostic assays and are in the process of ramping up production to help alleviate testing shortages. Thermo Fisher Scientific began shipping their COVID-19 testing kits in mid-March and are aiming to generate five million tests a week by April. Other companies such as Abbott Laboratories and Roche Diagnostics have also indicated that they aim to send hundreds of thousands of COVID-19 tests to the US each week.
Alison Casey, Medical Devices Analyst, GlobalData, comments: “In addition to this, there are currently almost 100 other IVD pipeline products for COVID-19. Many of these pipeline products are nucleic acid amplification tests and use the same fundamental technique as products recently launched by big name manufacturers.
“Interestingly, over half of these pipeline products are point-of-care devices, indicating that manufacturers are anticipating substantial future demand for rapid diagnostic testing.”