COVID19 Antigen Diagnostic Test Landscape

Overview

The global market for COVID19 Diagnostic Tests was valued at $16B in 2020 and is expected to grow at a CAGR (2020-2025) of 6.5%. The market is segmented into molecular tests, antigen tests, and antibody tests.

Molecular diagnostic tests to diagnose COVID19 were available in the USA a few months after the outbreak in China. On February 4, 2020, the US FDA issued an emergency use authorization (EUA) enabling the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel. Since then authorized molecular laboratories, molecular diagnostic companies, and in-vitro diagnostic companies have developed several COVID19 diagnostic tests. The U.S. FDA has authorized more than 262 coronavirus diagnostic tests under EUAs, which include 205 molecular tests, 51 antibody tests, and 6 antigen tests.

In this new report, LSI provides timely coverage and an assessment of the market opportunities for COVID19 diagnostic tests.   The initial demand for antibody tests has subsided due to a shift in the guidance from health authorities to focus on asymptomatic and symptomatic current infection cases. The WHO announced it will provide 120 million rapid COVID-19 tests to low-and middle-income countries. Abbott and Roche have scaled their production of rapid antigen tests and are expected to produce more than 50 million tests per month of BinaxNOW™ COVID-19 Ag Card and STANDARD Q SARS-CoV-2 Rapid Antigen Test respectively. Additionally, Point of Care (POC) antigen tests Veritor™ Plus System from BD, LumiraDx Sars-CoV-2 Ag from LumiraDx, and Sofia SARS Antigen Test were issued FDA EUA and will augment the rapid testing capabilities at hospitals and near-patient CLIA waived settings.

Combination tests that detect common flu A, B, and COVID19 are in demand ahead of the flu season. SARS-CoV-2 and influenza A/B test from Roche and Xpert Xpress SARS-CoV-2, influenza A and B, and respiratory syncytial virus (RSV) from Cepheid (Danaher Company) has been issued FDA EUA.

This report provides data and insight for healthtech executives seeking:

• Informed decisions for new product development
• Evaluation of technology transfer opportunities
• Manufacturing and distribution opportunities
• Thorough evaluation of progress of vaccine clinical trials
• Competitive landscape assessment
• More