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COVID-19 Antigen Diagnostic Test Landscape

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  • October 2020
  • Region: Global
  • Life Science Intelligence
  • ID: 5174720

The global market for COVID-19 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 COVID-19 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 COVID-19 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, the publisher provides timely coverage and an assessment of the market opportunities for COVID-19 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 COVID-19 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 the progress of vaccine clinical trials
  • Competitive landscape assessment

Table of Contents

1 Executive Summary2 Scope of the Report
3 COVID-19 Antigen Diagnostic Tests Segmentation
3.1 COVID-19 Antigen Diagnostic Tests List (Brief Commentary on Strengths & Weaknesses)
3.2 COVID-19 Antigen Diagnostic Tests by Sample Type
  • Nasopharyngeal (NP) Swab
  • Oropharyngeal (OP) Swab
  • Nasal Swab
  • Blood
  • Others
3.3 COVID-19 Antigen Diagnostic Tests by Method
  • Molecular (PCR) Testing
  • Antigen-based Testing
  • Others
3.4 COVID-19 Antigen Diagnostic Tests by Mode of Operation
  • Point of Care (POC)
  • Laboratory
4. COVID-19 Antigen Tests Clinical Trials
4.1 by Status
4.2 by Location
4.3 by Sponsor

5. Regulatory Approval
5.1 FDA Approved COVID19 Antigen Tests
5.2 CE Approved COVID19 Antigen Tests

6 COVID-19 Antigen Diagnostic Tests Competitive Landscape (Key Companies)

Companies Mentioned

  • Abbott
  • Abbott Diagnostics Scarborough, Inc.
  • Access Bio, Inc
  • AmonMed Biotechnology Co., Ltd
  • AMS UK Ltd.
  • Apollo Biomedical LLC
  • ArcDia International Ltd.
  • Becton, Dickinson and Company (BD)
  • Beijing Abace Biology Co. Ltd
  • Beijing Diagreat Biotechnologies Co., Ltd
  • Beijing Kewei Clinical Diagnostic Reagent Inc.
  • Beijing Savant Biotechnology Co., Ltd
  • BIOHIT HealthCare (Hefei) Co., Ltd
  • Bionote Inc.
  • Boditech Inc.
  • Cepheid
  • CerTest Biotec S.L.
  • Coris BioConcept
  • DiaSorin
  • Edinburgh Genetics Limited
  • GenBody, Inc.
  • Green Cross Medical Science Corp.
  • Hangzhou Deangel Biological Engineering Co., Ltd
  • Hangzhou Genesis Biodetection & Biocontrol Co., Ltd
  • Hologic
  • Humasis
  • Jiangsu Bioperfectus Technologies Co. Ltd
  • JOYSBIO (Tianjin) Biotechnology Co., Ltd
  • Liming Bio-Products Co., Ltd
  • LumiQuick Diagnostics Inc.
  • LumiraDx UK Ltd.
  • Medisys International SA
  • nal von minden GmbH
  • PCL Inc.
  • Precision Biosensor, Inc.
  • Qiagen
  • Quidel Corporation
  • RapiGEN Inc.
  • Roche
  • Shenzhen Bioeasy Biotechnology Co., Ltd
  • ThermoFisher