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
1 Executive Summary
2 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
3.3 COVID-19 Antigen Diagnostic Tests by Method
- Molecular (PCR) Testing
- Antigen-based Testing
3.4 COVID-19 Antigen Diagnostic Tests by Mode of Operation
- Point of Care (POC)
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)
- 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.
- CerTest Biotec S.L.
- Coris BioConcept
- Edinburgh Genetics Limited
- GenBody, Inc.
- Green Cross Medical Science Corp.
- Hangzhou Deangel Biological Engineering Co., Ltd
- Hangzhou Genesis Biodetection & Biocontrol Co., Ltd
- 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.
- Quidel Corporation
- RapiGEN Inc.
- SD BIOSENSOR, Inc.
- Shenzhen Bioeasy Biotechnology Co., Ltd