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US Infectious Respiratory Disease Diagnostics Key Players-Business, Deal & Patent Strategies

Date : 16 June 2026

Top Companies and Their Offerings

U.S. Infectious Respiratory Disease Diagnostics Market Comapnies are bioMerieux, QuidelOrtho Corporation, Abbott Laboratories, Becton, Dickinson and Company (BD), F. Hoffmann-La Roche Ltd, QIAGEN, Cepheid

Recent Developments in the Market

  • In February 2026, to accelerate the development and deployment of rapid diagnostic technologies for public health emergencies, Cepheid was selected as one of four national collaborators by the U.S. Centers for Disease Control and Prevention (CDC). The company had previously demonstrated its ability to minimize development timelines without compromising accuracy or quality during the COVID-19 pandemic by offering the first point-of-care PCR test for SARS-CoV-2 in the U.S.
  • In July 2025, an exclusive U.S. distribution agreement was announced between PHASE Scientific and Lumos Diagnostics for FebriDx®, a rapid point-of-care (POC) test. The product will utilize a single drop of blood for the diagnosis of bacterial acute respiratory infection and differentiate it from non-bacterial etiology within 10 minutes.
Tier 1
Company Name Headquarters Country Why Relevant to This Market Key Products/Services Related to Infectious Respiratory Disease Diagnostics
Abbott Laboratories Abbott Park, Illinois USA One of the largest respiratory diagnostics providers in the U.S., with strong positions in rapid point-of-care and molecular testing for influenza, RSV, and COVID-19. Extensive hospital and physician office penetration. ID NOW COVID-19, Flu A&B 2, RSV; Alinity m SARS-CoV-2 and respiratory assays; BinaxNOW respiratory tests
Roche Diagnostics (Roche Holding AG) Basel Switzerland Global leader in molecular diagnostics with a significant U.S. installed base and comprehensive respiratory pathogen testing portfolio. cobas SARS-CoV-2 & Influenza A/B assays; cobas Respiratory Flex Test; cobas 6800/8800 platforms
Cepheid (Danaher Corporation) Sunnyvale, California USA Market leader in cartridge-based molecular respiratory testing with widespread adoption across hospitals, laboratories, and near-patient settings. GeneXpert Systems; Xpert Xpress SARS-CoV-2/Flu/RSV; Xpert Respiratory Panels
BD (Becton, Dickinson and Company) Franklin Lakes, New Jersey USA Major participant in molecular diagnostics and clinical microbiology with strong respiratory infectious disease testing capabilities. BD MAX SARS-CoV-2/Flu assays; BD Respiratory Viral Panel; BD COR molecular solutions
bioMérieux Marcy-l'Étoile France Recognized leader in syndromic infectious disease diagnostics and multiplex respiratory pathogen testing, particularly in hospital laboratories.
Tier 2
Company Name Headquarters Country Why Relevant to This Market Key Products/Services Related to Keyword
QIAGEN Venlo Netherlands Significant multiplex respiratory testing portfolio QIAstat-Dx Respiratory Panel
QuidelOrtho San Diego, California USA Strong rapid respiratory diagnostics franchise Sofia Flu/RSV/COVID tests
Hologic Marlborough, Massachusetts USA Respiratory molecular diagnostics through Panther platform Panther Fusion Respiratory Assays
Thermo Fisher Scientific Waltham, Massachusetts USA Growing respiratory molecular diagnostics business TaqPath respiratory panels
Siemens Healthineers Erlangen, Bavaria Germany Strong immunodiagnostics and laboratory footprint Respiratory infectious disease testing solutions
Tier 3
Company Name Headquarters Country Why Relevant to This Market Key Products/Services Related to Infectious Respiratory Disease Diagnostics
Abbott Laboratories Abbott Park, Illinois USA One of the largest respiratory diagnostics providers in the U.S., with strong positions in rapid point-of-care and molecular testing for influenza, RSV, and COVID-19. Extensive hospital and physician office penetration. ID NOW COVID-19, Flu A&B 2, RSV; Alinity m SARS-CoV-2 and respiratory assays; BinaxNOW respiratory tests
Roche Diagnostics (Roche Holding AG) Basel Switzerland Global leader in molecular diagnostics with a significant U.S. installed base and comprehensive respiratory pathogen testing portfolio. cobas SARS-CoV-2 & Influenza A/B assays; cobas Respiratory Flex Test; cobas 6800/8800 platforms
Cepheid (Danaher Corporation) Sunnyvale, California USA Market leader in cartridge-based molecular respiratory testing with widespread adoption across hospitals, laboratories, and near-patient settings. GeneXpert Systems; Xpert Xpress SARS-CoV-2/Flu/RSV; Xpert Respiratory Panels
BD (Becton, Dickinson and Company) Franklin Lakes, New Jersey USA Major participant in molecular diagnostics and clinical microbiology with strong respiratory infectious disease testing capabilities. BD MAX SARS-CoV-2/Flu assays; BD Respiratory Viral Panel; BD COR molecular solutions
bioMérieux Marcy-l'Étoile France Recognized leader in syndromic infectious disease diagnostics and multiplex respiratory pathogen testing, particularly in hospital laboratories.

Market Value Chain Analysis

R&D

  • The R&D of the U.S. infectious respiratory disease diagnostics focuses on developing highly accurate multiplex molecular assays and decentralized point-of-care tests.
  • Key players: Abbott Laboratories, F. Hoffmann-La Roche Ltd, and Cepheid.

Clinical Trials and Regulatory Approvals

  • The diagnostic accuracy, sample compatibility, and ease of use are evaluated in the clinical trials and regulatory approvals of the U.S. infectious respiratory disease diagnostics.
  • Key players: Abbott Laboratories, F. Hoffmann-La Roche Ltd, and Cepheid.

Patient Support and Services

  • Online test-to-treat portals, technical troubleshooting hotlines, and copay assistance programs are provided in the patient support and services of the U.S. infectious respiratory disease diagnostics.
  • Key players: Abbott Laboratories, F. Hoffmann-La Roche Ltd, and Cepheid.

Market Growth

The U.S. infectious respiratory disease diagnostics market size was reported at US$ 8.42 billion in 2025 and is expected to rise to US$ 9.08 billion in 2026. According to forecasts,to reach US$ 17.84 billion by 2035. It will grow at a CAGR of 7.8%.

U.S. Infectious Respiratory Disease Diagnostics Market Size is USD 9.08 Billion in 2026.

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