U.S. Infectious Respiratory Disease Diagnostics Market To Reach $5.70 Billion By 2033

U.S. Infectious Respiratory Disease Diagnostics Market Growth & Trends

The U.S. infectious respiratory disease diagnostics market size is expected to reach USD 5.70 billion by 2033, registering a CAGR of 2.98% from 2026 to 2033, according to a new report by Grand View Research, Inc. The market is anticipated to decline due to the decrease in COVID-19 testing. However, the U.S. infectious respiratory disease diagnostics market is expected to be driven by technological advancements, an increase in the prevalence of infectious respiratory diseases, and high R&D investments by the key players, government, & NGOs to develop novel & innovative products to address the increased market demand.

For instance, in January 2021, Biomedical Advanced Research and Development Authority (BARDA) funded USD 598,000 and USD 679,000 to QIAGEN LLC and DiaSorin Molecular LLC, respectively to enhance the development of COVID-19 test kits and instruments.

The introduction of innovative products used for disease diagnosis is anticipated to fuel the U.S. respiratory infectious disease market growth. In April 2020, Bio-Rad Laboratories, Inc. introduced immunoassay test kits for the diagnosis of COVID-19 patients. These were blood-based immunoassay test kits. In the initial preliminary performance of the immunoassay, the test kit demonstrated a specificity of more than 99.0% in more than 700 patients.

In addition, PerkinElmer, Inc. received approval from the U.S. FDA for the use of a T-cell select reagent test kit for the automation of its tuberculosis spot in September 2022. It uses a globally regulated enzyme-linked immunosorbent spot (ELISPOT) interferon-gamma release assay to detect latent tuberculosis infection. This ELISPOT test enables laboratories to offer accurate results to patients with latent tuberculosis. Thus, technological advancements in infectious respiratory disease diagnostics are fueling the market.

Moreover, molecular diagnostics play an important role in infectious disease testing by offering quick & effective results. According to the Centers for Disease Prevalence and Prevention (CDC), the estimated incidence rate of tuberculosis was 2.4 cases per 100,000 populations as of 2021. Similarly, according to the American Thoracic Society, pneumonia affects around 1.0 million people annually, and 50,000 die from this disease. Thus, the increasing incidence of respiratory infections is expected to drive the U.S. infectious respiratory disease diagnostics market during the study period.

On the other hand, the presence of ambiguous regulatory frameworks and high prices of diagnostics products may hamper the U.S. infectious respiratory disease diagnostics market during the study period. High costs related to molecular & immunoassay tests and lack of alternative testing products are the other major reasons for increased prices of infectious respiratory disease diagnostic products in the U.S.

However, healthcare authorities have taken steps to reduce the burden of high costs on manufacturers. EUA received from the U.S. FDA for COVID-19 tests is expected to minimize development costs and accelerate the process to increase the availability at more testing sites. Hence, a decrease in development costs is anticipated to increase the affordability of tests for healthcare providers and patients.

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U.S. Infectious Respiratory Disease Diagnostics Market Report Highlights

• Based on product, the reagents segment dominated the market with a 65.38% revenue share in 2025. Furthermore, the instruments segment is expected to grow steadily, driven by demand for rapid, accurate, and wide-ranging respiratory pathogen detection.

• Based on technology, the molecular diagnostics diagnosis segment held the largest revenue share of 67.82% in 2025. The rapid/point-of-care diagnostics segment is expected to grow at the fastest CAGR of 7.14% during the forecast period.

• Based on application, the COVID-19 segment held the largest revenue share of 46.25% in 2025. Tuberculosis is a significant segment in the U.S. market, as early detection and surveillance are vital for stopping disease spread.

• Based on end-use, the diagnostic laboratories led the U.S. market with a share of 41.40% in 2025. The hospital segment holds a significant share in the U.S. market in 2025 as hospitals rely on advanced diagnostic technologies to ensure early and accurate detection of respiratory infections.

U.S. Infectious Respiratory Disease Diagnostics Market Segmentation

Grand View Research has segmented U.S. infectious respiratory disease diagnostics market report on the basis of product, technology, end-use, and region:

U.S. Infectious Respiratory Disease Diagnostics Product Outlook (Revenue, USD Million, 2021 - 2033)

• Instruments

• Reagents

• Services

U.S. Infectious Respiratory Disease Diagnostics Technology Outlook (Revenue, USD Million, 2021 - 2033)

• Molecular Diagnostics

• Immunoassays

• Microbiology

• Rapid/Point-of-Care Diagnostics

• Other Technologies

U.S. Infectious Respiratory Disease Diagnostics Application Outlook (Revenue, USD Million, 2021 - 2033)

• COVID-19

• Influenza

• Tuberculosis

• Respiratory Syncytial Virus (RSV)

• Non-tuberculosis Mycobacterium Testing

• Bacterial Pneumonia Testing

• Other Respiratory Diseases

U.S. Infectious Respiratory Disease Diagnostics End-use Outlook (Revenue, USD Million, 2021 - 2033)

• Hospitals

• Clinics

• Diagnostics Laboratories

• Research Institutes

List of the key players in the U.S. Infectious Respiratory Disease Diagnostics market

• Abbott

• Bio-Rad Laboratories, Inc

• Siemens Healthineers AG

• BIOMÉRIEUX

• BD

• QIAGEN

• QuidelOrtho Corporation

• F. Hoffmann-La Roche

• Koninklijke Philips N.V.

• Cepheid (Danaher Corporation)