U.S. Infectious Respiratory Disease Diagnostics Market Size, Share & Trends Analysis Report By Product Type (Instruments, Consumables, Services), By Sample Type, By Technology, By Application By End-use, And Segment - Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2023-2032

The U.S. infectious respiratory disease diagnostics market size was exhibited at USD 22.90 billion in 2022 and is projected to hit around USD 34.56 billion by 2032, growing at a CAGR of 4.2% during the forecast period 2023 to 2032.

Key Takeaways:

• The consumables segment dominated the U.S. industry in 2022 and accounted for the maximum share of more than 65.89%, 
• The nasopharyngeal swabs sample type segment dominated the U.S. industry in 2022 with a revenue share of more than 60.698%. 
• The molecular diagnostics segment dominated the U.S. industry in 2022 and accounted for the maximum share of more than 63.84% of the overall revenue. 
• The COVID-19 segment accounted for the largest share of the U.S. infectious respiratory disease diagnostics market in 2022, with 91.85%.

U.S. Infectious Respiratory Disease Diagnostics Market Report Scope

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.

Product Type Insights

The consumables segment dominated the U.S. industry in 2022 and accounted for the maximum share of more than 65.89%, which can be attributed to high usage rates. Rising research and development activities for the development of novel testing kits and assays, coupled with the increase in demand for the point-of-care are driving the segment. Moreover, the introduction of innovative solutions for validating and monitoring molecular diagnostic tests used for the detection of COVID-19 further contributed to the infectious respiratory disease diagnostics market growth.

For instance, in March 2020, AcroMetrix Coronavirus 2019 (COVID-19) RNA Control was made available by Thermo Fisher Scientific, Inc., to validate and monitor molecular diagnostic tests used for COVID-19. This RNA control is available for research use only by healthcare workers, laboratories, and researchers. However, the consumables segment is anticipated to witness a decline due to the decreased COVID-19 testing rates owing to increased vaccination programs in the U.S.

The instrument segment is expected to decline at a CAGR of 9.2% in the study period. There was an upsurge in the installations and sales of instruments such as CT scanners, X-ray machines, immunoassay analyzers, and PCR equipment during the COVID-19 outbreak. Several manufacturers increased the production capacity of CT systems due to the growing demand for chest CT examinations in COVID-19 patients.

For instance, in March 2020, GE Healthcare increased the manufacturing capacity of its medical equipment, such as CT, ultrasound, mobile X-ray, and ventilators, to meet the unprecedented demand during the pandemic. However, with the declining COVID-19 infection, the need for these instruments will reduce and might hamper the segment’s growth.

Sample Type Insights

The nasopharyngeal swabs sample type segment dominated the U.S. industry in 2022 with a revenue share of more than 60.698%. Nasopharyngeal swabs are used for the sample collection in various tests, such as rapid antigen detection tests, direct fluorescent antibody, and PCR. These tests are performed for the detection of diseases including COVID-19, RSV, and tuberculosis. Several swab manufacturers export their infectious respiratory disease diagnostic products in the U.S., such as COPAN ITALIA spa, Noble Bio, and others.

In the U.S., the import of nasopharyngeal swabs increased considerably during the pandemic by up to USD 5.0 million per month, which was USD 840,000 till 2019. Hence, the substantial rise in testing demand from November 2020 to January 2021 led to a shortage of swab supplies. However ongoing investments in additional capacity were able to handle the situation better than previous spikes in testing demand. This demand has further accelerated the launch of newer diagnostics tests in U. S. and is expected to assist the segment in maintaining its dominance in the infectious respiratory disease diagnostics market.

The saliva swabs segment is anticipated to witness market growth owing to the rising use of samples in infectious respiratory disease diagnosis coupled with the urgent need for noninvasive tests. Researchers were engaged in improving infectious respiratory disease diagnostic performance due to the heavy loads of samples during the pandemic. In a study published in May 2020, researchers established the sensitivity and specificity of saliva sample test, which was found to be around 84.2% and 98.9%, respectively.

As a result, market players started commercializing no-swabs saliva-based tests to meet the untapped opportunities in the infectious respiratory disease diagnostics market. For instance, in October 2022, Shield T3 launched a saliva-based PCR test for flu, COVID-19, and RSV. These kits enable the identification of viruses within 24 hours of sending samples.

Technology Insights

The molecular diagnostics segment dominated the U.S. industry in 2022 and accounted for the maximum share of more than 63.84% of the overall revenue. The rising use of high-throughput PCR technology, used for detecting respiratory viruses, is expected to drive the infectious respiratory disease diagnostics market. Influenza, RSV, and COVID-19 diseases have similar symptoms; hence, companies are trying to incorporate multiplex tests that can be used in diagnosing these diseases with a single swab.

For instance, in December 2020, GENETWORx, LLC launched a test that can detect three respiratory viruses (RSV, influenza A & B, and SARS-COV-2) from a single sample. Such capabilities of molecular diagnostics contributed to segment dominance in the infectious respiratory disease diagnostics market.

The immunoassay segment includes tests performed using techniques such as radioimmunoassay, enzyme immunoassays, and rapid tests. This segment is anticipated to witness significant growth during the forecast period due to technological advancements, increased demand for immunoassays, commercialization of innovative products, and a rise in patient awareness. In March 2021, BIOMÉRIEUX received a CE marking for VIDAS TB IGRA intended for diagnosing latent TB infection.

This fully automated assay eliminates manual sample preparation and delivers results faster without additional cost. Furthermore, as the incidence rate of COVID-19 is declining, demand for immunoassays for screening of the population at educational institutes and other offices may increase during the forecast period.

Application Insights

The COVID-19 segment accounted for the largest share of the U.S. infectious respiratory disease diagnostics market in 2022, with 91.85%. The large share is attributed to the increasing number of strategic initiatives by the operating players, such as collaborations, contracts, partnerships, and others, to develop and raise awareness about coronavirus test kits to meet the demand for diagnostic kits and combat COVID-19.

For instance, in December 2022, F. Hoffmann-La Roche Ltd entered into an agreement with Pfizer, Inc. to raise awareness and educate patients regarding the importance of early testing, thus helping in determining the proper course of treatment. However, demand for COVID-19 diagnostics testing is likely to decline with the rising number of vaccinations during the forecast period.

Moreover, the increasing prevalence of TB is anticipated to boost the infectious respiratory disease diagnostics market growth. For instance, according to CDC, it is estimated that 7,882 cases of tuberculosis were reported in 2021 in the U.S., which accounts for 2.4 cases per 100,000 persons. Hence, early diagnosis with adequate therapy and prevention measures against further transmission is essential for TB control in the country during the review period.

Moreover, the increasing launch of new highly sensitive and flexible molecular tests for the diagnosis of TB is expected to fuel infectious respiratory disease diagnostics market growth. For instance, in December 2022, Mylab launched PathoDetect MTB RIF and INH kit for the diagnosis of multidrug-resistant and TB variants in a single test.

End-Use Insights

Diagnostic laboratories accounted for the largest share of the U.S. infectious respiratory disease diagnostics market in 2022, with 41.90%. The large share is primarily due to the high market procedure and penetration volumes, as well as the presence of a large number of laboratories in U.S. markets. According to CDC around 70% of medical decisions are influenced by laboratory test results and around 14.0 billion laboratory tests are ordered annually for laboratory testing.

It is estimated that 40,000-80,000 deaths are preventable if diagnosis errors are minimized. In addition, an increase in the number of initiatives undertaken by the government to provide reimbursement for diagnostic tests is another major factor anticipated to drive the infectious respiratory disease diagnostics market.

Physician offices segment is expected to witness significant growth owing to the availability of Point-of-Care (PoC) devices used for rapid diagnosis of COVID-19, influenza, and RSV. Patients can avail a PoC test immediately and at their convenience. Moreover, the output time is short, enabling spontaneous clinical management decisions.

The segment growth is also due to the increasing need to develop new assays that offer quick PoC results. For instance, in April 2021, Chembio Diagnostics, Inc. launched a COVID-19/Flu A&B test, a rapid PoC test, which is suitable for distinguishing patients with influenza or COVID-19 in a shorter turnaround time in decentralized settings.

Key Companies & Market Share Insights

The unceasing demand for infectious respiratory disease diagnostics solutions by numerous end-users has created several market opportunities for the major players to capitalize in the country. For instance, in October 2022, Siemens Healthcare GmbH announced the launch of two combination tests for the detection of seasonal respiratory pathogens & SARS-CoV-2. Some of the key players in the U.S. infectious respiratory disease diagnostics market include:

• Abbott
• Koninklijke Philips N.V.
• Siemens Healthcare GmbH
• BIOMÉRIEUX
• Danaher
• QIAGEN
• BD
• F. Hoffmann-La Roche Ltd
• Quidel Corporation
• Thermo Fisher Scientific, Inc.

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the U.S. Infectious Respiratory Disease Diagnostics market.

By Product Type 

• Instruments
  • Respiratory Measurement Devices
  • Imaging Tests
  • Other Instruments
• Consumables
• Services

By Sample Type 

• Saliva
• Nasopharyngeal Swabs (NPS)
• Anterior Nasal Swabs
• Blood
• Others

By Technology 

• Immunoassay
• Molecular Diagnostics
• Microbiology
• Other Technologies

By Application 

• COVID-19
• Influenza
• Respiratory Syncytial Virus (RSV)
• Tuberculosis
• Streptococcus Testing
• Other Respiratory Disease Testing

By End-Use 

• Hospitals
• Diagnostic Laboratories
• Physician Offices
• Other End Users