U.S. Influenza Diagnostics Market Size, Share & Trends Analysis Report By Test Type (RIDT, RT-PCR, Cell Culture, Others), By End Use (Hospital, Laboratories, POCT) And Segment Forecasts, 2019 - 2026

Industry Insights

The U.S. influenza diagnostics market size was valued at USD 109.2 million in 2018 and is anticipated to grow at a CAGR of 5.4% during the forecast period. Influenza which is caused by the influenza virus is commonly known as flu. Influenza virus consists of three types, namely Type A, Type C and Type B which can be differentiated by their surface proteins, neuraminidase (NA), and hemagglutinin (HA).

Influenza is a contagious disease therefore, there is an easy transmission of the disease at public places by infected patients who often serve as carriers of the disease. Rise in prevalence of the disease in the U.S. is anticipated to propel the market. For instance, according to CDC, during the 2017-2018 flu season, the incidence of influenza began to rise in November which reached an extended period of high activity during January and February and remained high till March-end. Influenza activity was estimated at 7.7% which is the highest percentage of flu pandemic since 2009.

Rise in government initiatives towards enabling diagnosis has facilitated easy access to OTC tests that are user-friendly and aid in timely diagnosis. For instance, in 2018, the Biomedical Advanced Research and Development Authority (BARDA), a part of the U.S. Department of Health & Human Services announced its partnership with Diassess Inc. and Cue Health, Inc. to develop testing kits for influenza diagnosis. These OTC products are intended solely for home care settings facilitating concerned patients to test for the infection. BARDA plans on providing USD 14 million to Cue Health, Inc. and USD 10 million to Diassess Inc. for advanced development of diagnostic tests for influenza B and A virus OTC devices. Both companies are expected to design these devices to be cost-effective, user friendly, and provide results within 25 minutes.

Rising geriatric population is also anticipated to fuel market growth. Aging population are highly susceptible to various diseases as they are weak immunologically therefore are at a higher risk of contracting influenza. According to CDC, individuals aged 65 and above in the U.S. were accounted for 58% of influenza-related hospitalizations in 2018. These facts are indicative of the rising incidence in geriatric population necessitating an increasing demand for diagnostic products.

Additionally, individuals with high risk of contracting the flu virus consists of children, pregnant women, immunosuppressed patients suffering from various chronic diseases and healthcare workers. In April 2019, a total of 186 influenza related pediatric deaths in the U.S. had been reported to CDC. 49.1% pregnant women received the flu vaccination in 2018 and 38% of pregnant women received both flu and Tdap (Tetanus, diphtheria, and pertussis) vaccines.

However, standardization of results and expensive diagnostic devices are anticipated to hamper the growth of the market.

Test Type Insights

Based on test type, the U.S. influenza diagnostics market is segmented into RDIT, RT-PCR, cell culture, and others. RDIT held the largest market share in 2018 as they are easily available and are user-friendly facilitating effective diagnosis. Additionally, the WHO also recommends the use of RDIT for influenza diagnosis as they are moderately complex, sensitive, specific, and accurate. 

The RT-PCR method delivers results faster in comparison to cell culture ranging from 2 minutes to less than 2 hours. This technique also aids in the identification of antiviral resistance. Advancement in these technologies is further expected to boost market growth during the forecast period. For instance, Thermo Fisher Scientific Inc. offers QuantStudio 3 and 5 RT-PCR, which is simple and easy to use and is designed for both new and experienced users.  QuantStudio 3 and 5 RT-PCR is combined with Thermo Fisher Cloud platform that helps individuals to remotely monitor and access results and also enables collaboration with colleagues anytime and anywhere. Therefore, such technological advancements are anticipated to further fuel market growth during the forecast period.

Cell culture is one of the oldest and reliable methods of diagnosing the flu and takes 3 to 10 days post sampling to provide accurate results. This method provides accurate statistics and also enables healthcare professionals to distinguish between various types of influenza viruses.

Other tests for diagnosis of the disease include immunoassay kits. Rise in immunoassays offered by market players is expected to fuel market growth. For instance, Becton, Dickinson and Company offers BD Veritor Plus system, a digital immunoassay which is used for the detection of influenza A and B. This product is more efficient than RDITs in terms of sensitivity and specificity owing to its integrated software and efficient interpretation of various infectious diseases.

End-Use Insights

Based on end-use, the market is segmented into hospitals, laboratories, and POCT. Hospitals held the largest market in 2018 owing to rise in the prevalence of the flu in the U.S. According to CDC in 2018, there were approximately 30,453 laboratory-confirmed influenza-related hospitalizations which accounts for 9% of the U.S. population. Thus, increasing prevalence in the U.S. leading to rise in hospitalization is expected to propel the market.

POCT is also expected to boost market growth with its advanced technologies developed by market players. For instance, bioMerieux SA offers an easy-to-use, cost-effective, and reliable POCT product, BIONEXIA Influenza A+B, a rapid test for the detection of influenza A & B viruses in humans using the nasopharyngeal sample. New technological advancements in POCT kits facilitating error-free results are expected to boost the market in the forecast period.

Laboratory testing most often involve the usage of real time PCR technique. Some advantages of this testing include accurate results, sensitivity, cost-effectiveness and the ability to test multiple samples at once.

U.S. Influenza Diagnostics Market Share Insights

Some of the major players catering to the market are Alere, 3M Health Care, Meridian Bioscience, Inc., Becton, Dickinson and Company, Quidel Corporation, Meridian Bioscience, Inc., SA Scientific, Roche Diagnostics Corporation, Thermo Fisher Scientific Inc. and Sekisui Diagnostics. Major market players are focused on the development of technologically advanced products which is anticipated to positively impact market growth. For instance, in 2017, Alere Inc., received 510 (k) marketing clearance from the U.S. FDA for Alere i Influenza A & B 2 test which is used for the detection of influenza B & A infection in adults and children. This product is a rapid molecular assay that delivers accurate results in less amount of time with high specificity.

Additionally, Meridain Bioscience, Inc. also expanded its immunoCard STAT product line with the addition of immunoCard STAT Flu A & B. This product is used to detect the presence of influenza A & B in nasopharyngeal and nasal swabs within 10-15 minutes. Therefore, rising number of products launches by leading market players is further expected to fuel market growth during the forecast period.

Report Scope

Segments covered in the report

This report provides an analysis on the latest trends and opportunities in each of the sub-segments from 2015 to 2026. For the purpose of this study, Grand View Research has segmented the U.S. influenza diagnostics market report on the basis of test type and end use:

• Test Type (Revenue, USD Million, 2015 - 2026)

  • RIDT

  • RT-PCR

  • Cell Culture

  • Others

• End Use Outlook (Revenue, USD Million, 2015 - 2026)

  • Hospitals

  • POCT

  • Laboratories