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Influenza Diagnostic Tests Market Size By Test Type (Traditional Diagnostic Test {Rapid Influenza Diagnostic Test (RIDT), Direct Fluorescent Antibody Test (DFAT), Viral Culture, Serological Assay}, Molecular Diagnostic Assay {RT-PCR, Loop-mediated Isothermal Amplification-based Assay (LAMP), Nucleic Acid Sequence-based Amplification Test (NASBAT), Simple Amplification-based Assay (SAMBA)}), By End-use, Application Potential, Price Trends, Covid-19 Impact Analysis, Competitive Market Share & Forecast, 2022 – 2028

  • Report ID: GMI4242
  • Published Date: May 2022
  • Report Format: PDF

Industry Overview

Influenza Diagnostic Tests Market size surpassed USD 2 billion in 2021 and is estimated to witness a CAGR of 8% through 2028 due to several variables comprising the rising prevalence of influenza, rise in the demand for rapid diagnostic tests, and advancements in genomic & proteomic technologies among others.

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In developing nations, the prevalence of influenza is the highest due to socioeconomic status and levels of hygiene. Influenza is one of the major causes of contagious respiratory infection that in turn leads to the increasing demand for the product in hospitals and diagnostic laboratories. Additionally, the severe health concerns associated with flu strains A and B are anticipated to stimulate the demand for testing.

A significant increase in the preference for influenza diagnostic testing kits is to detect the antibody to the virus and surging adoption in hospitals & diagnostic centers for qualitative & quantitative detection of influenza. Thus, the increasing prevalence of influenza, further driving the co-morbidities and mortality rates globally along with expanding the availability of disease diagnosis products will propel the global influenza diagnostic tests market growth.

An influenza diagnostic test is an immunoassay that can detect the presence of influenza A and B viral nucleoprotein antigens in respiratory specimens and show the result in a qualitative form. Influenza commonly called the flu is a viral infection that harms patient’s respiratory systems comprising the nose, throat, and lungs. These are widely performed to diagnose the infection with influenza that causes fever, aching muscles, headache, etc.

However, variations in influenza diagnostic tests sensitivity and specificity may impede industry growth in the foreseeable future. The inaccurate sample volume represents a potential source of inaccuracy and error in a patient’s disease diagnosis. Sensitivity & specificity are critical parameters of influenza diagnostic tests precision and enable healthcare facilities to identify the accurateness of these tests.

Influenza diagnostic tests kits include all the items required for the execution of the test. However, a lack of proficiency to perform the test resulting in misdiagnosis may lead to serious damage. In a few cases, restriction on total volume in a test provides a limit of sensitivity that may generate false-negative results.

Accurate diagnosis is an important factor as is considered crucial for treatment selection, thus, insufficiency or inaccuracy in influenza diagnostic testing may lead to inappropriate treatment resulting in certain other complications. However, several industry players are emphasizing incorporating the innovative approaches to attain highly accurate point-of-care testing to minimize the above-mentioned disadvantages associated with influenza diagnostic tests.

The recent outbreak of COVID-19 has negatively impacted the influenza diagnostic tests industry revenue. The augmented demand for COVID-19 testing has significantly impacted other disease testing services comprising influenza diagnostic tests. In 2020, the incidence, as well as the mortality rate due to coronavirus was highest and people preferred to avoid any other treatment or diagnosis procedures at healthcare facilities.

The production facilities and supply chain were highly impacted owing to the high volume of COVID-19 patients & worldwide lockdown scenario. Most of the leading nations worldwide imposed a total lockdown and the total emphasis was shifted to the rise in demand for essential products & services, that hindered the manufacturing and adoption of influenza diagnostic testing market. 

However, in 2021, the technological advancements and incorporation of telemedicine in influenza infection diagnosis have augmented target disease diagnosis compliance and promoted the acceptance of influenza diagnostic testing products. Also, among COVID-19 infected patients, influenza was related to an increased risk of infection and hospitalization, with a heightened risk of respiratory failure.

Hence, the COVID-19 has impacted the influenza diagnostic tests market in the shorter run; however, the decreasing COVID-19 infection rates & patients and growing product demand is expected to drive the influenza diagnostic tests market share in the forthcoming period.

Growing prevalence of influenza is set to propel the market statistics

The growing prevalence of influenza will positively impact the market growth due to the preference and higher demand for early diagnosis & control of influenza. People with influenza infection have a greater risk of serious complications as this virus affects the respiratory tract by damage from the immune system response or by direct viral infection.

The testing enables the diagnosis of influenza in the respiratory tract and detects the infection that aids in assessing suitable treatment. Thus, the growing prevalence of influenza is expected to boost the demand for influenza diagnostic tests during the forecast period.

As per the World Health Organization report 2018, influenza is estimated to result in around 3 - 5 million cases of severe illness, and around 290,000 - 650,000 respiratory deaths worldwide.  Further, in the 2018-2019 flu season, the Centers for Disease Control and Prevention tested around 1,145,555 specimens for influenza in the U.S. Hence, owing to the above statistics rising prevalence of influenza is set to increase the demand for influenza diagnostic tests that will prove beneficial for the market growth.

Several benefits offered by traditional diagnostic test is expected to drive the preference for the tests

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Based on test type, the market is segmented into traditional diagnostic tests and molecular diagnostic assays. The traditional diagnostic test segment held USD 1,359 million in 2021, owing to the growing prevalence of influenza, increase in R&D activities, and the rising demand for point-of-care testing devices among others. Traditional influenza diagnostic test comprising rapid influenza diagnostic test (RIDT) is widely used at hospitals, diagnostic centers, etc.

The advancements in genomic and proteomic technologies have generated an enormous amount of data, that has resulted in the advent of novel rapid influenza diagnostic tests, serological assay, and direct fluorescent antibody tests useful for the diagnosis and management of influenza infections. Additionally, the efficacy and affordability of traditional influenza diagnostic tests upsurge their adoption.

The high sensitivity and specificity of these tests continue to increase their preference for the target disease diagnosis. Furthermore, under certain conditions, the sensitivity and specificity could be further improved to deliver more precise outcomes. Thus, affordability and clinical efficacy are projected to facilitate the influenza diagnostic tests market value during the analysis period.

Surging advantages delivered by diagnostic centers in influenza diagnostic testing is expected to spur the market forecasts

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Based on end-use, the market is segmented as hospitals, diagnostics centers, research laboratories, and others. The diagnostics centers segment is expected to grow at a significant pace to reach over USD 1,512 million by 2028 owing to the accessibility to specialized & effective diagnoses along with increasing awareness associated with flu virus infection.

The growth of diagnostic centers chains with evolving infrastructure offering a broad variety of influenza diagnostic testing products is set to spur the industry revenue. These centers are focusing on the expansion of their reach across the nations to provide improved diagnostic services including influenza testing. Moreover, the employment of advanced screening mechanisms at diagnostic centers drives patient preference. Thus, considering the above-mentioned factors, the increasing testing at diagnostic centers will drive the influenza diagnostic tests market growth during the estimation timeframe.

Rising prevalence of influenza and growing awareness regarding early-stage disease diagnosis in the North America region is set to stimulate the market trends

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North America influenza diagnostic tests market is anticipated to reach over USD 1,131 million by 2028 owing to the increasing prevalence of influenza, growing awareness regarding disease diagnosis & treatment, and the presence of major market players among others. As per the Centers for Disease Control and Prevention (CDC), between 2010 and 2020, the flu has resulted in 9 million – 41 million illnesses annually in the U.S. Thus, influenza testing has been significantly rising in the U.S. over the past few years.

The presence of prominent players such as Abbott, F. Hoffmann-La Roche Ltd, and Quidel Corporation among others in the region are engaged in new product development & commercialization that facilitates industrial expansion in North America. Furthermore, technological advancements in diagnostics and the presence of advanced healthcare infrastructure will propel market growth in the country.

Strategies implemented by major industry players are expected to generate business opportunities in the market

Some of the major market players operating in the influenza diagnostic tests industry are Quidel Corporation, Abbott, DiaSorin SpA, Thermo Fischer Scientific Inc., Becton, Dickinson and Company, Meridian Bioscience Inc., and F. Hoffmann-La Roche Ltd among others. Major market players are adopting strategic formulations such as forward integration, new product development, geographical expansion, and research collaborations to garner maximum industry share and promote company growth.

Recent industry developments:

  • In October 2020, Quidel Corporation announced the U.S. FDA Emergency Use Authorization (EUA) to market its Sofia 2 Flu + SARS Antigen FIA. This influenza diagnostic test uses latest immunofluorescence-based lateral flow technology for qualitative diagnosis of nucleocapsid protein from influenza A and influenza B. This approval helped the Quidel Corporation to bolster its influenza diagnostics product portfolio.
  • In September 2020, F. Hoffmann-La Roche Ltd received the U.S. FDA Emergency Use Authorization (EUA) for the use of cobas SARS-CoV-2 & Influenza A/B Test on the cobas 6800/8800 Systems. This diagnostic test is intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B in patients. This approval aided the company in propelling its influenza diagnostics product portfolio and strengthen its market presence.

Influenza diagnostic tests market report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2022 to 2028, for the following segments:

By Test Type

  • Traditional Diagnostic Test
    • Rapid Influenza Diagnostic Test (RIDT)
    • Direct Fluorescent Antibody Test (DFAT)
    • Viral Culture
    • Serological Assay
  • Molecular Diagnostic Assay
    • RT-PCR
    • Loop-mediated Isothermal Amplification-based Assay (LAMP)
    • Nucleic Acid Sequence-based Amplification Test (NASBAT)
    • Simple Amplification-based Assay (SAMBA)
    • Others

By End-use

  • Hospitals
  • Diagnostics Centers
  • Research Laboratories
  • Others

The above information is provided for the following regions and countries:

By Region

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Spain
    • Italy
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East & Africa
    • Saudi Arabia
    • South Africa
    • UAE
Authors: Sumant Ugalmugle, Rupali Swain

Frequently Asked Questions (FAQ) :

Global market for influenza diagnostic tests exceeded USD 2 billion in 2021 and is anticipated to grow at a CAGR of 8% between 2022 and 2028 owing to the growing demand for rapid diagnostic tests and the escalating prevalence of influenza.
The market revenue from traditional diagnostic tests hit USD 1,359 million in 2021 and will depict substantial growth through 2028 driven by an increase in R&D activities.
U.S. influenza diagnostic tests industry value is expected to cross USD 1,131 million until 2028 considering the rising awareness regarding disease diagnosis & treatment and the growing incidences of influenza.
Prominent players in the influenza diagnostic tests industry comprise Thermo Fischer Scientific Inc., Abbott, F. Hoffmann-La Roche Ltd., Quidel Corporation, DiaSorin SpA, Meridian Bioscience Inc., and others.

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  • Base Year: 2021
  • Companies covered: 10
  • Tables & Figures: 247
  • Countries covered: 18
  • Pages: 120
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