The Global Influenza Diagnostics Market size is estimated at USD 1.09 billion in 2024, and is expected to reach USD 1.43 billion by 2029, growing at a CAGR of 5.60% during the forecast period (2024-2029).
COVID- 19 has significantly impacted the influenza diagnostics market due to the closing of manufacturing facilities due to lockdowns, unfavorable regulations and guidelines changes, and supply chain disruptions globally. Additionally, there are several similarities between COVID-19 and influenza, such as both are contagious viruses and show similar symptoms of respiratory illness. As COVID-19 affects a patient's respiratory system, it is necessary to diagnose influenza too for safety purposes. This has increased the testing for influenza during the pandemic.
The rising prevalence of influenza and related chronic diseases increased research funding for influenza diagnostics, and rising demand for early diagnosis and control of influenza are all factors driving the market growth. Influenza is recognized as a significant cause of morbidity and mortality in humans, prompting the development and implementation of diagnostics to reduce health and economic consequences. According to the updates from January 2022 by the Centers for Disease Control and Prevention, flu caused 9 million 41 million illnesses, 140,000-710,000 hospitalizations, and 12,000-52,000 deaths annually in the United States between 2010 and 2020.
Furthermore, according to the World Health Organization (WHO) updates from February 2021, during the years 2021-2022, WHO GISRS laboratories tested over 490 516 specimens. A total of 12 368 people tested positive for influenza viruses, with 8 423 (68.1%) being influenza A and 3 945 (31.9%) being influenza B. Various initiatives and research funding are assisting in the market's expansion. For example, the National Institute of Allergy and Infectious Diseases (NIAID) has funded a diverse range of influenza research, including studies that are helping to develop vaccines, diagnostics, and therapeutics for seasonal and pandemic influenza.
Moreover, in September 2021, DiaSorin Molecular LLC received a CE mark for its Simplexa COVID-19 & Flu A/B Direct kit. The multiplex test allows for the in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus, and influenza B virus from the same patient sample in one reaction well. Also, in December 2021, Roche planned to launch the SARS-CoV-2 & Flu A/B Rapid Antigen Test for professional use in markets that accept CE Mark.
However, ensuring that all the rapid antigen flu tests meet new Food and Drug Administration (FDA) requirements for approval is critical. Hence, the stringent FDA regulations act as significant restraints for the market.
Rapid influenza diagnostic tests (RIDTs) are immunoassays that can detect influenza A and B viral nucleoprotein antigens in respiratory specimens and provide qualitative results. It can diagnose patients with influenza-like illness, especially if it is done within the first four days of symptoms appearing. The benefits of faster results and ease of use drive RIDT's popularity. Some RIDTs are also approved for use in the office or at the bedside. Because of their widespread use in point-of-care settings, the RIDT segment is also expected to increase.
However, because of its low to moderate sensitivities, one of the significant disadvantages of RIDT is that it produces false-negative results (50-70 percent ). When the novel H1N1 influenza epidemic struck in 2009, healthcare policymakers began to recognize the impact of its low sensitivity.
The high prevalence of influenza is expected to drive the regional market over the forecast period. For instance, according to statistics published by MedAlertHelp, in 2022, about 5% to 20% of Americans will be diagnosed with influenza yearly. Further, according to the data published by the Centers for Disease Control and Prevention, in October 2021, 35 million flu-related illnesses, 380,000 flu-related hospitalizations, 20,000 flu-related deaths, and 16 million flu-related medical visits were reported in the 2019-2020 season. This growing disease burden is anticipated to impact market growth over the coming years positively.
As per data published by the Centers for Disease Control and Prevention (CDC) 2021, RIDTs are commonly available across the region. The reason behind the wide availability of the test is the reduced period needed to generate results. RIDT can yield results in 15 minutes. With increasing influenza-associated hospitalization and pediatric deaths and the interest of government organizations to better manage the disease, the North American influenza diagnostics market is expected to grow in the future.
Additionally, product launches by market players in the region are also driving the Influenza diagnostics market growth in the North American region. For instance, in September 2021, the American College of Obstetrics and Gynecology (ACOG) launched a new seasonal flu campaign: ACOG Fights Flu, to raise awareness about the diagnosis and the treatment of influenza, thereby boosting the market in the region.
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COVID- 19 has significantly impacted the influenza diagnostics market due to the closing of manufacturing facilities due to lockdowns, unfavorable regulations and guidelines changes, and supply chain disruptions globally. Additionally, there are several similarities between COVID-19 and influenza, such as both are contagious viruses and show similar symptoms of respiratory illness. As COVID-19 affects a patient's respiratory system, it is necessary to diagnose influenza too for safety purposes. This has increased the testing for influenza during the pandemic.
The rising prevalence of influenza and related chronic diseases increased research funding for influenza diagnostics, and rising demand for early diagnosis and control of influenza are all factors driving the market growth. Influenza is recognized as a significant cause of morbidity and mortality in humans, prompting the development and implementation of diagnostics to reduce health and economic consequences. According to the updates from January 2022 by the Centers for Disease Control and Prevention, flu caused 9 million 41 million illnesses, 140,000-710,000 hospitalizations, and 12,000-52,000 deaths annually in the United States between 2010 and 2020.
Furthermore, according to the World Health Organization (WHO) updates from February 2021, during the years 2021-2022, WHO GISRS laboratories tested over 490 516 specimens. A total of 12 368 people tested positive for influenza viruses, with 8 423 (68.1%) being influenza A and 3 945 (31.9%) being influenza B. Various initiatives and research funding are assisting in the market's expansion. For example, the National Institute of Allergy and Infectious Diseases (NIAID) has funded a diverse range of influenza research, including studies that are helping to develop vaccines, diagnostics, and therapeutics for seasonal and pandemic influenza.
Moreover, in September 2021, DiaSorin Molecular LLC received a CE mark for its Simplexa COVID-19 & Flu A/B Direct kit. The multiplex test allows for the in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus, and influenza B virus from the same patient sample in one reaction well. Also, in December 2021, Roche planned to launch the SARS-CoV-2 & Flu A/B Rapid Antigen Test for professional use in markets that accept CE Mark.
However, ensuring that all the rapid antigen flu tests meet new Food and Drug Administration (FDA) requirements for approval is critical. Hence, the stringent FDA regulations act as significant restraints for the market.
Influenza Diagnostics Market Trends
Rapid Influenza Diagnostic Test (RIDT) is Expected to hold its Highest Market Share in the Test Type Segment
In the test type segment of the influenza diagnostics market, among all traditional diagnostic tests, the rapid influenza diagnostic test (RIDT) is believed to have the largest market share in the studied market.Rapid influenza diagnostic tests (RIDTs) are immunoassays that can detect influenza A and B viral nucleoprotein antigens in respiratory specimens and provide qualitative results. It can diagnose patients with influenza-like illness, especially if it is done within the first four days of symptoms appearing. The benefits of faster results and ease of use drive RIDT's popularity. Some RIDTs are also approved for use in the office or at the bedside. Because of their widespread use in point-of-care settings, the RIDT segment is also expected to increase.
However, because of its low to moderate sensitivities, one of the significant disadvantages of RIDT is that it produces false-negative results (50-70 percent ). When the novel H1N1 influenza epidemic struck in 2009, healthcare policymakers began to recognize the impact of its low sensitivity.
North America Dominates the Market and is Expected to do the Same in the Forecast Period
North America currently dominates the market for influenza diagnostics and is expected to continue its stronghold for a few more years.The high prevalence of influenza is expected to drive the regional market over the forecast period. For instance, according to statistics published by MedAlertHelp, in 2022, about 5% to 20% of Americans will be diagnosed with influenza yearly. Further, according to the data published by the Centers for Disease Control and Prevention, in October 2021, 35 million flu-related illnesses, 380,000 flu-related hospitalizations, 20,000 flu-related deaths, and 16 million flu-related medical visits were reported in the 2019-2020 season. This growing disease burden is anticipated to impact market growth over the coming years positively.
As per data published by the Centers for Disease Control and Prevention (CDC) 2021, RIDTs are commonly available across the region. The reason behind the wide availability of the test is the reduced period needed to generate results. RIDT can yield results in 15 minutes. With increasing influenza-associated hospitalization and pediatric deaths and the interest of government organizations to better manage the disease, the North American influenza diagnostics market is expected to grow in the future.
Additionally, product launches by market players in the region are also driving the Influenza diagnostics market growth in the North American region. For instance, in September 2021, the American College of Obstetrics and Gynecology (ACOG) launched a new seasonal flu campaign: ACOG Fights Flu, to raise awareness about the diagnosis and the treatment of influenza, thereby boosting the market in the region.
Influenza Diagnostics Industry Overview
The influenza diagnostics market is highly competitive and consists of several significant players. In terms of market share, few major players currently dominate the market. Companies like Coris BioConcept, DiaSorin SpA, F. Hoffmann-La Roche AG, Meridian Bioscience Inc., Quidel Corporation, and Sekisui Diagnostics others, hold a substantial share in the market.Additional Benefits:
- The market estimate (ME) sheet in Excel format
- 3 months of analyst support
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Table of Contents
1 INTRODUCTION
4 MARKET DYNAMICS
5 MARKET SEGMENTATION (Market Size by Value - USD million)
6 COMPETITIVE LANDSCAPE
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Abbott Laboratories
- Becton, Dickinson and Company
- Coris BioConcept
- DiaSorin SpA
- F. Hoffmann-La Roche Ltd
- Meridian Bioscience Inc.
- Quidel Corporation
- Sekisui Diagnostics
- Thermo Fisher Scientific Inc.
Methodology
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