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US Influenza Diagnostics Market Research Report By Type (PCR Tests, Antigen Tests, Serology Tests, Viral Culture, Rapid Diagnostic Tests), By Product (Reagents, Kits, Instruments, Consumables), By End-user (Hospitals, Clinics, Laboratories, Home Care), and By Technique (Molecular Diagnostics, Immunodiagnostics, Cell Culture)-Forecast to 2035


ID: MRFR/HC/55278-HCR | 200 Pages | Author: Rahul Gotadki| June 2025

US Influenza Diagnostics Market Overview


As per MRFR analysis, the US Influenza Diagnostics Market Size was estimated at 1.68 (USD Billion) in 2023. The US Influenza Diagnostics Market is expected to grow from 1.75 (USD Billion) in 2024 to 2.93 (USD Billion) by 2035. The US Influenza Diagnostics Market CAGR (growth rate) is expected to be around 4.791% during the forecast period (2025 - 2035).


Key US Influenza Diagnostics Market Trends Highlighted


Growing awareness of influenza's effects on public health is driving notable trends in the US influenza diagnostics market. The need for quicker and more precise diagnostic testing has increased as a result of an increase in seasonal flu outbreaks. Effective public health initiatives that highlight the significance of early influenza detection and treatment are also driving this need.


Technological developments, such as the creation of point-of-care and rapid diagnostic tests, are improving the capacity to identify influenza rapidly, which is crucial during peak seasons when prompt action can drastically slow the spread of the illness.


The use of machine learning and artificial intelligence in diagnostics is capturing market opportunities in the United States. In clinical contexts, these technologies can enhance test accuracy and streamline the decision-making process.


A wider population will have easier access to influenza diagnostics because to the possibility of remote testing choices brought about by the growth of telemedicine. Effective testing and treatment are also made possible by laws that enable greater access to healthcare services.


Influenza diagnostics are increasingly being customized to meet the needs of individual patients as part of a noticeable trend in personalized medicine in recent years. This change is a reflection of the US healthcare system's growing acceptance of precision health practices.


Furthermore, current studies on combination testing and quadrivalent vaccines highlight the value of diagnostics in influenza management, which is consistent with CDC guidelines for all-encompassing flu prevention measures.


All things considered, the US influenza diagnostics market is adjusting to the difficulties presented by influenza epidemics while also utilizing technological breakthroughs and legislative modifications to improve diagnostic capabilities.


US Influenza Diagnostics Market Overview


Source: Primary Research, Secondary Research, MRFR Database and Analyst Review


US Influenza Diagnostics Market Drivers


Increasing Incidence of Influenza in the US


The US Influenza Diagnostics Market is seeing growth due to the rising incidence of influenza cases. According to the Centers for Disease Control and Prevention (CDC), the United States experiences approximately 9 to 45 million cases of influenza annually, contributing to between 12,000 to 61,000 deaths each year.


This surge in infection rates necessitates improved diagnostic tools, leading to increased demand for rapid and accurate influenza testing. Organizations such as Abbott and Roche Diagnostics are intensifying their investments in Research and Development for novel diagnostic products aimed at addressing this significant public health concern.


Enhanced flu detection capabilities are essential for timely treatment and are expected to drive the growth of the US Influenza Diagnostics Market further, as healthcare providers strive to enhance patient outcomes and minimize complications associated with the disease.


Advancements in Diagnostic Technology


Technological advancements in diagnostic equipment are propelling growth in the US Influenza Diagnostics Market. The development of rapid molecular diagnostic tests has considerably improved the speed and accuracy of influenza detection. For instance, the FDA has approved newer tests that provide results in less than an hour.


The advancement in multiplex testing, which can detect multiple influenza strains simultaneously, is also gaining traction.


Companies like Cepheid and Quidel Corporation are at the forefront of these technological innovations. As a result, the availability of advanced diagnostic options is expected to enhance diagnostic capabilities across various healthcare settings in the US, ultimately expanding the market.


Government Initiatives and Funding


Government initiatives to combat influenza outbreaks are a critical driver for the US Influenza Diagnostics Market. The national strategy involves increased funding for influenza surveillance and prevention through initiatives led by the CDC and the Department of Health and Human Services (HHS).


In recent years, the US government has emphasized improving public health responses to viral infections, including providing financial support for Research and Development of better diagnostic tools.


For instance, in response to the COVID-19 pandemic, there was a marked increase in funding for respiratory disease diagnostics, which is likely to benefit the influenza diagnostics segment as well. Such governmental actions promote innovation and support for companies engaged in flu diagnostics, directly contributing to market growth.


US Influenza Diagnostics Market Segment Insights


Influenza Diagnostics Market Type Insights


The US Influenza Diagnostics Market is characterized by a diverse range of testing types that cater to various needs within the healthcare industry. Among these, Polymerase Chain Reaction (PCR) Tests are renowned for their accuracy and rapid turnaround time, making them a preferred choice in clinical settings.


These tests significantly enhance patient management and surveillance, as they can detect even minute amounts of viral RNA. Antigen Tests, on the other hand, are valued for their speed and simplicity, providing results in a matter of minutes; this makes them particularly effective in point-of-care settings and during outbreaks when quick decision-making is vital.


Furthermore, Serology Tests play a crucial role in understanding population immunity and prior exposure to influenza viruses, which is essential for public health strategies aimed at preventing future outbreaks.


Viral Culture remains an important method despite being less common due to its time-intensive process, as it allows for the isolation and identification of the influenza virus, contributing to effective vaccine development and surveillance.


Rapid Diagnostic Tests are also significant as they offer convenience and rapid results, facilitating timely treatment decisions, and are often utilized in emergency departments. The combination of these various types creates a comprehensive framework for influenza diagnostics, driving innovations in methodologies and technology, and supporting overall market growth.


Each of these testing types not only enhances the capabilities of healthcare providers but also addresses specific diagnostic needs, reflecting the trends towards precision medicine and personalized healthcare in the US.


Influenza Diagnostics Market Type Insights


Source: Primary Research, Secondary Research, MRFR Database and Analyst Review


Influenza Diagnostics Market Product Insights


The US Influenza Diagnostics Market is a rapidly evolving landscape with diverse product offerings that cater to the needs of healthcare professionals and patients. Within this segment, reagents play a critical role, as they are essential for various diagnostic tests, facilitating accurate and timely detection of influenza viruses.


Meanwhile, kits, which combine reagents and other necessary components, are highly sought after due to their convenience and efficiency, making them a preferred choice in both clinical and home testing settings.


Instruments designed for influenza diagnostics also contribute significantly to this market, providing advanced functionalities and improved testing accuracy, which are vital in laboratory environments. Furthermore, consumables, such as swabs and test tubes, offer the necessary accessories for sample collection and testing processes, ensuring that the workflow in diagnostic labs remains seamless.


As public health initiatives and increased awareness of influenza prevention continue to rise in the US, the demand for these products is expected to grow, supported by ongoing innovations and technology advancements in the healthcare sector. This will create abundant opportunities for manufacturers and stakeholders within the US Influenza Diagnostics Market.


Influenza Diagnostics Market End-user Insights


The US Influenza Diagnostics Market showcases significant growth potential within its End-user segment, which includes Hospitals, Clinics, Laboratories, and Home Care. Hospitals dominate this segment, providing comprehensive diagnostic tools and treatment options, ensuring prompt patient care during influenza outbreaks.


Clinics are also essential, often serving as the first point of contact for patients, driving demand for efficient testing methods to facilitate quicker diagnoses and mitigate the spread of the virus. Laboratories play a critical role in the accuracy and reliability of influenza testing, employing advanced technologies to conduct a range of tests, thus reinforcing their importance within the market.


Home Care has emerged as a growing segment, driven by the convenience and accessibility it offers patients, especially amidst rising healthcare costs and a shift towards more personalized care solutions. Overall, the US Influenza Diagnostics Market segmentation reflects a varied landscape, with each segment contributing uniquely to the goal of effective influenza management.


The increasing focus on early diagnosis and treatment is a key driver, as healthcare providers strive to enhance patient outcomes and reduce healthcare burdens associated with influenza outbreaks.


Influenza Diagnostics Market Technique Insights


The 'US Influenza Diagnostics Market' is a critical area of focus given the growing need for efficient and accurate influenza detection methods. The Technique segment plays a vital role within this market, encompassing various methodologies, including Molecular Diagnostics, Immunodiagnostics, and Cell Culture.


Molecular Diagnostics utilizes nucleic acid amplification techniques, which enhance the speed and sensitivity of influenza detection, thus making it a preferred option in clinical settings. Immunodiagnostics rely on antigen detection through antibody assays, offering rapid results that are fundamental during flu outbreaks, particularly in hospital emergency departments.


On the other hand, Cell Culture techniques, while more traditional, remain important for their ability to not only detect but also characterize the virus, contributing invaluable data for public health response strategies.


With the increasing incidence of influenza and the emphasis on effective disease management and control, the Technique segment is projected to be instrumental in enhancing influenza outbreak preparedness and response across the United States.


Continuous advancements and innovations in these diagnostic techniques are anticipated to drive market growth and improve patient outcomes by ensuring timely and accurate influenza diagnosis.


US Influenza Diagnostics Market Key Players and Competitive Insights


The US Influenza Diagnostics Market has evolved considerably, driven by an increasing demand for rapid and accurate influenza testing methods. This market is characterized by a mix of well-established firms and emerging players that are all vying for market share through innovation and improved product offerings.


With an uptick in influenza cases, especially during the flu season, the emphasis on timely diagnostics has heightened, prompting companies to enhance their technology and methodologies. The industry's competitive landscape is shaped by factors such as advancements in molecular diagnostics, point-of-care testing capabilities, and strategic partnerships focused on research and development.


Manufacturers are also facing pressure to comply with rigorous regulatory standards while striving to provide accurate and quicker diagnostic solutions to healthcare providers across the United States.


Quidel Corporation has established a significant footprint in the US Influenza Diagnostics Market, thanks to its innovative product line that includes rapid influenza tests capable of delivering results in a matter of minutes. The company's strength lies in its commitment to enhancing diagnostic capabilities, facilitating effective disease management in clinical settings.


Quidel Corporation has successfully positioned itself as a trusted provider by developing tests that not only meet the necessary regulatory requirements but also address the evolving needs of healthcare professionals.


This reputation for reliability is further supported by solid partnerships with healthcare facilities, which enhances their product accessibility and distribution. The company's focus on R&D ensures a continuous stream of improved diagnostics, allowing it to maintain its competitive edge in the market.


Siemens Healthineers holds a prominent position in the US Influenza Diagnostics Market, offering a range of products aimed at improving diagnostic acumen in clinical laboratories. Among its key offerings are advanced molecular diagnostic tests that help clinicians make informed decisions swiftly.


The company benefits from a robust market presence bolstered by a strong portfolio that includes integrated laboratory solutions that streamline the testing process. Siemens Healthineers has made strategic investments in technology, particularly in point-of-care testing, enhancing its ability to meet the growing demand for rapid testing solutions.


Mergers and acquisitions reinforce its growth strategy, as the company consistently seeks to expand its capabilities and market reach within the US. The synergy from these acquisitions allows Siemens Healthineers to innovate further, providing enhanced diagnostic tools that contribute positively to healthcare outcomes.


Key Companies in the US Influenza Diagnostics Market Include



  • Quidel Corporation

  • Siemens Healthineers

  • Roche Diagnostics

  • Hepatitis Diagnostics Lab

  • Diagnostics For All

  • GenMark Diagnostics

  • Thermo Fisher Scientific

  • HoffmannLa Roche Ltd

  • BD

  • bioMerieux

  • Hologic

  • Epivax

  • Abbott Laboratories

  • Cepheid


US Influenza Diagnostics Market Developments


Recent developments in the US Influenza Diagnostics Market show an increasing focus on rapid testing technologies amid rising concerns over respiratory illnesses. Companies like Quidel Corporation and Abbott Laboratories are launching innovative products aimed at enhancing diagnostic accuracy and speed.


In August 2023, Siemens Healthineers announced an expansion of its portfolio to include multiplex testing solutions that can detect various respiratory pathogens, including influenza. Furthermore, in September 2023, Roche Diagnostics introduced an upgraded version of its influenza test, which boasts improved sensitivity and specificity.


Currently, GenMark Diagnostics and Hologic are also making notable strides with their automated testing systems, which are streamlining workflows in healthcare settings across the country. In the realm of mergers and acquisitions, F. Hoffmann-La Roche Ltd announced plans to acquire a small innovative diagnostics firm in July 2023, indicating an ongoing trend of consolidation in the sector.


The overall growth in the market valuation of these companies is expected to enhance competition and drive advancements in diagnostic technologies, thereby significantly impacting patient care and public health responses in the US. The increased demand for influenza testing amidst broader public health efforts has positioned the sector for growth as it adapts to emerging healthcare challenges.


Influenza Diagnostics Market Segmentation Insights



  • Influenza Diagnostics Market Type Outlook

    • PCR Tests

    • Antigen Tests

    • Serology Tests

    • Viral Culture

    • Rapid Diagnostic Tests





  • Influenza Diagnostics Market Product Outlook

    • Reagents

    • Kits

    • Instruments

    • Consumables





  • Influenza Diagnostics Market End-user Outlook

    • Hospitals

    • Clinics

    • Laboratories

    • Home Care





  • Influenza Diagnostics Market Technique Outlook

    • Molecular Diagnostics

    • Immunodiagnostics

    • Cell Culture



Report Attribute/Metric Details
Market Size 2023 1.68(USD Billion)
Market Size 2024 1.75(USD Billion)
Market Size 2035 2.93(USD Billion)
Compound Annual Growth Rate (CAGR) 4.791% (2025 - 2035)
Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Base Year 2024
Market Forecast Period 2025 - 2035
Historical Data 2019 - 2024
Market Forecast Units USD Billion
Key Companies Profiled Quidel Corporation, Siemens Healthineers, Roche Diagnostics, Hepatitis Diagnostics Lab, Diagnostics For All, GenMark Diagnostics, Thermo Fisher Scientific, F. HoffmannLa Roche Ltd, BD, bioMerieux, Hologic, Epivax, Abbott Laboratories, Cepheid
Segments Covered Type, Product, End-user, Technique
Key Market Opportunities Rapid testing innovations, Point-of-care diagnostics, Increased vaccination monitoring, Digital health integration, AI-driven analytics tools
Key Market Dynamics rising influenza prevalence, technological advancements, regulatory approvals, growing patient awareness, increasing healthcare expenditure
Countries Covered US


Frequently Asked Questions (FAQ) :

The US Influenza Diagnostics Market was valued at 1.75 USD Billion in 2024.

By 2035, the US Influenza Diagnostics Market is projected to reach 2.93 USD Billion.

The market is expected to grow at a CAGR of 4.791% from 2025 to 2035.

PCR Tests held the largest market share, valued at 0.525 USD Billion in 2024.

PCR Tests are projected to reach a market value of 0.883 USD Billion by 2035.

Key players in the market include Quidel Corporation, Siemens Healthineers, Roche Diagnostics, and Thermo Fisher Scientific.

Antigen Tests were valued at 0.42 USD Billion in 2024 and are likely to reach 0.685 USD Billion by 2035.

The growth opportunities include advancements in diagnostic technology and increased awareness of influenza testing.

Rapid Diagnostic Tests are expected to reach a market value of 0.723 USD Billion by 2035.

The competitive landscape is shaped by leading companies such as Abbott Laboratories, BD, and bioMerieux, which contribute significantly to market shares.

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