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US Influenza Diagnostics Market

ID: MRFR/MED/55278-HCR
200 Pages
Rahul Gotadki
October 2025

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

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US Influenza Diagnostics Market Summary

As per MRFR analysis, the US influenza diagnostics market size was estimated at 2269.68 USD Million in 2024.. The US influenza diagnostics market is projected to grow from 2459.65 USD Million in 2025 to 5491.97 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 8.37% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The US influenza diagnostics market is experiencing robust growth driven by technological advancements and increasing healthcare expenditure.

  • Technological advancements in diagnostics are enhancing the accuracy and speed of influenza testing.
  • The market is witnessing a significant shift towards rapid testing solutions, catering to the demand for timely results.
  • Regulatory support and streamlined approvals are facilitating the introduction of innovative diagnostic tools.
  • Rising incidence of influenza cases and advancements in point-of-care testing are key drivers propelling market growth.

Market Size & Forecast

2024 Market Size 2269.68 (USD Million)
2035 Market Size 5491.97 (USD Million)

Major Players

Abbott (US), Roche (CH), Thermo Fisher Scientific (US), BD (US), Siemens Healthineers (DE), Cepheid (US), Hologic (US), BioMérieux (FR), QuidelOrtho (US)

US Influenza Diagnostics Market Trends

The influenza diagnostics market is currently experiencing notable advancements. These advancements are driven by technological innovations and an increasing emphasis on rapid testing methods.. The integration of molecular diagnostics, particularly PCR-based tests, has transformed the landscape, allowing for quicker and more accurate detection of influenza viruses. This shift is largely influenced by the growing demand for timely diagnosis, which is essential for effective patient management and outbreak control. Furthermore, the rise in awareness regarding influenza's potential complications has led to heightened screening efforts, particularly among vulnerable populations. As a result, healthcare providers are increasingly adopting advanced diagnostic tools to enhance patient outcomes. In addition to technological progress, regulatory support plays a crucial role in shaping the influenza diagnostics market. The U.S. Food and Drug Administration (FDA) has streamlined the approval process for new diagnostic tests, facilitating quicker access to innovative solutions. This regulatory environment encourages research and development, fostering a competitive landscape where companies strive to introduce novel products. Moreover, public health initiatives aimed at increasing vaccination rates and improving surveillance systems further contribute to the market's growth. Overall, the influenza diagnostics market appears poised for continued expansion, driven by a combination of technological advancements and supportive regulatory frameworks.

Technological Advancements in Diagnostics

Recent innovations in diagnostic technologies, particularly molecular methods, are enhancing the accuracy and speed of influenza detection. These advancements enable healthcare providers to deliver timely treatment, which is crucial for managing outbreaks effectively.

Regulatory Support and Streamlined Approvals

The regulatory landscape is evolving, with agencies like the FDA facilitating faster approvals for new diagnostic tests. This support encourages the development of innovative solutions, thereby expanding the range of available diagnostic options.

Increased Focus on Rapid Testing

There is a growing emphasis on rapid testing methods within the influenza diagnostics market. These tests provide quick results, allowing for immediate clinical decisions and improving patient management during peak influenza seasons.

US Influenza Diagnostics Market Drivers

Increased Healthcare Expenditure

Rising healthcare expenditure in the US is a significant driver for the influenza diagnostics market. As healthcare budgets expand, there is a greater emphasis on preventive care and early diagnosis, which includes investments in diagnostic technologies. The US healthcare spending is projected to reach approximately $6 trillion by 2027, indicating a robust market for diagnostic solutions. This increase in funding allows healthcare facilities to acquire advanced diagnostic equipment and technologies, thereby improving the accuracy and speed of influenza detection. Furthermore, as healthcare providers seek to enhance patient care and reduce hospitalizations, the demand for effective influenza diagnostics is likely to rise, fostering market growth.

Rising Incidence of Influenza Cases

The increasing incidence of influenza cases in the US is a primary driver for the influenza diagnostics market. According to the Centers for Disease Control and Prevention (CDC), seasonal influenza affects millions of individuals annually, leading to significant healthcare costs. In the 2021-2022 season, there were approximately 9 million to 35 million cases reported, highlighting the ongoing need for effective diagnostic tools. This trend suggests that healthcare providers are likely to invest more in diagnostic solutions to manage and control outbreaks. As the population ages and the prevalence of chronic diseases rises, the demand for accurate and timely influenza diagnostics is expected to grow, thereby propelling the market forward.

Emergence of Novel Influenza Strains

The emergence of novel influenza strains poses a continuous challenge to public health. This challenge drives the influenza diagnostics market.. As new strains develop, the need for updated and effective diagnostic tools becomes paramount. The CDC monitors these strains closely, and the identification of new variants can lead to increased testing and surveillance efforts. This dynamic environment necessitates the development of advanced diagnostic technologies capable of detecting a wide range of influenza viruses. The market is likely to respond to this need by innovating and enhancing existing diagnostic solutions, ensuring that healthcare providers are equipped to address the challenges posed by evolving influenza strains.

Advancements in Point-of-Care Testing

The influenza diagnostics market is experiencing a surge in demand for point-of-care (POC) testing solutions. These advancements allow for rapid and accurate diagnosis of influenza at the site of patient care, which is crucial for timely treatment. The convenience of POC testing is particularly appealing in emergency departments and outpatient settings, where quick decision-making is essential. The market for POC testing is projected to grow significantly, with estimates suggesting a CAGR of over 10% through 2025. This growth is driven by the need for immediate results, which can lead to better patient outcomes and reduced transmission rates. Consequently, the development of innovative POC diagnostic tools is likely to enhance the overall landscape of the influenza diagnostics market.

Growing Awareness of Influenza Vaccination

The growing awareness of the importance of influenza vaccination is influencing the influenza diagnostics market. Public health campaigns and educational initiatives have led to increased vaccination rates, which in turn necessitate effective diagnostic tools to monitor and manage influenza outbreaks. As vaccination efforts expand, healthcare providers require reliable diagnostics to differentiate between vaccinated and unvaccinated individuals, ensuring appropriate treatment protocols. This heightened awareness is likely to drive demand for diagnostic solutions that can provide accurate results in a timely manner. Consequently, the influenza diagnostics market may see a positive impact as healthcare systems adapt to the evolving landscape of influenza management.

Market Segment Insights

US Influenza Diagnostics Market Segment Insights

US Influenza Diagnostics Market Segment Insights

Influenza Diagnostics Market Type 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.

Influenza Diagnostics Market Product Insights

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

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

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.

Get more detailed insights about US Influenza Diagnostics Market

Key Players and Competitive Insights

The influenza diagnostics market is characterized by a dynamic competitive landscape, driven by the increasing prevalence of influenza and the demand for rapid and accurate diagnostic solutions. Key players such as Abbott (US), Roche (CH), and Thermo Fisher Scientific (US) are strategically positioned to leverage innovation and technological advancements. Abbott (US) focuses on enhancing its product portfolio through continuous research and development, while Roche (CH) emphasizes strategic partnerships to expand its diagnostic capabilities. Thermo Fisher Scientific (US) is actively pursuing mergers and acquisitions to bolster its market presence, indicating a trend towards consolidation in the sector. Collectively, these strategies contribute to a competitive environment that is increasingly focused on innovation and technological integration.

In terms of business tactics, companies are localizing manufacturing and optimizing supply chains to enhance efficiency and responsiveness to market demands. The market structure appears moderately fragmented, with several key players exerting influence over various segments. This fragmentation allows for diverse offerings, yet the collective strength of major companies shapes the competitive dynamics, fostering an environment where innovation is paramount.

In October 2025, Abbott (US) announced the launch of a new rapid influenza diagnostic test that utilizes advanced molecular technology, significantly reducing the time required for results. This strategic move not only enhances Abbott's product offerings but also positions the company to capture a larger share of the growing demand for rapid testing solutions. The introduction of this test is likely to strengthen Abbott's competitive edge in a market that increasingly values speed and accuracy.

In September 2025, Roche (CH) entered into a collaboration with a leading technology firm to integrate artificial intelligence into its diagnostic platforms. This partnership aims to enhance the accuracy of influenza diagnostics and streamline the testing process. By leveraging AI, Roche (CH) is poised to improve patient outcomes and operational efficiency, reflecting a broader trend towards digital transformation in the diagnostics sector.

In August 2025, Thermo Fisher Scientific (US) completed the acquisition of a smaller diagnostics company specializing in point-of-care testing. This acquisition is expected to expand Thermo Fisher's capabilities in the influenza diagnostics market, allowing for a more comprehensive product range. The strategic importance of this move lies in Thermo Fisher's ability to integrate innovative technologies and enhance its market position through a diversified portfolio.

As of November 2025, current competitive trends in the influenza diagnostics market include a strong emphasis on digitalization, sustainability, and the integration of AI technologies. Strategic alliances are increasingly shaping the landscape, enabling companies to pool resources and expertise. Looking ahead, competitive differentiation is likely to evolve from traditional price-based competition towards a focus on innovation, technological advancements, and supply chain reliability. This shift underscores the importance of agility and responsiveness in meeting the evolving needs of healthcare providers and patients.

Key Companies in the US Influenza Diagnostics Market market include

Industry 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.

Future Outlook

US Influenza Diagnostics Market Future Outlook

The influenza diagnostics market is projected to grow at 8.37% CAGR from 2024 to 2035, driven by technological advancements, increased awareness, and rising healthcare expenditures.

New opportunities lie in:

  • Development of rapid point-of-care testing devices
  • Integration of AI for predictive analytics in diagnostics
  • Expansion of telehealth services for remote testing solutions

By 2035, the market is expected to achieve substantial growth, reflecting evolving healthcare needs.

Market Segmentation

US Influenza Diagnostics Market Type Outlook

  • PCR Tests
  • Antigen Tests
  • Serology Tests
  • Viral Culture
  • Rapid Diagnostic Tests

US Influenza Diagnostics Market Product Outlook

  • Reagents
  • Kits
  • Instruments
  • Consumables

US Influenza Diagnostics Market End User Outlook

  • Hospitals
  • Clinics
  • Laboratories
  • Home Care

US Influenza Diagnostics Market Technique Outlook

  • Molecular Diagnostics
  • Immunodiagnostics
  • Cell Culture

Report Scope

MARKET SIZE 20242269.68(USD Million)
MARKET SIZE 20252459.65(USD Million)
MARKET SIZE 20355491.97(USD Million)
COMPOUND ANNUAL GROWTH RATE (CAGR)8.37% (2024 - 2035)
REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR2024
Market Forecast Period2025 - 2035
Historical Data2019 - 2024
Market Forecast UnitsUSD Million
Key Companies Profiled["Abbott (US)", "Roche (CH)", "Thermo Fisher Scientific (US)", "BD (US)", "Siemens Healthineers (DE)", "Cepheid (US)", "Hologic (US)", "BioMérieux (FR)", "QuidelOrtho (US)"]
Segments CoveredType, Product, End User, Technique
Key Market OpportunitiesIntegration of rapid testing technologies enhances early detection capabilities in the influenza diagnostics market.
Key Market DynamicsTechnological advancements drive rapid innovation in influenza diagnostics, enhancing accuracy and speed of detection.
Countries CoveredUS

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FAQs

What was the market size of the US Influenza Diagnostics Market in 2024?

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

What is the projected market size of the US Influenza Diagnostics Market by 2035?

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

What is the expected compound annual growth rate (CAGR) for the US Influenza Diagnostics Market from 2025 to 2035?

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

Which segment held the largest market share in 2024?

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

What will be the market value of PCR Tests in the US Influenza Diagnostics Market by 2035?

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

Who are the major players in the US Influenza Diagnostics Market?

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

What are the projected values of Antigen Tests in the market for 2024 and 2035?

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

What growth opportunities exist in the US Influenza Diagnostics Market?

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

What market value will Rapid Diagnostic Tests reach by 2035?

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

How is the competitive landscape of the US Influenza Diagnostics Market shaped?

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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