United States Influenza Diagnostics Market 2031 | Growth Drivers, Trends & Market Forecast, Competitive Landscape & Investment Opportunities

Market Size and Growth

The global Influenza Diagnostics Market is projected to grow steadily with a compound annual growth rate (CAGR) of 5.6% during the forecast period from 2024 to 2031. Influenza diagnostics, encompassing molecular assays, rapid influenza diagnostic tests (RIDTs), immunofluorescence assays, and serological tests, are critical tools in detecting influenza viruses for timely patient treatment. The rising incidence and prevalence of influenza infections worldwide have underscored the importance of accurate and rapid diagnostic solutions, driving market expansion globally.

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Key Development::

United States: Recent Diagnostics Developments

✅ In February 2025, Aptitude Medical Systems received FDA emergency‐use authorization (EUA) for its Metrix COVID/Flu Test a molecular multiplex diagnostic capable of simultaneously detecting SARS‐CoV‐2, Influenza A and Influenza B in ~20 minutes, enabling OTC/home‐use and point‐of‐care testing.

✅ In January 2025, Nuclein's DASH SARS‐CoV-2 and Flu A/B Test gained 510(k) clearance and a CLIA waiver from FDA offering rapid PCR‐based detection of COVID‐19 and influenza A/B in a single visit under 15 minutes.

✅ In 2025 (reported Sep 2025), a research team published a proof‐of‐concept AI‐enabled near‐infrared surface‐enhanced Raman spectroscopy (NIR‐SERS) platform capable of identifying respiratory viruses including influenza at strain‐level showing potential for future ultra‐rapid, high‐precision diagnostics beyond conventional PCR/antigen tests.

✅ In mid‐2025, established molecular and multiplex assays previously validated for common influenza viruses are being re‐evaluated in light of global circulation of novel flu variants; laboratories in US clinical networks are encouraged to ensure their assays maintain sensitivity and inclusivity for emerging strains.

Europe: Recent Influenza Diagnostics & Surveillance Developments

✅ In November 2025, WHO/Europe confirmed the 2025‐26 flu season has begun unusually early with test‐positivity across many countries already at 17% highlighting urgent need for robust diagnostics and surveillance.

✅ In November 2025, surveillance agencies across the region including the European Centre for Disease Prevention and Control (ECDC) reported a sharp rise in influenza cases, driven by an emerging A(H3N2) "subclade K" variant, underscoring the need for updated molecular diagnostics and rapid‐response strategies.

✅ In October-November 2025, regular updates from ECDC's weekly respiratory‐virus bulletins showed steadily increasing influenza activity (while RSV and SARS‐CoV‐2 remain relatively stable), reinforcing demand for multiplex diagnostics that can distinguish among co‐circulating respiratory pathogens.

✅ In August 2025, the Joint Research Centre (JRC), in collaboration with European reference labs, rolled out two new high‐precision digital RT‐PCR assays capable of detecting highly pathogenic avian influenza A(H5Nx) clade 2.3.4.4b viruses, as well as seasonal influenza A strains, with improved sensitivity and specificity.

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Market Overview
Influenza diagnostics help healthcare providers identify infection early, enabling effective clinical decisions and containment strategies. Molecular diagnostics, particularly RT-PCR tests, dominate the market due to high sensitivity and specificity. The advent of point-of-care testing has further enhanced accessibility and reduced turnaround time, even in remote settings. Increasing consumer and healthcare provider awareness about the benefits of early influenza diagnosis continue to drive demand.

Market Drivers
Rising incidence of influenza infections prompts urgent need for reliable diagnostics to manage outbreaks and reduce mortality.
Increasing government initiatives and surveillance programs to control seasonal and pandemic influenza cases.
Rapid diagnostic tests (RDTs) are gaining preference given their portability, ease of use, and timely results.
Technological advancements in nucleic acid amplification tests, multiplex assays, and next-generation sequencing enhance diagnostic accuracy and efficiency.
Growing healthcare infrastructure worldwide, particularly in emerging economies, improves access to influenza diagnostic services.
Market Restraints
High costs associated with advanced molecular diagnostic tests can limit penetration in low-income regions.
Variability of influenza strains requires continuous updating of test kits to maintain accuracy.
Sample collection challenges and quality control issues could impact test performance.
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COVID-19 Impact
The COVID-19 pandemic impacted the influenza diagnostics market by highlighting the importance of respiratory virus testing and accelerating improvements in laboratory capacity and diagnostic technology. Cross-utilization of testing platforms for both SARS-CoV-2 and influenza viruses fostered increased investments and innovation within the diagnostic sector.

Market Segmentation
By Test Type: The market is segmented into RT-PCR tests, rapid influenza diagnostic tests (RIDTs), immunofluorescence assays, and serological tests. RT-PCR holds the largest share due to reliability and growing usage.
By End User: Hospitals, diagnostic laboratories, clinics, and point-of-care settings with hospitals dominating the end-user segment for volume and revenue.
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Geographical Insights
North America leads the global influenza diagnostics market with extensive adoption of advanced technologies and supportive healthcare systems. Europe follows, driven by robust healthcare infrastructure and government programs. The Asia-Pacific region is expected to experience the fastest growth owing to rising influenza cases, increasing public awareness, expanding healthcare access, and proactive government initiatives in countries such as China, India, Japan, and South Korea.

Competitive Landscape
The influenza diagnostics market is highly competitive with key players innovating through new product launches, partnerships, and geographic expansions.

=> Leading companies include Abbott Laboratories, Roche Diagnostics, Siemens Healthineers, BioMerieux, and Quidel Corporation. Their strategic focus on research and development aims to improve diagnostic effectiveness and expand testing capacity.

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Comprehensive quantitative and qualitative analysis including market size, growth drivers, and challenges.

Detailed segmentation analysis by test types, end users, and geographies for targeted strategic insights.

Extensive profiling of key market participants with emphasis on recent developments, product portfolios, and growth strategies.

Insights into regulatory environment, technological progress, and market trends facilitating informed decision-making.

Evaluation of supply chain dynamics, competitive positioning, and emerging opportunities to maximize ROI.

DataM Intelligence continues to empower stakeholders with this insightful and data-driven market research report to capture growth potential amid evolving influenza diagnostics demands worldwide.

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