Influenza Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Test Type (Traditional Diagnostic Test, Molecular Diagnostic Assay), By End user (Hospital, Laboratories, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 2.32 Billion
CAGR (2026-2031)	7.05%
Fastest Growing Segment	Molecular Diagnostic Assay
Largest Market	North America
Market Size (2031)	USD 3.49 Billion

Market Overview

The Global Influenza Diagnostics Market will grow from USD 2.32 Billion in 2025 to USD 3.49 Billion by 2031 at a 7.05% CAGR. Influenza diagnostics encompass a specialized range of medical tests and devices, including rapid immunoassays and molecular assays, designed to detect viral antigens or genetic material in patient respiratory specimens. The market is primarily propelled by the rising global prevalence of seasonal influenza and the critical necessity for early and accurate disease detection to facilitate timely treatment and outbreak containment. This growth is further supported by an expanding geriatric population that requires frequent health monitoring and the increasing preference for rapid testing solutions in decentralized healthcare settings. According to the Centers for Disease Control and Prevention, clinical laboratories tested approximately 3.9 million respiratory specimens for influenza viruses during the 2024 to 2025 season, illustrating the substantial diagnostic volume that underpins market demand.

Despite these robust drivers, the market faces a significant challenge regarding the high cost associated with advanced molecular diagnostic platforms which restricts their adoption in resource, constrained regions. This financial barrier is frequently compounded by inconsistent reimbursement policies and the variable sensitivity of lower, cost rapid tests, which can lead to clinical hesitation and impede broader market expansion in cost, sensitive economies.

Key Market Drivers

The rising global prevalence of seasonal and pandemic influenza strains acts as a primary catalyst for the market, necessitating robust diagnostic volumes to manage patient care and prevent transmission. Continuous viral mutations and the resurgence of respiratory pathogens following the pandemic have intensified the disease burden, compelling healthcare systems to maintain high levels of vigilance. For instance, the 2023-2024 season exhibited significant morbidity; according to the Centers for Disease Control and Prevention, November 2024, in the '2023-2024 Influenza Season Summary', there were an estimated 40 million flu illnesses, 470,000 hospitalizations, and 28,000 deaths in the United States alone. This elevated incidence is not isolated to one region but represents a worldwide challenge that sustains market momentum. According to the European Centre for Disease Prevention and Control, November 2024, in the 'Seasonal influenza - Annual Epidemiological Report for 2023/2024', the percentage of sentinel primary care specimens testing positive for the influenza virus peaked at 39% during late 2023, underscoring the intense viral circulation that drives the consumption of diagnostic consumables globally.

Simultaneously, the market is experiencing a surge in demand for rapid Point-of-Care (POC) testing solutions, driven by the critical need for immediate clinical decision-making in decentralized settings. Healthcare providers are increasingly prioritizing syndromic panels and rapid molecular assays that deliver accurate results within minutes, allowing for timely antiviral administration and optimized patient flow. This shift toward decentralized diagnostics is evidenced by substantial commercial growth in the segment; according to bioMérieux, September 2024, in the 'First-Half 2024 Results', sales of the company's BIOFIRE respiratory panels increased by 17% in the second quarter of 2024, propelled by the competitiveness of rapid solutions and an expanded installed base. This trend reflects a broader structural transition in the market, where accessibility and speed are becoming as paramount as sensitivity in managing respiratory outbreaks.

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Key Market Challenges

The high cost associated with advanced molecular diagnostic platforms constitutes a substantial barrier to the expansion of the Global Influenza Diagnostics Market, particularly in resource-constrained economies. While molecular assays provide superior sensitivity compared to rapid immunoassays, the significant capital investment and operational expenses required for these sophisticated systems effectively exclude them from many decentralized healthcare settings and developing nations. This financial disparity forces a continued reliance on lower-cost alternatives that often exhibit variable sensitivity, leading to inconsistent clinical outcomes and hesitation among healthcare providers to adopt newer technologies. Consequently, the market suffers from fragmented growth, where advanced diagnostics are saturated in wealthy regions while vast potential markets remain untapped due to affordability issues.

This gap in diagnostic capability is clearly reflected in recent industry data regarding global preparedness. According to the Foundation for Innovative New Diagnostics (FIND), in July 2024, the Pathogen Diagnostic Readiness Index reported a global readiness score of only 56% for Influenza A and Influenza B, significantly trailing the capacity established for SARS-CoV-2. This low score indicates that a large portion of the global healthcare infrastructure lacks the adequate diagnostic tools necessary for effective management, a deficiency directly linked to the economic hurdles of deploying precise but expensive testing platforms.

Key Market Trends

The Widespread Adoption of Multiplex Syndromic Testing is fundamentally reshaping clinical workflows as healthcare systems prioritize the simultaneous detection of overlapping respiratory pathogens. This trend is driven by the clinical necessity to distinguish between Influenza A, Influenza B, RSV, and SARS-CoV-2 in a single high-throughput run, thereby optimizing patient management and resource allocation during peak viral seasons. The shift away from single-target assays is accelerating due to regulatory support for comprehensive panels that offer efficiency without compromising sensitivity. According to BioSpectrum India, February 2025, in the article 'Thermo Fisher announces 510(k) clearance of molecular clinical test...', Thermo Fisher Scientific received FDA clearance for its Applied Biosystems TaqPath Select Panel, a multiplex solution designed to detect and differentiate these four distinct viral targets in a single workflow, underscoring the industry's pivot toward consolidated diagnostic modalities.

Advancements in Microfluidic and Lab-on-a-Chip Technologies are further solidifying the market infrastructure by enabling sophisticated molecular processing within compact, automated cartridges. These technologies facilitate the miniaturization of complex laboratory procedures, allowing for precise sample preparation and amplification in decentralized environments with minimal operator intervention. The rapid expansion of installed bases for these microfluidic platforms indicates a structural reliance on cartridge-based ecosystems to handle fluctuating testing volumes. This scalability is evidenced by recent operational metrics; according to Danaher Corporation, January 2025, in the 'Fourth Quarter and Full Year 2024 Results' report, the global installed base of the company’s Cepheid GeneXpert system, which leverages advanced microfluidic cartridge technology, expanded to more than 60,000 instruments, reflecting the critical role of scalable tech in modern diagnostic strategies.

Segmental Insights

The Molecular Diagnostic Assay segment currently represents the fastest-growing category within the Global Influenza Diagnostics Market. This expansion is primarily driven by the superior sensitivity and specificity of molecular tests, which significantly outperform traditional rapid antigen tests in detecting low viral loads. Consequently, prominent regulatory bodies such as the U.S. FDA and the CDC prioritize these assays for confirming cases, particularly in clinical settings requiring high precision. The growing emphasis on early intervention further accelerates the adoption of these diagnostic platforms, as healthcare providers seek reliable results to administer appropriate antiviral therapies promptly.

Regional Insights

North America holds a dominant position in the Global Influenza Diagnostics Market, primarily driven by a well-established healthcare infrastructure and high awareness regarding infectious disease management. This leadership is reinforced by the Centers for Disease Control and Prevention (CDC), which maintains rigorous surveillance protocols that encourage widespread testing. Additionally, the region benefits from the strong presence of key industry manufacturers and favorable reimbursement policies. The U.S. Food and Drug Administration (FDA) further sustains this market advantage by streamlining regulatory pathways, ensuring rapid access to effective diagnostic tools for healthcare providers.

Recent Developments

• In January 2025, OSANG Healthcare secured 510(k) clearance from the U.S. Food and Drug Administration for its combination diagnostic kit capable of detecting COVID-19 and influenza. This approval followed the emergency use authorization that the product had received previously, transitioning it to a fully cleared status for the U.S. market. The company stated that this regulatory achievement for its rapid test would facilitate broader commercial distribution and production. This milestone positioned the product to better serve professional markets for respiratory virus diagnostics, ensuring reliable supply during periods of high demand for influenza testing.
• In October 2024, Healgen Scientific received marketing authorization from the U.S. Food and Drug Administration for its Rapid Check COVID-19/Flu A&B Antigen Test. This approval marked the first time an over-the-counter combined influenza and COVID-19 diagnostic test was authorized through the traditional premarket review pathway rather than under emergency use authorities. The test was designed for use by individuals experiencing respiratory symptoms, allowing them to collect their own anterior nasal swab samples and obtain results for both influenza and SARS-CoV-2 in approximately 15 minutes, thereby improving access to home-based diagnostics.
• In September 2024, Roche launched a new respiratory test kit utilizing its proprietary Temperature-Activated Signal Generation (TAGS) technology. This high-throughput solution was designed for use on the company's cobas 5800, 6800, and 8800 molecular diagnostic analyzers. The assay enabled the simultaneous detection of up to 12 respiratory pathogens, including influenza A and influenza B, within a single automated run. By utilizing a novel multiplexing approach that identified multiple targets using limited detection channels, this innovation aimed to significantly enhance diagnostic capability and laboratory efficiency for managing seasonal respiratory virus outbreaks worldwide.
• In July 2024, Hologic obtained expanded clearance from the U.S. Food and Drug Administration for its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. This regulatory milestone allowed the molecular diagnostic test to be used with anterior nasal swab specimens, adding to the previously approved nasopharyngeal sample type. The assay, which runs on the fully automated Panther Fusion system, was developed to detect and differentiate between influenza A, influenza B, respiratory syncytial virus, and the virus that causes COVID-19. This update provided greater flexibility for healthcare providers and streamlined sample collection processes during respiratory virus seasons.

Key Market Players

• Abbott Laboratories Limited
• Becton, Dickinson and Company
• Coris BioConcept
• DiaSorin SpA
• F. Hoffmann-La Roche Ltd
• Meridian Bioscience Inc
• Quidel Corporation
• Sekisui Diagnostics
• Thermo Fisher Scientific Inc

By Test Type	By End user	By Region
Traditional Diagnostic Test Molecular Diagnostic Assay	Hospital Laboratories Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Influenza Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Influenza Diagnostics Market, By Test Type:

• Traditional Diagnostic Test
• Molecular Diagnostic Assay

• Influenza Diagnostics Market, By End user:

• Hospital
• Laboratories
• Others

• Influenza Diagnostics Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE