Rapid Influenza Diagnostic Tests Market Size, Share, and Growth Forecast for 2025 - 2032

The global rapid influenza diagnostic tests market is anticipated to reach a value of US$ 982.0 Mn in 2025 and is set to witness a CAGR of 8.6% from 2025 to 2032. The market will likely attain a value of US$ 1,749.5 Mn in 2032. The growing demand for highly efficient and comprehensive diagnostic solutions is driving market expansion, with manufacturers focusing on multiplex testing to improve accuracy and efficiency.

For instance, in September 2024, Roche launched the cobas® Respiratory flex test, utilizing its proprietary TAGS (Temperature-Activated Generation of Signal) technology. This innovative test enables the simultaneous detection of up to 12 common respiratory viruses, including influenza A and B, RSV, and SARS-CoV-2, from a single patient sample, aligning with the market trend toward advanced, high-throughput diagnostics.

The demand for self-testing solutions is growing, reducing healthcare strain, and enabling faster diagnosis. In February 2023, Lucira Health received FDA approval for its OTC Lucira COVID-19 & Flu Home Test, delivering results for flu A, flu B, and COVID-19, highlighting the shift toward convenient, rapid diagnostics.

Key Highlights of the Rapid Influenza Diagnostic Tests Industry

• North America is expected to hold 38.4% of the market in 2025, driven by strong regulatory support, high adoption of innovative diagnostics, and frequent influenza outbreaks.
• The conventional segment by product type is projected to hold 60.2% of the market share in 2025, due to its cost-effectiveness, ease of use, widespread availability, and suitability for resource-limited settings.
• The influenza A+B test by test type is expected to account for 58.8% of the market in 2025, due to its ability to simultaneously detect both strains, improving diagnostic efficiency and guiding timely treatment decisions in clinical settings.
• The rise of at-home testing, led by FDA-approved kits like Lucira Check-It, boosts accessibility and early diagnosis. Multiplex testing advancements further expand the market by enhancing efficiency.

Historically the market has grown at a CAGR of 7.6%, driven by increasing influenza prevalence and the demand for fast, accurate testing.

Technological advancements, such as nucleic acid amplification tests (NAATs) have enhanced test accuracy and efficiency. For instance, Abbott’s ID NOW™ platform delivers molecular results in minutes, enabling faster and more reliable influenza detection in point-of-care settings.

From 2025 to 2032, the market is expected to expand at a CAGR of 8.6%, propelled by rising investments in disease surveillance, government initiatives, and the growing adoption of point-of-care testing. Increased awareness and accessibility of diagnostic solutions in both developed and emerging markets will further drive market growth, ensuring early detection and improved patient management.

Growth Drivers

Technological Advancements Enhancing Rapid Influenza Diagnostics

Innovations in molecular and immunoassay-based tests are significantly enhancing the accuracy, speed, and reliability of rapid influenza diagnostics. Modern molecular techniques, such as nucleic acid amplification tests (NAATs), provide higher sensitivity and specificity, reducing false negatives and enabling early detection. Additionally, digital immunoassay platforms improve result interpretation by minimizing human error. For example, BD’s Veritor™ Plus System utilizes advanced immunoassay technology with digital readout capabilities, offering objective and reliable influenza detection within minutes. Such advancements are driving market adoption by ensuring faster and more accurate diagnostics, particularly in clinical and point-of-care settings.

Market Restraining Factors

Pricing Constraints in Advanced Diagnostic Technologies

The high cost of advanced diagnostic tests remains a significant barrier to widespread adoption, particularly in resource-limited settings. Molecular diagnostic platforms, such as PCR-based rapid influenza tests, require sophisticated equipment, trained personnel, and costly reagents, making them less accessible in low- and middle-income regions. Digital influenza tests, while improving accuracy, also come with higher price points compared to conventional immunoassay-based rapid tests. For instance, Roche’s cobas® Liat System, a highly sensitive molecular point-of-care test, offers rapid results but is considerably more expensive than traditional lateral flow assays. These cost constraints hinder market penetration, especially in decentralized healthcare settings, where affordability is a key factor in diagnostic accessibility.

Key Market Opportunities

Self-Testing Kits Will Revolutionize Influenza Detection

The rise in home-based influenza testing presents a major opportunity for manufacturers as consumers seek convenient and rapid diagnostic solutions. Over-the-counter (OTC) self-testing kits enable early detection, reducing strain on healthcare facilities and minimizing transmission risks.

• In February 2023, the FDA granted Emergency Use Authorization (EUA) for the Lucira COVID-19 & Flu Home Test, the first at-home molecular test for detecting influenza A, influenza B, and COVID-19.

This approval highlights regulatory support for self-testing innovations, paving the way for more advanced home-use diagnostics. As demand for reliable, easy-to-use flu tests grows, manufacturers have a lucrative opportunity to expand their OTC product offerings, enhancing accessibility and driving market expansion.

Product Type Insights

Widespread Use of Conventional RIDTs Sustains Market Leadership

The conventional segment is expected to hold around 60.2% share of the total market in 2025, due to their cost-effectiveness, ease of use, and widespread availability in clinics, pharmacies, and hospitals. They remain the preferred choice for quick, on-site diagnosis without requiring complex lab equipment.

However, digital tests are growing rapidly, as seen with BD Veritor™ and Abbott ID NOW™, which provide enhanced accuracy and automated results, reducing human error and improving diagnostic efficiency.

Test Type Insights

Influenza A+B Testing: The Preferred Choice for Rapid Diagnosis

Influenza A+B Test segment by test type is expected to hold a larger share of about 58.8% in 2025. These combination tests are widely preferred as they allow simultaneous detection of both Influenza A and B strains, improving diagnostic efficiency and guiding appropriate treatment decisions. Their convenience and ability to differentiate between viral strains in a single test make them the first choice in clinical and point-of-care settings.

For example, Abbott's ID NOW™ Influenza A & B Test and Quidel QuickVue Influenza A+B Test are widely used in hospitals and clinics, offering rapid results within minutes, enabling timely intervention, and reducing transmission risks.

End User Insights

Diagnostic Centers and Laboratories Leading Market Growth

The Diagnostic Centers & Laboratories segment is expected to dominate the market, holding approximately 40.2% of the share in 2025, due to their well-established infrastructure, stringent quality control measures, and highly trained personnel, ensuring precise test interpretation. Their participation in external quality assessment programs enhances reliability, establishing them as the leading option for high-volume influenza testing. Additionally, these facilities utilize advanced molecular diagnostic techniques, improving sensitivity and reducing false negatives, further solidifying their market leadership.

North America Rapid Influenza Diagnostic Tests Market

FDA Approvals Propel North America’s Leadership in Rapid Influenza Testing

North America is expected to dominate 38.4% of the global market by 2025, with a strong regulatory framework and rapid approval of innovative diagnostics, ensuring widespread accessibility and reliability. For example, in October 2024, the FDA approved the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, the first OTC flu test cleared via the traditional review pathway. Similarly, BD’s Respiratory Viral Panel received full FDA approval in August 2023, reinforcing the region’s commitment to high-quality, efficient diagnostics.

Asia Pacific Rapid Influenza Diagnostic Tests Market

Skilled Workforce and High Production Capacity Boost Market Growth

By 2025, East Asia's market share is expected to reach 20.3%, driven by rising disease surveillance efforts and growing investments in advanced diagnostics. The WHO’s Global Influenza Strategy 2019-2030, supported by SEARO’s surveillance review in Indonesia (July–August 2024), underscores regional efforts in influenza control. The growing focus on improving influenza detection and expanding access to advanced diagnostics is driving product innovation in the Asia-Pacific region. Kaneka Corporation launched the “KANEKA Immunochromatography Flu A/B & SARS-CoV-2 Ag” test in Japan in May 2023, highlighting the region’s increasing investment in cutting-edge diagnostic solutions.

The rapid influenza diagnostic tests market is highly competitive, with key players such as F. Hoffmann-La Roche Ltd. and Abbott leading innovation. Companies like BD, QuidelOrtho, and Sekisui Diagnostics are expanding their product portfolios through technological advancements and regulatory approvals. Strategic collaborations, regulatory clearances, and digital and molecular diagnostics advancements continue to drive market growth and improve rapid influenza detection worldwide.

Key Industry Developments

• In June 2024, Roche announced that the U.S. FDA granted Emergency Use Authorization (EUA) for its cobas® liat SARS-CoV-2, Influenza A/B & RSV test. The RT-PCR assay, designed for the cobas® liat system, delivers results in 20 minutes using a single nasopharyngeal or anterior nasal swab. Suitable for various healthcare settings, the test detects SARS-CoV-2, influenza A/B, and RSV, enhancing rapid respiratory virus diagnosis.
• In March 2024, SEKISUI Diagnostics received EUA clearance for its OSOM Flu SARS-CoV-2 Combo Test, allowing use in both professional and home settings. The lateral flow immunochromatographic assay enables rapid, simultaneous detection and differentiation of influenza A, influenza B, and SARS-CoV-2 antigens.
• In June 2023, Kaneka Corporation received authorization for the manufacture and sale of the “KANEKA Immunochromatography Flu A/B & SARS-CoV-2 Ag”, a dual antigen test for COVID-19 and influenza. The product was launched on May 31 as an in-vitro diagnostic reagent, priced at 19,800 yen (for 10 tests, including tax).