Point-of-Care Influenza Diagnostics Market Size Worth USD 709.52 Million by 2033, Driven by Technological Innovation and Rise in Home-Based Testing

Point-of-Care Influenza Diagnostics Market Overview

The global point-of-care influenza diagnostics market reached approximately USD 440.47 million in 2025 and is expected to grow to USD 709.52 million by 2033, at a CAGR of 6.14% during the period from 2025 to 2033. Key growth drivers include increased prevalence and severity of seasonal and zoonotic influenza outbreaks, rapid adoption of decentralized testing, technological innovation in diagnostics, and integration with telehealth and home-based healthcare solutions.

Key Trends and Insights

  • North America led the global market with the highest revenue share of 32.90% in 2024.
  • The U.S. was the top market in North America.
  • Rapid antigen tests (RIDTs) dominated in test type, while molecular POC tests held the largest share at 46.49% in 2024.
  • Influenza A strain tests commanded the highest segment share at 48.25% in 2024.
  • Immunoassay-based technologies were most widely used, covering 42.74% of market share in 2024.

Market Drivers

Seasonal flu annually affects up to a billion people worldwide, with severe illness in millions and hundreds of thousands of respiratory deaths. Efficient rapid POC tests empower timely flu detection and intervention in clinics, pharmacies, urgent care, and even at home. Integration with telehealth and FDA-approved at-home tests, such as those introduced by Roche and Healgen, have enhanced early diagnosis, allowing real-time virtual consultations and symptom management. These shifts accelerate intervention, curb transmission, and increase testing reach across diverse settings.

Technological Innovation and Regulatory Environment

Technological breakthroughs in both rapid antigen and molecular diagnostics have improved sensitivity, accuracy, and convenience. Examples include CLIA-waived multiplex immunoassays like QuidelOrtho’s tests that enable triple detection (e.g., flu + SARS-CoV-2) and user-friendly at-home kits. Recent FDA emergency use authorizations, rapid RT-PCR advancements, and digital health tool integration—including AI decision support—are broadening the use and acceptance of POC influenza tests. Strategic collaborations and acquisitions continue, while regulatory approval remains critical for product entry and expansion.

Test Type Insights

Rapid antigen tests (RIDTs) led the market in 2024 due to their speed, accessibility, and affordability, supporting quick clinical decisions. Technological upgrades have increased their reliability, and digital/multiplex versions are increasingly common. Molecular point-of-care tests are growing rapidly for their superior sensitivity and lab-like accuracy, now available in compact, portable formats suitable for primary and urgent care settings.

Influenza Strain Insights

Influenza A test kits dominate the market because influenza A is the most common and rapidly evolving cause of seasonal and pandemic flu. Rapid detection is pivotal for outbreak control, while multiplex kits covering both A and B viruses see strong demand, exemplified by innovations that enable simultaneous detection of flu and COVID-19.

Technology Insights

Immunoassay-based platforms are widely deployed thanks to their cost-effectiveness and scalable application in point-of-care, especially for seasonal surges. Ongoing improvements are making them faster and more accurate. Molecular diagnostics—known for high sensitivity—support detection of low viral loads and differentiation between flu types, supporting critical and high-throughput needs.

End-Use Insights

  • Hospitals accounted for 38.35% of global revenues in 2024, leading adoption due to infrastructure, high patient volumes, and expertise in advanced diagnostics.
  • Home care settings are expanding quickly, driven by consumer demand for convenience, wider access to OTC rapid flu kits, and advances in self-testing technology.

Regional Insights

  • North America: Largest regional share due to high flu prevalence, robust health infrastructure, and early adoption of advanced diagnostics and telehealth.
  • Europe: Growth propelled by demand for rapid, user-friendly tests and public investment in disease surveillance.
  • Asia Pacific: Fastest-growing market, driven by high disease burden, technology adoption, and public health investments in countries like China, India, Japan, and South Korea.
  • Latin America & MEA: Steady market expansion based on rising awareness, increasing access, and growing use of decentralized and home-based solutions.

Top Companies

  • Abbott
  • Becton Dickinson (BD)
  • Danaher/Cepheid
  • Quidel Corporation
  • Qiagen
  • F. Hoffmann-La Roche Ltd
  • Bio-Rad
  • BioMerieux
  • Diasorin
  • Hologic
  • Thermo/Remel
  • Fujirebio
  • Visby Medical
  • Twist

Recent Developments

  • January 2023: Visby Medical received FDA emergency use authorization for its PCR-based respiratory health test, differentiating influenza A & B in CLIA-waived settings.
  • December 2022: Diasorin filed regulatory applications for LIAISON NES molecular POC platform (including flu, RSV, and COVID-19 panels) to expand its U.S. portfolio.
  • September 2025: QuidelOrtho launched QUICKVUE Influenza + SARS Test, expanding its decentralized rapid immunoassay offering.

Market Scope Summary

Report Attribute Details
Market Size (2025) USD 440.47 million
Forecast (2033) USD 709.52 million
CAGR (2025–2033) 6.14%
Historical Data 2021–2023
Segments Covered Test Type, Influenza Strain, Technology, End-Use, Region
Regions/Countries U.S., Canada, Mexico, UK, Germany, France, Italy, Spain, Norway, Sweden, Denmark, Japan, China, India, Australia, South Korea, Thailand, Brazil, Argentina, South Africa, Saudi Arabia, UAE, Kuwait
Top Companies Abbott, BD, Danaher/Cepheid, Quidel, Qiagen, Roche, Bio-Rad, BioMerieux, Diasorin, Hologic, Thermo/Remel, Fujirebio, Visby Medical, Twist

Market Segmentation

  • Test Type: Rapid Antigen Tests (RIDT), Molecular POC Tests, Biosensor-Based Tests, Others
  • Influenza Strain: Influenza A, Influenza B, Combined A & B Tests
  • Technology: Immunoassay-Based, Molecular Diagnostics, Nanotechnology-Based, Others
  • End-Use: Hospitals, Clinics, Homecare, Others
  • Regions: North America, Europe, Asia Pacific, Latin America, Middle East & Africa

Frequently Asked Questions

What is the market size for point-of-care influenza diagnostics in 2025?
The market is estimated at USD 440.47 million in 2025.

What is the projected growth rate?
The market will expand at a CAGR of 6.14% from 2025 to 2033.

Which region is the largest market?
North America led the global market in 2024 and is a key growth driver.

What is the dominant test type and technology?
Rapid antigen tests and immunoassay-based platforms are most widely used, with molecular diagnostics quickly gaining share.

Who are the leading companies in the market?
Major players include Abbott, BD, Danaher, Quidel, Qiagen, Roche, Bio-Rad, BioMerieux, Diasorin, Hologic, Thermo, Fujirebio, and Visby Medical.

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