U.S. And Europe Lateral Flow Assay Market Size, Share & Trends Analysis Report Product (Kits & Reagents, Lateral Flow Readers), By Application, By Technique, By Test Type, By End Use, By Country, And Segment Forecasts, 2025 - 2030

March 2025 | 100 pages | ID: U8BEA76384E1EN
Grand View Research, Inc.

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U.S. And Europe Lateral Flow Assay Market Growth & Trends

The U.S. and Europe lateral flow assay market size is anticipated treach USD 6.97 billion by 2030 and is projected tgrow at a CAGR of 5.48% from 2025 t2030, according ta new report by Grand View Research, Inc. This growth is driven by the increasing decentralization of diagnostic services, rapid adoption of point-of-care testing (POCT), advancements in rapid testing technologies, and the positive shift toward self-testing strategies. In addition, the rising prevalence of infectious diseases and heightened awareness of rapid test kits during the COVID-19 pandemic have created favorable conditions for the lateral flow assay market's expansion.

The integration of digital technologies intlateral flow devices is another pivotal trend. Smartphone-based readers, as well as highly customized stand-alone LFA readers, have allowed users tobtain semi-quantitative or fully quantitative results from traditionally qualitative assays. These technologies not only have the potential timprove diagnostic accuracy but alsenable real-time data sharing for epidemiological tracking and disease management. The increasing prevalence of infectious diseases throughout the world is a key driver fueling the expansion of the lateral flow assay market. These diseases necessitate novel diagnostic techniques for efficient treatment tstop the rising mortality rate.

The high prevalence of infectious diseases worldwide has been a major driver for the market growth. These diseases necessitate novel diagnostic techniques for efficient treatment tstop the rising mortality rate. The COVID-19 pandemic, in particular, highlighted the need for rapid and accessible diagnostic tools, leading ta surge in demand for LFAs. Beyond COVID-19, other infectious threats have emerged. For instance, in 2025, a highly pathogenic avian influenza A (H5N1) virus infection resulted in a fatality in Louisiana, USA, despite the use of personal protective equipment that was deemed inadequate. According tthe Centers for Disease Control and Prevention (CDC), while the general public faces a low risk, individuals working closely with infected animals-such as farmers, veterinarians, and wildlife facility staff-remain highly vulnerable. In 2024, 67 human cases of avian influenza were reported, with 40 linked texposure tdairy cattle and 23 associated with poultry farms. In response, the UK proactively secured 5 million doses of the H5 vaccine tmitigate potential risks in 2025.

Advancements in LFA technology have significantly improved the sensitivity, specificity, and overall performance of these assays, thereby expanding their applications. In December 2021, Eurofins Technologies introduced the RapidScan ST5-W lateral flow reader, designed for field and in-process testing applications that require qualitative tsemi-quantitative test results. Traditionally, commercial LFA test strips utilize the red coloration of gold nanoparticles (GNPs) or colored beads for detection. LFAs have proven highly sensitive in diagnosing diseases like HIV-AIDS, Hepatitis B, and C and assessing immune responses against SARS-CoV-2.

Advanced signal amplification techniques, including silver enhancement and GNP-enzyme conjugation (such as horseradish peroxidase), have significantly improved detection capabilities. Furthermore, integrating electrochemical sensing, Surface-Enhanced Raman Spectroscopy (SERS), fluorescence detection, and nanoparticles have enhanced the specificity of LFAs, allowing for multiplex detection and faster diagnostics. Future advancements, including next-generation chips, DNA amplification, and CRISPR-based technologies, hold the potential timprove LFA performance further. The use of quantum and nanomaterials is alsbeing explored tboost sensitivity.

The convenience and accessibility of home-based testing have led tincreased adoption of LFAs among consumers. In September 2024, InBios International Inc., a leading developer of diagnostic tests for emerging infectious diseases, obtained 510(k) clearance from the USFDA for its SCoV-2 Ag Detect Rapid Test. Featuring a patent-pending design, this user-friendly rapid antigen test requires nadditional equipment or mixing, can be stored at room temperature, and delivers results in just 20 minutes-offering a simple and accessible COVID-19 testing solution for home use. Beyond COVID-19, InBios International Inc. has secured a USD 16.5 million project aimed at enhancing the design of its Active Melioidosis Detect Plus (AMD Plus) device. The funding will support performance validation and regulatory approvals, demonstrating the growing investment in LFA-based diagnostics for infectious diseases beyond the pandemic. In December 2024, the USFDA approved the OraQuick HIV Self-Test, a qualitative immunoassay designed tdetect antibodies tHIV-1 and HIV-2 in oral fluid samples. Intended for over-the-counter (OTC) use, this test offers individuals a discreet and reliable way tscreen for HIV at home, contributing tearly diagnosis and timely medical intervention.

U.S. And Europe Lateral Flow Assay Market Report Highlights
    • The kits & reagents segment led the market with the largest revenue share of 68.48% in 2024, driven by technological advancements and rising demand for rapid diagnostics. Innovations in assay sensitivity, specificity, and ease of use have significantly contributed tmarket expansion.
  • Based on application, the clinical testing segment led the market with the largest revenue share of 77.18% in 2024. This growth is fueled by the increasing prevalence of infectious diseases and chronic conditions, along with the rising demand for rapid diagnostic solutions.
        • Based on technique, the sandwich assay segment led the market with the largest revenue share of 39.66% in 2024, driven by its accuracy, affordability, and ease of use. These assays are particularly valuable in low-resource healthcare settings, as they dnot require trained personnel. Sandwich assays are commonly used tdetect larger analytes that contain twepitopes or binding sites.
    • Based on test type, the lateral flow immunoassay (LFIA) segment led the market with the largest revenue share of 65.10% in 2024, solidifying its position as a widely used platform for rapid diagnostics since its introduction in the mid-1980s. Due ttheir ease of use, cost efficiency, and quick results, LFIA tests are highly adaptable, allowing for administration by healthcare professionals and patients at home.
  • Based on end use, the hospitals & clinics segment led the market with the largest revenue share of 35.99% in 2024. As primary diagnostic and treatment centers, hospitals and clinics play a crucial role in driving LFA adoption across the U.S. and Europe.
  • The U.S. market is experiencing robust growth, driven by continuous product innovation, strategic investments, and strong government support. Advances in LFA technology have significantly enhanced sensitivity and broadened applications, fueling market expansion.
CHAPTER 1. METHODOLOGY AND SCOPE

1.1. Market Segmentation and Scope
1.2. Market Definitions
1.3. Research Methodology
  1.3.1. Information Procurement
  1.3.2. Information or Data Analysis
  1.3.3. Market Formulation & Data Visualization
  1.3.4. Data Validation & Publishing
1.4. Research Scope and Assumptions
  1.4.1. List of Data Sources

CHAPTER 2. EXECUTIVE SUMMARY

2.1. Market Outlook
2.2. Segment Outlook
2.3. Competitive Insights

CHAPTER 3. U.S. AND EUROPE LATERAL FLOW ASSAY MARKET VARIABLES, TRENDS, & SCOPE

3.1. Market Introduction/Lineage Outlook
3.2. Market Size and Growth Prospects (USD Million)
3.3. Market Dynamics
  3.3.1. Market Drivers Analysis
    3.3.1.1. Increasing prevalence of infectious diseases
    3.3.1.2. Technological advancements in lateral flow
    3.3.1.3. Growing adoption in homecare settings
  3.3.2. Market Restraints Analysis
    3.3.2.1. Stringent Regulations
  3.3.3. Market Opportunities Analysis
    3.3.3.1. Growing demand for Point-of-Care (POC) Testing
    3.3.3.2. Expanding applications beyond healthcare
  3.3.4. Market Challenges Analysis
    3.3.4.1. Product Recalls
3.4. U.S. and Europe Lateral Flow Assay Market Analysis Tools
  3.4.1. Porter’s Analysis
    3.4.1.1. Bargaining power of the suppliers
    3.4.1.2. Bargaining power of the buyers
    3.4.1.3. Threats of substitution
    3.4.1.4. Threats from new entrants
    3.4.1.5. Competitive rivalry
  3.4.2. PESTEL Analysis
    3.4.2.1. Political landscape
    3.4.2.2. Economic and Social landscape
    3.4.2.3. Technological landscape
    3.4.2.4. Environmental landscape
    3.4.2.5. Legal landscape

CHAPTER 4. U.S. AND EUROPE LATERAL FLOW ASSAY MARKET: PRODUCT ESTIMATES & TREND ANALYSIS

4.1. U.S. and Europe Lateral Flow Assay Market: Product Movement Analysis
4.2. U.S. and Europe Lateral Flow Assay Market Estimates and Forecasts, by Product 2024 & 2030 (USD Million)
4.3. Kits & Reagents
  4.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.4. Lateral Flow Readers
  4.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  4.4.2. Benchtop Readers
    4.4.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  4.4.3. Digital Readers
    4.4.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

CHAPTER 5. U.S. AND EUROPE LATERAL FLOW ASSAY MARKET: APPLICATION ESTIMATES & TREND ANALYSIS

5.1. U.S. and Europe Lateral Flow Assay Market: Application Movement Analysis
5.2. U.S. and Europe Lateral Flow Assay Market Estimates and Forecasts, by Application 2024 & 2030 (USD Million)
5.3. Clinical Testing
  5.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  5.3.2. Infectious Disease Testing
    5.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    5.3.2.2. COVID-19
      5.3.2.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    5.3.2.3. Mosquito Borne Disease Testing
      5.3.2.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    5.3.2.4. Influenza Testing
      5.3.2.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    5.3.2.5. Sexually Transmitted Infection Testing
      5.3.2.5.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
      5.3.2.5.2. HIV Testing
        5.3.2.5.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
      5.3.2.5.3. HPV Testing
        5.3.2.5.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
      5.3.2.5.4. Chlamydia Testing
        5.3.2.5.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
      5.3.2.5.5. Gonorrhea Testing
        5.3.2.5.5.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
      5.3.2.5.6. Syphilis Testing
        5.3.2.5.6.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
      5.3.2.5.7. Other STI Testing
        5.3.2.5.7.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    5.3.2.6. Hepatitis
      5.3.2.6.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    5.3.2.7. Tuberculosis
      5.3.2.7.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    5.3.2.8. Other Infectious Diseases
      5.3.2.8.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  5.3.3. Cardiac Marker Testing
    5.3.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    5.3.3.2. Troponin I and T Testing
      5.3.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    5.3.3.3. CK-MB Testing
      5.3.3.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    5.3.3.4. BNP and NT-Probnp Testing
      5.3.3.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    5.3.3.5. Myoglobin Testing
      5.3.3.5.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    5.3.3.6. D-Dimer Testing
      5.3.3.6.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    5.3.3.7. Other Cardiac Marker Tests
      5.3.3.7.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  5.3.4. Pregnancy & Fertility Testing
    5.3.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    5.3.4.2. Pregnancy Testing
      5.3.4.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
    5.3.4.3. Fertility Testing
      5.3.4.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  5.3.5. Cholesterol Testing/Lipid Profile
    5.3.5.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  5.3.6. Drugs of Abuse Testing
    5.3.6.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
  5.3.7. Other Clinical Tests
    5.3.7.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
5.4. Veterinary Diagnostics
  5.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
5.5. Food Safety & Environment Testing
  5.5.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
5.6. Drug Development & Quality Testing
  5.6.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

CHAPTER 6. U.S. AND EUROPE LATERAL FLOW ASSAY MARKET: TECHNIQUE ESTIMATES & TREND ANALYSIS

6.1. U.S. and Europe Lateral Flow Assay Market: Technique Movement Analysis
6.2. U.S. and Europe Lateral Flow Assay Market Estimates and Forecasts, by Technique 2024 & 2030 (USD Million)
6.3. Sandwich Assays
  6.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
6.4. Competitive Assays
  6.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
6.5. Multiplex Detection Assays
  6.5.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

CHAPTER 7. U.S. AND EUROPE LATERAL FLOW ASSAY MARKET: TEST TYPE ESTIMATES & TREND ANALYSIS

7.1. U.S. and Europe Lateral Flow Assay Market: Test Type Movement Analysis
7.2. U.S. and Europe Lateral Flow Assay Market Estimates and Forecasts, by Test Type 2024 & 2030 (USD Million)
7.3. Lateral Flow Immunoassay
  7.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
7.4. Nucleic Acid Lateral Flow Assay
  7.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

CHAPTER 8. U.S. AND EUROPE LATERAL FLOW ASSAY MARKET: END USE ESTIMATES & TREND ANALYSIS

8.1. U.S. and Europe Lateral Flow Assay Market: End-use Movement Analysis
8.2. U.S. and Europe Lateral Flow Assay Market Estimates and Forecasts, by End-use 2024 & 2030 (USD Million)
8.3. Hospitals & Clinics
  8.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
8.4. Diagnostic Laboratories
  8.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
8.5. Home Care
  8.5.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
8.6. Pharmaceutical & Biotechnology Companies
  8.6.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
8.7. Other End-use
  8.7.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)

CHAPTER 9. U.S. AND EUROPE LATERAL FLOW ASSAY MARKET: REGIONAL ESTIMATES & TREND ANALYSIS

9.1. U.S. and Europe Lateral Flow Assay Market Share, By Region, 2024 & 2030 (USD Million)
9.2. U.S.
  9.2.1. Key Country Dynamics
  9.2.2. Competitive Scenario
  9.2.3. Regulatory Framework
  9.2.4. Reimbursement Scenario
  9.2.5. U.S. Lateral Flow Assay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
9.3. Europe
  9.3.1. Europe Lateral Flow Assay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  9.3.2. UK
    9.3.2.1. Key Country Dynamics
    9.3.2.2. Competitive Scenario
    9.3.2.3. Regulatory Framework
    9.3.2.4. Reimbursement Scenario
    9.3.2.5. UK Lateral Flow Assay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  9.3.3. Germany
    9.3.3.1. Key Country Dynamics
    9.3.3.2. Competitive Scenario
    9.3.3.3. Regulatory Framework
    9.3.3.4. Reimbursement Scenario
    9.3.3.5. Germany Lateral Flow Assay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  9.3.4. France
    9.3.4.1. Key Country Dynamics
    9.3.4.2. Competitive Scenario
    9.3.4.3. Regulatory Framework
    9.3.4.4. Reimbursement Scenario
    9.3.4.5. France Lateral Flow Assay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  9.3.5. Italy
    9.3.5.1. Key Country Dynamics
    9.3.5.2. Competitive Scenario
    9.3.5.3. Regulatory Framework
    9.3.5.4. Reimbursement Scenario
    9.3.5.5. Italy Lateral Flow Assay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  9.3.6. Spain
    9.3.6.1. Key Country Dynamics
    9.3.6.2. Competitive Scenario
    9.3.6.3. Regulatory Framework
    9.3.6.4. Reimbursement Scenario
    9.3.6.5. Spain Lateral Flow Assay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  9.3.7. Denmark
    9.3.7.1. Key Country Dynamics
    9.3.7.2. Competitive Scenario
    9.3.7.3. Regulatory Framework
    9.3.7.4. Reimbursement Scenario
    9.3.7.5. Denmark Lateral Flow Assay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  9.3.8. Sweden
    9.3.8.1. Key Country Dynamics
    9.3.8.2. Competitive Scenario
    9.3.8.3. Regulatory Framework
    9.3.8.4. Reimbursement Scenario
    9.3.8.5. Sweden Lateral Flow Assay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
  9.3.9. Norway
    9.3.9.1. Key Country Dynamics
    9.3.9.2. Competitive Scenario
    9.3.9.3. Regulatory Framework
    9.3.9.4. Reimbursement Scenario
    9.3.9.5. Norway Lateral Flow Assay Market Estimates and Forecasts, 2018 - 2030 (USD Million)

CHAPTER 10. COMPETITIVE LANDSCAPE

10.1. Recent Developments & Impact Analysis by Key Market Participants
10.2. Company Categorization
10.3. Company Heat Map Analysis
10.4. Company Profiles
  10.4.1. Abbott
    10.4.1.1. Participant’s Overview
    10.4.1.2. Financial Performance
    10.4.1.3. Product Benchmarking
    10.4.1.4. Recent Developments/ Strategic Initiatives
  10.4.2. Bio-Rad Laboratories, Inc
    10.4.2.1. Participant’s Overview
    10.4.2.2. Financial Performance
    10.4.2.3. Product Benchmarking
    10.4.2.4. Recent Developments/ Strategic Initiatives
  10.4.3. Siemens Healthineers AG
    10.4.3.1. Participant’s Overview
    10.4.3.2. Financial Performance
    10.4.3.3. Product Benchmarking
    10.4.3.4. Recent Developments/ Strategic Initiatives
  10.4.4. BIOMЙRIEUX
    10.4.4.1. Participant’s Overview
    10.4.4.2. Financial Performance
    10.4.4.3. Product Benchmarking
    10.4.4.4. Recent Developments/ Strategic Initiatives
  10.4.5. BD
    10.4.5.1. Participant’s Overview
    10.4.5.2. Financial Performance
    10.4.5.3. Product Benchmarking
    10.4.5.4. Recent Developments/ Strategic Initiatives
  10.4.6. QIAGEN
    10.4.6.1. Participant’s Overview
    10.4.6.2. Financial Performance
    10.4.6.3. Product Benchmarking
    10.4.6.4. Recent Developments/ Strategic Initiatives
  10.4.7. QuidelOrtho Corporation
    10.4.7.1. Participant’s Overview
    10.4.7.2. Financial Performance
    10.4.7.3. Product Benchmarking
    10.4.7.4. Recent Developments/ Strategic Initiatives
  10.4.8. F. Hoffmann-La Roche
    10.4.8.1. Participant’s Overview
    10.4.8.2. Financial Performance
    10.4.8.3. Product Benchmarking
    10.4.8.4. Recent Developments/ Strategic Initiatives
  10.4.9. DH Life Sciences, LLC.
    10.4.9.1. Participant’s Overview
    10.4.9.2. Financial Performance
    10.4.9.3. Product Benchmarking
    10.4.9.4. Recent Developments/ Strategic Initiatives
  10.4.10. Quest Diagnostics
    10.4.10.1. Participant’s Overview
    10.4.10.2. Financial Performance
    10.4.10.3. Product Benchmarking
    10.4.10.4. Recent Developments/ Strategic Initiatives


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