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Abbott
Bio-Rad Laboratories, Inc
Siemens Healthineers AG
BIOMERIEUX
BD
QIAGEN
QuidelOrtho Corporation
F. Hoffmann-La Roche
DH Life Sciences, LLC.
Quest Diagnostics
HBR
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U.S. Lateral Flow Assay Market Trends:
The U.S. lateral flow assay market size was valued at USD 2.82 billion in 2024 and is projected to reach USD 4.63 billion by 2033, growing at a CAGR of 6.08% from 2025 to 2033. The rising prevalence of infectious diseases places immense pressure on public health systems worldwide. With increasing urbanization, interconnectivity, antimicrobial resistance, and the rising impact of climate change, experts stress the urgent need for enhanced infectious disease surveillance, prevention, and diagnostic capabilities. The global rise in infectious diseases significantly drives the lateral flow assays (LFA) market by necessitating rapid diagnostic solutions. According to the Centers for Disease Control and Prevention (CDC), tuberculosis (TB) cases in the U.S. increased from 7,874 in 2022 to 10,347 in 2024, reflecting a notable public health challenge.
The mosquito-borne disease testing segment is projected to experience significant growth due to the rising prevalence of mosquito-borne infections, including West Nile virus (WNV), dengue, chikungunya, Zika virus, malaria, and yellow fever. The increasing incidence of these diseases has heightened the demand for rapid and efficient diagnostic solutions, particularly in regions prone to outbreaks. According to the Centers for Disease Control and Prevention (CDC), West Nile virus (WNV) has become endemic in the U.S., with cases reported in all 48 contiguous states and the District of Columbia, predominantly during the summer and fall months. As of November 2024, the CDC recorded 1,466 cases of WNV, while in 2022, 913 human cases were reported, with 70% classified as neuroinvasive and 30% as non-neuroinvasive. The increasing burden of mosquito-borne diseases, alongside ongoing health crises such as COVID-19 and monkeypox, underscores the urgent need for effective diagnostic and surveillance measures.
Public health initiatives also play a crucial role in market expansion. The CDC's Influenza Division International Program focuses on surveillance, pandemic preparedness, research, and vaccination programs to combat influenza. Additionally, the National Association of County and City Health Officials supports local health departments in influenza prevention and control.
U.S. Lateral Flow Assay Market Report Segmentation
This report forecasts revenue growth at the country level and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. lateral flow assay market report based on product, application, technique, and end use:
Product Outlook (Revenue, USD Million, 2021 - 2033)
Kits & Reagents
Lateral Flow Readers
Benchtop Readers
Digital Readers
Application Outlook (Revenue, USD Million, 2021 - 2033)
Clinical Testing
Infectious Disease Testing
COVID-19
Mosquito Borne Disease Testing
Malaria Testing
Dengue Testing
Zika Testing
Chikungunya Testing
Others
Influenza Testing
Sexually Transmitted Infection Testing
HIV Testing
HPV Testing
Chlamydia Testing
Gonorrhea Testing
Syphilis Testing
Other STI Testing
Hepatitis
Tuberculosis
Other Infectious Diseases
Cardiac Marker Testing
Troponin I and T Testing
CK-MB Testing
BNP and NT-Probnp Testing
Myoglobin Testing
D-Dimer Testing
Other Cardiac Marker Tests
Pregnancy & Fertility Testing
Pregnancy Testing
Fertility Testing
Cholesterol Testing/Lipid Profile
Drugs of Abuse Testing
Other Clinical Tests
Veterinary Diagnostics
Food Safety & Environment Testing
Drug Development & Quality Testing
Technique Outlook (Revenue, USD Million, 2021 - 2033)
Sandwich Assays
Competitive Assays
Multiplex Detection Assays
End Use Outlook (Revenue, USD Million, 2021 - 2033)
Hospitals & Clinics
Diagnostic Laboratories
Home Care
Pharmaceutical & Biotechnology Companies
Others
Table of Contents
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. 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
3.4. U.S. 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. Lateral Flow Assay Market: Product Estimates & Trend Analysis
4.1. U.S. Lateral Flow Assay Market: Product Movement Analysis
4.2. U.S. Lateral Flow Assay Market Estimates and Forecasts, by Product 2024 & 2033 (USD Million)
4.3. Kits & Reagents
4.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4. Lateral Flow Readers
4.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2. Benchtop Readers
4.4.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.3. Digital Readers
4.4.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 5. U.S. Lateral Flow Assay Market: Application Estimates & Trend Analysis
5.1. U.S. Lateral Flow Assay Market: Application Movement Analysis
5.2. U.S. Lateral Flow Assay Market Estimates and Forecasts, by Application 2024 & 2033 (USD Million)
5.3. Clinical Testing
5.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2. Infectious Disease Testing
5.3.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.2. COVID-19
5.3.2.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.3. Mosquito Borne Disease Testing
5.3.2.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.3.2. Malaria Testing
5.3.2.3.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.3.3. Dengue Testing
5.3.2.3.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.3.4. Zika Testing
5.3.2.3.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.3.5. Chikungunya Testing
5.3.2.3.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.3.6. Others
5.3.2.3.6.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.4. Influenza Testing
5.3.2.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.5. Sexually Transmitted Infection Testing
5.3.2.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.5.2. HIV Testing
5.3.2.5.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.5.3. HPV Testing
5.3.2.5.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.5.4. Chlamydia Testing
5.3.2.5.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.5.5. Gonorrhea Testing
5.3.2.5.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.5.6. Syphilis Testing
5.3.2.5.6.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.5.7. Other STI Testing
5.3.2.5.7.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.6. Hepatitis
5.3.2.6.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.7. Tuberculosis
5.3.2.7.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.2.8. Other Infectious Diseases
5.3.2.8.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.3. Cardiac Marker Testing
5.3.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.3.2. Troponin I and T Testing
5.3.3.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.3.3. CK-MB Testing
5.3.3.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.3.4. BNP and NT-Probnp Testing
5.3.3.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.3.5. Myoglobin Testing
5.3.3.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.3.6. D-Dimer Testing
5.3.3.6.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.3.7. Other Cardiac Marker Tests
5.3.3.7.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.4. Pregnancy & Fertility Testing
5.3.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.4.2. Pregnancy Testing
5.3.4.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.4.3. Fertility Testing
5.3.4.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.5. Cholesterol Testing/Lipid Profile
5.3.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.6. Drugs of Abuse Testing
5.3.6.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3.7. Other Clinical Tests
5.3.7.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.4. Veterinary Diagnostics
5.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.5. Food Safety & Environment Testing
5.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.6. Drug Development & Quality Testing
5.6.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 6. U.S. Lateral Flow Assay Market: Technique Estimates & Trend Analysis
6.1. U.S. Lateral Flow Assay Market: Technique Movement Analysis
6.2. U.S. Lateral Flow Assay Market Estimates and Forecasts, by Technique 2024 & 2033 (USD Million)
6.3. Sandwich Assays
6.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
6.4. Competitive Assays
6.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
6.5. Multiplex Detection Assays
6.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 7. U.S. Lateral Flow Assay Market: End Use Estimates & Trend Analysis
7.1. U.S. Lateral Flow Assay Market: End-use Movement Analysis
7.2. U.S. Lateral Flow Assay Market Estimates and Forecasts, by End-use 2024 & 2033 (USD Million)
7.3. Hospitals & Clinics
7.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
7.4. Diagnostic Laboratories
7.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
7.5. Home Care
7.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
7.6. Pharmaceutical & Biotechnology Companies
7.6.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
7.7. Other End-use
7.7.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 8. Competitive Landscape
8.1. Recent Developments & Impact Analysis by Key Market Participants
8.2. Company Categorization
8.3. Company Heat Map Analysis
8.4. Company Profiles
8.4.1. Abbott
8.4.1.1. Participant's Overview
8.4.1.2. Financial Performance
8.4.1.3. Product Benchmarking
8.4.1.4. Recent Developments/ Strategic Initiatives
8.4.2. Bio-Rad Laboratories, Inc
8.4.2.1. Participant's Overview
8.4.2.2. Financial Performance
8.4.2.3. Product Benchmarking
8.4.2.4. Recent Developments/ Strategic Initiatives
8.4.3. Siemens Healthineers AG
8.4.3.1. Participant's Overview
8.4.3.2. Financial Performance
8.4.3.3. Product Benchmarking
8.4.3.4. Recent Developments/ Strategic Initiatives
8.4.4. BIOMERIEUX
8.4.4.1. Participant's Overview
8.4.4.2. Financial Performance
8.4.4.3. Product Benchmarking
8.4.4.4. Recent Developments/ Strategic Initiatives
8.4.5. BD
8.4.5.1. Participant's Overview
8.4.5.2. Financial Performance
8.4.5.3. Product Benchmarking
8.4.5.4. Recent Developments/ Strategic Initiatives
8.4.6. QIAGEN
8.4.6.1. Participant's Overview
8.4.6.2. Financial Performance
8.4.6.3. Product Benchmarking
8.4.6.4. Recent Developments/ Strategic Initiatives
8.4.7. QuidelOrtho Corporation
8.4.7.1. Participant's Overview
8.4.7.2. Financial Performance
8.4.7.3. Product Benchmarking
8.4.7.4. Recent Developments/ Strategic Initiatives
8.4.8. F. Hoffmann-La Roche
8.4.8.1. Participant's Overview
8.4.8.2. Financial Performance
8.4.8.3. Product Benchmarking
8.4.8.4. Recent Developments/ Strategic Initiatives
8.4.9. DH Life Sciences, LLC.
8.4.9.1. Participant's Overview
8.4.9.2. Financial Performance
8.4.9.3. Product Benchmarking
8.4.9.4. Recent Developments/ Strategic Initiatives
8.4.10. Quest Diagnostics
8.4.10.1. Participant's Overview
8.4.10.2. Financial Performance
8.4.10.3. Product Benchmarking
8.4.10.4. Recent Developments/ Strategic Initiatives
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