U.S. Lateral Flow Assay Market Size, Share, Trends, Industry Analysis Report, By Product (Kits & Reagents, Lateral Flow Readers, Benchtop Readers), By Application, By Technique, By End Use

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The U.S. lateral flow assay market size is expected to reach USD 5.39 billion by 2034, according to a new study by Polaris Market Research. The report "U.S. Lateral Flow Assay Market Size, Share, Trends, Industry Analysis Report By Product (Kits & Reagents, Lateral Flow Readers, Benchtop Readers), By Application, By Technique, By End Use - Market Forecast, 2025-2034" gives a detailed insight into current market dynamics and provides analysis on future market growth.

A lateral flow assay is a simple, paper-based diagnostic device used to detect the presence of a target substance, such as proteins, hormones, or pathogens, in a liquid sample.

The lateral flow assay application is expanding in noninfectious and nonclinical settings. While lateral flow assays were originally designed for infectious disease testing, they are now being used in a much wider range of applications. In healthcare, tests are being developed for conditions such as cancer, heart disease, and even neurological disorders. These tests can detect biomarkers related to disease risk or progression, helping doctors monitor patients more easily. Beyond medicine, LFAs are also used in veterinary care, food safety, and environmental monitoring. For example, they detect allergens in food or harmful bacteria in water. In agriculture, they help monitor animal health quickly on-site. This broad range of uses means that the demand for lateral flow tests is not limited to hospitals and clinics. As new applications are developed, particularly in industries that need fast results without lab access, lateral flow technology becomes even more important. This expansion into nontraditional settings drives the U.S. lateral flow assay market expansion.

The use of smartphones and digital readers is changing how lateral flow assays are interpreted and recorded. Instead of relying solely on human eyes to judge a faint line, digital readers and apps help provide more accurate and consistent results. Many of these tools read the test strip, interpret the result, and even store or transmit data directly to healthcare providers. This digital integration is particularly helpful in remote monitoring, telemedicine, and managing chronic conditions. For example, a patient can test at home and send the result to their doctor without needing to visit a clinic. These digital features also reduce the chances of misreading the result and improve data collection for public health tracking. As digital health becomes more common in the U.S., the ability to pair tests with smart technology makes lateral flow assays even more appealing, especially for patients who want fast answers with professional follow-up options.

U.S. Lateral Flow Assay Market Report Highlights

The kits & reagents segment dominated with the largest share in 2024 period as these components form the core of any lateral flow testing system and are directly responsible for carrying out the test and producing results.

The multiplex detection assays segment is expected to experience significant growth due to their ability to detect multiple targets simultaneously in a single test.

A few key players in the U.S. market are Abbott; Bio-Rad Laboratories, Inc; Siemens Healthineers AG; BIOMERIEUX; BD; QIAGEN; QuidelOrtho Corporation; F. Hoffmann-La Roche; DH Life Sciences, LLC; and Quest Diagnostics.

Polaris Market Research has segmented the U.S. lateral flow assay market report on the basis of product, application, technique, and end use:

By Product (Revenue - USD Billion, 2020-2034)

Kits & Reagents

Lateral Flow Readers

Benchtop Readers

Digital Readers

By Application (Revenue - USD Billion, 2020-2034)

Clinical Testing

Veterinary Diagnostics

Food Safety & Environment Testing

Drug Development & Quality Testing

By Technique (Revenue - USD Billion, 2020-2034)

Sandwich Assays

Competitive Assays

Multiplex Detection Assays

By End Use (Revenue - USD Billion, 2020-2034)

Hospitals & Clinics

Diagnostic Laboratories

Home Care

Pharmaceutical & Biotechnology Companies

Others

Product Code: PM5957

1. Introduction

1.1. Report Description
- 1.1.1. Objectives of the Study
- 1.1.2. Market Scope
- 1.1.3. Assumptions
1.2. Stakeholders

2. Executive Summary

2.1. Market Highlights

3. Research Methodology

3.1. Overview
- 3.1.1. Data Mining
3.2. Data Sources
- 3.2.1. Primary Sources
- 3.2.2. Secondary Sources

4. U.S. Lateral Flow Assay Market Insights

4.1. AAMI Level 3 Surgical Gown Market - Market Snapshot
4.2. AAMI Level 3 Surgical Gown Market Dynamics
- 4.2.1. Drivers and Opportunities
  - 4.2.1.1. Rising Prevalence of Infectious Diseases
  - 4.2.1.2. Demand for Point of Care and Home Testing
- 4.2.2. Restraints and Challenges
  - 4.2.2.1. High Initial Investment
4.3. Porter's Five Forces Analysis
- 4.3.1. Bargaining Power of Suppliers (Moderate)
- 4.3.2. Threats of New Entrants: (Low)
- 4.3.3. Bargaining Power of Buyers (Moderate)
- 4.3.4. Threat of Substitute (Moderate)
- 4.3.5. Rivalry among existing firms (High)
4.4. PESTEL Analysis
4.5. AAMI Level 3 Surgical Gown Market Trends
4.6. Value Chain Analysis

5. U.S. Lateral Flow Assay Market, by Product

5.1. Key Findings
5.2. Introduction
- 5.2.1. U.S. Lateral Flow Assay Market, by Product, 2020-2034 (USD billion)
5.3. Kits & Reagents
- 5.3.1. U.S. Lateral Flow Assay Market, by Kits & Reagents, 2020-2034 (USD billion)
5.4. Lateral Flow Readers
- 5.4.1. U.S. Lateral Flow Assay Market, by Lateral Flow Readers, 2020-2034 (USD billion)
5.5. Benchtop Readers
- 5.5.1. U.S. Lateral Flow Assay Market, by Benchtop Readers, 2020-2034 (USD billion)
5.6. Digital Readers
- 5.6.1. U.S. Lateral Flow Assay Market, by Digital Readers, 2020-2034 (USD billion)

6. U.S. Lateral Flow Assay Market, by Application

6.1. Key Findings
6.2. Introduction
- 6.2.1. U.S. Lateral Flow Assay Market, by Application, 2020-2034 (USD billion)
6.3. Clinical Testing
- 6.3.1. U.S. Lateral Flow Assay Market, by Clinical Testing, 2020-2034 (USD billion)
6.4. Veterinary Diagnostics
- 6.4.1. U.S. Lateral Flow Assay Market, by Veterinary Diagnostics, 2020-2034 (USD billion)
6.5. Food Safety & Environment Testing
- 6.5.1. U.S. Lateral Flow Assay Market, by Food Safety & Environment Testing, 2020-2034 (USD billion)
6.6. Drug Development & Quality Testing
- 6.6.1. U.S. Lateral Flow Assay Market, by Drug Development & Quality Testing, 2020-2034 (USD billion)

7. U.S. Lateral Flow Assay Market, by Technique

7.1. Key Findings
7.2. Introduction
- 7.2.1. U.S. Lateral Flow Assay Market, by Medical Biotechnology, 2020-2034 (USD billion)
7.3. Sandwich Assays
- 7.3.1. U.S. Lateral Flow Assay Market, by Sandwich Assays, 2020-2034 (USD billion)
7.4. Competitive Assays
- 7.4.1. U.S. Lateral Flow Assay Market, by Competitive Assays, 2020-2034 (USD billion)
7.5. Multiplex Detection Assays
- 7.5.1. U.S. Lateral Flow Assay Market, by Multiplex Detection Assays, 2020-2034 (USD billion)

8. U.S. Lateral Flow Assay Market, by End Use

8.1. Key Findings
8.2. Introduction
- 8.2.1. U.S. Lateral Flow Assay Market, by End Use, 2020-2034 (USD billion)
8.3. Hospitals & Clinics
- 8.3.1. U.S. Lateral Flow Assay Market, by Hospitals & Clinics, 2020-2034 (USD billion)
8.4. Diagnostic Laboratories
- 8.4.1. U.S. Lateral Flow Assay Market, by Diagnostic Laboratories, 2020-2034 (USD billion)
8.5. Home Care
- 8.5.1. U.S. Lateral Flow Assay Market, by Home Care, 2020-2034 (USD billion)
8.6. Pharmaceutical & Biotechnology Companies
- 8.6.1. U.S. Lateral Flow Assay Market, by Pharmaceutical & Biotechnology Companies 2020-2034 (USD billion)
8.7. Others
- 8.7.1. U.S. Lateral Flow Assay Market, by Others 2020-2034 (USD billion)

9. Competitive Landscape

9.1. Expansion and Acquisition Analysis
- 9.1.1. Expansion
- 9.1.2. Acquisitions
9.2. Partnerships/Collaborations/Agreements/Exhibitions

10. Company Profiles

10.1. Abbott
- 10.1.1. Company Overview
- 10.1.2. Financial Performance
- 10.1.3. Product Benchmarking
- 10.1.4. Recent Development
10.2. Bio-Rad Laboratories, Inc
- 10.2.1. Company Overview
- 10.2.2. Financial Performance
- 10.2.3. Product Benchmarking
- 10.2.4. Recent Development
10.3. Siemens Healthineers AG
- 10.3.1. Company Overview
- 10.3.2. Financial Performance
- 10.3.3. Product Benchmarking
- 10.3.4. Recent Development
10.4. BIOMERIEUX
- 10.4.1. Company Overview
- 10.4.2. Financial Performance
- 10.4.3. Product Benchmarking
- 10.4.4. Recent Development
10.5. BD
- 10.5.1. Company Overview
- 10.5.2. Financial Performance
- 10.5.3. Product Benchmarking
- 10.5.4. Recent Development
10.6. QIAGEN
- 10.6.1. Company Overview
- 10.6.2. Financial Performance
- 10.6.3. Product Benchmarking
- 10.6.4. Recent Development
10.7. QuidelOrtho Corporation
- 10.7.1. Company Overview
- 10.7.2. Financial Performance
- 10.7.3. Product Benchmarking
- 10.7.4. Recent Development
10.8. F. Hoffmann-La Roche
- 10.8.1. Company Overview
- 10.8.2. Financial Performance
- 10.8.3. Product Benchmarking
- 10.8.4. Recent Development
10.9. DH Life Sciences, LLC.
- 10.9.1. Company Overview
- 10.9.2. Financial Performance
- 10.9.3. Product Benchmarking
- 10.9.4. Recent Development
10.10. Quest Diagnostics
- 10.10.1. Company Overview
- 10.10.2. Financial Performance
- 10.10.3. Product Benchmarking
- 10.10.4. Recent Development