North America Lateral Flow Assay Market Forecast to 2028 - COVID-19 Impact and Regional Analysis - by Product Type, Application, Technology, End User

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The North America lateral flow assay market is expected to grow from US$ 3,771.47 million in 2023 to US$ 5,255.35 million by 2028. It is estimated to record a CAGR of 6.9% from 2023 to 2028.

Increasing Use of Home-Based Assay Kits Fuels North America Lateral Flow Assay Market

Lateral flow assays (LFA) are paper-based tests designed for the detection of analytes (condition-specific biomolecules) in complex mixtures (biological samples), wherein samples are placed in a designated spot in a test device. These tests provide results within 5-30 minutes. Lateral flow assay kits exhibit stability over various environmental conditions and prolonged shelf life. Home tests based on lateral flow assays permit users to test self-collected samples and obtain results without the assistance of a trained medical professional. These tests are generally sold over the counter. A pregnancy test kit is one of the most familiar examples of home-based lateral flow assays. These assays are also designed for the diagnosis of infectious diseases, cardiovascular diseases, and stigmatized diseases such as HIV. Therefore, the rising prevalence of these diseases and the increasing adoption of lateral flow assay testing in home healthcare drive the lateral flow assay market growth. During the COVID-19 pandemic, many companies introduced at-home lateral flow assays for the diagnosis of SARS-CoV-2 infection due to people's reluctance to visit hospitals or diagnostic labs for testing.

In July 2020, BD Launched a portable, rapid point-of-care antigen test to detect SARS-CoV-2 infection in 15 minutes.

In August 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization for Abbott BinaxNOW COVID-19 Ag Card, a rapid test to detect the disease. BinaxNOW uses Abbott's proven lateral flow technology, making it a friendly and reliable method for frequent mass testing among healthcare providers.

North America Lateral Flow Assay Market Overview

The North America lateral flow assay market is segmented into the US, Canada, and Mexico. The US held the largest market share in 2022. The market growth in North America is attributed to the rising prevalence of various diseases, government support for the adoption of advanced diagnostics, and increasing efforts in R&D and other activities undertaken by market players. In addition, technological advancements in diagnostics benefit the North America lateral flow assay market. The growth of the US lateral flow assay market is attributed to the burgeoning demand for at-home kits for pregnancy testing and the rapidly increasing incidence of infectious diseases, such as HIV infection, hepatitis, H. pylori infection, and COVID-19. According to the Washington University School of Medicine, ~20 million women in the US rely on home pregnancy tests annually, which boosts the adoption of lateral flow assay-based pregnancy test kits. Moreover, the US is home to various companies developing advanced products for point-of-care diagnosis. For instance, in April 2020, US-based Bio-Rad Laboratories launched a blood-based immunoassay kit to identify antibodies to SARS-CoV-2. Thus, the innovative products manufactured by the US-based players and increasing diagnoses due to rapidly rising cases of infectious diseases in the country are a few factors boosting the lateral flow assay market growth.

North America Lateral Flow Assay Market Revenue and Forecast to 2028 (US$ Million)

North America Lateral Flow Assay Market Segmentation

The North America lateral flow assay market is segmented on the basis of product type, application, technology, end user, and country.

Based on product type, the North America lateral flow assay market is segmented into kits & reagents and lateral flow readers. The kits & reagents segment held a larger share of the market in 2023. The market for lateral flow readers is sub-segmented into portable/handheld readers and benchtop readers.

Based on application, the North America lateral flow assay market is segmented into clinical testing, veterinary diagnostics, food safety & environment testing, and drug development & quality testing. The clinical testing segment held the largest share of the market in 2023. The market for veterinary diagnostics is sub-segmented into companion animals and livestock. The market for the drug development & quality testing segment is further segmented into infectious diseases testing, cardiac marker testing, pregnancy and fertility testing, cholesterol testing/ lipid profile, drug of abuse testing, and others.

Based on technology, the North America lateral flow assay market is segmented into sandwich assays, competitive assays, and multiplex detection assays. The sandwich assays segment held the largest share of the market in 2023.

Based on end user, the North America lateral flow assay market is segmented into hospitals & clinics, pharmaceutical & biotechnology companies, diagnostics laboratories, homecare, veterinary clinics, and others. The hospitals & clinics segment held the largest share of the market in 2023.

Based on country, the North America lateral flow assay market is segmented into the US, Canada, and Mexico. The US dominated the market in this region in 2023.

Abbott Laboratories, Access Bio Inc, bioMerieux SA, Bio-Rad Laboratories Inc, Danaher Corp, Hoffmann-La Roche Ltd, Hologic Inc, Merck KGaA, Qiagen NV, and Thermo Fisher Scientific Inc are the leading companies operating in the North America lateral flow assay market.

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Product Code: BMIRE00028829

1. Introduction

1.1 Study Scope
1.2 The Insight Partners Research Report Guidance
1.3 Market Segmentation
- 1.3.1 North America Lateral Flow Assay Market - by Product Type
- 1.3.2 North America Lateral Flow Assay Market - by Application
- 1.3.3 North America Lateral Flow Assay Market - by Technology
- 1.3.4 North America Lateral Flow Assay Market - by End User
- 1.3.5 North America Lateral Flow Assay Market - by Country

2. North America Lateral Flow Assay Market - Key Takeaways

3. Research Methodology

3.1 Coverage
3.2 Secondary Research
3.3 Primary Research

4. North America Lateral Flow Assay Market - Market Landscape

4.1 Overview
4.2 North America PEST Analysis
4.3 Expert's Opinion

5. North America Lateral Flow Assay Market - Key Market Dynamics

5.1 Market Drivers
- 5.1.1 Increasing Use of Home-Based Assay Kits
- 5.1.2 Rising Popularity of Point-of-Care Testing
5.2 Market Restraints
- 5.2.1 Inconsistent Assay Results Due to Procedural Limitations
5.3 Market Opportunities
- 5.3.1 Evolving Applications of Lateral Flow Assays
5.4 Future Trends
- 5.4.1 Smartphone Usage and AI Integration in Lateral Flow Immunoassay
5.5 Impact analysis

6. Lateral Flow Assay Market - North America Analysis

6.1 North America Lateral Flow Assay Market Revenue Forecast and Analysis

7. North America Lateral Flow Assay Market Analysis - by Product Type

7.1 Overview
7.2 Kits & Reagents
- 7.2.1 Overview
- 7.2.2 Kits & Reagents: North America Lateral Flow Assay Market - Revenue and Forecast to 2028 (US$ Million)
7.3 Lateral Flow Readers
- 7.3.1 Overview
- 7.3.2 Lateral Flow Readers: North America Lateral Flow Assay Market - Revenue and Forecast to 2028 (US$ Million)
  - 7.3.2.1 Portable/Handheld Reader
    - 7.3.2.1.1 Overview
    - 7.3.2.1.2 Portable/Handheld Reader: North America Lateral Flow Assay Market - Revenue and Forecast to 2028 (US$ Million)
  - 7.3.2.2 Benchtop
    - 7.3.2.2.1 Overview
    - 7.3.2.2.2 Benchtop: North America Lateral Flow Assay Market - Revenue and Forecast to 2028 (US$ Million)

8. North America Lateral Flow Assay Market Analysis - by Application

8.1 Overview
8.2 North America Lateral Flow Assay Market Revenue Share, by Application (2022 and 2028)
8.3 Clinical Testing
- 8.3.1 Overview
- 8.3.2 Clinical Testing: North America Lateral Flow Assay Market - Revenue and Forecast to 2028 (US$ Million)
8.4 Veterinary Diagnostics
- 8.4.1 Overview
- 8.4.2 Veterinary Diagnostics: North America Lateral Flow Assay Market - Revenue and Forecast to 2028 (US$ Million)
- 8.4.3 Companion Animal
  - 8.4.3.1 Overview
  - 8.4.3.2 Companion Animal: North America Lateral Flow Assay Market - Revenue and Forecast to 2028 (US$ Million)
- 8.4.4 Livestock Animal
  - 8.4.4.1 Overview
  - 8.4.4.2 Livestock Animal: North America Lateral Flow Assay Market - Revenue and Forecast to 2028 (US$ Million)
8.5 Food Safety and Environment Testing
- 8.5.1 Overview
- 8.5.2 Food Safety and Environment Testing: North America Lateral Flow Assay Market - Revenue and Forecast to 2028 (US$ Million)
8.6 Drug Development and Quality Testing
- 8.6.1 Overview
- 8.6.2 Drug Development and Quality Testing: North America Lateral Flow Assay Market - Revenue and Forecast to 2028 (US$ Million)
- 8.6.3 Infectious Diseases Testing
  - 8.6.3.1 Overview
  - 8.6.3.2 Infectious Diseases Testing: North America Lateral Flow Assay Market - Revenue and Forecast to 2028 (US$ Million)
- 8.6.4 Cardiac Marker Testing
  - 8.6.4.1 Overview
  - 8.6.4.2 Cardiac Market Testing: North America Lateral Flow Assay Market - Revenue and Forecast to 2028 (US$ Million)
- 8.6.5 Pregnancy and Fertility Testing
  - 8.6.5.1 Overview
  - 8.6.5.2 Pregnancy and Fertility Testing: North America Lateral Flow Assay Market - Revenue and Forecast to 2028 (US$ Million)
- 8.6.6 Cholesterol Testing/Lipid Profile
  - 8.6.6.1 Overview
  - 8.6.6.2 Cholesterol Testing/Lipid Profile: North America Lateral Flow Assay Market - Revenue and Forecast to 2028 (US$ Million)
- 8.6.7 Drug of Abuse Testing
  - 8.6.7.1 Overview
  - 8.6.7.2 Drug of Abuse Testing: North America Lateral Flow Assay Market - Revenue and Forecast to 2028 (US$ Million)
- 8.6.8 Others
  - 8.6.8.1 Overview
  - 8.6.8.2 Others: North America Lateral Flow Assay Market - Revenue and Forecast to 2028 (US$ Million)

9. North America Lateral Flow Assay Market Analysis - by Technology

9.1 Overview
9.2 Sandwich Assays
- 9.2.1 Overview
- 9.2.2 Sandwich Assays: North America Lateral Flow Assays Market - Revenue and Forecast to 2028 (US$ Million)
9.3 Competitive Assays
- 9.3.1 Overview
- 9.3.2 Competitive Assays: North America Lateral Flow Assays Market - Revenue and Forecast to 2028 (US$ Million)
9.4 Multiplex Detection Assays
- 9.4.1 Overview
- 9.4.2 Multiplex Detection Assays: North America Lateral Flow Assays Market - Revenue and Forecast to 2028 (US$ Million)

10. North America Lateral Flow Assay Market Analysis - by End User

10.1 Overview
10.2 Hospitals & Clinics
- 10.2.1 Overview
- 10.2.2 Hospitals & Clinics: North America Lateral Flow Assays Market - Revenue and Forecast to 2028 (US$ Million)
10.3 Pharmaceutical & Biotechnology Companies
- 10.3.1 Overview
- 10.3.2 Pharmaceutical & Biotechnology Companies: North America Lateral Flow Assays Market - Revenue and Forecast to 2028 (US$ Million)
10.4 Diagnostic Laboratories
- 10.4.1 Overview
- 10.4.2 Diagnostic Laboratories: North America Lateral Flow Assays Market - Revenue and Forecast to 2028 (US$ Million)
10.5 Home Care
- 10.5.1 Overview
- 10.5.2 Home Care: North America Lateral Flow Assays Market - Revenue and Forecast to 2028 (US$ Million)
10.6 Veterinary Clinics
- 10.6.1 Overview
- 10.6.2 Veterinary Clinics: North America Lateral Flow Assays Market - Revenue and Forecast to 2028 (US$ Million)
10.7 Others
- 10.7.1 Overview
- 10.7.2 Others: North America Lateral Flow Assays Market - Revenue and Forecast to 2028 (US$ Million)

11. North America Lateral Flow Assay Market Country Analysis

11.1 Overview
- 11.1.1 North America Lateral Flow Assay Market, By Country, 2022 & 2028 (%)
  - 11.1.1.1 U.S.: North America Lateral Flow Assay Market Revenue and Forecasts to 2028 (US$ Mn)
    - 11.1.1.1.1 U.S.: North America Lateral Flow Assay Market Revenue and Forecasts to 2028 (US$ Mn)
    - 11.1.1.1.2 U.S.: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Product Type (US$ Mn)
    - 11.1.1.1.2.1 U.S.: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Lateral Flow Reader (US$ Mn)
    - 11.1.1.1.2.2 U.S.: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Application (US$ Mn)
    - 11.1.1.1.3 U.S.: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Clinical Testing (US$ Mn)
    - 11.1.1.1.4 U.S.: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Veterinary Diagnostics (US$ Mn)
    - 11.1.1.1.5 U.S.: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Technology (US$ Mn)
    - 11.1.1.1.6 U.S.: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By End User (US$ Mn)
  - 11.1.1.2 Canada: North America Lateral Flow Assay Market Revenue and Forecasts to 2028 (US$ Mn)
    - 11.1.1.2.1 Canada: North America Lateral Flow Assay Market Revenue and Forecasts to 2028 (US$ Mn)
    - 11.1.1.2.2 Canada: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Product Type (US$ Mn)
    - 11.1.1.2.2.1 Canada: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Lateral Flow Reader (US$ Mn)
    - 11.1.1.2.2.2 Canada: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Application (US$ Mn)
    - 11.1.1.2.3 Canada: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Clinical Testing (US$ Mn)
    - 11.1.1.2.4 Canada: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Veterinary Diagnostics (US$ Mn)
    - 11.1.1.2.5 Canada: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Technology (US$ Mn)
    - 11.1.1.2.6 Canada: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By End User (US$ Mn)
  - 11.1.1.3 Mexico: North America Lateral Flow Assay Market Revenue and Forecasts to 2028 (US$ Mn)
    - 11.1.1.3.1 Mexico: North America Lateral Flow Assay Market Revenue and Forecasts to 2028 (US$ Mn)
    - 11.1.1.3.2 Mexico: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Product Type (US$ Mn)
    - 11.1.1.3.2.1 Mexico: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Lateral Flow Reader (US$ Mn)
    - 11.1.1.3.2.2 Mexico: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Application (US$ Mn)
    - 11.1.1.3.3 Mexico: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Clinical Testing (US$ Mn)
    - 11.1.1.3.4 Mexico: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Veterinary Diagnostics (US$ Mn)
    - 11.1.1.3.5 Mexico: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By Technology (US$ Mn)
    - 11.1.1.3.6 Mexico: North America Lateral Flow Assay Market Revenue and Forecasts to 2028, By End User (US$ Mn)

12. North America Lateral Flow Assay Market-Industry Landscape

12.1 Overview
12.2 Growth Strategies in the North America Lateral Flow Assay Market
12.3 Inorganic Growth Strategies
- 12.3.1 Overview
12.4 Organic Growth Strategies
- 12.4.1 Overview

13. Company Profile

13.1 Hoffmann-La Roche Ltd
- 13.1.1 Key Facts
- 13.1.2 Business Description
- 13.1.3 Products and Services
- 13.1.4 Financial Overview
- 13.1.5 SWOT Analysis
- 13.1.6 Key Developments
13.2 Thermo Fisher Scientific Inc
- 13.2.1 Key Facts
- 13.2.2 Business Description
- 13.2.3 Products and Services
- 13.2.4 Financial Overview
- 13.2.5 SWOT Analysis
- 13.2.6 Key Developments
13.3 Abbott Laboratories
- 13.3.1 Key Facts
- 13.3.2 Business Description
- 13.3.3 Products and Services
- 13.3.4 Financial Overview
- 13.3.5 SWOT Analysis
- 13.3.6 Key Developments
13.4 Merck KGaA
- 13.4.1 Key Facts
- 13.4.2 Business Description
- 13.4.3 Products and Services
- 13.4.4 Financial Overview
- 13.4.5 SWOT Analysis
- 13.4.6 Key Developments
13.5 Hologic Inc
- 13.5.1 Key Facts
- 13.5.2 Business Description
- 13.5.3 Products and Services
- 13.5.4 Financial Overview
- 13.5.5 SWOT Analysis
- 13.5.6 Key Developments
13.6 Qiagen NV
- 13.6.1 Key Facts
- 13.6.2 Business Description
- 13.6.3 Products and Services
- 13.6.4 Financial Overview
- 13.6.5 SWOT Analysis
- 13.6.6 Key Developments
13.7 bioMerieux SA
- 13.7.1 Key Facts
- 13.7.2 Business Description
- 13.7.3 Products and Services
- 13.7.4 Financial Overview
- 13.7.5 SWOT Analysis
- 13.7.6 Key Developments
13.8 Bio-Rad Laboratories Inc
- 13.8.1 Key Facts
- 13.8.2 Business Description
- 13.8.3 Products and Services
- 13.8.4 Financial Overview
- 13.8.5 SWOT Analysis
- 13.8.6 Key Developments
13.9 Access Bio Inc
- 13.9.1 Key Facts
- 13.9.2 Business Description
- 13.9.3 Products and Services
- 13.9.4 Financial Overview
- 13.9.5 SWOT Analysis
- 13.9.6 Key Developments
13.10 Danaher Corp
- 13.10.1 Key Facts
- 13.10.2 Business Description
- 13.10.3 Products and Services
- 13.10.4 Financial Overview
- 13.10.5 SWOT Analysis
- 13.10.6 Key Developments

14. Appendix

14.1 Glossary of Terms