North America Lateral Flow Assay Market Forecast to 2028 – COVID-19 Impact and Regional Analysis – by Product Type (Kits & Reagents and Lateral Flow Readers), Application (Clinical Testing, Veterinary Diagnostics, Food Safety & Environment Testing, and Dr

North America Lateral Flow Assay Market Forecast to 2028 – COVID-19 Impact and Regional Analysis – by Product Type (Kits & Reagents and Lateral Flow Readers), Application (Clinical Testing, Veterinary Diagnostics, Food Safety & Environment Testing, and Drug Development & Quality Testing), Technology (Sandwich Assays, Competitive Assays, and Multiplex Detection Assays), End User (Hospitals & Clinics, Pharmaceutical & Biotechnology Companies, Diagnostics Laboratories, Homecare, Veterinary Clinics, and Others)

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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