North America Lateral Flow Assay Market Forecast to 2030 - Regional Analysis - by Product Type, Technique, Test Type, Application, and End User

The North America lateral flow assay market was valued at US$ 3.68 billion in 2022 and is expected to reach US$ 7.08 billion by 2030; it is estimated to register a CAGR of 8.5% from 2022 to 2030.

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 later flow assays permit users to test self-collected samples and get 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. Further, these assays are 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 October 2020, Siemens Healthineers launched the CLINITEST Rapid COVID-19 Antigen Self-Test that helps detect the infection in 15 minutes so that the infected individuals can be isolated sooner to avoid the disease spread.

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.

In September 2020, Roche launched a SARS-CoV-2 Rapid Antigen Test for markets accepting the CE Mark.

North America Lateral Flow Assay Market Overview

North America lateral flow assay market is segmented into the US, Canada, and Mexico. The US held the largest North America lateral flow assay market share in 2022. The market growth in the region is characterized by the growing prevalence of various diseases, government support for advanced diagnostics adoption, and increasing efforts in R&D and other activities undertaken by market players. In addition, technological advancements in the diagnosis industry are likely to be a major driver for the North America lateral flow assay market over the coming years.

The US lateral flow assay market holds a significant share in North America. The growth of the US lateral flow assay market is attributed to the growing demand for at-home kits for pregnancy testing and the rapidly increasing incidence of infectious diseases, such as HIV, Hepatitis, H. pylori, and COVID-19. According to the Washington University School of Medicine, annually, ~20 million women in the US rely on home pregnancy tests, which boosts the adoption of lateral flow assay-based pregnancy test kits.

North America Lateral Flow Assay Market Segmentation

The North America lateral flow assay market is categorized into product type, technique, test type, application, end user, and country.

Based on product type, the North America lateral flow assay market is bifurcated into kits & reagents and lateral flow readers. The kits & reagents segment held a larger North America lateral flow assay market share in 2022.

In terms of technique, the North America lateral flow assay market is segmented into sandwich assay, competitive assays, and multiplex detection assay. The sandwich assay segment held the largest North America lateral flow assay market share in 2022.

By test type, the North America lateral flow assay market is divided into lateral flow immunoassay and nucleic acid lateral flow assay. The lateral flow immunoassay segment held a larger North America lateral flow assay market share in 2022.

Based on application, the North America lateral flow assay market is categorized into clinical testing, veterinary diagnostics, food safety & environment testing, and drug development & quality testing. The clinical testing segment held the largest North America lateral flow assay market share in 2022.

By end user, the North America lateral flow assay market is segmented into hospitals and clinics, diagnostics laboratories, homecare, veterinary clinics, pharmaceutical & biotechnology companies, and others. The hospitals and clinics segment held the largest North America lateral flow assay market share in 2022.

By country, the North America lateral flow assay market is segmented into the US, Canada, and Mexico. The US dominated the North America lateral flow assay market share in 2022.

F. Hoffmann-La Roche Ltd, Siemens Healthineers AG, Becton Dickinson and Co, PerkinElmer Inc, Hologic Inc, QIAGEN NV, bioMerieux SA, QuidelOrtho Corp, Abbott Laboratories, Merck KGaA, Bio-Rad Laboratories Inc, and Thermo Fisher Scientific Inc are some of the leading companies operating in the North America lateral flow assay market.