Global Lateral Flow Assay Market - 2022-2029

Market Overview

Lateral Flow Assay Market size was valued US$ 8,924.03 million in 2021 and is estimated to reach US$ 12,816.53 million by 2029, growing at a CAGR of 4.4% during the forecast period (2022-2029).

Lateral flow assays (LFAs) are immunochromatographic assays used to detect the target analyte's presence or absence (such as pathogens) in samples. These are commonly used for diagnostics for laboratory use, home testing, and point-of-care testing. They are quick, inexpensive, easy-to-manufacture, and -use tests widely employed in medical and environmental applications, particularly in low resource settings.

Market Dynamics

The global lateral flow assay market is growing due to several factors: rising prevalence of infectious diseases, increasing demand for home-based lateral flow assay test kits, growing geriatric population, and rising demand for point-of-care testing.

Rising prevalence of infectious diseases worldwide is expected to drive market growth.

The increasing technological advancements in sample detection techniques are also expected to drive the global lateral flow assay market's growth over the forecast period. Several manufacturers are developing advanced test readers who measure the intensity of a sample's test line. There is rising adoption of handheld lateral flow assay readers owing to ease portability. The advancements in lateral flow assays in terms of selectivity, sensitivity, and quantification progress lead to several improvised functions. Also, the development of test-specific advanced image processing algorithms has led to the quantification of sample analytes. Alternative non-optical technologies, such as Magnetic Immunoassay (MIA) and capillary pumping of the sample fluid to reduce variations in sample volume, also boost the market's growth.

The growth in demand for point-of-care testing devices has led to new product launches. For instance, in February 2019, Abbott launched an advanced sensitive, rapid diagnostics test. Determine TM HBsAg 2 test used to detect Hepatitis B surface antigen and be used in most healthcare settings.

In September 2019, Mologic started developing a multimarker point-of-care diagnostic test using lateral flow technology anticipated to launch in Europe by 2020. The diagnostic test is part of the developer's mission to redefine lateral flow technology, which is evaluated as part of a University College London Hospitals (UCLH) study.

Also, the growing awareness and self-diagnosis are driving the demand for lateral flow assays. A rising home diagnosis trend has led to an increase in demand for self-test kits. These self-test kits can be easily available in hospitals, pharmacies, and online. The home diagnosis kits are offered for various disorders and indications, such as diabetes, high cholesterol levels, pregnancy tests, infections, among others. These self-diagnosis lateral flow assay kits are quick & easy to use and generally require a urine sample or a finger prick. The rising popularity of home-based lateral flow assay test kits is growing significantly in several countries, such as India, China, and South Africa, where infectious diseases, such as diabetes, tuberculosis, and HIV, are increasing.

Reluctance towards changing existing diagnostic practices is expected to hamper the market growth.

Factors such the stringent regulatory policies, long awaiting approvals for lateral flow assays, and aversion of people towards changing the existing medical practices hinder the market's growth. The product recalls, and implementation of some excise duties on medical devices in the U.S. are also some restraining factors.

Industry Analysis

The global lateral flow assay market provides in-depth analysis of the market based on various industry factors such as Porter's Five Forces, Regulatory Analysis, Supply Chain Analysis, Pricing Analysis, Product Innovation, Unmet Needs.

Segment Analysis

Kits and reagents segment is expected to hold the largest market share in global lateral flow assay market

The lateral flow assay market is classified into kits & reagents and lateral flow readers based on product. Among these, the kits & reagents segment accounted for the largest market share due to the rising application of lateral flow kits & reagents for point-of-care testing, increasing prevalence of chronic diseases, and growing usage of lateral flow kits in-home care. The emerging companies are collaborating to develop advanced and effective lateral flow test instruments. For instance, in January 2019, Anteo Diagnostics has collaborated with Sona Nanotech Inc. to advance the lateral flow test development speed and enhance lateral flow tests' performance. Also, lateral flow kits are improvised and developed for several other applications. For instance, in May 2019, Zimmer Biomet received the FDA approval to market Synovasure, a lateral flow test kit that helps detect periprosthetic joint infection in the synovial fluid of patients that have been evaluated for a knee revision surgery.

On the other hand, the lateral flow reader segment is anticipated to grow at the highest CAGR over the forecast period. The lateral flow readers interpret results precisely for routine sample testing, research, and several other applications. For instance, in March 2019, Alere (now Abbott) launched a quick influenza diagnostic test known as BinaxNOW Influenza A & B Card 2, which has been granted a CLIA waiver to be used with Abbott's diagnostic reader DIGIVAL. The diagnostic reader reads and interprets the lateral flow tests in just a few seconds, delivers the objective, and automates the results in any healthcare setting.

Based on application, the clinical testing segment was dominating the lateral flow assay market the rising incidences of chronic diseases and growing demand for patient-centric care.

Geographical Analysis

North America region holds the largest market share in the global lateral flow assay market

North America is dominating the global lateral flow assay market accounted for the largest market share, owing to the increasing incidence of chronic diseases, presence of a highly developed healthcare system, rising geriatric population, rising adoption of advanced products, and a large number of lateral flow assay kits manufacturing companies in this region. As per the US Centres for Disease Control and Prevention (CDC) data, there have been approximately 7 million influenza infections in the US in 2019, resulting in an estimated 84,000 hospitalizations. Thus, increasing the incidence of infectious diseases is expected to boost lateral flow assays' demand over the forecast period.

The Asia-Pacific lateral flow assay market is expected to grow at the fastest growth rate over the forecast period, owing to the rising prevalence of infectious diseases in countries such as China, Japan, and India. The increasing incidences of HIV are boosting the growth of the market.

Most of the major key players are based in North America such as Merck KGaA, Bio-Rad Laboratories, Thermo Fisher Scientific, Inc., and Danaher Corporation etc are contributing in making this region the largest shareholder in lateral flow assay market.

Competitive Landscape

The global lateral flow assay market is fragmented with a large number of global & local players. Some of the market's major players include Merck KGaA, F. Hoffmann-La Roche AG, Bio-Rad Laboratories, Inc., ABBOTT Laboratories, Siemens AG, Danaher Corporation, Becton, Dickinson and Company, QIAGEN N.V., Thermo Fisher Scientific Inc., bioMerieux SA, Hologic Inc., among others.

The key players adopt various growth strategies such as expansion, mergers & acquisitions, partnerships, product launches, and collaborations, contributing to the lateral flow assay market's growth globally. For instance,

Lateral flow assays (LFAs) are immunochromatographic assays used to diagnose target analytes' presence or absence (such as pathogens) in samples. These are commonly used for diagnostics for laboratory use, home testing, and point-of-care testing. They are quick, inexpensive, easy-to-manufacture, and -use tests widely employed in medical and environmental applications, particularly in low resource settings.

In September 2019, QIAGEN launched its newly enhanced GeneGlobe Design & Analysis Hub, bringing next-level experiment planning, execution, and follow-up to life science researchers.

In June 2019, Singapore-based Proteona Pte. Ltd. launched the ESCAPE proteogenomics assay designed specifically for Chimeric Antigen Receptor (CAR) T cell characterization. This is the first commercial product designed to characterize RNA and protein expression levels across thousands of single CAR T cells.

Key Companies to Watch

QIAGEN:

Overview: Qiagen a German company that develops sample and assay technologies used for molecular testing and diagnostics, and biopharma research. It was founded in 1984 and is headquartered in Hilden, Germany. Their products and services are being provided in around 25 countries.

Product Portfolio:

ESEQuant LR3: It is a very sensitive and cost-effective fluorescence measurement system used for rapid tests. This system is based on ready-to-use concept, helps to develop fluorescence or colorimetric tests easily. The combo of fluorescence reader and extensive developer´s Lateral Flow Studio Software gives an easy-to-modify and control lateral flow system.

Key Developments: In Sep 2020, Qiagen and NeuMoDx in partnership are manufacturing and marketing two fully integrated automated PCR devices.

The global lateral flow assay market report would provide an access to an approx. 45+market data table, 40+figures and 180pages.