Lateral Flow Assay Market – Insights
In the field of on-site diagnostics, lateral flow assay (LFA) are well-established commercial product due to their ability of providing precise, fast, and low-cost result such as home-based pregnancy tests. Lateral flow assay technology are rapidly evolved over the years and routinely used for point-of-care and companion diagnostic applications. Moreover, technological advances to transform the assays from simple qualitative tests into complex multi-analyte quantitative assay are driving growth of the lateral flow assay market. Lateral flow assay market is projected to witness growth over the forecast period, owing to increasing application in medical diagnostics, high prevalence of infectious disease, increasing demand for point-of-care testing, and high adoption of home-based lateral flow assay test. The global lateral flow assay market was valued at US$ 5.6 billion in 2017 and is expected to witness a CAGR of 7.5% over the forecast period (2017 – 2025).
Global Lateral Flow Assay Market Share (%), By Product Type, 2017 & 2025
Increasing adoption of home-based lateral flow assay test are driving growth of the lateral flow assay market
Increasing prevalence of lifestyle and infectious diseases rising the demand for point-of-care testing under home care settings which has the ability to provide result in real-time (5-15 minutes), and ease of use. The home pregnancy test is well recognized example of lateral flow assay technology, which detects the presence of a hormone produced during pregnancy and displays a binary result. Adoption of home-based lateral flow assay devices is increasing, owing to various features such as portable device, low production cost, immediate results, and overall ease of use. Lateral flow assay based point-of-care testing improves the quality of care, owing to various advantages offered by them such as cost savings, reduced doctor, visits and laboratory overhead costs. However, variance in lateral flow assay test results may hinder growth of the lateral flow assay market.
Lateral flow assay tests are designed to provide cheap, rapid, and easy tests. However, lateral flow assay tests are only suitable for primary screening of point-of-care. Moreover, they have several disadvantages such as inaccurate sample volume which reduces the precision of result, restricting the total volume in the test and gives a limit of sensitivity, and the analysis time is dependent on the nature of sample (if the sample is viscous, then the time for analysis increases).
Key players in the in-vitro clinical diagnostic device manufacturing are engaged in development of new point-of-care tests, which will provides the less variance and more accurate test results. For instance, in March 2018, U.S. Food and Drug Administration (FDA), approved immunoassay fecal occult blood test of Alfa Scientific Designs, Inc. for the diagnosis of precancerous polyps and colorectal cancer. This new test uses one drop of sample solution and provides result in less than one minute. It is five times quicker than the standard lateral flow assay test. For instance, in October 2014, Agdia, Inc., announced a new lateral flow test strip. The test is developed for examining seed quality by determining the presence or absence of Vip3A protein in transgenic corn. This increase in the demand for point-of-care testing devices and technological advancements in the lateral flow assay devices to introduce cost-effective, rapid, and affordable devices in market for early detection of disease are expected to drive growth of the lateral flow assay market over the forecast period.
High prevalence of infectious disease is expected to drive growth of the lateral flow assay market
High prevalence and increasing incidence of infectious disease are the major factors driving growth of the lateral flow assay market. According to the study published in journal Lancet Infectious Disease, in 2017, around 54,984,661 cases of 45 infectious diseases were reported with average yearly incidence 417·98 per 100?000 in china between January 2004 and December 2013. Furthermore, Hepatitis B and tuberculosis has shown high incidence rate of 81.57 and 80.33 per 100,000, respectively. Moreover, World Health Organization (WHO) estimated 212 million malaria cases worldwide in 2015, with highest incidence in African regions.
Key players operating in market include Bio-Rad Laboratories, Inc., Thermo Fisher Scientific Inc., Siemens Healthineers, Inc., Qiagen N.V., Becton, Dickinson and Company, Diagnostic Consulting Network, Inc., Tetracore, Inc., Humasis Co. Ltd., and F. Hoffmann-La Roche AG.
Lateral flow assay (LFA) offers simple, low-cost, rapid, point-of-care detection and quantification of analytes in complex mixtures, within 5-30 min. Low development costs and ease of operation of LFAs are results into expansion of its application in biomedicine, agriculture, veterinary, food safety and drug development. High prevalence of infectious disease and increasing adoption of lateral flow assay device in hospitals, physician’s clinics and clinical laboratories for the qualitative and quantitative detection of specific antigen and antibodies is expected to drive growth of lateral flow assay market over the forecast period. For instance, according to the World health Organization (WHO) January 2018 data findings, tuberculosis(TB) was reported to be one of the top 10 causes of death, in 2016 worldwide. Furthermore, in 2016, an estimated 1 million children were suffer from tuberculosis and 2, 50,000 children died of TB (including children with HIV associated TB).
The global lateral flow assay market is projected to witness significant growth over the forecast period, owing to growing adoption of lateral flow assay in various applications including clinical diagnostics, drug development, quality testing, veterinary diagnostic, food and environmental testing, micronutrient monitoring, diagnosing invasive pulmonary aspergillosis, qualitative and quantitative detection of specific antigens and antibodies, and gene amplification. For instance, according to the American Pharmaceutical Association (APhA) Academy of Student Pharmacists: Resolutions Committee-2015 report, 8,856 community pharmacies have a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver, which enables pharmacists to perform POC tests such as glucose measurement and other POC testing. Moreover, increasing adaptation of point-of-care testing in clinical diagnosis and integration of POC testing in lateral flow assay tests are expected to drive growth of the lateral flow assay market over the forecasted period. However, variance or inconsistency results by lateral flow assay would lead to lower adoption of the technology, which in turn would hinder the growth of lateral flow assay market.
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