Global Lateral Flow Assays Market By type (Kits & Reagents and Lateral Flow Readers), By Technique (Sandwich Assays, Competitive Assays, and Multiplex Detection Assays), By Sample Type (Blood Samples, Urine Samples, Saliva Samples, and Other Samples), By Application (Clinical Testing, Drug Development & Quality Testing, Veterinary Diagnostics, and Food Safety & Environmental Testing), By End User (Hospitals & Clinics, Diagnostics Laboratories, Pharmaceuticals & Biotechnology Companies, Home Care Settings, and Others), By Regional Outlook, Industry Analysis Report and Forecast, 2021 - 2027
The Global Lateral Flow Assays Market size is expected to reach $13.4 billion by 2027, rising at a market growth of 2.8% CAGR during the forecast period.
Lateral flow assays, also known as lateral flow immunochromatographic assays, are cellulose-based tools utilized to indicate the existence of an aimed analyte in a sample without the requirement for specialized and expensive equipment or highly qualified healthcare professionals. They have gained a lot of traction in homecare settings in the last few years. The growing worldwide prevalence of infectious illnesses, HIV, and cancer, which necessitates novel diagnostic methods and better treatment to address the rising death rate, is a significant driver augmenting the growth of the market.
COVID -19 Impacts
The COVID-19 pandemic has had a beneficial influence on the lateral flow assays market, since the requirement for quick identification of coronavirus infection has been a priority during these crisis. As the number of cases expanded across geographies, most of the leading lateral flow assays market players engaged in R&D and formed collaborations with some other industry players and government entities to create lateral flow diagnostic solutions for COVID-19 detection. This has resulted in many COVID-19 antibody and antigen test product releases, with excess manufacturing and distribution across areas to meet increased demand.
Market Growth Factors:
High prevalence of infectious disease across the globe
Despite major advances in sanitation and medicine, the worldwide incidence of infectious illnesses remains high. Also, regardless of the fact that no communicable illnesses are the largest cause of morbidity and death, infectious diseases continue to be a major public health problem across the world. Infectious illnesses take more than 15 million lives worldwide each year, as per the National Institute of Allergy and Infectious Diseases. According to the WHO World Malaria Report, there were 229 million malaria cases globally in 2019.
Continuous rise in geriatric population
Chronic illnesses such as cystic fibrosis, hepatitis, cardiovascular ailments, and cancer are frequently caused by age-related metabolic inefficiencies and physiological changes. Due to reduced immune systems, geriatric persons (65 years and older) are more prone to various disorders and infections. In 2020, there were approx. 900 million people in the world who are 65 or older. Because women outlive males, they make up the majority of the elder population, especially at later ages. Within next three decades, the global population of elderly people is expected to quadruple, reaching more than 2 billion by 2050.
Market Restraining Factors:
Challenges in acquiring quality raw materials
The purchase and validation of antigens and antibodies, known as key reagents, is one of the most difficult components of producing lateral flow assay tests. Antibodies used in assays must be verified for specificity, accuracy, reproducibility and stability, as any flaws in the reagent might cause the assay to fail. More than 1,000 data points must be examined and confirmed to qualify a single lot of reagents. Another problem is evaluating the stability of tests once an antibody or antibody combination has been found. For such an assay to classify as a commercial product, it must have a stable shelf life of at least 6 months, ideally 18–24 months.
Based on type, the market is segmented into Kits & Reagents and Lateral Flow Readers. The lateral flow reader acquired a significant revenue share in the lateral flow assays market in 2020. A lateral flow reader is a useful instrument for enhancing the lateral flow test's value. A reader should not be over-engineered, and maintenance and calibration should be kept to a bare minimum. Their internal algorithm test should be set up in such a way that the results may be interpreted using an internal calibration technique, which would support the growth of the segment.
Based on Technique, the market is segmented into Sandwich Assays, Competitive Assays, and Multiplex Detection Assays. The sandwich assays dominated the lateral flow assays market in 2020 with the largest revenue share. This growth is attributed to the improved assay sensitivity and specificity, as well as its wide range of applications in the detection of essential analytes like hepatitis and cardiac markers.
Sample Type Outlook
Based on Sample Type, the market is segmented into Blood Samples, Urine Samples, Saliva Samples, and Other Samples. The utilization of blood samples in lateral flow tests for infectious diseases including malaria, HIV, and syphilis, as well as increased knowledge of rapid testing solutions and the simplicity of detecting disease antibodies from blood samples, are all driving the growth of the segment.
Based on Application, the market is segmented into Clinical Testing, Drug Development & Quality Testing, Veterinary Diagnostics, and Food Safety & Environmental Testing. The Food Safety & Environmental Testing segment garnered a substantial revenue share in the lateral flow assays market in 2020. Lateral flow assays are widely used for food testing in order to ensure that a given product is safe for human consumption of not. Due to this, many food testing labs and government authorities are adopting these assays and hence, augmenting the growth of the segment.
End User Outlook
Based on End User, the market is segmented into Hospitals & Clinics, Diagnostics Laboratories, Pharmaceuticals & Biotechnology Companies, Home Care Settings, and Others. Diagnostics Laboratories segment acquired a significant revenue share. It is owing to the number of labs increasing across the world along with the high prevalence of various diseases across the world.
Based on Regions, the market is segmented into North America, Europe, Asia Pacific, and Latin America, Middle East & Africa. North America emerged as the leading region. It is due to an increase in the occurrence of several infectious diseases in the region, such as Lyme disease, COVID-19, TB, and a high death rate connected with HIV/AIDS.
The major strategies followed by the market participants are Product Launches. Based on the Analysis presented in the Cardinal matrix; F. Hoffmann-La Roche Ltd. is the forerunners in the Lateral Flow Assays Market. Companies such as Bio Rad Laboratories, Siemens AG, Thermo Fisher Scientific, Inc. are some of the key innovators in the Market.
The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Abbott Laboratories, Becton, Dickinson and Company, Hologic, Inc., Thermo Fisher Scientific, Inc., Danaher Corporation, Bio-Rad Laboratories, Inc., Quidel Corporation, Siemens AG, PerkinElmer, Inc., and F. Hoffmann-La Roche Ltd.
Recent Strategies Deployed in Lateral Flow Assays Market
Partnerships, Collaborations, Approvals and Agreements:
Nov-2021: Thermo Fisher Scientific received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0. They are highly precise assays developed with better target redundancy to compensate for current mutations and emerging SARS-CoV-2 variants.
Oct-2021: PerkinElmer got an emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay. This latest test would assist to alleviate confusion arising from similar symptoms caused by these infections and decrease further strain on the healthcare system during a pandemic.
Jul-2021: Hologic received a CE Mark for the usage of saliva samples with the Aptima SARS-CoV-2 assay in Europe. This Aptima SARS-CoV-2 test is a molecular diagnostic assay, which helps in detecting the genetic material of the pathogen causing COVID-19.
Jun-2021: Roche got a CE mark for its SARS-CoV-2 Antigen Self Test Nasal for at-home testing. This test works effortlessly with NAVIFY Pass, Roche’s digital solution that enables people and healthcare providers to quickly display, store, and share their COVID-19 test outcomes and vaccine status via a unique QR code.
May-2021: Siemens Healthineers received CE mark for its CLINITEST Rapid COVID-19 Antigen Self-Test. This test is used for the detection in individuals aged 12 years and above that includes at-home testing.
Mar-2021: BD entered into an agreement with ImageMover, a software platform. This agreement aimed to provide a companion mobile app, which allows more streamlined reporting of SARS-CoV-2 antigen testing outcomes performed on the BD Veritor Plus System at everyday testing locations like schools and businesses.
Mar-2021: Quidel Corporation got an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its new QuickVue. This QuickVue At-Home COVID-19 Test would enable patients with a prescription to simply perform the test themselves and get outcomes in 10 minutes.
Feb-2021: BD joined hands with Scanwell Health, a leader in smartphone-enabled at-home medical tests. This collaboration aimed to develop an at-home rapid test for SARS-CoV-2 using a BD antigen test and the Scanwell Health mobile app. Under this collaboration, BD aimed to produce a lateral flow antigen test and pair it with the Scanwell Health mobile app.
Dec-2020: Abbott received approval from the US Food and Drug Administration for BinaxNow rapid test for Covid-19. This test is the most affordable and broadly distributed rapid test into the home, under which the result is provided in minutes without the requirement to send it out for processing.
Dec-2020: PerkinElmer formed a partnership with Auriga Research India, Research Wing at Arbro Pharmaceuticals. This partnership aimed to conduct testing at Kempegowda International Airport Bengaluru (BIAL). The program would involve a COVID-19 sample collection booth near the gates and have a testing facility on the premises at BIAL.
Sep-2020: BD received CE marked to the IVD Directive (98/79/EC) for its rapid, point-of-care, SARS-CoV-2 antigen test for usage on the BD Veritor Plus System. The BD Veritor Plus System delivers an easy-to-use workflow, which makes it a perfect solution for point-of-care settings.
Product Launches and Product Expansions:
Jan-2022: Bio-Rad Laboratories introduced the Bio-Plex Pro Human SARS-CoV-2 Variant Neutralization Antibody Assays, for research use only (RUO). The assays enable scientists to calculate neutralizing antibodies rapidly and efficiently against wild-type and significant variants of SARS-CoV-2 virus.
Dec-2021: Roche and TIB Molbiol, a newly acquired subsidiary within the Roche Diagnostics division unveiled three additional Research Use Only (RUO) test kits: VirSNip SARS Spike ins214EPE (RUO), VirSNiP SARS-CoV-2 Spike S371L S373P (RUO), VirSNip SARS Spike E484A (RUO). These tests would help in the detection of different variants of the COVID-19 virus.
Dec-2021: Roche released the SARS-CoV-2 & Flu A/B Rapid Antigen Test. The combination rapid antigen test rapidly distinguishes between SARS-CoV-2 and influenza viruses A and B infections in less than 30 minutes, enabling informed decisions on patient & pandemic management decisions.
Nov-2021: Bio-Rad Laboratories unveiled the CFX Opus 96 Dx System and the CFX Opus 384 Dx System, real-time PCR detection systems. The CFX Opus 384 Dx Real-Time PCR System and the CFX Opus 96 Dx System are open systems, which can multiplex up to five targets to offer effective IVD assay development and testing.
Oct-2021: Hologic released the Novodiag system in Europe, a fully automated molecular diagnostic solution. The Novodiag system integrates real-time PCR and microarray capabilities. This would allow numerous pathogens to be identified in a single sample, delivering a simple and fast method to pinpoint patients most at risk with targeted and syndromic on-demand testing.
Jul-2021: Abbott launched Panbio COVID-19 Antigen Self-Test. This test is developed for the testing of the SARS-CoV-2 virus in adults and children with or without symptoms.
Jul-2021: Bio-Rad Laboratories released the Reliance SARS-CoV-2/FluA/FluB RT-PCR Kit (IVD) for European markets after fulfilling the CE-IVD mark requirements. The Reliance SARS-CoV-2/FluA/FluB RT-PCR Kit (IVD) is a molecular test developed for clinical diagnostic labs that helps in COVID-19 testing.
Jun-2021: Bio-Rad Laboratories launched its PREvalence ddPCR SARS-CoV-2 wastewater quantification kit. This kit is a precise, sensitive, and cost-effective tool for the identification of the SARS-CoV-2 infection in community wastewater. The assay assists a community to evaluate if the virus has been present days to weeks ahead before it is detected among individuals.
Mar-2021: PerkinElmer introduced two Research Use Only (RUO) solutions, PKamp VariantDetect SARS-CoV-2 RT-PCR Assay and Next Generation Sequencing-based NEXTFLEX Variant-Seq SARS-CoV-2 Kit. By utilizing nucleic acid extracted from samples that previously tested positive, laboratories can utilize these assays to identify genomic mutations reported in relation to SARS-CoV-2 variants.
Mar-2021: Roche released the Cobas SARS-CoV-2 Variant Set 1 Test. This test is aimed to detect and distinguish mutations found in variants that originated in the UK (B.1.1.7), South Africa (B.1.351), and Brazil (P.1).
Feb-2021: PerkinElmer released the PerkinElmer COVID-19 Antigen Test for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in nasal (NS) or nasopharyngeal (NP) swab specimens. The lateral flow immunoassay test could be utilized to screen or to help in diagnoses of COVID-19 in asymptomatic or symptomatic individuals.
Oct-2020: Roche introduced a high-volume SARS-CoV-2 Antigen test to harness high-volume testing of suspected COVID-19 patients. This Elecsys SARS-CoV-2 Antigen test is an automated laboratory assay developed to help in the diagnosis of SARS-CoV-2 infection.
Oct-2020: Siemens Healthineers unveiled its Clinitest Rapid COVID-19 Antigen Test in Europe. This test is used to detect people infected with SARS-CoV-2 in 15 minutes.
Sep-2020: Roche launched a SARS-CoV-2 Rapid Antigen Test. This SARS-CoV-2 Rapid Antigen Test would help in point-of-care settings for symptomatic and asymptomatic patients.
Acquisitions and Mergers:
Jul-2021: PerkinElmer UK took over Immunodiagnostics Systems Holdings. This acquisition aimed to grow its overall diagnostics business and especially its immunodiagnostics segment. In addition, the deal would allow PerkinElmer to integrate its channel expertise and testing capabilities with IDS’s chemiluminescence products in endocrinology, autoimmunity & infectious diseases to serve customers across the world.
Feb-2021: Quidel Corporation expanded its geographical footprint by opening a new manufacturing facility in Carlsbad, CA. This facility is dedicated to the production of Quidel’s popular QuickVue line of products. The 128,000 square-foot facilities would produce 600 million QuickVue SARS rapid antigen tests every year for the identification and diagnosis of COVID-19 infections.
Feb-2021: Thermo Fisher Scientific expanded its global footprint by establishing a manufacturing facility in Bengaluru, India. This facility aimed to develop customized Covid-19 testing kits suited to Indian conditions.
Scope of the Study
Market Segments covered in the Report:
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