Lateral Flow Assay Components Market Assessment, By Component Type [Membranes, Pads, Others], By Application Type [Clinical Testing, Veterinary Testing, Food Safety and Environmental Testing, Drug Development and Quality Testing, Others], By Technique Type [Sandwich Assays, Multiplex-Detection Assays, Competitive Assays], By End-user [Hospitals, Diagnostic Laboratories, Home-Care Settings, Pharmaceutical and Biotechnology Companies, Academic and Research Institutes], By Region, Opportunities and Forecast, 2017-2031F
Global lateral flow assay components market is projected to witness a CAGR of 5.55% during the forecast period 2024-2031, growing from USD 10.35 billion in 2023 to USD 15.95 billion in 2031. The market has experienced significant growth in recent years and is expected to maintain a strong pace of expansion in the coming years. Lateral flow-based assays (LFA) are used for qualitative and quantitative analysis, and their use is expanding across various applications. It is carried out using a strip which is made of several parts placed on a plastic piece. These parts include the nitrocellulose membrane, adsorption pad, conjugate pad, and sample application pad. LFA is a technique that combines the benefits of chromatography and biorecognition probes in the form of various LFA-based formats.
The global lateral flow assay components market is expected to expand due to factors such as increasing prevalence of infectious diseases, technological advancements, and the awareness among general population about clinical testing. LFA-based strips are easily available in the market for different types of diagnostic tests. The comfort that it offers at a very minimal price is one of the reasons behind its success. As market players are launching and developing different strips for a variety of tests, reliability on these strips is increasing, which is making them a product that is high in demand. The accuracy and swiftness of lateral flow-based assays’ tests have made them popular. International brands are investing in the development of these assays in partnerships, making its market profitable to invest in. For example, Upfront Diagnostics, a Cambridge, UK-based company, conducts clinical research of a lateral flow test. This test will enable paramedics to screen patients who may have suffered a stroke for big artery occlusions, allowing them to triage patients and provide the best care possible quickly. LVOne’s test results are derived from a finger prick, which uses two indicators and has a turnaround time of roughly 15 minutes, and paramedics can visually analyze the results.
Rising Prevalence of Infectious Diseases
The aging population is more susceptible to chronic illnesses like cystic fibrosis, cardiovascular diseases, hepatitis, and cancer because of physiological changes, metabolic issues, and weak immune systems. Changes in lifestyle, such as a sedentary lifestyle and increasing consumption of cigarettes and alcohol, will accelerate the spread of disease in the forecast period. It is anticipated that the rising incidences of infectious diseases like HIV and malaria, etc. will lead to increasing demand for lateral flow assay components. Infectious diseases are a major health concern worldwide, and efficient disease treatment depends on quick and precise diagnostic testing. LFAs are frequently employed in the detection of infectious illnesses, including malaria, HIV, and tuberculosis. Diagnostic testing carried out at or close to the location of patient care is referred to as ""point-of-care"" testing. Since point-of-care testing can yield results in a matter of minutes, requires no sample preparation, and is easy to use, LFAs are perfect for point-of-care testing. The need for self-testing at home has increased after the COVID-19 pandemic.
LFAs are a good choice for self-testing at home as they are simple provide fast results. The development of lateral flow tests that may be utilized for patient-specific diagnosis and therapy is being driven by the increasing need for personalized medicine. According to a report published by National Institutes of Health (NIH) in 2023, ever since the COVID-19 pandemic, the number of cases recorded increased by 259.4% (2,227,613 cases in 2021 and 8,006,631 cases in 2022), primarily due to five diseases: mumps (2656% rise), malaria (990% rise), polio (2100% rise), influenza (354% rise), and diphtheria (419% rise).
Clinical Testing Segment Drives Market Growth
Since clinical testing is important for diagnosing and detecting illnesses, it is expected to account for the highest market share in the lateral flow assay market. The need for these tests is anticipated to develop in tandem with the prevalence of infectious diseases and other illnesses, propelling the segment's expansion. The segment's demand has surged because of more self-test devices, including Atomo HIV Self-Test, TRUSTline HIV-Ab/Ag 4th Gen Rapid Test, Dr. Trust HIV Sure, and others, being approved as safe and accurate. Patients benefit from these self-test tools and kits in terms of assurance, quick diagnosis, increased convenience, and simplicity of use, all of which are projected to drive market growth. In addition, the COVID-19 pandemic has significantly boosted clinical testing launches and research, which has supported the segment's growth. EDX Medical Group Plc. announced in 2023 that scientists from Oxford and Cambridge were developing a new generation of rapid healthcare tests, known as ‘point-of-care’ tests. They are being used to detect and characterize a plethora of diseases within a very short time. These tests use combined multiple assays and a smartphone which can support real-time clinical decision-making and improve outcomes for patients.
Increasing Demand for Home-Based Testing Method
The market is expected to grow at a faster rate during the forecast period due to the rising demand for home-based testing kits for the detection of chronic diseases, pregnancy, fertility, coagulation, urine chemistry, and other tests. Additionally, the growing demand for point-of-care testing may further enhance the demand for lateral flow assay, and the device's usage is increasing rapidly. Major players in the field are prioritizing advanced point-of-care devices based on lateral flow assays for uses like HCG levels and ovulation-based pregnancy tests, diagnosing infectious diseases and medication, and measuring protein markers in the boost, which is anticipated to increase demand for lateral flow assays over time. Innovation in lateral flow assays is being fuelled by research and development, which is leading to the production of new and advanced assays for diagnostic testing. Lateral flow tests' sensitivity, specificity, and accuracy are being improved by technological developments, which increase their efficacy and dependability as diagnostic tools. In 2024, Maxim Bio received funds from NIH, totalling up to USD 4.4 million, in phase 2 of developing the FiarFly platform. It supports various tests at home as well as can prepare for clinical trials targeting influenza season. This tool is a flexible, low-cost and compact solution designed to bring diagnostic testing closer to the patient, providing lab-comparable performance at home at a very affordable cost.
North America Dominates the Global Lateral Flow Assay Components Market
Rising chronic illnesses, infectious diseases, changing lifestyles, increasing geriatric population, increasing investment in research and development, and the presence of major players in the region are why North America dominates the global lateral flow assay components market. Furthermore, due to rising rates of HIV/AIDS-related mortality as well as an increase in the prevalence of several chronic and infectious diseases, including tuberculosis and Lyme disease, North America is predicted to lead the global lateral flow assay components market during the forecast period. According to the Centers for Disease Control and Prevention, in 2022, influenza and pneumonia caused 41,917 deaths in the United States. Additionally, it has been noted that several infectious diseases, including meningitis and urinary tract infections, are spreading quickly and require prompt diagnosis. Additionally, the region's market is expected to be stimulated by the increasing number of diagnostic centres, growing awareness among public about diagnostic tests and technological advancements, all of which will contribute to the region's exceptional revenue share of the global market during the projection period.
In 2023, Inflammatix, Inc. announced that they were developing a blood test that would take 30 minutes to complete and could benefit emergency room doctors in the triage of patients who may have sepsis or other acute infections. The test can assist medical professionals in distinguishing between viral and bacterial infections and in creating risk scores that indicate the possibility that the patient may experience a serious illness in the next few days that will necessitate treatments like renal replacement therapy or mechanical breathing.
Future Market Scenario (2024-2031F)
The rising prevalence of various infectious diseases in the population is one of the biggest reasons why we can expect the lateral flow assay components market to grow in the forecast period. Viral infections are shown to be the most widespread among all and are most easily and commonly transmissible, which raises a concern and hence requires quick diagnosis. Technology and diagnostic approaches that are effective and cost-efficient are being introduced by players in this industry who are growing at an unmatched pace. The government is taking initiatives, bringing in new policies, and raising funds to improve the shape of healthcare around the globe. The successful creation of Optimer binders to enable a lateral flow test for the early diagnosis of Alzheimer's disease was announced in 2023 by Aptamer Group plc, the manufacturers of the new Optimer binders, and Neuro-Bio, an Oxford-based biotechnology business with a therapeutic emphasis on neurodegenerative disease.
Key Players Landscape and Outlook
Several companies, such as Danaher Corporation, PerkinElmer Inc., Merck KGaA, F. Hoffmann-La Roche Ltd, Siemens Healthineers AG, Becton, Dickinson and Company, Qiagen N.V., Abbott Laboratories, Bio-Rad Laboratories, Inc., and Thermo Fisher Scientific Inc., etc., are expanding their businesses by planning and adopting new strategies. They are complying with new strategic initiatives regarding the launches of newly developed LFA strips, to help researchers and increase their market presence. New product launches, agreements based on contracts, acquisitions and mergers, investments and partnerships are a few ways companies aim to increase their market shares.
The Tools for Life Sciences team at the Swiss Center for Electronics and Microtechnology (CSEM) is developing a state-of-the-art point-of-care solution for preeclampsia diagnostics in collaboration with MOMM Diagnostics. This innovative multiplexed sensing gadget simultaneously detects two important biomarkers linked to this common disease.
Bioengineers at Rice University announced that they successfully proposed a low-cost, point-of-care DNA test for HPV infections. This development may improve access to cervical cancer screening in low- and middle-income nations, where the illness claims the lives of over 300,000 women annually.