The global market for lateral flow assays is anticipated to expand at a CAGR of 2.2% during the forecast period of 2024 to 2032. The high prevalence of infectious diseases worldwide, the rapid development of the elderly population, the rising need for point-of-care testing, and the increasing use of home-based lateral flow assay equipment are the primary factors driving the expansion of this market. On the other hand, doctors' and patients' unwillingness to adapt existing diagnostic processes, as well as the low accuracy of lateral flow assays, are the primary obstacles.
Globally High Frequency of Infectious Disease as A Cause
Despite great advances in sanitation and medicine, the frequency of infectious diseases remains high throughout the world. Even though noncommunicable illnesses are the largest cause of morbidity and mortality, infectious diseases continue to be a global public health problem. In poor nations, the high frequency of infectious diseases such as HIV and malaria, along with underdeveloped healthcare infrastructure and rising public awareness, is anticipated to increase the adoption of lateral flow assay testing.
In poor nations, the high frequency of infectious diseases such as HIV and malaria, along with underdeveloped healthcare infrastructure and rising public awareness, is anticipated to increase the adoption of lateral flow assay testing. In addition, recent outbreaks of infectious diseases caused by the spread of viruses (such as Ebola, H1N1, and Zika) have highlighted the need for early disease detection capabilities, which is anticipated to fuel market expansion. The present COVID-19 epidemic has led to a strong demand for rapid diagnostic testing with lateral flow technology, which will contribute to the expansion of this market over the next year.
Rapidly Growing Elderly Population
Chronic diseases such as cystic fibrosis, hepatitis, cardiovascular ailments, and cancer are frequently the outcome of age-related physiological changes and metabolic inefficiency. Due to weakening immune systems, individuals aged 65 and older are more prone to various disorders and infectious infections. With the increasing prevalence of chronic diseases, the need for early and accurate disease identification is expanding. Due to its capacity to detect symptoms in their earliest stages, lateral flow assay techniques are becoming more popular for illness diagnosis. The global increase in the senior population, combined with the growing number of patients suffering from chronic diseases, has led to an increase in the need for lateral flow assay testing. In addition, age-related weakness has been a major worry during the care of COVID-19. Age and the presence of co-morbidities such as cardiovascular, lung, or kidney disease, cancer, and obesity increase the risk of death from COVID-19.
With the increasing prevalence of chronic diseases, the need for early and accurate disease identification is expanding. Due to its capacity to detect symptoms in their earliest stages, lateral flow assay techniques are becoming more popular for illness diagnosis. The global increase in the senior population, combined with the growing number of patients suffering from chronic diseases, has led to an increase in the need for lateral flow assay testing.
Increasing Prevalence of Home-Based Lateral Flow Tests
In the management of cardiovascular and infectious diseases, home-based lateral flow assay instruments play a crucial role. Potentially empowering patients to conduct self-tests at home, these devices are also particularly useful for detecting pregnancy and stigmatized illnesses such as HIV. As a result, the growing prevalence of these diseases and the increased implementation of lateral flow assay tests in-home care settings are anticipated to increase the demand for lateral flow assays. During COVID-19, a number of companies introduced home-based lateral flow assays for COVID-19 testing, as individuals feared getting tested at diagnostic laboratories or hospitals due to the huge volume of patients. This increased demand for home-based lateral flow tests. This resulted in the introduction of numerous home-based tests such as BinaxNOW COVID-19 Ag Card in August 2020 and Panbio fast COVID-19 test in September 2020, SARS-CoV-2 Rapid Antigen Test by Roche Diagnostics in September 2020. Other tests introduced during COVID-19 include the Sofia 2 Flu+ SARS Antigen FIA (Quidel Corporation), the CLINITEST Rapid COVID-19 Antigen test (Danaher Corporation), and the BD Veritor SARS CoV-2 Test (BD). The epidemic also fostered cooperation between government agencies and important players to increase the availability of diagnostic tests. For instance, in August 2020, Abbott Laboratories (US) and the US government struck an agreement for 150 million home-based BinaxNOW COVID-19 tests.
Demand For Point-Of-Care Diagnostics Is Increasing
Currently, the majority of diagnostic tests performed worldwide are laboratory-based. However, point-of-care (POC) testing based on lateral flow assays are rapidly replacing lengthy, conventional laboratory procedures. Due to the fact that point-of-care diagnostic tests require less complex infrastructure and training, they are less expensive than typical laboratory diagnostic procedures. The market for lateral flow assays is predicted to be dominated by point-of-care (POC) testing due to its importance in the face of a growing illness burden. According to the World Health Organization's Global Tuberculosis Report 2020, 1.4 million people died from tuberculosis-related illnesses in 2019; over 10 million people contracted tuberculosis in 2019. Due to their increasing acceptance in home care settings, infectious disease tests and cardiac markers are the POC testing market categories with the highest growth rate. Pregnancy and fertility tests, coagulation tests, and urine chemical tests are typical POC tests. In recent years, the market for lateral flow assay point-of-care (POC) testing has expanded dramatically due to the increased acceptance of lateral flow assay testing products in home care settings. Point-of-care testing aided by lateral flow assays is simple, rapid, economical, practical, and straightforward to interpret. These tests can be designed to detect the presence of pathogens in a number of materials, including whole blood, plasma, serum, and saliva, thereby enhancing their utility for point-of-care testing. In some instances, lateral flow assay point-of-care testing can also discover sub-clinically infected persons by focusing on biomarkers.
This trend is primarily driven by the increasing prevalence of chronic diseases, technological advances, greater patient awareness, and expanding access to innovative products. Companies are increasingly focusing on developing innovative lateral flow assay-based point-of-care (POC) devices for applications such as the confirmation of pregnancy (using hCG levels) and ovulation, screening for infectious diseases and drugs of abuse, and the measurement of protein markers in the blood to aid rapid clinical diagnostics of life-threatening events (such as heart attacks, strokes, and deep-vein thrombosis). Abbott Laboratories (US) created the ARCHITECT STAT Troponin I Blood Test in 2019, whilst Siemens AG developed the CLINITEK Microalbumin 2 strips for clinical diagnostics.
During the forecast period, the rising demand for point-of-care (POC) testing and the increasing emphasis on adopting lateral flow assay-based POC testing devices to achieve better portability are projected to drive the growth of the lateral flow assays market.
Demand For Lateral Flow Assays Is Increasing in The Food and Beverage Industry.
Food safety difficulties and public health concerns have led to the development of stricter food safety legislation in a number of nations. This boosted the demand for pathogen and toxin tests in virtually every sector of the food production business, including processed foods, meats, poultry, drinks, and dairy, as well as among the world's largest food manufacturers. In the past, the majority of food safety tests were conducted using standard laboratory-based microbiology techniques, but the use of quick, on-site tests is increasing in this field. Primarily, these tests are used to detect germs such as Listeria, Salmonella, and E. coli in raw materials, intermediate industrial products, and final goods. PerkinElmer released a COVID-19 environmental surface testing kit for food processors in August 2020. In addition, the food industry has demonstrated a demand for tests capable of identifying mycotoxins and allergens, such as R-RIDA Biopharm's QUICK quick testing. Merck KGaA (Germany) offers Singlepath L'mono for the detection of Listeria monocytogenes, Singlepath Salmonella for the detection of salmonella, and Singlepath Campylobacter for the detection of Campylobacter in foods.
Traditional microbiological testing requires finished products to be stored in a warehouse for two to four days pending test results, whereas fast technologies deliver microbial test findings in as little as twenty-four hours. These benefits, combined with the implementation of Hazard Analysis and Critical Control Points (HAACP) rules prescribing test protocols throughout the manufacturing process, are increasing the demand for lateral flow tests in the food production business. The combination of growing competitiveness in the European food business and the introduction of the European validation system MICROVAL for alternative food testing methods will allow Europe to catch up to the United States in terms of the use of rapid food testing technologies. In addition, significant food-exporting nations such as Mexico and Brazil, as well as expanding processed food industries in Asia-Pacific, will offer market participants engaged in lateral flow tests another path for expansion.
Inconsistent Lateral Flow Assay Test Findings to Limit the Market Growth
Although simple to conduct and less expensive than laboratory studies, lateral flow assays have been reported to be less precise. For example, the SARS-CoV-2 antibody tests, which are based on lateral flow technique, have demonstrated a substantial margin of error. This has resulted in false negatives, making it challenging to monitor the spread of the coronavirus. As a result of the low reliability of lateral flow assay testing, most doctors and patients favor molecular studies over fast tests for a more accurate diagnosis of COVID-19 and other infectious diseases.
Difficulties Sourcing High-Quality Raw Materials for The Creation of Lateral Flow Assays
The purchase and validation of antigens and antibodies, referred to as essential reagents, is one of the difficult elements of designing lateral flow assay tests. Antibodies intended for use in assays must be evaluated for precision, specificity, stability, and reproducibility, as flaws in the reagent can result in a failed experiment. The certification of a single lot of reagents needs the verification of over one thousand data points. Once an antibody or antibody pair has been discovered, a further difficulty is the stability testing of tests. To qualify as a commercial product, an assay must have a stable shelf life of at least 6 months, ideally 18–24 months. It takes more time, effort, and money to rectify assays that fail stability testing. Consequently, this would cause a delay in the time-to-market. These factors hinder the growth of the market for lateral flow tests over the forecast period.
Limited Reimbursements for Lateral Flow Assay Product Present Obstacles
In some nations around the world, the adoption of lateral flow assay-based diagnostic diagnostics has been limited due to reimbursement concerns. The escalating cost of healthcare is driving insurers to examine and evaluate the necessity of new diagnostic tests. In addition, payers are transitioning from fee-for-service to fee-for-value-based reimbursement systems. As a result, a diagnostic test that allows a physician to determine whether or not to pursue a certain treatment is either abandoned or underinvested due to inadequate compensation.
In numerous nations, reimbursement issues hinder the expansion of the lateral flow assay-based diagnostics market. In the UK, the National Health Service (NHS) is responsible for around 75% of healthcare payments. Only specified lateral flow assay devices, such as the CrAg lateral flow assays used to diagnose cryptococcosis, are reimbursable in primary care on the NHS. There is no distinct reimbursement policy for non-prescribed lateral flow test kits (such as cardiac markers and pregnancy kits).
Although the number of commercially available tests has increased, the majority are not coded according to the Current Procedural Terminology (CPT). To provide a medical biller with the necessary data to file a reimbursement claim, diagnostic reports must adhere to particular medical coding guidelines. Without coding and, consequently, reimbursement, physicians will not choose more expensive new diagnostic tests. As reimbursements for commercialized diagnostic tests are limited, so is the money required to finance research and development for new creative diagnostic methods. In addition, due to the lack of payment, patients have a greater preference for central lab testing.
The Evolving Use of Lateral Flow Tests to Open Significant Opportunities
In the past two decades, lateral flow tests have evolved significantly and are frequently utilized in point-of-care and diagnostic applications. Although lateral flow tests are commonly used for infectious disease detection, cardiac disease diagnosis, and veterinary applications, their use has risen in recent years for a number of novel applications. New application areas for lateral flow assays include saliva diagnostics, behavioral health, agriculture (GMO detection and crop quality testing), biowarfare (anthrax detection), environmental testing (detection of contaminating enzymes in manufacturing plants), and food microbiology (detection of E. coli O157, Salmonella, Listeria, and other food spoilage organisms).
OraSure Technologies (US) is one of the most prominent companies offering lateral flow saliva testing. Salivary LFIAs have also penetrated the market for applications such as drugs-of-abuse testing, and some systems have received FDA marketing clearance; nonetheless, testing remains predominantly qualitative. Rapid testing for infectious diseases has also been created using saliva. The salivary cortisol LFDs created by SOMA Bioscience (UK) have been utilized in sports research. Rapid Saliva Protein Test (RSPT) is a lateral flow saliva test developed by Medusa 19 Limited (UK) to measure the immunological response to SARS-CoV-2 infection.
The Kits and Reagents Dominated the Market by Product
The kits and reagents category held a larger revenue share in 2023, as these lateral flow kits provide more versatility to collect and detect any type of analyte without the need to spray the captured antibodies on the test strip. These kits are utilized in medicines, animal health, environmental testing, feed & food testing, and crop & plant testing due to their versatility. During the projected period, the introduction of new kits by industry leaders is expected to stimulate market growth. In July 2021, for instance, Abbott released its Panbio COVID-19 Antigen Self-Test in India. In January 2023, Roche Diagnostics India also introduced the COVID-19 At-Home Test.
Lateral flow tests are inexpensive, user-friendly, and yield accurate findings in a matter of minutes. These tests detect both immunoglobulin G and immunoglobulin M antibodies to SARS-CoV-2, the virus responsible for illnesses such as COVID-19. In March of 2020, Ozo Life introduced OZO COVID-19 Rapid Test Kits, which provide a latex-enhanced, high-sensitivity lateral flow immunoassay for the early detection of COVID-19. Consequently, an increase in strategic efforts undertaken by market participants is anticipated to contribute to the industry's growth throughout the forecast period.
Cleaning Testing Segment to Dominate the Market by Application
In 2023, the clinical testing category maintained the biggest market share of 75% because of the rise in infectious disease incidence. Based on clinical testing, the market is subdivided into infectious illnesses, cardiac marker testing, cholesterol/lipid testing, pregnancy & fertility testing, testing for drugs of abuse, and another clinical testing. The demand for quick diagnostic tests, such as lateral flow assays, is on the rise as the danger of pathogen-caused diseases and their exposure rises.
Due to its portability and convenience of use, lateral flow assay testing is utilized in clinical testing scenarios and numerous diagnostic businesses. The majority of the time, these tests are utilized to test for infectious diseases, pregnancy, and urine analysis. In addition, as oral fluid-based testing evolves, the use of lateral flow assays becomes more practical due to the noninvasive nature of specimen collection.
The segment of drug development and quality testing is anticipated to increase at the highest CAGR. Lateral flow assays are increasingly utilized for therapeutic medication monitoring due to their convenience, affordability, and ability to identify several indicators in samples. Such assays are utilized to obtain total and semi-quantitative results in a variety of less regulated and regulated businesses.
In addition, the widespread availability of antibiotic tests is another driver propelling market expansion over the predicted period. Charm Sciences Inc. provides Charm ROSA lateral flow assay for the detection of aflatoxin M1 and certain common antibiotics used to treat dairy cows. These tests employ patent-protected technology to target drug sensitivities at acceptable and regulated levels, hence minimizing the needless rejection of milk due to overly sensitive screening tests.
Sandwich Assays Dominated the Market by Technique
Due to their precision, affordability, and use, sandwich assays held the largest revenue share in 2023. The test can also be administered in healthcare settings with limited resources and without the need for trained people. Sandwich assays are often utilized for the detection of bigger analytes including about two epitopes or binding sites. Combining GOLD conjugation and Ulfa-Tag kit technology, Abcam offers a Universal Lateral Flow Assay Kit that enables the construction of unique sandwich assays. One of the benefits of such a kit is its compatibility with any combination of detection and capture antibodies. Therefore, an increase in the availability of technologically advanced sandwich assays is anticipated to drive the expansion of the sector.
During the study period, the multiplex detection assay segment is anticipated to increase at the highest CAGR. The increasing development of multiplex lateral flow tests by research and academic institutions is expected to be a major factor influencing market expansion. For example, a recent study published in the journal ACS Omega in August 2021 involves the fabrication of a unique multiplex spot array called Blind Spot. The assay is a six-plex assay with test spots printed in six places and a MACAW (Modular Automated Colorimetric Processing Widget) sensor for analysis and interpretation of test result photos. It overcomes the obstacles posed by capillary flow dynamics and design constraints encountered during the creation of assays with several horizontal test lines. Such developments in the design of multiplex lateral flow tests are anticipated to increase their application in the near future, consequently driving segment expansion.
Lateral Flow Immunoassay Segment Led the Market by Analyse Type
In 2023, the lateral flow immunoassay category had the highest revenue share. In physician offices, hospitals, clinical laboratories, and clinics, lateral flow-based assays are utilized for the quantitative and qualitative detection of an extensive range of antibodies and antigens. It is a simple and inexpensive analytical technique used for screening, monitoring, and diagnosing several disorders. Due to these qualities, the application of lateral flow immunoassays is extremely high; they can be used at home by any member of the medical staff or patient.
In the coming years, the market for nucleic acid lateral flow assay is expected to expand significantly. Currently, antibodies dominate the industry. However, various drawbacks of lateral flow immunoassays, such as large inter-batch variability, error margin, and storage needs of conventional antibody-based lateral flow assays, have led to recent advancements in nucleic acid lateral flow assays. In recent years, diagnostic diagnostics based on nucleic acids have received substantial interest.
Hospitals & Clinics to Remain as the Dominant End-user
The majority of the population relies on hospitals and clinics to diagnose and treat a variety of medical ailments. Consequently, hospitals & clinics held the greatest market share in 2023 at 35%. Constant changes in the healthcare industry have increased the demand for hospitals with superior diagnostic capabilities. Globally rising healthcare expenditures have greatly contributed to the expansion of the sector. In addition, numerous infectious diseases, such as influenza, HIV, and hepatitis, are easily transferred in hospitals, resulting in epidemics frequently. Hospitals must adhere to particular rules to provide effective patient quarantine measures, the safety of healthcare staff, and thorough sanitization in order to reduce or eradicate such incidents. These characteristics can positively affect market expansion.
As a result of strategic activities such as mergers & acquisitions, product research, product approvals & launches, and expansion of worldwide operations, the pharmaceutical and biotechnology firm’s category is anticipated to experience the highest CAGR throughout the projection period. Emerging market participants are engaging in a number of collaborations to strengthen their lateral flow test solutions. In March 2023, for instance, Abingdon Health plc and Vatic Health Limited signed a Memorandum of Understanding for the development and production of lateral flow testing for infectious diseases. During the projection period, an increase in such strategic partnerships is predicted to improve the development of lateral flow assays and contribute to segment growth.
North America Remains a Global Leader
North America had the greatest revenue share in 2023, with 35%. As a result of the COVID-19 pandemic, increased public awareness and a surge in the availability of a vast array of diagnostic tests are anticipated to spur substantial expansion. In the United States, there were around 300 million at-home, quick testing for COVID-19 in December 2021, which was 10 times more than the 24 million tests accessible in August 2021. In addition, the Biden administration announced in November 2021 an investment of around USD 650 million for enhancing rapid diagnostic testing and expanding access to COVID-19 tests.
In addition, a rise in the number of new entrants and approvals in this sector is predicted to contribute to the growth of the industry throughout the projection period. In November 2021, for instance, InBios International, Inc. acquired Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its SCoV-2 Ag Detect Rapid Self-Test, which may offer results within 20 minutes.
The Asia-Pacific region is anticipated to grow at a quick CAGR as a result of increased cooperation between market entrants and initiatives implemented by the government and major players. In addition, a rise in awareness efforts by industry leaders is projected to contribute to the expansion of the regional market. The National Strategic Plan (NSP) for Malaria Elimination (2017-2023) of the Indian Government, for instance, aims to raise awareness and eradicate malaria in the country by 2030. Under the nation's National Health Mission, the National Vector Borne Disease Control Programme is expected to have a budget of 106.53 billion US dollars.
Acquisitions and Innovations to Win the Market Shares
To grow their market position, key companies in the lateral flow assay business are pursuing several organic and inorganic tactics, including partnerships, mergers and acquisitions, regional expansion, and strategic collaborations. For instance, Quidel Corporation reached a deal to buy Ortho Clinical Diagnostics in December 2021. It is anticipated that the acquisition will positively impact the company's growth by improving its diagnostics portfolio. Abbott Laboratories (United States), Quidel Corporation (United States), F. Hoffman-La Roche AG (Switzerland), Danaher Corporation (United States), Siemens AG (Germany), B.D. (United States), Bio-Rad Laboratories (United States), Thermo Fisher Scientific, Inc. (United States), PerkinElmer Inc. (United States), Hologic Inc. (United States), QIA
Recent Market Developments in Lateral Flow Assays:
Historical & Forecast Period
This study report represents analysis of each segment from 2022 to 2032 considering 2023 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2024 to 2032.
The current report comprises of quantitative market estimations for each micro market for every geographical region and qualitative market analysis such as micro and macro environment analysis, market trends, competitive intelligence, segment analysis, porters five force model, top winning strategies, top investment markets, emerging trends and technological analysis, case studies, strategic conclusions and recommendations and other key market insights.
Research Methodology
The complete research study was conducted in three phases, namely: secondary research, primary research, and expert panel review. key data point that enables the estimation of Lateral Flow Assays market are as follows:
Market forecast was performed through proprietary software that analyzes various qualitative and quantitative factors. Growth rate and CAGR were estimated through intensive secondary and primary research. Data triangulation across various data points provides accuracy across various analyzed market segments in the report. Application of both top down and bottom-up approach for validation of market estimation assures logical, methodical and mathematical consistency of the quantitative data.
| ATTRIBUTE | DETAILS |
|---|---|
| Research Period | 2022-2032 |
| Base Year | 2023 |
| Forecast Period | 2024-2032 |
| Historical Year | 2022 |
| Unit | USD Million |
| Segmentation | |
Type
| |
Application
| |
Technique
| |
Test Type
| |
Sample
| |
End User
| |
|
Region Segment (2022-2032; US$ Million)
|
Key questions answered in this report
