During the forecast period of 2024 to 2032, the global market for lateral flow tests is projected to develop at a CAGR of 2.2%. The high prevalence of infectious diseases globally, the rapid growth of the older population, the rising demand for point-of-care testing, and the increased use of home-based lateral flow assay equipment are the key drivers driving the growth of this market. On the other hand, doctors' and patients' reluctance to modify established diagnostic procedures, as well as the inaccuracy of lateral flow assays, are the key impediments.
Despite significant breakthroughs in sanitation and medicine, infectious diseases continue to be prevalent throughout the world. Even though noncommunicable diseases are the leading cause of morbidity and mortality, infectious diseases remain a worldwide public health concern. In developing nations, the high prevalence of infectious diseases such as HIV and malaria, along with deficient healthcare infrastructure and increased public awareness, is expected to expand the use of lateral flow assay testing.
In developing nations, the high prevalence of infectious diseases such as HIV and malaria, along with deficient healthcare infrastructure and increased public awareness, is expected to expand lateral flow assay testing. In addition, recent outbreaks of infectious diseases caused by the spread of viruses (including Ebola, H1N1, and Zika) have highlighted the need for early disease detection capabilities, which are expected to fuel market growth. The current COVID-19 outbreak has increased the demand for quick diagnostic testing with lateral flow technology, which will contribute to the growth of this market over the next year.
Chronic diseases such as cystic fibrosis, hepatitis, cardiovascular disorders, and cancer usually result from age-related physiological changes and metabolic inefficiencies. Due to weakened immune systems, adults 65 and older are more susceptible to a variety of diseases and infections. As the prevalence of chronic diseases rises, so does the demand for early and accurate disease identification. As a result of its ability to detect symptoms in their earliest phases, lateral flow assay techniques are gaining popularity in the field of disease detection. Increased demand for lateral flow assay testing has resulted from the global increase in the elderly population and the growing number of patients with chronic conditions. In addition, age-related weakening has been a significant concern during COVID-19 care. Age and co-morbidities such as cardiovascular, lung, or kidney disease, cancer, and obesity enhance the chance of death from COVID-19.
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As the prevalence of chronic diseases rises, so does the demand for early and accurate disease identification. As a result of its ability to detect symptoms in their earliest phases, lateral flow assay techniques are gaining popularity in the field of disease detection. Increased demand for lateral flow assay testing has resulted from the global increase in the elderly population and the growing number of patients with chronic conditions.
Home-based lateral flow assay equipment serves a key role in the treatment of cardiovascular and infectious disorders. In addition to potentially empowering patients to undertake self-tests at home, these gadgets are especially useful for detecting pregnancy and stigmatized diseases like HIV. Consequently, the increasing prevalence of these diseases and the increased deployment of lateral flow assay tests in-home care settings are expected to enhance the demand for lateral flow assays. During the COVID-19 outbreak, a number of companies developed home-based lateral flow assays for COVID-19 testing, as individuals feared being tested at diagnostic laboratories or hospitals due to the high volume of patients. This boosted the demand for lateral flow testing conducted at home. This led to the release of various home-based tests, including the BinaxNOW COVID-19 Ag Card in August 2020 and the Panbio quick COVID-19 test in September 2020, as well as the SARS-CoV-2 Rapid Antigen Test by Roche Diagnostics in September 2020. 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 were also introduced during COVID-19 (BD). Additionally, the outbreak spurred collaboration between government agencies and key players in order to expand the availability of diagnostic tests. In August of 2020, for instance, Abbott Laboratories (US) and the US government reached a deal for 150 million home-based BinaxNOW COVID-19 tests.
Currently, laboratory-based tests account for the majority of diagnostic procedures conducted worldwide. In contrast, point-of-care (POC) testing based on lateral flow tests is quickly replacing time-consuming, conventional laboratory procedures. Point-of-care diagnostic tests are less expensive than standard laboratory diagnostic techniques because they require less complex infrastructure and training. The market for lateral flow assays is anticipated to be dominated by point-of-care (POC) testing due to the significance of POC testing in the context of a rising disease burden. According to the Global Tuberculosis Report 2020 from the World Health Organization, 1,4 million people died from tuberculosis-related illnesses in 2019 and over 10 million individuals contracted tuberculosis in 2019. The POC testing market segment with the fastest growth rate is infectious disease tests and cardiac markers, due to their rising adoption in home care settings. Typical POC testing includes pregnancy and fertility tests, coagulation tests, and urine chemical tests. Due to the rising acceptability of lateral flow assay testing products in home care settings, the market for point-of-care (POC) lateral flow assay testing has exploded in recent years. Assisted by lateral flow assays, point-of-care testing is simple, rapid, affordable, practical, and easy to interpret. These tests can be designed to identify the presence of pathogens in a variety of samples, including whole blood, plasma, serum, and saliva, boosting their utility for point-of-care testing. Biomarker-based lateral flow assay point-of-care testing can detect subclinically infected individuals in some cases.
This trend is primarily driven by the rising prevalence of chronic diseases, technological advancements, increased patient awareness, and broader access to innovative products. Companies are increasingly emphasizing the development of 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 in rapid clinical diagnostics of life-threatening events (such as heart attacks, strokes, and deep-vein thrombosis). In 2019, Abbott Laboratories (US) launched the ARCHITECT STAT Troponin I Blood Test, and Siemens AG created the CLINITEK Microalbumin 2 strips for clinical diagnostics. During the forecast period, the increasing need for point-of-care (POC) testing and the emphasis on adopting lateral flow assay-based POC testing equipment to achieve greater portability are anticipated to boost the growth of the lateral flow assays market.
In a number of countries, food safety issues and public health concerns have prompted stronger food safety regulations. This increased the demand for pathogen and toxin testing in practically every area of the food production industry, including processed foods, meats, poultry, beverages, and dairy products, as well as among the major food manufacturers in the globe. Historically, the bulk of food safety tests was conducted using normal laboratory-based microbiology techniques, although the use of rapid, on-site tests is growing in this field. These tests are primarily used to detect Listeria, Salmonella, and E. coli in raw materials, intermediate industrial products, and finished commodities. In August 2020, PerkinElmer announced a COVID-19 environmental surface testing kit for food manufacturers. In addition, the food industry has indicated a need for tests that can identify mycotoxins and allergens, such as R-RIDA Biopharm's Rapid quick test. Single path 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 are all offered by Merck KGaA (Germany).
Traditional microbiological testing necessitates that finished products be held in a warehouse for two to four days pending test results, whereas rapid methods provide microbial test results within twenty-four hours. These advantages, coupled with the implementation of Hazard Analysis and Critical Control Points (HAACP) regulations dictating test protocols throughout the manufacturing process, are driving up demand for lateral flow tests in the food manufacturing industry. The combination of increasing European food industry competitiveness and the implementation of the European validation system MICROVAL for alternative food testing methods will allow Europe to catch up to the United States in terms of rapid food testing technologies. In addition, key food-exporting nations like Mexico and Brazil, as well as increasing processed food industries in Asia-Pacific, will provide market participants involved in lateral flow studies with an additional avenue for growth.
Although lateral flow assays are simple to execute and less expensive than laboratory studies, they have been observed to be less accurate. For instance, the SARS-CoV-2 antibody tests, which are based on the lateral flow approach, have exhibited a significant margin of error. This has led to false negatives, making it difficult to monitor the coronavirus's spread. Due to the unreliability of lateral flow assay testing, the majority of physicians and patients prefer molecular investigations over rapid tests for a more accurate diagnosis of COVID-19 and other infectious disorders.
The acquisition and confirmation of antigens and antibodies, known as necessary reagents, is one of the most challenging aspects of constructing lateral flow assay procedures. Antibodies designed for use in assays must be examined for accuracy, specificity, stability, and reproducibility; otherwise, the experiment may fail. Over a thousand data points must be verified for the certification of a single lot of reagents. Once an antibody or antibody pair has been developed, the stability testing of assays becomes a challenge. An assay must have a stable shelf life of at least 6 months, ideally 18–24 months, to qualify as a commercial product. Remediating assays that fail stability testing requires extra time, effort, and money. Consequently, the time-to-market would be prolonged. These factors restrain the market expansion for lateral flow tests over the forecast period.
Due to payment problems, the use of lateral flow assay-based diagnostics has been limited in various regions around the world. The rising expense of healthcare compels insurers to review and assess the need for additional diagnostic tests. Moreover, payers are shifting from fee-for-service to fee-for-value-based payment systems. Due to inadequate pay, a diagnostic test that allows a physician to evaluate whether or not to pursue a certain treatment is either abandoned or underinvested.
In a number of regions, reimbursement issues impede the growth of the market for lateral flow assay-based diagnostics. The National Health Service (NHS) is responsible for approximately 75% of healthcare payments in the United Kingdom. On the NHS, only some lateral flow test devices, such as the CrAg lateral flow assays used to diagnose cryptococcosis, are reimbursable in primary care. There is no specific reimbursement policy for nonprescription lateral flow test kits (such as cardiac markers and pregnancy kits).
Despite an increase in the number of commercially available tests, the majority are not coded according to Current Procedural Terminology (CPT). Diagnostic reports must adhere to specific medical coding requirements in order to give a medical biller the essential information to submit a reimbursement claim. Without coding and, as a result, reimbursement, physicians will not select more expensive new diagnostic tests. As reimbursements for commercially available diagnostic tests are restricted, so are the funds necessary to finance the research and development of innovative new diagnostic methods. In addition, patients have a larger preference for central lab testing due to the lack of payment.
In the past two decades, lateral flow tests have seen tremendous development and are routinely used in diagnostic and point-of-care settings. In spite of the fact that lateral flow tests are routinely employed for infectious illness detection, heart disease diagnostics, and veterinary applications, their use has increased in recent years for a variety of unique applications. New lateral flow assay applications include saliva diagnostics, behavioral health, agriculture (GMO detection and crop quality testing), biowarfare (anthrax detection), environmental testing (detection of contaminated enzymes in manufacturing facilities), and food microbiology (detection of E. coli O157, Salmonella, Listeria, and other food spoilage organisms).
OraSure Technologies (US) is one of the leading providers of lateral flow saliva testing. Salivary LFIAs have also penetrated the market for applications such as drugs-of-abuse testing, and some systems have FDA marketing approval; nonetheless, qualitative testing remains the norm. Using saliva, rapid tests for infectious disorders have also been developed. SOMA Bioscience (UK salivary)'s cortisol LFDs have been utilized in sports research. Rapid Saliva Protein Test (RSPT) is a lateral flow saliva test designed by Medusa 19 Limited (UK) to evaluate the immune response to SARS-CoV-2 infection.
In 2023, the kits and reagents category held a larger revenue share, since lateral flow kits offer greater versatility to collect and detect any type of analyte without the need to spray captured antibodies on the test strip. Due to their versatility, these kits are utilized in medical, animal health, environmental testing, feed & food testing, and crop & plant testing. During the forecast period, the release of new kits by industry leaders is anticipated to spur market expansion. In India, Abbott announced its Panbio COVID-19 Antigen Self-Test in July 2021, for instance. Additionally, in January 2023, Roche Diagnostics India announced the COVID-19 At-Home Test.
Lateral flow tests are affordable, user-friendly, and provide precise results in minutes. These tests reveal immunoglobulin G and immunoglobulin M antibodies to SARS-CoV-2, the virus that causes COVID-19. Ozo Life announced OZO COVID-19 Rapid Test Kits in March 2020. These kits provide a latex-enhanced, high-sensitivity lateral flow immunoassay for the early identification of COVID-19. Consequently, a rise in strategic initiatives by market participants is expected to contribute to the growth of the industry throughout the forecast period.
Because of the increase in infectious disease frequency, the clinical testing category retained a 75% market share in 2023. On the basis of clinical testing, the market is split into infectious diseases, cardiac marker testing, cholesterol/lipid testing, pregnancy & fertility testing, drug misuse testing, and another clinical testing. As the risk of pathogen-caused diseases and their exposure increases, the necessity for rapid diagnostic procedures, such as lateral flow assays, also increases. Due to its portability and usability, lateral flow assay testing is utilized in clinical testing situations and by a variety of diagnostic companies. Most commonly, these tests are used to detect infectious illnesses, pregnancy, and urine analysis. In addition, as oral fluid-based testing evolves, the noninvasive aspect of specimen collection makes lateral flow assays more applicable.
The segment of drug development and quality testing is projected to grow at the fastest rate. Lateral flow assays are increasingly utilized for therapeutic medication monitoring due to their ease of use, cost, and capacity to detect many markers in samples. In a range of less regulated and regulated industries, these assays are utilized to generate full and semi-quantitative data. In addition, the widespread availability of antibiotic testing is another factor that will push market growth throughout the forecast period. Charm Sciences Inc. offers the Charm ROSA lateral flow assay for the detection of aflatoxin M1 and popular antibiotics used to treat dairy cattle. These tests use patent-protected technology to target drug sensitivities at acceptable and controlled levels, thereby minimizing the wasteful rejection of milk owing to screening tests that are overly sensitive.
Sandwich assays held the biggest revenue share in 2023 due to their accuracy, affordability, and utility. Additionally, the test can be conducted in healthcare settings with minimal resources and untrained personnel. Sandwich assays are frequently employed for the detection of larger analytes with about two epitopes or binding sites. Abcam offers a Universal Lateral Flow Assay Kit that permits the development of novel sandwich assays by combining GOLD conjugation and Ulfa-Tag kit technology. This kit's flexibility with any combination of detection and capture antibodies is one of its advantages. Therefore, it is projected that an increase in the availability of technologically improved sandwich assays will fuel the growth of the sector.
The sector of multiplex detection assays is predicted to grow at the greatest CAGR over the study period. The rising development of multiplex lateral flow tests by research and academic organizations is anticipated to be a significant factor in the expansion of the market. A recent study published in the journal ACS Omega in August 2021, for instance, involves the creation of a Blind Spot array of multiplex spots. It is a six-plex assay with test spots printed in six locations and a MACAW (Modular Automated Colorimetric Processing Widget) sensor for processing and interpretation of test result photographs. It addresses the challenges caused by capillary flow dynamics and design limits encountered when developing assays with several horizontal test lines. In the near future, such advancements in the design of multiplex lateral flow tests are predicted to boost their applicability, hence driving the segment growth.
In 2023, the category of lateral flow immunoassays had the largest revenue share. In doctor's offices, hospitals, clinical laboratories, and clinics, lateral flow-based assays are used for the quantitative and qualitative detection of a vast array of antibodies and antigens. It is a straightforward and cost-effective analytical approach used for screening, monitoring, and diagnosing a variety of illnesses. Due to these characteristics, the application of lateral flow immunoassays is quite widespread; any member of the medical staff or patient can use them at home. The market for nucleic acid lateral flow assay is anticipated to increase rapidly in the future years. Antibodies currently dominate the market. Recent developments in nucleic acid lateral flow assays have been prompted by the disadvantages of conventional antibody-based lateral flow assays, such as substantial inter-batch variability, error margin, and storage requirements. In recent years, there has been significant interest in nucleic acid-based diagnostics.
The majority of people rely on hospitals and clinics to diagnose and treat a wide range of medical conditions. Thus, hospitals & clinics maintained a 35% market share in 2023. The demand for hospitals with excellent diagnostic capabilities has expanded due to the industry's constant transformations. Increasing healthcare expenditures on a global scale have significantly contributed to the sector's growth. Moreover, various infectious diseases, including influenza, HIV, and hepatitis, are easily transmitted in hospitals, resulting in regular outbreaks. In order to prevent or eliminate such occurrences, hospitals must adhere to specific regulations governing the quarantining of patients, the protection of medical personnel, and proper sanitation. These traits may contribute to the expansion of the market.
As a consequence of strategic initiatives such as mergers & acquisitions, product development, product approvals & launches, and expansion of global operations, it is expected that the pharmaceutical and biotechnology firm's category would enjoy the largest CAGR throughout the forecast period. Emerging market participants are collaborating on a variety of lateral flow testing methods. Abingdon Health plc and Vatic Health Limited, for instance, inked a Memorandum of Understanding in March 2023 for the development and manufacture of lateral flow diagnostics for infectious diseases. During the forecast period, an increase in these strategic collaborations is anticipated to enhance the development of lateral flow assays and contribute to the expansion of the segment.
In 2023, North America had the highest revenue share, at 35%. As a result of the COVID-19 pandemic, it is projected that greater public awareness and a boom in the availability of a large array of diagnostic tests will stimulate enormous growth. Around 300 million at-home, rapid COVID-19 tests were available in the United States in December 2021, 10 times more than the 24 million tests available in August 2021. In addition, in November 2021, the Biden administration announced an expenditure of approximately USD 650 million to improve rapid diagnostic testing and expand access to COVID-19 tests. In addition, an increase in the number of new entrants and approvals is anticipated to contribute to the expansion of this industry throughout the forecast period. In November 2021, for example, InBios International, Inc. obtained Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its SCoV-2 Ag Detect Rapid Self-Test, which may provide results within 20 minutes.
As a consequence of greater cooperation between market entrants and measures implemented by the government and large players, the Asia-Pacific region is projected to grow at a rapid CAGR over the next five years. In addition, an increase in industry leaders' awareness campaigns is anticipated to help to the growth of the regional market. For instance, the National Strategic Plan (NSP) for Malaria Elimination (2017-2023) of the Indian Government intends to improve awareness and eradicate malaria in the country by 2030. The National Vector Borne Disease Control Programme is anticipated to have a budget of 106,53 billion US dollars under the National Health Mission.
Key players in the lateral flow assay industry are adopting various organic and inorganic strategies, including as partnerships, mergers and acquisitions, regional expansion, and strategic collaborations, to strengthen their market position. In December 2021, Quidel Corporation reached an agreement to acquire Ortho Clinical Diagnostics. The acquisition is projected to have a favorable impact on the company's growth by enhancing 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.
Recent Trends in the Market for Lateral Flow Assays:
