Lateral Flow Assay Market

"Ongoing spreading of Covid-19 and numerous infectious diseases across the world will result in favorable growth for lateral flow assay market creating 6,230.2 USD Million in 2021"

Scope of lateral flow assay market

Covid-19 is becoming one of the most fatal pandemics in history and carries a massive challenge to the healthcare system worldwide. However, with a growing desire for point-of-care tests, speedy and cheaper immunoassays are extensively utilized, such as lateral flow assay, which can be used for early, rapid, and large-scale detection of SARS-CoV-2 infection. This outbreak provided vast opportunities for research and development in health care along with the number of major players to leverage into lateral flow assay realms all around the globe. For example, in June 2020, Abbott Company had launched a lateral flow Covid-19 rapid antibody test on its Panbio™ system in selected countries pursuant to a CE Mark. And, in the same year in August, they launched its BinaxNOW™ Covid-19 Ag Card test, a portable, lateral flow rapid test to spot Covid-19 pursuant to a EUA in the U.S. Not only this, but the other companies are also creating their dominance during the pandemic just to stop the overwhelming condition of Covid-19. For example, on 1st September 2020, Roche launched its lateral flow assay test kit named SARS-CoV-2 Rapid Antigen Test. In the most challenging year in existing memory, many manufacturers rose to the lateral flow assay kits, making key contributions to the effort to defeat Covid-19 globally. Whereas, the U.S. Food and Drug Administration has granted Emergency Use Authorization (EUA) for the over-the-counter sale of iHealth Labs’ Covid-19 Antigen Rapid Test. iHealth is currently manufacturing around 100 million tests monthly and is anticipated to boost capacity to almost 200 million beginning from January 2022.

Segmentation Analysis of Lateral Flow Assays market:

The global Lateral Flow Assays market research reports segments as follows:

Global Lateral Flow Assays Market: By Testing Type

• Qualitative
• Quantitative

Global Lateral Flow Assays Market: By Analysis

• Single Analyte
• Multi Analyte

Global Lateral Flow Assays Market: By Application

• Clinical
• Food & Beverage
• Veterinary
• Environmental
• Others

Furthermore, to sense and to quantify precise analytes remaining in a complex mixture, lateral flow assay is extensively used in diverse applications (pregnancy test, HIV test, HBV test, etc.). Most commonly, loads of key players are investing in lateral flow assay kits or readers for detecting Covid-19. Rather than this, lateral flow assay has broad applications in the food safety sector together with the environmental testing sector. For instance, on December 13, 2021, Eurofins Technologies had launched its new Lateral Flow Reader RapidScan ST5-W as a single platform authenticated for numerous food and environmental rapid tests. Apart from the food and environmental sector, lateral flow assay is hugely adopted for testing HIV and tuberculosis. In accordance with the evidence published on 4th November 2019, World health organization has recommended its guidance for the use of lateral flow urine lipoarabinomannan assay (LAM) in the diagnosis of tuberculosis. As well, WHO has informed wider use of urinary LAM assays for analysis of TB in people living with HIV. Additional to the aforementioned facts, lateral flow assay is also used pregnancy test that gives rapid results and can be done deprived of any sophisticated equipment or trained manpower. Moreover, the lateral flow assays are adopted in other many applications including agriculture, veterinary, clinical, forensic, pharmaceutical, and others.

Despite noteworthy improvements in sanitation and medicine, the global prevalence of infectious diseases is still high. Even though non-communicable diseases are the primary cause of morbidity and mortality, infectious diseases endure a key public health concern throughout the globe. For instance, in accordance with the National Institute of Allergy and Infectious Diseases, worldwide infectious diseases claim almost 15 million lives annually. In 2019, as per the WHO World Malaria Report, nearly 229 million malaria cases arose globally. Likewise, according to the WHO 2021, a projected approximately 37.7 million people were alive with HIV at the end of 2020. Such high occurrence of infectious diseases, such as malaria and HIV, coupled with the underdeveloped healthcare infrastructural services and cumulative public consciousness in emerging countries, is dynamically pouring the acceptance of lateral flow assay tests in these countries. For instance, lateral flow assay kit, Biocard™ Malaria Pf/Pv is one of a Rapid sandwich test kit for differential detection of Malaria P.falciparum and P.vivax species by HRP-2 and pLDH antigen capture. Besides, the Health Security Agency in UK has verified the lateral flow devices now in use and has informed on December 15, 2021 that they do detect omicron and work as well as they did against other variants like a delta.  By considering the prevalence of infectious diseases and the importance of lateral flow assay over it, profuse players coupled with organizations are also entering into the realm of lateral flow assay.        

On a geographic basis, North America is dominating the lateral flow assay market due to the massive presence of major players. Numbers of major players such as Abbott Laboratories, Bio-Rad Laboratories Inc., Thermo Fisher Scientific, Inc., are pouring millions into the production of lateral flow assays. More specifically, the U.S. is hugely contributing followed by Europe. Europe is the fastest-growing region in the lateral flow assay market with numbers of fueling factors such as the prevalence of infectious diseases, and many more. Asia is expected to boost the market growth since it is home to some of the world's oldest populations, those ages 65 and above.

Global Lateral Flow Assays Market: Market Player Analysis

• Abbott Laboratories
• BioMerieux S.A
• Bio-Rad Laboratories Inc.
• Thermo Fisher Scientific, Inc.
• Siemens Healthineers
• Hologic Inc.
• Hoffmann-La Roche Ltd
• Others

Market Trends of Lateral Flow Assays Market:

Lateral flow Assays, also known as immunochromatographic strip (ICS) tests, are care tests that reduce the time from hours to minutes waiting for test results, require less training for the operator, and reduce the cost of both equipment development and care. Lateral flow (LF) devices and tests have been a popular platform for rapid immunoassay since its inception in the mid-1980s. Furthermore, many factors driving the growth of the point-of-care market as a whole have led to an increase in lateral flow point-of-care testing. These include the globalization of infectious diseases and related public health problems, advances in treatment, and the need to keep an eye on a growing group of people with chronic illnesses if doctors can diagnose the problem quickly. Such as cardiovascular disease, cancer, and other chronic conditions, and many other factors. The ability to achieve decentralized testing and faster test results is emerging as a tool for more efficient diagnosis and patient evaluation and to improve the quality of patient care. The use of these lateral flow assays is increasing day by day in many sectors in the market. Lateral flow assays are being used extensively in Clinical Applications, Food Safety Applications, Veterinary Applications, Environmental Applications, Pharmacy, Agriculture, Forensic labs, and others.

Clinical Applications: Currently, clinical diagnostic tests rely on analysis performed in a central laboratory that yield results after hours or even days. Delay in result due to time can affect decisions seriously which will negatively affect clinical outcomes in many cases, the potential benefits of using LFIA in the clinical field are self-evident. LFIA makes significant contributions to screening, diagnosis, monitoring, and surveillance. Immediate clinical assessment has a tremendous impact on disease management in reducing workload, increasing workflow, improving clinical care and patient outcomes, and reducing potential costs also. Furthermore, the use of LFIA allows patients to receive a diagnosis and specific treatment during the same consultation and reduces the number of clinical visits by avoiding referrals, and also helps to eliminate problems related to delay in initiating therapy, long-term benefits should not be underestimated. For example, LFIA is also helping to differentiate between bacterial and viral infections. Additionally, LFIA has an innate utility for use outside the laboratory. Therefore, in addition to the work performed by healthcare professionals in hospital laboratories, LFIA is used in the form of self-testing in hospital wards, dispensaries, health centers, doctors 'offices, and patients' homes.

However, many other LFIAs have been developed and used over time for different clinical purposes. The great success of LFIA in the clinical field may be related to its direct effect on human health and also because of the clinical intent of the first application.

Below mentioned information on some of the latest trending LFIAs are being used.

COVID-19 Antibody Rapid Test Kit

The COVID-19 epidemic has affected the definition of daily life in almost every country. To cope with this epidemic, rigorous testing is very important. Coronavirus LFA is considered to be one of the most promising techniques considered in this novel test. Lateral Flow Immunoassays, In this case, SARS-CoV-2 is responsible for detecting antibodies in the body when it comes in contact with a foreign body, which causes COVID-19. Furthermore, human immune system first produces antibodies “Immunoglobulin M (IgM)” whose immediate potency is bound to the coronavirus. It has been reported that IgM antibodies are visible in the human body about five days after a new infection. After 8 to 10 days of COVID-19, IgG antibodies have a high binding affinity to the virus, resulting in higher efficacy in fighting the virus. However, the COVID-19 IgM / Immunoglobulin M (IgG) antibody test kit qualitatively detects the combined or separate presence of IgG and IgM antibodies, studying the immune response of an infected patient.

COVID-19 Viral Antigen Test: The COVID-19 antigen test kit is considered another COVID-19 testing method for diagnosing active cases of COVID-19, especially in the early stages of infection, and for determining whether the patient is infectious to others. By detecting the presence of viral antigens in the nasal, oral, and respiratory tract, a patient can determine if they are actively releasing the virus, which can spread to others. These tests are probably the easiest to run in the early stages of infection as they help to confirm the viral presence 2 days before the onset of symptoms.

LFIA Neutralizing antibody test for COVID-19 vaccine development

Neutral antibodies are responsible for binding to cell-free viruses, preventing viral infections, and preventing cells from becoming infected. Several studies have suggested that these antibodies may play a key role in preventing new strains of coronavirus. After SARS-CoV-2 infection, the hosts produce these neutral antibodies to reduce the chance of recurrent infection. It has been reported that the spike protein in the novel Coronavirus of 2019, which is a glycoprotein that mediates the invasion of viruses in human cells, can be used as a target by neutral antibodies. Recent studies have shown that the Covid-19 vaccine may be effective if high levels of neutralizing antibodies against the spike protein of SARS-CoV-2 are reached. Antibody depletion may be an effective method for evaluating immunity against Covid-19 during the clinical stage and, therefore, plays an important role in testing the effectiveness of vaccination against the new coronavirus. Thus, the detection of ineffective antibodies may help in the development of vaccination against COVID-19. JOYSBIO launched the Lateral Flow Rapid Covid-19 Neutralizing Antibody Test Kit which detects semi-quantitative levels of neutral antibody against SARS-CoV-2 in serum, plasma, and whole blood samples.

LFA application for pregnancy (HCG hormone) test

Rapid detection of the HCG (Human chorionic gonadotropin) hormone is one of the most convenient techniques for determining early pregnancy. During the early stages of pregnancy, HCG is a hormone that is responsible for stopping menstrual shedding of the lining of the uterus to prevent menstruation. Since HCG is a protein, it can be easily detected with the help of LFIA techniques. HCG contains several multigenic sites, suggesting that antibodies may bind to the HCG hormone, direct or sandwich ace, applied in LFIA, in several places. The HCG lateral flow test, or pregnancy test, is used to determine the concentration of HCG (Human chorionic gonadotropin) in urine samples.

Rapid test cassettes for the diagnostics of HIV

Another commonly used commercial use of the lateral flow test is to diagnose human immunodeficiency virus (HIV). Specific antibodies to HIV type 1 are produced primarily in response to HIV-1 subtype B antigens. It has been reported that the use of specific antigens for HIV has better efficacy than indirect immunoassays. The HIV test cassette can capture and detect reagents through HIV infection using a multi-valence of HIV-specific antibodies. This could lead to the discovery of several antibodies that play an important role in the early diagnosis of HIV-1 and HIV-2 antibodies, which could have a significant impact on the overall effectiveness of HIV prevention and treatment.

Lateral flow assays for the detection of Hepatitis B Virus (HBV)

The global spread of the Hepatitis B virus (HBV) is high and is one of the leading causes of preventable death. HBV Point of Care (POC) is the most commonly used diagnostic technique for HBV. It contains specific antibodies that supplement HBV. These tests are usually quantitative and the results of the readings are binary, including only the absence and presence of HBV. Although LFIA is qualitative, studies have shown that it has a high sensitivity, which reduces the number of false positives and false negatives, leading to higher accuracy. Human serum or plasma, which is whole blood, is being used for rapid testing for the hepatitis C virus (HCV). Late flow tests also have a high sensitivity to detect HCV. 

Food Safety Applications: -

Unprotected food can cause more than 200 diseases ranging from gastrointestinal infections to cancer. In addition, 420,000 people die each year and more than 600 million get sick from eating contaminated food. To reduce this alarming number, food safety must be guaranteed throughout the food chain to avoid the presence of potential toxins such as veterinary drugs, heavy metals, pesticides, toxins, fertilizers, pathogens, and undeclared allergens. Adherence to good agriculture and good production practices is the cornerstone of this goal. However, only a comprehensive network of controls can further reduce the risk. Furthermore, the use of LFIA in food safety can help to manage food risk by increasing the number of analyzes, making them accessible, faster and cheaper, from raw materials to ready-to-eat products, and allowing food safety monitoring along the product chain. Furthermore, their simple and fast use makes them an ideal tool for risk analysis and critical control point (HACCP) processes. Moreover, compared to LFIAs dedicated to the clinical diagnostic field who have to deal with a limited sample matrix, LFIAs face additional challenge due to food matrix for food safety which can be complex and numerous. To get an idea of such diversity we can only think of how different it would be to analyze cereals, biscuits, meat, spices, milk, alcoholic and non-alcoholic beverages, drinking water, etc. Accordingly, the need of each new equipment is different. For example, in the entire production chain, may require very different approaches to monitoring mycotoxins in food and feed, and in all these situations, LFIA should be strong and favorable enough to ensure valid analysis. Depending on the properties of the target analyzer and the corresponding matrix, it may sometimes be necessary to use organic solvents to draw conclusions. However, antibodies and LFIA components (especially nitrocellulose membranes) have narrow tolerance for organic solvents. Therefore, determining the optimal solvent system for both analytical solubility and methodological performance can be a challenging task in test development. Sometimes an additional softening step in the right buffer is required to provide the right medium to allow the search for a more efficient analyst.

Veterinary Applications

Veterinary services are needed to ensure the health of animals and, in a broader context, to prevent and control animal diseases that infect humans (zoonosis’), to ensure hygienic safety of global trade in terrestrial and aquatic animals, and animal products, and to improve the animal welfare worldwide. Veterinary medicine shares many similarities with clinical diagnostics for human health. In this area too, making the right decision on time can have a big impact on the outcome.

However, early detection, effective surveillance, transparency, and rapid response to disease outbreaks are key to preventing and controlling animal diseases. Controlling diseases affecting terrestrial and aquatic animals and improving the well-being of these animals is a key component of the World Organization’s (OIE, Office International des Episodes) mandate, and has clear health benefits for both. Consider the impact on the sustainability of animals and humans, but also socio-economic and environmental systems. Additionally, nowadays, with the rapid growth of trade and tourism, animal diseases can spread further. The official sanitary status of countries regarding animal diseases has become an important factor in maintaining animal health, public health, and safe international trade. 182 OIE member countries have pledged to report the health status of terrestrial and aquatic animals in their territories in a timely and transparent manner. Disease detection and outbreak reporting should be as fast as possible to minimize their negative effects. Of course, the most worrying diseases are infectious diseases due to their ease of spread and their dramatic consequences (in some cases killing large numbers of livestock). In this context, the use of rapid screening tests can help identify and accelerate the infectious disease and thus direct quick and focused action to prevent its spread.

Furthermore, around 60% of the pathogens affecting humans are of animal origin, it is easy to understand the important role of early detection of these diseases in animals at their origin. Furthermore, the use of diagnostic rapid tests in the veterinary field has increased over the past decades due to the desire of pet owners to keep pet’s healthy and increased acceptance by farmers of the benefits of near-animal testing. Currently, veterinarians use rapid tests to examine commercial livestock and domestic pets for many medical conditions. These tests have potential utility in many veterinary settings, including private clinics, educational veterinary medical centers, communities in remote areas, and research applications in education, government, and industry.

Moreover, another driving force for the increasing acceptance of diagnostic rapid tests in veterinary medicine is the growing consumer concern about infectious diseases in antibiotics and milk, eggs, and meat, and widespread public concern about the spread of the disease through animal populations. Some of these concerns are strictly related to food security and human health and have been linked to global concerns over antibiotic resistance leading to loss of food production, poor animal welfare, and additional costs.

Therefore, At the World Health Assembly in May 2015, it became clear that the antibiotic resistance crisis needed to be managed urgently. As a result, in the same year, the WHO launched the Global Action Plan on Antibiotic Resistance, which has five strategic objectives. Among these objectives, the focus was on optimizing the use of antibiotics for human and animal health and increasing investment in diagnostic tools. It was pointed out that effective, rapid, low-cost diagnostic tools are needed to guide the optimal use of antibiotics in human and animal medicine, and that such tools should be integrated into clinical, pharmacy and veterinary practices. Ensuring that fast and affordable point-of-care tests are available for serious animal diseases is the most widely used antibiotic, reducing the misuse of these drugs in animal treatments that will improve antibiotic stewardship and animal health and well-being. On this basis, reliable LFIAs can help veterinarians and farmers to use antibiotic agents responsibly and judiciously, thus maintaining their therapeutic efficacy. Given the huge diversity of animal species and their associated characteristics, LFIAs are recommended for veterinary use in serum, urine, oral and nasal secretions, breast secretions, milk, feces, respiratory tract, etc.

Environmental Applications

Environmental pollution has become a global problem. Many pollutants and contaminants enter the atmosphere due to anthropogenic activities or natural phenomena like industry, agriculture, transportation, daily life, etc. Pollutants and contaminants can be air-, soil- or waterborne and can pass from one medium to another (e.g., from soil to water). They can, directly and indirectly, affect human health and the socio-economic development of a country. Therefore, detecting and monitoring air, soil, and water pollutants is a major concern. Thus, LFIA plays vital role in Environmental monitoring.

On Special Requirement Lateral Flow Assay Market Report is also available for below Regions and Country:

North America

• U.S.
• Canada

Europe

• Germany
• France
• U.K.
• Italy
• Spain
• Sweden
• Netherland
• Turkey
• Switzerland
• Belgium
• Rest of Europe

Asia-Pacific

• South Korea
• Japan
• China
• India
• Australia
• Philippines
• Singapore
• Malaysia
• Thailand
• Indonesia
• Rest Of APAC

Latin America

• Mexico
• Colombia
• Brazil
• Argentina
• Peru
• Rest of South America

Middle East and Africa

• Saudi Arabia
• UAE
• Egypt
• South Africa
• Rest Of MEA

Key Benefits of Lateral Flow Assay Market Report

• Global Lateral Flow Assay Market report covers in-depth historical and forecast analysis.
• Global Lateral Flow Assay Market research report provides detailed information about Market Introduction, Market Summary, Global market Revenue (Revenue USD), Market Drivers, Market Restraints, Delivery Robot Companies, Market opportunities, Competitive Analysis, Regional and Country levels.
• Global Lateral Flow Assay Market report helps to identify opportunities in the marketplace.
• Global Lateral Flow Assay Market report covers extensive analysis of emerging trends and competitive landscape