The global lateral flow assay market size was valued at USD 5.58 billion in 2020 and is expected to expand at a substantial CAGR during the forecast period, 2021-2028. The growth of the market is attributed to the rising cases of infectious diseases and wide availability of advanced diagnostic devices for diseases.
Lateral flow assays include a range of simple cellulose-based test devices used to detect or identify a particular substance present in the liquid sample, which is primarily used for clinical testing purposes. The assays are mainly designed to detect infectious diseases and examine the causal agents for such diseases. Some of the common diseases detected by the lateral flow assays include hepatitis B and others. These test devices offer certain advantages such as simple to use and cost-effective. One of the key aspects for the wide adoption of the devices is due to easy availability of equipment for laboratory testing, point of care testing and, home testing as they do not require various advanced equipment.
According to a report published by World Health Organization (WHO), around 219 million malaria cases were reported from 87 countries and more than 435,000 deaths were recorded due to malaria in 2017. Another report suggests that an amount of USD 3 billion has been sanctioned by WHO to develop various barriers including preventive drugs against malaria. As taking a leading initiative, WHO partnered with various organizations such as Roll Back Malaria (RBM), African Union Commission, and others to create awareness on diagnosis of malaria and its prevention. In another report by WHO, around 257 million people were diagnosed with hepatitis B, around 71 million people with hepatitis C, about 10 million people with tuberculosis. The COVID-19 pandemic had a positive impact on the lateral flow assay market owing to the fact that the tests can be taken at home without having sent the samples to laboratories and can be used with basic training. Small size, low-cost, and high speed in result are major factors that make devices popular in low or mid economic countries where the majority population are deprived of advanced healthcare facilities.
Market Trends, Drivers, Restraints, and Opportunities
- Wide prevalent of infectious diseases and the outbreak of COVID-19 pandemic are anticipated to fuel the market growth during the forecast period.
- Increasing number of initiatives for public awareness regarding the preventive measures of diseases taken by governments such as to develop a barrier against malaria are expected to propel the market growth.
- Rising collaboration and technological advancement that help in the development of innovative lateral flow kits are anticipated to drive the market expansion in the coming years.
- High taxation on medical devices and less availability of skilled technicians handling various testing procedures are key challenges that can restrain the market growth. Ongoing R&D programs and clinical experiments to enhance the techniques and procedures of the devices are projected to create lucrative opportunities for the market growth.
Scope of the Project
The report on the global lateral flow assay market includes an assessment of the market, trends, segment, and regional markets. Overview and dynamics have also been included in the report.
| Attributes | Details |
| Report Title | Lateral Flow Assay Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast |
| Base Year | 2020 |
| Historic Data | 2018-2019 |
| Forecast Period | 2021-2028 |
| Segmentation | Products (Kits & Reagents and Lateral Flow Readers [Benchtop Readers and Digital/Mobile Readers]), Applications (Veterinary Diagnostics, Clinical Testing [Infectious Diseases Testing {Mosquito Borne Disease Testing, Influenza Testing, Sexually Transmitted Infection Testing (HPV Testing, HIV Testing, Gonorrhea Testing, Chlamydia Testing, Syphilis Testing, and Others), Hepatitis, Tuberculosis, and Others}, Cardiac Marker Testing {Troponin I & T Testing, BNP & NT-ProBNP Testing, D-Dimer Testing, CK-Mb Testing, and Others}, Pregnancy & Fertility Testing {Pregnancy Testing and Fertility Testing}, Cholesterol Testing/Lipid Profile Testing, Drugs Of Abuse Testing, and Others], Food Safety & Environment Testing, and Drug Development & Quality Testing), Techniques (Sandwich Assay, Competitive Assay, and Multiplex Detection Assay), End-Users (Homecare, Pharmaceutical & Biotechnology Companies, Hospitals & Clinics, Diagnostic Laboratories, and Others) |
| Regional Scope | Asia Pacific, North America, Latin America, Europe, and Middle East & Africa |
| Report Coverage | Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, and Trends, and Revenue Forecast |
| Key Players Covered in the Report | Abbott Laboratories; Quidel Corp.; Hologic Inc.; Thermo Fisher Scientific Inc.; F.Hoffmann-La Roche; Siemens AG; Danaher Corp.; Becton, Dickinson and Co.; Bio-Rad; bioMerieux; and PerkinElmer. |
Market Segment Insights
Lateral flow readers segment is anticipated to account for a large market share
On the basis of products, the lateral flow assay market is bifurcated into kits & reagents and lateral flow readers. The lateral flow readers segment is further bifurcated into benchtop readers and digital/mobile readers. The kits & reagents segment is anticipated to hold a high market share in the coming years due to the wide use of kits and reagents for disease diagnosis. However, the lateral flow reader is expected to account for a large market share during the forecast period owing to provide accurate analysis for research purposes, development of advanced techniques, and regular sample testing. For the advancement of lateral flow test kits, new players in the market are collaborating with various research institutes as a development strategy. This is anticipated to fuel the market during the forecast period. Moreover, rising approval of diagnostic kits of lateral flow assay from regulatory bodies present another key insight for the segment expansion. For example, Synovasure, a kit developed by Zimmer Biomet was approved by the US Food and Drug Administration (FDA) in 2019 to be a used as lateral flow test kit.
Clinical testing segment is expected to hold a key share of the market
On the basis of applications, the market is segmented into veterinary diagnostics, clinical testing, food safety & environment testing, and drug development & quality testing. The clinical testing segment is further categorized as infectious diseases testing, cardiac marker testing, pregnancy & fertility testing, cholesterol testing/lipid profile testing, drugs of abuse testing, and others. The infectious diseases segment is further segregated into mosquito-borne disease testing, influenza testing, sexually transmitted infection testing, hepatitis, tuberculosis, and others. The sexually transmitted infection testing segment is further segmented into HPV testing, HIV testing, gonorrhea testing, chlamydia testing, syphilis testing, and others. The cardiac marker testing is divided into troponin I and T testing, BNP and NT-proBNP testing, D-dimer testing, CK-MB testing, and others.
The clinical testing segment is expected to hold a large share of the market during the forecast period owing to extensive clinical experiments to find advanced drugs and treatment methods for infectious diseases. According to a report by the U.S. Department of Health & Human Services, around 36.9 million people were living with AIDS/HIV, among which 1.8 million individuals were above the age of 15 in the year 2017. Moreover, rising number of cardiac disorder patients across the globe is anticipated to help the segment growth. Cardiac markers are used to assess the heart’s functioning and offer preventive treatment on early stage.
Sandwich assay segment is anticipated to dominate the market
Based on techniques, the lateral flow assay market is divided into sandwich assay, competitive assay, and multiplex detection assay. The sandwich assay segment is expected to dominate the market during the forecast period owing to factors such as low-cost, affordable, and accurate of the technology. Sandwich assays do not require any special training to handling the diagnostic process and get the results easily. A colored line mark in the test line shows a positive result; while no colored line denotes negative result.
Homecare segment is expected to rise at a rapid pace
On the basis of end-users, the market is categorized as homecare, pharmaceutical & biotechnology companies, hospitals & clinics, diagnostic laboratories, and others. The homecare segment is anticipated to rise at a rapid pace as these kits are extensively used by health professionals by giving minimal training. Moreover, these kits are also adopted rapidly as they provide fast diagnostic test at low resource settings. Meanwhile, the hospitals & clinics segment is expected to exhibit a significant growth rate in the market during the forecast period owing to wide adopting of the availability of advanced diagnostic devices and presence of specialized medical staff including doctors and technicians in hospitals as well as clinical centers.
North America is anticipated to dominate the market
In terms of region, the global rapid medical diagnostic kits market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is expected to dominate the market in the coming years due to early adoption of advanced technology for screening test, presence of a large number of health-conscious people, and wide prevalence of infectious diseases such as influenza in the region. Furthermore, the presence of key global players especially in the US is another major factor driving the regional market growth. Meanwhile, the market of Europe is anticipated to register a strong growth rate due to wide awareness of infectious diseases and inclination to early detection of the diseases. On the other hand, the market of Asia Pacific is projected to constitute a major market share during the forecast period owing to wide prevalence of infectious diseases such as HIV/AIDS and broad governments’ initiatives for the development of advanced treatment from emerging economies including China, Japan, and India.
Segments
Segments Covered in the Report
The global lateral flow assay market has been segmented on the basis of
Products
- Kits & Reagents
- Lateral Flow Readers
- Benchtop Readers
- Digital/Mobile Readers
Applications
- Veterinary Diagnostics
- Clinical Testing
- Infectious Diseases Testing
- Mosquito Borne Disease Testing
- Influenza Testing
- Sexually Transmitted Infection Testing
- HPV Testing, HIV Testing
- Gonorrhea Testing
- Chlamydia Testing
- Syphilis Testing
- Others
- Hepatitis
- Tuberculosis
- Others
- Cardiac Marker Testing
- Pregnancy & Fertility Testing
- Cholesterol Testing/Lipid Profile Testing
- Drugs of Abuse Testing
- Others
- Food Safety & Environment Testing
- Drug Development & Quality Testing
Techniques
- Sandwich Assay
- Competitive Assay
- Multiplex Detection Assay
End-users
- Homecare
- Pharmaceutical & Biotechnology Companies
- Hospitals & Clinics
- Diagnostic Laboratories
Regions
- Asia Pacific
- North America
- Latin America
- Europe
- Middle East & Africa
Key Players
- Abbott Laboratories
- Quidel Corp.
- Hologic Inc.
- Thermo Fisher Scientific Inc.
- F.Hoffmann-La Roche
- Siemens AG
- Danaher Corp.
- Becton
- Dickinson and Co.
- Bio-Rad
- bioMerieux
- PerkinElmer
Competitive Landscape
Key Players competing in the global lateral flow assay market are Abbott Laboratories; Quidel Corp; Hologic Inc.; Thermo Fisher Scientific Inc.; F.Hoffmann-La Roche; Siemens AG; Danaher Corp; Becton, Dickinson and Company; Bio-Rad; bioMerieux; and PerkinElmer.
Some of these key players have been actively engaged in the development of new technology to improve their testing kits. For instance, in December 2017, Atomo Diagnostics announced that its newly launched device named Atomo HIV Self-test was given CE mark by regulatory bodies. Moreover, BinaxNOW Influenza A & B Card 2, a test for rapid influenza diagnostic test, was launched by Alere (now Abbott) in 2019 to analyze and read lateral flow tests with the aim to deliver results in a short period of time. This test was to be used with DIGIVAL, another Abbott’s diagnostic reader.
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