The global lateral flow assay market is expected to grow from USD 8,232.8 million in 2020 to USD 12,489.0 million by 2027, at a CAGR of 4.8% from 2021 to 2027. Lateral flow assays, also referred to as lateral flow immunochromatographic assays, are cellulose-based devices used to detect the presence of a target analyte in the sample without the need for specialized and costly equipment and highly skilled healthcare professionals for their operation, which gained significant traction among the homecare settings, fueling the market.
The key factors propelling the market studied include growing infectious diseases, increasing technological advancements and government initiatives. Also, the major factors attributing to the growth of the lateral flow assay market are a rise in the global prevalence of infectious diseases, HIV, which necessitate novel diagnostic methods for efficient treatment to eradicate the growing mortality rate. Lateral flow tests have changed rapidly and are frequently used in POC and diagnostic programs. Although lateral flow tests are widely used in the diagnosis of infectious diseases, cardiovascular diagnoses have also been picked up in the past few years. This increase in the application of lateral flow applications brings an opportunity for market growth in the forecast period.
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Global Lateral Flow Assay Market Dynamics
Drivers: Increased demand for point-of-care testing and technological advancements
Point-of-care diagnostics is gaining wide acceptance by different patients across the world because samples are collected from the patient’s location for performing tests and the results can be achieved in very less time, due to the use of micro fluids, chips, and nano diagnostics. This has made the testing process smooth, with relative ease and minimum time consumption to take the tests and deliver the results. Also, shortage of skilled clinicians available to perform the tests has driven the way for many countries to adopt point-of-care diagnostic testing.
Integration of microfluidics was done to reduce issue of inaccurate sample delivery. For instance, HemaStrip design, originally developed at Saliva Diagnostic Systems in Vancouver used a capillary collector molded to the end of a plastic tube in which the strips are present.
In recent years, major advances in LFA development have included novel signal enhancement techniques, the use of new labels, improved quantification systems and simultaneous detection. Some new techniques have been used to enhance the signal from gold nanoparticles (colloidal nanoparticles) (GNPs have adopted silver enhancement technology or combinations of GNPs with an enzyme (such as horseradish peroxidase), which results in catalytic amplification of the signal.
Some successful developments of simultaneous detection techniques include a combination of colloidal gold nanoparticles and oligonucleotides for the simultaneous detection of antigens and antibodies and the use of two conjugate pads for the simultaneous detection of two proteins called multiplexed lateral flow biosensors. This simultaneous detection can be very advantageous for detecting multiple biomarkers at a time.
Hence the growing prevalence of infectious disease increasing the demand for point of care test and the advancements in the lateral flow assays are expected to boost the market growth in the forecast period.
Restraints: Stringent and tedious regulatory framework that delays the approval of products
Diagnostic tools or diagnostic kits are becoming more important in the healthcare sector. One of the major issues faced by companies in developing and producing kits or tools or devices is to be updated on the regulatory requirements and implement them in the process. Currently, different countries follow different regulatory requirements for approval of medical devices.
Healthcare providers rely on a variety of tools to diagnose conditions and guide treatment decisions. In the United States, diagnostic tests are regulated by the United States Food and Drug Administration (FDA). The FDA classifies diagnostic tests as medical devices. Moreover, the regulatory framework used for medical devices closely resembles that used to regulate prescription medications.
Medical devices vary widely in their complexity and risks or benefits. Thus, the Federal Food, Drug, and Cosmetic Act has established the risk-based device classification, such as Class I or “low risk,” Class II or “moderate risk”, and Class III or “high risk”, for medical devices. Each device is assigned to a regulatory class based on the level of control necessary, so that there is a reasonable assurance of its safety and effectiveness. Medical device classification depends on the intended use and indications for use.
Therefore, the process required for a new commercial test to gain approval for marketing by the US FDA can be a costly and time-consuming process, which sometimes takes many years, depending on how complicated the test is. Therefore, the stringent regulatory issues, along with longer timelines in developing a new commercial test, act as a major hindering factor for the lateral flow assay market’s growth.
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Scope of the Report
The study categorizes the lateral flow assay market based on product, technique, application, and end user at the regional and global levels.
- Clinical Testing
- Pregnancy Testing
- Influenza Testing
- D-Dimer Testing
- Other Clinical Testing
- Drug Abuse Testing
- Other Application
By End User
- Home Care
- Hospitals and Clinics
- Other End Users
- North America (US, Canada, Mexico)
- South America (Brazil, Argentina, Colombia, Peru, Rest of Latin America)
- Europe (Germany, Italy, France, UK, Spain, Poland, Russia, Slovenia, Slovakia, Hungary, Czech Republic, Belgium, the Netherlands, Norway, Sweden, Denmark, Rest of Europe)
- Asia Pacific (China, Japan, India, South Korea, Indonesia, Malaysia, Thailand, Vietnam, Myanmar, Cambodia, the Philippines, Singapore, Australia & New Zealand, Rest of Asia Pacific)
- The Middle East & Africa (Saudi Arabia, UAE, South Africa, Northern Africa, Rest of MEA)
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The clinical testing segment of the lateral flow assay market is projected to account for the largest share, by mode of operation
Based on the application, the lateral flow assay market has been segmented into clinical testing, drug abuse testing, and others. The clinical testing segment accounted for the largest share of 57% of the global lateral flow assay market in 2020. The increasing demand for the home testing kits, that provides rapid results and the growing awareness on point-of-care-diagnostics in testing pregnancy are the major factors driving the market growth over the forecast period. The application of lateral flow assay in other clinical testing involve mosquito borne disease testing such as malaria, dengue, sexually transmitted infections, hepatitis, Epstein Barr Virus (infectious mononucleosis), Chlamydia infections, Human Immuno Deficiency Syndrome (HIV), Human Papiloma Virus (HPV) infection, COVID-19, Cholesterol level testing, Blood glucose level detection among others.
Asia Pacific accounts for the highest CAGR during the forecast period in the lateral flow assay market
Based on the regions, the global lateral flow assay market has been segmented across North America, Asia-Pacific, Europe, South America, and the Middle East & Africa. In 2020, North America estimated to lead to market with 42% market share and valued USD 3,209.6 million in 2020. Moreover, Asia Pacific accounted for the highest growth rate of 8.07% during the forecast period. China represents one of the major healthcare industries in Asia Pacific Region. Furthermore, advancements in the technologies and growing infectious diseases and rising R&D expenditure likely to drive the market growth. In China, tuberculosis is the leading cause of death from infectious disease among adults. According to the World Health Organization in 2019 there are 8,33,000 people that fell ill with tuberculosis in China. However, China is still among the 30 high-burden tuberculosis countries in the world, and tuberculosis remains a public health concern. With this increasing burden of tuberculosis there is an immense need for proper diagnostic methods. This indicates the rising potential for lateral flow immunoassay testing in this segment.
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Moreover, the recent outbreak of COVID -19 has created a huge demand for the diagnostics in the country that is expected to have significant growth over forecast period.
Key Market Players
The lateral flow assay market is mildly concentrated in nature with few numbers of global players operating in the market such as Abbott Laboratories, F. Hoffman-La Roche Ltd, Danaher Corporation, Siemens AG, Becton, Dickinson and Company, bioMérieux SA, Bio-Rad Laboratories, Thermo Fisher Scientific, Inc., PerkinElmer Inc., QIAGEN N.V., Quidel Corporation, and Merck KGaA, among others. These players have been adopting various winning strategies to gain higher shares or retain leading positions in the market.