Lateral Flow Analytics Market Research Report on Current Status and Future Growth Prospects to 2030 – SMU Daily Mustang
The Global Lateral Flow Assays 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. also called 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 expensive equipment and highly trained healthcare professionals for their operation, which have gained popularity among home care facilities, fueling the market.
Major factors propelling the market studied include growth in infectious diseases, increase in technological advancements, and government initiatives. In addition, the major factors attributed to the growth of the lateral flow test market are an increase in the global prevalence of infectious disease, HIV, which requires new diagnostic methods for effective treatment to eradicate the mortality rate croissant. Lateral flow tests have changed rapidly and are frequently used in POCs and diagnostic programs. Although lateral flow tests are widely used in the diagnosis of infectious diseases, cardiovascular diagnostics have also been revived in recent years. This increase in the application of lateral flow applications provides an opportunity for market growth over the forecast period.
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Global Lateral Flow Testing Market Dynamics
Engines: increasing demand for point-of-care testing and technological advances
Point-of-care diagnostics are gaining acceptance by different patients around the world, as samples are taken from the patient’s location for testing and results can be obtained in a very short time, thanks to the use of microfluids, chips and nano diagnostics. This made the testing process smooth, with relative ease and minimal time to take the tests and deliver the results. Additionally, the shortage of qualified clinicians available to perform the tests has led many countries to adopt point-of-care diagnostic tests.
The integration of microfluidics has been achieved to reduce the problem of inaccurate sample delivery. For example, the HemaStrip design, originally developed by Saliva Diagnostic Systems in Vancouver, used a capillary manifold molded into the end of a plastic tube in which the strips are present.
In recent years, major advances in the development of LFAs have included new signal enhancement techniques, the use of new markers, improved quantification systems, and simultaneous detection. Some new techniques have been used to enhance the signal of gold nanoparticles (colloidal nanoparticles) (GNPs have adopted silver enhancement technology or combinations of GNP with an enzyme (such as horseradish peroxidase), resulting in catalytic signal amplification.
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 buffers for the simultaneous detection of two proteins called biosensors at multiplexed side streams. This simultaneous detection can be very advantageous for detecting several biomarkers at the same time.
Hence, the rising prevalence of infectious diseases is increasing the demand for point-of-care testing and advancements in lateral flow testing are expected to drive the market growth over the forecast period.
Constraints: Rigorous and cumbersome regulatory framework that delays product approval
Diagnostic tools or diagnostic kits are becoming more and more important in the healthcare industry. One of the main issues faced by companies in the development and production of kits or tools or devices is to be up to date on the regulatory requirements and implement them in the process. Currently, different countries follow different regulatory requirements for the 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. In addition, the regulatory framework used for medical devices is very similar to that used to regulate prescription drugs.
Medical devices vary widely in their complexity and their risks or benefits. Thus, the Federal Food, Drug, and Cosmetic Act has established the classification of devices based on risk, 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 a regulatory class based on the level of control needed, so that there is reasonable assurance of its safety and effectiveness. The classification of medical devices depends on the intended use and the indications for use.
Therefore, the process required for a new commercial test to gain US FDA marketing approval can be a lengthy and costly process, sometimes taking many years, depending on the complexity of the test. Hence, stringent regulatory issues, along with longer timelines for developing a new commercial test, is a major impediment to the growth of the lateral flow test market.
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The study categorizes the Lateral Flow Test market on the basis of product, technique, application, and end-user at regional and global levels.
- Lateral stream readers
- Kits and reagents
- sandwich test
- Competitive trial
- Multiplex test
- Clinical tests
- Pregnancy test
- Flu screening
- D-dimer test
- Other clinical tests
- Drug addiction test
- other app
Per end user
- Home Care
- Hospitals and Clinics
- Other end users
- North America (United States, Canada, Mexico)
- South America (Brazil, Argentina, Colombia, Peru, Rest of Latin America)
- Europe (Germany, Italy, France, United Kingdom, Spain, Poland, Russia, Slovenia, Slovakia, Hungary, Czech Republic, Belgium, Netherlands, Norway, Sweden, Denmark, Rest of Europe)
- Asia-Pacific (China, Japan, India, South Korea, Indonesia, Malaysia, Thailand, Vietnam, Myanmar, Cambodia, Philippines, Singapore, Australia and New Zealand, Rest of Asia-Pacific)
- The Middle East and Africa (Saudi Arabia, United Arab Emirates, South Africa, North Africa, Rest of MEA)
Clinical Testing Segment of Lateral Flow Testing Market Expected to Account for Largest Share, By Mode of Operation
Based on application, the lateral flow testing market has been segmented into clinical testing, drug addiction testing, and others. The clinical testing segment accounted for the largest share of 57% of the global lateral flow testing market in 2020. service in pregnancy test are the major factors driving the growth of the market over the forecast period. Application of lateral flow test in other clinical tests involves testing of mosquito-borne diseases such as malaria, dengue fever, sexually transmitted infections, hepatitis, Epstein Barr virus (infectious mononucleosis) , Chlamydia Infections, Human Immunodeficiency Syndrome (HIV), Human Papilloma Virus (HPV Infection), COVID-19, Cholesterol Level Test, Blood Sugar Level Detection, among others.
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Asia Pacific region accounts for the highest CAGR over the forecast period in the lateral flow analysis market
Based on regions, the global lateral flow analysis market has been segmented into North America, Asia-Pacific, Europe, South America, and Middle East & Africa. In 2020, North America is expected to lead the market with 42% market share and worth USD 3,209.6 million in 2020. Additionally, Asia-Pacific accounted for the highest growth rate high by 8.07% over the forecast period. China represents one of the major healthcare industries in the Asia-Pacific region. Additionally, advancements in technologies, growth in infectious diseases, and increasing expenditure on R&D are likely to drive the growth of the market. In China, tuberculosis is the leading cause of death from infectious disease among adults. According to the World Health Organization in 2019, 8.33,000 people fell ill with tuberculosis in China. However, China is still among the top 30 TB-burden countries in the world, and TB remains a public health problem. With this increasing burden of tuberculosis, there is an immense need for appropriate diagnostic methods. This indicates the growing potential of lateral flow immunoassays in this segment.
Moreover, the recent COVID -19 outbreak has created a huge demand for diagnostics in the country which is expected to witness significant growth over the forecast period.
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Main market players
The lateral flow assay market is slightly concentrated in nature with few 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 NV, Quidel Corporation, and Merck KGaA, among others. These players have adopted various winning strategies to gain higher shares or maintain leading positions in the market.