Lateral Flow Assay Market Size to Worth Around USD 16.74 BN by 2032

Ottawa, June 13, 2023 (GLOBE NEWSWIRE) — According to Precedence Research, the global lateral flow assay market size is estimated to hit around USD 15.48 billion by 2030. Lateral flow assays work by detecting the presence or absence of a specific target analyte, such as a biomarker or antigen, in a patient’s sample (e.g., blood, urine, saliva). Lateral flow assays are rapid, easy to use, and do not require specialized equipment or technical expertise. They are used for a variety of applications, including pregnancy testing, infectious disease diagnosis, drug screening, and environmental monitoring. However, they may not be as sensitive or specific as other diagnostic methods and may produce false positives or false negatives in certain situations.

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There are many lab-based apps available that are enabled by the reading apparatus, but they do not require high-tech or expensive equipment. In human health, lateral flow studies are frequently employed. They are employed in residential, point-of-care, and laboratory checking for medical diagnostics. The most popular and well-known uses of lateral flow measurements are home pregnancy checks. However, lateral flow test tools are also used to detect contamination in water, animal feed, and other sources as well as animal illnesses in animals.

Sandwich assays and competing assays are the two categories under which lateral flow studies are categorized. A colored line at the test line position indicates a good sandwich assay. A colored line at the test line position is shown to be absent in a good competitive analysis. One or more test lines can be used to make sandwich and competing tests. For instance, the multiplexed sandwich assay PCRD for nucleic acid lateral flow ELISA has two test lines and one control line. In lateral flow experiments inside the conjugate cushion, nanoparticles of conjugated gold, carbon, or dyed latex are used. Other marking choices include magnetic beads and colored polystyrene beads.

Readers and lateral flow test kits are two different varieties of lateral flow assays. The scanners measure the data, whereas the kits provide a qualitative analysis that shows the existence or lack of sickness. Tabletop and portable lateral flow test devices are the two different models. These battery-operated, compact, low-cost devices have few attachment requirements but offer patients and lab staff a great deal of freedom. A dipstick, lancets, a cartridge, and test sheets for pathogen identification are included in lateral flow assay packages. The sample is placed on the testing apparatus, and the results can be seen as a hue change brought on by conjugate formation.

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Report highlights

• In 2022, the flexibility of lateral flow kits to capture and identify analytes without spraying captured antibodies on test strips resulted in the kits and reagents sector holding a larger revenue share.
• The clinical testing sector accounted for the biggest portion (77%) due to the increased prevalence of infectious diseases. The simplicity, accessibility, and precision of sandwich tests are expected to lead to the highest revenue share, with the added benefit of not requiring qualified personnel, making them ideal for healthcare environments with limited resources.
• The sector that sold lateral flow immunoassays had the highest revenue share in 2022.
• The pharmaceutical and biotechnology firms’ sector is projected to experience the fastest Compound Annual Growth Rate (CAGR) during the forecast period due to strategic efforts such as mergers and acquisitions, product research, product approvals and launches, and the expansion of global operations.
• North America had the highest income percentage (37%) in 2022, and the COVID-19 pandemic, which increased access to various diagnostic tests and raised public awareness, is expected to drive significant development.

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Scope of this report

Regional Snapshots

Due to an increase in the prevalence of various infectious and chronic illnesses, such as Lyme disease and TB, as well as an elevated fatality rate linked to HIV/AIDS in the area, North America is anticipated to lead the global market for lateral flow assays throughout the projection period. Due to a big patient population and cost with rising discretionary income, the United States is expected to retain the highest market share in North America.

With the COVID-19 pandemic, there has been a shift towards home-based testing, and lateral flow assays are well-suited for this application due to their ease of use and rapid turnaround time. Additionally, the market in the region is anticipated to grow, supporting its outstanding portion of the global market income over the course of the projection period. These factors include the number of diagnostic centers, the increased adoption rate of sophisticated infrastructure, and the rise in consumer consciousness. Furthermore, the growing focus on R&D to adopt novel diagnostic solutions is ultimately bolstering the growth of this market across North America. For instance, the American Chemical Society published a research article on ultrasensitive and highly specific lateral flow assay for point-of-care diagnosis, in February 2021.

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Abbott Laboratories increased the output of coronavirus test kits in 2020, adding a novel device that might allow for widespread COVID-19 screening. The business has revealed that it is creating a “lateral flow” blood test, which could be used to test the entire populace in large numbers. This development is anticipated to have a favorable effect on the market in the area.

Market dynamics

Drivers

Several key factors are driving the growth of the global lateral flow assay market, including the widespread occurrence of infectious diseases, an increasing elderly population, a growing demand for point-of-care testing, a rising need for lateral flow assay kits for home use, and increasing disposable income levels in developing nations. The global lateral flow assay market is anticipated to be driven by additional factors like technical development and rising product usage. The demand for point-of-care testing in-home care environments that can provide findings in real-time (5-15 minutes) and is user-friendly is rising due to the increased prevalence of infectious and lifestyle diseases.

Functional advancements in lateral flow studies in terms of sensitivity, selectivity, and quantitative developments are being brought about by technological development. The intensity of a sample’s test line is frequently evaluated using manufacturers’ test readers. The appeal of portable lateral flow assay readers has grown as a result of their increasing portability and downsizing. The use of various frequencies for sample illumination and various sample recognition systems, such as CMOS or CCD detecting technologies, are driving technological advancements in lateral flow assay testing tools.

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Additionally, the development of advanced image processing methods tailored specifically for testing has improved sample analyte measurement. Because these tools are so easy to use, the Lateral Flow Assay Market is expected to expand. Commercial interest is growing in alternative non-optical techniques like capillary pumping of sample fluid to reduce variation in sample volume and magnetic immunoassay (MIA).

Restraints

The market environment for lateral flow assays may be hampered by the stringent regulatory standards set by healthcare organizations like the U.S. FDA and the complicated clearance procedures. Lateral flow assays, which are classified as Class II devices, need to go through the 510(k) premarket notice procedure before they can be sold to the general public. These devices must undergo time-consuming review processes and tedious paperwork due to the stringent laws that govern them. There is a good possibility that the manufacturer will face significant penalties if these laws are broken or ignored.

Opportunities

The government has improved testing procedures to remain ahead of illness as a result of the rising frequency of infectious diseases. When a viral epidemic first starts, the government takes three preventive steps: testing, contact tracing, and isolation of positive cases. Before the vaccine is created and given to every person, these procedures are essential. The market will benefit greatly from the expanding government support for the development of highly accurate lateral flow tests through financing and supportive policies. Studies and studies being done to evaluate artificial intelligence’s effectiveness to increase the precision and accuracy of test results have produced encouraging results. As a result, the market will expand faster thanks to technical progress and product innovations driven by both public and private actors.

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Challenge

Only point-of-care initial screening is suitable for lateral flow assay assays. They also have a number of disadvantages, including inaccurate sample volume, which affects the precision of the result, restricting the total volume of the test and giving a sensitivity limit, and analysis times that rely on the type of sample. Additionally, strict oversight and inconsistent test results are likely to restrain the global market for lateral flow assays.

Recent developments

• In January 2021, the global American company Abbott, which manufactures medical equipment and provides healthcare services, revealed that it had obtained CE certification for two additional applications of its Panbio COVID-19 Ag Rapid Test Device for the identification of the SARS-CoV-2 virus. (Asymptomatic testing and self-swabbing). A PanBio COVID-19 immunochromatographic test for the quick detection of the Sars-CoV-2 virus was introduced by the firm in 2020.
• Thermo Fisher Scientific, an American provider of scientific equipment, reagents and supplies, and software services, declared the inauguration of its new Bioprocessing Collaboration Center (BCC) in St. Louis, Missouri, for the month of September 2020. The building is next to the company’s biologics manufacturing plant, and with a $50 million extension, Thermo Fisher’s bioproduction and pharma services companies will combine their skills to expedite innovation, improve efficiency, and double production capacity.

Market Segmentation

By Product

• Kits & Reagents
• Lateral Flow Readers
  • Lateral Flow Readers
  • Benchtop Readers
  • Digital Readers

By Application

• Clinical Testing
  • Infectious Disease Testing
    • COVID-19
    • Mosquito Borne Disease Testing
    • Influenza Testing
    • Sexually Transmitted Infection Testing
      • STI Testing
      • HIV Testing
      • HPV Testing
      • Chlamydia Testing
      • Gonorrhea Testing
      • Syphilis Testing
      • Other STI Testing
        • Hepatitis
        • Tuberculosis
        • Other Infectious Diseases
      • Cardiac Marker Testing
        • Troponin I and T Testing
        • CK-MB Testing
        • BNP and NT-Probnp Testing
        • Myoglobin Testing
        • D-Dimer Testing
        • Other Cardiac Marker Tests
      • Pregnancy & Fertility Testing
        • Pregnancy Testing
        • Fertility Testing
      • Cholesterol Testing/Lipid Profile
      • Drugs of Abuse Testing
      • Other Clinical Tests
    • Veterinary Diagnostics
    • Food Safety & Environment Testing
    • Drug Development & Quality Testing

By Technique

• Sandwich Assays
• Competitive Assays
• Multiplex Detection Assays

By Test Type

• Lateral Flow Immunoassay
• Nucleic Acid Lateral Flow Assay

By End-User

• Hospitals & Clinics
• Diagnostic Laboratories
• Home Care
• Pharmaceutical & Biotechnology Companies
• Others

By Geography

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa

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