Lateral Flow Assay Market Size to Reach USS 24.39 Bn by 2033

The global lateral flow assay market size was evaluated at USD 16.18 billion in 2023 and is expected to attain around USS 24.39 billion by 2033, growing at a CAGR of 3.8% from 2024 to 2034. The U.S. lateral flow assay market size is predicted to grow around USD 6.46 billion by 2034 increasing from USD 16.8 billion in 2024, growing at a CAGR of 4% from 2024 to 2034.

The lateral flow assay market has grown in recent years due to the increasing demand for multiplex monitoring measurements, with multiple test lines that can quickly and simultaneously check the various measurements present in the model.

Lateral Flow Assay Market at a Glance

The lateral flow assay market is growing rapidly because developing and introducing new technologies to the diagnostic industry requires hundreds of millions of dollars and years of work, and improving and continuing to improve LFA technology is another good way to go. This process has the potential to create materials that can become powerful tools for new and complex applications such as early cancer detection. Applications in biomedical, agricultural, food and environmental research.

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This type of testing has recently gained traction due to its ability to provide direct patient diagnosis. Lateral flow assays (LFA) are paper-based platforms used to detect and quantify analytes in complex mixtures, where a sample is placed in a test device and the contents are visible within 5-30 minutes. The low construction cost and ease of manufacturing of LFA expands its application to many areas requiring rapid testing.

Key Takeaways:

· North America has generated largest market share of 37% in 2023.

· By Product, the kits and reagents segment held a maximum market share.

· By Application, the clinical testing segment has maximum market share of 77% in 2023.

· By Application, the drug development and quality testing segment is predicted to grow at the highest CAGR forecast period.

· By Technique, the sandwich assays segment is predicted to generate the greatest revenue share between 2023 and 2032.

· By Technique, the multiplex detection assay segment is expected to expand at the largest CAGR between 2023 and 2032.

· By Test Type, the lateral flow immunoassays segment had the largest market share.

· By Test Type, the nucleic acid lateral flow assay segment is predicted to grow at a remarkable CAGR forecast period

· By End-user, the pharmaceutical and biotechnology firms segment is expected to expand at the fastest CAGR forecast period.

Regional Stance

North America had the highest market share. Leverages extensive knowledge of product analysis and interactions between product ingredients. Use expert lateral flow analysis R&D researchers and specialized laboratories for problem solving. Work with international partners who have quality systems. Support professionals can be confident in solving specific problems. Canada’s healthcare system is a health insurance system available to all Canadian citizens. It is publicly funded and managed according to government guidelines in the state or region. Transform Health is a coalition of organizations advocating a balanced digital transformation of health systems to ensure health for all. Due to the growth of the commercial economy, the Mexican Health Foundation (FUNSALUD) was commissioned by Transform Health to lead the collaboration in Mexico.

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Recent Breakthroughs in Lateral Flow Assay Market

· In February 2024, Ascential Medical & Life Sciences (M&LS) announced that it has received the 2024 Advanced Lateral Laminar Flow Conference (ALFC) Diagnostic Leadership Award.

· In March 2023, QuidelOrtho Corporation announced that it has received a De Novo application from the U.S. Food and Drug Administration (FDA) granting the company authorization to market the novel Sofia 2 SARS Antigen + FIA. The Sofia 2 SARS Antigen + FIA is the first rapid antibiotic test to be approved by the FDA to detect COVID-19. The Sofia 2 SARS Antigen + FIA is a lateral flow immunofluorescence assay for use with the Sofia 2 Fluorescence Immunoassay Analyzer and is designed to detect SARS-CoV in direct anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory tract infections.

Report Highlights

By Product

Kits and reagents are the most common and widely used products in the LFA market. Lateral flow test kit is a simple, ready-to-use kit for the rapid and cost-effective development of lateral flow dipstick tests for the detection of proteins, antibodies and amplified product DNA. It can be used to create external assessments to increase the number of users. Different products can be used to attack them, such as antibodies, antibodies and PCR, lamp-amplified DNA products and RPA reactions. No need to extract capture antibodies. Lateral flow assays (LFA), also known as immunochromatographic assays or rapid tests, are rapid, easy-to-use, portable devices that detect the presence of target drugs in test fluid without the need for specialized workers and expensive products.

By Application

Due to a rise in the prevalence of infectious diseases, the clinical testing sector had the biggest portion. Infectious disease testing, a large part of the human LFA industry, is used to screen for respiratory diseases (e.g., influenza, SARS-CoV-2, syncytial respiratory diseases, Strep A); malaria, dengue, Zika, sexually transmitted diseases (chlamydia, syphilis, gonorrhea); The most important development needed in the future will be the ability to interpret content in its entirety and collect and disseminate information through rapid testing via ubiquitous digital technology.

The industry sector with the highest CAGR growth. Recent work has focused on high-affinity molecules and screening to minimize nonspecific binding. Additionally, new specific molecules such as CRISPR/Cas systems can be integrated into LFA diagnostics to achieve not only highly sensitive but also specific POC diagnostics. With ongoing development, LFA will soon provide competitive functionality with POC testing processes while maintaining rapid prototypes. Lateral flow assay development has been successful in developing simple and easy-to-use diagnostic tests to confirm the presence of multiple pathogens, biomarkers, and antibodies in a specific disease under consideration. External velocity measurement is used for both qualitative and quantitative measurements.

By Technique

Sandwich assay format is dominated in the lateral flow assay market. Sandwich assay formats are typically used to identify larger analytes with at least two binding sites or epitopes. In general, antibodies directed against one binding site will bind to nanoparticles, while antibodies against other binding sites are used in the test line of the assay. If the test drug is present in the sample, it will bind to the antibody-nanoparticle conjugate and the antibody of the test line, causing a positive problem. The sandwich format makes the signal strength of the test line proportional to the amount of analyte present in the sample.

During the research period, the multiplex detection assay sector is anticipated to experience the highest CAGR growth. A multiplex assay is an immunoassay that uses magnetic beads to measure multiple parameters simultaneously in a single test. A multiplex assay is a derivative of ELISA that uses conjugated microbeads to detect antibodies. A multiplex assay is an assay that combines assays for multiple assays into a single panel. These assays are popular because they offer the advantage of saving sample volume and time, increasing throughput compared to assays that measure a single assay, such as enzyme-linked immunosorbent assays (ELISAs).

By Test Type

The sector of lateral flow immunoassays had the highest revenue share. lateral flow immunoassay is a highly effective test for rapid detection of drug targets. There are many definitions for this platform, including LFT, immunochromatographic strip test or rapid diagnosis. Many people are already familiar with this technology in the form of rapid diagnosis of COVID-19, which is already widespread outside.

Over the anticipated years, the nucleic acid lateral flow assay is expected to expand significantly. Nucleic acid lateral flow assays use LAMP reaction products that may or may not amplify the target nucleic acid region. Add 3 drops of LAMP product to the sample cup on the container side. Usually 10 minutes is sufficient to allow the sample to flow through the membrane and complete release of the conjugate. These reactions may involve multiple primer sets to achieve multiple detection targets. In clinical sites, nasal/oropharyngeal swabs are the easiest to extract nucleic acids and are most commonly used for respiratory purposes.

By End User

Pharmaceutical and biotechnology firms sector is anticipated to expand at the fastest CAGR during the forecast period. Lateral flow analysis (LFA) is frequently used in monitoring systems due to its simplicity and efficiency. Lateral flow chromatography (LFA) systems are an easy-to-use, disposable, inexpensive diagnostic tool used to detect biomarkers in blood and urine samples. For this reason, LFA has recently attracted great attention, especially during epidemics.

LFAs are widely used in hospitals and clinics for the diagnosis of infectious diseases, pregnancy, and other conditions. Rapid detection of the HCG hormone is one of the easiest ways to detect early pregnancy. In early pregnancy, HCG is a hormone that prevents the uterine lining from shedding each month to prevent menstruation. Another common commercial application of blood tests is the diagnosis of human immunodeficiency virus (HIV). HIV type 1-specific antibodies are produced against HIV-1 subtype B antigens. HBV point-of-care (POC) is the most commonly used HBV testing method.

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Market Dynamics

Driver

Versatility and Accessibility in Point-of-Care Diagnostics

Lateral flow assay market (LFIA) are driving growth in the industry because they are easy, inexpensive, and widely used in screening, diagnosing, and monitoring many diseases. Their versatility allows physicians and patients to perform these tests at home, with applications ranging from managing cardiovascular disease and infectious diseases to monitoring hormones, vitamins, enzymes, and cancer biomarkers. Originally designed for diabetes and pregnancy testing, the LFIA device can now detect a wide range of diagnostic tests, including bacteria, viruses, and heart disease. This expansion and ease of access is a major factor driving the growth of lateral flow assay market.

Restraint

Manufacturing Challenges and Complexity

The growth of the lateral flow assay market is limited by the complexity of manufacturing equipment. The variety of LFA tests often leads to issues such as inconsistent materials, overlapping of compound materials, and defective materials. Although emphasis has been placed on improving the detection and selection of antigens or the best antibodies, these manufacturing challenges still have an impact on the expansion of the business. The effective interaction of various components in LFA equipment requires attention to detail, which affects the manufacturing process and limits the overall market growth.

Opportunity

Innovations in Signal Amplification and Detection

Recent advances in lateral flow assay market offer significant opportunities. New signal amplification strategies, including silver enhancement and enzymatic conjugation with colloidal gold nanoparticles (GNPs), increase sensitivity and detection limits to 0.1 ng/ml. Integration of new reagents such as magnetic products with manufacturing methods such as thermal contrast, lasers, and LEDs enables signal amplification up to 1000-fold.

Additionally, advances in simultaneous detection technology, such as integration of colloidal gold nanoparticles with oligonucleotides for simultaneous detection of antigens and antibodies and use of two conjugated pads for simultaneous detection of multiple proteins, indicate the expansion of LFA technology. These advances are driving workflow growth outward and creating new opportunities.

Key Players Lateral Flow Assay Market

· Abbott Laboratories

· Thermo Fisher Scientific, Inc.

· F. Hoffmann-La Roche AG

· Bio-Rad Laboratories, Inc

· bioMérieux SA

· Quidel Corporation

· Hologic, Inc.

· PerkinElmer, Inc.

· Merck KGaA

· BD

· Siemens Healthineers

· Danaher Corporation

· QIAGEN N.V.

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

o STI Testing

o HIV Testing

o HPV Testing

o Chlamydia Testing

o Gonorrhea Testing

o Syphilis Testing

o Other STI Testing

§ Hepatitis

§ Tuberculosis

§ Other Infectious Diseases

o 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

o Pregnancy & Fertility Testing

§ Pregnancy Testing

§ Fertility Testing

o Cholesterol Testing/Lipid Profile

o Drugs of Abuse Testing

o 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 & Africa (MEA)

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