Lateral Flow Immunoassay (LFIA) Based Rapid Test Market 2025: The Critical Role of Challenges In Ensuring Quality Control For Rapid Diagnostic Testing Driver in Industry Evolution

Lateral Flow Immunoassay (LFIA) Based Rapid Test

How much is the lateral flow immunoassay (lfia) based rapid test market worth, and how is it expected to expand?

The lateral flow immunoassay (LFIA) based rapid test market size has declined steeply in recent years. It decline grow from ” $8.03 billion in 2024 to $7.23 billion in 2025 at a compound annual growth rate (CAGR) of -9.9%.  The decline in the historic period can be attributed to limited sensitivity and specificity, complexity of multiplexing, cross-reactivity issues, storage and shelf-life challenges, limited quantitative capability.

The lateral flow immunoassay (LFIA) based rapid test market size is expected to see steady growth in the next few years. It will grow to $8.3 billion in 2029 at a compound annual growth rate (CAGR) of 3.5%.  The decline in the forecast period can be attributed to global supply chain disruptions, regulatory challenges, increased competition, emergence of alternative technologies, integration with digital health platforms. Major trends in the forecast period include developing advanced technologies for multiple or repetitive LFIA based rapid test and storage/ communication of results, focus on partnerships and collaborations, develop at home test kits, invest in artificial intelligence-based tests for diseases screening and detection, and should develop low-cost test kits for easy access to patients at low cost.

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Which industry factors have accelerated the lateral flow immunoassay (lfia) based rapid test market’s expansion?

Quality control remains a pressing issue that is expected to halt the development of lateral flow immunoassay (LFIA) based rapid test market. Increased operational costs, including salaries and technology investments, have pressured profit margins for many law firms. For instance, in June 2023, according to PLOS, a US-based non-profit organization, LFIA products on the market do not consistently meet high standards of reliability and specificity. A retrospective evaluation of four LFIA tests revealed that their diagnostic performance varied widely, with some tests showing as low as 47% accuracy for IgG detection.

What are the primary segments of the lateral flow immunoassay (lfia) based rapid test market?
The lateral flow immunoassay (LFIA) based rapid test market covered in this report is segmented –

1) By Technique: Competitive Assay, Sandwich Assay, Multiplex Detection Assay
2) By Application: Infectious Disease, Pregnancy And Fertility, Toxicology, Cardiac Marker And Cholesterol Testing, Other Applications
3) By End-Users: Hospitals And Clinics, Diagnostic Laboratories, Home Care, Other End Users

Subsegments:
1) By Competitive Assay: Direct Competitive Assays, Indirect Competitive Assays
2) By Sandwich Assay: Single-step Sandwich Assays, Two-step Sandwich Assays
3) By Multiplex Detection Assay: Multi-analyte Assays, Simultaneous Detection Of Various Targets

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Which firms are leading the lateral flow immunoassay (lfia) based rapid test market?

Major companies operating in the lateral flow immunoassay (LFIA) based rapid test market include  Abbott Laboratories, F. Hoffmann-La Roche, Quidel Corporation, Becton, Dickinson and Company, Danaher Corporation, Siemens AG, Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., PerkinElmer Inc., Hologic, Inc., LTEK Co., Ltd., JOYSBIO Biotechnology, Jiangsu Medomics Medical Technologies, Diagnocure, Ubio Biotechnology Systems, Elabscience® Immunoassay Kits, FyoniBio / Glycotope GmbH, Atomo Diagnostics Limited, INDICAL Bioscience, Lionex Gmbh, BIOMED Labordiagnostik GmbH, Charles River Laboratories, EKF Diagnostics, Launch Diagnostics, Diagnostic Instruments Ltd, Qiagen N.V., Merck KGaA, XPhyto Therapeutics, 3a Diagnostics, Roche Holding AG, BATM, Biomaxima, SensDx, Vitrosens Biotechnology, Bioeasy Biotechnology, Fujirebio, Immunodiagnostic Systems Holdings PLC, Mesa Biotech Inc, CTK Biotech

Which market trends are set to define the future of the lateral flow immunoassay (lfia) based rapid test market?

Major companies operating in the lateral flow immunoassay (LFIA)-based rapid test market are focusing on technologies such as qPCR technology to enhance the sensitivity and specificity of their tests, improve detection speed, and expand the range of pathogens or biomarkers that can be identified, ultimately leading to more reliable and accurate diagnostic solutions for various healthcare applications. QPCR (quantitative polymerase chain reaction) technology is a molecular biology technique used to amplify and quantify DNA or RNA sequences in real time. It enables the precise measurement of gene expression levels or the detection of specific pathogens in various samples. For instance, in November 2023, F. Hoffmann-La Roche AG, a Switzerland-based pharmaceutical company, launched the LightCycler PRO System. The LightCycler PRO builds on Roche’s legacy of qPCR systems, utilizing gold-standard technology for high quality, precision, and reliability. These capabilities are crucial for accurate patient diagnosis and effective clinical decision-making.

Which geographic trends are shaping the lateral flow immunoassay (lfia) based rapid test market, and which region has the highest market share?

The countries covered in the lateral flow immunoassay (LFIA) based rapid test market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Canada, Spain

What Does The Lateral Flow Immunoassay (LFIA) Based Rapid Test Market Report 2025 Offer?

The lateral flow immunoassay (lfia) based rapid test market research report from The Business Research Company offers global market size, growth rate, regional shares, competitor analysis, detailed segments, trends, and opportunities.

Lateral Flow Immunoassay (LFIA) based rapid test is a simple technology-based diagnostic device that is used to determine the presence of a target such as pathogens or biomarkers in samples collected from the human body. These samples may include urine, saliva, blood, sweat and other fluids.

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