Lateral Flow Immunoassay (LFIA) Based Rapid Test Market Report 2025

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.

Quality control continues to be a significant challenge anticipated to impede the growth of the lateral flow immunoassay (LFIA) rapid test market. Rising operational costs, encompassing salaries and technology investments, have strained profit margins for numerous firms. For example, in June 2023, a report from PLOS, a US-based non-profit organization, highlighted that LFIA products available in the market do not consistently adhere to high standards of reliability and specificity. A retrospective assessment of four LFIA tests indicated considerable variability in diagnostic performance, with some tests demonstrating accuracy rates as low as 47% for IgG detection.

The lateral flow immunoassay (LFIA) based rapid test market is set to experience growth fueled by the increasing prevalence of chronic diseases. These long-term health conditions demand early detection, point-of-care testing, and regular monitoring, with LFIA-based rapid tests offering prompt results and aiding in the management of chronic diseases. The World Health Organization reports a significant number of deaths attributed to non-communicable diseases (NCDs) annually, emphasizing the role of LFIA in addressing conditions such as cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes. The market is thus stimulated by the rising incidence of chronic diseases.

Major companies in the lateral flow immunoassay (LFIA)-based rapid test market are concentrating on technologies like qPCR (quantitative polymerase chain reaction) to improve the sensitivity and specificity of their tests, accelerate detection speed, and broaden the range of pathogens or biomarkers that can be identified. This focus aims to lead to more reliable and accurate diagnostic solutions for various healthcare applications. qPCR technology is a molecular biology method used to amplify and quantify DNA or RNA sequences in real time, allowing for precise measurements of gene expression levels or the detection of specific pathogens in various samples. For example, in November 2023, F. Hoffmann-La Roche AG, a Switzerland-based pharmaceutical company, introduced the LightCycler PRO System. This system builds on Roche's legacy of qPCR technologies, employing gold-standard techniques to ensure high quality, precision, and reliability - capabilities that are vital for accurate patient diagnosis and effective clinical decision-making.

Leading companies in the lateral flow immunoassay (LFIA)-based rapid test market are also investing in Integrated Health Solutions to enhance diagnostic efficiency, optimize workflows, and deliver comprehensive patient care through improved data sharing and collaboration across healthcare platforms. Integrated Health Solutions encompass comprehensive healthcare systems that link various services, technologies, and data to enhance patient care and streamline operations. For instance, in June 2024, F. Hoffmann-La Roche AG launched analytical units for its Cobas Pro integrated solutions. The Cobas Pro system can process up to 1,000 samples per hour with its sample supply unit and features high-speed analytical units capable of conducting up to 900 tests per hour for the ion-selective electrode (ISE) and 1,000 tests per hour for the Cobas C 503 unit, which specializes in clinical chemistry.

In August 2023, Danaher Corporation acquired Abcam plc for $5.7 billion, aligning with Danaher's strategy to bolster its life sciences business. The acquisition of Abcam, a UK-based biotechnology company specializing in LFIA-based rapid tests, is expected to enhance value for shareholders and deliver outstanding results for both the workforce and clients.

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.

North America was the largest region in the lateral flow immunoassay (LFIA) based rapid test market in 2024. Asia-Pacific was the second largest region in the global lateral flow immunoassay (LFIA) based rapid test market. The regions covered in the lateral flow immunoassay (LFIA) based rapid test market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. 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.

The rapid test based on Lateral Flow Immunoassay (LFIA) is a straightforward technology-driven diagnostic device employed for detecting the presence of specific targets, such as pathogens or biomarkers, in samples obtained from the human body. These samples encompass various bodily fluids such as urine, saliva, blood, and sweat.

The primary techniques include the competitive assay, sandwich assay, and multiplex detection assay. The competitive assay specifically determines the presence of targets, such as pathogens or biomarkers, within the collected samples. Its applications span infectious diseases, pregnancy and fertility assessments, toxicology, and others, making it applicable in diverse settings such as hospitals, clinics, diagnostic laboratories, home care, and more.

The lateral flow immunoassay (LFIA) based rapid test market research report is one of a series of new reports that provides lateral flow immunoassay (LFIA) based rapid test market statistics, including lateral flow immunoassay (LFIA) based rapid test industry global market size, regional shares, competitors with a lateral flow immunoassay (LFIA) based rapid test market share, detailed lateral flow immunoassay (LFIA) based rapid test market segments, market trends and opportunities, and any further data you may need to thrive in the lateral flow immunoassay (LFIA) based rapid test industry. This lateral flow immunoassay (LFIA) based rapid test market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Lateral Flow Immunoassay (LFIA) based rapid test market consists of sales of conjugate pads, nitrocellulose membrane and absorbent pad. Values in this market are factory gate values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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