Microfluidic Immunoassay Market Size, Share, Forecast, & Trends Analysis by Product (Cartridge [Polymer, Glass], Reagent, System) Technology (Electrochemical, Optical) Application (Cardiology, Oncology, Infectious Disease) End User—Global Forecast to 2031

The Microfluidic Immunoassay Market was valued at $0.92  billion in 2023. This market is expected to reach $1.59  billion by 2031, from an estimated $0.98  billion in 2024, at a CAGR of 7.3% during the forecast period 2024-2031.

Microfluidic Immunoassay Market Size & Forecast

The growth of this market is driven by the increasing use of microfluidic immunoassays in drug discovery & development and biomarker detection, the advantages of lab-on-chip immunoassays over conventional immunoassays, pharmaceutical & biotechnology companies’ increasing focus on research & development, and the miniaturization of biological and chemical assays. Moreover, the increasing demand for point-of-care diagnostics and recent advancements in microfluidic immunoassay technology are expected to generate market growth opportunities.

Microfluidic Immunoassay Market Growth Drivers

Increasing Use of Microfluidic Immunoassay in Biomarker Detection and Drug Discovery & Development

Pharmaceutical and biotechnology companies allocate significant resources to research. Microfluidic immunoassay is majorly used for the detection of biomarkers associated with diseases for understanding disease mechanism for drug development and disease detection. Microfluidic immunoassays have become increasingly important in maintaining precision and accuracy in drug research & development and reducing the time required for research.

Numerous drug discovery processes can benefit from the use of microfluidics, including drug compound synthesis, screening, delivery, and the development of carrier systems. Microfluidic immunoassays have applications in drug screening due to their benefits, such as improved throughput, reduced consumption of reagents, automation, reduced reaction time, seamless integration and parallelization, simplification of operational steps, and reduced waste generation.

Pharmaceutical and biotechnology companies combine microfluidic immunoassays with various detection technologies for high-throughput screening and the detection and mechanistic study of drugs. The players operating in this market are collaborating to develop advanced microfluidic immunoassay products.

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Increasing Funding for Microfluidic Immunoassay Research

Microfluidics sector is gaining traction in recent years owing to the ongoing research in the field and increasing applications in drug discovery and diagnostics. The key players operating in the market and government agencies are providing funding and grants for the research.

• In April 2022, India’s Ministry of Electronics & Information Technology provided USD 0.1 million (INR 93 Lakhs) has provided the funding for the ‘Microfluidic Point-of-Care System for Molecular Diagnostics’ project. The project is a part of the Centre of Excellence in Nanoelectronics: Phase -III (CeNSE). The project timeline was announced as 15-04-2018 to 14-04-2022. However, the project has been extended and is still ongoing.
• In November 2021, Parallel Fluidics (U.S.), a manufacturer of microfluidic devices, raised USD 1.8 million in a round of financing from technologists, investors, and founders. The company planned to use this funding to increase its capacity and capability in manufacturing microfluidics devices.

Microfluidic Immunoassay Market Trends

Multiplexed Panel Detection

In many cases, a single molecular event is inadequate to indicate the pathophysiology of diseases such as cancer. The adoption of multiplexed diagnostic testing has increased due to its benefits, such as reduced reagent consumption, multiple analyte detection, improved sensitivity, and shorter reaction time. Therefore, microfluidic detection of multiple analytes in a single test has become a growing trend. Many companies are developing multiple-analyte tests to expand their LOC portfolios. POC-based multi-analyte testing for infectious microorganisms could be useful in diagnosing diseases and initiating treatment, as getting results for a laboratory culture-based analysis would be time-consuming, and a single parametric test may not provide accurate diagnosis. A single lab-on-chip device enabling the diagnosis of the most common sexually transmitted diseases in a single run can save time and money.

Paper-based Microfluidics

Microfluidics technology integrates entire lab procedures on a single chip. Therefore, the technology has generated significant interest in recent years, mainly due to the reduced requirement of cumbersome instruments. Lab-on-chip technology has evolved over nearly two decades, with various materials used in the design and manufacture of the devices. Paper is gaining much traction as the material of choice for manufacturing microfluidics based POC cartridges, mainly due to the advantages of paper, such as low costs and affordability, compatibility with several medical applications, and ability to transport fluid (through capillary forces) without needing any external forces. Presently, both industry and academia are focused on research into paper-based microfluidics. The study published in 2022, presents the development of a paper-based microfluidic device capable of remote biofluid collection, followed by an analysis of the dried clinical samples using a miniature mass spectrometer. The stability and sensitivity of the developed paper-based immunoassay platform would allow miniature mass spectrometers to be used for point-of-care malaria detection as well as in large-scale surveillance screening to aid eradication programs.

Microfluidic Immunoassay Market Opportunity

Increasing Demand for Point-of-Care Testing

Existing laboratory diagnostic technologies require sophisticated infrastructure, expensive reagents, stable electricity supply, long assay times, and trained staff. Also, laboratories and medical testing facilities are often limited and inaccessible to patients in remote areas. Hence, developing countries are increasingly facing the burden of infectious and non-communicable diseases, leading to high mortality. According to the WHO, globally, an estimated 1 billion cases of influenza are registered annually, with 3-5 million being severe cases. Deploying rapid and easy-to-use POC tests and microfluidics based POC tests in low-income countries can enable enhanced disease diagnosis on-site without the need for trained healthcare professionals.

Moreover, laboratory testing requires a significant amount of time and reagent consumption. For instance, urinalysis at a laboratory/medical testing facility takes 24–48 hours to deliver results. This time can be reduced considerably with the use of lab-on-chip POC tests. Thus, manufacturers of POC diagnostics, including microfluidic immunoassays, can expand to untapped markets in developing countries to leverage these opportunities.

Microfluidic Immunoassay Market Analysis: Key Findings

By Product: In 2024, the Microfluidic Cartridges Segment to Dominate the Microfluidic Immunoassay Market

Based on product, the microfluidic immunoassay market is segmented into consumables and systems. In 2024, the consumables segment is expected to account for the largest share of 69.6% of the microfluidic immunoassay market. The consumables segment is further segmented into microfluidic cartridges and reagents. The microfluidic cartridges segment is expected to account for the largest share. Cartridges have become essential tools for diagnosing various diseases. These assays are used for testing infectious diseases, cancer markers, cytokines, cardiac markers, autoimmune diseases, and endocrine diseases. Their increasing application areas in clinical diagnostics and R&D are driving the market's growth.

By Technology: In 2024, the Electrochemical Detection Segment to Dominate the Microfluidic Immunoassay Market

Based on technology, the microfluidic immunoassay market is segmented into electrochemical detection and optical detection. In 2024, the electrochemical detection segment is expected to account for the largest share of the microfluidic immunoassay market. Electrochemical detection has been widely employed in point-of-care testing owing to its cost efficiency, ability to analyze turbid samples, and adaptability for miniaturization. Electrochemical detection coupled with microfluidics is a promising detection technology for immunoassays owing to the benefits such as simple and portable assay, low sample consumption, low detection limit, and rapid method contributing to the largest share of the segment.

By Application: In 2024, the Cardiology Segment to Dominate the Microfluidic Immunoassay Market

Based on application, the global microfluidic immunoassay market is segmented into cardiology, infectious diseases, oncology, and other applications. In 2024, the cardiology segment is expected to account for the largest share of 53.5% of the microfluidic immunoassay market. Cardiac markers are released in the blood after injury to the heart muscles. These indicators are used as a measure to diagnose cardiovascular diseases. The rising prevalence of cardiovascular diseases is increasing the demand for microfluidic immunoassay detection kits. According to, American Heart Association (U.S.), a non-profit organization involved in consumer education about cardiovascular disease, more than 350,000 cardiac arrests occur outside the hospital each year. The microfluidic cartridges detects cardiac biomarkers for accurate diagnosis. The microfluidic cardiac biomarker tests are also used in the biomedical and clinical research. These biomarkers are objectively measured and used to indicate a certain biological state, whether physiological, pathological, or pharmacological, and gather information about normal molecular physiology as well as cardiovascular disease (CVD) activity and progression, which can further be used in drug discovery is further supporting the largest share of segment.

The oncology segment is expected to grow at the highest CAGR of 8.7% during the forecast period. The increasing prevalence of cancer (malignant tumor) and the development of microfluidic devices for the analysis of various biomarkers, including proteins, circulating tumor cells, exosomes, and cell-free DNA, contributed to the highest CAGR of the segment. For instance, cancer is a major health concern globally and is one of the leading causes of morbidity and mortality across the world. According to GLOBOCAN, the global burden of cancer is expected to increase from 19.3 million cases in 2020 to 24.6 million cases by 2030.

By End User: In 2024, the Pharmaceutical & Biotechnology Companies Segment to Dominate the Microfluidic Immunoassay Market

Based on end user, the microfluidic immunoassay market is segmented into pharmaceutical & biotechnology companies, diagnostic laboratories, hospitals, and other end users. In 2024, the pharmaceutical & biotechnology companies segment is expected to account for the largest share of the market. The rising number of research laboratories, increasing investment in R&D, and rising funding for research laboratories support the largest share of the market.  The funding for research laboratories is increasing due to the increasing demand for new drugs and therapies.

Geographical Analysis

In 2024, North America to Dominate the Microfluidic Immunoassay Market

In 2024, North America is expected to account for the largest share of the 40.3% of microfluidic immunoassay market. The largest share of the region is attributed to rising government support and spending for research activities, rising R&D investment by pharmaceutical & biopharmaceutical companies, high number of laboratory tests performed annually, developed healthcare infrastructure in the region, the growing trend for self-testing, a high number of CLIA-waived tests, and increasing prevalence of chronic diseases. according to the WHO, new cancer cases in the U.S. are expected to increase from 2.2 million in 2020 to 2.7 million by 2030. Microfluidic immunoassays have a major application in cancer diagnosis and targeted therapy based on biomarkers. Therefore, the increasing prevalence of cancer is expected to propel the growth of the microfluidic immunoassay market in the region.

Moreover, the market in Asia-Pacific is slated to register the highest growth rate of 9.1% during the forecast period. The growth of the microfluidic immunoassay market in Asia-Pacific is attributed to the rising research funding in the healthcare and pharmaceutical industry, the rising number of research laboratories, the advancing research framework, and the growing number of diagnostic laboratories in countries such as China, India, Japan, South Korea, and others.  For instance, in 2022, the R&D spending of BeiGene Ltd. (China), one of the major pharmaceutical companies, increased by 12.4% from 2021. The increasing use of microfluidic immunoassay in precision medicine and government initiatives for precision medicine is also driving the market growth.

Microfluidic Immunoassay Market: Key Companies

The report offers a competitive landscape based on an extensive assessment of the product offerings and geographic presence of leading market players and the key growth strategies adopted by them over the past few years (2021–2024). The report offers a competitive landscape based on an extensive assessment of the product portfolio offerings, geographic presences, and key strategic developments adopted by leading market players in the industry over the years (2021–2024). The key players operating in the global microfluidic immunoassay market are Becton, Dickinson and Company (U.S.), Revvity, Inc. (U.S.), Abbott Laboratories (U.S.), Siemens Healthineers AG (Germany), Nanomix Corporation (U.S.), Micropoint Biotechnologies Co., Ltd. (China), Biosurfit SA (Portugal), Koninklijke Philips N.V. (Netherland), NanoEnTek Inc. (South Korea), and QuidelOrtho Corporation (U.S.).

Microfluidic Immunoassay Market Overview: Latest Developments from Key Industry Players

• In March 2023, QuidelOrtho Corporation (U.S.) received a De Novo request from the U.S. Food and Drug Administration (FDA) for the marketing of Sofia 2 SARS Antigen+ FIA. The assay is a lateral flow (microfluidic) immunofluorescent sandwich assay used for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) and nasal (NS) swab specimens.
• In November 2022, Nanomix Corp. (U.S.) entered into a distribution agreement with Gepa Srl (Italy). The agreement is for the distribution of the eLab system in Italy.
• In November 2022, LumiraDx Healthcare Pvt Ltd (India) launched a C-Reactive protein point of care antigen test in India. The test gives result in four minutes. The test is used to combat antimicrobial resistance in India.
• In October 2022, Micropoint Biotechnologies Co., Ltd. (China) received a CE marking for the Micropoint COVID-19 Ag test.

Microfluidic Immunoassay Market Research Summary

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