PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1782005
PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1782005
ELISA Diagnostics Tests Market size was valued at US$ 1,690.32 Million in 2024, expanding at a CAGR of 5.93% from 2025 to 2032.
The global Enzyme-Linked Immunosorbent Assay (ELISA) market revolves around a diagnostic test designed to detect and measure antibodies in biological samples. By using this test, one can ascertain whether the sample has antibodies against or linked to a particular antigen associated with an infectious disease. As an immunogenic reaction to dangerous chemicals known as pathogens, proteins called antibodies are created to fight invading diseases. The biological process of ELISA involves the adsorption of an antigen onto a solid surface. An enzyme-linked antibody is permitted to be present with the antigen and is identified by the addition of an enzyme specific substrate. The ELISA test is crucial for diagnosing viral illnesses such syphilis, rotavirus, Zika virus, HIV, and the varicella zoster virus, which causes shingles and chickenpox. It is commonly used as a preliminary screening method before more detailed tests and also has applications in pharmaceutical quality control, including endotoxin detection and protein quantification.
ELISA Diagnostics Tests Market- Market Dynamics
Growing disease burden increases demand for early diagnostics
The rise of infectious and chronic diseases worldwide drives the need for early and accurate diagnostic methods. ELISA tests are vital because they can detect specific proteins, antigens, and antibodies early in the disease process. Companies like Thermo Fisher Scientific and Bio-Rad Laboratories commonly use ELISA kits for early HIV detection. This helps improve patient outcomes and reduce transmission. During the COVID-19 pandemic, Abbott created ELISA-based antibody tests to identify prior infections. This supported public health efforts and helped with vaccine distribution. Additionally, Bio-Techne provides ELISA kits for cancer biomarkers like PSA and CA-125. These kits aid in early diagnosis and treatment monitoring. These examples show how the rising number of diseases is increasing the global demand for ELISA diagnostic tests. Healthcare systems are focusing on sensitive, affordable, and reliable tools for early disease detection and management.
For Instance,
In October 2021, Siemens Healthineers launched a new ELISA-based assay designed for the early detection of autoimmune diseases, responding to the rising global prevalence of conditions like rheumatoid arthritis and lupus. This launch helps clinicians diagnose these complex diseases earlier, improving patient management.
ELISA Diagnostics Tests Market- Key Insights
As per the analysis shared by our research analyst, the global market is estimated to grow annually at a CAGR of around 5.93% over the forecast period (2025-2032)
Based on test type segmentation, sandwich ELISA was predicted to show maximum market share in the year 2024
Based on application segmentation, infectious diseases was the leading application in 2024
On the basis of region, North America was the leading revenue generator in 2024
The global ELISA diagnostics tests market is segmented on the basis of test type, application, end user, and region.
The market is divided into four categories based on test type: competitive ELISA, indirect ELISA, multiple & portable ELISA, sandwich ELISA. The sandwich ELISA sector dominates the market. This is due to its superior sensitivity and specificity compared to other ELISA formats. This method involves capturing the target antigen between two layers of antibodies, which enhances the accuracy of detecting low concentrations of biomarkers in complex samples such as blood or serum. Because of these advantages, Sandwich ELISA is extensively used in clinical diagnostics for a wide range of applications including infectious disease detection, cancer biomarker identification, and hormone level measurement. Its reliability and ability to provide quantitative results make it the preferred choice among healthcare providers and research laboratories.
The market is divided into three categories based on end user: hospitals & diagnostic centers, pharmaceutical & biotechnology companies, veterinary hospitals & diagnostic laboratories. Hospitals & diagnostic centers dominates the market. This dominance is driven by the widespread use of ELISA tests in clinical settings for disease diagnosis, monitoring, and screening. Hospitals and diagnostic centers require reliable and rapid testing solutions to manage infectious diseases, chronic conditions, and other health concerns, making them the largest consumers of ELISA kits and related products. Their continuous demand for accurate and high throughput diagnostic tools ensures that this segment holds the largest market share compared to pharmaceutical companies and veterinary diagnostic laboratories.
ELISA Diagnostics Tests Market- Geographical Insights
North America dominates the global ELISA diagnostics tests market during the forecast period in 2024.
North America has the largest share in the ELISA Diagnostic Tests market. This is mainly due to its strong healthcare infrastructure and high volumes of diagnostic testing. The region benefits from significant government and private sector investment in medical research and public health. Major players like Thermo Fisher Scientific, Abbott, and Bio-Rad Laboratories drive ongoing innovation and the availability of quality ELISA kits and instruments. Hospitals and labs throughout the U.S. and Canada commonly use ELISA tests to diagnose a variety of infectious and chronic diseases. Moreover, a high level of awareness about early disease detection and favourable reimbursement policies help support widespread use of these tests. Together, these factors make North America the leading region in this market.
Asia Pacific is estimated to register the highest CAGR in the ELISA diagnostics tests market during the forecast period in 2024.
The Asia-Pacific region is seeing the fastest growth in the ELISA Diagnostic Tests market. This growth is due to an increase in infectious and lifestyle related diseases. Countries such as China, India, and Southeast Asian nations are expanding their healthcare infrastructure and investing more in diagnostic technologies. There is a rising awareness among healthcare professionals and the public about the importance of early diagnosis, which is increasing the demand for ELISA-based tests. Government health initiatives and large screening programs are also promoting the use of reliable diagnostic tools like ELISA. Furthermore, the low cost of ELISA kits makes them a popular option in budget-conscious healthcare settings. These factors are driving significant market growth in the region.
The ELISA Diagnostic Tests market is filled with competition, featuring a mix of global and local players focused on product innovation, forming partnerships, and expanding their reach. Major names like Thermo Fisher Scientific, Abbott, Bio-Rad Laboratories, Danaher Corporation (Beckman Coulter), and F. Hoffmann-La Roche Ltd. are at the forefront. They have extensive portfolios of ELISA tests and strong global distribution networks. These companies invest heavily in research and development to create ELISA systems that are more sensitive, automated, and user-friendly for clinical and research applications. Emerging and mid-sized companies like Bio-Techne, RayBiotech, OriGene Technologies, and Elabscience are also gaining traction. They target specific disease areas and offer custom assay development. Additionally, firms like GenScript Biotech and Eurofins Scientific are evolving in the Asia-Pacific and European markets through collaborations and local manufacturing efforts.
Technological innovations, such as multiplex ELISA, portable ELISA platforms, and automation systems, further shape this competitive landscape. As disease prevalence increases and the need for early diagnosis becomes urgent, the competition intensifies. Companies are focusing on affordability, speed, and accuracy.
In May 2024, Merck KGaA announced the acquisition of Mirus Bio for approximately USD 600 million. While focused on viral vector manufacturing, the acquisition strengthens Merck's downstream analytics capabilities, including ELISA-based platforms. This deal supports the company's strategic vision to enhance its life sciences portfolio and advance solutions in gene therapy and bioprocessing diagnostics
In April 2023, Thermo Fisher Scientific Inc. introduced a next-generation ELISA kit platform aimed at providing enhanced sensitivity and faster results for both clinical and research settings. The new kits incorporate advanced signal detection technology, which shortens assay times and improves consistency across various biomarker analyses. This launch highlights Thermo Fisher's ongoing commitment to advancing diagnostic precision and operational efficiency in laboratories around the globe
In February 2023, Abcam plc expanded its ELISA product portfolio with the launch of a new range of recombinant monoclonal antibody-based ELISA kits. Designed for cancer and autoimmune disease research, these kits deliver enhanced specificity and consistency across experiments. The launch underscores Abcam's commitment to reproducibility and high-quality research tools, supporting the advancing needs of academic and biopharmaceutical research communities
In February 2023, Merck KGaA through its life science division MilliporeSigma, launched multiplex ELISA kits specifically designed for detecting cytokines and chemokines in preclinical research. These kits enable the simultaneous measurement of multiple analytes, improving both data depth and assay efficiency. This launch enhances Merck's presence in the diagnostic and life sciences space, aligning with the growing demand for advanced tools in biomarker discovery and translational research.