Enzyme Linked Immunosorbent Assay Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Enzyme Linked Immunosorbent Assay Market is projected to expand from USD 3.79 Billion in 2025 to USD 6.08 Billion by 2031, reflecting a compound annual growth rate (CAGR) of 8.21%. ELISA is a widely utilized plate-based analytical method designed to detect and measure soluble substances, including antibodies, antigens, proteins, and hormones, within biological samples. The market’s growth is primarily fueled by the increasing global burden of chronic and infectious diseases, which demands frequent and precise diagnostic testing for effective management. Furthermore, the growing application of these assays in drug discovery and development processes significantly strengthens demand. According to the International Diabetes Federation, there were roughly 589 million adults living with diabetes globally in 2024, emphasizing the urgent need for dependable biomarker analysis and ongoing health monitoring solutions.

However, the market faces a substantial obstacle regarding the availability of advanced alternative diagnostic technologies, such as polymerase chain reaction (PCR) and molecular diagnostics, which frequently provide superior sensitivity and more rapid turnaround times. The fierce competition presented by these sophisticated platforms potentially restricts the usage of traditional immunoassays within specific high-precision clinical sectors, as healthcare providers may favor newer methods for their speed and accuracy.

Market Drivers

The escalating prevalence of chronic and infectious diseases acts as a major engine for the Global Enzyme Linked Immunosorbent Assay Market, necessitating rigorous diagnostic protocols where ELISA serves as the gold standard for identifying specific antibodies and antigens. The significant burden of infectious pathogens necessitates high testing volumes to ensure effective disease control and management. For instance, the World Health Organization's 'Global Tuberculosis Report 2024', released in October 2024, estimated that 10.8 million individuals contracted tuberculosis worldwide in 2023, underlining the vital need for precise infectious disease screening. Additionally, chronic diseases heavily influence market demand; the American Cancer Society's 'Cancer Facts & Figures 2024' report from January 2024 projected that the United States would exceed 2 million new cancer cases for the first time in 2024, highlighting the increasing requirement for reliable tumor marker analysis via established immunoassay systems.

Concurrently, the broadening scope of biopharmaceutical R&D and drug discovery initiatives is a significant propeller of market growth. Pharmaceutical firms rely heavily on ELISA throughout the drug development pipeline for tasks such as immunogenicity testing, pharmacokinetic studies, and toxicity screening of biologics. As the industry sharpens its focus on developing novel therapeutics, investment in research infrastructure has escalated, leading to a direct rise in the consumption of reagents and assay kits. According to Roche's 'Annual Report 2023' published in March 2024, the group’s core research and development investments climbed to CHF 13.2 billion, demonstrating the substantial financial commitment that fuels the demand for high-precision bioanalytical instruments. This sustained capital allocation towards discovery ensures a continuous requirement for sensitive diagnostic assays.

Market Challenges

The principal impediment to the expansion of the Global Enzyme Linked Immunosorbent Assay (ELISA) Market is the mounting competition from advanced diagnostic technologies, specifically polymerase chain reaction (PCR) and molecular diagnostics. These alternative systems provide faster turnaround times and enhanced sensitivity compared to conventional plate-based immunoassays. As a result, laboratories and healthcare providers are increasingly preferring these advanced methods for scenarios demanding immediate clinical decisions and high precision, such as genetic analysis and infectious disease testing. This trend effectively curtails the uptake of ELISA kits in sectors where accuracy and speed are critical, thereby reducing their potential share in high-value clinical markets.

The scale of this technological shift is evident in recent industry activities that emphasize these competing platforms. According to the Association for Diagnostics & Laboratory Medicine, the 2024 Clinical Lab Expo featured nearly 900 exhibitors, clearly highlighting the industry's transition toward automated and advanced molecular technologies. This aggregation of commercial focus and innovation on sophisticated alternatives accentuates the shifting market dynamics. As healthcare systems and manufacturers increasingly direct resources toward these more sensitive and rapid diagnostic tools, the demand for traditional enzyme-linked assays encounters persistent pressure, hindering their growth in vital diagnostic areas.

Market Trends

The increasing integration of automated high-throughput ELISA workstations is transforming laboratory workflows by meeting the urgent need for reproducibility and operational efficiency. Facing rising sample volumes, bioanalytical laboratories and diagnostic centers are decisively moving away from manual plate handling in favor of fully integrated robotic systems that reduce labor costs and human error. This shift is especially prominent in the immunodiagnostics field, where automation facilitates the swift processing of complex assays while maintaining precision. According to Revvity's 'Annual Report for Fiscal Year 2024' from February 2025, the company reported diagnostics segment revenue of $1.50 billion, bolstered significantly by a $43.7 million rise in immunodiagnostics revenue, signaling strong demand for advanced automated solutions.

At the same time, the market is undergoing a major shift toward single-molecule detection technologies and ultrasensitive digital ELISA, spurred by the need to detect low-abundance biomarkers that conventional analog methods miss. This technological advancement enables clinicians and researchers to quantify proteins at femtogram levels, creating new opportunities for early disease detection in fields like oncology and neurology. The transition to these next-generation platforms is gaining speed as they become more clinically validated and accessible. As noted by RTTNews in November 2025 regarding the 'Quanterix Corp Q3 Loss Increases, Misses Estimates' report, Quanterix announced a 12.3% year-over-year revenue increase to $40.23 million for the third quarter, highlighting the increasing commercial momentum of its digital biomarker detection systems.

Key Players Profiled in the Enzyme Linked Immunosorbent Assay Market

• Thermo Fisher Scientific Inc.
• Bio-Rad Laboratories, Inc.
• Agilent Technologies, Inc.
• Merck KGaA
• Promega Corporation
• Neogen Corporation
• F. Hoffmann-La Roche Ltd.
• Siemens Healthineers AG
• Becton, Dickinson and Company
• BioMerieux SA

Report Scope

In this report, the Global Enzyme Linked Immunosorbent Assay Market has been segmented into the following categories:

Enzyme Linked Immunosorbent Assay Market, by Type:

• Direct ELISA
• Indirect ELISA
• Sandwich ELISA

Enzyme Linked Immunosorbent Assay Market, by Application:

• Disease diagnosis
• Vaccine Development
• Other

Enzyme Linked Immunosorbent Assay Market, by End User:

• Hospitals
• Research & Academic Institutions

Enzyme Linked Immunosorbent Assay Market, by Region:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Enzyme Linked Immunosorbent Assay Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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