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Enzyme Linked Immunosorbent Assay Market

The market for Enzyme Linked Immunosorbent Assay was estimated at $2.1 billion in 2024; it is anticipated to increase to $3.3 billion by 2030, with projections indicating growth to around $4.6 billion by 2035.

Report ID:DS1801053
Author:Debadatta Patel - Senior Consultant
Published Date:
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Life Science
Medical Device
Enzyme Linked Immunosorbent Assay
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Market Data
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Table of Contents

Global Enzyme Linked Immunosorbent Assay Market Outlook

Revenue, 2024

$2.1B

Forecast, 2034

$4.3B

CAGR, 2025 - 2034

7.4%

The Enzyme Linked Immunosorbent Assay industry revenue is expected to be around $2.3 billion in 2025 and expected to showcase growth with 7.4% CAGR between 2025 and 2034. In modern clinical immuno diagnosis ELISA provides a vital tool and that is why healthcare systems are now prioritising the quick detection of clinically important proteins in routine clinical care. Growing demand is driven by the increased number of people suffering from chronic and infectious diseases, in addition to extensive screening programs and an acceleration of drug and vaccine development. Eighty two per cent of immunoassay utilisation is in clinical diagnosis and the monitoring of infectious diseases. These are the two main applications of the immunoassay technique in the medical field. The dominant technology in the field is the ELISA sandwich technique, which will be responsible for $0.5 billion in sales in the year 2024. This is due to its high specificity as well as its compatibility with automation systems found in laboratories and its ability to be used in a variety of environments.

These ELISA systems permit the identification and measurement of antigens, antibodies or other biological molecules. This is accomplished through enzymatically tagged immunological reactions that produce either colour or light signals. These assays exhibit characteristics such as high analytical sensitivity and specificity, a wide dynamic range, consistent results and compatibility with manual or automated systems. As such, they are essential to research laboratories, diagnostic offices and clinical settings. Standardised testing systems are now increasingly sought after by laboratories in the fields of virology, bacteriology, immunology, oncology and food safety. This is also true of those involved in the monitoring of the environment and the control of the quality of products from biotechnology. Recent developments fuelled by growing interest include ready to use assay kits, digital data integration, decentralized testing and point of care diagnostics, as well as multiplex ELISA technology.

Enzyme Linked Immunosorbent Assay market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2024-2034
Enzyme Linked Immunosorbent Assay Market Outlook

Market Key Insights

  • The Enzyme Linked Immunosorbent Assay market is projected to grow from $2.1 billion in 2024 to $4.3 billion in 2034. This represents a CAGR of 7.4%, reflecting rising demand across Disease Diagnosis, Food Allergen Testing, and Research and Development.

  • Among the key players dominating this market are the likes of F. Hoffmann La Roche Ltd., Danaher Corp., and Thermo Fisher Scientific Inc., who are contributing to its competitive landscape.

  • The North American and the Chinese markets are forecasted to see the greatest growth rates in the Enzyme Linked Immunosorbent Assay market, the growth rates are forecasted to be 4.8% to 7.1% respectively, between the years 2023 and 2030.

  • The highest growth rate is expected for the emerging markets of Brazil, India and Mexico, with CAGR of between 8.5 10.2% .

  • By 2030 technological advancements are predicted to elevate the enzyme linked immunosorbent assay kits market by $100 million.

  • Over the period 2024 to 2034 the enzyme linked immunosorbent assay market is due to expand by $2.2 billion. Market expansion is primarily coming from in Infectious Disease and drug screening applications, as manufacturers expand their activities.

  • With

    rising prevalence of chronic diseases, and

    Advancements in Biotechnology, Enzyme Linked Immunosorbent Assay market to expand 104% between 2024 and 2034.

enzyme linked immunosorbent assay kits market size with pie charts of major and emerging country share, CAGR, trends for 2025 and 2032
Enzyme Linked Immunosorbent Assay - Country Share Analysis

Opportunities in the Enzyme Linked Immunosorbent Assay

An elderly population is also driving the Japanese market for autoimmune and cancer blood tests. The indirect ELISA market is expected to grow from $0.42 billion in 2024 to $0.61 billion in 2030 with a CAGR of 6.5%. Firms which localise ELISA calibration standards, strengthen partnerships with hospitals and assist in novel biomarker validation can dominate the Japanese clinical ELISA market in high value specialty segments.

Growth Opportunities in North America and Asia Pacific

The main driver of the ELISA in North America is mainly the expanding demand for drug screening and sophisticated clinical diagnostics. There is strong demand in this region for equipment that can integrate ELISA kits with laboratory automation and microplate readers capable of processing large quantities of biomarkers. The biomarkers in question are used in cardiology, the detection of diseases which affect the immune system and in oncology. Potential exists in the region of bespoke, high end immunoassay kits and automated ELISA platforms for laboratories and research institutions. Alongside this, there are also panels tailored to meet the evolving requirements of legislation. The market for diagnostic products is fiercely competitive, with many large corporations competing against local companies that are quicker to adapt and differentiate through the provision of customised testing services, rapid technical advice and integration with IT systems used in laboratories. The key growth drivers in the region are robust healthcare spending, a high incidence of chronic conditions, an established pharmaceutical research and development industry and a trend towards immunoassay testing procedures which result in faster results and better clinical decision making.
The adoption rate of Enzyme Linked Immunosorbent Assay technology in the Asian Pacific region is increasing rapidly within the clinical diagnostics and infectious disease sectors. This increased adoption can be attributed to improving laboratory facilities and a rise in public health screening. In regions where healthcare is sought, the biggest opportunities are in immunoassay kits which are cost effective, localized manufacturing, and diagnostic panels tailored to specific regions. These include panels which deal with disorders of metabolism and infectious diseases. Another opportunity exists in a combination of laboratory testing and diagnostic tests which are portable. As the global market develops, competition between various firms is characterised by a large number of regional and local companies launching ELISA kits, these companies provide competitive ELISA kits which enable differentiation by the robustness of assays, through the of sample, and technical support given to users. The region is characterised by a large and aging population, and also by an ageing population. Government investment in diagnostic facilities is growing, as is clinical trial and biosimilar activity. Awareness of preventative healthcare is rising. This is leading to a growing demand for drug testing and immunogenicity.

Market Dynamics and Supply Chain

01

Driver: Rising Prevalence of Chronic Diseases Coupled with Expanded Infectious Disease Screening and Preventive Healthcare

The enzyme linked immunosorbent assay kits market is also significantly driven by the increasing global prevalence of chronic diseases and the expansion of infectious disease screening and preventive healthcare initiatives. Chronic conditions such as cardiovascular diseases, diabetes, and autoimmune disorders require frequent monitoring of biomarkers, antigens, and antibodies, fueling steady demand for sensitive ELISA kits in clinical diagnostics and research settings. In parallel, heightened public health focus on early detection of infectious diseases, including HIV, hepatitis, dengue, and emerging pathogens, has also expanded screening programs across hospitals, public health laboratories, and screening centers worldwide. This expansion is also reinforced by government health policies and awareness campaigns aimed at reducing disease burden through early intervention. Together, chronic disease management and robust infectious disease screening programs necessitate high‑throughput, reliable immunoassay solutions capable of delivering accurate, reproducible results. As a result, end‑users increasingly adopt advanced ELISA platforms that support multiplexing, automation, and integration with digital lab workflows, further driving market growth.
A key driver for enzyme linked immunosorbent assay kits is also the continuous advancement of high‑throughput and multiplex assay technologies. These innovations allow simultaneous detection of multiple biomarkers with improved sensitivity, specificity, and reduced sample volume, significantly optimizing workflows in research laboratories, clinical diagnostics, and biopharmaceutical development. Enhanced automation, integration with digital laboratory information systems, and compatibility with robotic platforms further increase assay efficiency, reproducibility, and data reliability. Such advancements support faster drug discovery, biomarker validation, and large-scale screening, strengthening adoption across healthcare and life science industries.
02

Restraint: High Costs and Technical Complexity of Advanced ELISA Platforms Limit Adoption in Smaller Labs

One major restraint in the enzyme linked immunosorbent assay kits market is the high cost and technical complexity associated with advanced ELISA systems, especially high‑throughput and multiplex platforms. Smaller clinical laboratories and research facilities often lack budgets or skilled personnel to adopt these technologies, opting for simpler or alternative immunoassays. This limits revenue growth for premium ELISA offerings and slows broader market penetration, particularly in emerging markets where healthcare spending is constrained.
03

Opportunity: Rising biologics and biosimilar development in United States biopharmaceutical industry demanding high-throughput sandwich Enzyme Linked Immunosorbent Assay and Expanding infectious disease surveillance programs in Indian public health laboratories adopting cost-efficient competitive Enzyme Linked Immunosorbent Assay

The biologics industry in the US is seeing a surge in the development of new biological products which is creating a high demand for the development of new high throughput assays for detecting immunogenicity and biomarkers. In the year 2024, Sandwich enzyme linked immunosorbent assays comprise the largest technology category, and it had a value of $0.50 billion. By 2030, it is predicted to be of the value of $0.77 billion, having an annual growth rate of 7.4%. This growth is due to a compound annual growth rate of 7.4%. Organisations that are ELISA kit automation integrators, validated pharmacokinetic panel suppliers and developers of companion assays can arrange these supply agreements across preclinical, discovery and clinical phases.
The diagnostic capacity of Indias expanding infectious disease programmes is hampered by the unavailability of low cost immunoassays which are also standardised. A competitive enzyme linked immunosorbent assay which uses lower levels of consumable reagents, is expected to grow worldwide from $0.25 billion in 2024 to $0.40 billion by 2030 at a CAGR of 8.05%. By modifying ELISA kits to target local pathogens, streamlining laboratory procedures and coordinating with government run screening programs, suppliers can capitalise on significant unmet demand in cities categorised as tier 2 and tier 3.
04

Challenge: Competition from Alternative Immunoassay Technologies Reduces Demand for Traditional ELISA Kits

The growing use of alternative immunoassay methods such as chemiluminescent immunoassays, lateral flow assays, and PCR‑based diagnostic tools is restraining demand for traditional ELISA kits. These alternatives offer faster turnaround, higher automation, and, in some cases, greater sensitivity, prompting labs and hospitals to shift purchasing preferences. This competitive pressure can reduce ELISA kit sales and force manufacturers to innovate or adjust pricing strategies to maintain market share.

Supply Chain Landscape

1

Raw Materials Supply

Thermo Fisher Scientific Inc.Bio-Rad Laboratories Inc
2

Enzyme Linked Immunosorbent Assay

Thermo Fisher Scientific Inc.Danaher Corp.F. Hoffmann-La Roche Ltd
3

Distribution & Logistics

Siemens Healthineers AGBio-Rad Laboratories Inc
4

Clinical Research Use

Clinical diagnosticsbiopharmaceutical researchimmunodiagnostics
Enzyme Linked Immunosorbent Assay - Supply Chain

Use Cases of Enzyme Linked Immunosorbent Assay in Disease Diagnosis & Food Allergen Testing

Disease Diagnosis : ELISA kits are extensively used in clinical laboratories and hospitals for accurate disease diagnosis by detecting specific antigens or antibodies in patient samples. Sandwich and indirect ELISA formats are commonly used to identify infections such as HIV, hepatitis, dengue, and COVID‑19, along with biomarkers for autoimmune and inflammatory conditions, enabling early and reliable clinical decision‑making. These assays provide high sensitivity and specificity, making them essential tools for routine screening, monitoring disease progression, and evaluating treatment response. Leading players such as Thermo Fisher Scientific, Bio‑Rad Laboratories, Abbott, and Roche dominate this segment with comprehensive diagnostic ELISA portfolios that support global healthcare needs.
Food Allergen Testing : In the food industry, ELISA kits are the preferred solution for detecting and quantifying allergenic proteins such as gluten, peanuts, milk, and soy to ensure product safety and regulatory compliance. Sandwich ELISA tests provide sensitive, low‑level detection of allergen residues in raw and processed foods, helping manufacturers avoid costly recalls and protect consumer health. Companies like Neogen Corporation, Eurofins Scientific, R‑Biopharm, and Creative Diagnostics lead this application with validated, user‑friendly kits tailored for quality control laboratories and food processing facilities.
Research and Development : In research and development, ELISA kits are indispensable for quantifying proteins, hormones, cytokines, and other biomarkers in academic, pharmaceutical, and biotechnology labs. These assays support drug discovery, immunology studies, and biomarker validation by providing reproducible, high‑throughput data. Researchers use flexible sandwich, competitive, and multiplex ELISA formats to study immune responses, monitor therapeutic effects, and screen compounds during preclinical and clinical phases. Major ELISA suppliers like Thermo Fisher Scientific, Bio‑Rad, Merck KGaA, and BD offer extensive research‑focused kits and customizable assay solutions that enhance scientific discovery and innovation.

Recent Developments

Recent developments in enzyme linked immunosorbent assay kits emphasize multiplex immunoassays, automation, and biomarker‑specific assays that boost throughput and diagnostic precision. A key market trend is the integration of high‑sensitivity ELISA platforms with digital laboratory information systems and immunoassay analyzers, enabling streamlined workflow and real‑time data analysis. Manufacturers are also expanding disease‑specific panels and custom ELISA solutions for research, clinical diagnostics, and biopharma applications, enhancing assay versatility and adoption.

January 2025 : Thermo Fisher introduced a competitive ELISA kit for highly sensitive quantification of prostaglandin E2 in various biological matrices, enhancing research and diagnostic capabilities with sub‑picogram detection limits and broad dynamic range for biomarker studies.
December 2024 : Danaher finalized its $5.7 billion acquisition of Abcam, integrating Abcam’s SimpleStep ELISA kits, recombinant antibodies, and immunoassay R&D assets into its diagnostics and life sciences portfolio to strengthen immunoassay offerings.
June 2024 : Bio‑Rad launched a reagent solution combining SpyCatcher technology with IgM detection, streamlining antibody engineering and enhancing ELISA assay flexibility for immunoassay workflows.

Impact of Industry Transitions on the Enzyme Linked Immunosorbent Assay Market

As a core segment of the Medical Device industry, the Enzyme Linked Immunosorbent Assay market develops in line with broader industry shifts. Over recent years, transitions such as Technological Advancements and Development of Novel Biomarkers have redefined priorities across the Medical Device sector, influencing how the Enzyme Linked Immunosorbent Assay market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.
01

Technological Advancements

Assays employing enzyme linked immunosorbent technology are becoming increasingly automated, leading to significant market expansion. Projections suggest that this change will generate an extra $100 million in revenue by the year 2030. In diagnostic and research laboratories, ELISA kits are becoming increasingly automated. This process decreases the time taken to complete hands on work and also standardises the test. Advances in multiplexing and detection technology have improved test sensitivity and specificity. This enables the accurate profiling of a variety of conditions and the identification of relevant genetic markers. Suppliers that quickly integrate these automation and multiplexing capabilities into their Enzyme Linked Immunosorbent Assays will be able to capture a disproportionate share of the USD 100 million opportunity. This will be through premium pricing, higher test volumes and stronger loyalty from laboratories.
02

Development of Novel Biomarkers

The emergence of highly targeted biomarkers is transforming the ELISA test kit market by enabling more precise and disease-specific assays. Advances in genomics, proteomics, and personalized medicine are driving the design of kits that can detect specific proteins, antibodies, or antigens linked to cancers, autoimmune disorders, and infectious diseases. This transition impacts associated industries such as diagnostic imaging, biopharmaceutical development, and clinical laboratory services, where accurate biomarker detection guides treatment decisions and drug development. For example, pharmaceutical companies increasingly use ELISA kits to monitor therapeutic response in clinical trials, while hospitals adopt biomarker-specific kits to improve early disease detection and patient management. These innovations are fostering collaboration between kit manufacturers, research institutions, and diagnostic service providers, enhancing workflow efficiency, data reliability, and overall healthcare outcomes.