Enzyme Linked Immunosorbent Assay Market Size and Outlook 2031

Report Description

Forecast Period	2027-2031
Market Size (2025)	USD 3.79 Billion
CAGR (2026-2031)	8.21%
Fastest Growing Segment	Sandwich ELISA
Largest Market	North America
Market Size (2031)	USD 6.08 Billion

Market Overview

The Global Enzyme Linked Immunosorbent Assay Market will grow from USD 3.79 Billion in 2025 to USD 6.08 Billion by 2031 at a 8.21% CAGR. The Enzyme-Linked Immunosorbent Assay (ELISA) is a plate-based analytical technique widely utilized for detecting and quantifying soluble substances such as antibodies, antigens, proteins, and hormones within biological samples. The primary driver supporting the growth of this market is the escalating global prevalence of chronic and infectious diseases, which necessitates frequent and accurate diagnostic testing to facilitate effective disease management. Additionally, the expanding role of these assays in drug discovery and development processes significantly reinforces demand. According to the International Diabetes Federation, in 2024, approximately 589 million adults were living with diabetes worldwide, a statistic that highlights the critical necessity for reliable biomarker analysis and continuous health monitoring tools.

However, a significant challenge that could impede market expansion is the availability of alternative advanced diagnostic technologies, such as molecular diagnostics and polymerase chain reaction (PCR), which often offer higher sensitivity and faster turnaround times. The intense competition from these sophisticated platforms may limit the adoption of traditional immunoassays in certain high-precision clinical applications.

Key Market Drivers

The rising prevalence of infectious and chronic diseases serves as a primary catalyst for the Global Enzyme Linked Immunosorbent Assay Market. These conditions necessitate robust diagnostic protocols, where ELISA remains a gold standard for detecting specific antigens and antibodies. The burden of infectious pathogens drives substantial testing volumes for effective disease management and control. According to the World Health Organization (WHO), October 2024, in the 'Global Tuberculosis Report 2024', an estimated 10.8 million people fell ill with tuberculosis globally in 2023, highlighting the critical need for accurate infectious disease screening. Furthermore, the chronic disease segment contributes significantly to market demand. According to the American Cancer Society, January 2024, in the 'Cancer Facts & Figures 2024' report, the United States alone projected over 2 million new cancer cases for the first time in 2024, underscoring the growing necessity for reliable tumor marker analysis using established immunoassay platforms.

Simultaneously, the expansion of biopharmaceutical R&D and drug discovery activities significantly propels market growth. Pharmaceutical companies extensively utilize ELISA during the drug development pipeline for pharmacokinetic studies, immunogenicity testing, and toxicity screening of biologics. As the industry intensifies its focus on novel therapeutics, investment in research infrastructure has surged, directly increasing the consumption of assay kits and reagents. According to Roche, March 2024, in the 'Annual Report 2023', the group's core research and development investments increased to CHF 13.2 billion, reflecting the immense financial commitment driving the demand for high-precision bioanalytical tools. This sustained capital allocation towards discovery ensures a continuous requirement for sensitive diagnostic assays to support the rigorous testing mandates of modern drug development.

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Key Market Challenges

The primary challenge hindering the growth of the Global Enzyme Linked Immunosorbent Assay (ELISA) Market is the intensifying competition from advanced diagnostic technologies, particularly molecular diagnostics and polymerase chain reaction (PCR). These alternative platforms offer superior sensitivity and significantly faster turnaround times compared to traditional plate-based immunoassays. Consequently, healthcare providers and laboratories are increasingly favoring these advanced methods for applications requiring high precision and immediate clinical decision-making, such as infectious disease testing and genetic analysis. This shift effectively limits the adoption of ELISA kits in segments where speed and accuracy are paramount, reducing their potential market share in high-value clinical settings.

The magnitude of this technological transition is reflected in recent industry activities that prioritize these competing platforms. According to the Association for Diagnostics & Laboratory Medicine, in 2024, the Clinical Lab Expo hosted nearly 900 exhibitors, distinctly showcasing the industry's pivot towards advanced molecular and automated technologies. This concentration of innovation and commercial focus on sophisticated alternatives underscores the changing market dynamics. As manufacturers and healthcare systems increasingly allocate resources to these faster, more sensitive diagnostic tools, the demand for traditional enzyme-linked assays faces direct and sustained pressure, hampering their expansion in critical diagnostic sectors.

Key Market Trends

The rising adoption of automated high-throughput ELISA workstations is fundamentally reshaping laboratory workflows by addressing the critical need for operational efficiency and reproducibility. As diagnostic centers and bioanalytical laboratories face increasing sample volumes, there is a distinct shift away from manual plate handling toward fully integrated robotic systems that minimize human error and labor costs. This trend is particularly evident in the immunodiagnostics sector, where automation enables the rapid processing of complex assays without compromising precision. According to Revvity, February 2025, in the 'Annual Report for Fiscal Year 2024', the company's diagnostics segment revenue reached $1,500.9 million, driven largely by a $43.7 million increase in immunodiagnostics revenue, reflecting the robust demand for advanced automated solutions.

Simultaneously, the market is experiencing a significant transition to ultrasensitive digital ELISA and single-molecule detection technologies, driven by the requirement to identify low-abundance biomarkers that traditional analog methods cannot detect. This technological evolution allows researchers and clinicians to quantify proteins at femtogram levels, opening new avenues for early disease detection in neurology and oncology. The shift toward these next-generation platforms is accelerating as they become more accessible and validated for clinical use. According to RTTNews, November 2025, in the 'Quanterix Corp Q3 Loss Increases, Misses Estimates' report, Quanterix reported that its third-quarter revenue rose 12.3% year-over-year to $40.23 million, underscoring the growing commercial traction of its digital biomarker detection platforms.

Segmental Insights

The Sandwich ELISA segment represents the fastest-growing category in the Global Enzyme Linked Immunosorbent Assay Market, driven by its exceptional specificity and sensitivity. This method utilizes a dual-antibody format to capture and detect the target antigen, ensuring precise measurement even in complex biological fluids without requiring extensive purification. These distinct technical advantages make it the preferred choice for detecting low-abundance biomarkers in clinical diagnostics and pharmaceutical research. As the demand for accurate infectious disease testing and chronic disease monitoring rises, the adoption of Sandwich ELISA continues to expand rapidly across the global healthcare sector.

Regional Insights

North America maintains a dominant position in the Global Enzyme Linked Immunosorbent Assay Market, driven principally by the high prevalence of chronic and infectious diseases requiring frequent testing. The region benefits from robust healthcare infrastructure and substantial investments in research and development by established biotechnology companies. Furthermore, supportive initiatives and product approvals from regulatory bodies, such as the U.S. Food and Drug Administration, facilitate the rapid commercialization of diagnostic tools. This alignment of clinical demand, industrial capacity, and regulatory support reinforces North America’s leadership in the global sector.

Recent Developments

In April 2025, the Tecan Group announced a strategic agreement to acquire specific assets related to key ELISA immunoassay products from Cisbio Bioassays SAS, a subsidiary of Revvity, Inc. This asset purchase included the manufacturing processes for four specific ELISA kits used for specialty diagnostics and disease monitoring, as well as research applications. To ensure the continued availability of these products during the transition, Tecan’s subsidiary, IBL International GmbH, entered into a Master Distributorship Agreement to resell the kits until the asset transfer was fully completed.
In August 2024, Innovative Research, Inc. introduced a new range of breakthrough ELISA and Chemiluminescent Immunoassay (CLIA) kits aimed at enhancing diagnostic accuracy and research efficiency. These new products were designed to provide researchers with high-sensitivity tools for the detection of various biomarkers in complex biological samples. The launch highlighted the company's focus on expanding its immunodiagnostic offerings to meet the growing demand for reliable and precise assay kits in the life sciences and clinical research sectors.
In April 2024, Creative Diagnostics announced the launch of a comprehensive portfolio of ELISA-based assays designed specifically to support vaccine development and bioprocess applications. These new kits were introduced to address the critical needs of virology and microbiology research, facilitating the measurement of vaccine titers, purity, affinity, and potency. The company aimed to streamline the workflow for researchers by providing high-quality, validated tools for the quantification of antigenic epitopes and the detection of immunogenic responses in both animal and human models.
In March 2024, the U.S. Food and Drug Administration (FDA) granted marketing authorization to Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH for its Technozym ADAMTS13 Activity test. This device is an enzyme-linked immunosorbent assay (ELISA) intended to measure ADAMTS13 activity in human platelet-poor plasma. The authorization allows the test to be used alongside other clinical and laboratory findings to assist healthcare providers in diagnosing thrombotic thrombocytopenic purpura (TTP) in specific patient populations. This regulatory milestone represents a significant advancement in the availability of diagnostic tools for blood clotting disorders.

Key Market Players

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
BioMérieux SA

By Type	By Application	By End User	By Region
Direct ELISA Indirect ELISA Sandwich ELISA	Disease diagnosis Vaccine Development Other	Hospitals Research & Academic Institutions	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Enzyme Linked Immunosorbent Assay Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

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

United States
Canada
Mexico

Europe

France
United Kingdom
Italy
Germany
Spain

Asia Pacific

China
India
Japan
Australia
South Korea

South America

Brazil
Argentina
Colombia

Middle East & Africa

South Africa
Saudi Arabia
UAE

Competitive Landscape

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

Available Customizations:

Global Enzyme Linked Immunosorbent Assay Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

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

Global Enzyme Linked Immunosorbent Assay Market is an upcoming report to be released soon. If you wish an early delivery of this report or want to confirm the date of release, please contact us at [email protected]

Table of content

1. Product Overview

1.1. Market Definition

1.2. Scope of the Market

1.2.1. Markets Covered

1.2.2. Years Considered for Study

1.2.3. Key Market Segmentations

2. Research Methodology

2.1. Objective of the Study

2.2. Baseline Methodology

2.3. Key Industry Partners

2.4. Major Association and Secondary Sources

2.5. Forecasting Methodology

2.6. Data Triangulation & Validation

2.7. Assumptions and Limitations

3. Executive Summary

3.1. Overview of the Market

3.2. Overview of Key Market Segmentations

3.3. Overview of Key Market Players

3.4. Overview of Key Regions/Countries

3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Enzyme Linked Immunosorbent Assay Market Outlook

5.1. Market Size & Forecast

5.1.1. By Value

5.2. Market Share & Forecast

5.2.1. By Type (Direct ELISA, Indirect ELISA, Sandwich ELISA)

5.2.2. By Application (Disease diagnosis, Vaccine Development, Other)

5.2.3. By End User (Hospitals, Research & Academic Institutions)

5.2.4. By Region

5.2.5. By Company (2025)

5.3. Market Map

6. North America Enzyme Linked Immunosorbent Assay Market Outlook

6.1. Market Size & Forecast

6.1.1. By Value

6.2. Market Share & Forecast

6.2.1. By Type

6.2.2. By Application

6.2.3. By End User

6.2.4. By Country

6.3. North America: Country Analysis

6.3.1. United States Enzyme Linked Immunosorbent Assay Market Outlook

6.3.1.1. Market Size & Forecast

6.3.1.1.1. By Value

6.3.1.2. Market Share & Forecast

6.3.1.2.1. By Type

6.3.1.2.2. By Application

6.3.1.2.3. By End User

6.3.2. Canada Enzyme Linked Immunosorbent Assay Market Outlook

6.3.2.1. Market Size & Forecast

6.3.2.1.1. By Value

6.3.2.2. Market Share & Forecast

6.3.2.2.1. By Type

6.3.2.2.2. By Application

6.3.2.2.3. By End User

6.3.3. Mexico Enzyme Linked Immunosorbent Assay Market Outlook

6.3.3.1. Market Size & Forecast

6.3.3.1.1. By Value

6.3.3.2. Market Share & Forecast

6.3.3.2.1. By Type

6.3.3.2.2. By Application

6.3.3.2.3. By End User

7. Europe Enzyme Linked Immunosorbent Assay Market Outlook

7.1. Market Size & Forecast

7.1.1. By Value

7.2. Market Share & Forecast

7.2.1. By Type

7.2.2. By Application

7.2.3. By End User

7.2.4. By Country

7.3. Europe: Country Analysis

7.3.1. Germany Enzyme Linked Immunosorbent Assay Market Outlook

7.3.1.1. Market Size & Forecast

7.3.1.1.1. By Value

7.3.1.2. Market Share & Forecast

7.3.1.2.1. By Type

7.3.1.2.2. By Application

7.3.1.2.3. By End User

7.3.2. France Enzyme Linked Immunosorbent Assay Market Outlook

7.3.2.1. Market Size & Forecast

7.3.2.1.1. By Value

7.3.2.2. Market Share & Forecast

7.3.2.2.1. By Type

7.3.2.2.2. By Application

7.3.2.2.3. By End User

7.3.3. United Kingdom Enzyme Linked Immunosorbent Assay Market Outlook

7.3.3.1. Market Size & Forecast

7.3.3.1.1. By Value

7.3.3.2. Market Share & Forecast

7.3.3.2.1. By Type

7.3.3.2.2. By Application

7.3.3.2.3. By End User

7.3.4. Italy Enzyme Linked Immunosorbent Assay Market Outlook

7.3.4.1. Market Size & Forecast

7.3.4.1.1. By Value

7.3.4.2. Market Share & Forecast

7.3.4.2.1. By Type

7.3.4.2.2. By Application

7.3.4.2.3. By End User

7.3.5. Spain Enzyme Linked Immunosorbent Assay Market Outlook

7.3.5.1. Market Size & Forecast

7.3.5.1.1. By Value

7.3.5.2. Market Share & Forecast

7.3.5.2.1. By Type

7.3.5.2.2. By Application

7.3.5.2.3. By End User

8. Asia Pacific Enzyme Linked Immunosorbent Assay Market Outlook

8.1. Market Size & Forecast

8.1.1. By Value

8.2. Market Share & Forecast

8.2.1. By Type

8.2.2. By Application

8.2.3. By End User

8.2.4. By Country

8.3. Asia Pacific: Country Analysis

8.3.1. China Enzyme Linked Immunosorbent Assay Market Outlook

8.3.1.1. Market Size & Forecast

8.3.1.1.1. By Value

8.3.1.2. Market Share & Forecast

8.3.1.2.1. By Type

8.3.1.2.2. By Application

8.3.1.2.3. By End User

8.3.2. India Enzyme Linked Immunosorbent Assay Market Outlook

8.3.2.1. Market Size & Forecast

8.3.2.1.1. By Value

8.3.2.2. Market Share & Forecast

8.3.2.2.1. By Type

8.3.2.2.2. By Application

8.3.2.2.3. By End User

8.3.3. Japan Enzyme Linked Immunosorbent Assay Market Outlook

8.3.3.1. Market Size & Forecast

8.3.3.1.1. By Value

8.3.3.2. Market Share & Forecast

8.3.3.2.1. By Type

8.3.3.2.2. By Application

8.3.3.2.3. By End User

8.3.4. South Korea Enzyme Linked Immunosorbent Assay Market Outlook

8.3.4.1. Market Size & Forecast

8.3.4.1.1. By Value

8.3.4.2. Market Share & Forecast

8.3.4.2.1. By Type

8.3.4.2.2. By Application

8.3.4.2.3. By End User

8.3.5. Australia Enzyme Linked Immunosorbent Assay Market Outlook

8.3.5.1. Market Size & Forecast

8.3.5.1.1. By Value

8.3.5.2. Market Share & Forecast

8.3.5.2.1. By Type

8.3.5.2.2. By Application

8.3.5.2.3. By End User

9. Middle East & Africa Enzyme Linked Immunosorbent Assay Market Outlook

9.1. Market Size & Forecast

9.1.1. By Value

9.2. Market Share & Forecast

9.2.1. By Type

9.2.2. By Application

9.2.3. By End User

9.2.4. By Country

9.3. Middle East & Africa: Country Analysis

9.3.1. Saudi Arabia Enzyme Linked Immunosorbent Assay Market Outlook

9.3.1.1. Market Size & Forecast

9.3.1.1.1. By Value

9.3.1.2. Market Share & Forecast

9.3.1.2.1. By Type

9.3.1.2.2. By Application

9.3.1.2.3. By End User

9.3.2. UAE Enzyme Linked Immunosorbent Assay Market Outlook

9.3.2.1. Market Size & Forecast

9.3.2.1.1. By Value

9.3.2.2. Market Share & Forecast

9.3.2.2.1. By Type

9.3.2.2.2. By Application

9.3.2.2.3. By End User

9.3.3. South Africa Enzyme Linked Immunosorbent Assay Market Outlook

9.3.3.1. Market Size & Forecast

9.3.3.1.1. By Value

9.3.3.2. Market Share & Forecast

9.3.3.2.1. By Type

9.3.3.2.2. By Application

9.3.3.2.3. By End User

10. South America Enzyme Linked Immunosorbent Assay Market Outlook

10.1. Market Size & Forecast

10.1.1. By Value

10.2. Market Share & Forecast

10.2.1. By Type

10.2.2. By Application

10.2.3. By End User

10.2.4. By Country

10.3. South America: Country Analysis

10.3.1. Brazil Enzyme Linked Immunosorbent Assay Market Outlook

10.3.1.1. Market Size & Forecast

10.3.1.1.1. By Value

10.3.1.2. Market Share & Forecast

10.3.1.2.1. By Type

10.3.1.2.2. By Application

10.3.1.2.3. By End User

10.3.2. Colombia Enzyme Linked Immunosorbent Assay Market Outlook

10.3.2.1. Market Size & Forecast

10.3.2.1.1. By Value

10.3.2.2. Market Share & Forecast

10.3.2.2.1. By Type

10.3.2.2.2. By Application

10.3.2.2.3. By End User

10.3.3. Argentina Enzyme Linked Immunosorbent Assay Market Outlook

10.3.3.1. Market Size & Forecast

10.3.3.1.1. By Value

10.3.3.2. Market Share & Forecast

10.3.3.2.1. By Type

10.3.3.2.2. By Application

10.3.3.2.3. By End User

11. Market Dynamics

11.1. Drivers

11.2. Challenges

12. Market Trends & Developments

12.1. Merger & Acquisition (If Any)

12.2. Product Launches (If Any)

12.3. Recent Developments

13. Global Enzyme Linked Immunosorbent Assay Market: SWOT Analysis

14. Porter's Five Forces Analysis

14.1. Competition in the Industry

14.2. Potential of New Entrants

14.3. Power of Suppliers

14.4. Power of Customers

14.5. Threat of Substitute Products

15. Competitive Landscape

15.1. Thermo Fisher Scientific Inc

15.1.1. Business Overview

15.1.2. Products & Services

15.1.3. Recent Developments

15.1.4. Key Personnel

15.1.5. SWOT Analysis

15.2. Bio-Rad Laboratories, Inc

15.3. Agilent Technologies, Inc

15.4. Merck KGaA

15.5. Promega Corporation

15.6. Neogen Corporation

15.7. F. Hoffmann-La Roche Ltd

15.8. Siemens Healthineers AG

15.9. Becton, Dickinson and Company

15.10. BioMérieux SA

16. Strategic Recommendations

17. About Us & Disclaimer

Report Description

Table of content

Figures and Tables

Frequently asked questions

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