Austin, Oct. 24, 2025 (GLOBE NEWSWIRE) -- Enzyme-Linked Immunosorbent Assay (ELISA) Market Size & Growth Analysis
According to SNS Insider, the global Enzyme-Linked Immunosorbent Assay (ELISA) Market was valued at USD 2.29 billion in 2025E and is projected to reach USD 3.63 billion by 2033, expanding at a CAGR of 5.98% during 2026–2033. The United States continues to lead the market, backed by a strong network of diagnostic laboratories, rising chronic disease prevalence, and growing research in immunodiagnostics.
More than 50 million ELISA tests are performed annually worldwide, primarily across clinical diagnostics, pharmaceuticals, and food safety. Indirect and sandwich ELISA together represent nearly 60% of global testing volume. With the rise in chronic and infectious diseases, growing R&D investments, and the need for accurate, high-throughput assays, the ELISA market is set for steady long-term growth.
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Enzyme-Linked Immunosorbent Assay (ELISA) Market Overview
ELISA is a well-established immunoassay technique used for detecting and quantifying proteins, antibodies, hormones, and pathogens. Its applications have broadened from traditional clinical diagnostics into pharmaceutical quality control, food safety testing, and environmental monitoring.
In 2025, ELISA-based diagnostic kits formed the backbone of testing in both developed and emerging markets due to their precision, cost-effectiveness, and versatility. With biotechnology and automation advancing rapidly, laboratories are now transitioning toward high-throughput and point-of-care (POC) ELISA platforms, enabling faster turnaround times without compromising accuracy.
However, challenges such as limited access to skilled personnel and infrastructure in smaller or resource-constrained labs remain a bottleneck. Around 40% of small laboratories worldwide still face a shortage of trained professionals for advanced immunoassay execution, impacting consistency and throughput.
Major Players in the Global ELISA Market Include:
- Thermo Fisher Scientific Inc.
- Bio-Rad Laboratories, Inc.
- Agilent Technologies, Inc.
- Merck KGaA
- PerkinElmer, Inc.
- Abbott Laboratories
- Roche Diagnostics
- Danaher Corporation (Beckman Coulter)
- bioMérieux S.A.
- Abcam plc
- Enzo Life Sciences, Inc.
- R&D Systems (Bio-Techne)
- Eurofins Scientific
- ZEUS Scientific, Inc.
- BioLegend, Inc.
- Creative Diagnostics
- Grifols
- Dynex Technologies
- Berthold Technologies
- Tecan Group Ltd.
Enzyme-Linked Immunosorbent Assay (ELISA) Market Segment Insights:
By Product Type
In 2025, Sandwich ELISA held the largest market share of 36.15%, supported by its high sensitivity, reproducibility, and suitability for detecting low-abundance biomarkers in complex samples, making it the standard choice in clinical and infectious disease testing. Competitive ELISA is expected to grow at the highest CAGR of 7.39%, driven by its effectiveness in measuring small molecules such as hormones, toxins, and drug residues, along with its rising adoption in pharmaceutical bioanalysis, food safety surveillance, and doping control applications.
By Application
Clinical Diagnostics contributed the highest share of 56.80% in 2025, as ELISA remains integral to early disease screening, routine pathology workflows, and chronic disease monitoring across hospitals and diagnostic networks. Pharmaceutical & Biotech Testing is projected to grow at the fastest CAGR of 7.68%, fueled by expanding biologics development, vaccine R&D, immunogenicity testing, and regulatory-driven assay validation in preclinical and clinical studies.
By End-User
Diagnostic Laboratories accounted for 30.30% of the market in 2025, owing to their high throughput capacity, widespread automation of ELISA analyzers, and continuous demand for routine as well as specialized diagnostic testing. Pharmaceutical Companies are expected to grow at the fastest CAGR of 7.97%, as ELISA is increasingly deployed across drug discovery, batch quality control, clinical trial analytics, and regulatory submission workflows, particularly in biologics and vaccine manufacturing environments.
Regional Analysis
North America leads the global ELISA market with a 42.23% share in 2025, driven by advanced healthcare infrastructure and widespread diagnostic adoption. More than 21 million ELISA assays were used in the zone in 2025 for clinical diagnosis and research, and in finally preventing new medicines.
The Asia Pacific ELISA market is projected to grow at a CAGR of 7.06% during 2026–2033, making it the fastest-growing region globally. Growth is being driven by increasing healthcare spending, growing burden of infectious diseases and expansion in the use of high-throughput tests.
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Recent News:
- In July 2025, Thermo Fisher Scientific announced the acquisition of Solventum's purification and filtration business for approximately USD 4.1 billion.
- In May 2025, Bio-Rad Laboratories expanded its portfolio by introducing new anti-idiotypic antibodies and SpyCatcher reagents.
Exclusive Sections of the Report (The USPs):
GLOBAL TEST VOLUME & UTILIZATION INTELLIGENCE – helps you quantify the scale of ELISA demand with annual test volume growth, regional usage intensity, and YoY adoption trends to identify high-consumption markets and expansion pockets.
PRODUCT MIX PENETRATION ANALYTICS – helps you assess real-world usage dispersion across Direct, Indirect, Sandwich, and Competitive ELISA formats to uncover which assay classes dominate testing consumption and where substitution opportunities exist.
END-USER DEPLOYMENT INTENSITY INDEX – helps you map ELISA infrastructure readiness across hospitals, diagnostic labs, research institutes, pharma and biotech setups, along with repeat-use frequency for chronic and infectious monitoring to pinpoint sticky revenue pools.
APPLICATION-LEVEL DEMAND DRIVERS – helps you understand which domains (clinical diagnostics, research, food & beverage safety, environmental testing) generate the highest test share and where demand is shifting from laboratory-based to point-of-care ELISA models.
REGIONAL MARKET PENETRATION BENCHMARKS – helps you compare ELISA adoption across North America, Europe, Asia-Pacific, LATAM, and MEA and identify contrasts between emerging vs developed healthcare ecosystems to guide entry or expansion strategy.
Enzyme-Linked Immunosorbent Assay (ELISA) Market Report Scope
| Report Attributes | Details |
| Market Size in 2025 | USD 2.29 Billion |
| Market Size by 2033 | USD 3.63 Billion |
| CAGR | CAGR of 5.98% From 2026 to 2033 |
| Base Year | 2025 |
| Forecast Period | 2026-2033 |
| Historical Data | 2022-2024 |
| Key Segments | By Product Type (Direct ELISA, Indirect ELISA, Sandwich ELISA, Competitive ELISA, Others) By Application (Clinical Diagnostics, Research Laboratories, Pharmaceutical & Biotech Testing, Food & Beverage Testing, Environmental Testing, Others) By End User (Hospitals & Clinics, Diagnostic Laboratories, Research Institutions, Pharmaceutical Companies, Others) |
| Regional Analysis/Coverage | North America (US, Canada), Europe (Germany, UK, France, Italy, Spain, Russia, Poland, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Australia, ASEAN Countries, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Mexico, Colombia, Rest of Latin America). |
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