ENZYME IMMUNOASSAY MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2025 - 2032)

Global Enzyme Immunoassay Market Size and Forecast – 2025 to 2032

The global enzyme immunoassay market is estimated to be valued at USD 19.14 Bn in 2025 and is expected to reach USD 24.85 Bn by 2032, exhibiting a compound annual growth rate (CAGR) of 3.8% from 2025 to 2032. This steady growth reflects increasing adoption of enzyme immunoassays across clinical diagnostics, pharmaceuticals, and biotechnology sectors, driven by rising demand for accurate, rapid, and cost-effective diagnostic solutions worldwide.

Key Takeaways of the Global Enzyme Immunoassay Market

• Reagents and kits segment is expected to dominate the global enzyme immunoassay market, accounting for 50.3% share in 2025.
• Enzyme-Linked Immunosorbent Assay (ELISA) continues to be the core technology in this field, holding a projected share of 40.2% in 2025.
• The infectious disease diagnostics segment represent the leading application area, capturing an estimated 30.5% of the market share in 2025.
• North America is expected to lead the market, holding a share of 39.3% in 2025. Asia Pacific is anticipated to be the fastest-growing region, with a market share of 24.6% in 2025.

Market Overview

Current market trends indicate a shift towards advanced assay technologies with enhanced sensitivity and specificity, fueling innovation in enzyme immunoassay platforms. Integration of automation and digital tools is expanding the market scope, improving throughput and reducing manual errors. Moreover, the rising prevalence of chronic diseases and growing healthcare expenditure are further propelling the demand, alongside increasing investment in research and development aimed at broadening assay applications across infectious diseases, immunology, and oncology.

Current Events and Its Impact

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Segmental Insights

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Enzyme Immunoassay Market Insights, By Product Type - Reagents and Kits Contribute the Highest Share of the Market Owing to Their Critical Role in Assay Accuracy and Versatility

The global enzyme immunoassay market is majorly influenced by the dominance of reagents and kits that are indispensable for the performance of the assays with an estimated 50.3% share in 2025, easy handling, and extensive use in different procedures.

Reagents and kits are the necessary ingredients for all the processes that help in the detection and measurement of antigens or antibodies, thus, providing the chemical base for enzyme immunoassays. Their creation and constant reworking have been the sin qua none of delivering the enhanced sensitivity, specificity, and reproducibility, which are now the very factors in clinical diagnostics and research.

Enzyme Immunoassay Market Insights, By Technology - Enzyme-Linked Immunosorbent Assay (ELISA) leads the Market due to its Proven Reliability and Extensive Clinical Adoption

Enzyme-Linked Immunosorbent Assay (ELISA) technology still is at the top of the list of immunoassay methods with an estimated share of 40.2% in 2025, thus bringing with it established trust, robustness in methodologies and wide-spread acceptance. The ease with which the ELISA technique may be performed combined with highly sensitive and specific attributes is the reason why it is chosen over the rest in the case of many diagnostics and research applications all over the world.

In September 2021, Thermo Fisher Scientific, world's most prominent company in the field of analytical instruments and life science solutions, presented its fully automated Thermo Scientific Gallery Enzyme Master and Gallery Plus Enzyme Master analyzers for enzyme immunoassay applications. The systems carry out enzyme incubation, reagent addition, and measurement automatically to produce accurate and reproducible results while making method development easier.

Enzyme Immunoassay Market Insights, By Application - Infectious Disease Diagnostics Dominates the Market Driven by the Critical Need for Rapid and Accurate Pathogen Detection

Infectious diseases diagnostics still is the largest application segment of the global enzyme immunoassay market with an estimated 30.5% share in 2025, which is clearly a result of the ongoing global burden of infectious diseases and the increasing importance placed on quick, accurate diagnosis. The prompt identification of all types of infections bacterial, viral, fungal, and parasitic has, and most probably will still have, a great deal to do with the use of enzyme immunoassays in the diagnostic process because they are basically the only method that can distinguish the type of infection quickly.

The year 2023 was a significant milestone in the history of human and medical development when respiratory infections, sexually transmitted diseases, and even bloodborne pathogens, on the other hand, came up all at once, pointing out the great need for reliable diagnostic tools. One of these tools is the enzyme immunoassay, which is capable of very sensitive detection of pathogen-specific antigens or host antibodies and thus making it possible to diagnose early and monitor the infection.

Role of Artificial Intelligence (AI) in the Enzyme Immunoassay Market

• Artificial intelligence (AI) is transforming the enzyme immunoassay market by improving efficiency, accuracy, and automation. AI algorithms enable faster interpretation of assay data, reducing manual errors and turnaround time in diagnostics. Predictive analytics supports early disease detection and process optimization, while machine learning refines reagent formulation and assay calibration. Leading companies such as Abbott Laboratories and Siemens Healthineers use AI to automate sample analysis and enhance real-time result accuracy, lowering operational costs and boosting productivity.
• AI also creates new opportunities for personalized diagnostics, digital assay platforms, and data-driven quality control. Cloud-integrated AI systems allow continuous learning from global test data, improving assay performance and reliability. Platforms like Beckman Coulter’s DxONE demonstrate how AI enhances workflow automation and predictive maintenance. However, challenges such as data privacy and integration costs remain. To leverage AI effectively, EIA players should prioritize secure data management, partnerships with AI innovators, and scalable automation strategies. Overall, AI offers a strong pathway to innovation and competitiveness, provided its adoption aligns with regulatory and ethical frameworks.

Regional Insights

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North America Enzyme Immunoassay Market Analysis and Trends

The current trend in the global enzyme immunoassay market is Northeast America's leadership with a well-established medical infrastructure with an estimated 39.3% of the market share in 2025. This is supported by a large number of diagnostics-making biotech and pharma companies, and government funding for R&D in diagnostics. The U.S., being the biggest contributor to that region, benefits from strong regulatory frameworks such as the U.S. FDA's rapid approval process for diagnostic assays which allows quick marketing of new products.

Major companies which are Thermo Fisher Scientific, Bio-Rad Laboratories, and Abbott Laboratories, have large product lines and also good distribution networks in this region, thus making North America's position at the forefront of this market even more powerful. For instance, in March 2023, Roche Diagnostics, which is a prominent biotechnology and diagnostics company, got U.S. FDA clearance for a new immunoassay that was designed for the early detection of a particular cancer, thereby increasing its share of precision diagnostics.

Asia Pacific Enzyme Immunoassay Market Analysis and Trends

The enzyme immunoassay market is expected to experience the fastest growth in the Asia Pacific region, which is to be attributed to improved healthcare infrastructure, the share of 24.6% in 2025, the rise of chronic disease cases, and the increase in healthcare funds in developing countries. China and India are among the countries that are experiencing the fastest industrial growth, along with a large middle-class population benefiting from more access to advanced healthcare diagnostics.

At the same time, the presence of international and local companies creating R&D and manufacturing facilities in the region has made the products more accessible and cheaper. F. Hoffmann-La Roche Ltd, Maccura Biotechnology, and Wondfo Biotech Co. are among the major players whose regional footprints are constantly expanding and thus have a crucial role in this vigorous growth.

Enzyme Immunoassay Market Outlook for Key Countries

U.S. Enzyme Immunoassay Market Analysis and Trends

the U.S. enzyme immunoassay market  is the most competitive and innovation-oriented in the world, which is also a strong factor for the country's market to lead. The strong academic-industry partnerships and the large sum invested in diagnostic research have contributed to the sustainability of the market. The likes of Thermo Fisher Scientific and Abbott Laboratories have put their heads together to come up with sophisticated assays that address a range of clinical tasks, infectious disease detection and oncology being the main ones. The comprehensive health insurance coverage and a proactive regulatory environment spell faster adoption of the new immunoassay technologies, thus reinforcing the country's market strength.

In August 2023, Quest Diagnostics, a leading U.S. provider of diagnostic information services, received U.S. FDA Breakthrough Device Designation for its AAVrh74 ELISA enzyme immunoassay test, designed to detect antibodies to AAVrh74 capsid in patients with Duchenne muscular dystrophy. The test supports Sarepta Therapeutics, a precision genetic medicine company, in identifying candidates for its FDA-approved gene therapy ELEVIDYS.

Germany Enzyme Immunoassay Market Analysis and Trends

The Germany enzyme immunoassay market is the most competitive and innovation-oriented in the world, which is also a strong factor for the country's market to lead. The strong academic-industry partnerships and the large sum invested in diagnostic research have contributed to the sustainability of the market. The likes of Thermo Fisher Scientific and Abbott Laboratories have put their heads together to come up with sophisticated assays that address a range of clinical tasks, infectious disease detection and oncology being the main ones. The comprehensive health insurance coverage and a proactive regulatory environment spell faster adoption of the new immunoassay technologies, thus reinforcing the country's market strength.

In May 2023, Tosoh Bioscience, a Germany based global diagnostics company, introduced the AIA-CL300, a compact automated chemiluminescent enzyme immunoassay analyzer designed for efficient testing in laboratories of all sizes. Combining advanced automation with high analytical sensitivity, the device offers quick results within 15–35 minutes and a throughput of up to 30 tests per hour.

China Enzyme Immunoassay Market Analysis and Trends

The China enzyme immunoassay market is getting more and more interesting. It is mainly due to the government’s increasing investment in the healthcare infrastructure, and the introduction of policies that support domestic biotechnology companies. Maccura Biotechnology and Wondfo Biotech are among the companies that have seized the opportunity by selling enzyme immunoassay products that are already competitively priced, considering the fact that they manufacture locally.

In October 2025, Anixa Biosciences, a U.S.-based biotechnology company focused on cancer treatment and prevention, received a new Chinese patent for its breast cancer vaccine technology developed with Cleveland Clinic. The vaccine uses an enzyme immunoassay-based approach to target α-lactalbumin, a protein linked to certain breast cancers, aiming to trigger immune protection without affecting healthy tissue.

India Enzyme Immunoassay Market Analysis and Trends

India is expected to be a big market with the rising awareness of health, increasing spending diagnostics in both private and public sectors, and also the opening of medical centers in smaller cities. Besides, the National Health Mission is another intervention that the government has put in place to ensure that the public has access to healthcare which in turn will support the demand for low-cost and reliable enzyme immunoassay tests.

In September 2025, FirstIndia reported that India’s in-vitro diagnostics (IVD) market is rapidly advancing with technologies like Chemiluminescence Immunoassay (CLIA) and Enzyme-Linked Immunosorbent Assay (ELISA) driving growth. ELISA continues to serve cost-sensitive and decentralized labs due to its affordability and reliability, while CLIA is emerging as the preferred choice for high-volume, automated, and precise testing in infection serology, endocrinology, and oncology.

Market Players, Key Developments, and Competitive Intelligence

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Key Developments

• In June 2025, Fujirebio, a global leader in enzyme immunoassay and in vitro diagnostics and part of H.U. Group Holdings Inc., expanded its neuro testing portfolio with the launch of the fully automated Lumipulse G sTREM2 assay for Research Use Only. The new chemiluminescent enzyme immunoassay enables the quantitative measurement of soluble Triggering Receptor Expressed on Myeloid Cells 2 (sTREM2) in cerebrospinal fluid and blood within 35 minutes.
• In May 2025, Revvity Inc., a global innovator in life sciences and diagnostics, introduced the fully automated IDS i20 analytical random-access platform from its EUROIMMUN division, designed for chemiluminescence enzyme immunoassay (ChLIA) applications. The CE-marked and U.S. FDA-listed IDS i20 enables laboratories to consolidate multiple specialty tests covering endocrinology, allergy, autoimmune, infectious disease, Alzheimer’s, and therapeutic drug monitoring on a single instrument.
• In July 2024, Fujirebio, a global leader in enzyme immunoassay, launched the fully automated Lumipulse G GFAP assay for Research Use Only on its LUMIPULSE G immunoassay systems. The Chemiluminescent Enzyme Immunoassay enables quantitative measurement of glial fibrillary acidic protein (GFAP) in human plasma and serum within 35 minutes, supporting research on neurological diseases such as Alzheimer’s, Parkinson’s, multiple sclerosis, and stroke.
• In January 2023, Abbott Laboratories, a global healthcare leader specializing in diagnostics and medical devices, launched a new high-throughput enzyme immunoassay analyzer designed to enhance laboratory efficiency through faster and more accurate testing.

Top Strategies Followed by Global Enzyme Immunoassay Market Players

• Global enzyme immunoassay market is largely and mainly dominated by the prominent players who are ready to spend their finance on research and development (R&D) to innovate the next generation of high-performance, high-sensitivity, and high-precision immunoassay products. Such heavy investments will help them to keep a technical edge and offer futuristic solutions that will cater to the needs of clinical, pharmaceutical, and environmental applications, and thus the demand will be broad. The largest market leaders also tend to aim at forming strategic partnerships and collaborations with foremost industry players, original equipment manufacturers (OEMs), and research institutes.
  • In February 2025, VION Biosciences, a U.S.-based life science platform company specializing in diagnostics, drug discovery, and specialty materials, announced its acquisition of BioAssay Systems, a San Francisco biotech firm known for developing high-throughput enzymatic and enzyme immunoassay solutions for life science research.

• Mid-priced players in the enzyme immunoassay market choose cost-effectiveness mainly as their main competitive strategy. These companies focusing on providing reliable immunoassay solutions that are affordable and at the same time have a good quality and price relationship have already recognized the price sensitivity of some consumer groups especially in less developed areas and small medical facilities.
  • Mid-level players in the enzyme immunoassay market include companies such as Calbiotech Inc., DiaMetra Srl, and DRG International Inc. These firms focus on cost-effective immunoassay kits for diagnostic laboratories in developing regions, maintaining affordability without sacrificing accuracy or reliability.

• Small-scale the small players in the global enzyme immunoassay market have a clear differentiation by taking a very specific approach to the market through the creation of specialized features or innovative products. They play on being quick and innovative by using the latest technologies like microfluidics, automation, or multiplexing which make them able to come up with solutions that are specific to certain diagnostic applications or rare disease screening
  • Small-scale players such as Abnova Corporation, RayBiotech Life Inc., and BioVision Inc. differentiate themselves through innovation and specialization. These companies leverage technologies like microfluidic assay platforms, multiplex enzyme immunoassays, and automation-ready kits for research and niche clinical applications, including oncology and rare disease detection.

Market Report Scope

Enzyme Immunoassay Market Report Coverage

Enzyme Immunoassay Market Dynamics

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Enzyme Immunoassay Market Driver - Rising Burden of Infectious and Chronic Diseases

The growing number of infectious and chronic diseases worldwide is one of the key factors that have increased the adoption of enzyme immunoassay technologies. More and more patients suffering from conditions like HIV/AIDS, hepatitis, heart diseases, cancer, and autoimmune diseases demand accurate, fast, and affordable diagnosis. Among these, enzyme immunoassays are up to the task as they would be able to detect even the slightest of biomarker changes that are associated with the diseases thus allowing the medical practitioners to strategize for early diagnosis, disease monitoring, and timely therapeutic intervention. Moreover, the emergence of new infectious diseases and the continuous risk of pandemics stress the importance of reliable diagnostic assays in public health management.

In September 2025, the World Health Organization (WHO) reported a sharp rise in the global burden of chronic or noncommunicable diseases, which claimed around 43 million lives in 2021—accounting for 75% of non-pandemic-related deaths. The data highlighted cardiovascular diseases, cancers, chronic respiratory conditions, and diabetes as the leading causes, with 80% of premature deaths occurring in low- and middle-income countries. 

Moreover, in April 2025, a study presented at ESCMID Global 2025 in Vienna revealed that over 3 million children died in 2022 from antimicrobial resistance (AMR)-related infections, highlighting the rising burden of infectious diseases worldwide.

Enzyme Immunoassay Market Opportunity - Integration of Artificial Intelligence and Big Data Analytics to Enhance Diagnostic

The combination of artificial intelligence (AI) and big data analytics is, on the one hand, a major opportunity for the global enzyme immunoassay market, on the other hand, a major change in the area of diagnostic capabilities and assay performance enhancement. The AI-powered algorithms will be able to examine the immense number of datasets that are derived from the immunoassay tests, and to be precise, the identification of the patterns and correlations that are highly complex and usually missed during the traditional analysis will continue. This upsurge in data interpretation is going to facilitate the timely diagnosis and increased accuracy of diseases thus making enzyme immunoassays more clinically useful and trustworthy.

In June 2023, Siemens Healthineers, a global innovator in healthcare technology, partnered with a biotechnology company to develop an advanced immunoassay technology, combining Siemens’ automation capabilities with cutting-edge biomarker innovation.

Analyst Opinion (Expert Opinion)

• The enzyme immunoassay market is continuously growing and this is mainly due to the increase in infectious and chronic diseases, the automation of diagnostic platforms, and government funding for healthcare infrastructure. The development of technology such as multiplex and microfluidic EIAs is speeding up the assays and making them more precise, while the demand is increasing in both clinical labs and biopharma research. Due to the difficult regulatory validation, high machine costs, and competition from molecular diagnostics, there are still major challenges to overcome for wider acceptance.
• Some recent events such as Next Generation Dx Summit 2024 (Washington D.C.), India Diagnostics Summit 2024 (Gurugram), and Immunogenicity & Bioassay Summit 2024 have allured innovations related to assay design, automation, and decentralized diagnostics. Indian government healthcare project Free Diagnostics Service along with public-private partnerships for laboratory capacity building is one of the several initiatives that are globally making the enzyme immunoassay ecosystem stronger. Enzyme immunoassays will undoubtedly be part of the arsenal of precision diagnostics and accessibility that will be essential in clinical decision-making and disease monitoring.

Market Segmentation

• Product Type Insights (Revenue, USD Bn, 2020 - 2032)
  • Reagents and Kits
  • Analyzers/Instruments
  • Software and Automation Systems
  • Consumables and Accessories
• Technology Insights (Revenue, USD Bn, 2020 - 2032)
  • Enzyme-Linked Immunosorbent Assay (ELISA)
  • Enzyme-Linked Fluorescent Assay (ELFA)
  • Chemiluminescent Enzyme Immunoassay (CL-EIA)
  • Rapid Test Enzyme Immunoassay
  • Multiplex Enzyme Immunoassay
• Application Insights (Revenue, USD Bn, 2020 - 2032)
  • Infectious Disease Diagnostics
  • Oncology
  • Cardiology
  • Autoimmune Diseases
  • Endocrinology
  • Drug Monitoring and Toxicology
  • Allergy Testing
  • Others
• Specimen Type Insights (Revenue, USD Bn, 2020 - 2032)
  • Blood/Serum
  • Urine
  • Saliva
  • Tissue Samples
  • Others (CSF, Plasma)
• Automation Level Insights (Revenue, USD Bn, 2020 - 2032)
  • Manual
  • Semi-automated
  • Fully automated
• End User Insights (Revenue, USD Bn, 2020 - 2032)
  • Hospitals and Clinics
  • Diagnostic Laboratories
  • Research and Academic Institutes
  • Pharmaceutical and Biotechnology Companies
  • Contract Research Organizations (CROs)
• Regional Insights (Revenue, USD Bn, 2020 - 2032)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Abbott
  • Roche Diagnostics
  • Siemens Healthineers
  • bioMérieux
  • Beckman Coulter (Danaher)
  • Thermo Fisher Scientific
  • Bio-Rad Laboratories
  • Revvity (PerkinElmer)
  • DiaSorin
  • QuidelOrtho
  • EUROIMMUN (a Revvity company)
  • Randox Laboratories
  • Bio-Techne (R&D Systems)
  • Merck KGaA (MilliporeSigma)
  • Tecan

Sources

Primary Research Interviews

Industry Stakeholders List

• Diagnostics Manufacturers
• Laboratory Equipment Distributors
• Biotech R&D Directors
• Healthcare Procurement Managers
• Hospital Laboratory Heads
• Clinical Pathology Experts

End Users List

• Clinical Diagnostic Laboratories
• Pharmaceutical Research Firms
• Academic Research Institutions
• Contract Research Organizations (CROs)
• Public Health Testing Centers
• Hospital-Based Testing Facilities

Government and International Databases

• World Health Organization (WHO)
• U.S. Food and Drug Administration (FDA)
• European Medicines Agency (EMA)
• National Institutes of Health (NIH)
• Centers for Disease Control and Prevention (CDC)
• World Bank Data Portal

Trade Publications

• BioTechniques
• Genetic Engineering & Biotechnology News (GEN)
• Clinical Laboratory News
• Medical Laboratory Observer (MLO)
• The Scientist Magazine
• BioProcess International

Academic Journals

• Journal of Immunological Methods
• Analytical Biochemistry
• Clinical Chemistry
• PLOS ONE (Biotechnology Section)
• Nature Biotechnology
• Journal of Clinical Laboratory Analysis

Reputable Newspapers

• The Wall Street Journal (Health & Science)
• The New York Times (Health Section)
• Financial Times (Healthcare & Biotech)
• The Guardian (Science)
• Reuters Health
• Bloomberg Health

Industry Associations

• American Association for Clinical Chemistry (AACC)
• European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)
• International Federation of Clinical Chemistry (IFCC)
• Diagnostics Manufacturers Association of Europe (MedTech Europe)
• Biotechnology Innovation Organization (BIO)
• International Society for Laboratory Hematology (ISLH)

Public Domain Resources

• PubChem (NIH)
• ClinicalTrials.gov
• Google Scholar
• OpenFDA
• National Center for Biotechnology Information (NCBI)

Proprietary Elements

• CMI Data Analytics Tool: Proprietary analytics tool to analyze real-time market trends, consumer behavior, and technology adoption in market
• Proprietary CMI Existing Repository of Information for Last 8 Years