Enzyme Immunoassay Market Size, Share and Trends 2025 to 2034

Enzyme Immunoassay Market Size and Forecast 2025 to 2034

The global enzyme immunoassay market size accounted for USD 17.80 billion in 2024 and is predicted to increase from USD 18.51 billion in 2025 to approximately USD 26.35 billion by 2034, expanding at a CAGR of 4.00% from 2025 to 2034. The enzyme immunoassay sector is expanding quickly because of an increased need for prompt disease detection and trustworthy, non-invasive methods.

Enzyme Immunoassay Market Key Takeaways

• North America dominated the global market with the largest market share of 68% in 2024.
• Asia Pacific is expected to grow at a CAGR of 6.64% during the forecast period.
• By product, the reagents and kits segment held the major market share of 68% in 2024.
• By product, the software and services segment is projected to expand at a solid CAGR in the coming years.
• By specimen, the blood sample segment held a dominant presence in the market in 2024.
• By specimen, the urine specimen segment is seen to grow at the fastest CAGR in the upcoming years.
• By application, the infectious disease testing segment dominated the market with the largest share in 2024.
• By application, the oncology segment is expected to witness the fastest growth during the predicted timeframe.
• By end-use, the hospital segment dominated the market with the highest share in 2024.
• By end-use, the clinical laboratories segment is projected to grow with the fastest CAGR in the market during the forecast period.

Artificial Intelligence Enhancing Enzyme Immunoassay Precision

Artificial intelligence (AI) is transforming the enzyme immunoassay market by enhancing diagnostic precision, effectiveness, and speed. AI technologies are being integrated into immunoassay systems to enhance data analysis, automate procedures, and minimize human mistakes by increasing the accuracy and efficiency of results. The incorporation of AI with high throughput systems and cloud-based platforms facilitates extensive testing while maintaining reliable accuracy in clinical diagnostics and research.

• In October 2024, Siemens Healthineers launched the Atellica Integrated Automation platform with the goal of transforming immunoassays through automation, enhancing error detection, and allowing real-time changes by tackling staffing issues and increasing testing capability.

U.S. Enzyme Immunoassay Market Size and Growth 2025 to 2034

The U.S. enzyme immunoassay market size was exhibited at USD 6.46 billion in 2024 and is projected to be worth around USD 9.73 billion by 2034, growing at a CAGR of 4.18% from 2025 to 2034.

Innovative Diagnostics Propels the Dominance of North America

North America dominated the enzyme immunoassay market in 2024 because of its sophisticated healthcare system, substantial investments in research and development, and prompt adoption of innovative diagnostic technologies. The strong healthcare infrastructure of the region enables extensive implementation of enzyme immunoassays in hospitals, diagnostic labs, and research facilities. The widespread occurrence of chronic and infectious illnesses such as cancer, diabetes, and heart disease increases the need for accurate diagnostics. A robust Research and Development ecosystem, supportive regulatory conditions, and technological progress such as AI, automation, and high-throughput systems improve the effectiveness and precision of enzyme immunoassays. These elements guarantee that North America stays at the leading edge of the market.

• In 2024, Abbott will remain at the forefront of diagnostics, engaging in the ADLM Clinical Lab Expo with the introduction of new products and workshops. U.S. government organizations, such as the National Institute of Justice, finance initiatives to enhance enzyme immunoassay methods, including the collaboration between Abbott Laboratories and Healthcare Providers.

The U.S. Market Trends

The U.S. leads the enzyme immunoassay market, supported by a robust healthcare system and engaged biotechnology companies. Increasing chronic and infectious illnesses drive the demand for enzyme immunoassay. Major firms such as Abbott and Thermo Fisher Scientific allocate resources to Research and Development. The Food and Drug Administration expedites the approval process for diagnostic technologies, whereas organizations like the Centers for Disease Control and Prevention and the National Institutes of Health promote enzyme immunoassay integration into public health programs.

Asia Pacific is the Future Hub for Enzyme Immunoassay

Asia Pacific is anticipated to grow at the fastest rate in the market during the forecast period, driven by elements like heightened healthcare funding, rising disease prevalence, advancements in biotechnology, government actions, and a broader role for the private sector. Nations such as China, India, Japan, and South Korea are putting resources into healthcare infrastructure and enhancing diagnostic capabilities, resulting in an increased demand for precise diagnostic tools like enzyme immunoassays. The area is increasingly emerging as a center for biotechnology and pharmaceutical advancements, with firms creating affordable and precise enzyme immunoassay kits designed for local healthcare requirements. Governments are allocating resources to healthcare reforms and public health initiatives to improve diagnostic abilities and disease monitoring.

• In February 2024, Fujirebio, a diagnostics company from Japan, teamed up with Chinese healthcare providers to broaden the application of Lumipulse® G automated immunoassay systems, concentrating on cancer diagnostics and domestic production.

India: A Key Force in the Market

The enzyme immunoassay market in India is expanding due to rising healthcare demand, government efforts, and biotechnology breakthroughs. The nation encounters a substantial challenge with infectious and chronic ailments, requiring precise diagnostic instruments. Government initiatives such as the National Tuberculosis Elimination Program incorporate enzyme immunoassays for early identification. The booming biotechnology industry and economical manufacturing capabilities of India facilitate the production of affordable enzyme immunoassay kits by satisfying both local and international needs.

China: A Leading Manufacturer in Enzyme Immunoassay

The enzyme immunoassay market in China is rapidly expanding because of healthcare facility investments, a high disease rate, and advances in diagnostic technologies. The government has emphasized public health programs to enhance disease identification, with enzyme immunoassays being crucial in widespread testing for infectious and chronic illnesses. Partnerships between international firms such as Fujirebio and regional healthcare organizations highlight the incorporation of sophisticated automated immunoassay technologies. Robust manufacturing strength and emphasis on the technological advancement of China establish it as a significant contender in the global market. The increasing incidence of chronic conditions and infectious diseases demands efficient diagnostic methods by propelling the market forward.

Europe: A Notable Region in the Enzyme Immunoassay Sector

Europe is expected to grow at a considerable rate in the upcoming period because of its emphasis on innovative healthcare systems, strong regulatory standards, and significant rates of chronic illnesses. Nations such as Germany, France, and the UK are at the forefront of adopting innovative diagnostic technologies. Europe also gains from governmental programs and financial support for healthcare improvements, including the initiatives by the European Union for disease monitoring and public health systems. Top diagnostic firms and laboratories, like BioMérieux and Siemens Healthineers, play a crucial role in market expansion via innovations and collaborations.

• In January 2024, Sysmex Corporation extended its amyloid beta (Aβ) accumulation detection reagents to Europe, a strategy intended to enhance immunoassay-based diagnostics in the European market utilized in blood tests to detect brain Aβ accumulation, assisting in Alzheimer’s disease diagnosis.

Market Overview

The enzyme immunoassay market represents an important segment of the immunoassay sector, employing enzyme-linked antibodies to identify and measure proteins or antigens in biological samples. This method is commonly utilized in clinical diagnostics, pharmaceutical analysis, and food safety testing because of its great sensitivity and specificity. The market is a rapidly evolving part of the diagnostics sector, employing enzymes as markers to identify and measure substances such as proteins, hormones, antigens, and antibodies. These tests are essential for diagnostic evaluations, biomedical studies, quality assurance, and industrial uses. 

The market holds great importance in the in-vitro diagnostics industry because of its exceptional specificity, sensitivity, and versatility across different formats, shaped by factors like the increase in chronic illnesses, point-of-care testing, and advancements in biotechnology. Progress in automation, AI incorporation, and tailored medicine continues to drive its growth, tackling the rising incidence of chronic and infectious illnesses.

Enzyme Immunoassay Market Growth Factors

• Increasing aging population: The rising global elderly population leads to a higher occurrence of age-related illnesses, making routine diagnostic testing essential. Enzyme immunoassay serves as a valuable method for tracking health issues such as cancer, autoimmune diseases, and heart conditions in senior individuals.
• Point-of-care testing solutions: Fast outcomes in point-of-care testing solutions are propelling advancements in enzyme immunoassays. Portable enzyme immunoassay kits and devices are being utilized more frequently in remote locations for glucose monitoring, diagnosing infectious diseases, and analyzing hormone levels, allowing for faster decision-making and treatment.
• Regulatory approvals and strategic partnerships: Regulatory approvals and strategic partnerships in the enzyme immunoassay sector, like FDA approvals, promote innovation, scalability, and accessibility, whereas government funding for healthcare infrastructure improves disease identification and treatment.

Market Scope

Market Dynamics

Drivers

Rising prevalence of chronic and infectious diseases

The primary factor propelling the enzyme immunoassay market is the rising prevalence of chronic and infectious diseases worldwide, including ailments such as diabetes, cardiovascular conditions, and cancer. This, in turn, enhances the need for timely and precise diagnostic techniques. This trend seeks to enhance patient results and lessen disease impact, requiring the creation of effective diagnostic instruments for disease identification and management. Enzyme immunoassay, an economical and effective approach for early disease identification and monitoring, is a favored option in clinical diagnostics.

• In April 2024, Creative Diagnostics launched a sensitive Kanamycin ELISA Kit for the quick detection of kanamycin residues in biological products, maintaining safety standards and quality control in biopharmaceutical production.

Restraint

Interference in enzyme immunoassay 

The enzyme immunoassay market encounters considerable restraints from interference in immunoassay, potentially resulting in imprecise results and adverse clinical consequences. Elements leading to this problem consist of production flaws, pollution, and incorrect test applications. Removing these interferences continues to be a major challenge since no single approach can entirely eliminate them.

• In May 2023, QuidelOrtho recalled 8,000 Triage Cardiac Panel devices because of reduced troponin levels, which present significant health risks to patients. The FDA categorized this as a Class I recall, posing a risk of injury or death.

Opportunity

Rising demand for effective diagnostic tools in healthcare establishments

The enzyme immunoassay market is set to expand due to the rising demand for effective diagnostic tools in healthcare establishments. Incorporating complex technology can improve assay sensitivity, specificity, and efficiency, providing a significant opportunity for companies to invest in innovative approaches. Technological advancements in enzyme immunoassays, such as chemiluminescence, fluorescence, and sophisticated kits, have improved sensitivity, specificity, and throughput, minimizing manual intervention and errors in large-scale diagnoses.

• In October 2024, the Institute of Science Tokyo introduced the OpenGUS immunoassay, a flexible platform for the sensitive detection of analytes with engineered probes, providing exceptional sensitivity, ease of use, and adaptability for allergens, cardiovascular markers, and inflammation indicators.

Product Insights

The reagents and kits segment dominated the enzyme immunoassay market in 2024. This is because of their wide-ranging applications in clinical diagnostics, pharmaceutical analysis, and food safety assessments. Enzyme immunoassay reagents and kits are essential in identifying diseases such as HIV, hepatitis, and cancer, owing to their remarkable sensitivity and specificity. The growing prevalence of infectious and chronic illnesses has heightened the need for dependable diagnostic tools, rendering them essential in healthcare environments.

• In September 2024, Molecular Designs acquired Lamda Biotech, broadening its product range to enhance its position in academic research and pharmaceutical sectors while incorporating a team of experts in reagent and kit development.

The software and services segment is projected to expand rapidly in the market in the coming years, driven by the rising complexity of tests and the demand for precise results. As laboratories and healthcare institutions enhance their diagnostic capabilities, they are more frequently adopting advanced software solutions for data management and accuracy. The increasing need for automation in laboratories is fueled by elements like efficiency, data handling, remote access, cost savings, and high-throughput technologies. These solutions assist in reducing human errors, managing extensive data sets, and maintaining regulatory compliance.

Specimen Insights

The blood sample segment will hold a dominant presence in the market in 2024 because of its effectiveness, availability, and dependability in diagnostic uses. Blood samples offer precise measurements of biomarkers such as hormones, proteins, and antigens, improving diagnostic accuracy. Improvements in micro-sampling have resulted in a more patient-friendly process. Blood enzyme immunoassays are utilized for the diagnosis of conditions such as infectious diseases, cancer, autoimmune disorders, and metabolic disorders. Blood samples are simpler to collect, transport, and analyze than other specimens, providing reliable results in clinical labs.

• In February 2025, Beckman Coulter Diagnostics launched research-use-only blood-based biomarker immunoassays to evaluate phosphorylated tau217, glial fibrillary acidic protein, neurofilament light chain, and apolipoprotein ε4 biomarkers using the DxI 9000 immunoassay analyzer.

The urine specimen segment is seen to grow at the fastest rate in the upcoming years, owing to its non-invasive collection technique, convenience in handling, and affordability. They are favored for clinical and diagnostic uses, especially in identifying infectious diseases, substance abuse, and metabolic disorders. The need for urinary immunoassays is anticipated to increase markedly because of the growing prevalence of chronic and infectious diseases, while advancements in assay design are boosting sensitivity and specificity.

Application Insights

The infectious disease testing segment dominated the enzyme immunoassay market with the largest share in 2024, propelled by the rising occurrence of infectious illnesses such as HIV, hepatitis, malaria, and COVID-19. Enzyme immunoassays are crucial for identifying, tracking, and controlling these illnesses because of their sensitivity, specificity, and economical nature. The growing inclination toward centralized lab testing and progress in enzyme immunoassay technologies have further enhanced their prevalence. The main factors contributing to this dominance are the extensive occurrence of infectious diseases, broad applicability, worldwide emphasis on early detection, advancements in technology, and public health initiatives, all of which have enhanced the uptake of enzyme immunoassays in healthcare environments.

The oncology segment is expected to witness the fastest rate of growth during the predicted timeframe because of its vital importance in the early detection of cancer, monitoring treatment, and assessing prognosis. The main factors consist of increasing cancer occurrence, biomarker-driven diagnostics, technological progress, tailored medicine, and less invasive diagnostic methods. Enzyme immunoassays identify biomarkers such as alpha-fetoprotein, prostate-specific antigen, and CA 19-9, facilitating early diagnosis and tracking. The increasing emphasis on personalized medicine and targeted treatments boosts the need for advanced diagnostic solutions in oncology.

End-Use Insights

The hospital segment dominated the enzyme immunoassay market with the highest share in 2024 because of its function in delivering sophisticated diagnostic services, targeted testing, and patient support. Hospitals manage a considerable number of diagnostic tests, especially for serious conditions such as cancer, infectious diseases, and heart disorders. They provide extensive testing services, combine immunoassay outcomes with medical treatment, and concentrate on long-term illnesses. Their strong infrastructure and resources enable the incorporation of innovative diagnostic technologies, improving their efficiency in clinical environments.

• In early 2024, Thermo Fisher Scientific and Cleveland Clinic revealed a collaboration to create innovative diagnostic solutions leveraging enzyme immunoassay technologies, with the goal of enhancing diagnostic precision and accelerating patient care in medical facilities.

The clinical laboratories segment is projected to grow with the fastest CAGR in the market during the forecast period. This is because of a rising need for accurate, large-scale diagnostic testing. These dedicated centers process significant quantities of samples each day, guaranteeing quick and precise results. Major influencers consist of elevated testing quantities, sophisticated infrastructure, outsourcing tendencies, technological progress, and extensive test options. The segment is the quickest expanding end-use category owing to swift results, high sensitivity and specificity, scalability, and cost-efficiency, making it essential for patient management and treatment success.

Enzyme Immunoassay Market Companies

• Siemens Healthineers
• Danaher Corporation (Beckman Coulter)
• bioMérieux SA
• QuidelOrtho Corporation
• Sysmex Corporation
• Bio-Rad Laboratories, Inc.
• F. Hoffmann-La Roche AG
• Becton, Dickinson and Company
• Thermo Fisher Scientific, Inc.

Leaders Announcements

• In November 2023, Sysmex and Fujirebio broadened their contract development collaboration to address neurodegenerative diseases, concentrating on creating reagents for the HISCL-Series automated immunoassay system of Sysmex to enhance diagnostics for Alzheimer's disease.
• In February 2024, Labcorp and Roche Diagnostics joined forces to introduce the Elecsys enzyme immunoassay platform of Roche, leading to better automation, broader test options for oncology, infectious diseases, and cardiac biomarkers, along with improved diagnostic precision.
• In June 2024, Fujirebio and Agape Diagnostics formed a partnership to create cartridge-based chemiluminescence immunoassay system reagents, which are scheduled to be launched, providing more than 30 diagnostic parameters spanning medical fields such as oncology and infectious diseases.

Recent Developments

• In November 2023, Neogen launched the Veratox® VIP assay, a precise quantitative ELISA test for identifying walnut allergens. It delivers a strong performance for various sample types and gives results in 30 minutes.
• In July 2023, Anbio Biotechnology Limited introduced the AF-100S FIA Solution, a portable analyzer for point-of-care immunodiagnostics, showcasing swift diagnostic solutions and ease of use in healthcare settings.
• In July 2023, Roche Diagnostics India launched the Elecsys® HCV Duo, the first fully automated immunoassay in India capable of detecting both antigen and antibody status from a single plasma or serum sample, facilitating earlier diagnosis and disease prevention.

Segments Covered in the Report

By Product

• Reagents and Kits
• Analyzers/Instruments
• Software and Services

By Specimen 

• Blood
• Saliva
• Urine
• Other Specimens

By Application 

• Therapeutic Drug Monitoring
• Oncology
• Cardiology
• Endocrinology
• Infectious Disease Testing
• Autoimmune Diseases
• Others

By End-Use

• Hospitals
• Blood Banks
• Clinical Laboratories
• Pharmaceutical and Biotech Companies
• Academic Research Centers
• Others

By Geography

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa