Immunoassay Market

Immunoassay Market Size and Forecast

The global Immunoassay Market is valued at USD 35.57 Billion in 2024 and is projected to reach a value of USD 60.5 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 4.95% between 2025 and 2035.

Immunoassay Market Key Highlights

• Based on the Product Type, the Reagents & Kits category accounted for significant market share in Immunoassay market industry for 67.60% in 2024
• In 2024, by Technology, Enzyme-Linked Immunosorbent Assay (ELISA) dominated the Immunoassay market with 84.30% of market share
• Based on the Specimen, the blood category accounted for significant market share in Immunoassay market industry in 2024
• Based on the Application, the Infectious Disease Testing category accounted for significant market share in Immunoassay market industry for 36.58% in 2024
• In 2024, by End Use, the Hospitals & Clinics dominated the Immunoassay market with 33.40% of market share
• North America dominated the Immunoassay market industry with 41.30% Immunoassay market share in 2024
• Asia Pacific region is anticipated to grow at the highest CAGR during the forecast period in Immunoassay market industry

Immunoassay Market Drivers

Growth in Biopharmaceuticals and Biotechnology Industries

The growth of the biopharmaceutical and biotechnology industries is a key driver of the Immunoassay market. For drive the development of innovative biologics, biosimilars, and personalized medicine, there is a growing need for extremely sensitive and specific immunoassays for drug discovery, development, and quality control. In biopharmaceutical research Immunoassays tools are used because they can detect biomarkers, assure treatment efficacy, and track immune responses. Furthermore, in clinical diagnostics increased usage of immunoassay for cancer diagnosis, infectious disease testing, and autoimmune condition identification, is boosting Immunoassay market growth. The increased investment in biotechnology R&D, together with regulatory support for biopharmaceutical innovation, is likely to boost immunoassay usage globally.

Increasing Demand For Point-Of-Care Testing And Personalized Medicine

Increasing the demand for point-of-care testing and personalized medicine is a key driver of a Immunoassay market. The healthcare shifts towards decentralized and personalized approaches, there is increasing interest in portable immunoassay devices that can deliver rapid results outside of traditional laboratory settings. Furthermore, advancements in multiplexing technologies allow for simultaneous detection of multiple analytes in a single sample, expanding the applications of immunoassays in disease diagnosis, drug development, and research.

Increasing Incidence of Chronic Diseases

The increasing incidence of chronic diseases such as cancer, cardiovascular disorders, and autoimmune diseases, along with the rising burden of infectious diseases like HIV, tuberculosis, hepatitis, and emerging viral infections (e.g., COVID-19, Zika, and influenza), is a significant driver of Immunoassay market. The growing demand for highly sensitive, rapid, and cost-effective diagnostic solutions is driving healthcare providers and research institutions to adopt advanced immunoassay technologies such as chemiluminescence immunoassays (CLIAs), enzyme-linked immunosorbent assays (ELISAs), and lateral flow assays (LFAs). Additionally, government initiatives and investments in disease surveillance programs, vaccination campaigns, and routine screening further enhance the adoption of immunoassay-based diagnostics worldwide.

Product Type Insights

The Product Type segment is divided into Reagents & Kits, Analyzers/Instruments, Software and Services. The Reagents & Kits segment is categorized into ELISA Reagents & Kits, Rapid test reagents & kits, ELISPOT Reagents & kits, Western blot Reagents & kits, Other Reagents & kits. The Reagents & kits segment held the dominant share in 2024, accounting for significant Immunoassay industry share of 67.60%.

Reagents & Kits: Reagents and kits form a crucial part of the Immunoassay market, enabling accurate and efficient detection of biomarkers for disease diagnosis and research applications. These include a variety of specialized test kits and chemical reagents designed for different immunoassay techniques.

• ELISA Reagents & Kits: Enzyme-Linked Immunosorbent Assay (ELISA) reagents and kits are widely used for detecting and quantifying proteins, antibodies, hormones, and other biomolecules in samples. The demand for automated ELISA kits is growing as laboratories seek high-throughput testing solutions.
• Rapid Test Reagents & Kits: These kits provide quick, point-of-care (PoC) diagnostics and are designed for home testing, emergency rooms, and decentralized healthcare settings. They are widely used for detecting infectious diseases (e.g., COVID-19, HIV, malaria), pregnancy, and drug abuse. The rising preference for lateral flow assays (LFAs) and smartphone-integrated rapid tests is boosting Immunoassay market growth
• ELISPOT Reagents & Kits: Enzyme-Linked Immunospot (ELISPOT) assays are specialized immunoassays used to detect and analyze individual immune cells secreting specific cytokines. These are extensively used in vaccine development, immuno-oncology, and infectious disease research. Their ability to provide single-cell resolution insights makes them valuable for studying immune responses
• Western Blot Reagents & Kits: Western blot kits and reagents are essential for protein detection and analysis, particularly in research laboratories and clinical diagnostics. They are widely used in HIV confirmatory testing, neurology research, and molecular biology applications

Analyzers/Instruments: Immunoassay analyzers and instruments are essential laboratory equipment designed to automate, standardize, and enhance the accuracy of immunoassay testing. These systems improve workflow efficiency and reduce human errors, making them highly valuable in hospitals, diagnostic labs, and research facilities.

• Open-Ended Systems: Open-ended immunoassay analyzers allow users to customize assays by selecting reagents and kits from different manufacturers. These systems are mostly preferred by research institutions, large diagnostic laboratories, and specialty testing centers. They enable the integration of new assays and the modification of testing protocols, making them ideal for advanced research and personalized medicine applications
• Closed-Ended Systems: Closed-ended immunoassay analyzers operate exclusively with proprietary reagents and kits from specific manufacturers. These systems provide highly standardized, validated, and automated solutions for routine clinical diagnostics. Hospitals and large reference laboratories favor these analyzers due to their ease of use, reduced risk of contamination, and consistent test performance. The demand for fully automated, high-throughput closed systems is increasing with the growing need for large-scale diagnostic testing

Software and Services: Software solutions play a critical role in data management, assay automation, and result interpretation in immunoassay testing. These tools enhance efficiency, accuracy, and regulatory compliance by integrating laboratory instruments with data analysis platforms and cloud-based storage. Furthermore, the services segment includes a wide range of offerings such as installation, maintenance, training, assay development, and contract research services. Many laboratories and healthcare providers rely on outsourced immunoassay services for complex testing and biomarker discovery.

Technology Insights

The Technology segment is divided into Enzyme-Linked Immunosorbent Assay (ELISA), Radioimmunoassay (RIA), Chemiluminescent Immunoassay (CLIA), Fluorescent Immunoassay (FIA), Rapid Tests (Lateral Flow Assays, Immunochromatographic Assays), Western Blot, Nephelometric and Turbidimetric Immunoassays, Electrochemiluminescence Immunoassay (ECLIA). The Enzyme-Linked Immunosorbent Assay (ELISA) segment is categorized into Direct ELISA, Indirect ELISA, Sandwich ELISA, Competitive ELISA. The Enzyme-Linked Immunosorbent Assay (ELISA) segment held the dominant share in 2024, accounting for significant Immunoassay industry share of 59.40%.

Enzyme-Linked Immunosorbent Assay (ELISA): ELISA is known for its high sensitivity and specificity, making it essential for clinical diagnostics, food safety, and biomedical research applications.

• Direct ELISA: Direct ELISA involves detecting an antigen using an enzyme-labeled antibody that binds directly to the target molecule. This method is simple and rapid, commonly used in viral and bacterial antigen detection, toxin screening, and allergy testing
• Indirect ELISA: Indirect ELISA uses a secondary antibody to amplify the detection signal, improving assay sensitivity. It is frequently employed in antibody screening for infections, autoimmune disorders, and vaccine development, making it a versatile diagnostic tool in research and clinical applications
• Sandwich ELISA: Sandwich ELISA captures an antigen between two antibodies, offering high specificity and sensitivity. It is widely used for biomarker detection, cytokine analysis, and hormone level monitoring, playing a crucial role in clinical diagnostics and pharmaceutical research
• Competitive ELISA: Competitive ELISA measures antigen concentration by detecting competitive binding interactions. It is commonly used for hormone analysis, drug testing, and small molecule detection, particularly in forensic toxicology, environmental monitoring, and clinical diagnostics

Radioimmunoassay (RIA): RIA is a highly sensitive technique that uses radioactive isotopes to quantify antigens or antibodies. It is extensively used in hormone assays, tumor marker detection, and pharmacokinetics research, but its use has declined due to radiation safety concerns.

Chemiluminescent Immunoassay (CLIA): CLIA employs light-emitting chemical reactions for signal detection, offering high sensitivity and automation. It is commonly used in infectious disease diagnostics, cancer screening, and endocrinology, providing faster and more accurate results than traditional ELISA.

Fluorescent Immunoassay (FIA): FIA uses fluorescent-labeled antibodies to detect target molecules, offering real-time and high-throughput testing. It is widely used in point-of-care (PoC) diagnostics, drug monitoring, and allergen detection, benefiting from improved sensitivity and multiplexing capabilities.

Rapid Tests (Lateral Flow Assays, Immunochromatographic Assays): Rapid immunoassays provide quick, point-of-care diagnostics through lateral flow and immunochromatographic techniques. They are extensively used for COVID-19, HIV, pregnancy, and drug abuse testing, offering convenient, low-cost, and immediate results.

Western Blot: Western blot is a protein detection technique combining gel electrophoresis and immunoassay. It is commonly used in HIV confirmatory testing, neurology research, and protein biomarker analysis, offering high specificity but requiring longer processing times.

Nephelometric and Turbidimetric Immunoassays: These assays measure antigen-antibody complexes based on light scattering properties. They are widely used in autoimmune disease diagnostics, kidney function testing, and protein quantification, offering rapid and automated analysis.

Electrochemiluminescence Immunoassay (ECLIA): ECLIA uses electrochemically activated luminescent reactions to detect biomarkers with ultra-high sensitivity. It is a preferred technology in cancer diagnostics, infectious disease testing, and cardiac biomarker analysis, benefiting from automation and multiplex testing capabilities.

Specimen Insights

The Specimen segment is divided into Blood, Serum/Plasma, Saliva, Urine, Tissue samples, and others. The blood segment held the dominant share in 2024, accounting for significant Immunoassay industry share.

• Blood: Blood is a primary specimen in immunoassay testing, used for detecting infections, monitoring chronic diseases, and diagnosing autoimmune disorders. It provides comprehensive insights into a patient’s immune response, hormone levels, and biomarkers for conditions like cancer, cardiovascular diseases, and metabolic disorders
• Serum/Plasma: Serum and plasma are derived from blood and are widely used in immunoassays for hormone analysis, infectious disease testing, and biomarker detection. Serum, which lacks clotting factors, and plasma, containing anticoagulants, enable highly sensitive and specific diagnostic evaluations in clinical and research settings
• Saliva: Saliva is a non-invasive specimen increasingly used for hormonal, viral, and drug testing. It allows for easy and painless collection, making it ideal for point-of-care diagnostics, stress biomarker analysis, and disease monitoring, especially in conditions like HIV, COVID-19, and hormone imbalances
• Urine: Urine-based immunoassays are widely used for pregnancy tests, drug screening, and kidney function analysis. It offers a non-invasive, convenient, and cost-effective diagnostic approach, enabling detection of metabolic disorders, infectious diseases, and hormonal imbalances without the need for venipuncture
• Tissue Samples: Immunoassays using tissue specimens help in tumor profiling, genetic mutation detection, and personalized medicine approaches, allowing targeted therapies and better disease prognosis

Application Insights

The Application segment is divided into Therapeutic Drug Monitoring, Oncology, Cardiology, Endocrinology, Infectious Disease Testing, Autoimmune Diseases, Others. The Infectious disease testing segment held the dominant share in 2024, accounting for significant Immunoassay industry share of 36.98%.

• Infectious Disease Testing: Immunoassays are widely used to diagnose viral, bacterial, and parasitic infections like HIV, COVID-19, hepatitis, and tuberculosis. These tests provide rapid, accurate detection of pathogens and antibodies, essential for disease surveillance, outbreak control, and timely treatment initiation
• Therapeutic Drug Monitoring (TDM): It is crucial for antibiotics, immunosuppressants, and chemotherapy drugs, helping to prevent toxicity, optimize treatment efficacy, and personalize medication regimens for conditions like epilepsy, organ transplantation, and psychiatric disorders
• Oncology: Immunoassays in oncology detect cancer biomarkers, monitor tumor progression, and assess treatment response. They aid in early detection of cancers like breast, lung, and prostate cancer by identifying biomarkers such as PSA, CA-125, and HER2, facilitating early intervention and targeted therapies
• Cardiology: Cardiology immunoassays help diagnose cardiac diseases by detecting biomarkers like troponin, BNP, and CK-MB. These assays enable early detection of heart attacks, heart failure, and cardiovascular risks, allowing timely medical intervention and monitoring of disease progression in high-risk patients
• Endocrinology: Endocrinology applications focus on diagnosing hormonal imbalances and endocrine disorders like diabetes, thyroid dysfunction, and adrenal diseases. Immunoassays detect hormones such as insulin, TSH, cortisol, and reproductive hormones, playing a vital role in fertility treatments and metabolic disease management

Immunoassay Market Regional Trends

In 2024, the North America captured 41.30% of the revenue share.

North America Immunoassay Market Trends

North America Immunoassay Market is driven by high healthcare expenditure, increasing prevalence of chronic diseases, and technological advancements. Moreover, the region has a well-established healthcare infrastructure and favorable reimbursement policies, which drive the market’s growth. For instance, in April 2024, Abbotts i-STAT TBI cartridge has received clearance from the U.S. Food and Drug Administration (FDA) to be used with whole blood, allowing doctors to help assess patients with suspected concussion at the patients bedside and obtain lab-quality results in 15 minutes. Previously, the tests to help with the assessment of TBI were only cleared for use with plasma or serum, requiring samples to be sent to a lab for processing and testing.

Asia Pacific Immunoassay Market Trends

Asia Pacific Immunoassay Market is driven by factors such as the rising prevalence of chronic diseases, increasing healthcare investments, and advancements in diagnostic technologies. The growth of the Asia Pacic Immunoassay market is also supported by improvements in healthcare access and the expansion of diagnostic services in urban and rural areas. Additionally, the region’s emphasis on enhancing healthcare quality and increasing the adoption of advanced diagnostic technologies contributes significantly to its projected market leadership.

Based on the provided market data, Vantage Market Research offers customizations in the reports to meet the specific needs of clients.

Immunoassay Market Trends

1. Rising Prevalence of Infectious and Chronic Diseases: Increasing cases of cancer, cardiovascular diseases, and infectious diseases (COVID-19, HIV, hepatitis, etc.) are driving demand for immunoassay-based diagnostics
2. Growth in Point-of-Care (POC) Testing: Rising demand for rapid and portable testing solutions for early disease detection, especially in remote and decentralized healthcare settings
3. Advancements in Immunoassay Technologies: Development of high-sensitivity assays, automation, and digital integration in ELISA, CLIA, and multiplex assays are enhancing accuracy and efficiency
4. Increasing Adoption of Automation in Diagnostics: Laboratory automation is reducing human errors, increasing throughput, and improving result accuracy in immunoassay testing
5. Growing Applications in Drug Monitoring & Biomarker Discovery: Immunoassays are being widely used for therapeutic drug monitoring, biomarker detection, and precision medicine
6. Shift Toward Chemiluminescence Immunoassays (CLIA): CLIA is becoming the preferred method due to its higher sensitivity, faster turnaround time, and better dynamic range compared to traditional ELISA
7. Expanding Role in Personalized Medicine: Immunoassay-based tests are increasingly used in companion diagnostics to guide targeted therapies

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Competitive Landscape

The global Immunoassay market is highly competitive, characterized by the significant presence of many market players operating on a global and regional scale. Key players in this market focus on product innovations, strategic collaborations, mergers and acquisitions, and capacity expansions to sustain their market position. Major companies such as Roche Diagnostics, Abbott Laboratories, Siemens Healthineers, Thermo Fisher Scientific, bioMérieux, Beckman Coulter, and Ortho Clinical Diagnostics dominate the industry. These companies invest heavily in R&D to develop high-sensitivity, automated, and multiplex immunoassays for a wide range of applications, including infectious disease testing, oncology, and therapeutic drug monitoring.

The key players in the global Immunoassay market include - Danaher among others.

Latest Announcements

Bio-Rad launches external quality assurance services specialty immunoassay program

• In October 2024, Bio-Rad Laboratories has launched its External Quality Assurance Services (EQAS) Specialty Immunoassay (SPIA) Program. The new EQAS SPIA program is a liquid, independent, and confidential external assessment program that consolidates 13 complex and highly tested specialty immunoassay analytes, including procalcitonin, active vitamin B12, interleukin-6, and fructosamine, at both normal and abnormal levels

Roche announces collaboration with Lilly to enhance early diagnosis of Alzheimers disease

• In March 2023, Roche announced that it has entered into a collaboration with Eli Lilly and Company to support development of Roche’s Elecsys Amyloid Plasma Panel (EAPP). The EAPP is an innovative blood test that aims to facilitate the earlier diagnosis of Alzheimer’s disease

Immunoassay Market Segments Covered in the report:

By Product Type:

• Reagents & Kits
  • ELISA Reagents & Kits
  • Rapid test reagents & kits
  • ELISPOT Reagents & kits
  • Western blot Reagents & kits
  • Other Reagents & kits
• Analyzers/Instruments
  • Open Ended System
  • Close Ended System
• Software and Services

By Technology:

• Enzyme-Linked Immunosorbent Assay (ELISA)
  • Direct ELISA
  • Indirect ELISA
  • Sandwich ELISA
  • Competitive ELISA
• Radioimmunoassay (RIA)
• Chemiluminescent Immunoassay (CLIA)
• Fluorescent Immunoassay (FIA)
• Rapid Tests (Lateral Flow Assays, Immunochromatographic Assays)
• Western Blot
• Nephelometric and Turbidimetric Immunoassays
• Electrochemiluminescence Immunoassay (ECLIA)
• Other Emerging Technologies

By Specimen:

• Blood
• Serum/Plasma
• Saliva
• Urine
• Tissue Samples
• Others

By Application:

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

By End Use:

• Hospital and Clinics
• Diagnostics Laboratories
• Research and Academic Institutes
• Pharmaceuticals & Biotechnology Companies
• Blood Banks & Organ Transplant Centers
• Home Care Settings
• Veterinary Clinics & Diagnostic Labs

Immunoassay Market Regions and Countries:

North America

• U.S.
• Canada
• Mexico

Europe

• Germany
• France
• U.K.
• Italy
• Spain
• Nordic Countries
• Benelux Union
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• New Zealand
• Australia
• South Korea
• South-East Asia
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Rest of Latin America

The Middle-East and Africa

• Saudi Arabia
• UAE
• Egypt
• Kuwait
• South Africa
• Rest of Middle-East Africa