Product Code: GVR-3-68038-066-8
Immunoassay Market Growth & Trends:
The global immunoassay market size is expected to reach USD 35.10 billion by 2030, registering a CAGR of 4.59% from 2025 to 2030, according to a new report by Grand View Research, Inc. The introduction of PoC rapid tests and automated immunoassay analyzers is boosting market growth. In addition, the rising number of chronic and infectious diseases is leading to high market growth.
According to the American Cancer Society, there were an estimated 16.9 million cancer patients/survivors in 2020. Around 1.8 million cancer cases were diagnosed in the U.S., according to the National Cancer Institute 2019 data. According to the American Cancer Society, nearly 606,880 deaths occurred due to cancer in the U.S. in 2019. Thus, the rise in the number of cancer cases being diagnosed is driving the demand for immunoassays. This is expected to boost the market growth in the coming years.
Furthermore, growing awareness regarding infectious diseases and preventive measures has led to a high demand for rapid diagnostic test products, thereby increasing sales. Based on a survey by the WHO on the World malaria report 2018, manufacturers reported sales of 276 million for lateral flow assays in 2017. It also reported that around 75.0% of malaria cases were diagnosed using lateral flow assays in sub-Saharan Africa in 2017.
Several smartphone-based devices and associated tools have emerged as next-generation point-of-care diagnostics or testing devices, thereby boosting the market growth. For instance, a smartphone application combined with the autonomous capillary microfluidic chip is used for the rapid testing of cardiac troponin I in myocardial infarction. This platform can be easily used in resource-limited settings, providing test results within 12 minutes. Thus, novel technological advancements are anticipated to further drive the market over the forecast period.
The first implementation of the Atellica immunoassay solutions with Aptio automation in the United States was announced by Siemens Healthcare GmbH in April 2018. The objective of this product was designed to promote advanced technological products in the U.S. In December 2020, Beckman Coulter, a Danaher business, introduced its first high-quality as well as throughput assay for the COVID-19 antigen detection, officially named Access SARS-CoV-2 Antigen assay. In July 2018, Cygnus Technologies and Gyros Protein Technologies collaborated to produce immunoassay to identify biotherapeutic toxins. The two companies' strategic alliance will primarily focus on offering bioanalytical solutions and increasing biotherapeutics manufacturing efficiencies.
Immunoassay Market Report Highlights:
- In 2024, kits and reagents led the market with a 66.10% share, driven by increasing demand for personalized medicine and targeted therapies for diseases. However, the software and services of the immunoassays segment is projected to grow at the fastest CAGR during the forecast period and are delivering testing services for clinical and research uses.
- The infectious disease application in the immunoassay industry led the market with a 66.10% share and is expected to grow at a CAGR of 5.43% over the forecast period. Oncology and autoimmune diseases are projected to grow at a significant growth during the forecast period.
- Enzyme immunoassays secured the dominant market share in 2024 of 63.90% focusing on personalized medicine, cancer diagnostics, cardiovascular disease testing, and infectious disease detection. However, the others segment is projected to grow at the fastest CAGR during the forecast period.
- Blood held the largest market share of 41.54% in 2024, being the largest specimen used for performing immunoassays. Urine is expected to be the fastest-growing segment over the forecast period, driven by its non-invasive nature, ease of collection, and widespread application in disease diagnostics.
- In 2024, the hospitals in the immunoassay industry held a 32.54% share. Others are projected to grow at a CAGR of 5.45% during the forecast period.
- North America immunoassay market held the largest revenue share at 47.43% in 2024, primarily supported by robust healthcare systems, a high incidence of chronic illnesses, and a growing awareness of new diagnostic technologies. Asia Pacific is set to record the fastest CAGR, propelled by healthcare reforms, infrastructure enhancements, and a large patient pool.
Table of Contents
Chapter 1. Methodology and Scope
- 1.1. Market Segmentation and Scope
- 1.2. Market Definitions
- 1.3. Research Methodology
- 1.3.1. Information Procurement
- 1.3.2. Information or Data Analysis
- 1.3.3. Market Formulation & Data Visualization
- 1.3.4. Data Validation & Publishing
- 1.4. Research Scope and Assumptions
- 1.4.1. List of Data Sources
Chapter 2. Executive Summary
- 2.1. Market Outlook
- 2.2. Segment Outlook
- 2.3. Competitive Insights
Chapter 3. Immunoassay Market Variables, Trends, & Scope
- 3.1. Market Introduction/Lineage Outlook
- 3.2. Market Size and Growth Prospects (USD Million)
- 3.3. Market Dynamics
- 3.3.1. Market Drivers Analysis
- 3.3.1.1. Rising incidence of chronic and infectious diseases
- 3.3.1.2. Increasing demand for point-of-care diagnostics
- 3.3.1.3. Growing demand for portable and automated immunoassays
- 3.3.2. Market Restraints Analysis
- 3.3.2.1. Lower detection limit
- 3.3.2.2. Limitations associated with immunoassay techniques
- 3.4. Immunoassay Market Analysis Tools
- 3.4.1. Porter's Five Forces Analysis
- 3.4.1.1. Bargaining power of the suppliers
- 3.4.1.2. Bargaining power of the buyers
- 3.4.1.3. Threats of substitution
- 3.4.1.4. Threats from new entrants
- 3.4.1.5. Competitive rivalry
- 3.4.2. PESTEL Analysis
- 3.4.2.1. Political landscape
- 3.4.2.2. Economic and Social landscape
- 3.4.2.3. Technological landscape
- 3.4.2.4. Environmental landscape
- 3.4.2.5. Legal landscape
Chapter 4. Immunoassay Market: Product Estimates & Trend Analysis
- 4.1. Immunoassay Market: Product Movement Analysis
- 4.2. Immunoassay Market Estimates and Forecasts, by Product 2024 & 2030 (USD Million)
- 4.3. Assays, Kits, and Reagents
- 4.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.3.2. ELISA Reagents & Kits
- 4.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.3.3. Rapid Tests Reagents & Kits
- 4.3.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.3.4. ELISPOT Reagents & Kits
- 4.3.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.3.5. Western Blot Reagents & Kits
- 4.3.5.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.3.6. Other Reagents & Kits
- 4.3.6.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.4. Analyzers/Instruments
- 4.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.4.2. Open Ended Systems
- 4.4.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.4.3. Closed Ended Systems
- 4.4.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.5. Software and Services
- 4.5.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 5. Immunoassay Market: Application Estimates & Trend Analysis
- 5.1. Immunoassay Market: Application Movement Analysis
- 5.2. Immunoassay Market Estimates and Forecasts, by Application 2024 & 2030 (USD Million)
- 5.3. Therapeutic Drug Monitoring
- 5.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.4. Oncology
- 5.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.5. Cardiology
- 5.5.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.6. Endocrinology
- 5.6.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.7. Infectious Disease Testing
- 5.7.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.8. Autoimmune Diseases
- 5.8.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.9. Others
- 5.9.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 6. Immunoassay Market: Technology Estimates & Trend Analysis
- 6.1. Immunoassay Market: Technology Movement Analysis
- 6.2. Immunoassay Market Estimates and Forecasts, by Technology 2024 & 2030 (USD Million)
- 6.3. Radioimmunoassay (RIA)
- 6.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.4. Enzyme Immunoassays (EIA)
- 6.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.4.2. Chemiluminescence Immunoassays (CLIA)
- 6.4.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.4.3. Fluorescence Immunoassays (FIA)
- 6.4.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.5. Rapid Test
- 6.5.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.6. Others
- 6.6.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 7. Immunoassay Market: Specimen Estimates & Trend Analysis
- 7.1. Immunoassay Market: Specimen Movement Analysis
- 7.2. Immunoassay Market Estimates and Forecasts, by Specimen 2024 & 2030 (USD Million)
- 7.3. Blood
- 7.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 7.4. Saliva
- 7.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 7.5. Urine
- 7.5.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 7.6. Others
- 7.6.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 8. Immunoassay Market: End Use Estimates & Trend Analysis
- 8.1. Immunoassay Market: End--use Movement Analysis
- 8.2. Immunoassay Market Estimates and Forecasts, by End-use 2024 & 2030 (USD Million)
- 8.3. Hospitals
- 8.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.4. Blood Banks
- 8.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.5. Clinical Laboratories
- 8.5.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.6. Pharmaceutical and Biotech Companies
- 8.6.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.7. Academic Research Centers
- 8.7.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 8.8. Others
- 8.8.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 9. Immunoassay Market: Regional Estimates & Trend Analysis
- 9.1. Immunoassay Market Share, By Region, 2024 & 2030 (USD Million)
- 9.2. North America
- 9.2.1. North America Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.2.2. U.S.
- 9.2.2.1. Key Country Dynamics
- 9.2.2.2. Target Disease Prevalence
- 9.2.2.3. Competitive Scenario
- 9.2.2.4. Regulatory Framework
- 9.2.2.5. Reimbursement Scenario
- 9.2.2.6. U.S. Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.2.3. Canada
- 9.2.3.1. Key Country Dynamics
- 9.2.3.2. Target Disease Prevalence
- 9.2.3.3. Competitive Scenario
- 9.2.3.4. Regulatory Framework
- 9.2.3.5. Reimbursement Scenario
- 9.2.3.6. Canada Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.2.4. Mexico
- 9.2.4.1. Key Country Dynamics
- 9.2.4.2. Target Disease Prevalence
- 9.2.4.3. Competitive Scenario
- 9.2.4.4. Regulatory Framework
- 9.2.4.5. Reimbursement Scenario
- 9.2.4.6. Mexico Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.3. Europe
- 9.3.1. Europe Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.3.2. UK
- 9.3.2.1. Key Country Dynamics
- 9.3.2.2. Target Disease Prevalence
- 9.3.2.3. Competitive Scenario
- 9.3.2.4. Regulatory Framework
- 9.3.2.5. Reimbursement Scenario
- 9.3.2.6. UK Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.3.3. Germany
- 9.3.3.1. Key Country Dynamics
- 9.3.3.2. Target Disease Prevalence
- 9.3.3.3. Competitive Scenario
- 9.3.3.4. Regulatory Framework
- 9.3.3.5. Reimbursement Scenario
- 9.3.3.6. Germany Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.3.4. France
- 9.3.4.1. Key Country Dynamics
- 9.3.4.2. Target Disease Prevalence
- 9.3.4.3. Competitive Scenario
- 9.3.4.4. Regulatory Framework
- 9.3.4.5. Reimbursement Scenario
- 9.3.4.6. France Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.3.5. Italy
- 9.3.5.1. Key Country Dynamics
- 9.3.5.2. Target Disease Prevalence
- 9.3.5.3. Competitive Scenario
- 9.3.5.4. Regulatory Framework
- 9.3.5.5. Reimbursement Scenario
- 9.3.5.6. Italy Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.3.6. Spain
- 9.3.6.1. Key Country Dynamics
- 9.3.6.2. Target Disease Prevalence
- 9.3.6.3. Competitive Scenario
- 9.3.6.4. Regulatory Framework
- 9.3.6.5. Reimbursement Scenario
- 9.3.6.6. Spain Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.3.7. Denmark
- 9.3.7.1. Key Country Dynamics
- 9.3.7.2. Target Disease Prevalence
- 9.3.7.3. Competitive Scenario
- 9.3.7.4. Regulatory Framework
- 9.3.7.5. Reimbursement Scenario
- 9.3.7.6. Denmark Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.3.8. Sweden
- 9.3.8.1. Key Country Dynamics
- 9.3.8.2. Target Disease Prevalence
- 9.3.8.3. Competitive Scenario
- 9.3.8.4. Regulatory Framework
- 9.3.8.5. Reimbursement Scenario
- 9.3.8.6. Sweden Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.3.9. Norway
- 9.3.9.1. Key Country Dynamics
- 9.3.9.2. Target Disease Prevalence
- 9.3.9.3. Competitive Scenario
- 9.3.9.4. Regulatory Framework
- 9.3.9.5. Reimbursement Scenario
- 9.3.9.6. Norway Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.4. Asia Pacific
- 9.4.1. Asia Pacific Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.4.2. Japan
- 9.4.2.1. Key Country Dynamics
- 9.4.2.2. Target Disease Prevalence
- 9.4.2.3. Competitive Scenario
- 9.4.2.4. Regulatory Framework
- 9.4.2.5. Reimbursement Scenario
- 9.4.2.6. Japan Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.4.3. China
- 9.4.3.1. Key Country Dynamics
- 9.4.3.2. Target Disease Prevalence
- 9.4.3.3. Competitive Scenario
- 9.4.3.4. Regulatory Framework
- 9.4.3.5. Reimbursement Scenario
- 9.4.3.6. China Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.4.4. India
- 9.4.4.1. Key Country Dynamics
- 9.4.4.2. Target Disease Prevalence
- 9.4.4.3. Competitive Scenario
- 9.4.4.4. Regulatory Framework
- 9.4.4.5. Reimbursement Scenario
- 9.4.4.6. India Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.4.5. Australia
- 9.4.5.1. Key Country Dynamics
- 9.4.5.2. Target Disease Prevalence
- 9.4.5.3. Competitive Scenario
- 9.4.5.4. Regulatory Framework
- 9.4.5.5. Reimbursement Scenario
- 9.4.5.6. Australia Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.4.6. South Korea
- 9.4.6.1. Key Country Dynamics
- 9.4.6.2. Target Disease Prevalence
- 9.4.6.3. Competitive Scenario
- 9.4.6.4. Regulatory Framework
- 9.4.6.5. Reimbursement Scenario
- 9.4.6.6. South Korea Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.4.7. Thailand
- 9.4.7.1. Key Country Dynamics
- 9.4.7.2. Target Disease Prevalence
- 9.4.7.3. Competitive Scenario
- 9.4.7.4. Regulatory Framework
- 9.4.7.5. Reimbursement Scenario
- 9.4.7.6. Thailand Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.5. Latin America
- 9.5.1. Latin America Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.5.2. Brazil
- 9.5.2.1. Key Country Dynamics
- 9.5.2.2. Target Disease Prevalence
- 9.5.2.3. Competitive Scenario
- 9.5.2.4. Regulatory Framework
- 9.5.2.5. Reimbursement Scenario
- 9.5.2.6. Brazil Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.5.3. Argentina
- 9.5.3.1. Key Country Dynamics
- 9.5.3.2. Target Disease Prevalence
- 9.5.3.3. Competitive Scenario
- 9.5.3.4. Regulatory Framework
- 9.5.3.5. Reimbursement Scenario
- 9.5.3.6. Argentina Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.6. Middle East and Africa
- 9.6.1. Middle East and Africa Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.6.2. South Africa
- 9.6.2.1. Key Country Dynamics
- 9.6.2.2. Target Disease Prevalence
- 9.6.2.3. Competitive Scenario
- 9.6.2.4. Regulatory Framework
- 9.6.2.5. Reimbursement Scenario
- 9.6.2.6. South Africa Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.6.3. Saudi Arabia
- 9.6.3.1. Key Country Dynamics
- 9.6.3.2. Target Disease Prevalence
- 9.6.3.3. Competitive Scenario
- 9.6.3.4. Regulatory Framework
- 9.6.3.5. Reimbursement Scenario
- 9.6.3.6. Saudi Arabia Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.6.4. UAE
- 9.6.4.1. Key Country Dynamics
- 9.6.4.2. Target Disease Prevalence
- 9.6.4.3. Competitive Scenario
- 9.6.4.4. Regulatory Framework
- 9.6.4.5. Reimbursement Scenario
- 9.6.4.6. UAE Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
- 9.6.5. Kuwait
- 9.6.5.1. Key Country Dynamics
- 9.6.5.2. Target Disease Prevalence
- 9.6.5.3. Competitive Scenario
- 9.6.5.4. Regulatory Framework
- 9.6.5.5. Reimbursement Scenario
- 9.6.5.6. Kuwait Immunoassay Market Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 10. Competitive Landscape
- 10.1. Recent Developments & Impact Analysis by Key Market Participants
- 10.2. Company Categorization
- 10.3. Company Heat Map Analysis
- 10.4. Company Profiles
- 10.5. Abbott
- 10.5.1. Participant's Overview
- 10.5.2. Financial Performance
- 10.5.3. Product Benchmarking
- 10.5.4. Recent Developments/ Strategic Initiatives
- 10.6. Siemens Healthineers AG
- 10.6.1. Participant's Overview
- 10.6.2. Financial Performance
- 10.6.3. Product Benchmarking
- 10.6.4. Recent Developments/ Strategic Initiatives
- 10.7. Danaher Corporation (Beckman Coulter)
- 10.7.1. Participant's Overview
- 10.7.2. Financial Performance
- 10.7.3. Product Benchmarking
- 10.7.4. Recent Developments/ Strategic Initiatives
- 10.8. bioMerieux SA
- 10.8.1. Participant's Overview
- 10.8.2. Financial Performance
- 10.8.3. Product Benchmarking
- 10.8.4. Recent Developments/ Strategic Initiatives
- 10.9. Quidel Corporation
- 10.9.1. Participant's Overview
- 10.9.2. Financial Performance
- 10.9.3. Product Benchmarking
- 10.9.4. Recent Developments/ Strategic Initiatives
- 10.10. Sysmex Corporation
- 10.10.1. Participant's Overview
- 10.10.2. Financial Performance
- 10.10.3. Product Benchmarking
- 10.10.4. Recent Developments/ Strategic Initiatives
- 10.11. Ortho Clinical Diagnostics
- 10.11.1. Participant's Overview
- 10.11.2. Financial Performance
- 10.11.3. Product Benchmarking
- 10.11.4. Recent Developments/ Strategic Initiatives
- 10.12. Bio-Rad Laboratories, Inc.
- 10.12.1. Participant's Overview
- 10.12.2. Financial Performance
- 10.12.3. Product Benchmarking
- 10.12.4. Recent Developments/ Strategic Initiatives
- 10.13. F. Hoffmann-La Roche AG
- 10.13.1. Participant's Overview
- 10.13.2. Financial Performance
- 10.13.3. Product Benchmarking
- 10.13.4. Recent Developments/ Strategic Initiatives
- 10.14. Becton, Dickinson, and Company
- 10.14.1. Participant's Overview
- 10.14.2. Financial Performance
- 10.14.3. Product Benchmarking
- 10.14.4. Recent Developments/ Strategic Initiatives
- 10.15. Thermo Fisher Scientific, Inc.
- 10.15.1. Participant's Overview
- 10.15.2. Financial Performance
- 10.15.3. Product Benchmarking
- 10.15.4. Recent Developments/ Strategic Initiatives