Immunoassays remain a foundational pillar of the in vitro diagnostics (IVD) landscape, underpinning a broad range of clinical testing applications despite the maturity of many platforms. Their continued relevance reflects both their versatility across disease areas and the steady pace of technological refinement that has sustained growth and clinical adoption over time. This Kalorama Information report, High‑Growth Immunoassay Tests: Trends, Technologies, and Market Opportunities, 2026, examines the current and evolving role of immunoassays across centralized laboratory and point of care (POC) settings, highlighting why the segment remains strategically important for diagnostic manufacturers and healthcare stakeholders.
A Market Defined by Breadth and Evolution
Immunoassays encompass two core segments: high volume testing performed in centralized laboratories for screening, diagnosis, and patient monitoring, and rapid or point of care formats used for similar clinical purposes in decentralized settings. Across both segments, immunoassays support the detection of a wide array of analytes, including proteins, antibodies, hormones, and drugs. While many assays and platforms are well established, ongoing improvements in sensitivity, reliability, and automation continue to reinforce their clinical value.
Innovation Beyond Maturity: AI Driving the Next Phase of Immunoassays
Recent developments in immunoassay technology are reshaping what has traditionally been viewed as a mature market. Key innovation themes include expanded multiplexing capabilities, platform miniaturization to support point of care deployment, and the development of assays targeting novel biomarkers. Because artificial intelligence (AI) is driving much of the technology based growth, this report offers insights into key AI trends wherever relevant. AI is increasingly influencing immunoassay development and use by enabling predictive biomarker discovery, automating complex data interpretation, accelerating assay optimization, and supporting more sophisticated multi analyte detection strategies.
Scope of Analysis
This report provides a global assessment of immunoassay technologies across centralized laboratory systems and point of care formats, including immunochromatographic and lateral flow tests. Coverage emphasizes developed regions while also recognizing the critical role immunoassays play in expanding diagnostic access in settings with limited laboratory infrastructure. Market analysis is based on manufacturer revenues, reflecting testing volumes and utilization rather than downstream pricing or reimbursement dynamics.
Research Approach
Kalorama Information’s analysis is grounded in a rigorous combination of secondary research and primary industry engagement. Secondary research drew from a broad range of public and proprietary sources to establish market context and competitive positioning. These findings were validated and expanded through extensive interviews with industry executives, product managers, healthcare providers, consultants, and other stakeholders. All estimates were cross checked and triangulated to ensure consistency and reliability, with forecasts informed by historical trends, technological innovation, and global market expansion.
Strategic Relevance
As immunoassay technologies continue to evolve, the market reflects a balance between entrenched clinical reliance and emerging opportunities for differentiation—particularly as AI enabled tools reshape development pipelines and diagnostic workflows. This report focuses on the most relevant recent developments, streamlining legacy considerations where appropriate, and provides senior decision makers with a clear, current view of where immunoassays stand and where future growth and innovation are most likely to emerge.
Table of Contents
CHAPTER 1: EXECUTIVE SUMMARY
- ABOUT KALORAMA INFORMATION
- OVERVIEW
- SCOPE AND METHODOLOGY
- MARKET OVERVIEW
- Table 1-1: Global Immunoassay Market, Highest Growth Segments, 2025 and 2030 (Revenue: $ million) (Share & CAGR: %) [Disease Segment, Region, Technology, Venue]
- Figure 1-1: Global Immunoassay Market, Highest Growth Segments, CAGR 2025-2030 (%) [Disease Segment, Region, Technology, Venue]
- COMPETITIVE SUMMARY
CHAPTER 2: INTRODUCTION
- HISTORY OF IMMUNOASSAYS
- THE FUTURE OF IMMUNOASSAYS
- HIGH GROWTH TRENDS
CHAPTER 3: HIGH GROWTH TECHNOLOGY, TRENDS, AND INNOVATIONS
- OVERVIEW – IMMUNOASSAYS
- Table 3-1: Immunoassay Sensitivity, by Technology Type and Setting (Lab, POC) [CLIA, ELISA, FIA, IHC, LFIA, RIA]
- Chemiluminescent Immunoassay (CLIA)
- Enzyme-Linked Immunosorbent Assay (ELISA)
- Digital ELISA
- Fluoroimmunoassay (FIA)
- Immunohistochemistry (IHC)
- Lateral Flow Immunoassay (LFIA)
- Radioimmunoassay (RIA)
- Western Blotting
- OVERVIEW – INSTRUMENT PLATFORMS
- Microtiter Plate-Based Immunoassays and Automation
- Automation in Immunoassays
- Platform Innovations: Miniaturization, Microfluidics, and Multiplexing
- Point-of-Care (POC) and Miniaturized Devices
- Lab-on-a-Chip (LOC) and Biochips
- SPECIMEN TYPES
- Blood
- Urine
- Saliva
- Table 3-2: Selected Companies with Saliva or Oral-Fluid Collection Devices
- IMMUNOASSAY TECHNOLOGY INNOVATIONS
- Table 3-3: Selected Immunoassay Technologies
CHAPTER 4: HIGH GROWTH MARKET SEGMENTS BY SETTING
- CENTRALIZED LABORATORIES
- Table 4-1: Global Lab-based Immunoassay Market, by Application Segment, 2025 & 2030 (Revenue: $ million) (Share & CAGR: %) [Allergy, Autoimmune, Cardiac Markers, Genetic, Infectious Disease, Metabolic Disorders and Other Hormones, Toxicology, Tumor Markers, Other]
- Figure 4-1: Global Lab-based Immunoassay Market, by Application Segment, 2025 & 2030 ($ million) [Allergy, Autoimmune, Cardiac Markers, Genetic, Infectious Disease, Metabolic Disorders and Other Hormones, Toxicology, Tumor Markers, Others]
- High Growth Market Segments
- Companies Marketing to Centralized Laboratories
- Table 4-2: Selected Companies Marketing Central Lab-Based Immunoassays Worldwide
- RAPID AND POINT-OF-CARE TESTING
- Table 4-3: Global POC-based Immunoassay Market, by Application Segment, 2025 & 2030 (Revenue: $ million) (Share & CAGR: %) [Cardiac Markers, Hormone/Fertility, Infectious Disease, Oncology (markers and FOBT), Toxicology, Other]
- Figure 4-2: Global POC-based Immunoassay Market, by Application Segment, 2025 & 2030 ($ million) [Cardiac Markers, Hormone/Fertility, Infectious Disease, Oncology (markers and FOBT), Toxicology, Other]
- High Growth Market Segments
- High Growth Testing Locations
- POC Testing in Hospitals
- Physician’s Office Laboratories and Clinics
- Retail Clinics
- Other Professional POC Testing
- Self-Testing
- Companies Marketing Immunoassay for POC Testing
- Table 4-4: Selected Companies Marketing Immunoassay and/or Lateral Flow Tests for POC Worldwide
CHAPTER 5: IMMUNOASSAY DIAGNOSTIC MARKET ACTIVITY BY APPLICATION
- Table 5-1: Global Immunoassay Market, by Disease Segment, 2025 & 2030 (Revenue: $ million) (Share & CAGR: %) [Allergy, Autoimmune, Cardiac Markers, Genetic, Infectious Disease, Metabolic Disorders and Other Hormones, Toxicology, Tumor Markers, Others]
- Figure 5-1: Global Immunoassay Market, by Disease Segment, 2025 & 2030 ($ million) [Allergy, Autoimmune, Cardiac Markers, Genetic, Infectious Disease, Metabolic Disorders and Other Hormones, Toxicology, Tumor Markers, Others]
- HIGH GROWTH MARKET SEGMENTS
- ALLERGY
- Table 5-2: Selected Companies Marketing Immunoassays for Allergy Diagnostics
- High Growth Sectors with the Allergy Segment
- AUTOIMMUNE DISEASE
- Table 5-3: Selected Autoantibodies Detected by Autoimmune Immunoassays
- High Growth Sectors with the Autoimmune Segment
- CARDIAC MARKERS
- Table 5-4: Selected Cardiac Marker Immunoassays
- Table 5-5: Selected Cardiac Marker Innovations
- High Growth Sectors with the Cardiac Marker Segment
- GENETIC TESTING
- High Growth Sectors with the Genetics Segment
- INFECTIOUS DISEASE
- Lab-based Infectious Disease Immunoassays
- Table 5-6: Global Lab-based Infectious Disease Immunoassay Sales, 2025 & 2030 (Revenue: $ million) (Share & CAGR: %) [Blood banking, C. diff, Hepatitis, HIV, MRSA, Respiratory, STD, Staphylococci, TORCH, Other infectious diseases]
- Figure 5-2: Global Lab-based Infectious Disease Immunoassay Sales, 2025 & 2030 ($ million) [Blood banking, C. diff, Hepatitis, HIV, MRSA, Respiratory, STD, Staphylococci, TORCH, Other infectious diseases]
- Table 5-7: Selected Infectious Disease Immunoassays
- Table 5-8: Selected Companies Marketing Immunoassays for Infectious Disease
- Blood Screening
- Hepatitis
- Lyme Disease
- Vaccine Candidate
- Rapid and POC Testing
- Retroviral
- Sexually Transmitted Diseases
- ToRCH
- COVID-19
- Table 5-9: Selected Antigen POC and Home Immunoassay Tests for SARS-CoV-2
- Other Infectious Diseases
- High Growth Infectious Disease Immunoassays
- METABOLIC DISORDERS AND OTHER HORMONES
- Table 5-10: Selected Metabolic and Other Hormone Immunoassays
- Fertility/Pregnancy/Reproductive Hormones
- Table 5-11: Selected Fertility and Reproductive Hormone Immunoassays
- Thyroid
- Table 5-12: Selected Thyroid Hormone Immunoassays
- High Growth Sectors with the Metabolic and Hormone Segment
- ONCOLOGY - TUMOR MARKERS
- Lab-based Oncology Immunoassays
- Table 5-13: Global Lab-based Tumor Marker Immunoassay Sales, 2025 ($ million) [AFP, CA-125, CEA, PSA, Others]
- Table 5-14: Selected Companies Marketing Immunoassays for Tumor Markers
- Table 5-15: Selected Companies Marketing Metabolic Immunoassays
- High Growth Sectors with the Oncology – Tumor Marker Segment
- TOXICOLOGY
- Drugs of Abuse
- Table 5-16: Selected Drugs of Abuse Immunoassays
- High Growth Sectors within the Drugs of Abuse Segment
- Therapeutic Drug Monitoring
- Table 5-17: Selected Therapeutic Drug Monitoring Immunoassays
- High Growth Sectors within the TDM Segment
- OTHER HIGH GROWTH DISEASE CATEGORIES IN THE IMMUNOASSAY DISEASE MARKET
- Table 5-18: Selected Other Immunoassays
- Alzheimer’s Disease
- Table 5-19: Selected Alzheimer’s Disease Immunoassays
- Gastrointestinal Disorders
- Table 5-20: Selected Inflammatory Bowel Disease Test Innovations
- Transplant Management
- Table 5-21: Selected Immunoassays for Transplant Medicine
- Preeclampsia
- Table 5-22: Selected Women’s Health Innovations
- Other Specialty Immunoassays
- Table 5-23: Selected Immunoassay Innovations
CHAPTER 6: MARKET DRIVERS AND CHALLENGES FOR HIGH GROWTH IMMUNOASSAYS
- HIGH GROWTH IMMUNOASSAY MARKET – OVERVIEW
- DRIVERS
- Artificial Intelligence (AI)
- Ultra Sensitivity
- Autonomous Laboratory Operations
- Decentralized POC Systems
- AI-Driven Biomarker Discovery
- Software as a Medical Device
- System-Based Approach
- Federated Learning
- Telehealth Reimbursement
- National Testing Coordination Forum
- Standardization of Host-Response Frameworks
- CHALLENGES
- Staffing Shortages
- Regulatory Confusion for Lab-Developed Tests
- MIXED EFFECTS
- Geopolitical Tightening
- New Tariffs
- Global Medical Inflation
CHAPTER 7: IMMUNOASSAY MARKET ANALYSIS
- MARKET OVERVIEW AND HIGH GROWTH MARKET SEGMENTS
- Table 7-1: Global Immunoassay Market, Highest Growth Segments, 2025 and 2030 (Revenue: $ million) (Share & CAGR: %) [by Venue, Disease Segment, Technology, Region]
- Figure 7-1: Global Immunoassay Market, Highest Growth Segments, CAGR 2025-2030 (%) [Disease Segment, Region, Technology, Venue]
- Total Market by Testing Venue
- Table 7-2: Global Immunoassay Market, by Venue, 2025 and 2030 (%) (Revenue: $ million) (Share & CAGR: %) [Lab-based, POC-based]
- Figure 7-2: Global Immunoassay Market, by Venue, CAGR 2025-2030 (%) [Lab-based, POC-based]
- POC Immunoassay Market by Disease Category
- Table 7-3: Global POC Immunoassay Market, by Disease Category, 2025 and 2030 (Revenue: $ million) (Share & CAGR: %) [Cardiac Markers, Hormone/Fertility, Infectious Disease, Oncology (markers and FOBT), Toxicology, Other]
- Figure 7-3: Global POC Immunoassay Market, by Disease Category, CAGR 2025-2030 (%) [Cardiac Markers, Hormone/Fertility, Infectious Disease, Oncology (markers and FOBT), Toxicology, Other]
- Total Market Disease Segments
- Table 7-4: Global Immunoassay Market, by Application Segment, 2025 and 2030 (Revenue: $ million) (Share & CAGR: %) [Allergy, Autoimmune, Cardiac Markers, Genetic, Infectious Disease, Metabolic Disorders and Other Hormones, Toxicology, Tumor Markers, Others]
- Figure 7-4: Global Immunoassay Market, by Application Segment, CAGR 2025-2030 (%) [Allergy, Autoimmune, Cardiac Markers, Genetic, Infectious Disease, Metabolic Disorders and Other Hormones, Toxicology, Tumor Markers, Others]
- Total Market by Technology Type
- Table 7-5: Global Immunoassay Market, by Technology, 2025 and 2030 (Revenue: $ million) (Share & CAGR: %) [Chemiluminescent Immunoassay (CLIA), Digital ELISA, Enzyme‑linked Immunosorbent Assay (ELISA), Fluorescence Immunoassay (FIA), Immunohistochemistry (IHC), Lateral Flow Immunoassay (LFIA), Radioimmunoassay (RIA), Western Blot, Other]
- Figure 7-5: Global Immunoassay Market, by Technology, CAGR 2025-2030 (%) [Chemiluminescent Immunoassay (CLIA), Digital ELISA, Enzyme‑linked Immunosorbent Assay (ELISA), Fluorescence Immunoassay (FIA), Immunohistochemistry (IHC), Lateral Flow Immunoassay (LFIA), Radioimmunoassay (RIA), Western Blot, Other]
- Total Market by Region
- Table 7-6: Global Immunoassay Market, by Geographic Region, 2025 and 2030 (Revenue: $ million) (Share & CAGR: %) [North America, Europe, Asia Pacific, Rest of World]
- Figure 7-6: Global Immunoassay Market, by Geographic Region, CAGR 2025–2030 (%) [North America, Europe, Asia Pacific, Rest of World]
- North America
- Europe
- Table 7-7: Global Immunoassay Market, by European Country, 2025 and 2030 (Revenue: $ million) (Share & CAGR: %) [France, Germany, Italy, Spain, United Kingdom, Others]
- Figure 7-7: Global Immunoassay Market, by European Country, CAGR 2025-2030 (%) [France, Germany, Italy, Spain, United Kingdom, Others]
- Asia Pacific
- Table 7-8: Global Immunoassay Market, by Asia Pacific Country, 2025 and 2030 (Revenue: $ million) (Share & CAGR: %) [China, India, Japan, Others]
- Figure 7-8: Global Immunoassay Market, by Asia Pacific Country, CAGR 2025–2030 (%) [China, India, Japan, Others]
- Rest of World
- Table 7-9: Global Immunoassay Market, by Rest of World Country, 2025 and 2030 (Revenue: $ million) (Share & CAGR: %) [Brazil, Mexico, Saudi Arabia, South Africa, Turkey, Others]
- Figure 7-9: Global Immunoassay Market, by Rest of World Country, CAGR 2025–2030 (%) [Brazil, Mexico, Saudi Arabia, South Africa, Turkey, Others]
- Emerging International Markets
- Table 7-10: Selected Companies Outside of North America, Europe, or Japan Marketing Immunoassays
- COMPETITIVE ANALYSIS
- Table 7-11: Global Immunoassay Market Analysis, by Competitor Revenues, Product Focus, and Market Share ($ million) (%) [Abbott, Becton Dickinson, Bio‑Rad, bioMérieux, Bruker - CALID, Danaher, DiaSorin, QuidelOrtho, Revvity, Roche, Siemens Healthineers, Thermo Fisher Scientific, Others]
- Figure 7-10: Global Immunoassay Market Analysis, Share by Competitor Revenues (%) [Abbott, Becton Dickinson, Bio‑Rad, bioMérieux, Bruker - CALID, Danaher, DiaSorin, QuidelOrtho, Revvity, Roche, Siemens Healthineers, Thermo Fisher Scientific, Others]
CHAPTER 8: COMPANY PROFILES
- CLIA & HIGH-THROUGHPUT LAB SYSTEMS
- RAPID TESTS & POINT-OF-CARE (POC)
- SPECIALIZED & NEXT-GEN TECHNOLOGIES
- ELISA & SPECIALTY REAGENT PROVIDERS
- COMPANY PROFILES
- 1 STEP DETECT ASSOCIATES, LLC
- Table 8-1: 1-Step Detect Associates Corporate Summary
- Company Overview
- Products
- Financials
- ABBOTT LABORATORIES
- Table 8-2: Abbott Corporate Summary
- Company Overview
- Products
- Financials
- ABINGDON HEALTH, LTD.
- Table 8-3: Abingdon Health Corporate Summary
- Company Overview
- Products
- Financials
- ABNOVA CORP.
- Table 8-4: Abnova Summary
- Company Overview
- Products
- Financials
- ACCESS BIO, INC
- Table 8-5: Access Bio Summary
- Company Overview
- Products
- Financials
- ACCUBIOTECH CO, LTD.
- Table 8-6: AccuBioTech Corporate Summary
- Company Overview
- Products
- Financials
- ACON LABORATORIES, INC
- Table 8-7: ACON Laboratories Corporate Summary
- Company Overview
- Products
- Financials
- AESKU. DIAGNOSTICS
- Table 8-8: AESKU.DIAGNOSTICS Corporate Summary
- Company Overview
- Products
- Financials
- AGILENT TECHNOLOGIES
- Table 8-9: Agilent Corporate Summary
- Company Overview
- Products
- Financials
- AIDIAN OY
- Table 8-10: Aidian Corporate Summary
- Company Overview
- Products
- Financials
- ALFA SCIENTIFIC DESIGNS, INC
- Table 8-11: Alfa Scientific Design
- Company Overview
- Products
- Financials
- AUTOBIO DIAGNOSTICS CO., LTD
- Table 8-12: Autobio Diagnostics Corporate Summary
- Company Overview
- Products
- Financials
- BECTON DICKINSON (BD)
- Table 8-13: BD Corporate Summary
- Company Overview
- Products
- Financials
- BIOMÉRIEUX SA
- Table 8-14: bioMérieux SA Corporate Summary
- Company Overview
- Products
- Financials
- BIO-RAD LABORATORIES INC.
- Table 8-15: Bio-Rad Labs Corporate Summary
- Company Overview
- Products
- Financials
- BIO-TECHNE
- Table 8-16: Bio-Techne Corporate Summary
- Company Overview
- Products
- Financials
- BODITECH MED INC.
- Table 8-17: Boditech Med Corporate Summary
- Company Overview
- Products
- Financials
- BRUKER-CALID
- Table 8-18: Bruker-CALID Corporate Summary
- Company Overview
- Products
- Financials
- CHEMBIO DIAGNOSTIC SYSTEMS, INC.
- Table 8-19: Chembio Diagnostic Corporate Summary
- Company Overview
- Products
- Financials
- CTK BIOTECH, INC.
- Table 8-20: CTK Biotech Corporate Summary
- Company Overview
- Products
- Financials
- DANAHER (BECKMAN COULTER, RADIOMETER, HEMOCUE)
- Table 8-21: Beckman Coulter Corporate Summary
- Company Overview
- Products
- Beckman Coulter
- Radiometer
- HemoCue
- Financials
- DIALAB GMBH
- Table 8-22: DIALAB Summary
- Company Overview
- Products
- Financials
- DIASORIN S.P.A.
- Table 8-23: DiaSorin Corporate Summary
- Company Overview
- Products
- Financials
- DIASYS DIAGNOSTIC SYSTEMS GMBH (MINDRAY)
- Table 8-24: DiaSys Diagnostic Systems Corporate Summary
- Company Overview
- Products
- Financials
- DIAZYME LABORATORIES, INC.
- Table 8-25: Diazyme Laboratories Corporate Summary
- Company Overview
- Products
- Financials
- EIKEN CHEMICAL CO LTD.
- Table 8-26: Eiken Chemical Corporate Summary
- Company Overview
- Products
- Financials
- EKF DIAGNOSTICS HOLDINGS PLC
- Table 8-27: EKF Diagnostics Corporate Summary
- Company Overview
- Products
- Financials
- ELITECHGROUP S.A.S.
- Table 8-28: ELITechGroup Corporate Summary
- Company Overview
- Products
- Financials
- EUROIMMUN (GERMANY)
- Table 8-29: Euroimmun Corporate Summary
- Company Overview
- Products
- Financials
- FUJIREBIO-US, INC.
- Table 8-30: Fujirebio Corporate Summary
- Company Overview
- Products
- Financials
- GENBIO
- Table 8-31: GenBio Corporate Summary
- Company Overview
- Products
- Financials
- GRIFOLS INTERNATIONAL S.A.
- Table 8-32: Grifols International S.A. Corporate Summary
- Company Overview
- Products
- Financials
- HOB BIOTECH (CHINA)
- Table 8-33: HOB Biotech Corporate Summary
- Company Overview
- Products
- Financials
- HYCOR BIOMEDICAL, INC.
- Table 8-34: HYCOR Biomedical Corporate Summary
- Company Overview
- Products
- Financials
- MERIDIAN BIOSCIENCE, INC
- Table 8-35: Meridian BioScience Corporate Summary
- Company Overview
- Products
- Financials
- MESO SCALE DIAGNOSTICS (MSD)
- Table 8-36: Meso Scale Diagnostics (MSD) Corporate Summary
- Company Overview
- Products
- Financials
- ORASURE TECHNOLOGIES, INC.
- Table 8-37: OraSure Technologies Corporate Summary
- Company Overview
- Products
- Financials
- QIAGEN
- Table 8-38: Qiagen Corporate Summary
- Company Overview
- Products
- Financials
- QUANTERIX CORPORATION
- Table 8-39: Quanterix Corporate Summary
- Company Overview
- Products
- Financials
- QUIDELORTHO CORPORATION
- Table 8-40: QuidelOrtho Corporate Summary
- Company Overview
- Products
- Financials
- RANDOX LABORATORIES
- Table 8-41: Randox Laboratories Corporate Summary
- Company Overview
- Products
- Financials
- REVVITY
- Table 8-42: Revvity Corporate Summary
- Company Overview
- Products
- Financials
- ROCHE DIAGNOSTIC CORPORATION
- Table 8-43: Roche Corporate Summary
- Company Overview
- Products
- Financials
- SIEMENS HEALTHINEERS
- Table 8-44: Siemens Healthineers Corporate Summary
- Company Overview
- Products
- Financials
- SNIBE (CHINA)
- Table 8-45: SNIBE Corporate Summary
- Company Overview
- Products
- Financial
- SPEAR BIO
- Table 8-46: Spear Bio Corporate Summary
- Company Overview
- Products
- Financial
- SYSMEX CORPORATION
- Table 8-47: Sysmex Corporate Summary
- Company Overview
- Products
- Financials
- THERMO FISHER SCIENTIFIC, INC
- Table 8-48: Thermo Fisher Scientific Corporate Summary
- Company Overview
- Products
- Financials
- TOSOH BIOSCIENCE, INC.
- Table 8-49: Tosoh Bioscience Corporate Summary
- Company Overview
- Products
- Financials
- TRINITY BIOTECH PLC
- Table 8-50: Trinity Biotech Corporate Summary
- Company Overview
- Products
- Financials