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High‑Growth Immunoassay Tests: Trends, Technologies, and Market Opportunities, 2026
Publication Date: May 7, 2026
Tags: Blood Banking, Cardiovascular Disease, Diagnostics, Diagnostics Market Research, ELISA, Genetic Diseases, Hepatitis, Immunoassay, In Vitro Diagnostics (IVD), Infectious Diseases, POC, Point-of-Care (POC) Diagnostics, Point-of-Care (POC) Testing, Respiratory Diseases
Pages: 400
SKU: 26-040KA
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.
Chapter 1: Executive Summary
About Kalorama Information
Overview
Scope and Methodology
High Growth Segments
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)
Market Exits: Qualigen
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
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