-
Report details
-
36
Figures
-
179
Tables
|
Global Immunoassay Market: Trends, Technologies, and Growth Opportunities, 2025
12 Jun 2025
Kalorama Information’s new report, Global Immunoassay Market: Trends, Technologies, and Growth Opportunities, 2025, provides an in-depth analysis of one of the most pivotal segments of the in vitro diagnostics (IVD) industry with market estimates and forecasts spanning 2024-2029. Immunoassays—diagnostic tests that detect target analytes via antibody-antigen interactions—are foundational tools in clinical laboratories and point-of-care (POC) settings, enabling the detection of proteins, hormones, drugs, and infectious agents.
The global immunoassay market continues to expand, driven by advances in automation, miniaturization, multiplexing, and biomarker discovery. Despite being a mature technology, immunoassays are evolving rapidly to meet modern healthcare needs—from central labs to self-testing applications.
Market Segmentation
By Setting
- Centralized Lab-Based Immunoassays:
- Used in core labs for diagnostics, monitoring, and screening.
- Market Sales: Major contributors include infectious diseases, cardiac markers, and tumor markers.
- Top segments covered:
- Infectious Disease
- Cardiac Markers
- Metabolic Disorders & Hormones
- Tumor Markers
- Autoimmune & Allergy Testing
- Point-of-Care (POC) Immunoassays:
- Includes lateral flow and other rapid tests in hospitals, clinics, retail settings, and self-testing.
- Rapidly growing due to ease of use and decentralized access.
- Top segments covered:
- Infectious Disease
- Hormone/Fertility
- Cardiac Markers
- Oncology & FOBT
- Toxicology
Breakout By Disease Category
- Infectious Disease: Largest and most diverse segment; includes tests for HIV, hepatitis, MRSA, STDs, COVID-19, and TORCH.
- Cardiac Markers: Strong growth from heart failure and acute care testing.
- Hormones & Fertility: High usage in both labs and POC; includes reproductive and thyroid hormones.
- Oncology/Tumor Markers: Focus on PSA, CEA, CA-125, AFP with lab-based dominance.
- Toxicology & Drug Monitoring: Used in pain management, emergency medicine, and substance abuse programs.
- Autoimmune & Allergy: Emerging targets and expanded panels for systemic diseases.
- Genetic Testing: Includes prenatal screening and gene expression profiling via immunoassay platforms.
- Other Emerging Areas: Alzheimer’s disease, gastrointestinal disorders, transplant medicine, and women’s health (e.g., preeclampsia).
Analysis of Geographic Trends
- Developed Markets:
- North America and Western Europe dominate due to high healthcare infrastructure and adoption of advanced diagnostics.
- Developed Asia Pacific also plays a key role.
- Emerging Markets:
- Immunoassays are key to expanding access in Latin America, Eastern Europe, Southeast Asia, and Africa, where centralized diagnostics are limited.
- Lateral flow and self-testing are critical tools in resource-limited settings.
Scope and Methodology
This report presents the global immunoassay market in U.S. dollars, covering the years 2024 through 2029. It analyzes a wide range of immunoassay technologies, from high-throughput lab instruments to manual point-of-care (POC) tests, including rapid immunochromatographic or lateral flow formats.
The primary focus is on developed regions—North America, Western Europe, and developed Asia-Pacific—while also recognizing the importance of POC testing in expanding diagnostic access in underserved areas.
Market data reflects manufacturer revenue rather than retail prices or reimbursements. Segment values generally align with test volumes, as instrument costs are often bundled into per-test pricing.
A blend of primary and secondary research underpins the report's findings. Secondary sources included public and proprietary databases, industry reports, regulatory filings, company publications, and peer-reviewed journals. These sources provided context, competitor identification, and strategic insights.
To validate and deepen the research, Kalorama conducted over 30 interviews with industry experts such as executives, product and marketing leaders, consultants, healthcare professionals, and government representatives. These interviews provided qualitative insights into market dynamics and trends.
Additional outreach to companies yielded specific figures on revenue, market share, and product performance. All data were verified against multiple sources and, when possible, triangulated using public disclosures, proprietary insights, and expert feedback.
Market sizing and forecasts are based on 2024 as the base year, with projections through 2029 supported by historical trends, demographic shifts, technological advances, and global market expansion. Competitive analysis reflects the landscape in 2024, with forward-looking trends identified for subsequent years.
Page Count: 460
Table of Contents
-
Chapter 1: Executive Summary
-
Overview
-
Scope and Methodology
-
Market Overview
-
Competitive Summary
-
Chapter 2: Introduction
-
History and Future of Immunoassays
-
Immunoassay Technology Continues to Evolve
-
Chapter 3: Technology, Trends, and Innovations
-
Overview – Immunoassays
-
Chemiluminescent Immunoassay (CLIA)
-
Enzyme-Linked Immunosorbent Assay (ELISA)
-
Fluoroimmunoassay (FIA)
-
Immunohistochemistry (IHC)
-
Lateral Flow Immunoassay (LFIA)
-
Radioimmunoassay (RIA)
-
Western Blotting
-
Immunoassay Technology Innovations and Emerging Trends
-
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
-
Case Example: Veravas VeraBIND Technology
-
Specimen Types
-
Chapter 4: Market Segment by Setting
-
Centralized Laboratories
-
Companies Marketing to Centralized Laboratories
-
Rapid and Point-of-Care Testing
-
POC Testing in Hospitals
-
Physician’s Office Laboratories and Clinics
-
Retail Clinics
-
Other Professional POC Testing
-
Self-Testing
-
Companies Marketing Immunoassay for POC Testing
-
Chapter 5: Immunoassay Diagnostic Market Activity by Application
-
Allergy
-
Autoimmune Disease
-
Cardiac Markers
-
Genetic Testing
-
Infectious Disease
-
Lab-based Infectious Disease Immunoassays
-
Blood Screening
-
Hepatitis
-
Lyme Disease
-
Rapid and POC Testing
-
Retroviral
-
Sexually Transmitted Diseases
-
ToRCH
-
COVID-19
-
Other Infectious Diseases
-
Metabolic Disorders and Other Hormones
-
Fertility/Pregnancy/Reproductive Hormones
-
Thyroid
-
Oncology - Tumor Markers
-
Lab-based Oncology Immunoassays
-
Toxicology
-
Drugs of Abuse
-
Therapeutic Drug Monitoring
-
Other Disease Categories in Immunoassay Disease Market
-
Chapter 6: Market Opportunities and Issues for Immunoassays
-
Immunoassay Market – Overview
-
Immunoassay Market Drivers and Challenges
-
New and Emerging Areas of Immunoassay Innovation
-
Gastrointestinal Disorders
-
Transplant Management
-
Preeclampsia
-
Alzheimer’s Disease
-
Emerging International Markets
-
Lab-Developed Tests
-
Staffing Shortages
-
Outlook for Immunoassays
-
Chapter 7: Immunoassay Market Analysis
-
Market Overview and Market Segments
-
Central Lab-based Immunoassay Market
-
Point of Care/Rapid Test Immunoassays by Disease Category
-
Immunoassay Market by Technology Type
-
Competitive Analysis
-
Immunoassay Market by Geographic Regions
-
North America
-
Europe
-
Asia Pacific
-
Rest of World
-
Chapter 8: Company Profiles
-
1 Step Detect Associates, LLC
-
Company Overview
-
Products
-
Abbott Laboratories
-
Company Overview
-
Products
-
Performance Review
-
Abingdon Health, Ltd.
-
Company Overview
-
Products
-
Access Bio, Inc.
-
Company Overview
-
Products
-
AccuBioTech Co, Ltd.
-
Company Overview
-
Products
-
ACON Laboratories, Inc
-
Company Overview
-
Products
-
AESKU. DIAGNOSTICS
-
Company Overview
-
Products
-
Aidian Oy
-
Company Overview
-
Products
-
Alfa Scientific Designs, Inc
-
Company Overview
-
Products
-
American Laboratory Products Company (ALPCO)
-
Company Overview
-
Products
-
Anbio Biotechnology
-
Company Overview
-
Products
-
ARKRAY, Inc
-
Company Overview
-
Products
-
Arlington Scientific, Inc.
-
Company Overview
-
Products
-
Artron Laboratories Inc.
-
Company Overview
-
Products
-
Associates of Cape Cod, Inc. (ACC)
-
Company Overview
-
Products
-
Autobio Diagnostics Co., Ltd
-
Company Overview
-
Products
-
Avioq, Inc.
-
Company Overview
-
Products
-
Awareness Technology
-
Company Overview
-
Products
-
Beckman Coulter, Inc
-
Company Overview
-
Products
-
Becton Dickinson (BD)
-
Company Overview
-
Products
-
Company Financials
-
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
-
Company Overview
-
Products
-
Bhat Bio-Tech India Private Ltd. (BBI)
-
Company Overview
-
Products
-
BioCheck, Inc.
-
Company Overview
-
Products
-
Biohit Oyj (Biohit Healthcare)
-
Company Overview
-
Products
-
bioLytical Laboratories
-
Company Overview
-
Products
-
BioMedomics, Inc.
-
Company Overview
-
Products
-
Biomerica
-
Company Overview
-
Products
-
Company Financials
-
bioMérieux SA
-
Company Overview
-
Products
-
Company Financials
-
BioPorto Diagnostics
-
Company Overview
-
Products
-
Company Financials
-
Bio-Rad Laboratories Inc.
-
Company Overview
-
Products
-
Company Financials
-
Bioscience (Tianjin) Diagnostic Technology Co., Ltd.
-
Company Overview
-
Products
-
Bio-Techne
-
Company Overview
-
Products
-
Company Financials
-
Biotron Diagnostics, Inc.
-
Company Overview
-
Products
-
Boditech Med Inc.
-
Company Overview
-
Products
-
Performance Review
-
Boson Biotech Co. Ltd
-
Company Overview
-
Products
-
BUHLMANN Laboratories AG
-
Company Overview
-
Products
-
Certest Biotec
-
Company Overview
-
Products
-
Chembio Diagnostic Systems, Inc.
-
Company Overview
-
Products
-
Clarity Diagnostics, LLC
-
Company Overview
-
Products
-
Confirm Biosciences
-
Company Overview
-
Products
-
CTK Biotech, Inc.
-
Company Overview
-
Products
-
Diagenics Group SE
-
Company Overview
-
Products
-
DIALAB GmbH
-
Company Overview
-
Products
-
Diametra
-
Company Overview
-
Products
-
DiaSorin S.p.A.
-
Company Overview
-
Products
-
Company Financials
-
DiaSource ImmunoAssays SA
-
Company Overview
-
Products
-
DiaSys Diagnostic Systems GmbH (Mindray)
-
Company Overview
-
Products
-
Diazyme Laboratories, Inc.
-
Company Overview
-
Products
-
Dr. Fooke-Achterrath Laboratorien GmbH
-
Company Overview
-
Products
-
Eiken Chemical Co Ltd.
-
Company Overview
-
Products
-
Performance Review
-
EKF Diagnostics Holdings plc
-
Company Overview
-
Products
-
ELITechGroup S.A.S.
-
Company Overview
-
Products
-
Eurobio Scientific
-
Company Overview
-
Products
-
Eurospital Spa
-
Company Overview
-
Products
-
EY Laboratories
-
Company Overview
-
Products
-
Fujirebio-US, Inc.
-
Company Overview
-
Products
-
GenBio
-
Company Overview
-
Products
-
Gold Standard Diagnostics
-
Company Overview
-
Products
-
Grifols International S.A.
-
Company Overview
-
Products
-
Company Financials
-
Hemosure, Inc.
-
Company Overview
-
Products
-
HYCOR Biomedical, Inc.
-
Company Overview
-
Products
-
Immuno-Mycologics, Inc.
-
Company Overview
-
Products
-
Immunosciences Lab, Inc.
-
Company Overview
-
Products
-
Immunostics, Inc
-
Company Overview
-
Products
-
InBios International, Inc.
-
Company Overview
-
Products
-
JAL Innovation PTE LTD
-
Company Overview
-
Products
-
Jant Pharmacal Corporation
-
Company Overview
-
Products
-
J. Mitra & Co Pvt. Ltd
-
Company Overview
-
Products
-
KRONUS
-
Company Overview
-
Products
-
Kypha
-
Company Overview
-
Products
-
Labsystems Diagnostics Oy
-
Company Overview
-
Products
-
LamdaGen Corporation
-
Company Overview
-
Products
-
LifeSign, LLC
-
Company Overview
-
Products
-
Macherey-Nagel GmbH & Co. KG
-
Company Overview
-
Products
-
Medix Biochemica
-
Company Overview
-
Products
-
MedMira, Inc
-
Company Overview
-
Products
-
Performance Review
-
Mercodia AB
-
Company Overview
-
Products
-
Meridian BioScience, Inc
-
Company Overview
-
Products
-
Monobind, Inc
-
Company Overview
-
Products
-
Nano-Ditech Corporation
-
Company Overview
-
Products
-
Nexus Dx Inc
-
Company Overview
-
Products
-
Nova Biomedical, Corp.
-
Company Overview
-
Products
-
Oasis Diagnostics Corporation
-
Company Overview
-
Products
-
Operon
-
Company Overview
-
Products
-
OPKO Health, Inc
-
Company Overview
-
Products
-
Performance Review
-
OraSure Technologies, Inc.
-
Company Overview
-
Products
-
Performance Review
-
PixCell Medical Technologies
-
Company Overview
-
Products
-
Polymedco, Inc
-
Company Overview
-
Products
-
Precision Biosensor
-
Company Overview
-
Products
-
Preventis GmbH
-
Company Overview
-
Products
-
Princeton Biomeditech Corporation
-
Company Overview
-
Products
-
PTS Diagnostics
-
Company Overview
-
Products
-
Qualigen, Inc.
-
Company Overview
-
Products
-
Quanterix Corporation
-
Company Overview
-
Products
-
QuidelOrtho Corporation
-
Company Overview
-
Products
-
Performance Review
-
Radiometer Medical A/S
-
Company Overview
-
Products
-
Response Biomedical Corp
-
Company Overview
-
Products
-
Reszon Diagnostics International Sdn. Bhd.
-
Company Overview
-
Products
-
Revvity
-
Company Overview
-
Products
-
Performance Review
-
Roche Diagnostic Corporation
-
Company Overview
-
Products
-
Performance Review
-
Savyon Diagnostics Ltd.
-
Company Overview
-
Products
-
Sekisui Diagnostics LLC
-
Company Overview
-
Products
-
Siemens Healthineers
-
Company Overview
-
Products
-
Performance Review
-
Syntron Bioresearch, Inc.
-
Company Overview
-
Products
-
Sysmex Corporation
-
Company Overview
-
Products
-
Performance Review
-
TECHLAB, Inc.
-
Company Overview
-
Products
-
Teco Diagnostics
-
Company Overview
-
Products
-
Thermo Fisher Scientific, Inc
-
Company Overview
-
Products
-
Company Financials
-
Tosoh Bioscience, Inc.
-
Company Overview
-
Products
-
Company Financials
-
Trinity Biotech PLC
-
Company Overview
-
Products
-
True Diagnostics
-
Company Overview
-
Products
-
VedaLab
-
Company Overview
-
Products
-
Vircell
-
Company Overview
-
Products
-
WAMA Diagnostica
-
Company Overview
-
Products
-
Werfen Group
-
Company Overview
-
Products
-
Zeus Scientific, Inc.
-
Company Overview
-
Products
|
More information about this product
Other Users Also Viewed
8 Oct 2024
Kalorama Information's IVD Test Procedure Volumes, 2024-2029 report provides a deep dive into the global trends shaping in vitro diagnostic (IVD) procedural volumes. Designed to complement Kalorama’s comprehensive market analysis in The Worldwide…
|