Summary

Biomarker-based Immunoassays Market Summary

The global biomarker-based immunoassays market size was valued at USD 5.15 billion in 2024 and is expected to reach USD 8.33 billion by 2033, growing at a CAGR of 5.4% from 2025 to 2033. The market growth is fueled by the rising global burden of chronic diseases such as cancer, cardiovascular disorders, and neurological conditions, which require precise and early diagnostic tools.

Increasing demand for personalized medicine has driven clinicians and pharmaceutical companies to adopt biomarker-guided strategies, where immunoassays play a central role in both disease detection and therapeutic monitoring. The increasing reliance on companion diagnostics, along with regulatory support for biomarker-driven disease development, has solidified immunoassays as an essential technology in modern healthcare. Additionally, public and private investments in translational research and clinical diagnostics have sped up adoption across hospitals, laboratories, and academic institutions.

Technological advancements are also reshaping the scope of the market, with multiplexing platforms, high-throughput analyzers, and next-generation immunoassay systems enabling the simultaneous detection of multiple biomarkers with enhanced sensitivity and specificity. The integration of artificial intelligence (AI) and machine learning (ML) into biomarker-based testing improves data interpretation, while liquid biopsy-based immunoassays offer less invasive options for oncology and neurology diagnostics. Companies are also developing reagents and kits tailored for predictive and prognostic biomarkers, which are increasingly valuable in precision medicine. These innovations not only enhance diagnostic accuracy but also reduce turnaround times, making biomarker immunoassays more accessible and clinically relevant.

Global Biomarker-based Immunoassays Market Report Segmentation

This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2021 to 2033. For the purpose of this report, Grand View Research has segmented the biomarker-based immunoassays market on the basis sample, product, biomarkers, diseases, end-use, and region:

• Sample Outlook (Revenue, USD Million, 2021 - 2033)
• Blood
• Tissue
• Urine
• Saliva
• Product Outlook (Revenue, USD Million, 2021 - 2033)
• Consumables
• Instruments/ Analyzers
• Reagent & Kits
• Services
• Biomarker Outlook (Revenue, USD Million, 2021 - 2033)
• Safety & toxicity biomarkers
• Efficacy & Pharmacodynamic Biomarkers
• Predictive & Prognostic Biomarkers
• Surrogate/Exploratory Biomarkers
• Diseases Outlook (Revenue, USD Million, 2021 - 2033)
• Cancer
• Cardiovascular Diseases
• Neurological Diseases
• Immunological Diseases
• Others
• End-use Outlook (Revenue, USD Million, 2021 - 2033)
• Hospitals & Clinics
• Diagnostic Laboratories
• Research & Academic Institutes
• Others
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
o U.S.
o Canada
o Mexico
• Europe
o Germany
o UK
o France
o Italy
o Spain
o Denmark
o Sweden
o Norway
• Asia Pacific
o Japan
o China
o India
o Australia
o South Korea
o Thailand
• Latin America
o Brazil
o Argentina
• Middle East and Africa (MEA)
o South Africa
o Saudi Arabia
o UAE
o Kuwait

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Table of Contents

Table of Contents

Chapter 1. Methodology and Scope
1.1. Market Segmentation & Scope
1.2. Market Definitions
1.2.1. Sample Segment
1.2.2. Product Segment
1.2.3. Biomarker Segment
1.2.4. Diseases Segment
1.2.5. End Use Segment
1.3. Information analysis
1.3.1. Market formulation & data visualization
1.4. Data validation & publishing
1.5. Information Procurement
1.5.1. Primary Research
1.6. Information or Data Analysis
1.7. Market Formulation & Validation
1.8. Market Biomarkerl
1.9. Total Market: CAGR Calculation
1.10. Objectives
1.10.1. Objective 1
1.10.2. Objective 2
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Snapshot
2.3. Competitive Insights Landscape
Chapter 3. Global Biomarker-Based Immunoassays Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent market outlook
3.1.2. Related/ancillary market outlook.
3.2. Market Dynamics
3.2.1. Market driver analysis
3.2.1.1. Rising demand for precision medicine and personalized therapies
3.2.1.2. Increasing prevalence of chronic and infectious diseases
3.2.1.3. Technological advancements in immunoassay platforms
3.2.2. Market restraint analysis
3.2.2.1. High cost of advanced biomarker assays and platforms
3.3. Global Biomarker-Based Immunoassays Market Analysis Tools
3.3.1. Industry Analysis - Porter’s
3.3.2. PESTEL Analysis
Chapter 4. Global Biomarker-Based Immunoassays Market: Sample Estimates & Trend Analysis
4.1. Segment Dashboard
4.2. Global Biomarker-Based Immunoassays Market Sample Movement Analysis
4.3. Global Biomarker-Based Immunoassays Market Size & Trend Analysis, by sample, 2018 to 2030 (USD Million)
4.4. Blood
4.4.1. Blood market estimates and forecasts 2021 to 2033 (USD Million)
4.5. Tissue
4.5.1. Tissue market estimates and forecasts 2021 to 2033 (USD Million)
4.6. Saliva
4.6.1. Saliva market estimates and forecasts 2021 to 2033 (USD Million)
4.7. Urine
4.7.1. Urine market estimates and forecasts 2021 to 2033 (USD Million)
Chapter 5. Global Biomarker-Based Immunoassays Market: Product Estimates & Trend Analysis
5.1. Segment Dashboard
5.2. Global Biomarker-Based Immunoassays Market Product Movement Analysis
5.3. Global Biomarker-Based Immunoassays Market Size & Trend Analysis, by product, 2021 to 2033 (USD Million)
5.4. Consumables
5.4.1. Consumables market estimates and forecasts 2021 to 2033 (USD Million)
5.5. Instruments/Analyzers
5.5.1. Instruments/Analyzers market estimates and forecasts 2021 to 2033 (USD Million)
5.6. Reagent & Kits
5.6.1. Reagent & kits market estimates and forecasts 2021 to 2033 (USD Million)
5.7. Services
5.7.1. Services market estimates and forecasts 2021 to 2033 (USD Million)
Chapter 6. Global Biomarker-Based Immunoassays Market: Biomarker Estimates & Trend Analysis
6.1. Segment Dashboard
6.2. Global Biomarker-Based Immunoassays Market Biomarker Movement Analysis
6.3. Global Biomarker-Based Immunoassays Market Size & Trend Analysis, by biomarkers, 2021 to 2033 (USD Million)
6.4. Safety & toxicity biomarkers
6.4.1. Safety & toxicity biomarkers market estimates and forecasts 2021 to 2033 (USD Million)
6.5. Efficacy & Pharmacodynamic Biomarkers
6.5.1. Efficacy & Pharmacodynamic Biomarkers market estimates and forecasts 2021 to 2033 (USD Million)
6.6. Predictive & Prognostic Biomarkers
6.6.1. Predictive & prognostic biomarkers market estimates and forecasts 2021 to 2033 (USD Million)
6.7. Surrogate/Exploratory Biomarkers
6.7.1. Surrogate/exploratory biomarkers market estimates and forecasts 2021 to 2033 (USD Million)
Chapter 7. Global Biomarker-Based Immunoassays Market: Diseases Estimates & Trend Analysis
7.1. Segment Dashboard
7.2. Global Biomarker-Based Immunoassays Market Diseases Movement Analysis
7.2.1. Global Biomarker-Based Immunoassays Market Size & Trend Analysis, by diseases, 2021 to 2033 (USD Million)
7.3. Cancer
7.3.1. Cancer market estimates and forecasts 2021 to 2033 (USD Million)
7.4. Cardiovascular Diseases
7.4.1. Cardiovascular diseases market estimates and forecasts 2021 to 2033 (USD Million)
7.5. Neurological Diseases
7.5.1. Neurological diseases market estimates and forecasts 2021 to 2033 (USD Million)
7.6. Immunological Diseases
7.6.1. Immunological diseases testing market estimates and forecasts 2021 to 2033 (USD Million)
7.7. Others
7.7.1. Others market estimates and forecasts 2021 to 2033 (USD Million)
Chapter 8. Global Biomarker-Based Immunoassays Market: End Use Estimates & Trend Analysis
8.1. Segment Dashboard
8.2. Global Biomarker-Based Immunoassays Market End Use Movement Analysis
8.2.1. Global Biomarker-Based Immunoassays Market Size & Trend Analysis, by End Use, 2021 to 2033 (USD Million)
8.3. Hospitals & Clinics
8.3.1. Hospitals and clinics market estimates and forecasts 2021 to 2033 (USD Million)
8.4. Diagnostic Laboratories
8.4.1. Diagnostic Laboratories market estimates and forecasts 2021 to 2033 (USD Million)
8.5. Research & Academic Institutes
8.5.1. Research & Academic Institutes market estimates and forecasts 2021 to 2033 (USD Million)
8.6. Others
8.6.1. Others market estimates and forecasts 2021 to 2033 (USD Million)
Chapter 9. Biomarker-Based Immunoassays Market: Regional Estimates & Trend Analysis
9.1. Regional Dashboard
9.2. Market Size, & Forecasts Trend Analysis, 2021 to 2033:
9.3. North America
9.3.1. U.S.
9.3.1.1. Key country dynamics
9.3.1.2. Regulatory framework/ reimbursement structure
9.3.1.3. Competitive scenario
9.3.1.4. U.S. market estimates and forecasts 2021 to 2033 (USD Million)
9.3.2. Canada
9.3.2.1. Key country dynamics
9.3.2.2. Regulatory framework/ reimbursement structure
9.3.2.3. Competitive scenario
9.3.2.4. Canada market estimates and forecasts 2021 to 2033 (USD Million)
9.3.3. Mexico
9.3.3.1. Key country dynamics
9.3.3.2. Regulatory framework/ reimbursement structure
9.3.3.3. Competitive scenario
9.3.3.4. Mexico market estimates and forecasts 2021 to 2033 (USD Million)
9.4. Europe
9.4.1. UK
9.4.1.1. Key country dynamics
9.4.1.2. Regulatory framework/ reimbursement structure
9.4.1.3. Competitive scenario
9.4.1.4. UK market estimates and forecasts 2021 to 2033 (USD Million)
9.4.2. Germany
9.4.2.1. Key country dynamics
9.4.2.2. Regulatory framework/ reimbursement structure
9.4.2.3. Competitive scenario
9.4.2.4. Germany market estimates and forecasts 2021 to 2033 (USD Million)
9.4.3. France
9.4.3.1. Key country dynamics
9.4.3.2. Regulatory framework/ reimbursement structure
9.4.3.3. Competitive scenario
9.4.3.4. France market estimates and forecasts 2021 to 2033 (USD Million)
9.4.4. Italy
9.4.4.1. Key country dynamics
9.4.4.2. Regulatory framework/ reimbursement structure
9.4.4.3. Competitive scenario
9.4.4.4. Italy market estimates and forecasts 2021 to 2033 (USD Million)
9.4.5. Spain
9.4.5.1. Key country dynamics
9.4.5.2. Regulatory framework/ reimbursement structure
9.4.5.3. Competitive scenario
9.4.5.4. Spain market estimates and forecasts 2021 to 2033 (USD Million)
9.4.6. Norway
9.4.6.1. Key country dynamics
9.4.6.2. Regulatory framework/ reimbursement structure
9.4.6.3. Competitive scenario
9.4.6.4. Norway market estimates and forecasts 2021 to 2033 (USD Million)
9.4.7. Sweden
9.4.7.1. Key country dynamics
9.4.7.2. Regulatory framework/ reimbursement structure
9.4.7.3. Competitive scenario
9.4.7.4. Sweden market estimates and forecasts 2021 to 2033 (USD Million)
9.4.8. Denmark
9.4.8.1. Key country dynamics
9.4.8.2. Regulatory framework/ reimbursement structure
9.4.8.3. Competitive scenario
9.4.8.4. Denmark market estimates and forecasts 2021 to 2033 (USD Million)
9.5. Asia Pacific
9.5.1. Japan
9.5.1.1. Key country dynamics
9.5.1.2. Regulatory framework/ reimbursement structure
9.5.1.3. Competitive scenario
9.5.1.4. Japan market estimates and forecasts 2021 to 2033 (USD Million)
9.5.2. China
9.5.2.1. Key country dynamics
9.5.2.2. Regulatory framework/ reimbursement structure
9.5.2.3. Competitive scenario
9.5.2.4. China market estimates and forecasts 2021 to 2033 (USD Million)
9.5.3. India
9.5.3.1. Key country dynamics
9.5.3.2. Regulatory framework/ reimbursement structure
9.5.3.3. Competitive scenario
9.5.3.4. India market estimates and forecasts 2021 to 2033 (USD Million)
9.5.4. Australia
9.5.4.1. Key country dynamics
9.5.4.2. Regulatory framework/ reimbursement structure
9.5.4.3. Competitive scenario
9.5.4.4. Australia market estimates and forecasts 2021 to 2033 (USD Million)
9.5.5. South Korea
9.5.5.1. Key country dynamics
9.5.5.2. Regulatory framework/ reimbursement structure
9.5.5.3. Competitive scenario
9.5.5.4. South Korea market estimates and forecasts 2021 to 2033 (USD Million)
9.5.6. Thailand
9.5.6.1. Key country dynamics
9.5.6.2. Regulatory framework/ reimbursement structure
9.5.6.3. Competitive scenario
9.5.6.4. Thailand market estimates and forecasts 2021 to 2033 (USD Million)
9.6. Latin America
9.6.1. Brazil
9.6.1.1. Key country dynamics
9.6.1.2. Regulatory framework/ reimbursement structure
9.6.1.3. Competitive scenario
9.6.1.4. Brazil market estimates and forecasts 2021 to 2033 (USD Million)
9.6.2. Argentina
9.6.2.1. Key country dynamics
9.6.2.2. Regulatory framework/ reimbursement structure
9.6.2.3. Competitive scenario
9.6.2.4. Argentina market estimates and forecasts 2021 to 2033 (USD Million)
9.7. MEA
9.7.1. South Africa
9.7.1.1. Key country dynamics
9.7.1.2. Regulatory framework/ reimbursement structure
9.7.1.3. Competitive scenario
9.7.1.4. South Africa market estimates and forecasts 2021 to 2033 (USD Million)
9.7.2. Saudi Arabia
9.7.2.1. Key country dynamics
9.7.2.2. Regulatory framework/ reimbursement structure
9.7.2.3. Competitive scenario
9.7.2.4. Saudi Arabia market estimates and forecasts 2021 to 2033 (USD Million)
9.7.3. UAE
9.7.3.1. Key country dynamics
9.7.3.2. Regulatory framework/ reimbursement structure
9.7.3.3. Competitive scenario
9.7.3.4. UAE market estimates and forecasts 2021 to 2033 (USD Million)
9.7.4. Kuwait
9.7.4.1. Key country dynamics
9.7.4.2. Regulatory framework/ reimbursement structure
9.7.4.3. Competitive scenario
9.7.4.4. Kuwait market estimates and forecasts 2021 to 2033 (USD Million)
Chapter 10. Competitive Landscape
10.1. Company/Competition Categorization
10.2. Strategy Mapping
10.3. Company Market Share Analysis, 2024
10.4. List of Key Certification Providers/Scheme Owners
10.5. Company Profiles/Listing
10.5.1. F. Hoffmann-La Roche AG
10.5.1.1. Company overview
10.5.1.2. Financial performance
10.5.1.3. Product benchmarking
10.5.1.4. Strategic initiatives
10.5.2. Abbott
10.5.2.1. Company overview
10.5.2.2. Financial performance
10.5.2.3. Product benchmarking
10.5.2.4. Strategic initiatives
10.5.3. Thermo Fisher Scientific Inc
10.5.3.1. Company overview
10.5.3.2. Financial performance
10.5.3.3. Product benchmarking
10.5.3.4. Strategic initiatives
10.5.4. Eurofins Scientific
10.5.4.1. Company overview
10.5.4.2. Financial performance
10.5.4.3. Product benchmarking
10.5.4.4. Strategic initiatives
10.5.5. QIAGEN
10.5.5.1. Company overview
10.5.5.2. Financial performance
10.5.5.3. Product benchmarking
10.5.5.4. Strategic initiatives
10.5.6. Bio-Rad Laboratories, Inc.
10.5.6.1. Company overview
10.5.6.2. Financial performance
10.5.6.3. Product benchmarking
10.5.6.4. Strategic initiatives
10.5.7. Siemens Healthineers AG
10.5.7.1. Company overview
10.5.7.2. Financial performance
10.5.7.3. Product benchmarking
10.5.7.4. Strategic initiatives
10.5.8. Merck KGaA
10.5.8.1. Company overview
10.5.8.2. Financial performance
10.5.8.3. Product benchmarking
10.5.8.4. Strategic initiatives
10.5.9. PerkinElmer Inc.
10.5.9.1. Company overview
10.5.9.2. Financial performance
10.5.9.3. Product benchmarking
10.5.9.4. Strategic initiatives
10.5.10. Agilent Technologies, Inc.
10.5.10.1. Company overview
10.5.10.2. Financial performance
10.5.10.3. Product benchmarking
10.5.10.4. Strategic initiatives