Immunoassay Market
Immunoassay Market Forecasts to 2032 - Global Analysis By Product Type (Reagents & Kits, Analyzers, Software & Services, and Other Product Types), Platform, Technology, Specimen Type, Application, End User, and By Geography
According to Stratistics MRC, the Global Immunoassay Market is accounted for $40.74 billion in 2025 and is expected to reach $69.38 billion by 2032 growing at a CAGR of 7.9% during the forecast period. An immunoassay is a biochemical test that measures the presence or concentration of a substance, typically in a liquid sample, using the reaction between an antigen and an antibody. It is widely used in diagnostics, pharmaceutical research, and environmental testing to detect hormones, drugs, proteins, or pathogens. Immunoassays offer high sensitivity and specificity, making them essential tools in disease diagnosis, therapeutic drug monitoring, and biomedical research applications.
According to the National Development Council, the geriatric population of Taiwan will reach 19.9% in 2025, 23.9% in 2030, and 27.3% in 2035.
Market Dynamics:
Driver:
Rising prevalence of chronic diseases
The increasing prevalence of chronic diseases such as cancer, cardiovascular disorders, and autoimmune conditions is driving demand for immunoassay testing. Immunoassays play a crucial role in disease diagnosis, monitoring, and treatment management, leading to their widespread adoption in clinical settings. Additionally, advancements in assay technologies have improved sensitivity and specificity, enhancing their application in diagnostic laboratories. The aging population and rising incidence of infectious diseases further contribute to market expansion.
Restraint:
High cost of instruments and reagents
High initial investment requirements for advanced assay systems deter small and medium healthcare providers from adopting these technologies. The recurring expenses of reagents and consumables add to the overall operational cost, limiting accessibility, particularly in developing economies. Additionally, stringent regulatory standards necessitate expensive validation processes, increasing financial burden on manufacturers. Cost constraints also hinder widespread adoption of automated immunoassay analyzers in resource-limited healthcare settings.
Opportunity:
Point-of-Care testing demand
POC immunoassay systems enable rapid and accurate disease diagnosis, facilitating timely medical intervention. The convenience and efficiency of POC testing are driving adoption across hospitals, clinics, and home healthcare settings. Technological advancements in portable immunoassay devices are enhancing accessibility, especially in remote and underserved regions. Rising awareness regarding early disease detection is further boosting demand for POC immunoassays. Market participants are investing in innovation to develop user-friendly and cost-effective POC testing solutions.
Threat:
Limited standardization
Variability in assay performance can lead to inconsistencies in diagnostic results, affecting clinical decision-making. Laboratories and healthcare providers struggle with interoperability issues when integrating immunoassay systems from different manufacturers. The absence of universally accepted assay protocols complicates quality control efforts, raising concerns about test reliability. Regulatory bodies emphasize standardization, but achieving harmonization across diverse technologies remains complex.
Covid-19 Impact
The COVID-19 pandemic significantly boosted the immunoassay market due to the urgent need for rapid and accurate diagnostic testing. Demand surged for antibody and antigen tests to detect and monitor the virus, driving innovation and increased production capacity. Governments and healthcare organizations invested heavily in diagnostics, expanding market size and accelerating regulatory approvals. Post-pandemic, the heightened awareness of infectious diseases and preparedness for future outbreaks continue to sustain growth and technological advancement in the immunoassay sector.
The reagents & kits segment is expected to be the largest during the forecast period
The reagents & kits segment is expected to account for the largest market share during the forecast period, due to its critical role in immunoassay testing procedures. High consumption rates of reagents in hospitals, diagnostic laboratories, and research institutions contribute to its significant market share. The rising number of diagnostic tests globally is increasing the demand for immunoassay reagents. Continuous advancements in reagent formulations are improving assay sensitivity, fuelling their widespread adoption.
The hospitals & clinics segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the hospitals & clinics segment is predicted to witness the highest growth rate, driven by increasing patient volumes and diagnostic needs. Immunoassays are widely used in hospitals for disease screening, therapeutic monitoring, and emergency diagnostics. The integration of automated immunoassay analyzers in hospital laboratories is improving efficiency and accuracy. Rising healthcare investments and the demand for high-throughput testing solutions are propelling market expansion.
Region with largest share:
During the forecast period, the Asia Pacific region is expected to hold the largest market share due to its rapidly expanding healthcare sector. Increasing government investments in medical infrastructure are fuelling market growth across key countries such as China, India, and Japan. Rising awareness regarding early disease diagnosis and prevention is driving immunoassay adoption. The growing prevalence of infectious and chronic diseases is accelerating demand for advanced diagnostic solutions.
Region with highest CAGR:
Over the forecast period, the North America region is anticipated to exhibit the highest CAGR, owing to its advanced healthcare infrastructure and strong regulatory framework. The presence of leading diagnostic companies and research institutions accelerates innovation in immunoassay technologies. Increasing healthcare expenditure and government initiatives supporting precision medicine are driving market expansion. The rising burden of chronic diseases and demand for early diagnostic solutions are fuelling immunoassay adoption.
Key players in the market
Some of the key players profiled in the Immunoassay Market include Abbott Laboratories, F. Hoffmann-La Roche Ltd., Siemens Healthineers, Danaher Corporation, Thermo Fisher Scientific Inc., bioMérieux SA, DiaSorin S.p.A., Becton, Dickinson and Company (BD), Sysmex Corporation, Bio-Rad Laboratories, Inc., QuidelOrtho Corporation, PerkinElmer Inc., QIAGEN N.V., Merck KGaA, and Fujirebio, Inc.
Key Developments:
In February 2025, Abbott and Shedd Aquarium are announcing one of Shedd’s largest corporate gifts in recent history – a $10 million pledge from Abbott and Abbott's philanthropic foundation, Abbott Fund. The investment cements the longstanding partnership between Shedd, Abbott, and Abbott Fund to enrich the cultural, educational and environmental fabric of Chicago and spark passion for protecting the ocean environment.
In July 2024, Siemens Healthineers, a leading medical technology company, announced that the Multix Impact E digital radiography X-ray machine will now be manufactured in India, marking a significant milestone in the company's commitment to providing better access to care for patients in the country.
Product Types Covered:
• Reagents & Kits
• Analyzers
• Software & Services
• Other Product Types
Platforms Covered:
• Laboratory-Based
• Point-of-Care (POC) Testing
Technologies Covered:
• Enzyme-Linked Immunosorbent Assay (ELISA)
• Chemiluminescence Immunoassays (CLIA)
• Fluorescence Immunoassays (FIA)
• Radioimmunoassay (RIA)
• Lateral Flow Assays
• Others Technologies
Specimen Types Covered:
• Blood
• Urine
• Saliva
• Other Specimens
Applications Covered:
• Infectious Diseases
• Therapeutic Drug Monitoring
• Oncology
• Autoimmune Diseases
• Cardiology
• Endocrinology
• Other Applications
End Users Covered:
• Hospitals & Clinics
• Diagnostic Laboratories
• Academic & Research Institutes
• Pharmaceutical & Biotechnology Companies
• Blood Banks
• Home Care Settings
• Other End Users
Regions Covered:
• North America
o US
o Canada
o Mexico
• Europe
o Germany
o UK
o Italy
o France
o Spain
o Rest of Europe
• Asia Pacific
o Japan
o China
o India
o Australia
o New Zealand
o South Korea
o Rest of Asia Pacific
• South America
o Argentina
o Brazil
o Chile
o Rest of South America
• Middle East & Africa
o Saudi Arabia
o UAE
o Qatar
o South Africa
o Rest of Middle East & Africa
What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2024, 2025, 2026, 2028, and 2032
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements
Free Customization Offerings:
All the customers of this report will be entitled to receive one of the following free customization options:
• Company Profiling
o Comprehensive profiling of additional market players (up to 3)
o SWOT Analysis of key players (up to 3)
• Regional Segmentation
o Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
o Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances
Table of Contents
1 Executive Summary
2 Preface
2.1 Abstract
2.2 Stake Holders
2.3 Research Scope
2.4 Research Methodology
2.4.1 Data Mining
2.4.2 Data Analysis
2.4.3 Data Validation
2.4.4 Research Approach
2.5 Research Sources
2.5.1 Primary Research Sources
2.5.2 Secondary Research Sources
2.5.3 Assumptions
3 Market Trend Analysis
3.1 Introduction
3.2 Drivers
3.3 Restraints
3.4 Opportunities
3.5 Threats
3.6 Product Analysis
3.7 Technology Analysis
3.8 Application Analysis
3.9 End User Analysis
3.10 Emerging Markets
3.11 Impact of Covid-19
4 Porters Five Force Analysis
4.1 Bargaining power of suppliers
4.2 Bargaining power of buyers
4.3 Threat of substitutes
4.4 Threat of new entrants
4.5 Competitive rivalry
5 Global Immunoassay Market, By Product Type
5.1 Introduction
5.2 Reagents & Kits
5.2.1 ELISA Kits
5.2.2 Rapid Test Kits
5.2.3 Western Blot Kits
5.2.4 PCR-based Kits
5.3 Analyzers
5.3.1 Open-Ended Systems
5.3.2 Closed-Ended Systems
5.4 Software & Services
5.4.1 Data Management Software
5.4.2 Maintenance Services
5.4.3 Validation & Custom Services
5.5 Other Product Types
6 Global Immunoassay Market, By Platform
6.1 Introduction
6.2 Laboratory-Based
6.3 Point-of-Care (POC) Testing
7 Global Immunoassay Market, By Technology
7.1 Introduction
7.2 Enzyme-Linked Immunosorbent Assay (ELISA)
7.3 Chemiluminescence Immunoassays (CLIA)
7.4 Fluorescence Immunoassays (FIA)
7.5 Radioimmunoassay (RIA)
7.6 Lateral Flow Assays
7.7 Others Technologies
8 Global Immunoassay Market, By Specimen Type
8.1 Introduction
8.2 Blood
8.3 Urine
8.4 Saliva
8.5 Other Specimens
9 Global Immunoassay Market, By Application
9.1 Introduction
9.2 Infectious Diseases
9.3 Therapeutic Drug Monitoring
9.4 Oncology
9.5 Autoimmune Diseases
9.6 Cardiology
9.7 Endocrinology
9.8 Other Applications
10 Global Immunoassay Market, By End User
10.1 Introduction
10.2 Hospitals & Clinics
10.3 Diagnostic Laboratories
10.4 Academic & Research Institutes
10.5 Pharmaceutical & Biotechnology Companies
10.6 Blood Banks
10.7 Home Care Settings
10.8 Other End Users
11 Global Immunoassay Market, By Geography
11.1 Introduction
11.2 North America
11.2.1 US
11.2.2 Canada
11.2.3 Mexico
11.3 Europe
11.3.1 Germany
11.3.2 UK
11.3.3 Italy
11.3.4 France
11.3.5 Spain
11.3.6 Rest of Europe
11.4 Asia Pacific
11.4.1 Japan
11.4.2 China
11.4.3 India
11.4.4 Australia
11.4.5 New Zealand
11.4.6 South Korea
11.4.7 Rest of Asia Pacific
11.5 South America
11.5.1 Argentina
11.5.2 Brazil
11.5.3 Chile
11.5.4 Rest of South America
11.6 Middle East & Africa
11.6.1 Saudi Arabia
11.6.2 UAE
11.6.3 Qatar
11.6.4 South Africa
11.6.5 Rest of Middle East & Africa
12 Key Developments
12.1 Agreements, Partnerships, Collaborations and Joint Ventures
12.2 Acquisitions & Mergers
12.3 New Product Launch
12.4 Expansions
12.5 Other Key Strategies
13 Company Profiling
13.1 Abbott Laboratories
13.2 F. Hoffmann-La Roche Ltd.
13.3 Siemens Healthineers
13.4 Danaher Corporation
13.5 Thermo Fisher Scientific Inc.
13.6 bioMérieux SA
13.7 DiaSorin S.p.A.
13.8 Becton, Dickinson and Company (BD)
13.9 Sysmex Corporation
13.10 Bio-Rad Laboratories, Inc.
13.11 QuidelOrtho Corporation
13.12 PerkinElmer Inc.
13.13 QIAGEN N.V.
13.14 Merck KGaA
13.15 Fujirebio, Inc.
List of Tables
1 Global Immunoassay Market Outlook, By Region (2024-2032) ($MN)
2 Global Immunoassay Market Outlook, By Product Type (2024-2032) ($MN)
3 Global Immunoassay Market Outlook, By Reagents & Kits (2024-2032) ($MN)
4 Global Immunoassay Market Outlook, By ELISA Kits (2024-2032) ($MN)
5 Global Immunoassay Market Outlook, By Rapid Test Kits (2024-2032) ($MN)
6 Global Immunoassay Market Outlook, By Western Blot Kits (2024-2032) ($MN)
7 Global Immunoassay Market Outlook, By PCR-based Kits (2024-2032) ($MN)
8 Global Immunoassay Market Outlook, By Analyzers (2024-2032) ($MN)
9 Global Immunoassay Market Outlook, By Open-Ended Systems (2024-2032) ($MN)
10 Global Immunoassay Market Outlook, By Closed-Ended Systems (2024-2032) ($MN)
11 Global Immunoassay Market Outlook, By Software & Services (2024-2032) ($MN)
12 Global Immunoassay Market Outlook, By Data Management Software (2024-2032) ($MN)
13 Global Immunoassay Market Outlook, By Maintenance Services (2024-2032) ($MN)
14 Global Immunoassay Market Outlook, By Validation & Custom Services (2024-2032) ($MN)
15 Global Immunoassay Market Outlook, By Other Product Types (2024-2032) ($MN)
16 Global Immunoassay Market Outlook, By Platform (2024-2032) ($MN)
17 Global Immunoassay Market Outlook, By Laboratory-Based (2024-2032) ($MN)
18 Global Immunoassay Market Outlook, By Point-of-Care (POC) Testing (2024-2032) ($MN)
19 Global Immunoassay Market Outlook, By Technology (2024-2032) ($MN)
20 Global Immunoassay Market Outlook, By Enzyme-Linked Immunosorbent Assay (ELISA) (2024-2032) ($MN)
21 Global Immunoassay Market Outlook, By Chemiluminescence Immunoassays (CLIA) (2024-2032) ($MN)
22 Global Immunoassay Market Outlook, By Fluorescence Immunoassays (FIA) (2024-2032) ($MN)
23 Global Immunoassay Market Outlook, By Radioimmunoassay (RIA) (2024-2032) ($MN)
24 Global Immunoassay Market Outlook, By Lateral Flow Assays (2024-2032) ($MN)
25 Global Immunoassay Market Outlook, By Others Technologies (2024-2032) ($MN)
26 Global Immunoassay Market Outlook, By Specimen Type (2024-2032) ($MN)
27 Global Immunoassay Market Outlook, By Blood (2024-2032) ($MN)
28 Global Immunoassay Market Outlook, By Urine (2024-2032) ($MN)
29 Global Immunoassay Market Outlook, By Saliva (2024-2032) ($MN)
30 Global Immunoassay Market Outlook, By Other Specimens (2024-2032) ($MN)
31 Global Immunoassay Market Outlook, By Application (2024-2032) ($MN)
32 Global Immunoassay Market Outlook, By Infectious Diseases (2024-2032) ($MN)
33 Global Immunoassay Market Outlook, By Therapeutic Drug Monitoring (2024-2032) ($MN)
34 Global Immunoassay Market Outlook, By Oncology (2024-2032) ($MN)
35 Global Immunoassay Market Outlook, By Autoimmune Diseases (2024-2032) ($MN)
36 Global Immunoassay Market Outlook, By Cardiology (2024-2032) ($MN)
37 Global Immunoassay Market Outlook, By Endocrinology (2024-2032) ($MN)
38 Global Immunoassay Market Outlook, By Other Applications (2024-2032) ($MN)
39 Global Immunoassay Market Outlook, By End User (2024-2032) ($MN)
40 Global Immunoassay Market Outlook, By Hospitals & Clinics (2024-2032) ($MN)
41 Global Immunoassay Market Outlook, By Diagnostic Laboratories (2024-2032) ($MN)
42 Global Immunoassay Market Outlook, By Academic & Research Institutes (2024-2032) ($MN)
43 Global Immunoassay Market Outlook, By Pharmaceutical & Biotechnology Companies (2024-2032) ($MN)
44 Global Immunoassay Market Outlook, By Blood Banks (2024-2032) ($MN)
45 Global Immunoassay Market Outlook, By Home Care Settings (2024-2032) ($MN)
46 Global Immunoassay Market Outlook, By Other End Users (2024-2032) ($MN)
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.
List of Figures
RESEARCH METHODOLOGY
We at ‘Stratistics’ opt for an extensive research approach which involves data mining, data validation, and data analysis. The various research sources include in-house repository, secondary research, competitor’s sources, social media research, client internal data, and primary research.
Our team of analysts prefers the most reliable and authenticated data sources in order to perform the comprehensive literature search. With access to most of the authenticated data bases our team highly considers the best mix of information through various sources to obtain extensive and accurate analysis.
Each report takes an average time of a month and a team of 4 industry analysts. The time may vary depending on the scope and data availability of the desired market report. The various parameters used in the market assessment are standardized in order to enhance the data accuracy.
Data Mining
The data is collected from several authenticated, reliable, paid and unpaid sources and is filtered depending on the scope & objective of the research. Our reports repository acts as an added advantage in this procedure. Data gathering from the raw material suppliers, distributors and the manufacturers is performed on a regular basis, this helps in the comprehensive understanding of the products value chain. Apart from the above mentioned sources the data is also collected from the industry consultants to ensure the objective of the study is in the right direction.
Market trends such as technological advancements, regulatory affairs, market dynamics (Drivers, Restraints, Opportunities and Challenges) are obtained from scientific journals, market related national & international associations and organizations.
Data Analysis
From the data that is collected depending on the scope & objective of the research the data is subjected for the analysis. The critical steps that we follow for the data analysis include:
- Product Lifecycle Analysis
- Competitor analysis
- Risk analysis
- Porters Analysis
- PESTEL Analysis
- SWOT Analysis
The data engineering is performed by the core industry experts considering both the Marketing Mix Modeling and the Demand Forecasting. The marketing mix modeling makes use of multiple-regression techniques to predict the optimal mix of marketing variables. Regression factor is based on a number of variables and how they relate to an outcome such as sales or profits.
Data Validation
The data validation is performed by the exhaustive primary research from the expert interviews. This includes telephonic interviews, focus groups, face to face interviews, and questionnaires to validate our research from all aspects. The industry experts we approach come from the leading firms, involved in the supply chain ranging from the suppliers, distributors to the manufacturers and consumers so as to ensure an unbiased analysis.
We are in touch with more than 15,000 industry experts with the right mix of consultants, CEO's, presidents, vice presidents, managers, experts from both supply side and demand side, executives and so on.
The data validation involves the primary research from the industry experts belonging to:
- Leading Companies
- Suppliers & Distributors
- Manufacturers
- Consumers
- Industry/Strategic Consultants
Apart from the data validation the primary research also helps in performing the fill gap research, i.e. providing solutions for the unmet needs of the research which helps in enhancing the reports quality.
For more details about research methodology, kindly write to us at info@strategymrc.com
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