The global market for Immunodiagnostics was valued at US$24.6 Billion in 2024 and is projected to reach US$29.9 Billion by 2030, growing at a CAGR of 3.3% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The report includes the most recent global tariff developments and how they impact the Immunodiagnostics market.
Their utility spans both qualitative and quantitative applications, ranging from enzyme-linked immunosorbent assays (ELISA) and chemiluminescent immunoassays (CLIA) to lateral flow immunoassays used in point-of-care testing. With increasing demand for decentralized diagnostics and home-based health monitoring, immunodiagnostics are also being integrated into compact platforms and multiplexed test formats, making them more accessible and efficient in both clinical and non-clinical settings.
Additionally, smartphone-linked devices and microfluidic lab-on-chip technologies are expanding point-of-care applications, especially in resource-limited settings. AI-driven algorithms are being integrated into diagnostic software to improve interpretation accuracy and clinical decision-making. Moreover, the incorporation of fluorescence, electrochemical, and photonic detection techniques is enhancing the analytical performance of immunodiagnostic tools, making them more reliable for personalized and precision medicine.
North America dominates due to the presence of leading diagnostic firms, high healthcare spending, and a strong regulatory framework. Europe follows with growing emphasis on preventive diagnostics and screening programs. Asia-Pacific is the fastest-growing region, driven by rising healthcare access in countries like China and India, increasing awareness of early diagnosis, and expanding insurance coverage. Africa and Latin America are also seeing growing adoption as infrastructure and disease surveillance programs improve.
From an end-use perspective, the rising adoption of home-based testing, growing investment in personalized medicine, and the integration of immunodiagnostics in drug development workflows are fueling demand. Government screening programs, especially in oncology and infectious diseases, and the expansion of decentralized lab networks are also key growth contributors. As diagnostic precision becomes increasingly vital in modern healthcare, immunodiagnostics will continue to be a cornerstone of laboratory medicine worldwide.
Segments: Product Type (Reagents, Instruments, Software & Services); Technology (Enzyme-linked Immunosorbent Assay, Chemiluminescence Immunoassay, Fluorescent Immunoassay, Radioimmunoassay, Other Technologies); Application (Infectious Diseases, Oncology & Endocrinology, Bone & Mineral Diseases, Autoimmune Disorders, Cardiac Biomarkers, Drug Monitoring, Other Applications); End-Use (Hospitals, Clinical Laboratories, Academic & Research Institutes, Other End-Uses).
Geographic Regions/Countries: World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.
The analysts continuously track trade developments worldwide, drawing insights from leading global economists and over 200 industry and policy institutions, including think tanks, trade organizations, and national economic advisory bodies. This intelligence is integrated into forecasting models to provide timely, data-driven analysis of emerging risks and opportunities.
Global Immunodiagnostics Market - Key Trends & Drivers Summarized
Why Are Immunodiagnostics Critical in Early Disease Detection and Monitoring?
Immunodiagnostics are laboratory-based diagnostic techniques that utilize antigen-antibody interactions to detect and quantify biomarkers in patient samples such as blood, urine, or saliva. These tests are crucial in diagnosing infectious diseases, autoimmune disorders, hormonal imbalances, cancer, and allergies. They are widely used in hospitals, diagnostic laboratories, and research institutions for their high specificity, sensitivity, and rapid turnaround time. As healthcare systems focus on preventive diagnostics and early intervention, immunodiagnostic tools are becoming foundational in modern medical testing.Their utility spans both qualitative and quantitative applications, ranging from enzyme-linked immunosorbent assays (ELISA) and chemiluminescent immunoassays (CLIA) to lateral flow immunoassays used in point-of-care testing. With increasing demand for decentralized diagnostics and home-based health monitoring, immunodiagnostics are also being integrated into compact platforms and multiplexed test formats, making them more accessible and efficient in both clinical and non-clinical settings.
How Are Technological Innovations Enhancing Test Accuracy and Speed?
The immunodiagnostics market is undergoing rapid transformation through advancements in assay chemistry, biosensor design, and detection systems. High-throughput automated analyzers, nanomaterial-enhanced immunoassays, and digital immunoassay platforms are significantly improving test sensitivity and multiplexing capabilities. These innovations are allowing for the simultaneous detection of multiple biomarkers from a single sample, which is particularly beneficial in cancer screening, autoimmune profiling, and infectious disease panels.Additionally, smartphone-linked devices and microfluidic lab-on-chip technologies are expanding point-of-care applications, especially in resource-limited settings. AI-driven algorithms are being integrated into diagnostic software to improve interpretation accuracy and clinical decision-making. Moreover, the incorporation of fluorescence, electrochemical, and photonic detection techniques is enhancing the analytical performance of immunodiagnostic tools, making them more reliable for personalized and precision medicine.
Which Applications and Regions Are Driving Demand for Immunodiagnostic Testing?
Key clinical applications include infectious disease diagnostics (e.g., HIV, hepatitis, COVID-19), oncology markers (e.g., PSA, CA125), cardiovascular risk profiling (e.g., troponins), and autoimmune panels (e.g., ANA, rheumatoid factor). Hospitals and diagnostic labs remain the largest end-users, followed by home healthcare, academic research centers, and biopharmaceutical companies. The demand for immunodiagnostic testing is especially strong in chronic disease management and post-surgical monitoring.North America dominates due to the presence of leading diagnostic firms, high healthcare spending, and a strong regulatory framework. Europe follows with growing emphasis on preventive diagnostics and screening programs. Asia-Pacific is the fastest-growing region, driven by rising healthcare access in countries like China and India, increasing awareness of early diagnosis, and expanding insurance coverage. Africa and Latin America are also seeing growing adoption as infrastructure and disease surveillance programs improve.
The Growth in the Immunodiagnostics Market Is Driven by Several Factors…
The growth in the immunodiagnostics market is driven by several factors including the global rise in chronic and infectious diseases, advances in assay automation and sensitivity, and increasing demand for rapid and accurate diagnostics. Technological improvements in multiplex immunoassays, lab-on-chip systems, and AI-enhanced test platforms are expanding both clinical and point-of-care use. Regulatory approvals for new biomarkers and test kits are also contributing to market expansion.From an end-use perspective, the rising adoption of home-based testing, growing investment in personalized medicine, and the integration of immunodiagnostics in drug development workflows are fueling demand. Government screening programs, especially in oncology and infectious diseases, and the expansion of decentralized lab networks are also key growth contributors. As diagnostic precision becomes increasingly vital in modern healthcare, immunodiagnostics will continue to be a cornerstone of laboratory medicine worldwide.
Report Scope
The report analyzes the Immunodiagnostics market, presented in terms of market value (US$ Thousand). The analysis covers the key segments and geographic regions outlined below.Segments: Product Type (Reagents, Instruments, Software & Services); Technology (Enzyme-linked Immunosorbent Assay, Chemiluminescence Immunoassay, Fluorescent Immunoassay, Radioimmunoassay, Other Technologies); Application (Infectious Diseases, Oncology & Endocrinology, Bone & Mineral Diseases, Autoimmune Disorders, Cardiac Biomarkers, Drug Monitoring, Other Applications); End-Use (Hospitals, Clinical Laboratories, Academic & Research Institutes, Other End-Uses).
Geographic Regions/Countries: World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.
Key Insights:
- Market Growth: Understand the significant growth trajectory of the Immunodiagnostics Reagents segment, which is expected to reach US$16.8 Billion by 2030 with a CAGR of a 3.9%. The Immunodiagnostics Instruments segment is also set to grow at 2.7% CAGR over the analysis period.
- Regional Analysis: Gain insights into the U.S. market, valued at $6.7 Billion in 2024, and China, forecasted to grow at an impressive 6.3% CAGR to reach $6.0 Billion by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.
Why You Should Buy This Report:
- Detailed Market Analysis: Access a thorough analysis of the Global Immunodiagnostics Market, covering all major geographic regions and market segments.
- Competitive Insights: Get an overview of the competitive landscape, including the market presence of major players across different geographies.
- Future Trends and Drivers: Understand the key trends and drivers shaping the future of the Global Immunodiagnostics Market.
- Actionable Insights: Benefit from actionable insights that can help you identify new revenue opportunities and make strategic business decisions.
Key Questions Answered:
- How is the Global Immunodiagnostics Market expected to evolve by 2030?
- What are the main drivers and restraints affecting the market?
- Which market segments will grow the most over the forecast period?
- How will market shares for different regions and segments change by 2030?
- Who are the leading players in the market, and what are their prospects?
Report Features:
- Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2024 to 2030.
- In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
- Company Profiles: Coverage of players such as Abbott Laboratories, Agilent Technologies, Inc., bioMérieux SA, Bio-Rad Laboratories Inc., Cepheid and more.
- Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.
Some of the 34 companies featured in this Immunodiagnostics market report include:
- Abbott Laboratories
- Agilent Technologies, Inc.
- bioMérieux SA
- Bio-Rad Laboratories Inc.
- Cepheid
- DiaSorin S.p.A.
- Erba Diagnostics Mannheim GmbH
- F. Hoffmann-La Roche AG
- Grifols, S.A.
- Guardant Health
- Illumina, Inc.
- Immunodiagnostic Systems Holdings PLC
- Inova Diagnostics, Inc.
- Johnson & Johnson
- NeoGenomics Laboratories
- Quest Diagnostics Incorporated
- Siemens Healthineers AG
- Sysmex Corporation
- Thermo Fisher Scientific Inc.
- Trinity Biotech plc
Tariff Impact Analysis: Key Insights for 2025
Global tariff negotiations across 180+ countries are reshaping supply chains, costs, and competitiveness. This report reflects the latest developments as of April 2025 and incorporates forward-looking insights into the market outlook.The analysts continuously track trade developments worldwide, drawing insights from leading global economists and over 200 industry and policy institutions, including think tanks, trade organizations, and national economic advisory bodies. This intelligence is integrated into forecasting models to provide timely, data-driven analysis of emerging risks and opportunities.
What's Included in This Edition:
- Tariff-adjusted market forecasts by region and segment
- Analysis of cost and supply chain implications by sourcing and trade exposure
- Strategic insights into geographic shifts
Buyers receive a free July 2025 update with:
- Finalized tariff impacts and new trade agreement effects
- Updated projections reflecting global sourcing and cost shifts
- Expanded country-specific coverage across the industry
Table of Contents
I. METHODOLOGYII. EXECUTIVE SUMMARY2. FOCUS ON SELECT PLAYERSIII. MARKET ANALYSISCANADAITALYSPAINRUSSIAREST OF EUROPESOUTH KOREAREST OF ASIA-PACIFICARGENTINABRAZILMEXICOREST OF LATIN AMERICAIRANISRAELSAUDI ARABIAUNITED ARAB EMIRATESREST OF MIDDLE EASTIV. COMPETITION
1. MARKET OVERVIEW
3. MARKET TRENDS & DRIVERS
4. GLOBAL MARKET PERSPECTIVE
UNITED STATES
JAPAN
CHINA
EUROPE
FRANCE
GERMANY
UNITED KINGDOM
ASIA-PACIFIC
AUSTRALIA
INDIA
LATIN AMERICA
MIDDLE EAST
AFRICA
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Abbott Laboratories
- Agilent Technologies, Inc.
- bioMérieux SA
- Bio-Rad Laboratories Inc.
- Cepheid
- DiaSorin S.p.A.
- Erba Diagnostics Mannheim GmbH
- F. Hoffmann-La Roche AG
- Grifols, S.A.
- Guardant Health
- Illumina, Inc.
- Immunodiagnostic Systems Holdings PLC
- Inova Diagnostics, Inc.
- Johnson & Johnson
- NeoGenomics Laboratories
- Quest Diagnostics Incorporated
- Siemens Healthineers AG
- Sysmex Corporation
- Thermo Fisher Scientific Inc.
- Trinity Biotech plc
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 484 |
| Published | May 2025 |
| Forecast Period | 2024 - 2030 |
| Estimated Market Value ( USD | $ 24.6 Billion |
| Forecasted Market Value ( USD | $ 29.9 Billion |
| Compound Annual Growth Rate | 3.3% |
| Regions Covered | Global |
