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Immunoassay Market - Global Forecast 2025-2032

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    Report

  • 187 Pages
  • November 2025
  • Region: Global
  • 360iResearch™
  • ID: 4904903
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The immunoassay market is undergoing rapid transformation, powered by technological innovation and evolving healthcare needs. Senior executives navigating this sector will find themselves at the center of a dynamic landscape where clinical demand meets next-generation diagnostic capabilities.

Market Snapshot: Growth and Trajectory in the Immunoassay Market

The immunoassay market grew from USD 28.29 billion in 2024 to USD 30.38 billion in 2025. Sustained by a compound annual growth rate (CAGR) of 7.37%, it is projected to reach USD 49.98 billion by 2032. This trajectory is catalyzed by the integration of automated platforms, digital analytics, and the increasing necessity for precise biomarker detection in diagnostics, research, and healthcare management. The primary keyword, immunoassay market, underpins this expansion, reflecting the sector’s essentiality in shaping modern diagnostics and personalized medicine.

Scope & Segmentation: Comprehensive View of Technologies, Applications, and Geography

  • Type: Qualitative immunoassays, Quantitative immunoassays
  • Technology: Enzyme immunoassays, Enzyme-linked immunosorbent assay, Fluorescent immunoassay, Lateral flow assay, Radioimmunoassay, Western blot
  • Instruments: Analyzers & kits, Biosensors, Microfluidic devices, Microplates, PCR devices, Reagents (antibodies, antigens, blocking reagents, buffers & standards, enzymes, substrates), Software & services
  • Sample Types: Blood, saliva, tissue, urine
  • Detection Modes: Chemiluminescent, colorimetric, fluorometric, radioisotopic
  • Application Areas: Allergy, autoimmune diseases, cardiology, endocrinology, infectious diseases, oncology, toxicology (drug screening, environmental testing)
  • End Users: Contract research organizations, diagnostic laboratories, hospitals & clinics, pharmaceutical & biotechnology companies, research institutions
  • Deployment Types: Laboratory tests, point-of-care tests
  • Regions: Americas (United States, Canada, Mexico, Brazil, Argentina, Chile, Colombia, Peru), Europe (United Kingdom, Germany, France, Russia, Italy, Spain, Netherlands, Sweden, Poland, Switzerland), Middle East (United Arab Emirates, Saudi Arabia, Qatar, Turkey, Israel), Africa (South Africa, Nigeria, Egypt, Kenya), Asia-Pacific (China, India, Japan, Australia, South Korea, Indonesia, Thailand, Malaysia, Singapore, Taiwan)
  • Companies Covered: Abbott Laboratories, Agilent Technologies, Almac Group, ANP Technologies, Autobio Diagnostics, Becton Dickinson, Bio-Rad Laboratories, Bio-Techne, BioLegend, bioMérieux, Biosurfit, Boditech Med, Charles River Laboratories, Danaher, Diasorin, Dynex Technologies, Epitope Diagnostics, Roche, Fapon Biotech, Gyros Protein Technologies, H.U. Group Holdings, J. Mitra, Kamiya Biomedical, Philips, Merck, MiCo BioMed, NanoEntek, Nanōmix, OPKO Health, Promega, QIAGEN, Quanterix, QuidelOrtho, Randox Laboratories, Revvity, Sekisui Diagnostics, Shenzhen Micropoint, Shenzhen Mindray, Siemens Healthineers, Sysmex, Tecan, Thermo Fisher, Tosoh Corporation, WAK-Chemie Medical, Zoetis, Zybio

Key Takeaways: Strategic Insights for Senior Decision-Makers

  • Immunoassay platforms are transitioning to fully automated, high-throughput systems, reducing manual intervention and operational bottlenecks in laboratories.
  • Development of multiplex and digital immunoassay technologies enhances the capacity for simultaneous biomarker analysis and real-time patient insights.
  • Microfluidic platforms and portable devices are supporting decentralized diagnostics, catering to the growing demand for point-of-care and near-patient testing.
  • Adoption of artificial intelligence and advanced analytics enables predictive insights for patient stratification and improved clinical decision-making.
  • Regional dynamics reveal diverse growth drivers: mature healthcare infrastructure and innovation funding propel adoption in the Americas and Europe, while Asia-Pacific and select African and Middle Eastern markets focus on laboratory expansion and technology transfer.
  • Leading companies are leveraging strategic partnerships and portfolio diversification to strengthen market presence and respond to evolving clinical and regulatory environments.

Tariff Impact: Navigating Policy-Driven Supply Chain Complexities

Recent United States tariff measures have introduced heightened supply chain complexity for immunoassay manufacturers. This policy shift has driven reevaluations in sourcing, cost management, and inventory planning. Some firms are expanding domestic operations or seeking alternative partners in untaxed regions, while others are optimizing procurement strategies and communicating transparently with clients to mitigate further risk exposure and maintain supply continuity.

Methodology & Data Sources

This report was developed using a phased methodology: comprehensive secondary research, expert interviews with industry stakeholders, and rigorous triangulation of qualitative and quantitative data. Cross-functional peer review and scenario validation ensured the reliability of all findings.

Why This Report Matters

  • Enables business leaders to make informed investments and innovation decisions based on robust, segment-specific insights.
  • Offers clarity on global drivers, regional opportunities, and competitive strategies for scalable market growth.
  • Equips procurement and R&D leaders to adapt to regulatory shifts and manage supply chain risks effectively.

Conclusion

The immunoassay market continues to evolve through synergy among innovation, operational adaptability, and data-driven strategies. Stakeholders positioned for collaboration and technological advancement will capture the most value from this expanding sector.

 

Additional Product Information:

  • Purchase of this report includes 1 year online access with quarterly updates.
  • This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.

Table of Contents

1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Rapid point-of-care immunoassays enabling decentralized COVID-19 and influenza testing with integrated digital readout platforms
5.2. Multiplexed microfluidic immunoassays driving high-throughput biomarker profiling in oncology and autoimmune disorder diagnostics
5.3. Nanoparticle-enhanced immunoassays boosting ultrasensitive detection of low-abundance serum biomarkers for early disease screening
5.4. Adoption of recombinant antibody fragments in immunoassays improving batch consistency and reducing cross-reactivity in clinical labs
5.5. Integration of artificial intelligence algorithms in immunoassay data analysis for real-time anomaly detection and reporting
5.6. Transition from analog to digital immunoassays leveraging single-molecule counting for enhanced quantitative precision in research settings
5.7. Development of lateral flow immunoassays with smartphone-based quantification for home monitoring of chronic disease biomarkers
5.8. Expansion of immunoassay-based companion diagnostics to guide targeted therapy selection in personalized oncology treatment regimens
5.9. Regulatory convergence and harmonization of immunoassay validation guidelines accelerating global product approvals and market entry timelines
5.10. Implementation of automated high-throughput immunoassay workstations to streamline serum and plasma sample processing in large clinical labs
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Immunoassay Market, by Type
8.1. Qualitative Immunoassays
8.2. Quantitative Immunoassays
9. Immunoassay Market, by Technology
9.1. Enzyme Immunoassays
9.2. Enzyme-Linked Immunosorbent Assay
9.3. Fluorescent Immunoassay
9.4. Lateral Flow Assay
9.5. Radioimmunoassay
9.6. Western Blot
10. Immunoassay Market, by Instruments
10.1. Analyzers & Kits
10.2. Biosensors
10.3. Microfluidic Devices
10.4. Microplates
10.5. PCR Devices
10.6. Reagents
10.6.1. Antibodies
10.6.2. Antigens
10.6.3. Blocking Reagents
10.6.4. Buffers & Standards
10.6.5. Enzymes
10.6.6. Substrates
10.7. Software & Services
11. Immunoassay Market, by Sample Types
11.1. Blood Samples
11.2. Saliva Samples
11.3. Tissue Samples
11.4. Urine Samples
12. Immunoassay Market, by Detection Modes
12.1. Chemiluminescent
12.2. Colorimetric
12.3. Fluorometric
12.4. Radioisotopic
13. Immunoassay Market, by Application Areas
13.1. Allergy
13.2. Autoimmune Diseases
13.3. Cardiology
13.4. Endocrinology
13.5. Infectious Diseases
13.6. Oncology
13.7. Toxicology
13.7.1. Drug Screening
13.7.2. Environmental Testing
14. Immunoassay Market, by End Users
14.1. Contract Research Organizations
14.2. Diagnostic Laboratories
14.3. Hospitals & Clinics
14.4. Pharmaceutical & Biotechnology Companies
14.5. Research Institutions
15. Immunoassay Market, by Deployment Types
15.1. Laboratory Tests
15.2. Point-of-care Test
16. Immunoassay Market, by Region
16.1. Americas
16.1.1. North America
16.1.2. Latin America
16.2. Europe, Middle East & Africa
16.2.1. Europe
16.2.2. Middle East
16.2.3. Africa
16.3. Asia-Pacific
17. Immunoassay Market, by Group
17.1. ASEAN
17.2. GCC
17.3. European Union
17.4. BRICS
17.5. G7
17.6. NATO
18. Immunoassay Market, by Country
18.1. United States
18.2. Canada
18.3. Mexico
18.4. Brazil
18.5. United Kingdom
18.6. Germany
18.7. France
18.8. Russia
18.9. Italy
18.10. Spain
18.11. China
18.12. India
18.13. Japan
18.14. Australia
18.15. South Korea
19. Competitive Landscape
19.1. Market Share Analysis, 2024
19.2. FPNV Positioning Matrix, 2024
19.3. Competitive Analysis
19.3.1. Abbott Laboratories
19.3.2. Agilent Technologies Inc.
19.3.3. Almac Group Limited
19.3.4. ANP Technologies, Inc.
19.3.5. Autobio Diagnostics Co., Ltd.
19.3.6. Becton, Dickinson and Company
19.3.7. Bio-Rad Laboratories, Inc.
19.3.8. Bio-Techne Corporation
19.3.9. BioLegend, Inc.
19.3.10. bioMérieux S.A.
19.3.11. Biosurfit SA
19.3.12. Boditech Med Inc.
19.3.13. Charles River Laboratories International, Inc.
19.3.14. Danaher Corporation
19.3.15. Diasorin S.p.A.
19.3.16. Dynex Technologies, Inc.
19.3.17. Epitope Diagnostics Inc.
19.3.18. F. Hoffmann-La Roche Ltd.
19.3.19. Fapon Biotech Inc.
19.3.20. Gyros Protein Technologies AB by Mesa Laboratories, Inc.
19.3.21. H.U. Group Holdings Inc.
19.3.22. J. Mitra & Co. Pvt. Ltd.
19.3.23. Kamiya Biomedical Company
19.3.24. Koninklijke Philips N.V.
19.3.25. Merck KGaA
19.3.26. MiCo BioMed, Inc.
19.3.27. NanoEntek
19.3.28. Nanomix, Inc.
19.3.29. OPKO Health, Inc.
19.3.30. Promega Corporation
19.3.31. QIAGEN N.V.
19.3.32. Quanterix Corporation
19.3.33. QuidelOrtho Corporation
19.3.34. Randox Laboratories Ltd.
19.3.35. Revvity, Inc. (Formarly PerkinElmer, Inc.)
19.3.36. Sekisui Diagnostics, LLC
19.3.37. Shenzhen Micropoint Biotechnologies Co., Ltd.
19.3.38. Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
19.3.39. Siemens Healthineers AG
19.3.40. Sysmex Corporation
19.3.41. Tecan Trading AG
19.3.42. Thermo Fisher Scientific Inc.
19.3.43. Tosoh Corporation
19.3.44. WAK-Chemie Medical GmbH
19.3.45. Zoetis Inc.
19.3.46. Zybio Inc.

Companies Mentioned

The companies profiled in this Immunoassay market report include:
  • Abbott Laboratories
  • Agilent Technologies Inc.
  • Almac Group Limited
  • ANP Technologies, Inc.
  • Autobio Diagnostics Co., Ltd.
  • Becton, Dickinson and Company
  • Bio-Rad Laboratories, Inc.
  • Bio-Techne Corporation
  • BioLegend, Inc.
  • bioMérieux S.A.
  • Biosurfit SA
  • Boditech Med Inc.
  • Charles River Laboratories International, Inc.
  • Danaher Corporation
  • Diasorin S.p.A.
  • Dynex Technologies, Inc.
  • Epitope Diagnostics Inc.
  • F. Hoffmann-La Roche Ltd.
  • Fapon Biotech Inc.
  • Gyros Protein Technologies AB by Mesa Laboratories, Inc.
  • H.U. Group Holdings Inc.
  • J. Mitra & Co. Pvt. Ltd.
  • Kamiya Biomedical Company
  • Koninklijke Philips N.V.
  • Merck KGaA
  • MiCo BioMed, Inc.
  • NanoEntek
  • Nanōmix, Inc.
  • OPKO Health, Inc.
  • Promega Corporation
  • QIAGEN N.V.
  • Quanterix Corporation
  • QuidelOrtho Corporation
  • Randox Laboratories Ltd.
  • Revvity, Inc. (Formarly PerkinElmer, Inc.)
  • Sekisui Diagnostics, LLC
  • Shenzhen Micropoint Biotechnologies Co., Ltd.
  • Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
  • Siemens Healthineers AG
  • Sysmex Corporation
  • Tecan Trading AG
  • Thermo Fisher Scientific Inc.
  • Tosoh Corporation
  • WAK-Chemie Medical GmbH
  • Zoetis Inc.
  • Zybio Inc.

Table Information