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Immunoassay Market - Global Forecast 2025-2032

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    Report

  • 187 Pages
  • October 2025
  • Region: Global
  • 360iResearch™
  • ID: 4904903
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The Immunoassay Market is rapidly evolving, providing essential solutions that underpin diagnostics, healthcare innovation, and biomedical research. Senior decision-makers seeking to optimize strategies and capture emerging opportunities require precise, actionable market intelligence to navigate this dynamic environment.

Market Snapshot: Immunoassay Market Growth and Outlook

The global Immunoassay Market advanced from USD 28.29 billion in 2024 to USD 30.38 billion in 2025, and is forecast to propel further at a CAGR of 7.37%, reaching USD 49.98 billion by 2032. This growth trajectory highlights transformative industry shifts fueled by technological innovation, regulatory change, and the need for advanced diagnostic platforms across clinical and research settings.

Scope & Segmentation

  • 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 (including Antibodies, Antigens, Blocking Reagents, Buffers & Standards, Enzymes, Substrates), Software & Services
  • Sample Types: Blood Samples, Saliva Samples, Tissue Samples, Urine Samples
  • 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 Test
  • Regional Coverage: Americas (including North America: United States, Canada, Mexico; Latin America: Brazil, Argentina, Chile, Colombia, Peru), Europe, Middle East & Africa (incorporating United Kingdom, Germany, France, Russia, Italy, Spain, Netherlands, Sweden, Poland, Switzerland, United Arab Emirates, Saudi Arabia, Qatar, Turkey, Israel, South Africa, Nigeria, Egypt, Kenya), Asia-Pacific (China, India, Japan, Australia, South Korea, Indonesia, Thailand, Malaysia, Singapore, Taiwan)
  • Key Players: 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. (Formally 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.

Key Takeaways

  • Immunoassay advancements are transitioning from manual to highly automated, data-integrated platforms, facilitating wider adoption in both central labs and point-of-care environments.
  • Sophisticated technologies like microfluidics and multiplexing are reducing assay times and sample requirements, enabling comprehensive testing from minimal patient samples.
  • Digital and AI-driven analytics are becoming integral to workflows, supporting improved patient stratification and enhancing the precision of diagnostic outputs for personalized medicine strategies.
  • Segment dynamics show increasing diversity—from traditional enzyme immunoassays to lateral flow and biosensor formats—addressing both established and emerging needs across broad clinical specialties.
  • Regionally, strong infrastructure and reimbursement strategies drive innovation uptake in the Americas, whereas emerging Asia-Pacific and EMEA markets are scaling capacity and expanding local technology partnerships.
  • Leading players are leveraging innovation in reagents and analyzer platforms, while forging strategic alliances for greater market access and responsive service models.

Tariff Impact: Navigating 2025 Trade Dynamics

Recent United States tariff policies on immunoassay instruments and consumables have influenced supply chain and procurement strategies. Organizations are implementing dual sourcing and investing in domestic production where feasible. Such approaches enhance flexibility and reduce exposure to policy-driven cost fluctuations, empowering stakeholders to maintain stable supply channels and foster customer trust despite regulatory uncertainty.

Methodology & Data Sources

This analysis draws on an extensive multi-phase process including secondary research, direct interviews with industry leaders, and triangulation of quantitative market indicators. Rigorous validation—comprising peer review and scenario testing—ensures findings are accurate and decision-ready for strategic planning.

Why This Report Matters

  • Supports strategic decisions by highlighting actionable growth opportunities and risk mitigation strategies in the immunoassay sector.
  • Delivers clarity on evolving technology trends, regional market forces, and shifting procurement scenarios essential for competitive positioning.
  • Equips leaders to anticipate key inflection points and focus investment where innovation will have the strongest market impact.

Conclusion

Innovation, operational agility, and strategic partnerships remain central to capitalizing on Immunoassay Market opportunities. Stakeholders prioritizing diversified sourcing, integrated analytics, and collaborative growth models will be best positioned for future market leadership.

 

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.
List of Tables
List of Figures

Samples

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Companies Mentioned

The key 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