Immunoassay Market by Type, Technology, Instruments, Sample Types, Detection Modes, Application Areas, End Users, Deployment Types

List of Tables

The Immunoassay Market was valued at USD 26.30 billion in 2023 and is projected to grow to USD 28.29 billion in 2024, with a CAGR of 7.24%, reaching USD 42.90 billion by 2030.

KEY MARKET STATISTICS
Base Year [2023]	USD 26.30 billion
Estimated Year [2024]	USD 28.29 billion
Forecast Year [2030]	USD 42.90 billion
CAGR (%)	7.24%

The immunoassay market stands at the forefront of modern diagnostics, offering both superior sensitivity and specificity in detecting a wide array of biomarkers and disease states. Over the past decades, innovation has propelled immunoassays into a central role in both clinical and research settings, driven by the continuous quest for improved health outcomes and the urgent need for early disease detection.

In recent years, this field has expanded through technological advancements and a deeper understanding of biological systems. The integration of novel methodologies has helped bridge the gap between traditional diagnostic practices and the demands of a rapidly changing healthcare industry. Cutting-edge research and an evolving regulatory environment have further accentuated the importance of immunoassays, making them indispensable in disease monitoring, therapeutic development, and clinical management.

Industry experts highlight that the impetus for growth within this market stems from both the quality of detection and the versatility of applications. The progression from conventional methods to more refined techniques has been reinforced by significant improvements in assay design, automation, and data integration. Such developments not only enhance the efficiency of diagnostic procedures but also support a broader spectrum of scientific inquiries and clinical interventions.

Transformative Shifts Redefining the Immunoassay Ecosystem

The immunoassay sector is undergoing transformative shifts that are redefining its operational framework and market dynamics. With innovations continually emerging, the transition from traditional manual assays to robust, automated platforms marks a significant evolution in diagnostic technology. This shift has curtailed turnaround times and increased reproducibility, allowing clinicians and researchers to make more accurate and timely decisions.

Digital transformation and the integration of data analytics have also revolutionized the landscape. Advanced imaging, machine learning algorithms, and real-time monitoring systems now work in tandem with assay instruments to ensure that the complexity of biological markers is captured and interpreted accurately. This fusion of technology not only enhances the accuracy of immunoassays but also broadens their range of applications, from personalized medicine to large-scale epidemiological studies.

Parallel to technological enhancements, regulatory changes and a solid push toward standardization have collectively set a new benchmark for assay performance and reliability. Enhanced quality control measures and stringent compliance protocols are now more prevalent, ensuring that innovations are seamlessly transitioned from research concepts to mainstream clinical tools. These shifts collectively drive a market that is more responsive to healthcare demands and better prepared to meet future challenges with agility and precision.

Key Segmentation Insights Across the Immunoassay Spectrum

For a deeper understanding of the immunoassay market, it is critical to explore the various dimensions that influence its segmentation. The market is studied from multiple perspectives, beginning with the type of immunoassays where qualitative immunoassays and quantitative immunoassays illustrate differences in performance and application that are instrumental for personalized diagnostics. Equally important is the segmentation based on technology; a range of platforms including enzyme immunoassays, enzyme-linked immunosorbent assays, fluorescent immunoassays, lateral flow assays, radioimmunoassays, and the ever-reliable western blot serve as benchmarks for sensitivity and specificity in varied clinical applications.

Moving on, segmentation based on instruments reveals a comprehensive landscape where analyzers and kits, biosensors, microfluidic devices, microplates, PCR devices, reagents, and software and services each contribute distinct value. In particular, the reagent segment stands out as it is further analyzed into subcategories such as antibodies, antigens, blocking reagents, buffers and standards, enzymes, and substrates-all of which play pivotal roles in ensuring assay accuracy and reliability. Complementing these intricate details is the segmentation based on sample types where blood samples, saliva samples, tissue samples, and urine samples offer just a glimpse into the diversity of clinical specimens processed by these tests.

Analysis extends to detection modes that are fundamental to the interpretation of results, encompassing chemiluminescent, colorimetric, fluorometric, and radioisotopic techniques. Equally significant is the segmentation by application areas, which highlights the multi-faceted nature of immunoassays through their deployment in fields such as allergy, autoimmune diseases, cardiology, endocrinology, infectious diseases, oncology, and toxicology, with the latter including specialized segments like drug screening and environmental testing.

Diving deeper, the segmentation based on end users maps out a landscape where contract research organizations, diagnostic laboratories, hospitals and clinics, pharmaceutical and biotechnology companies, alongside research institutions, harness the potential of these assays. Finally, segmentation by deployment types reaffirms the dual approach of integrating both laboratory tests and point-of-care tests, thereby presenting a complete picture of how immunoassays are embedded into modern clinical workflows. Each segmentation element offers critical insights into the market's current state and future potential, ensuring that strategic decisions are informed by a multi-dimensional understanding of this dynamic space.

Based on Type, market is studied across Qualitative Immunoassays and Quantitative Immunoassays.

Based on Technology, market is studied across Enzyme Immunoassays, Enzyme-Linked Immunosorbent Assay, Fluorescent Immunoassay, Lateral Flow Assay, Radioimmunoassay, and Western Blot.

Based on Instruments, market is studied across Analyzers & Kits, Biosensors, Microfluidic Devices, Microplates, PCR Devices, Reagents, and Software & Services. The Reagents is further studied across Antibodies, Antigens, Blocking Reagents, Buffers & Standards, Enzymes, and Substrates.

Based on Sample Types, market is studied across Blood Samples, Saliva Samples, Tissue Samples, and Urine Samples.

Based on Detection Modes, market is studied across Chemiluminescent, Colorimetric, Fluorometric, and Radioisotopic.

Based on Application Areas, market is studied across Allergy, Autoimmune Diseases, Cardiology, Endocrinology, Infectious Diseases, Oncology, and Toxicology. The Toxicology is further studied across Drug Screening and Environmental Testing.

Based on End Users, market is studied across Contract Research Organizations, Diagnostic Laboratories, Hospitals & Clinics, Pharmaceutical & Biotechnology Companies, and Research Institutions.

Based on Deployment Types, market is studied across Laboratory Tests and Point-of-care Test.

Key Regional Insights Shaping Market Trends

The regional dynamics of the immunoassay market provide a nuanced understanding of its growth trajectory and operational challenges across diverse geographical landscapes. In the Americas, rapid technological adoption and substantial investments in healthcare infrastructure have led to significant advances in diagnostic capabilities. With a robust network of hospitals, research centers, and diagnostic laboratories, the region is positioned to harness the expanding applications of immunoassays effectively.

Within Europe, the Middle East, and Africa, a combination of stringent regulatory environments and increasing funding for healthcare innovations is driving progress. Regulatory frameworks in these regions are evolving to better accommodate emerging technologies, thereby fostering an ecosystem where immunoassays can flourish. Moreover, targeted initiatives for improving public health and disease management have further catalyzed the integration of advanced diagnostic tools.

The Asia-Pacific region stands out due to its rapid industrialization and consistent growth in healthcare expenditure, which have spurred the adoption of next-generation immunoassays. Diverse economies within this region contribute unique perspectives, but common threads such as a rising focus on early diagnosis, efficient sample processing, and cost-effective healthcare delivery converge to promote a competitive yet collaborative market environment. As such, each region contributes distinct insights that collectively drive the global advancement of immunoassay technologies, guiding market stakeholders toward a holistic understanding of regional opportunities and challenges.

Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

Key Companies Driving Innovation and Market Expansion

Several leading companies have carved out distinctive positions within the immunoassay market, leveraging innovation and operational expertise to meet evolving industry demands. Major names such as Abbott Laboratories and Agilent Technologies Inc. have been instrumental in advancing assay technologies with a focus on both reliability and efficiency. Companies like Almac Group Limited, ANP Technologies, Inc., and Autobio Diagnostics Co., Ltd. continue to introduce groundbreaking solutions that address a wide range of clinical applications.

Other significant contributors include Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., Bio-Techne Corporation, and BioLegend, Inc., all of which have strengthened their market presence through advanced product offerings and strategic collaborations. Moreover, bioMerieux S.A., Biosurfit SA, and Boditech Med Inc. have consistently pushed the envelope in assay precision and implementation. In addition, multinational giants such as Charles River Laboratories International, Inc. and Danaher Corporation have played a vital role in bolstering market growth through investment in research and innovation.

Further, companies like Diasorin S.p.A., Dynex Technologies, Inc., Epitope Diagnostics Inc., and F. Hoffmann-La Roche Ltd. have continued to lead by example, ensuring that their technological prowess translates into impactful clinical solutions. The list extends with Fapon Biotech Inc., Gyros Protein Technologies AB by Mesa Laboratories, Inc., H.U. Group Holdings Inc., and J. Mitra & Co. Pvt. Ltd. making significant contributions. Additional pioneers such as Kamiya Biomedical Company, Koninklijke Philips N.V., Merck KGaA, and MiCo BioMed, Inc. have also positioned themselves as key players.

Notably, further companies including NanoEntek, Nanomix, Inc., OPKO Health, Inc., Promega Corporation, QIAGEN N.V., Quanterix Corporation, and QuidelOrtho Corporation are continuously redefining industry standards. Contributions from Randox Laboratories Ltd., Revvity, Inc. (formerly 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., and Zybio Inc. further illustrate the collaborative and competitive dynamics that are driving innovation and market expansion in this space.

The report delves into recent significant developments in the Immunoassay Market, highlighting leading vendors and their innovative profiles. These 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., bioMerieux 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, Nanomix, 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., and Zybio Inc.. Actionable Recommendations for Industry Leaders to Bolster Market Position

Industry leaders must adopt a multi-pronged strategy to capitalize on the continuous advancements in the immunoassay sector. A deep dive into emerging technology trends and a commitment to leveraging digital transformation will be crucial in enhancing diagnostic capabilities. Decision makers should focus on integrating automated platforms with advanced data analytics to streamline assay operations, thus contributing to reduced turnaround times and enhanced diagnostic precision.

Investing in comprehensive R&D and fostering collaborations across academia and industry can further drive innovation. Such partnerships offer an opportunity to merge foundational scientific research with commercial-scale manufacturing, ultimately enabling the development of next-generation immunoassays. Leaders should also consider direct engagement with regulatory bodies to advocate for faster approval pathways and more coherent compliance frameworks. This can help mitigate the challenges associated with the rapid introduction of new technologies and secure a competitive edge in an evolving market.

Strategically aligning business models with market segmentation insights-whether by type, technology, instruments, sample types, detection modes, application areas, end users, or deployment types-ensures that product development fits precisely into unmet needs. In parallel, geographic diversification remains a potent strategy for mitigating risks and tapping into varying regional growth drivers. By understanding local market nuances and tailoring products to regional demands, companies can better navigate through competitive pressures while optimizing their market footprint.

Finally, implementing robust post-market surveillance and feedback mechanisms is essential to ensure continuous improvement. By actively monitoring product performance and customer satisfaction, industry leaders gain invaluable insights that allow for iterative enhancements, thus cementing their positions as innovators in the immunoassay arena.

Conclusion: Navigating the Future of Immunoassay Innovation

The immunoassay market is on an upward trajectory characterized by technological refinement, strategic segmentation, and dynamic regional influences. As the industry continues its march towards enhanced diagnostic accuracy and efficient testing solutions, stakeholders are presented with unprecedented opportunities for growth and innovation. The integration of automated systems, cutting-edge detection methods, and versatile instrumentation has substantially transformed traditional practices. This evolution underscores the importance of agility and forward-thinking strategies in addressing both current and future challenges.

At its core, the journey within the immunoassay landscape is one of continuous adaptation and proactive engagement. By staying abreast of emerging trends and harnessing the power of digital transformation, market players can better align their offerings with the evolving needs of healthcare providers and patients alike. The path forward not only necessitates technological investment but also a renewed focus on collaboration, regulatory diligence, and targeted market segmentation.

In summary, the future of immunoassays is bright, with ample opportunities for those willing to innovate and invest in robust diagnostic frameworks. The evolving market, driven by transformative shifts and strategic insights, promises to deliver enhanced patient outcomes and drive significant advancements in both clinical and research domains.

Product Code: MRR-43127F7279BC

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

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Rising chronic and infectious diseases and benefits of early diagnosis
  - 5.1.1.2. Emerging application of multiplex detection immunoassay technique in drug development
  - 5.1.1.3. Increasing need for point-of-care immunoassay testing kits
- 5.1.2. Restraints
  - 5.1.2.1. Concerns associated with product recall for immunoassay instruments
- 5.1.3. Opportunities
  - 5.1.3.1. Increasing government support and funding fosters research and development in immunoassay technologies
  - 5.1.3.2. Technological advancements in the automated equipment associated with immunoassay
- 5.1.4. Challenges
  - 5.1.4.1. Issues with assay validation due to variations in sample quality and reagent performance
5.2. Market Segmentation Analysis
- 5.2.1. Deployment Type: Significant preference for point of care point of care in immunoassay
- 5.2.2. Application Areas: Adoption of immunoassay in allergy diagnostics to obtain comprehensive results quickly
- 5.2.3. Technology: Utilization of ELISA for detecting proteins, peptides, and hormones in biological samples
- 5.2.4. Instruments: Wide utility of analyzer to ensure high throughput and accuracy
- 5.2.5. Sample Types: Increasing the use of saliva samples in immunoassay for rapid and at-home testing
- 5.2.6. Detection Modes: Rising usage of fluorometric detection due to its enhanced sensitivity and multiplexing capabilities
- 5.2.7. End Users: Usage of assays in hospitals & clinics to provide swift and reliable results for diagnostics and patient monitoring
- 5.2.8. Type: Growing emphasis on personalized medicine and advancements in oncology drives the adoption of quantitative immunoassays
5.3. Porter's Five Forces Analysis
- 5.3.1. Threat of New Entrants
- 5.3.2. Threat of Substitutes
- 5.3.3. Bargaining Power of Customers
- 5.3.4. Bargaining Power of Suppliers
- 5.3.5. Industry Rivalry
5.4. PESTLE Analysis
- 5.4.1. Political
- 5.4.2. Economic
- 5.4.3. Social
- 5.4.4. Technological
- 5.4.5. Legal
- 5.4.6. Environmental

6. Immunoassay Market, by Type

6.1. Introduction
6.2. Qualitative Immunoassays
6.3. Quantitative Immunoassays

7. Immunoassay Market, by Technology

7.1. Introduction
7.2. Enzyme Immunoassays
7.3. Enzyme-Linked Immunosorbent Assay
7.4. Fluorescent Immunoassay
7.5. Lateral Flow Assay
7.6. Radioimmunoassay
7.7. Western Blot

8. Immunoassay Market, by Instruments

8.1. Introduction
8.2. Analyzers & Kits
8.3. Biosensors
8.4. Microfluidic Devices
8.5. Microplates
8.6. PCR Devices
8.7. Reagents
- 8.7.1. Antibodies
- 8.7.2. Antigens
- 8.7.3. Blocking Reagents
- 8.7.4. Buffers & Standards
- 8.7.5. Enzymes
- 8.7.6. Substrates
8.8. Software & Services

9. Immunoassay Market, by Sample Types

9.1. Introduction
9.2. Blood Samples
9.3. Saliva Samples
9.4. Tissue Samples
9.5. Urine Samples

10. Immunoassay Market, by Detection Modes

10.1. Introduction
10.2. Chemiluminescent
10.3. Colorimetric
10.4. Fluorometric
10.5. Radioisotopic

11. Immunoassay Market, by Application Areas

11.1. Introduction
11.2. Allergy
11.3. Autoimmune Diseases
11.4. Cardiology
11.5. Endocrinology
11.6. Infectious Diseases
11.7. Oncology
11.8. Toxicology
- 11.8.1. Drug Screening
- 11.8.2. Environmental Testing

12. Immunoassay Market, by End Users

12.1. Introduction
12.2. Contract Research Organizations
12.3. Diagnostic Laboratories
12.4. Hospitals & Clinics
12.5. Pharmaceutical & Biotechnology Companies
12.6. Research Institutions

13. Immunoassay Market, by Deployment Types

13.1. Introduction
13.2. Laboratory Tests
13.3. Point-of-care Test

14. Americas Immunoassay Market

14.1. Introduction
14.2. Argentina
14.3. Brazil
14.4. Canada
14.5. Mexico
14.6. United States

15. Asia-Pacific Immunoassay Market

15.1. Introduction
15.2. Australia
15.3. China
15.4. India
15.5. Indonesia
15.6. Japan
15.7. Malaysia
15.8. Philippines
15.9. Singapore
15.10. South Korea
15.11. Taiwan
15.12. Thailand
15.13. Vietnam

16. Europe, Middle East & Africa Immunoassay Market

16.1. Introduction
16.2. Denmark
16.3. Egypt
16.4. Finland
16.5. France
16.6. Germany
16.7. Israel
16.8. Italy
16.9. Netherlands
16.10. Nigeria
16.11. Norway
16.12. Poland
16.13. Qatar
16.14. Russia
16.15. Saudi Arabia
16.16. South Africa
16.17. Spain
16.18. Sweden
16.19. Switzerland
16.20. Turkey
16.21. United Arab Emirates
16.22. United Kingdom

17. Competitive Landscape

17.1. Market Share Analysis, 2023
17.2. FPNV Positioning Matrix, 2023
17.3. Competitive Scenario Analysis
- 17.3.1. ADx and Alamar Biosciences Partner to enhance neurodegenerative disease biomarker detection
- 17.3.2. Emery pharma and Marin Biologic partnership to streamline drug development
- 17.3.3. VION Biosciences expands diagnostic capabilities with strategic acquisition of Ansh Labs
- 17.3.4. Bio-Rad's launch of SPIA plus transforms specialty immunoassay testing with precision controls
- 17.3.5. Roche acquires LumiraDx's Point of Care technology platform for sustainable healthcare improvements
- 17.3.6. Beckman Coulter advances healthcare with new chemistry and immunoassay analyzer
- 17.3.7. MilliporeSigma and Merck KGaA partneres to enhance research through SMCxPRO immunoassay technology
- 17.3.8. Beckman Coulter and MeMed strengthen partnership to enhance infection diagnostics
- 17.3.9. Fujirebio and Agappe partnership for local manufacturing of CLIA based immunoassays
- 17.3.10. Fujirebio and Sysmex to collaborate on development of unique immunoassays
- 17.3.11. Shimadzu Corporation invested in IMMUNOSENS Co., Ltd. for implementation of immunoassay technology
- 17.3.12. Fapon rolls out new chemiluminescence immunoassay system
- 17.3.13. Beckman Coulter's DxI 9000 immunoassay analyzer with increased assay development sensitivity
- 17.3.14. Beckman Coulter and Fujirebio Partner to Bolster Access to Patient-friendly, Blood-based Alzheimer's Disease Test
- 17.3.15. SGS offers enhanced automated immunoassay testing at Poitiers Laboratory
17.4. Strategy Analysis & Recommendation
- 17.4.1. Danaher Corporation
- 17.4.2. F. Hoffmann-La Roche Ltd.
- 17.4.3. Siemens Healthineers AG
- 17.4.4. Thermo Fisher Scientific Inc.

Companies Mentioned

1. Abbott Laboratories
2. Agilent Technologies Inc.
3. Almac Group Limited
4. ANP Technologies, Inc.
5. Autobio Diagnostics Co., Ltd.
6. Becton, Dickinson and Company
7. Bio-Rad Laboratories, Inc.
8. Bio-Techne Corporation
9. BioLegend, Inc.
10. bioMerieux S.A.
11. Biosurfit SA
12. Boditech Med Inc.
13. Charles River Laboratories International, Inc.
14. Danaher Corporation
15. Diasorin S.p.A.
16. Dynex Technologies, Inc.
17. Epitope Diagnostics Inc.
18. F. Hoffmann-La Roche Ltd.
19. Fapon Biotech Inc.
20. Gyros Protein Technologies AB by Mesa Laboratories, Inc.
21. H.U. Group Holdings Inc.
22. J. Mitra & Co. Pvt. Ltd.
23. Kamiya Biomedical Company
24. Koninklijke Philips N.V.
25. Merck KGaA
26. MiCo BioMed, Inc.
27. NanoEntek
28. Nanomix, Inc.
29. OPKO Health, Inc.
30. Promega Corporation
31. QIAGEN N.V.
32. Quanterix Corporation
33. QuidelOrtho Corporation
34. Randox Laboratories Ltd.
35. Revvity, Inc. (Formarly PerkinElmer, Inc.)
36. Sekisui Diagnostics, LLC
37. Shenzhen Micropoint Biotechnologies Co., Ltd.
38. Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
39. Siemens Healthineers AG
40. Sysmex Corporation
41. Tecan Trading AG
42. Thermo Fisher Scientific Inc.
43. Tosoh Corporation
44. WAK-Chemie Medical GmbH
45. Zoetis Inc.
46. Zybio Inc.