Immunoassay Market by Product, Technology, Specimen, Indication, End User

List of Tables

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

An immunoassay is a biochemical test that measures the presence or concentration of a molecule through an antigen-antibody interaction. It plays an essential role in diagnostics, pharmaceutical analysis, and biochemical research. The necessity for immunoassays arises from the growing demand for accurate and rapid diagnostic solutions, especially in clinical diagnostics, environmental monitoring, and food safety testing. Their application encompasses disease diagnosis, therapeutic drug monitoring, and pregnancy testing, among others. End-use segments include hospitals, research laboratories, and biotechnology firms. The immunoassay market is influenced by factors such as technological advancements, a rising prevalence of chronic diseases, and increasing awareness of early disease detection. Emerging opportunities include the integration of AI and machine learning for enhanced data interpretation, expanding Point-of-Care Testing (POCT), and the development of multiplex assays for simultaneously detecting multiple analytes. Innovation can focus on portable and user-friendly devices, automation to enhance throughput, and improved assay sensitivity and specificity. However, market growth faces challenges like high costs of advanced assay solutions, stringent regulatory standards, and possible technical limitations in assay performance. Additionally, issues such as cross-reactivity and matrix interference can affect assay accuracy. Successful navigation of these challenges requires strategic investment in R&D for robust assay development and potential expansion into developing economies where demand for diagnostic tools is burgeoning. Innovative areas for exploration include biosensors, microfluidics, and nanotechnology to enhance assay performance and efficiency. The immunoassay market is competitive and characterized by continuous technological innovation and partnerships to expand product offerings. Companies must focus on deploying newer technologies that streamline workflows and offer strong customer support. Leveraging collaborations with research institutes and healthcare providers can foster innovation and market penetration, placing businesses at the forefront of meeting evolving healthcare demands.

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%

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Immunoassay Market

The Immunoassay Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

Market Drivers
- Rising chronic and infectious diseases and benefits of early diagnosis
- Growing usage of immunoassay in the food & beverage sector
- Emerging application of multiplex detection immunoassay technique in drug development
Market Restraints
- Cross-reactivity issues associated with immunoassay
Market Opportunities
- Technological advancements in the number of automated instruments and equipment associated with immunoassay
- High potential of immunoassay in environment monitoring
Market Challenges
- Issues with assay validation due to variations in sample quality and reagent performance

Porter's Five Forces: A Strategic Tool for Navigating the Immunoassay Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Immunoassay Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Immunoassay Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Immunoassay Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Immunoassay Market

A detailed market share analysis in the Immunoassay Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Immunoassay Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Immunoassay Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Strategy Analysis & Recommendation: Charting a Path to Success in the Immunoassay Market

A strategic analysis of the Immunoassay Market is essential for businesses looking to strengthen their global market presence. By reviewing key resources, capabilities, and performance indicators, business organizations can identify growth opportunities and work toward improvement. This approach helps businesses navigate challenges in the competitive landscape and ensures they are well-positioned to capitalize on newer opportunities and drive long-term success.

Key Company Profiles

The report delves into recent significant developments in the Immunoassay Market, highlighting leading vendors and their innovative profiles. These include H.U. Group Holdings Inc., Charles River Laboratories International, Inc., Siemens Healthineers AG, Tosoh Corporation, Merck KGaA, Gyros Protein Technologies AB, MiCo BioMed, Inc., OPKO Health, Inc., Promega Corporation, BioLegend, Inc., Epitope Diagnostics Inc., Dynex Technologies, Inc., Danaher Corporation, PerkinElmer, Inc., Bio-Rad Laboratories, Inc., Tecan Trading AG, NanoEntek, Zoetis Inc., Shenzhen Micropoint Biotechnologies Co., Ltd., Boditech Med Inc., Thermo Fisher Scientific Inc., Nanomix, Inc., bioMerieux S.A., QuidelOrtho Corporation, Quanterix Corporation, ANP Technologies, Inc., Diasorin S.p.A., Shenzhen Mindray Bio-Medical Electronics Co., Ltd., Randox Laboratories Ltd., Abbott Laboratories, Sysmex Corporation, Almac Group Limited, Biosurfit SA, Bio-Techne Corporation, Koninklijke Philips N.V., F. Hoffmann-La Roche Ltd., Becton, Dickinson, and Company, Agilent Technologies Inc., Kamiya Biomedical Company, QIAGEN N.V., Fapon Biotech Inc., WAK-Chemie Medical GmbH, Zybio Inc., J. Mitra & Co. Pvt. Ltd., and Autobio Diagnostics Co., Ltd..

Market Segmentation & Coverage

This research report categorizes the Immunoassay Market to forecast the revenues and analyze trends in each of the following sub-markets:

Based on Product, market is studied across Analyzer and Consumables. The Consumables is further studied across Assay Kits, Microwell Plates & Tubes, and Reagents.
Based on Technology, market is studied across Chemiluminescence Immunoassay, Enzyme-linked Immunosorbent Assay, Fluoroimmunoassay, Radioimmunoassay, and Rapid Diagnostic Tests (RDTs)/Lateral Flow Immunoassay.
Based on Specimen, market is studied across Blood, Saliva, and Urine.
Based on Indication, market is studied across Cardiology, Endocrinology, Infectious Disease, Oncology, and Orthopedics.
Based on End User, market is studied across Blood Banks, Diagnostics Laboratories, Food & Beverage Companies, Hospitals, Pharmaceutical Companies & CROs, and Research & Academic Laboratories.
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.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

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. Growing usage of immunoassay in the food & beverage sector
  - 5.1.1.3. Emerging application of multiplex detection immunoassay technique in drug development
- 5.1.2. Restraints
  - 5.1.2.1. Cross-reactivity issues associated with immunoassay
- 5.1.3. Opportunities
  - 5.1.3.1. Technological advancements in the number of automated instruments and equipment associated with immunoassay
  - 5.1.3.2. High potential of immunoassay in environment monitoring
- 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. Product: Development of novel immunoassay kits for diagnostics of infectious and autoimmune diseases
- 5.2.2. Technology: Utilization of enzyme-linked immunosorbent assay technology for food allergies and drugs of abuse treatment
- 5.2.3. Specimen: Emergence of saliva diagnostics due to its non-invasive collection methods
- 5.2.4. Indication: Optimization within immunoassay technologies to cater growing need across infectious disease
- 5.2.5. End User: Rising demand for immunoassay across emergency care, intensive care units, and outpatient clinics
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 Product

6.1. Introduction
6.2. Analyzer
6.3. Consumables
- 6.3.1. Assay Kits
- 6.3.2. Microwell Plates & Tubes
- 6.3.3. Reagents

7. Immunoassay Market, by Technology

7.1. Introduction
7.2. Chemiluminescence Immunoassay
7.3. Enzyme-linked Immunosorbent Assay
7.4. Fluoroimmunoassay
7.5. Radioimmunoassay
7.6. Rapid Diagnostic Tests (RDTs)/Lateral Flow Immunoassay

8. Immunoassay Market, by Specimen

8.1. Introduction
8.2. Blood
8.3. Saliva
8.4. Urine

9. Immunoassay Market, by Indication

9.1. Introduction
9.2. Cardiology
9.3. Endocrinology
9.4. Infectious Disease
9.5. Oncology
9.6. Orthopedics

10. Immunoassay Market, by End User

10.1. Introduction
10.2. Blood Banks
10.3. Diagnostics Laboratories
10.4. Food & Beverage Companies
10.5. Hospitals
10.6. Pharmaceutical Companies & CROs
10.7. Research & Academic Laboratories

11. Americas Immunoassay Market

11.1. Introduction
11.2. Argentina
11.3. Brazil
11.4. Canada
11.5. Mexico
11.6. United States

12. Asia-Pacific Immunoassay Market

12.1. Introduction
12.2. Australia
12.3. China
12.4. India
12.5. Indonesia
12.6. Japan
12.7. Malaysia
12.8. Philippines
12.9. Singapore
12.10. South Korea
12.11. Taiwan
12.12. Thailand
12.13. Vietnam

13. Europe, Middle East & Africa Immunoassay Market

13.1. Introduction
13.2. Denmark
13.3. Egypt
13.4. Finland
13.5. France
13.6. Germany
13.7. Israel
13.8. Italy
13.9. Netherlands
13.10. Nigeria
13.11. Norway
13.12. Poland
13.13. Qatar
13.14. Russia
13.15. Saudi Arabia
13.16. South Africa
13.17. Spain
13.18. Sweden
13.19. Switzerland
13.20. Turkey
13.21. United Arab Emirates
13.22. United Kingdom

14. Competitive Landscape

14.1. Market Share Analysis, 2023
14.2. FPNV Positioning Matrix, 2023
14.3. Competitive Scenario Analysis
- 14.3.1. Thermo Fisher to Acquire Olink for USD 3.1 billion, Expanding Proteomics Presence
- 14.3.2. Fujirebio and Sysmex to Collaborate On Development of Unique Immunoassays
- 14.3.3. Mindray Has Agreed to Acquire 75% Stake in Germany-Based DiaSys Diagnostic Systems GmbH
- 14.3.4. CVC Fund "Shimadzu Future Innovation Fund" has Invested in IMMUNOSENS Co., Ltd., Developing Immunoassay Technology.
- 14.3.5. Fapon Rolls Out New Chemiluminescence Immunoassay System
- 14.3.6. Beckman Coulter's DxI 9000 Immunoassay Analyzer with Increased Assay Development Sensitivity Makes First North American Appearance at 2023 AACC
- 14.3.7. Beckman Coulter and Fujirebio Partner to Bolster Access to Patient-friendly, Blood-based Alzheimer's Disease Test
- 14.3.8. MakatiMed First PH and ASEAN Hospital to Acquire Atellica VTLi Patient-Side Immunoassay Analyzer
- 14.3.9. QuidelOrtho Receives De Novo FDA Authorization for Sofia 2 SARS Antigen+ FIA
- 14.3.10. SGS Offers Enhanced Automated Immunoassay Testing at Poitiers Laboratory
- 14.3.11. Siemens launches Centre of Excellence for Immunoassay Instrument R&D
14.4. Strategy Analysis & Recommendation

Companies Mentioned

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