Immunoassay Market by Product (Analyzer, Consumables), Technology (Chemiluminescence Immunoassay, Enzyme-linked Immunosorbent Assay, Fluoroimmunoassay), Specimen, Indication, End User - Global Forecast 2024-2030

Immunoassay Market by Product (Analyzer, Consumables), Technology (Chemiluminescence Immunoassay, Enzyme-linked Immunosorbent Assay, Fluoroimmunoassay), Specimen, Indication, End User - Global Forecast 2024-2030


The Immunoassay Market size was estimated at USD 26.30 billion in 2023 and expected to reach USD 28.29 billion in 2024, at a CAGR 7.24% to reach USD 42.90 billion by 2030.

An immunoassay is a highly sensitive and specific biochemical technique used to quantify or detect a wide range of molecules, including proteins, hormones, antibodies, and other biologically relevant substances. The growth of the immunoassay market can be attributed to several influencing factors, such as the increasing prevalence of chronic diseases, rising demand for personalized medicine, expanding use of immunoassays in oncology diagnostics, and advancements in technology leading to higher throughput capabilities with improved accuracy. Moreover, the COVID-19 pandemic has also contributed significantly to the growth of this market due to the surge in demand for rapid testing solutions. However, high costs associated with advanced immunoassay systems may hamper their adoption by smaller laboratories or resource-limited settings. Additionally, stringent regulatory guidelines regarding product approvals can prolong the time to market for new products. To overcome these challenges and sustain business growth in the immunoassay market, organizations are exploring potential areas of innovation and research, including focusing on R&D efforts to create cost-effective solutions that cater to a wider user base across different healthcare settings worldwide. Additionally, collaborating with academic institutions and research centers to foster breakthrough innovations in assay design, targeting novel analytes or applications not currently addressed by existing products. Along with these, market participants are developing novel biomarkers for the early detection of diseases, leading to an expansion in clinical applications of immunoassays.

Regional Insights

In the Americas, the United States and Canada have witnessed a growing demand for immunoassays due to a rising prevalence of chronic diseases such as cancer and cardiovascular disorders. Increasing healthcare spending in these countries has also supplemented increased focus on early detection of diseases; laboratories are investing heavily in advanced technologies such as enzyme-linked immunosorbent assays (ELISA) and chemiluminescence immunoassays (CLIA). Apart from these, recent patents filed in this region encompass improvements in assay sensitivity and specificity while reducing cross-reactivity issues. In EU countries, the Middle East and Africa region has seen significant growth in the immunoassay market due to rising consumer health awareness. Initiatives led by governments and healthcare organizations have bolstered public investment in diagnostic services. Key players in this market focus on developing new products catering to specific regional customer requirements. Emerging countries across the Asia Pacific, such as India and China, present a considerable growth opportunity for immunoassay manufacturers due to increasing healthcare expenditure, rising prevalence of chronic diseases requiring diagnostic testing services, improving laboratory infrastructure, and growing awareness about early disease detection. Furthermore, customizing products to cater to specific disease patterns in emerging markets has helped expand key profiles. Additionally, the regional government has launched several initiatives to promote public-private partnerships in developing innovative diagnostic methods, providing support and investment for academic institutions and private enterprises.

Market Insights
  • Market Dynamics

    The market dynamics represent an ever-changing landscape of the Immunoassay Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.
    • 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
            • Market Segmentation Analysis
              • Product: Development of novel immunoassay kits for diagnostics of infectious and autoimmune diseases
              • Technology: Utilization of enzyme-linked immunosorbent assay technology for food allergies and drugs of abuse treatment
              • Specimen: Emergence of saliva diagnostics due to its non-invasive collection methods
              • Indication: Optimization within immunoassay technologies to cater growing need across infectious disease
              • End User: Rising demand for immunoassay across emergency care, intensive care units, and outpatient clinics
              • Market Disruption Analysis
              • Porter’s Five Forces Analysis
              • Value Chain & Critical Path Analysis
              • Pricing Analysis
              • Technology Analysis
              • Patent Analysis
              • Trade Analysis
              • Regulatory Framework Analysis
              FPNV Positioning Matrix

              The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Immunoassay Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

              Market Share Analysis

              The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Immunoassay Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

              Recent Developments
              • Thermo Fisher to Acquire Olink for USD 3.1 billion, Expanding Proteomics Presence

                Thermo Fisher Scientific, Inc. has acquired Olink Holding for approximately USD 3.1 billion to enhance its presence in proteomics. The acquisition of Olink underscores the profound impact of proteomics as Thermo Fisher's customers continue to advance life science research and precision medicine.

                Fujirebio and Sysmex to Collaborate On Development of Unique Immunoassays

                Fujirebio Holdings, Inc. and Sysmex Corporation expanded their partnership in immunoassay tests. This partnership encompasses various areas such as research, manufacturing, clinical development, and sales and marketing.

                Mindray Has Agreed to Acquire 75% Stake in Germany-Based DiaSys Diagnostic Systems GmbH

                Mindray acquired a 75% equity interest in DiaSys Diagnostic Systems GmbH from Gorka Holding GmbH for approximately Euro 115 million. This acquisition enhanced Mindray's overseas supply chain platform and facilitated penetration into medium to large customer segments. By acquiring DiaSys, Mindray aims to strengthen its position in the market, delivering innovative solutions and high-quality products to meet the growing needs of healthcare professionals and patients worldwide.
              Strategy Analysis & Recommendation

              The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Immunoassay Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.

              Key Company Profiles

              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., 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, 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., PerkinElmer, Inc., Promega Corporation, QIAGEN N.V., Quanterix Corporation, QuidelOrtho Corporation, Randox Laboratories Ltd., 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..

              Market Segmentation & Coverage

              This research report categorizes the Immunoassay Market to forecast the revenues and analyze trends in each of the following sub-markets:
              • Product
                • Analyzer
                • Consumables
                  • Assay Kits
                  • Microwell Plates & Tubes
                  • Reagents
                  • Technology
                    • Chemiluminescence Immunoassay
                    • Enzyme-linked Immunosorbent Assay
                    • Fluoroimmunoassay
                    • Radioimmunoassay
                    • Rapid Diagnostic Tests (RDTs)/Lateral Flow Immunoassay
                    • Specimen
                      • Blood
                      • Saliva
                      • Urine
                      • Indication
                        • Cardiology
                        • Endocrinology
                        • Infectious Disease
                        • Oncology
                        • Orthopedics
                        • End User
                          • Blood Banks
                          • Diagnostics Laboratories
                          • Food & Beverage Companies
                          • Hospitals
                          • Pharmaceutical Companies & CROs
                          • Research & Academic Laboratories
                          • Region
                            • Americas
                              • Argentina
                              • Brazil
                              • Canada
                              • Mexico
                              • United States
                                • California
                                • Florida
                                • Illinois
                                • New York
                                • Ohio
                                • Pennsylvania
                                • Texas
                                • Asia-Pacific
                                  • Australia
                                  • China
                                  • India
                                  • Indonesia
                                  • Japan
                                  • Malaysia
                                  • Philippines
                                  • Singapore
                                  • South Korea
                                  • Taiwan
                                  • Thailand
                                  • Vietnam
                                  • Europe, Middle East & Africa
                                    • Denmark
                                    • Egypt
                                    • Finland
                                    • France
                                    • Germany
                                    • Israel
                                    • Italy
                                    • Netherlands
                                    • Nigeria
                                    • Norway
                                    • Poland
                                    • Qatar
                                    • Russia
                                    • Saudi Arabia
                                    • South Africa
                                    • Spain
                                    • Sweden
                                    • Switzerland
                                    • Turkey
                                    • United Arab Emirates
                                    • United Kingdom


                                    Please Note: PDF & Excel + Online Access - 1 Year


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. Market Disruption Analysis
5.4. Porter’s Five Forces Analysis
5.4.1. Threat of New Entrants
5.4.2. Threat of Substitutes
5.4.3. Bargaining Power of Customers
5.4.4. Bargaining Power of Suppliers
5.4.5. Industry Rivalry
5.5. Value Chain & Critical Path Analysis
5.6. Pricing Analysis
5.7. Technology Analysis
5.8. Patent Analysis
5.9. Regulatory Framework Analysis
6. Immunoassay Market, by Product
6.1. Introduction
6.2. Analyzer
6.3. Consumables
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
15. Competitive Portfolio
15.1. Key Company Profiles
15.2. Key Product Portfolio

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