Product Code: CD1273
The global immunoassay market reached US$ 36.87 billion in 2024 and is expected to reach US$ 68.60 billion by 2033, growing at a CAGR of 7.1% during the forecast period 2025-2033.
Immunoassay is a bioanalytical technique that utilizes antigen-antibody affinity to differentiate and quantify molecules of interest in biological samples. Immunoassays are laboratory procedures that enable the rapid and precise identification of specific compounds.
Immunoassays are widely used in various fields, including clinical diagnostics, drug discovery, and food testing, to identify and measure the presence of specific substances in a sample.
Market Dynamics: Drivers & Restraints
Increasing Innovation and Launches of Advanced Immunoassay Instruments
The immunoassay market is driven by several factors. One of the significant factors driving the market include increasing innovation and launches of advanced immunoassay instruments. Key players in the market are introducing advanced systems to meet the needs of professionals seeking solutions that are advanced and precise. For instance, in July 2023, Siemens Healthineers introduced the Atellica CI Analyzer for clinical chemistry and immunoassay testing. Also, in August 2023, Fapon launched its latest chemiluminescence immunoassay system, Shine i8000/9000. The high-speed and fully automated analyzer has an ultra-high throughput of 900 tests per hour and features an integrated and compact design with stable performance at the American Association of Clinical Chemistry (AACC) Clinical Lab Expo and Meeting.
Similarly in November 2022, Gethin Biotech launched the new MAGICAL 6000 chemiluminescence immunoassay Analyzer at MEDICA. It is a compact and innovative chemiluminescence immunoassay analyzer that is ideal for mid to high-workflow laboratories that require a one-step chemiluminescence solution.
The companies are introducing immunoassay systems with specific features. For instance, in July 2024, H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio announced the availability of the Lumipulse G GFAP assay for the fully automated, random-access LUMIPULSE G immunoassay systems. The Research Use Only (RUO) assay is now available in Japan and the United States.
High Cost of Instruments & Reagents
The high cost of instruments and reagents is anticipated to pose a significant challenge to the growth of the immunoassay market. Immunoassays, which are essential diagnostic tools in clinical and research settings, require specialized and often expensive instruments, as well as a consistent supply of reagents for testing. These costs can be prohibitive, especially for smaller laboratories or healthcare facilities in developing regions with limited budgets. As a result, the financial burden of maintaining and operating immunoassay systems could lead to a slower adoption rate, hindering market growth.
Segment Analysis
The global immunoassay market is segmented based on type, product type, specimen, application, end-user, and region.
Type:
ELISA in the type segment is expected to dominate the immunoassay market.
The ELISA segment is expected to hold the major market share over the forecast period. ELISA is an immunological assay commonly used to measure antibodies, antigens, proteins, and glycoproteins in biological samples. Some examples include diagnosis of HIV infection, pregnancy tests, and measurement of cytokines or soluble receptors in cell supernatant or serum.
The ELISA technique is most frequently used due to its ability and efficiency in detecting and quantifying biomarkers. A wide range of conditions, from bacterial and viral infections (like Lyme disease and HIV) to endocrine conditions, like thyroid disease can be detected using ELISA which makes it more preferable over other immunoassays. Several existing and emerging market players are adopting strategies such as partnerships and collaborations with each other to expand their businesses which is contributing to the segment's expansion.
Many key players are launching efficient and advanced ELISA kits that help in detecting disease conditions. For instance, in February 2023, Charles River Laboratories International, Inc. announced the launch of its first Enzyme-Linked Immunosorbent Assay (ELISA) Kit for the detection and quantitation of residual host cell proteins (HCP) in CHO-based biotherapeutics.
Additionally, in February 2024, Krishgen Biosystems is proud to announce the launch of our newest product, the CRM197 ELISA. This kit is designed with a direct sandwich assay format to facilitate accurate and efficient detection of CRM197 with better specificity and sensitivity compared to conventional ELISA kits which employ only one antibody. Double antibodies are used in this kit.CRM197 ELISA kit is used as an analytical tool for the quantitative determination of CRM197 in culture supernatants, vaccines and other biological preparations.
Geographical Analysis
North America is expected to dominate the immunoassay market.
North America holds the largest market share and is expected to continue throughout the forecast period. The rise in demand for diagnostics related to chronic diseases and the availability of technologically advanced diagnostic techniques are expected to propel market growth over the forecast period.
The rising prevalence of infectious diseases and other diseases such as cardiovascular diseases, and cancer among others is creating an opportunity for local market players to boost their sales of diagnostic products. The incidence of diseases such as diabetes, cancer, and infectious diseases increases the demand for diagnostic tests, especially immunoassays, for early detection and observation. Collaborations among academic institutions, research groups, and companies allow for the exchange of knowledge and resources, which boosts market innovation.
The key market players are introducing innovative solutions with advanced features which could increase the region's market expansion. For instance, in July 2024, Beckman Coulter Diagnostics launched the new DxC 500i Clinical Analyzer, an integrated clinical chemistry and immunoassay analyzer. Utilizing Beckman Coulter's common reagents and consumables across its scalable clinical chemistry and immunoassay portfolio, the DxC 500i Analyzer enables commutable patient results, offering hospitals and healthcare networks strategic benefits in patient care and inventory management. Additionally, the increasing research and development and the increasing drug discovery in the region are also expected to propel the market growth.
Competitive Landscape
The global market players in the immunoassay market include Beckman Coulter, Inc., F. Hoffmann-La Roche Ltd, Siemens Healthineers AG, BioMerieux SA, Bio-Rad Laboratories, Inc., Abbott, DiaSorin S.p.A., BD, Thermo Fisher Scientific Inc., and Merck KGaA, among others.
Why Purchase the Report?
- Pipeline & Innovations: Reviews ongoing clinical trials, and product pipelines, and forecasts upcoming pharmaceutical advancements.
- Type Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
- Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
- Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
- Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
- Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
- Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
- Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
- Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
- Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient Type delivery.
- Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
- Post-market Surveillance: Uses post-market data to enhance product safety and access.
- Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.
The global immunoassay market report would provide approximately 45 tables, 46 figures, and 180 pages.
Target Audience 2024
- Manufacturers: Pharmaceutical, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
- Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
- Technology & Innovation: R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
- Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
- Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
- Supply Chain: Distribution and Supply Chain Managers.
- Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
- Academic & Research: Academic Institutions.
Table of Contents
1. Market Introduction and Scope
- 1.1. Objectives of the Report
- 1.2. Report Coverage & Definitions
- 1.3. Report Scope
2. Executive Insights and Key Takeaways
- 2.1. Market Highlights and Strategic Takeaways
- 2.2. Key Trends and Future Projections
- 2.3. Snippet by Type
- 2.4. Snippet by Product Type
- 2.5. Snippet by Specimen
- 2.6. Snippet by Application
- 2.7. Snippet by End-User
- 2.8. Snippet by Region
3. Dynamics
- 3.1. Impacting Factors
- 3.1.1. Drivers
- 3.1.1.1. Increasing Innovation and Launches of Advanced Immunoassay Instruments
- 3.1.1.2. Rising Prevalence of Chronic & Infectious Diseases
- 3.1.2. Restraints
- 3.1.2.1. The High Cost of Instruments & Reagents
- 3.1.2.2. Complex Assay Procedures
- 3.1.3. Opportunity
- 3.1.3.1. Increasing Research and Development
- 3.1.4. Impact Analysis
4. Strategic Insights and Industry Outlook
- 4.1. Market Leaders and Pioneers
- 4.1.1. Emerging Pioneers and Prominent Players
- 4.1.2. Established leaders with the largest-selling Brand
- 4.1.3. Market leaders with established Product
- 4.2. CXO Perspectives
- 4.3. Latest Developments and Breakthroughs
- 4.4. Case Studies/Ongoing Research
- 4.5. Regulatory and Reimbursement Landscape
- 4.5.1. North America
- 4.5.2. Europe
- 4.5.3. Asia Pacific
- 4.5.4. South America
- 4.5.5. Middle East & Africa
- 4.6. Porter's Five Force Analysis
- 4.7. Supply Chain Analysis
- 4.8. Patent Analysis
- 4.9. SWOT Analysis
- 4.10. Unmet Needs and Gaps
- 4.11. Recommended Strategies for Market Entry and Expansion
- 4.12. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
- 4.13. Pricing Analysis and Price Dynamics
- 4.14. Key Opinion Leaders
5. Immunoassay Market, By Type
- 5.1. Introduction
- 5.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 5.1.2. Market Attractiveness Index, By Type
- 5.2. ELISA*
- 5.2.1. Introduction
- 5.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 5.3. Radioimmunoassay (RIA)
- 5.4. Fluorescence Immunoassays (FIA)
- 5.5. Chemiluminescence Immunoassays (CLIA)
- 5.6. Rapid Assays
- 5.7. Others
6. Immunoassay Market, By Product Type
- 6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 6.1.2. Market Attractiveness Index, By Product Type
- 6.2. Reagents & kits*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 6.2.3. ELISA Reagents & Kits
- 6.2.4. Rapid Test Reagents & Kits
- 6.2.5. ELISPOT Reagents & Kits
- 6.2.6. Western Blot Reagents & Kits
- 6.2.7. Others
- 6.3. Analyzers
- 6.3.1. Open-ended Systems
- 6.3.2. Closed-ended Systems
- 6.4. Software & Services
7. Immunoassay Market, By Specimen
- 7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 7.1.2. Market Attractiveness Index, By Specimen
- 7.2. Blood*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 7.3. Saliva
- 7.4. Urine
- 7.5. Other
8. Immunoassay Market, By Application
- 8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 8.1.2. Market Attractiveness Index, By Application
- 8.2. Therapeutic Drug Monitoring*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 8.3. Drug Discovery
- 8.4. Disease Diagnosis
- 8.4.1. Infectious Disease
- 8.4.2. Cancer
- 8.4.3. Endocrinology
- 8.4.4. Autoimmune Disorders
- 8.4.5. Cardiology
- 8.4.6. Hematology
- 8.4.7. Others
- 8.5. Other
9. Immunoassay Market, By End-User
- 9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 9.1.2. Market Attractiveness Index, By End-User
- 9.2. Hospitals*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
- 9.3. Blood Banks
- 9.4. Clinical Laboratories
- 9.5. Pharmaceutical and Biotech Companies
- 9.6. Academic Research Centers
- 9.7. Others
10. Immunoassay Market, By Regional Market Analysis and Growth Opportunities
- 10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 10.1.2. Market Attractiveness Index, By Region
- 10.2. North America
- 10.2.1. Introduction
- 10.2.2. Key Region-Specific Dynamics
- 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.2.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 10.2.8.1. U.S.
- 10.2.8.2. Canada
- 10.2.8.3. Mexico
- 10.3. Europe
- 10.3.1. Introduction
- 10.3.2. Key Region-Specific Dynamics
- 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.3.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 10.3.8.1. Germany
- 10.3.8.2. U.K.
- 10.3.8.3. France
- 10.3.8.4. Spain
- 10.3.8.5. Italy
- 10.3.8.6. Rest of Europe
- 10.4. South America
- 10.4.1. Introduction
- 10.4.2. Key Region-Specific Dynamics
- 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.4.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 10.4.8.1. Brazil
- 10.4.8.2. Argentina
- 10.4.8.3. Rest of South America
- 10.5. Asia-Pacific
- 10.5.1. Introduction
- 10.5.2. Key Region-Specific Dynamics
- 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 10.5.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
- 10.5.8.1. China
- 10.5.8.2. India
- 10.5.8.3. Japan
- 10.5.8.4. South Korea
- 10.5.8.5. Rest of Asia-Pacific
- 10.6. Middle East and Africa
- 10.6.1. Introduction
- 10.6.2. Key Region-Specific Dynamics
- 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
- 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Specimen
- 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
- 10.6.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
11. Competitive Landscape and Market Positioning
- 11.1. Competitive Overview and Key Market Players
- 11.2. Market Share Analysis and Positioning Matrix
- 11.3. Strategic Partnerships, Mergers & Acquisitions
- 11.4. Key Developments in Product Portfolios and Innovations
- 11.5. Company Benchmarking
12. Company Profiles
- 12.1. Beckman Coulter, Inc.*
- 12.1.1. Company Overview
- 12.1.2. Product Portfolio
- 12.1.2.1. Product Description
- 12.1.2.2. Product Key Performance Indicators (KPIs)
- 12.1.2.3. Historic and Forecasted Product Sales
- 12.1.2.4. Product Sales Volume
- 12.1.3. Financial Overview
- 12.1.3.1. Company Revenue
- 12.1.3.2. Geographical Revenue Shares
- 12.1.3.3. Revenue Forecasts
- 12.1.4. Key Developments
- 12.1.4.1. Mergers & Acquisitions
- 12.1.4.2. Key Product Development Activities
- 12.1.4.3. Regulatory Approvals, etc.
- 12.1.5. SWOT Analysis
- 12.2. F. Hoffmann-La Roche Ltd
- 12.3. Siemens Healthineers AG
- 12.4. BioMerieux SA
- 12.5. Bio-Rad Laboratories, Inc
- 12.6. Abbott
- 12.7. DiaSorin S.p.A.
- 12.8. BD
- 12.9. Thermo Fisher Scientific Inc.
- 12.10. Merck KGaA
LIST NOT EXHAUSTIVE
13. Assumption and Research Methodology
- 13.1. Data Collection Methods
- 13.2. Data Triangulation
- 13.3. Forecasting Techniques
- 13.4. Data Verification and Validation
14. Appendix
- 14.1. About Us and Services
- 14.2. Contact Us