Immunoassay Market Size, Share, Industry, Forecast and Outlook (2025 – 2033)

Overview

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.

Executive Summary 

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. 

For more details on this report – Request for Sample

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, BioMérieux 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.

Suggestions for Related Report

• Colorimetric Immunoassays (CI) Analyzer Market
• Radioimmunoassay Market
• Chemiluminescence Immunoassay Market

For more clinical diagnostics-related reports, please click here