Immunoassay Market, by Product (Reagents and Kits, Analyzers), by Technology (ELISA, Chemiluminescence Immunoassay, Immunofluorescence assay, Rapid Test, ELISpot, Western Blotting, Others), by Specimen (Infectious Diseases, Endocrinology, Oncology, Bone and Mineral Disorders, Cardiology, Blood Screening, Autoimmune Disorders, Allergy Diagnostics, Toxicology, Newborn Screening, Others), by End user (Hospitals and Clinics, Clinical Laboratories, Pharmaceutical and Biotechnology Companies, Blood Banks, Research and Academic Laboratories, Home Care Settings) : Global Opportunity Analysis and Industry Forecast, 2024 - 2033

Market Introduction and Definition 

Immunoassay is a biochemical technique used to detect and quantify the presence of a specific molecule, typically a protein or antigen, in a sample. It relies on the interaction between an antibody and its target molecule, resulting in a measurable signal, such as color change or fluorescence. Immunoassays are widely used in medical diagnostics, pharmaceutical research, and environmental monitoring. They play a crucial role in diagnosing diseases, monitoring therapeutic drug levels, detecting biomarkers, and screening for infectious agents. The high specificity, sensitivity, and scalability of immunoassays make them indispensable tools in modern healthcare and scientific research, facilitating accurate and efficient analysis of biological samples. 

Key Takeaways 

• The immunoassay market share study covers 20 countries. The research includes a segment analysis of each country in terms of value for the projected period. 
• More than 1, 500 product literatures, industry releases, annual reports, and other such documents of major immunoassay industry participants along with authentic industry journals, trade associations' releases, and government websites have been reviewed for generating high-value industry insights. 
• The study integrated high-quality data, professional opinions and analysis, and critical independent perspectives. The research approach is intended to provide a balanced view of global markets and to assist stakeholders in making educated decisions in order to achieve their most ambitious growth objectives. 

Key Market Dynamics 

One driver of the immunoassay market is the increasing prevalence of chronic and infectious diseases, driving demand for accurate and efficient diagnostic tools. With the rise in conditions such as cancer, cardiovascular diseases, and infectious outbreaks, there is a growing need for rapid and reliable diagnostic tests that can detect specific biomarkers or pathogens. According to World Health Organization (WHO) , cardiovascular diseases (CVDs) are the leading cause of death globally, taking an estimated 17.9 billion lives each year.  Immunoassays offer high sensitivity and specificity, making them valuable tools for disease detection and monitoring, thus driving immunoassay market. 

A significant restraint for the immunoassay market is the high development and manufacturing costs associated with new assays. Developing immunoassays requires extensive research, validation, and regulatory approval, which can be time-consuming and expensive. Additionally, the complexity of immunoassay technology may require specialized equipment and trained personnel, further increasing costs. These high barriers to entry can deter smaller companies from entering the market and limit innovation, potentially restraining market growth. 

An opportunity for the immunoassay market lies in the growing demand for point-of-care testing and personalized medicine. As healthcare shifts towards decentralized and personalized approaches, there is increasing interest in portable immunoassay devices that can deliver rapid results outside of traditional laboratory settings. Furthermore, advancements in multiplexing technologies allow for simultaneous detection of multiple analytes in a single sample, expanding the applications of immunoassays in disease diagnosis, drug development, and research. Capitalizing on these trends can drive market expansion and innovation within the immunoassay industry. 

Market Segmentation 

The immunoassay market share is segmented into segmented based on product, technology, specimen, application, end user and region. Based on product, the market is bifurcated into reagents & kits, and analyzers. Depending on technology, it is categorized into ELISA, Chemiluminescence Immunoassay (CLIA) , Immunofluorescence assay (IFA) , Rapid Test, ELISpot, Western Blotting and Others. By Specimen it is segregated into blood, saliva, urine and others. By application, it is categorized into infectious diseases, endocrinology, oncology, bone & mineral disorders, cardiology, blood screening, autoimmune disorders, allergy diagnostics, toxicology, newborn screening, and others. By end user, it is categorized into hospitals & clinics, clinical laboratories, pharmaceutical & biotechnology companies and CROs, blood banks, research & academic laboratories, and home care settings. By region, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA. 

Regional/Country Market Outlook 

The immunoassay market size exhibits regional variation driven by factors such as healthcare infrastructure, disease prevalence, regulatory environment, and economic development. In North America, the market is propelled by a well-established healthcare system, extensive R&D investments, and a high prevalence of chronic diseases. Europe follows a similar trajectory with strong regulatory frameworks supporting market growth. In the Asia-Pacific region, rapid economic development, increasing healthcare expenditure, and a large patient population drive market expansion. Emerging economies like China and India present significant growth opportunities due to rising healthcare investments and increasing adoption of advanced diagnostic technologies. However, challenges such as fragmented healthcare systems and limited access to healthcare in some regions may hinder market growth. Overall, the immunoassay market forecast demonstrates dynamic regional dynamics, reflecting the diverse healthcare landscapes and economic conditions across different geographies. 

• In April 2023, bioMérieux, a world leader in the field of in vitro diagnostics, announces the CE-marking of VIDAS KUBE, the next generation automated immunoassay system for the renowned VIDAS range. This innovation will benefit clinical labs and food industries by providing results to help speed up patient care and protect consumers.
• In February 2023, Roche Diagnostics announced that it has expanded its collaboration with Janssen Biotech Inc. (Janssen) to create companion diagnostics for targeted therapies, further strengthening research and innovation activities. This agreement will broaden opportunities for Roche and Janssen to collaborate in the precision medicine field with multiple companion diagnostics technologies, including immunohistochemistry (IHC) , digital pathology, next generation sequencing, polymerase chain reaction and immunoassays.

Industry Trends 

• At FOCIS (Federation of Clinical Immunology Societies) 2023, Magnus Fontes, General Manager of Institute Roche, together with Emanuele De Rinaldis, co-directed the course on Systems Immunology. The course provided a broad understanding of foundational concepts in systems biology, statistics, and mathematics necessary to generate scientific hypotheses, devise scientific and analytical strategies, and run analyses and interpretations. 
• In March 2021, researchers at the University of Central Florida stated that they are working to develop a screening method that is 300 times more successful in detecting a cancer biomarker than that of existing methods. This technique makes use of nanoparticles with platinum-rich shells and nickel-rich cores, which enhance the sensitivity of ELISA. 

Oncology Cases Statistics for Global Immunoassay Market 

The increasing number of cancer cases projected over the coming decades underscores the growing demand for immunoassay technologies in cancer diagnosis and management. With estimated new oncology cases expected to rise from 19.98 billion in 2022 to 35.29 billion by 2050, the need for accurate, sensitive, and efficient diagnostic tools becomes paramount. Immunoassays play a crucial role in cancer screening, early detection, treatment monitoring, and prognostic assessment. These assays enable the detection of specific biomarkers associated with various cancer types, facilitating timely intervention and personalized treatment strategies. As the global cancer burden continues to escalate, the immunoassay market is poised for substantial growth, driven by the increasing demand for advanced diagnostic solutions to address the challenges posed by the rising prevalence of cancer worldwide. 

Competitive Landscape 

The major players operating in the immunoassay market include F. Hoffmann-La Roche Ltd., Danaher Corporation, Abbott Laboratories, Siemens Healthineers (Siemens AG) , DiaSorin S.p.A., Sysmex Corporation, bioMerieux SA, Ortho Clinical Diagnostics, Thermo Fisher Scientific, Inc., Becton, Dickinson and Company, and Merck kGaA. Other players in immunoassay market includes Revvity, Bio-Rad Laboratories, Qiagen Inc., Agilent Technologies Inc, Mindray Biomedical and so on. 

Recent Key Strategies and Developments 

• In November 2022, Bio-Rad Laboratories, Inc., a global leader in life science research and clinical diagnostic products, announced an expanded portfolio of independent quality controls (QC) products including InteliQ and Liquichek compact vials, for the Abbott Alinity ci-series integrated clinical chemistry and immunoassay testing instruments. 
• In July 2023, Roche Diagnostics India Pvt. Ltd., announce the launch of the Elecsys HCV Duo which is India’s first commercially available fully automated immunoassay that allows simultaneous and independent determination of the hepatitis C virus (HCV) antigen and antibody status from a single human plasma or serum sample. This means that the test can be used to detect the early stage of infection, as well as when the patient is recovering from the virus, or even during chronic infection. 

Key Benefits for Stakeholders

• This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the immunoassay market analysis from 2024 to 2033 to identify the prevailing immunoassay market opportunity.
• The market research is offered along with information related to key drivers, restraints, and opportunities.
• Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
• In-depth analysis of the immunoassay market segmentation assists to determine the prevailing market opportunities.
• Major countries in each region are mapped according to their revenue contribution to the global market.
• Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.

The report includes the analysis of the regional as well as global immunoassay market trends, key players, market segments, application areas, and market growth strategies.
 

Key Sources Referred 

• World Health Organization (WHO)  
• National Health Service (NHS)  
• Federation of Clinical Immunology Societies (FOCIS)  
• Alliance for Immunoassay 
• LumiraDx Limited  
• Roche Diagnostics 
• Centers for Disease Control and Prevention (CDC)  
• Food and Drug Administration (FDA)  
• National Institutes of Health (NIH)  
• National Health Mission (NHM)