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Immunoassays: A $27 Billion Market of Intrigue and Opportunity

The global market for lab-based immunoassays, inclusive of both infectious disease and non-infectious disease analytes and instruments, reached $27 billion in 2023 and is forecast to experience modest growth in the foreseeable future. The findings are based on data published in In Vitro Diagnostics Business Outlook, 2024, a bi-monthly newsletter focused on global IVD products and developments published by leading market research firm Kalorama Information.

Kalorama reveals that major immunoassay product segments to watch include:

  • Hepatitis testing
  • Cardiac markers
  • HAIs/Sepsis
  • COVID-19
  • Respiratory infections (excl. COVID)

Immunoassays are crucial in vitro diagnostic tests that utilize antibodies or antigens to measure the presence or concentration of macromolecules or small molecules in a sample. These tests rely on the binding of antibodies to antigens to identify the presence of a specific substance, or analyte. Immunoassays are utilized in various forms, including automated, manual, ELISAs, enzyme immunoassays, bead arrays, microarrays, and more recently, those utilizing mass spectrometry. They play a dominant role in laboratory medicine, serving as essential tools in diagnosing and monitoring numerous diseases and medical conditions.

In the field of IVD, immunoassays are considered one of the cornerstone technologies due to their versatility, sensitivity, and specificity. They continue to be a key focus of research and development in the IVD industry, with ongoing efforts to improve performance, reduce costs, and expand the range of analytes that can be detected.

Contrary to initial expectations that molecular IVD techniques would surpass immunoassays, the opposite has occurred. Immunoassays have gained prominence, evidenced by the development of new assays for metabolic pathways, women’s health, diabetes, gastrointestinal disorders, and a wide range of autoimmune diseases.

Metabolic pathways, comprising proteins, enzymes, coenzymes, and various cellular elements, play a significant role in promoting and predicting disease evolution. The combination of genes, proteins, and pathways has created a comprehensive toolbox for modern post-genomic laboratory medicine.

The market growth is expected to continue, driven by novel areas of development, despite the significant impact of the COVID-19 market contraction. Immunoassay markets, while mature, are benefiting from innovations that are creating new opportunities for market expansion. The development of immunoassays for COVID-19 has led to a focus on tests using saliva, which has now extended to other areas of development, including cortisol analysis.

Globally, the top 10 country markets for lab-based immunoassays represent roughly 75% of the worldwide market.  The United States is the largest individual country market with 41% share.

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About Kalorama Information

Kalorama Information, part of Science and Medicine Group, is the leading publisher of market research in healthcare areas, including in vitro diagnostics (IVD), biotechnology, medical devices, and pharmaceuticals. Kalorama Information produces dozens of reports a year. The firm offers a Knowledge Center, which provides access to all published reports.

Kalorama Information’s studies feature independent primary research conducted by experienced analysts. Researchers build their market analysis independently from published databases, validating data with inside industry contacts and extensive secondary research, so you can have confidence that you’re getting your information from the most trusted source in the industry!