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IVD Trends to Watch: $12 Billion Immunoassays Market Set for Growth Through 2029

Immunoassays, which are tests based on the binding of antibodies to antigens to identify the presence of a substance (an analyte), have been a cornerstone of clinical lab medicine since the mid-1960s. These tests, whether automated, manual, ELISAs, enzyme immunoassays, bead arrays, microarrays, or those using mass spectrometry, play a dominant role in laboratory medicine. They are indispensable tools in diagnosing and monitoring a wide range of diseases and medical conditions.

In 2024, the immunoassay market experienced growth, with COVID-19 testing continuing to impact certain areas, according to Kalorama Information’s comprehensive 1,700-page report, The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 17th Edition. Kalorama estimates that the global market for immunoassays, excluding those for infectious diseases and blood unit screening, exceeds $12 billion. The industry is forecasted to grow at a compound annual growth rate (CAGR) approaching 4% through 2029.  Proteins, Diabetes/HbA1c, Cardiac Markers, Tumor Markers, Autoimmune, and Thyroid will experience the highest CAGR among analyte types from 2024 to 2029 (see chart).

Significant growth opportunities in the immunoassay market are driven by innovations, including new platforms, technologies, and novel biomarkers. These advancements will continue to propel the evolution and expansion of immunoassays in clinical lab medicine.

Despite the rise of molecular techniques, which were once predicted to overshadow immunoassays, the potential of these tests has only grown alongside market sales. New assays for metabolic pathways, women’s health, diabetes, gastrointestinal disorders, and autoimmune diseases have been commercialized, highlighting the expanding scope of immunoassays.

Growth prospects are especially promising in developing countries. Factors driving this growth include the increasing middle-class population, better insurance coverage, and economic improvements in regions like Southeast Asia and Latin America. Major diagnostic companies and smaller local firms are targeting these markets, with much of the growth expected from existing technologies like ELISA and lateral flow tests.

However, all immunoassays will have to pass the test of medical research to prove their contribution to improved patient outcomes.  Increased knowledge of disease physiology derived from molecular biology and human genome studies will enhance the position of analytes used in chronic conditions such as cardiovascular disease, autoimmune disorders and diabetes.  The function of genes is measured by presence of tangible products—proteins of every size and molecular structure. Thus, immunoassays combined with DNA probe studies will have an important place in post genomic medicine.

Looking ahead, the future prospects for immunoassays remain robust. Immunoassays have proven their resilience and adaptability, ensuring their continued relevance and importance in the ever-evolving landscape of medical diagnostics.

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For more information, purchase The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 17th Edition.

The 17th edition of The Worldwide Market for In Vitro Diagnostic (IVD) Tests offers extensive market sizing and forecasting for every segment of the IVD industry from 2024 to 2029.

This comprehensive 1,700-page report is based on detailed vendor reporting, insightful interviews, and thorough analysis of global IVD activities.

As the IVD market is set for dynamic growth over the next five years, this essential resource highlights the hottest trends, key growth areas, and the companies best positioned to benefit. Kalorama Information’s report, now in its 17th edition, is indispensable for anyone interested in or involved with the IVD industry. It provides reliable estimates, real-world forecasts from 2024 to 2029, and crucial insights to fully understand the IVD market. Covering every significant test category in detail, it’s like having ten market research reports in one comprehensive volume.