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Meticulous Research®—a leading market research company, published a research report titled, ‘IVD Assay Development Market Size, Share, Forecast, & Trends Analysis by Offering (Assay Development, Packaging Development) Technology (Immunoassay, Molecular Diagnostics, Biochemistry) Application (Oncology, Diabetes) – Global Forecast to 2031.’ According to this latest publication from Meticulous Research®, the IVD assay development market is projected to reach $8.39 billion by 2031, at a CAGR of 7.9% from 2024 to 2031.
The growth of the IVD assay development market is driven by the rising prevalence of chronic diseases & the increasing geriatric population, the high burden of infectious diseases, the growing focus on the development of POC IVD assays, and rising healthcare expenditures. However, the evolving regulatory landscape restrains this market’s growth.
Moreover, the emerging economies and the use of advanced technologies in IVD assay development are expected to generate growth opportunities for market stakeholders. Maintaining product quality & protecting proprietary information pose challenges to the growth of the market.
Key Players
The key players profiled in the IVD assay development market report are Thermo Fisher Scientific Inc. (U.S.), Avioq, Inc. (U.S.), Creative Biolabs, Inc (U.S.), Maxim Biomedical, Inc. (U.S.), Bio-Techne Corporation (U.S.), Merck KGaA (Germany), PeploBio Ltd (U.K.), ICON plc (Ireland), NeoDx Biotech Labs Pvt. Ltd. (India), Eclevar Medtech (France), Savyon Diagnostics (Israel), Promega Corporation (U.S.), and Future Diagnostics Solutions B.V. (Netherlands).
The IVD assay development market is segmented by offering, technology, and application. The report also evaluates industry competitors and analyzes the IVD assay development market at the regional and country levels.
Among the offerings studied in this report, in 2024, the IVD assay development services segment is anticipated to dominate the IVD assay development market, with a share of 45.1%. Assay development services have various phases, including the selection of key raw materials, the screening of raw materials, preliminary feasibility studies, the optimization of assay parameters, the verification of assay designs, and clinical sample testing. The increased usage of IVD tests in drug discovery is driving the demand for IVD assay development services. IVD assays are essential for assessing pharmaceutical candidates, detecting biomarkers, making treatment decisions, and identifying patients for specific therapy. With pharmaceutical companies' transition to customized medicine and precision therapies, the demand for high-quality IVD assays is fast increasing. These are factors contributing to the segment’s dominant position in the IVD assay development market.
Among the technologies studied in this report, in 2024, the immunoassay/immunochemistry segment is anticipated to dominate the IVD assay development market, with a share of 42.3%. Immunoassay/immunochemistry is a bioanalytical method in which the quantitation of the analyte depends on the reaction of an antigen and an antibody. Immunoassay technologies utilize antigen-antibody reactions for the detection of causative agents. In addition, higher preference for immunodiagnostics compared to other technologies owing to its inherent specificity and high throughput and the emergence of advanced diagnostic immunoassay formats. Further, the growing use of immunoassays in Point-of-care (PoC) infectious disease testing, the increasing need to develop novel assays, and the rising aging population are factors contributing to the segment’s dominant position in the IVD assay development market.
Among the applications studied in this report, in 2024, the infectious diseases segment is anticipated to dominate the IVD assay development market. Infectious diseases are transmissible illnesses that can spread rapidly, making accurate diagnosis essential to prevent further transmission. IVD assays are widely recognized as effective tools for diagnosing infectious diseases. The segment’s dominant position in the IVD assay development market can be attributed to government initiatives to promote awareness and testing, advancements in diagnostic techniques, recent outbreaks of infectious diseases globally, and the rising prevalence of such diseases. According to the WHO, there were 39.9 million cases of HIV worldwide at the end of 2023, compared to 25.6 million cases in 2021.
Among the regions studied in this report, in 2024, North America is anticipated to dominate the IVD assay development market, with a share of 37.8%. The large share of this segment is attributed to factors such as favorable government investments and funding for disease investigation & prevention, high prevalence of various infectious diseases and chronic diseases, well-developed healthcare sector, awareness regarding early disease diagnosis, early adoption of advanced innovative diagnostic products which are significant factors driving the growth of the IVD assay development market in the region.
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