According to the most recent analysis by Emergen Research, Immunoassay market size reached USD 39.72 Billion in 2021 and is expected to register a revenue CAGR of 3.9% during the forecast period, according to latest analysis by Emergen Research. Increase in prevalence of chronic and infectious diseases is a major factor driving market revenue growth. According to the International Diabetes Federation (IDF), in 2021 approximately 537 million were living with diabetes worldwide and the number is estimated to rise to 643 million by 2030.
The development of efficient immunoassay technologies is still another important driver boosting market revenue growth. For instance, on September 2022, Neogen Corporation unveiled the second kit in its new Veratox VIP line of higher quantitative ELISA assays, the unique Veratox VIP test for cashew detection. The new Veratox VIP for cashew allergy test performs well with various sample types while adhering to the fundamental testing methodology of the Veratox product line. Additionally, the product can be used to evaluate samples from a broad range of product categories and processing scenarios, including heat-processed and ultra-high temperature matrices. Veratox VIP for Cashew uses the same testing methods Neogen uses for its other Veratox products, including a 30-minute time-to-result and ready-to-use, non-hazardous reagents.
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The use of immunoassays has a number of drawbacks. Cross-reactivity has consistently presented a problem for the immunoassays’ dependability and specificity. In immunoassays, antibodies bind to structural analogues of the target antibody/analyte. High sample volume requirements for detection, complicated procedures, unsuitability for high-throughput screening analysis (ELISA), and reagent instability are further problems.
Low-concentration analytes or target molecules are not thought to be acceptable for the standard colorimetric readout ELISA. In order to identify viral RNA sequences, immunoassays are not thought of as precise tests. They have been reported to have problems recognising specific biomolecules including interferons, rheumatoid factor, and non-specific IgM. In the first stages of the infection, immunoassays might potentially produce misleading negative results. The slightly symptomatic to asymptomatic individuals with a low titer of antibodies in response to the coronavirus infection struggle with this incorrect sensitivity.
Major companies in the market report include : Siemens Healthcare GmbH, Biomérieux, Abbott, Becton Dickinson and Company (BD), Beckman Coulter, Inc., Hologic, Inc., Ortho Clinical Diagnostics, Bio-Rad Laboratories, Inc., F. Hoffmann-La Roche Ltd., and Thermo Fisher Scientific.
In 2021, the reagents and kits category contributed a sizeable portion of revenue. Immunoassay kits use immunological proteins or antibodies to detect chemicals of interest. These molecules of interest could be hormones, antibodies, or viral or bacterial antigens. Applications for immunoassay reagents and kits have been broadened by multiplex immunoassays in a variety of industries, including pharmaceutical companies, biotechnology and life science enterprises, food and beverage (F&B) corporations, and environmental monitoring. Additionally, the introduction of molecular tests, as well as a rise in reagent and kit sales, are driving demand for immunoassay testing kits.
In 2021, the Enzyme-Linked Immunosorbent Assay (ELISA) segment contributed a sizable portion of revenue. Every antigen-antibody pair used in ELISA contains an enzyme-labeled antigen or antibody, and the enzyme activity is measured colorimetrically. These are easy to use, don’t require any specialist equipment, and both seasoned lab workers and research lab newbies can easily pick up ELISA skills. The test is most frequently used to identify or diagnose viral infections, particularly infections caused by blood-borne viruses including the HIV, Hepatitis B, and C viruses. It is anticipated that rising prevalence of these diseases will fuel this segment’s market revenue growth.
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Emergen Research has segmented the global immunoassay market based on product, technology, application, end-use, and region:
- Product Outlook (Revenue, USD Billion; 2019-2030)
- Reagents and Kits
- Technology Outlook (Revenue, USD Billion; 2019-2030)
- Radioimmunoassay (RIA)
- Enzyme-Linked Immunosorbent Assay (ELISA)
- Rapid Test
- Fluoroimmunoassay (FIA)
- Chemiluminescence Immunoassay (CLIA)
- Application Outlook (Revenue, USD Billion; 2019-2030)
- Therapeutic Drug Monitoring
- Infectious Disease Testing
- Autoimmune Diseases
- End-Use Outlook (Revenue, USD Billion; 2019-2030)
- Biotechnology & Pharmaceutical Industries
- Blood Banks
- Clinical Laboratories
- Academic Research Centers
- Regional Outlook (Revenue, USD Billion; 2019-2030)
- North America
- Rest of Europe
- Asia Pacific
- South Korea
- Rest of APAC
- Latin America
- Rest of LATAM
- Middle East & Africa
- Saudi Arabia
- South Africa
- Rest of Middle East & Africa
- North America
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