New Product Launches are driving the Immunoassay Market

The global immunoassay market is anticipated to grow at a CAGR of 6.08% during the forecast period (2024-2031). The market growth is driven by the growing number of diseases. The market is segmented by product (analyzer and consumable), technology (radioimmunoassay, counting immunoassay, enzyme immunoassays, fluoroimmunoassay, and chemiluminescence immunoassay), and geography (North America, Europe, Asia-Pacific, and the Rest of the World).

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Market Dynamics

• In December 2024, Roche received CE mark approval for its cobas® Mass Spec solution, which includes the cobas® i 601 analyzers and an Ionify® reagent pack of four assays for steroid hormones.
• In August 2024, Wondfo presented new products at the 76th Annual American Congress of Clinical Chemistry and Exposition of Clinical Laboratory Medicine (ADLM). The products included the new fully automatic chemiluminescence immunoassay analyzer FC-2100, the fluorescence immunoassay analyzer Finecare™ FIA Meter X1 and X2, and the automatic blood gas analyzer Ucare-6000. The immunoassay analyzer covers 0.64 sqm, and the test speed is up to 200T/h. The first result shows within 12 minutes.
• In March 2024, Sysmex Corp. launched six testing parameters, including, HISCL LH Assay Kit, HISCL FSH Assay Kit, HISCL Prolactin Assay Kit, HISCL Estradiol Assay Kit, HISCL Progesterone Assay Kit, and HISCL Testosterone Assay Kit. The parameters will be applied to gynecological and gonadal hormone immunoassay panels in Japan. The testing parameters are applicable for Automated Immunoassay System HISCL-5000/HISCL-800 (HISCL-Series) and will address a wide range of laboratory needs.   
• In January 2024, Fujirebio Holdings, Inc. and Agappe Diagnostics Ltd entered into a Contract Development and Manufacturing Organization (CDMO) partnership for a Cartridge-based CLIA system reagents manufacturing project. The project is aimed at manufacturing immunology equipment Mispa i60 and Mispa i121. The analyzers and reagents are sold under Agappe’s brand.
• In July 2023, the Atellica CI Analyzer by Siemens Healthineers received FDA clearance. The product is available for immunoassay and clinical chemistry testing in major markets, globally.
• In September 2022, Spear Bio presented its immunoassay technology at the American Association of Clinical Chemistry’s scientific meeting and clinical lab expo, in Chicago. The company unveiled the NAB-Sure™ SARS-CoV-2 neutralizing antibody (NAb) test kit. The product is useful against COVID-19 and serves various applications including COVID-19 serosurveillance, vaccine efficacy testing, and longitudinal antibody durability testing.
• In October 2022, Roche launched SARS-CoV-2 rapid antigen tests (“2.0”) for COVID-19 test, for professional use (SARS-CoV-2 Rapid Antigen Test 2.0 (nasopharyngeal sampling), SARS-CoV-2 Rapid Antigen Test 2.0 Nasal (nasal sampling)) and self-testing (SARS-CoV-2 Antigen Self-Test Nasal (nasal sampling)).

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SARS-CoV-2 Rapid Antigen Test 2.01 (nasopharyngeal sampling) is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 in human nasopharyngeal swab samples.   

SARS-CoV-2 Rapid Antigen Test 2.0 Nasal2 (nasal sampling) is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasal swab samples.

SARS-CoV-2 Antigen Self-Test Nasal3 is for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in human nasal samples.

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