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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