Chemiluminescence Immunoassay Market by Product (Instruments, Consumables), Technology (Chemiluminescence Enzyme, Microparticle Chemiluminescence), Sample (Blood, Urine), Application (Infectious Disease, Oncology), End User - Global Forecast to 2028" projects a substantial growth trajectory, with an anticipated increase from USD 13.2 billion in 2023 to a projected USD 19.0 billion by 2028. This expansion is expected to occur at a Compound Annual Growth Rate (CAGR) of 7.5% throughout the forecast period.

The prominent drivers fueling this growth in the chemiluminescence immunoassay market include the escalating prevalence of chronic diseases, noteworthy advancements in enhancing chemiluminescence immunoassay technologies in recent years, a surging demand for point-of-care testing (POCT), the flourishing biotechnology and biopharmaceutical sectors, and a rapid upsurge in the global geriatric population. Furthermore, emerging markets like India and China are poised to provide lucrative growth prospects for companies operating within the chemiluminescence immunoassay market over the forecast duration.

Nonetheless, the market's expansion faces a restraint in the form of the high costs associated with Chemiluminescence Immunoassay (CLIA) systems, limiting its growth potential.

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Key Market Players:

The major players operating in this market are F. Hoffmann-La Roche Ltd. (Switzerland), Danaher Corporation (US), Siemens Healthineers AG (Germany), DiaSorin S.p.A. (Italy), Abbott Laboratories (US), Shenzhen Mindray Bio-medical Electronics Co., Ltd. (China), Sysmex Corporation (Japan), Diatron (Hungary), Getein Biotech, Inc. (China), Werfen (Spain), QuidelOrtho Corporation (US), EUROIMMUN (Germany), Merck KGaA (Germany), Tosoh Corporation (Japan), Trivitron Healthcare (India), Abnova Corporation (Taiwan), Elabscience (US), Maccura Biotechnology Co., Ltd. (China), Autobio Diagnostics Co., Ltd. (China), Jiangsu Zecen Biotech Co., Ltd (China), Rayto Life and Analytical Sciences Co., Ltd. (China), Daan Gene Co., Ltd. (China), DYNEX TECHNOLOGIES, Inc. (US), Zybio, Inc. (China), Wiener Laboratorios SAIC (Argentina), Tianjin Era Biology Technology Co., Ltd. (China).

The rising demand for point-of-care testing (POCT) is another significant factor contributing to market expansion. Chemiluminescence immunoassay systems are increasingly being adopted for POCT due to their rapid and reliable results, enabling efficient patient management and treatment decisions.

The growth of the biotechnology and biopharmaceutical industries also plays a role in driving the chemiluminescence immunoassay market. These industries heavily rely on immunoassay techniques for drug discovery, development, and monitoring, leading to increased adoption of chemiluminescence immunoassay systems.

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In 2022, the consumables segment held the largest share of the chemiluminescence market, by product segment

Based on product, the global chemiluminescence immunoassay market is categorized into consumables and instruments. The repetitive purchase of consumables such as reagents for every test is a major factor driving the growth of the segment. Besides the availability of efficient assays and reagents for diagnostic purposes has propelled its demand among end users.

In 2022, the infectious disease diagnostics segment held the largest share of the chemiluminescence market, by application segment

The chemiluminescence immunoassay market, by application, has been segmented into infectious diseases, endocrinology, oncology, bone & mineral disorders, cardiology, blood screening, autoimmune disorders, allergy diagnostics, toxicology, newborn screening, gastroenterology, neurology, respiratory, therapeutic drug monitoring, metabolic disorders, and other applications. The large share of this segment can be attributed to the development and introduction of advanced assays for the diagnosis of different diseases & conditions, and the increase in the population with infectious diseases.

North America dominates the global chemiluminescence immunoassay market

Based on the region, the chemiluminescence immunoassay market is segmented into North America, Europe, Asia Pacific, and Rest of the world. In 2022, North America accounted for the largest share of the chemiluminescence immunoassay market. The large share of North America in this market can be attributed to the increasing prevalence of infectious diseases and cancer and rising healthcare spending, which is highly developed in the US and Canada.

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Chemiluminescence Immunoassay Market Dynamics:

Drivers:

1. Rising incidence of chronic and infectious diseases across the globe

Restraints:

1. High cost of CLIA related products

Opportunities:

1. Increasing number of collaborations and partnerships in the CLIA market

Challenges:

1. Lack of skilled professionals and aging workforce

Recent Developments:

• In May 2023, EUROIMMUN's parent company PerkinElmer's life science and diagnostics business segment, has been rebranded as Revvity.
• In December 2022, Mindray launched CLIA-based assays, IL-6, PCT, and sCD14-S, which have high sensitivity, a wide linearity range, great precision, and good anti-interference ability.
• In December 2022, Sysmex received manufacturing and marketing approval in Japan for the HISCL β-Amyloid 1-42 Assay Kit and the HISCL β-Amyloid 1-40 Assay Kit to measure amyloid beta (Aβ) in the blood.
• In November 2022 Getein Biotech, Inc. launched MAGICL 6000, a compact and innovative chemiluminescence immunoassay analyzer used in mid to high-workflow laboratories
• In June 2022, QuidelOrtho Corporation was formed through a transaction between Quidel Corporation and Ortho Clinical Diagnostics to form a leading in vitro diagnostics company.

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Chemiluminescence Immunoassay Market Advantages:

• Sensitivity and Specificity: Chemiluminescence immunoassays provide high sensitivity and specificity in detecting target molecules. The use of specific antibodies and the amplification of chemiluminescent signals result in low detection limits and minimal interference from background noise, ensuring accurate and reliable results.
• Wide Analyte Range: Chemiluminescence immunoassays can detect a diverse range of analytes, including proteins, hormones, tumor markers, infectious agents, and drugs. This versatility allows for comprehensive testing across various applications, including clinical diagnostics, pharmaceutical research, environmental monitoring, and food safety.
• Multiplexing Capabilities: Chemiluminescence immunoassays enable multiplexing, the simultaneous detection of multiple analytes in a single assay. This capability is particularly valuable in clinical diagnostics, where it allows for the efficient and cost-effective assessment of multiple biomarkers, aiding in disease diagnosis, prognosis, and treatment monitoring.
• Speed and Automation: Chemiluminescence immunoassays offer rapid results due to the short incubation times required for chemiluminescent reactions. Additionally, the integration of automated systems and robotic platforms streamlines the workflow, reducing manual handling and increasing throughput. This combination of speed and automation enhances laboratory efficiency and productivity.

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