The global chemiluminescence immunoassay market was evaluated at US$ 7.22 billion in 2023 and is expected to attain around US$ 15.15 billion by 2033, growing at a CAGR of 7.7% from 2024 to 2033. The growth of the chemiluminescence immunoassay market is propelled by its distinct advantages over other types of immunoassay methods, such as fluorescence detection or light absorption.
Market Overview
The chemiluminescence immunoassay market is experiencing rapid growth, driven by its versatility and effectiveness in various industries, including medicine and diagnostics. CLIA, a variation of the standard enzyme immunoassay (EIA), utilizes a biochemical technique in immunology to determine sample concentrations based on the intensity of light emitted by a chemical and biological reaction. This powerful combination of immunoreaction and chemiluminescent technology has gained popularity in diagnostics due to its accuracy and reliability.
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By integrating chemiluminescent systems and immunoreactions, CLIA offers a superior approach for detecting antigens or antibodies compared to conventional tests. As a result, the chemiluminescence immunoassay market is witnessing significant expansion as industries increasingly adopt this innovative technique for a wide range of applications.
Key Insights
- North America held dominating share of 51.14% in 2023.
- By product, the consumable segment led the market in 2023 with market share 70%.
- By application, the endocrinology segment dominated the market with the largest share in 2023.
- By end-user, the hospitals segment has accounted maximum market share of 37% in 2023.
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Regional Stance
North America dominated a significant portion of the global market share and is poised to maintain this position throughout the assessment period. In Canada, the Industrial Biotechnology program collaborates with local companies to address technological challenges in producing high-value chemicals, ingredients, and products from renewable biomass, serving as an alternative to traditional feedstocks. These products find applications across various consumer and industrial sectors, including personal care, food and nutrition, household goods, and agriculture.
The Asia Pacific region presents significant opportunities for the chemiluminescence immunoassay market, with projections indicating rapid growth throughout the forecast period. India has launched an ambitious biotechnology program aimed at leveraging its abundant human and biodiversity resources, primarily through government-sponsored initiatives with limited private industry involvement. In China, biotechnology and related industries are rapidly advancing, with experts at the China National Center of Biotechnological Development indicating the nation's trajectory toward becoming a biotechnology powerhouse. As biotechnologies continue to proliferate, China and other regional stakeholders are actively working to develop regulatory and ethical frameworks to support this burgeoning sector's growth.
Report Highlights
By Product
The consumable segment led the market with the largest share in 2023. Under the products segment, the consumables sub-segment is observed to grow at a notable rate. Consumables play a crucial role in CLIA (Chemiluminescence Immunoassay), a sensitive laboratory technique utilized for detecting and quantifying specific molecules in patient samples. The increasing number of requests for CLIA tests, coupled with a rise in inappropriate requests, has led to a significant reduction in the pretest probability of disease. Consequently, there is a growing need for enhanced attention to the diagnostic specificity of tests used for screening anti-intracellular antigen autoantibodies, highlighting the importance of consumables in ensuring accurate diagnostic outcomes.
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By Applications
The chemiluminescence immunoassay market encompasses a wide range of applications spanning various medical disciplines, including disorders, endocrine diseases, infectious diseases, oncology, cardiovascular disorders, hepatitis, retrovirus, allergies, drug discovery and development, autoimmunity, and others. The endocrinology segment have garnered significant market share within this sector. Notably, CLIA introduces proportional bias in cortisol and testosterone levels, thereby mitigating sex differences in testosterone levels. However, the steroid measurement method has not shown significant moderation in the relationship between hormones and psychopathology. These diverse applications underscore the versatility and importance of CLIA technology in addressing complex medical conditions and advancing healthcare solutions.
By End User
The hospitals segment emerged as the primary end-users, capturing the majority market share within the chemiluminescent immunoassay market. Chemiluminescent immunoassay, a variant of the standard enzyme immunoassay (EIA), is a key biochemical technique in immunology, serving as a vital diagnostic tool in medicine across various industries.
Compared to other immunoassay methods such as fluorescence detection or light absorption, chemiluminescence offers distinct advantages, notably its ultra-sensitivity, enabling the detection of minute amounts of biological molecules. These benefits position chemiluminescence as a preferred choice for hospitals and other end-users seeking accurate and reliable diagnostic solutions.
Market Dynamics
Driver
Advancements in Diagnostic Technology
The rapid evolution of diagnostic technology, particularly in the identification of antibodies, has propelled the chemiluminescence immunoassay market forward, aligning its capabilities closely with automated clinical chemistry laboratories. The analytical and diagnostic advantages of chemiluminescence technology, including its wide dynamic range, high sensitivity and specificity, quantitative results, automation, reduced turnaround time, and ability to run numerous antibody tests, have positioned it as the most advanced option in clinical laboratories. Anticipated advancements in analytical platforms, such as flow-injection chemiluminescent immunoassay, two-dimensional resolution for multiplex immunoassay, and magnetic nanoparticles chemiluminescence immunoassay, are expected to further enhance the clinical efficacy of antibody tests, driving growth in the chemiluminescence immunoassay market.
Restraint
High Cost of Equipment
The adoption of chemiluminescence immunoassay market faces hurdles such as the need for specialized equipment and costly reagents, potentially limiting accessibility across laboratories. Lot-to-lot variability in reagents poses further challenges, impacting assay quality and necessitating meticulous analysis. These limitations, leveraging expertise in assay optimization presents opportunities for improved CLIA development, albeit with careful consideration of calibration and control variations.
Opportunity
Advancements in Immunoassay Technology
The integration of a chemiluminescence system with immune reactions in the chemiluminescence immunoassay analyzer has revolutionized diagnostic testing. Recognized globally as an advanced labeled immunoassay technique, it offers unparalleled accuracy and specificity, positioning it as a cornerstone in testing methodologies. As a successor to radioimmunoassay, enzyme immunoassay, fluorescence immunoassay, and time-resolved immunoassay, chemiluminescence immunoassay represents the next generation of immunoassay technology. With its versatility in testing applications expanding to include thyroid function, reproductive hormones, infectious diseases, tumor markers, and more, the chemiluminescence immunoassay market is ripe with opportunities for growth.
Recent Developments
- In January 2023, Azure Biosystems Inc. announced the launch of chemiSOLO, a high-performance, personal chemiluminescent imaging system characterized by its compact size and cost-effectiveness.
- In January 2024, Fujirebio and Agappe entered into an agreement for business collaboration in the field of CLIA-based immunoassay.
- In April 2023, Fapon Biotech launched its Chemiluminescence One-Stop Solution Strategy in India.
Key Players in the Chemiluminescence Immunoassay Market
- Hoffmann-La Roche AG
- Siemens Healthineers
- Abbott Laboratories
- DiaSorin S.p.A.
- Ortho Clinical Diagnostics
- Immunodiagnostic Systems
- Beckman Coulter Inc.
- Inova Diagnostics, Inc.
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Maccura Biotechnology Co., Ltd
Market Segmentation
By Product
- Consumables
- Instruments
- Automated
- Semi-automated
- Software & Services
By Application
- Cardiology
- Therapeutic Drug Monitoring
- Oncology
- Endocrinology
- Autoimmune Disease
- Infectious Disease
- Others
By End-use
- Clinical Laboratories
- Hospitals
- Pharmaceutical & Biotechnology Companies
- Others
By Geography
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa (MEA)
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