Chemiluminescence Immunoassay Market Outlook 2032
The global chemiluminescence immunoassay (CLIA) market size was USD 17.9 Billion in 2023 and is likely to reach USD 36.7 Billion by 2032, expanding at a CAGR of 8.3% during 2024–2032. The market growth is attributed to the increasing demand for high sensitivity diagnostic tests and growing prevalence of chronic disease.
Chemiluminescence immunoassay (CLIA) analyzers are light detectors specifically designed to detect the development of antigen-antibody complexes through light emission. These tools are frequently used to determine complex formation in a variety of situations, including endocrine disorders, oncology, infectious diseases, hepatitis & retrovirus, cardiovascular disorders, and many more. Rising disease burden around the globe is propelling the market. For instance,
- In 2021, according to World Health Organization, over 38.4 million people were affected by HIV, and efforts by international organizations have helped manage the disease with antiviral therapies.
- The same source states that, approximately 537 million adults (20–79 years) live with diabetes, and this number is predicted to rise to 643 million by 2030 and 783 million by 2045.
Recent developments in CLIA technology have aimed to improve sensitivity, specificity, and ease of use. Innovations include using gold nanoparticles for chemiluminescence, automating CLIA platforms, and integrating with other techniques. Multiplex CLIA allows simultaneous detection of multiple analytes from a single sample, while ongoing research focuses on integrating CLIA with other techniques, developing portable CLIA systems for point-of-care testing, and exploring new chemiluminescent substrates. These trends demonstrate CLIA technology's adaptability to various testing environments.
Impact of Artificial Intelligence (AI) in Chemiluminescence Immunoassay (CLIA) Market
Artificial Intelligence (AI) is significantly transforming the market for chemiluminescence immunoassays (CLIAs). AI can handle complex datasets, enabling faster and more accurate interpretation of results. It also has predictive capabilities, suggesting outcomes based on historical data, improving clinical decision-making. AI integrates with laboratory automation systems to streamline workflows and increase throughput without compromising quality.
Machine learning optimize assay conditions, ensuring improved performance and reliability. AI systems monitor and adjust for batch-to-batch variability, ensuring consistent performance over time. AI help identify new biomarker signatures by analyzing large datasets from CLIA platforms, potentially leading to the discovery of new diagnostic targets. It integrates CLIA data with electronic health records, enhancing personalized medicine. This integration is a part of a broader trend in the pharmaceutical and biotechnology industries, promoting efficiency and innovation in the CLIA market.
Chemiluminescence Immunoassay (CLIA) Market Dynamics
Major Drivers
Increasing demand for high sensitivity diagnostic tests is driving the market. The ability of CLIA to provide high sensitivity and specificity makes it popular for the detection of low-concentration analytes in various medical conditions. Furthermore, the growing prevalence of chronic disease such as, cancer, diabetes, and cardiovascular conditions, requiring regular monitoring a diagnostic test is boosting the market.
Existing Restraints
High costs of CLIA systems and complexity of tests needing skilled professionals are hindering the market. High cost of CLIA limits its adoption, particularly in developing countries. Furthermore, there are numerous alternative methods for conducting immunoassays, such as enzyme-linked immunosorbent assays, radioimmunoassay, and others that compete with CLIA technology.
Emerging Opportunities
Development of portable and user-friendly CLIA devices for point-of-care testing, which provide quick results outside of traditional laboratory settings, is a significant opportunity. Advancements such as multiplexing capabilities that allow multiple tests to be run simultaneously on one CLIA platform can cater to the needs for comprehensive screening, especially for complex diseases such as cancer.
Scope of the Chemiluminescence Immunoassay (CLIA) Market Report
The market report includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.
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Attributes
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Details
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Report Title
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Chemiluminescence Immunoassay (CLIA) Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast
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Base Year
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2023
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Historic Data
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2017–2022
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Forecast Period
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2024–2032
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Segmentation
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Product (Software & Services, Consumables, and Instruments [Automated and Semi Automated]), Technology (Chemiluminescence Enzyme Technology, Electrochemiluminescence Immunoassay, and Microparticle Chemiluminescent Immunoassay), Sample Type (Blood, Urine, Saliva, and Others), Application (Infectious Disease, Endocrinology, Oncology, Cardiology, Gastroenterology, Neurology, Respiratory, Toxicology, Allergy, Autoimmune Diseases, Blood Screening, Bone & Mineral Disorders, Newborn Screening, Therapeutic Drug Monitoring, Metabolic Disorders, and Others), End-user (Hospital, Clinical Laboratory, and Pharmaceuticals & Biotechnology Industries)
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Regional Scope
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Asia Pacific, North America, Latin America, Europe, and Middle East & Africa
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Report Coverage
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Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, Market Trends, and Revenue Forecast
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Key Players Covered in the Report
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Abbott Laboratories; Beckman Coulter Inc.; DiaSorin S.p.A.; F. Hoffmann-La Roche AG; Immunodiagnostic Systems; Inova Diagnostics, Inc.; Maccura Biotechnology Co., Ltd.; Ortho Clinical Diagnostics; Shenzhen Mindray Bio-Medical Electronics Co., Ltd.; and Siemens Healthineers.
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Chemiluminescence Immunoassay (CLIA) Market Segment Insights
Product Segment Analysis
Based on product, the chemiluminescence immunoassay (CLIA) market is divided into software & services, consumables, and instruments. The instrument segment dominated the global market in 2023 due to the development of fully automated instruments. Increasing advancements, numerous product launches in this field, and emerging opportunities developed by key market players are propelling the segment.
The consumables segment is anticipated to expand at a substantial CAGR during the forecast period due to repetitive buying of reagents and kits. The reoccurring expenses of frequently purchasing the products is expected to drive the segment during the forecast period. Moreover, increasing availability of advanced consumables offering superior performance and reliability is expected to boost the segment during the forecast period.
Technology Segment Analysis
On the basis of technology, the global market is segregated into chemiluminescence enzyme technology, electrochemiluminescence immunoassay, and microparticle chemiluminescent immunoassay. The chemiluminescence enzyme technology (CLEIA) segment is anticipated to register a considerable CAGR in 2023 owing to high sensitivity and specificity. Increasing number of applications of CLEIA such as, diagnostics, pharmaceutical research, food quality control, and weather analysis is expected to propel the segment during the predicted period.
Sample Type Segment Analysis
On the basis of sample type, the chemiluminescence immunoassay (CLIA) market is segmented into blood, urine, saliva, and others. The blood segment is expected to register a robust growth in 2023. Widespread use of blood tests in the clinical setting for the detection and monitoring of a variety of conditions, from infections to chronic diseases is fueling the segment. Furthermore, increased prevalence of chronic diseases, growing demand for early disease detection, and the development of more sophisticated and sensitive CLIA technologies that require minimal blood volumes are likely to drive the segment.
The saliva segment is expected to expand at a significant growth rate over the projection period growing demand for point-of-care testing with saliva. Saliva testing fits well with the growing demand for point-of-care diagnostics that can provide real-time results to facilitate rapid decision-making in clinical settings. Moreover, the lower risks of infections with saliva samples as compared to blood samples is expected to propel the segment.
Application Segment Analysis
Based on application, the market is divided into infectious disease, endocrinology, oncology, cardiology, gastroenterology, neurology, respiratory, toxicology, allergy, autoimmune diseases, blood screening, bone & mineral disorders, newborn screening, therapeutic drug monitoring, metabolic disorders, and others. The infectious disease segment dominated the global market in 2023 owing to the increasing burden of microbes and rising prevalence of microbial infections.
COVID-19 has exponentially increased the global burden of infectious disease from 2019 to 2022. The increasing need for rapid and accurate method of disease diagnosis with high-throughput is propelling the market. The versatility and sensitivity of CLIA methods make them suitable for a wide range of infectious pathogens, solidifying their role in the rapid diagnosis and management of such diseases, propelling the segment.
The oncology segment is anticipated to grow at a substantial CAGR during the forecast period due to the increasing demand for early cancer detection. Rising cancer prevalence is increasing the demand for a precision diagnostic, thus boosting the segment. For instance,
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In 2020, According to World Health Organization (WHO), Cancer is the leading cause of death worldwide, accounting for nearly 10 million deaths or nearly one in six deaths.
Advancements in oncology research are leading to new biomarkers and the effectiveness of CLIA in providing sensitive and specific results for cancer-related biomarkers, anticipated to propel the segment, duringthe forecast period.
End-user Segment Analysis
On the basis of end-user, the global market is segregated into hospital, clinical laboratory, and pharmaceuticals & biotechnology industries. The hospitals segment is anticipated to register a considerable CAGR in 2023 due to the increasing number of hospitalizations. Rising prevalence of chronic disease is leading to the specific disease diagnosis, boosting the segment. Additionally, advanced diagnostic technologies used to find rapid and accurate results for the immediate start of treatment is fueling the segment.
The clinical laboratory segment is projected to register a robust growth rate during the assessment years owing to its cost effectiveness. The increasing number of clinical laboratories worldwide is propelling the segment. Moreover, increasing number of collaborations among key players and clinical laboratories is expected to drive the segment, during the projection period. For instance,
In August 2017, Abbott Laboratories has secured a contract worth USD 252 million with North West London Pathology (NWLP) to deliver diagnostic equipment and consumables, including Abbott's Alinity ci-series diagnostic instruments.
Regional Analysis
In terms of region, the global chemiluminescence immunoassay (CLIA) market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is expected to dominate the market during the forecast period owing to several leading market players. Presence of top-notch infrastructure in this region and increasing awareness of latest developed solution is propelling the market in this region. Furthermore, rising prevalence of chronic disorders such as cancer, cardiovascular disease, asthma, and diabetes, is fueling the demand for CLIA.
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On 29 February 2024, according to the Centers for Disease Control and Prevention, the US has 129 million people with at least one major chronic disease, with five of the top 10 leading causes of death being preventable and treatable. Over the past two decades, prevalence has increased, and a high proportion of people are dealing with multiple chronic conditions. Chronic diseases significantly impact the US healthcare system, with 90% of the annual USD 4.1 trillion expenditure attributed to managing and treating chronic diseases and mental health conditions.
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The market in Asia Pacific is projected to grow at a significant pace in the years to come owing to rising population and high risks for chronic illnesses. Growing consumer base with rapidly growing population and burgeoning middle class, is driving the regional market. Countries such as China and India are facing significant economic growth, leading to increased spending power is fueling the regional market.
Segments
The chemiluminescence immunoassay (CLIA) market has been segmented on the basis of
Product
- Software & Services
- Consumables
- Instruments
Technology
- Chemiluminescence Enzyme Technology
- Electrochemiluminescence Immunoassay
- Microparticle Chemiluminescent Immunoassay
Sample Type
- Blood
- Urine
- Saliva
- Others
Application
- Infectious Disease
- Endocrinology
- Oncology
- Cardiology
- Gastroenterology
- Neurology
- Respiratory
- Toxicology
- Allergy
- Autoimmune Diseases
- Blood Screening
- Bone & Mineral Disorders
- Newborn Screening
- Therapeutic Drug Monitoring
- Metabolic Disorders
- Others
End-user
- Hospital
- Clinical Laboratory
- Pharmaceuticals & Biotechnology Industries
Region
- Asia Pacific
- North America
- Latin America
- Europe
- Middle East & Africa
Key Players
Competitive Landscape
Key players competing in the global chemiluminescence immunoassay (CLIA) market are Abbott Laboratories; Beckman Coulter Inc.; DiaSorin S.p.A.; F. Hoffmann-La Roche AG; Immunodiagnostic Systems; Inova Diagnostics, Inc.; Maccura Biotechnology Co., Ltd.; Ortho Clinical Diagnostics; Shenzhen Mindray Bio-Medical Electronics Co., Ltd.; and Siemens Healthineers.
These companies adopted development strategies including mergers, acquisitions, partnerships, collaboration, product launches, and production expansion to expand their consumer base worldwide. For instance,
- In December 2022, Mindray introduced CLIA-based assays for IL-6, PCT, and sCD 14-S, which have excellent sensitivity, a broad linearity range, high precision, and good anti-interference capabilities.
- In June 2022, Roche introduced the BenchMark ULTRA PLUS system, their most advanced tissue staining platform. The BenchMark ULTRA PLUS device is designed to automatically stain histological or cytological specimens on microscope slides using specialized immunohistochemistry, immunocytochemistry, or in situ hybridization chemicals for in vitro diagnostic (IVD) purposes.
- In February 2022, Sysmex formed a business partnership with KAINOS Laboratories to improve immunochemistry diagnostic reagents and provide diagnostic reagents for HISCL systems.
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