Chemiluminescence Immunoassay Market Toward US$ 25.2 Billion By 2034

Overview

New York, NY – May 28, 2025 – Global Chemiluminescence Immunoassay Market size is expected to be worth around US$ 25.2 billion by 2034 from US$ 13.2 billion in 2024, growing at a CAGR of 6.7% during the forecast period 2025 to 2034.

Chemiluminescence Immunoassay (CLIA) is gaining significant momentum across global diagnostic laboratories due to its superior sensitivity, specificity, and automation capabilities. This technique combines the precision of immunoassays with the sensitivity of chemiluminescent reactions, enabling accurate detection of low-abundance biomarkers in clinical samples.

CLIA works by tagging antibodies with chemiluminescent molecules, which emit light during antigen-antibody interactions. The intensity of emitted light is directly proportional to the concentration of the target analyte. This method supports both qualitative and quantitative assessments, making it ideal for hormone analysis, infectious disease detection, oncology markers, and cardiac diagnostics.

The technology is widely adopted in hospitals, reference laboratories, and point-of-care settings, driven by increasing demand for rapid and high-throughput diagnostic solutions. Key advantages include reduced turnaround time, enhanced reproducibility, and minimal sample volume requirement.

Recent advances in CLIA systems focus on improved assay throughput, integration with automated analyzers, and expanded test menus to meet the growing needs of personalized medicine. Furthermore, the ongoing shift towards preventive healthcare and early disease detection continues to support CLIA adoption worldwide. With regulatory approvals and quality standards becoming more stringent, CLIA platforms are expected to play a central role in clinical diagnostics, supporting timely treatment decisions and improved patient outcomes.

Key Takeaways

• Market Size and Growth: In 2023, the Chemiluminescence Immunoassay (CLIA) market generated revenue of US$ 13.2 billion. It is projected to expand at a compound annual growth rate (CAGR) of 6.7%, reaching approximately US$ 25.2 billion by 2033.
• By Product Type: The market is categorized into analyzers and reagents. Reagents emerged as the leading product type in 2023, capturing a 61.2% share of total market revenue.
• By Application: Applications include oncology, therapeutic drug monitoring, cardiology, endocrinology, autoimmune disease, infectious disease, and others. Among these, therapeutic drug monitoring held a dominant position, accounting for 45.3% of the market share.
• By Sample Type: The market is segmented into blood, saliva, urine, and others. The blood sample type dominated the segment, contributing 64.3% of the market revenue in 2023.
• By End User: Key end users include hospitals, clinical laboratories, pharmaceutical & biotechnology companies, and others. Pharmaceutical and biotechnology companies led this segment with a 56.2% share of total revenue.
• By Region: North America was the leading regional market, securing a 41.2% market share in 2023.

Segmentation Analysis

• Product Type Analysis: In 2023, the reagents segment dominated the product type category with a 61.2% market share. This growth is attributed to the increasing need for accurate, high-throughput diagnostic tools. Reagents are vital in facilitating precise analyte detection in chemiluminescence immunoassays. With the rising prevalence of chronic diseases and the demand for advanced diagnostics, innovations in reagent sensitivity and stability are expected to further drive segment growth in clinical and research applications.
• Application Analysis: Therapeutic drug monitoring accounted for 45.3% of the application segment in 2023. The rise of personalized medicine is fueling demand for precise drug level measurements to ensure safe and effective dosing. Chemiluminescence immunoassays enable accurate monitoring, especially for biologics and chemotherapy. As healthcare shifts towards individualized care, the focus on minimizing toxicity and improving treatment outcomes will likely increase reliance on these assays for therapeutic management.
• Sample Type Analysis: The blood segment led the sample type category with a 64.3% share in 2023, due to the widespread use of blood-based diagnostics. Blood samples offer high accuracy for detecting conditions like infections, cancer, and heart disease. Their non-invasive nature and suitability for point-of-care settings contribute to growing adoption. As chronic diseases rise, improved blood collection methods and demand for frequent testing are expected to support continued segment expansion.
• End-user Analysis: Pharmaceutical and biotechnology companies held a 56.2% share of the end-user segment in 2023. These entities increasingly utilize chemiluminescence immunoassays for biomarker detection, drug monitoring, and clinical research. With a focus on personalized medicine, rapid diagnostics are essential for efficient drug development. As trials grow in complexity and precision, demand for scalable, automated assay platforms is expected to rise, reinforcing the segment’s role in advancing innovative therapies.

Market Segments

By Product Type

• Analyzers
• Reagents

By Application

• Oncology
• Therapeutic Drug Monitoring
• Cardiology
• Endocrinology
• Autoimmune Disease
• Infectious Disease
• Others

By Sample Type

• Blood
• Saliva
• Urine
• Others

By End-user

• Hospitals
• Pharmaceutical & Biotechnology Companies
• Clinical Laboratories
• Others

Regional Analysis

In 2023, North America led the Chemiluminescence Immunoassay (CLIA) market, accounting for a 41.2% revenue share. This dominance is driven by advanced diagnostic infrastructure, rising healthcare expenditure, and the growing need for accurate testing methods. The increasing burden of chronic conditions, including cardiovascular diseases and cancers, has reinforced the demand for high-sensitivity diagnostic tools like CLIA. In November 2023, Medical & Biological Laboratories Co., Ltd. introduced the iStar 500, a compact CLIA analyzer, enhancing diagnostic capabilities in emergency settings and mid-sized labs across the region.

Meanwhile, the Asia Pacific region is projected to register the highest CAGR during the forecast period. Countries such as China, India, and Japan are investing heavily in modernizing healthcare systems, expanding access to diagnostics, and addressing the rising prevalence of chronic and infectious diseases. In December 2022, Sysmex received approval in Japan to market the HISCL β-Amyloid assay kits for Alzheimer’s diagnostics. Regional growth is further supported by government initiatives and private investments in healthcare technology. These developments are expected to drive significant adoption of CLIA systems across Asia Pacific in the coming years.

Emerging Trends

• Integration with Digital Microfluidics: The adoption of integrated digital microfluidic platforms has been advancing rapidly in chemiluminescence immunoassay (CLIA) workflows. These systems automate sample handling and reagent mixing on a single chip, reducing hands-on time and contamination risk. The miniaturized format also permits faster assay turnaround, with some platforms delivering results in under 30 minutes, down from several hours in conventional setups.
• Enhanced Sensitivity and Dynamic Range: Recent peroxidase-mediated CLIA reagents have demonstrated superior analytical performance. A study reported limits of detection as low as 0.1 pg/mL for certain biomarkers, with linear dynamic ranges spanning five orders of magnitude. This improvement allows quantification of both very low-abundance and high-concentration analytes within the same assay, supporting broader clinical applications.
• Point-of-Care (POC) Chemiluminescence Systems: Compact POC CLIA devices are entering clinical practice, enabling near-patient testing. The Accre 8 system, for example, performs a full chemiluminescent assay in a single step with minimal calibration, yielding results in under 15 minutes. In a validation study of 239 samples, the system achieved an area under the ROC curve of 0.98 compared to laboratory-based LC-MS/MS methods, confirming its reliability for rapid diagnostics.
• Synergy with Molecular Diagnostics: CLIA platforms are increasingly being combined with nucleic acid tests to improve diagnostic accuracy. During the COVID-19 pandemic, chemiluminescent microparticle immunoassays were used alongside RT-PCR to confirm SARS-CoV-2 infections. This dual-modality approach enhanced overall sensitivity to 99% and specificity to 98%, supporting more robust case identification in clinical and public health laboratories.

Use Cases

• Infectious Disease Screening (Hepatitis C Virus): Chemiluminescence immunoassays are routinely employed for anti-HCV antibody screening in blood banks and clinical laboratories. The VITROS® Anti-HCV assay—a CLIA format approved by the FDA—has been integrated into national screening protocols. In the United States, an estimated 2.4 million individuals (1.0% of the population) are living with HCV infection, underscoring the need for high-throughput CLIA testing to identify and link these patients to care.
• Cardiac Marker Quantification (Troponin I/T): High-sensitivity CLIA assays for cardiac troponins have become the standard for early myocardial infarction diagnosis. Modern CLIA platforms can detect troponin concentrations as low as 0.006 ng/mL, with coefficients of variation below 5% at the 99th percentile cutoff. This precision enables emergency departments to rule in or rule out acute coronary syndrome within 1 hour of presentation, reducing unnecessary hospital admissions.
• Point-of-Care Vitamin B12 Measurement: The Accre 8 POC CLIA device has been validated for on-site vitamin B12 testing, providing results in less than 15 minutes. In a study of 239 serum samples, the assay showed a regression slope of 1.44 versus LC-MS/MS (gold standard) and an AUC of 0.98, indicating excellent agreement. Such rapid quantification supports immediate therapeutic decisions in outpatient and resource-limited settings.

Conclusion

Chemiluminescence Immunoassay (CLIA) continues to gain global prominence due to its exceptional sensitivity, specificity, and automation potential. Its widespread adoption across hospitals, laboratories, and pharmaceutical companies is supported by growing demand for rapid, high-throughput diagnostics and the rise of personalized medicine.

North America leads the market, while Asia Pacific shows strong growth potential. Innovations in digital microfluidics, point-of-care systems, and reagent sensitivity are enhancing clinical outcomes. With broad applications ranging from infectious disease screening to cardiac diagnostics, CLIA systems are expected to remain integral to modern healthcare, driving improved diagnostic accuracy, timely treatment, and patient-centered care worldwide.

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