Chemiluminescence Immunoassay Market to Hit USD 17.72 Billion by 2032, Driven by Increasing Diagnostic Demand and Technological Advancements – SNS Insider

SNS Insider Unveils Strategic Insights into the U.S. Chemiluminescence Immunoassay Market’s Growth Trajectory—Valued at USD 3.66 Billion in 2023—Powered by Rapid Diagnostic Adoption and Rising Chronic Disease Burden

Austin, June 16, 2025 (GLOBE NEWSWIRE) — Chemiluminescence Immunoassay Market Size & Growth Analysis:

According to SNS Insider, the Chemiluminescence Immunoassay (CLIA) Market was valued at USD 11.76 billion in 2023 and is projected to reach USD 17.72 billion by 2032, growing at a CAGR of 4.68% during the forecast period 2024–2032. This growth is primarily driven by the increasing incidence of chronic and infectious diseases, coupled with the demand for highly sensitive and specific diagnostic tools. Additional growth factors include the growing emphasis on early disease detection and the expansion of clinical laboratory infrastructure in emerging markets.


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In the United States, the CLIA market reached a valuation of USD 3.66 billion in 2023. With robust healthcare spending and early adoption of automated immunoassay platforms, the US market is expected to maintain strong momentum through 2032.

Market Overview

High-sensitivity chemiluminescent immunoassay (CLIA) assays with a short detection time and broad indications ranges in oncology, endocrinology, and infectious disease testing have gained widespread popularity as diagnostic methods. They are increasingly being applied in hospital laboratories and private diagnostic centers owing to their ability to give precise results for low-concentration analytes. In addition, advances in developing the multiplex ability have enabled the simultaneous detection of a variety of biomarkers, thereby further enhancing the throughput and cost-effectiveness of these analyses.

The rise in global chronic diseases such as cardiovascular diseases, diabetes, and cancer has only added to the need for early diagnosis tools. As more people are entering the geriatric age group and personalized medicine programs being adopted, the market is likely to grow at a steady rate. Also, the positive reimbursement policies and government support for diagnostics infrastructure in developed economies are likely to drive market penetration.

Major Players Analysis Listed in this Report are:

  • F. Hoffmann-La Roche AG (Elecsys CLIA Analyzers)
  • Danaher Corporation (Beckman Coulter Access Immunoassay Systems)
  • Siemens Healthineers (ADVIA Centaur Immunoassay Systems)
  • Abbott Laboratories (ARCHITECT i1000SR Immunoassay Analyzer)
  • DiaSorin S.p.A. (LIAISON XL Analyzer)
  • Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (CL-900i CLIA Analyzer)
  • Ortho Clinical Diagnostics (VITROS Immunodiagnostic Products)
  • Tosoh Corporation (AIA-CL Series Analyzers)
  • Sysmex Corporation (HISCL Series Immunoassay Analyzers)
  • Randox Laboratories Ltd. (Evidence Investigator Analyzer)
  • bioMérieux (VIDAS Immunoassay Systems)
  • Inova Diagnostics, Inc. (QUANTA Flash CLIA Assays)
  • Maccura Biotechnology Co., Ltd. (iMagic CLIA Analyzer)
  • Immunodiagnostic Systems (IDS-iSYS Multi-Discipline Automated System)
  • Shenzhen New Industries Biomedical Engineering Co., Ltd. (MAGLUMI CLIA Analyzers)

Chemiluminescence Immunoassay Market Report Scope

Report Attributes Details
Market Size in 2023 USD 11.76 billion
Market Size by 2032 USD 17.72 billion
CAGR (2024–2032) 4.68%
U.S. Market 2023 USD 3.66 billion
Base Year 2023
Forecast Period 2024–2032
Key Regional Coverage North America (US, Canada, Mexico), Europe (Germany, France, UK, Italy, Spain, Poland, Turkey, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Singapore, Australia, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Rest of Latin America)

Segment Analysis

By Product:

The biggest contributor to the CLIA market in 2023 was consumables, which accounted for 65.7% of market revenue. This is due to the ongoing need for assay kits, reagents, calibrators, and quality control products. Repeat purchases of consumables are fostered by the need for multiple test cycles of hospital and laboratory use, particularly for screening for hormones and infectious diseases.

Consumable is also anticipated to record more rapid growth over the forecast period as panels for disease-specific testing and multiplexing kits were introduced, and users are moving towards the adoption of fully automated immunoassay analyzers that utilize standard consumables to a large extent.

By Sample Type:

The blood Sample category captured the largest market share in 2023 due to high diagnostic sensitivity, sample ease, and compatibility with multiple CLIA analyzers. Blood tests were a large volume of testing and are ideal for detecting hormones, tumor markers, cardiac markers, and infectious diseases.

The urine sample segment will lead the market with the highest growth rate during the forecast period. Increasing demand for non-invasive diagnostic analysis and the longer test menu of renal and metabolic disorders by using urine-based CLIA tests are some of the drivers responsible for its anticipated market growth.

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Chemiluminescence Immunoassay Market Segmentation

By Product

  • Instruments
  • Automated
  • Semi-automated
  • Consumables
  • Software & Services

By Sample Type

  • Blood
  • Urine
  • Saliva
  • Other Sample Types

By Application

  • Therapeutic Drug Monitoring
  • Oncology
  • Cardiology
  • Endocrinology
  • Infectious Disease
  • Autoimmune Disease
  • Other Applications

By End-use

  • Hospitals
  • Clinical Laboratories
  • Pharmaceutical & Biotechnology Companies
  • Other End-uses

Regional Analysis

Regionally, in 2023, North America dominated the market because of the presence of big diagnostic industry players, widespread insurance coverage, and huge test volumes for chronic and infectious diseases. Market dominance was further strengthened by having a developed clinical laboratory infrastructure within the region and high penetration of automated analyzers.

Asia Pacific is anticipated to be the fastest-growing market during the forecast period 2024-2032. Asia Pacific’s growth is fueled by the escalating prevalence of infectious diseases, the growing focus on decentralized point-of-care testing from centralized laboratories, and developing countries’ increased healthcare access and availability of diagnostic technologies.

Table of Contents – Major Key Points

1. Introduction

2. Executive Summary

3. Research Methodology

4. Market Dynamics Impact Analysis

5. Statistical Insights and Trends Reporting

6. Competitive Landscape

7. Chemiluminescence Immunoassay Market by Product

8. Chemiluminescence Immunoassay Market by Sample Type

9. Chemiluminescence Immunoassay Market by Application

10. Chemiluminescence Immunoassay Market by End-use

11. Regional Analysis

12. Company Profiles

13. Use Cases and Best Practices

14. Conclusion

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