Global Chemiluminescence Immunoassay Market Size Study & Forecast, by Product (Instruments, Consumables), Sample Type (Blood, Urine), Application, End-use and Regional Forecasts 2025-2035

Description

The Global Chemiluminescence Immunoassay (CLIA) Market, valued at approximately USD 12.25 billion in 2024, is set to expand at a compelling CAGR of 4.60% during the forecast period from 2025 to 2035. Chemiluminescence immunoassay, a sophisticated diagnostic technology that utilizes the emission of light from a chemical reaction to detect the presence of specific antigens or antibodies, has become a cornerstone in clinical laboratories due to its unparalleled sensitivity, specificity, and throughput capabilities. This technique is increasingly being adopted across a wide spectrum of applications-from infectious disease diagnostics and oncology to endocrinology and cardiovascular disease detection-owing to its ability to deliver rapid, precise, and reproducible results. The acceleration in demand is largely driven by the global rise in chronic and infectious diseases, coupled with the growing emphasis on early and accurate diagnosis as part of precision medicine initiatives.

Rising healthcare expenditure, the integration of automated analyzers, and continuous technological innovations in assay kits are further propelling market expansion. Laboratories and hospitals worldwide are transitioning from traditional immunoassay methods to CLIA-based systems due to their operational efficiency and cost-effectiveness in high-volume testing environments. For example, the surge in biomarker-based screening programs and the increased adoption of CLIA in point-of-care testing are reshaping diagnostic pathways, reducing turnaround times, and enhancing patient outcomes. Nevertheless, market growth may encounter restraints in the form of high equipment costs and the need for skilled personnel to operate advanced analyzers, especially in resource-limited healthcare settings.

From a regional standpoint, North America currently holds the lion's share of the CLIA market, supported by its mature healthcare infrastructure, robust reimbursement framework, and strong presence of industry leaders investing heavily in R&D for assay innovation. Europe follows closely, driven by a rising demand for specialized diagnostics, favorable government screening programs, and a growing geriatric population susceptible to chronic conditions. Meanwhile, the Asia Pacific region is anticipated to register the fastest growth through 2035, fueled by rapid healthcare modernization, increasing laboratory automation, and a surge in awareness around preventive diagnostics in countries such as China, India, and Japan. Emerging markets in Latin America and the Middle East & Africa are also making headway as they expand laboratory networks, enhance diagnostic capabilities, and attract private investments into healthcare infrastructure.

Major market player included in this report are:

Abbott Laboratories
Siemens Healthineers AG
F. Hoffmann-La Roche Ltd.
Beckman Coulter, Inc.
BioMerieux SA
Thermo Fisher Scientific Inc.
Ortho Clinical Diagnostics
Danaher Corporation
Mindray Medical International Limited
DiaSorin S.p.A.
Sysmex Corporation
Agilent Technologies, Inc.
Randox Laboratories Ltd.
QuidelOrtho Corporation
Becton, Dickinson and Company

Global Chemiluminescence Immunoassay Market Report Scope:

Historical Data - 2023, 2024
Base Year for Estimation - 2024
Forecast period - 2025-2035
Report Coverage - Revenue forecast, Company Ranking, Competitive Landscape, Growth factors, and Trends
Regional Scope - North America; Europe; Asia Pacific; Latin America; Middle East & Africa
Customization Scope - Free report customization (equivalent up to 8 analysts' working hours) with purchase. Addition or alteration to country, regional & segment scope*

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values for the coming years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within the countries involved in the study. The report also provides detailed information about crucial aspects, such as driving factors and challenges, which will define the future growth of the market. Additionally, it incorporates potential opportunities in micro-markets for stakeholders to invest, along with a detailed analysis of the competitive landscape and product offerings of key players. The detailed segments and sub-segments of the market are explained below:

By Product:

Instruments
Consumables

By Sample Type:

Blood
Urine

By Application:

Infectious Diseases
Oncology
Endocrinology
Cardiology
Others

By End-use:

Hospitals
Diagnostic Laboratories
Research & Academic Institutes
Others

By Region:

North America
U.S.
Canada
Europe
UK
Germany
France
Spain
Italy
ROE
Asia Pacific
China
India
Japan
Australia
South Korea
RoAPAC
Latin America
Brazil
Mexico
Middle East & Africa
UAE
Saudi Arabia
South Africa
Rest of Middle East & Africa

Key Takeaways:

Market Estimates & Forecast for 10 years from 2025 to 2035.
Annualized revenues and regional level analysis for each market segment.
Detailed analysis of geographical landscape with Country level analysis of major regions.
Competitive landscape with information on major players in the market.
Analysis of key business strategies and recommendations on future market approach.
Analysis of competitive structure of the market.
Demand side and supply side analysis of the market.

Chapter 1. Global Chemiluminescence Immunoassay Market Report Scope & Methodology

1.1. Research Objective
1.2. Research Methodology
- 1.2.1. Forecast Model
- 1.2.2. Desk Research
- 1.2.3. Top Down and Bottom-Up Approach
1.3. Research Attributes
1.4. Scope of the Study
- 1.4.1. Market Definition
- 1.4.2. Market Segmentation
1.5. Research Assumption
- 1.5.1. Inclusion & Exclusion
- 1.5.2. Limitations
- 1.5.3. Years Considered for the Study (Historical Data - 2023, 2024; Base Year for Estimation - 2024; Forecast period - 2025-2035)

Chapter 2. Executive Summary

2.1. CEO/CXO Standpoint
2.2. Strategic Insights
2.3. ESG Analysis
2.4. Key Findings

Chapter 3. Global Chemiluminescence Immunoassay Market Forces Analysis

3.1. Market Forces Shaping The Global Chemiluminescence Immunoassay Market (2024-2035)
3.2. Drivers
- 3.2.1. Rising incidence of chronic and infectious diseases driving diagnostic volumes and demand for high-throughput CLIA platforms
- 3.2.2. Technological advancements - automation, AI-assisted interpretation and integrated LIS connectivity improving throughput and accuracy
3.3. Restraints
- 3.3.1. High capital expenditure for advanced instruments and ongoing maintenance costs limiting adoption in resource-constrained settings
- 3.3.2. Shortage of skilled laboratory personnel and stringent regulatory/compliance requirements impeding rapid deployment in some regions
3.4. Opportunities
- 3.4.1. Expanding point-of-care and decentralized testing adoption - portable CLIA systems and turnkey solutions for remote/ambulatory care
- 3.4.2. Growing biomarker screening programs, recurring consumables revenues and partnerships for emerging-market laboratory upgrades

Chapter 4. Global Chemiluminescence Immunoassay Industry Analysis

4.1. Porter's 5 Forces Model
- 4.1.1. Bargaining Power of Buyer
- 4.1.2. Bargaining Power of Supplier
- 4.1.3. Threat of New Entrants
- 4.1.4. Threat of Substitutes
- 4.1.5. Competitive Rivalry
4.2. Porter's 5 Force Forecast Model (2024-2035)
4.3. PESTEL Analysis
- 4.3.1. Political
- 4.3.2. Economical
- 4.3.3. Social
- 4.3.4. Technological
- 4.3.5. Environmental
- 4.3.6. Legal
4.4. Top Investment Opportunities
4.5. Top Winning Strategies (2025)
4.6. Market Share Analysis (2024-2025)
4.7. Global Pricing Analysis And Trends 2025
4.8. Analyst Recommendation & Conclusion

Chapter 5. Global Chemiluminescence Immunoassay Market Size & Forecasts by Product 2025-2035

5.1. Market Overview
5.2. Global Chemiluminescence Immunoassay Market Performance - Potential Analysis (2025)
5.3. Instruments
- 5.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 5.3.2. Market size analysis, by region, 2025-2035
5.4. Consumables
- 5.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 5.4.2. Market size analysis, by region, 2025-2035

Chapter 6. Global Chemiluminescence Immunoassay Market Size & Forecasts by Sample Type 2025-2035

6.1. Market Overview
6.2. Global Chemiluminescence Immunoassay Market Performance - Potential Analysis (2025)
6.3. Blood
- 6.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.3.2. Market size analysis, by region, 2025-2035
6.4. Urine
- 6.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 6.4.2. Market size analysis, by region, 2025-2035

Chapter 7. Global Chemiluminescence Immunoassay Market Size & Forecasts by Application 2025-2035

7.1. Market Overview
7.2. Global Chemiluminescence Immunoassay Market Performance - Potential Analysis (2025)
7.3. Infectious Diseases
- 7.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 7.3.2. Market size analysis, by region, 2025-2035
7.4. Oncology
- 7.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 7.4.2. Market size analysis, by region, 2025-2035
7.5. Endocrinology
- 7.5.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 7.5.2. Market size analysis, by region, 2025-2035
7.6. Cardiology
- 7.6.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 7.6.2. Market size analysis, by region, 2025-2035
7.7. Others
- 7.7.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 7.7.2. Market size analysis, by region, 2025-2035

Chapter 8. Global Chemiluminescence Immunoassay Market Size & Forecasts by End-use 2025-2035

8.1. Market Overview
8.2. Global Chemiluminescence Immunoassay Market Performance - Potential Analysis (2025)
8.3. Hospitals
- 8.3.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 8.3.2. Market size analysis, by region, 2025-2035
8.4. Diagnostic Laboratories
- 8.4.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 8.4.2. Market size analysis, by region, 2025-2035
8.5. Research & Academic Institutes
- 8.5.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 8.5.2. Market size analysis, by region, 2025-2035
8.6. Others
- 8.6.1. Top Countries Breakdown Estimates & Forecasts, 2024-2035
- 8.6.2. Market size analysis, by region, 2025-2035

Chapter 9. Global Chemiluminescence Immunoassay Market Size & Forecasts by Region 2025-2035

9.1. Global Chemiluminescence Immunoassay Market, Regional Market Snapshot
9.2. Top Leading & Emerging Countries
9.3. North America Chemiluminescence Immunoassay Market
- 9.3.1. U.S. Chemiluminescence Immunoassay Market
  - 9.3.1.1. Product breakdown size & forecasts, 2025-2035
  - 9.3.1.2. Application breakdown size & forecasts, 2025-2035
- 9.3.2. Canada Chemiluminescence Immunoassay Market
  - 9.3.2.1. Product breakdown size & forecasts, 2025-2035
  - 9.3.2.2. Application breakdown size & forecasts, 2025-2035
9.4. Europe Chemiluminescence Immunoassay Market
- 9.4.1. UK Chemiluminescence Immunoassay Market
  - 9.4.1.1. Product breakdown size & forecasts, 2025-2035
  - 9.4.1.2. Application breakdown size & forecasts, 2025-2035
- 9.4.2. Germany Chemiluminescence Immunoassay Market
  - 9.4.2.1. Product breakdown size & forecasts, 2025-2035
  - 9.4.2.2. Application breakdown size & forecasts, 2025-2035
- 9.4.3. France Chemiluminescence Immunoassay Market
  - 9.4.3.1. Product breakdown size & forecasts, 2025-2035
  - 9.4.3.2. Application breakdown size & forecasts, 2025-2035
- 9.4.4. Spain Chemiluminescence Immunoassay Market
  - 9.4.4.1. Product breakdown size & forecasts, 2025-2035
  - 9.4.4.2. Application breakdown size & forecasts, 2025-2035
- 9.4.5. Italy Chemiluminescence Immunoassay Market
  - 9.4.5.1. Product breakdown size & forecasts, 2025-2035
  - 9.4.5.2. Application breakdown size & forecasts, 2025-2035
- 9.4.6. Rest of Europe Chemiluminescence Immunoassay Market
  - 9.4.6.1. Product breakdown size & forecasts, 2025-2035
  - 9.4.6.2. Application breakdown size & forecasts, 2025-2035
9.5. Asia Pacific Chemiluminescence Immunoassay Market
- 9.5.1. China Chemiluminescence Immunoassay Market
  - 9.5.1.1. Product breakdown size & forecasts, 2025-2035
  - 9.5.1.2. Application breakdown size & forecasts, 2025-2035
- 9.5.2. India Chemiluminescence Immunoassay Market
  - 9.5.2.1. Product breakdown size & forecasts, 2025-2035
  - 9.5.2.2. Application breakdown size & forecasts, 2025-2035
- 9.5.3. Japan Chemiluminescence Immunoassay Market
  - 9.5.3.1. Product breakdown size & forecasts, 2025-2035
  - 9.5.3.2. Application breakdown size & forecasts, 2025-2035
- 9.5.4. Australia Chemiluminescence Immunoassay Market
  - 9.5.4.1. Product breakdown size & forecasts, 2025-2035
  - 9.5.4.2. Application breakdown size & forecasts, 2025-2035
- 9.5.5. South Korea Chemiluminescence Immunoassay Market
  - 9.5.5.1. Product breakdown size & forecasts, 2025-2035
  - 9.5.5.2. Application breakdown size & forecasts, 2025-2035
- 9.5.6. Rest of APAC Chemiluminescence Immunoassay Market
  - 9.5.6.1. Product breakdown size & forecasts, 2025-2035
  - 9.5.6.2. Application breakdown size & forecasts, 2025-2035
9.6. Latin America Chemiluminescence Immunoassay Market
- 9.6.1. Brazil Chemiluminescence Immunoassay Market
  - 9.6.1.1. Product breakdown size & forecasts, 2025-2035
  - 9.6.1.2. Application breakdown size & forecasts, 2025-2035
- 9.6.2. Mexico Chemiluminescence Immunoassay Market
  - 9.6.2.1. Product breakdown size & forecasts, 2025-2035
  - 9.6.2.2. Application breakdown size & forecasts, 2025-2035
9.7. Middle East and Africa Chemiluminescence Immunoassay Market
- 9.7.1. UAE Chemiluminescence Immunoassay Market
  - 9.7.1.1. Product breakdown size & forecasts, 2025-2035
  - 9.7.1.2. Application breakdown size & forecasts, 2025-2035
- 9.7.2. Saudi Arabia (KSA) Chemiluminescence Immunoassay Market
  - 9.7.2.1. Product breakdown size & forecasts, 2025-2035
  - 9.7.2.2. Application breakdown size & forecasts, 2025-2035
- 9.7.3. South Africa Chemiluminescence Immunoassay Market
  - 9.7.3.1. Product breakdown size & forecasts, 2025-2035
  - 9.7.3.2. Application breakdown size & forecasts, 2025-2035

Chapter 10. Competitive Intelligence

10.1. Top Market Strategies
10.2. Abbott Laboratories
- 10.2.1. Company Overview
- 10.2.2. Key Executives
- 10.2.3. Company Snapshot
- 10.2.4. Financial Performance (Subject to Data Availability)
- 10.2.5. Product/Services Port
- 10.2.6. Recent Development
- 10.2.7. Market Strategies
- 10.2.8. SWOT Analysis
10.3. Siemens Healthineers AG
10.4. F. Hoffmann-La Roche Ltd.
10.5. Thermo Fisher Scientific Inc.
10.6. Danaher Corporation
10.7. Beckman Coulter, Inc.
10.8. BioMerieux SA
10.9. Ortho Clinical Diagnostics
10.10. Mindray Medical International Limited
10.11. DiaSorin S.p.A.
10.12. Sysmex Corporation
10.13. Agilent Technologies, Inc.
10.14. Randox Laboratories Ltd.
10.15. QuidelOrtho Corporation
10.16. Becton, Dickinson and Company