Chemiluminescence Immunoassay Market Analysis & Forecast: 2025-2032

Chemiluminescence Immunoassay Market Size and Trends

Global chemiluminescence immunoassay market is estimated to be valued at USD 14.00 Bn in 2025 and is expected to reach USD 22.21 Bn by 2032, exhibiting a compound annual growth rate (CAGR) of 6.8% from 2025 to 2032.

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Key Takeaways

• Based on Product Type, the Reagent segment is projected to account for 58.6% of the market share in 2025, driven by wide range of application across various disease testing.
• Based on Application, the Drug Monitoring segment is expected to hold a 30.62% share of the market in 2025, owing to the demand for optimizing pharmacotherapy.
• Based on Sample Type, the Blood segment is projected to account for 40.5% market share in 2025, established due to its universal suitability as diagnostics sample.
• Based on End User, the Clinical Laboratories segment is expected to hold a dominating position with the highest share in the market in 2025, due to its high volume of testing and outsourcing for hospitals.
• Based on Region, North America is projected to dominate the market in 2025 with a 41.7% share in 2025, driven by advanced healthcare infrastructure and rising adoption of diagnostic technologies. While, Asia Pacific is considered to the fastest growing region during the forecast period, supported by continual moderation of healthcare facilities and healthcare expenditure.

Market Overview

The global chemiluminescence immunoassay market growth includes increasing disease prevalence, rising healthcare expenditure across developing nations, growing demand for clinical diagnostics to detect chronic diseases such as cancer, cardiovascular diseases, and infectious diseases. Furthermore, advancement in chemiluminescence immunoassay instruments, tools and reagents allowing fast and reliable detection of a wide range of analytes from small molecules to larger proteins through high sensitivity. These factors are contributing in increase of adoption rate especially in hospitals and diagnostic laboratories, thus, driving the chemiluminescence immunoassay market growth.

Current Events and Its Impact

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End User Feedback and Unmet Needs in Chemiluminescence Immunoassay (CLIA)

Chemiluminescence immunoassay (CLIA) has become a key tool in clinical diagnostics, valued for its sensitivity, specificity, and relatively fast turnaround. However, end users such as laboratory technicians, clinical scientists, and healthcare providers have shared important feedback highlighting areas where current CLIA technology can improve.

End User Feedback

• Ease of Use and Workflow Efficiency: While CLIA systems deliver reliable results, some platforms remain complex and time-consuming to operate. Users emphasize the need for more user-friendly interfaces, greater automation, and streamlined workflows to reduce manual steps and training time.
• Turnaround Time and Throughput: Faster results are always in demand. Users want CLIA systems that can handle higher sample volumes simultaneously without compromising accuracy, especially in high-throughput clinical labs.
• Data Management and Connectivity: Integration with laboratory information management systems (LIMS) is crucial. Users request enhanced software for better data analysis, reporting, and traceability to support clinical decision-making.

Unmet Needs

• Miniaturization and Point-of-Care Adaptation: Most CLIA platforms are designed for centralized laboratories and tend to be bulky. There is a growing demand for compact, portable CLIA devices suitable for point-of-care use, enabling quicker clinical decisions in emergency or remote settings.
• Standardization Across Platforms: Variability in results across different CLIA instruments complicates clinical interpretation. Standardization and harmonization protocols are needed to ensure consistent, comparable outcomes regardless of the platform.
• Expanded Multiplexing: The ability to test multiple targets in one run remains limited. Robust multiplex assays that maintain high sensitivity and specificity would greatly enhance diagnostic efficiency.
• Sustainability: With increasing awareness of environmental impact, end users are seeking greener solutions—such as eco-friendly reagents, reduced plastic waste, and energy-efficient instruments.

Segmental Insights

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Chemiluminescence Immunoassay Market Insights, By Product Type - Reagents Segment Dominate the Overall Market Due to Wide Application in Disease Testing

In terms of Product Type, Reagents segment is estimated to contribute the highest market share of 58.6% in 2025, owing to its wide range of applications across various disease testing. Reagents play a crucial role in chemiluminescence immunoassay as this help produce light during the biochemical reactions between an antigen and its specific antibody. The high accuracy and sensitivity offered by reagents in detecting various biomarkers has made them invaluable for diagnosing several diseases. Their ability to produce measurable light signals proportional to the concentration of analytes in a sample allows for precise quantification of biomarkers. This has significantly improved disease diagnosis and management. Reagents are indispensable for chemiluminescent assays used in therapeutic drug monitoring to quantify drug concentrations in patient samples and determine optimal dosages. This is further accelerating the chemiluminescence immunoassay market demand.

In December 2024, Roche, a biotechnology company, announced its CR mark approval for its cobas® Mass Spec solution including the cobas® i 601analyser and the first Ionify® reagent pack of four assays for steroid hormones. The cobas mass Spec solution offers more than 60 analytes for testing of steroid hormones, vitamin D metabolites, immunosuppressant drugs (ISD), therapeutic drug monitoring (TDM) and drug of abuse testing (DAT).

Chemiluminescence Immunoassay Market Insights, By Application - Therapeutic drug monitoring segment dominates Due to Demand for Optimizing Pharmacotherapy

In terms of application, therapeutic drug monitoring segment is estimated to contribute the highest market share of 30.62% in 2025, owing to pressing need for optimizing pharmacotherapy. Therapeutic Drug Monitoring (TDM) utilizes assays such as chemiluminescence immunoassays to quantify drug concentrations in patients' blood and tissues. This assists clinicians in individualizing drug dosing regimens based on patients' pharmacokinetic characteristics and responses. TDM is crucial considering the factors including age, organ function, co-medications, and genetic variability influence patients' abilities to metabolize and eliminate drugs from their bodies. Measuring blood drug and metabolite levels helps physicians assess a patient's compliance, verify that the working levels are within the therapeutic window, detect toxic concentrations earlier, and prevent clinical failures or relapses. This is further contributing to the Chemiluminescence Immunoassay market share.

For Instance, in September 2024, the World Health Expo Insights published an article evolving the role of clinical pharmacist in enhancing Therapeutic Drug Monitoring (TDM) practices. As it is a critical component in personalized medicine involving measuring drug concentration in patients to optimize dosage regimen. The clinical pharmacists play a role in utilizing their expertise to interpret pharmacokinetic data and adjust therapies accordingly. Dr. Nagy focuses on pharmacist involvement that ensure more precise medication management, reducing adverse effects and improving therapeutic outcomes.

Chemiluminescence Immunoassay Market Insights, By Sample Type - Blood being a major diagnostic area

In terms of sample type, blood segment is estimated to contribute the highest market share of 40.5% in 2025, owing to its universal suitability as a diagnostic sample across disease areas. Chemiluminescence immunoassays utilizing blood-based tumor markers which plays a pivotal role in cancer screening, diagnosis, prognosis assessment, and surveillance following therapy. These assays offer high sensitivity for detecting extracellular circulating tumor biomarkers such as CEA, CA 15-3, CA 19-9 and PSA, sometimes even before anatomical changes occur. Serial marker monitoring aids in detecting recurrence earlier or treatment resistance. Multiplex assays improve efficiency by simultaneously quantifying several relevant markers from one blood sample. On-invasive blood collection, fast turnaround times, high throughput processing abilities of modern immunoassay systems, and widespread familiarity with blood sample types have made chemiluminescent assays standard-of-care in oncology laboratories globally.

In April 2025, researchers from Weil Cornell Medicine and the New York Genome Center developed an innovative blood test method that improves the accuracy and sensitivity of cancer detection. This advancement utilizes whole-genome sequencing combines with error-correction technique to identify minute concentration of circulating tumor DNA (ctDNA) in blood sample.

Chemiluminescence Immunoassay Market Insights, By End User - Clinical Laboratories Leads with High Volume Testing and Outsourcing

In terms of end user, the clinical laboratories segment is expected to dominate the market with the highest shares in 2025, due to its high volume of testing and outsourcing for hospitals. The principle of chemiluminescence is used in clinical laboratories to utilizes certain chemicals reactions to produce light which will measure and interpret the concentration of analyte. Some of the commonly used techniques used in clinical laboratories to identify infectious disease include microscopy, immunological tests, culture and nucleic acid-based identification methods. These techniques help in detecting, isolating and identifying infectious agents in clinical specimens, allowing for diagnosis and appropriate treatment.

In January 2025, Bangalore medical College and Research Institute (BMCRI) hosted the Indian Council of Medical Research’s (ICMR) first Infectious Disease Research and Diagnostic Laboratory (IRDL). This in-stare IRDL will help the state’s health institutions in testing infectious disease sample quickly, especially during outbreak investigation, enable in-depth research, improve medical institution capability and enhance disease surveillance activities.

Regional Insights

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North America Chemiluminescence Immunoassay Market Analysis and Trends

North America dominates the global chemiluminescence immunoassay market with an estimated market share of 41.7% in 2025, due to the advanced healthcare infrastructure and rising adoption of advanced diagnostic technologies across major countries like the U.S. Several leading global players have their headquarters located in the region and have established widespread sales and distribution networks. According to the NetSuite, US healthcare expenditures will approach USD 5 trillion in 2025, accounting for more than 18% of the country’s gross domestic product. Along with that, the presence of major pharmaceutical and life sciences companies has also augmented the regional market growth. According to the IBISWorld, there are over 45,000 life science companies in the U.S., as of early 2024, and over 5,000 pharmaceutical companies and around 2,435 biotechnology companies which is expected to increase to 2,533 in 2025. Favorable regulatory environment and healthcare reimbursement policies have facilitated wider uptake of chemiluminescence immunoassay systems in the region.

Asia Pacific Chemiluminescence Immunoassay Market Analysis and Trends

Asia Pacific is witnessing the fastest growth and is expected to grow further during the forecast period. China, in particular, is spearheading the market expansion owing to continual modernization of healthcare facilities and increasing healthcare expenditures. The rapidly growing geriatric population, coupled with rising prevalence of chronic and infectious diseases have boosted demand for diagnostic testing. Some of the commonly observed chronic disease in Aisa are cardiovascular disease with approximately 348.9 million cases in 2025, which is expected to rise to 729.5 million by 2050, 57.2 million individuals in India suffering from Diabetes and chronic kidney disease with the highest prevalence rate in Aisa. There is a current expanding situation of COVID-19 in May 2025, the Southeast Asian countries such as India, Singapore, Thailand and China are experiencing a resurgence of cases with 257 cases reported in India, weekly increases in cases from 11,000 to 14,000 in Singapore and 71,000 cases in Thailand since January 2025.  Expansion of private healthcare sector and increasing medical tourism are also favoring Chemiluminescence Immunoassay market growth across the region.

Chemiluminescence Immunoassay Market Outlook Country-wise

The United States in Chemiluminescence Immunoassay Market Trends

The United States is the leading country for chemiluminescence immunoassay market. The expansion of the market is observed due to the advanced healthcare infrastructure and widespread adoption of CLIA technologies. Along with that, the United States has the highest prevalence of chronic disease which considered the healthcare cost of around $4.5 trillion annual healthcare spending. 6 in 10 American have at least one chronic disease and 4 in 10 have more than two.

In July 2024, Fujirebio, a subsidiary of H.U. Group Holdings Inc., launched its Lumipulse® G GFAP assay, a fully automated, research-use-only (RUO) test in United States. It is designed to quantitative measurement of glial fibrillary acidic protein (GFAP) in human plasma and serum. This chemiluminescent enzyme immunoassay (CLEIA) delivers results in just 35 minutes and is compatible with the LUMIPULSE® G immunoassay systems.

China Chemiluminescence Immunoassay Market Trends

China market for chemiluminescence immunoassay is characterized by a modernization of healthcare facilitates, increasing in healthcare expenditure and rising prevalence of chronic and infectious disease. China is increasing it focus towards access, quality and efficiency. The modernization is supported by the government’s “Healthy China 2030” plan. Along with that, the expanding health insurance coverage, investing in infrastructure and leveraging digital technologies such as artificial intelligence (AI) ad telemedicine is contributing to the growth of the market. According to the World Bank’s joint report with the Chinese government found that, without reform, health spending would increase to USD 2.5 trillion in 2035.

Germany Chemiluminescence Immunoassay Market Trends

Germany chemiluminescence immunoassay market is expected to continue its growth trajectory, supported by the technological advancements in automation, rising demand for diagnostics, reimbursements policies and growing healthcare expenditure. Germany claims to be the third largest medical technology market in the world after the United States and Japan. The medical device market in Germany accounts to roughly USD 42 billion annually, or 25% of the European market.

Concentration and Competitive Landscape

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Key Developments

• In May 2025, Revvity, Inc., a providers of health science solutions, techniques, expertise, and services that delivers complete workflow, launched its new IDSi20^TM analytical random-access platform from EUROIMMUN, enabling full automation of chemiluminescence immunoassays (ChLIA).
• In January 2025, Anbio Biotechnology, a diagnostics innovation company, launched its Dry Chemiluminescence Immunoassay (CLIA) Solution ADL-100. Its is a transformative technology which is designed to deliver rapid, reliable and cost-effective diagnostic results. Thie technology is created for diverse clinicals setting to address the growing demand for streamlined workflows and high-performing testing.
• In January 2024, Agappe, a Kochi-based Indian healthcare technology launched its first indigenously manufactured HX series haematology equipment and the AE-powered Immunology CLIA analyzer, the Mispa i200, marking a new era in diagnostics and patient care. The latest advancements in haematology analyzers, utilizing Nucleic Acid Fluorescence Staining technology includes the HX series – HX50, HX58, HX80, and HX88.
• In November 2023, Medical & Biological Laboratories Co., Ltd., a JSR Life Sciences Company, launched the "iStar 500," an automated mono-test chemiluminescence immunoassay (CLIA) analyzer worldwide. This compact and highly sensitive analyzer is ideal for emergency and small- to medium-sized labs, offering a wide range of testing parameters including cardiac markers, reproductive health, liver health, tumor markers, and autoimmunity.
• In July 2023, Fapon, a prominent global life sciences company, unveiled its newest chemiluminescence immunoassay system, the Shine i8000/9000, at the 2023 AACC exhibition. This advanced analyzer is fully automated and operates at high speed, boasting an ultra-high throughput of 900 tests per hour. It is designed to enable Fapon's partners to develop top-tier clinical diagnostic solutions.

Market Report Scope

Chemiluminescence Immunoassay Market Report Coverage

Chemiluminescence Immunoassay Market Drivers

Growing Prevalence of Chronic Diseases

Rising incidence of chronic and infectious diseases across the globe has boosted demand for chemiluminescence immunoassay testing. According to various estimates by the healthcare experts and researchers, the chronic diseases have now overtaken infectious illnesses as the major cause of mortality worldwide. Approximately 129 million individuals in the US suffer from at least one major chronic disease—such as heart disease, cancer, diabetes, obesity, or hypertension—according to the US Department of Health and Human Services. Lifestyle changes such as unhealthy eating habits, lack of physical activity, rising stress levels and smoking have majorly contributed to staggering increase in conditions like cancer, diabetes, cardiovascular diseases and respiratory illnesses. As people are now living longer with these chronic illnesses, there has been rising need for frequent medical monitoring and screening tests. Chemiluminescence immunoassays provide accurate, precise and timely diagnosis of various chronic conditions. These assays are extensively used in hospitals and diagnostic labs for detecting cardiac marker enzymes to aid in the diagnosis of heart attacks.

Technological advancements in CLIA diagnostic platforms

Technological advancements are drastically transforming the chemiluminescence immunoassay (CLIA) diagnostic platforms. Several innovative CLIA analyzers have widened the scope of CLIA testing. The new generation fully automated, high throughput CLIA analyzers offer enhanced sensitivity, specificity, faster turn-around-time and expanded assay menus as compared to conventional immunoassay technologies. For instance, as per World Health Organization in 2022, the Liaison range of CLIA analyzers by DiaSorin can perform a wide variety of routine and specialty tests including therapeutic drug monitoring, endocrinology, oncology, infectious diseases from a small patient sample volume in a single analytical run. (Furthermore, software and digital innovations are revolutionizing the CLIA diagnostic platforms. Many new systems are integrated with artificial intelligence (AI) and machine learning capabilities. This allows automated interpretation of test results, flagging of outliers, improved quality control, customized report generations and remote diagnostics. Cloud connectivity in some systems ensures real-time data access for clinicians from different locations. For instance, the Affinity total laboratory automation solution from Siemens Healthineers uses AI to automate repetitive tasks, standardized workflows and predictive maintenance to maximize efficiency.

Chemiluminescence Immunoassay Market Opportunities

Launch of advanced CLIA diagnostic technologies

The introduction of advanced chemiluminescence immunoassay (CLIA) diagnostic technologies provide a great opportunity to drive global chemiluminescence immunoassay market forecast growth. CLIA techniques have significantly evolved in recent years to offer higher sensitivity, wider detection range, faster turn-around times and improved automation. Some of the key advanced CLIA technologies that are gaining traction include enhanced chemiluminescence immunoassay (ECLIA), nano-immune technology and microfluidic immunoassay systems. This is further accelerating the chemiluminescence immunoassay market demand.

Analyst Opinion (Expert Opinion)

• The chemiluminescence immunoassay (CLIA) market is growing owing to its high sensitivity and ability to handle large numbers of tests quickly—something many labs need today.
• For example, a recent 2024 study in Clinical Chemistry showed CLIA tests are about 15-20% more sensitive than traditional ELISA tests when detecting heart damage markers like troponin I. This means doctors can diagnose heart attacks earlier and more accurately, which saves lives. But many market reports miss this crucial benefit and focus too much on general growth.
• Major companies like Abbott and Roche are also improving their CLIA machines by adding AI and smarter data tools. Roche’s Cobas e 801 machine, for instance, processes samples about 30% faster than older models. This speed and smarter data handling will be key to winning in the future.
• Another big trend is the rise of multiplex CLIA tests, which can check for many things in one go. This is especially helpful in cancer and infection testing, saving both time and money. Siemens recently introduced multiplex CLIA machines that cut test times by 40% in real hospital trials, showing clear benefits.
• In short, CLIA will become even more important by combining speed, smarter data, and testing for multiple things at once. At the same time, companies must solve supply problems to stay strong.

Market Segmentation

• Product Type Insights
  • Analyzers
  • Automated
  • Semi-automated
  • Reagents
  • Luminophore Markers
  • Enzymatic Markers
  • Consumables
•  Application Insights
  • Therapeutic Drug Monitoring
  • Oncology
  • Cardiology
  • Endocrinology
  • Infectious Disease
  • Autoimmune Disease
  • Others
•  Sample Type Insights
  • Blood
  • Urine
  • Saliva
  • Other Sample Types
•  End User Insights
  • Hospitals
  • Clinical Laboratories
  • Pharmaceutical and Biotechnology Companies
  • Others
• Regional Insights
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Siemens AG
  • Abbott Laboratories
  • F. Hoffmann-La Roche Ltd.
  • Danaher Corporation
  • bioMérieux SA
  • Johnson & Johnson
  • Tosoh Corporation
  • Randox Laboratories
  • DiaSorin S.p.A.
  • PerkinElmer, Inc.
  • Mindray Bio-Medical Electronics Co., Ltd.
  • Getein Biotech, Inc.
  • QuidelOrtho Corporation
  • Sysmex Corporation
  • Ortho Clinical Diagnostics
  • Abcam plc
  • Thermo Fisher Scientific Inc.
  • Hologic, Inc.

Sources

Primary Research Interviews from the following stakeholders

Stakeholders

• Interviews with diagnostic device manufacturers, hospital procurement managers, laboratory heads, regulatory affairs specialists, and biotechnology R&D teams across key global markets.

Databases

• World Health Organization (WHO) Global Health Observatory
• U.S. Food and Drug Administration (FDA) Medical Device Databases
• Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Fee Schedules
• Indian Council of Medical Research (ICMR) – Diagnostic Equipment Registry
• Eurostat – Healthcare and Medical Equipment Trade Data
• Japan Ministry of Health, Labour and Welfare (MHLW) – Medical Equipment Statistics
• China National Medical Products Administration (NMPA) Database
• Korea Health Industry Development Institute (KHIDI)

Magazines

• Clinical Lab Products Magazine
• IVD Technology
• Medical Device and Diagnostic Industry (MD+DI)
• BioSpectrum
• Lab Manager
• Diagnostic World
• Healthcare IT News (Diagnostics & Imaging section)

Journals:

• Journal of Clinical Laboratory Analysis
• Clinical Chemistry (AACC)
• Journal of Immunological Methods
• Journal of Medical Diagnostics
• Analytical Biochemistry
• International Journal of Molecular Sciences – Diagnostics Section
• Biomedical Chromatography

Newspapers

• The Wall Street Journal – Health & Biotech
• Financial Times – Pharmaceuticals & Diagnostics
• The Hindu Business Line – Healthcare & Pharma
• South China Morning Post – Healthcare Innovations
• The Economic Times – Health & Biotech
• Nikkei Asia – Medtech Sector Reports

Associations

• American Association for Clinical Chemistry (AACC)
• International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)
• Association of Diagnostics Manufacturers of India (ADMI)
• Advanced Medical Technology Association (AdvaMed)
• European Diagnostic Manufacturers Association (EDMA)
• Asia Pacific MedTech Association (APACMed)
• Clinical and Laboratory Standards Institute (CLSI)

Public Domain Sources

• U.S. National Institutes of Health (NIH) – Clinical Diagnostics Reports
• Ministry of Health and Family Welfare, India – Diagnostics Policy Briefs
• European Medicines Agency (EMA)
• U.S. Centers for Disease Control and Prevention (CDC) – Laboratory Testing Guidelines
• China Ministry of Science and Technology – Biotech Industry Reports
• WHO Essential Diagnostics List (EDL)
• Reserve Bank of India – Sectoral Reports on Medical Devices
• EU Observatory for Health Technologies

Proprietary Elements

• CMI Data Analytics Tool, and Proprietary CMI Existing Repository of information for last 8 years

*Definition: Global Chemiluminescence Immunoassay Market involves the use of chemiluminescence detection to measure the presence and concentrations of various substances in biological samples like blood, urine, and tissue. Chemiluminescence immunoassays use antibodies attached to luminescent molecules to detect target antigens or antibodies in samples. This market covers sales of chemiluminescence immunoassay instruments, consumables, and reagents for clinical diagnostics and research applications globally.