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Chemiluminescence Immunoassay Systems Market

The market for Chemiluminescence Immunoassay Systems was estimated at $14.2 billion in 2024; it is anticipated to increase to $22.1 billion by 2030, with projections indicating growth to around $32.0 billion by 2035.

Report ID:DS1801114
Author:Debadatta Patel - Senior Consultant
Published Date:
Datatree
Life Science
Medical Device
Chemiluminescence Immunoassay Systems
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Report Summary
Market Data
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Table of Contents

Global Chemiluminescence Immunoassay Systems Market Outlook

Revenue, 2024

$14.2B

Forecast, 2034

$29.7B

CAGR, 2025 - 2034

7.7%

The Chemiluminescence Immunoassay Systems (CLIA) industry revenue is expected to be around $15.3 billion in 2025 and expected to showcase growth with 7.7% CAGR between 2025 and 2034. The significance of Chemiluminescence Immunoassay Systems in clinical diagnostics on a global scale is highlighted by a strong outlook. The majority of applications for this technology, 57.2%, are in infectious disease and endocrinology testing. The driving forces behind this demand are increasing screening programmes, chronic disease management, and test menus being consolidated in high volume hospital laboratories. Rising workload requirements for laboratories are driven by the need for the highly automated and high throughput testing systems which produce both quicker results and higher accuracy. Advanced chemiluminescent immunoassays are the leading technology within the in vitro diagnostics market for clinical chemistry. By 2024, this technology was expected to achieve $6.84 billion at the worldwide level in sales. The technologys success is due to chemiluminescent immunoassays providing extensive menus, high precision and existing laboratory automation systems compatibility. These factors ensure that clinical chemistry diagnostic equipment will remain a vital component of both developed and developing health care systems.

These systems are chemiluminescence immunoassay systems, that are automated systems used to perform immunoassays through chemiluminescence reactions. This makes them suitable for doing sensitive antigen/antibody reactions and also has a large range of measurement. The Laboratory equipment services available usually include high level data management and random access capabilities. In addition, the laboratory analyzers also offer multiple test touch screen controls and interface with a variety of software packages. Furthermore, the analyzers often feature communication links with various laboratory data management systems. These laboratory analyzers are often applied in various laboratories such as immunology, endocrinology, cardiology, oncology, virology and microbiology laboratories. The demand for ECLIA technology is being driven by several factors, including the increasing number of tests available that utilise ECLIA technology, the trend for laboratory testing to be concentrated in centralised laboratories, and hospital laboratories which are larger in size taking up the technology. Additionally, the investment in laboratory automation systems is growing, these systems help to streamline procedures, improve traceability and allow for data driven decision making in laboratories that diagnose conditions in a test tube.

Chemiluminescence Immunoassay Systems market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2024-2034
Chemiluminescence Immunoassay Systems Market Outlook

Market Key Insights

  • By 2034, the projected value of the chemiluminescence immunoassay systems market is $29.7 billion, rising from $14.2 billion in 2024. At a compound annual growth rate of 7.7%, this market is rising due to higher demand in Clinical Diagnostics, in pharmaceutical research and development and Food and Environmental testing.

  • Among the major players influencing the market dynamics are Danaher Corporation, Siemens Healthineers and F Hoffman La Roche Ltd. They form the competitive market landscape.

  • The US and China are expected to have the highest market shares in the chemiluminescence immunoassay systems market, and their sales will rise at a compound annual growth rate of 5 7.4% over the period 2023 2029.

  • Fast growth is expected in the markets of India, South Korea and Brazil, which will expand at compound annual rates of between 8.9% and 10.6%.

  • The Chemiluminescence Immunoassay Systems market is likely to grow thanks to advancements in automation. By 2030, it is predicted this will be worth $935 million.

  • Over the ten years 2024 2034 the Chemiluminescence Immunoassay Systems market is due to increase by $15.6 billion. In this period the Endocrinology & Oncology sector is set to account for a larger proportion of the Chemiluminescence Immunoassay Systems manufactured.

  • Chemiluminescence immunoassay systems are set to see a 110% rise between 2034 and 2024 due to a growth in chronic illnesses and medical advancements.

chemiluminescence immunoassay systems market size with pie charts of major and emerging country share, CAGR, trends for 2025 and 2032
Chemiluminescence Immunoassay Systems - Country Share Analysis

Opportunities in the Chemiluminescence Immunoassay Systems

Latin America is also decentralising diagnostic tasks in the fight against the recurring waves of dengue fever, Zika and Covid 19. For provincial laboratory settings, chemiluminescence immunoassay systems are necessary which have to provide a suitable balance between throughput, cost and robustness for use in infectious disease diagnosis. By the year 2030, the revenue for global instrument manufacturers is predicted to increase from $6.84 billion to $10.91 billion. This development highlights mid tier analyzers. Collaboration among the government, regional distributors and manufacturers would be beneficial if the latter bundle equipment, training and supplies together. The largest volume and consumables growth will be seen by networks adopting chemiluminescent multiplexing menus.

Growth Opportunities in North America and Asia Pacific

In North America, chemiluminescence immunoassay systems gain the greatest market share in the oncology sector. This is driven by the high volume of cancer testing, by the sophisticated clinical laboratory tests available and by the reimbursement which encourages the use of cancer biomarkers. The key region's in which Diagnostics is poised to capitalise are in the placement of high throughput analysers and automated immunoassay platforms in consolidated reference labs. Another region is the development of assays in cardiology and oncology for random access testing. The company also aims to integrate clinical laboratory improvement amendments certified analysers with the IT systems used in hospitals to support the precision medicine programmes in place. Intense competition is presently being observed in the IVD sector with well known global brands, along with smaller companies developing new products, racing to secure a market share by implementing service contracts, more extensive assay offerings and automated testing processes. As a result, a steady increase in the speed of their systems and their ability to detect conditions analytically is witnessed. The main factors driving growth in this industry are the increased prevalence of chronic illnesses, a need for laboratories to automate their processes, the demand for more accurate test results due to higher quality requirements and the demand for tests that can check for several illnesses at once.
The Chemiluminescence Immunoassay Systems market in the Asia Pacific is mainly driven by the infectious diseases sector, which is characterised by high testing rates for viruses, bacteria and newly emerging pathogens. The endocrinology sector is also driving the demand for these systems, mainly in connection with thyroid, fertility and metabolic testing panels. The key region's of opportunity lie in introducing the medium scale automated immunoassay equipment which can be used in a wide range of tests into secondary and tertiary hospitals and private and public hospitals laboratories. It is also beneficial to tailor thes of tests for infectious diseases to the local region's health problems. Another region is the use of pay and rent models for the chemicals used in the tests to reduce the initial costs involved. The market is characterised by both local and global companies with differing price performance ratios, customer service and the ability of their machines to cope with varying sample sizes. The main drivers in the market are government backed immunisation and screening programmes, an increasing demand for high tech diagnostic services and a rise in healthcare infrastructure. Chemiluminescent analyzers are being taken up more quickly now as they provide better results in less time.

Market Dynamics and Supply Chain

01

Driver: Rising Prevalence of Chronic Diseases Coupled with Growing Demand for Rapid Diagnostics

The increasing prevalence of chronic diseases such as cardiovascular disorders, diabetes, and infectious diseases is also significantly driving demand for chemiluminescence immunoassay systems. These conditions require frequent monitoring of biomarkers, antibodies, and hormones, which CLIA platforms can also efficiently detect with high sensitivity and specificity. Separately, the growing demand for rapid and accurate diagnostic solutions is also fueling adoption in hospitals, clinical laboratories, and point-of-care facilities. Advancements in automation, high-throughput testing, and integration with laboratory information management systems enable faster turnaround times, improved workflow efficiency, and reduced manual errors. Together, these factors are also expanding the use of CLIA systems for both routine testing and specialized diagnostics, especially in regions with rising healthcare expenditure and increased focus on preventive care.
Innovations in chemiluminescence assay reagents, enhanced detection chemistries, and multiplex platforms are also accelerating CLIA adoption. High-sensitivity assays allow for the detection of low-abundance biomarkers, improving early disease diagnosis. Multiplex detection systems enable simultaneous testing of multiple analytes from a single sample, saving time and reducing costs. These technological advancements enhance clinical utility, drive lab efficiency, and support personalized medicine initiatives, positioning CLIA systems as essential tools in modern diagnostic laboratories.
02

Restraint: High Equipment and Operational Costs Limit Adoption in Resource‑Constrained Settings

The high upfront costs of chemiluminescence immunoassay systems and the ongoing expense of proprietary reagents and maintenance restrict adoption, especially in small clinics and emerging markets. Many facilities opt for lower‑cost alternatives like ELISA or rapid tests despite lower sensitivity, slowing revenue growth for premium CLIA platforms. For example, budget‑limited laboratories may defer upgrades for high‑throughput analyzers, dampening overall demand and restricting market penetration in price‑sensitive regions.
03

Opportunity: Automation-driven demand for high-throughput CLIA in large US reference laboratory networks and Rising adoption of Chemiluminescence Immunoassay Systems in oncology diagnostics across rapidly modernizing Indian hospitals

U.S. public health laboratories are struggling to cope with an increasing workload. This surge is brought about by higher than normal volumes of tests and insufficient staff. The situation is made worse by an increased need for timely results. Newer chemiluminescence immunoassay equipment integrates and automates procedures previously carried out by hand, giving laboratory technicians a lot more time for other jobs. Companies that collaborate with laboratories to develop and implement laboratory software and high throughput testing may secure partnerships that last for several years. As the standard testing procedures become automated on chemiluminescent machines, a greater number of reagent and calibrator sales will be seen than sales of the equipment itself. US reference laboratories are now modernizing older immunochemistry analyzers in order to run a broader range of tests for cancer and hormonal problems.
A considerable rise in cancer cases in India is observed but access to sophisticated immune diagnostic techniques is limited to the few major cities. In secondary and tertiary hospitals, the chemiluminescence immunoassay system offers sensitive tests for various cancer related substances in the blood. By 2030, it is forecast that consumables revenues will reach 7.25 billion U.S. dollars. This represents an increase from 4.89 billion U.S. dollars. It is the oncology sector that is predicted to drive the growth rate of these consumables. The access to automated immunoassay analyzers can be quickly increased by regional hospital chains working in conjunction with equipment manufacturers on a reagent rental basis. Theses of oncology workflow analyzers are still quite rare and of high quality.
04

Challenge: Complexity of Workflow and Need for Skilled Personnel Slows Uptake and Routine Use

CLIA often require specialized training, complex sample handling, and robust laboratory infrastructure, which can deter adoption in decentralized labs or rural healthcare settings. The need for skilled technologists and strict quality control increases operational burden and labor costs. For instance, smaller diagnostic centers may underutilize advanced CLIA capabilities or favor simpler immunoassay methods, limiting volume growth and broader integration into routine screening and disease monitoring.

Supply Chain Landscape

1

Reagent Production

DiaSorin S.p.A.Abbott Laboratories
2

Chemiluminescence Immunoassay Systems

F. Hoffmann-La Roche Ltd.Siemens Healthineers AG
3

Diagnostics Distribution

Danaher CorporationAbbott Laboratories
4

Clinical End-users

Diagnostic laboratoriesHospital immunodiagnostics departments
Chemiluminescence Immunoassay Systems - Supply Chain

Use Cases of Chemiluminescence Immunoassay Systems in Clinical Diagnostics & Pharmaceutical Research

Clinical Diagnostics : Chemiluminescence Immunoassay Systems play a role in clinical diagnostics by helping detect and measure various molecules like hormones, medications, viruses and proteins. They aid in detection of diseases accurately due to their high sensitivity, wide range of detection and ability to process tests efficiently. Major companies such as Abbott Laboratories and Siemens Healthineers are players, in this field.
Pharmaceutical Research and Development : CLIA are widely employed in studies to identify biomarkers evaluate drug effectiveness and measure toxicity levels. They provide benefits such as precise specificity, sensitivity, reliability and the capacity to process small sample quantities. Key players, in the pharmaceutical research sector utilizing these systems include Roche Diagnostics and Danaher Corporation.
Food and Environmental Analysis : In the field of food and analysis these tools are employed to identify and measure different impurities and toxins in food products, water bodies, soil samples and air samples. They offer advantages such, as precise analytical sensitivity, minimal detection thresholds and the capability to examine numerous substances simultaneously thereby guaranteeing thorough analysis.

Recent Developments

The chemiluminescence immunoassay systems market is advancing with automation, AI integration, and expanded assay capabilities, strengthening clinical diagnostics and laboratory workflows. Many laboratories are retiring semi‑automated methods in favor of fully automated CLIA analyzers that offer high‑throughput testing, sample preparation automation, and LIS/cloud connectivity for real‑time data management. AI‑powered analytics are also reducing false positives and prioritizing emergency diagnostics, enhancing diagnostic accuracy and turnaround times. A key trend is the rise of multiplex CLIA panels that detect multiple biomarkers per sample, meeting growing demand in oncology, endocrinology, and infectious disease testing.

June 2025 : Siemens Healthineers & ALZpath licensing agreement for neurodegenerative diagnostics on Atellica immunoassay systems, expanding assay menus with pTau217 blood‑based Alzheimer’s testing and strengthening chemiluminescence immunoassay capabilities for emerging disease biomarkers.
April 2024 : Roche received U.S. FDA clearance for its Elecsys Anti‑Müllerian Hormone Plus chemiluminescence immunoassay, enhancing reproductive health testing accuracy on automated immunoassay platforms and boosting adoption in fertility and women’s health diagnostics.
September 2023 : Siemens Healthineers’ Atellica CI analyzer received FDA clearance for immunoassay and clinical chemistry testing in low‑ to mid‑volume laboratories, broadening access to automated chemiluminescence immunoassay diagnostics across varied clinical settings.

Impact of Industry Transitions on the Chemiluminescence Immunoassay Systems Market

As a core segment of the Medical Device industry, the Chemiluminescence Immunoassay Systems market develops in line with broader industry shifts. Over recent years, transitions such as Transition Towards Automation and Digital Connectivity and AI-Driven Analytics have redefined priorities across the Medical Device sector, influencing how the Chemiluminescence Immunoassay Systems market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.
01

Transition Towards Automation

The CLIA market is set to undergo a digital transformation due to automation. The total value of this market will be boosted by $935 million by 2030 due to the increased usage of fully automated immunoassay platforms. High capacity clinical laboratories are now forced to buy instruments capable of high throughput and precise results and which call for a minimal level of operator intervention. By facilitating advanced automation of laboratory procedures, the goal of improving a laboratorys efficiency and productivity can be reached. This improved efficiency results in higher productivity, lower costs of testing and also greater use of laboratory instruments. Companies that build in random access capabilities, high volume operational capacity and comprehensive quality control into their CLIA will be in a position to capture this incremental value pool and gain market share in the reference laboratory and hospital segments that order in high volume.
02

Digital Connectivity and AI-Driven Analytics

CLIA systems are increasingly incorporating digital connectivity and artificial intelligence to enhance diagnostic accuracy and workflow efficiency. Smart software algorithms can analyze luminescent signals, detect anomalies, and flag potential errors, supporting faster clinical decision-making. For instance, AI-enabled CLIA platforms in hospital networks allow integration with laboratory information systems, improving traceability and predictive maintenance. In pharmaceutical research, these advanced platforms enable precise quantification of biomarkers, supporting drug development and real-time monitoring of therapeutic responses. This transition is driving cross-industry collaborations between diagnostics manufacturers, AI software providers, and healthcare institutions, accelerating the adoption of intelligent immunoassay solutions globally.