The global chemiluminescence immunoassay market size was valued at USD 7.77 billion in 2024 and is projected to surpass around USD 16.18 billion by 2034, representing a solid CAGR of 7.98% from 2025 to 2034.
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Chemiluminescence Immunoassay Market Highlights:
• The worldwide chemiluminescence immunoassay market size accounted for $8.37 billion in 2025.
• The market is expected to grow to $16.18 billion by 2034.
• The market is expected to grow at a solid CAGR of 7.98% during the forecast period from 2025 to 2034.
• North America led the global chemiluminescence immunoassay market with the largest share of 52% in 2024.
• Asia Pacific is projected to grow at the fastest CAGR during the forecast period.
• The endocrine segment has held a major market share in 2024.
• The consumables segment accounted for the significant market share in 2024.
• The hospitals segment contributed the highest market share in 2024.
Market Overview and Industry Potential
The chemiluminescence immunoassay (CLIA) is one of the widely used immunological assays to diagnose and detect a certain type of disease in the human body. The chemiluminescence immunoassay market deals with the wide adoption of reagents, enzymes, and substrates required to perform CLIA and other assays like electro-chemiluminescence immunoassay (ECLIA). The emergence of several infectious diseases raised the need for rapid, sensitive, and accurate disease detection techniques in healthcare. Several biological molecules including proteins, peptides, hormones, etc. can be detected with the help of enzyme-labeled antibodies, antigens, and specific substrates.
The use of different types of markers, such as enzyme markers and luminophore markers, enzymes like horseradish peroxidase and alkaline phosphatase, substrates like luminol, and reagents like streptavidin, offers precise and ultra-sensitive ways of detection, which enhances the quality of the reaction methods. Thermo Fisher Scientific Inc. presented iBright Imaging Systems which provide essential features to easily capture data from nucleic acids gels, protein gels, chemiluminescent western blots, and fluorescent western blots.
Major Trends in the Chemiluminescence Immunoassay Market
Imaging Systems with Outstanding Features:
These imaging systems help efficiently analyze western blots and gels. The iBright Imaging Systems offered by Thermo Fisher Scientific Inc. is well-equipped with advanced modes like powerful camera technology with a 9.1MP camera to capture images precisely. It has a clear interface layout with a 12.1-inch touchscreen balance. The fluorescent multiplexing feature helps to capture four proteins in a single blot. The system has built-in software and the company also offers iBright Analysis Software to streamline the image analysis process. The relative quantitation, molecular weight estimation, etc. are possible with these imaging systems.
Digital Microfluidics and Electrowetting on Dielectric (EWOD):
These digital microfluidics platforms offer sample preparation, mixing, separation, and detection within a single chip in immunoassays. They are applicable in the detection of antigens and antibodies for infectious diseases, tumor-related molecular diagnostics, hormone assays, and several other detection methods. However, EWOD is a strong biological and chemical diagnostic technique that offers a small sample size, high throughput, high sensitivity, and automation.
Role of Artificial Intelligence in the Chemiluminescence Immunoassay Market
Artificial intelligence helps clinicians to predict clinical outcomes, make informed decision-making, and diagnose patients efficiently. The insertion of AI in clinical microbiology informatics is progressive, facilitating the use of enormous clinical datasets. These clinical datasets may include genomic information from isolated bacteria, mass spectra, large digital photographs, metagenomic microbial results, etc.
Moreover, artificial neural networks (ANN), hybrid intelligent systems, expert systems, and evolutionary computation are included as advanced systems in medical technologies. The surgical navigation systems assist in computer-aided surgery, pain management, and psychotic diseases in augmented medicine.
Chemiluminescence Immunoassay Market Report Coverage
|
Report Coverage |
Details |
|
Market Size in 2024 |
USD 7,770 Million |
|
Market Size in 2025 |
USD 8,370 Million |
|
Market Size by 2034 |
USD 16,180 Million |
|
Growth Rate from 2025 to 2034 |
7.98% |
|
Leading Region |
North America |
|
Base Year |
2024 |
|
Forecast Period |
2025 to 2034 |
|
Segments Covered |
Product Type, Application Type, and End Users |
|
Regions Covered |
North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa |
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Key Regions Analysis:
U.S. Chemiluminescence Immunoassay Market Revenue and Growth 2025 to 2034
In
terms of revenue, The U.S. chemiluminescence immunoassay market is predicted to
increase from USD 3.03 billion in 2025 to approximately USD 6,1 billion by 2034.
The market is projected to expand at an impressive 8.20% CAGR over the next ten
years (2025 to 2034).
North America dominated the chemiluminescence immunoassay market due to the well-established healthcare infrastructure, the wide adoption of cutting-edge chemiluminescence immunoassay solutions, etc. The availability of novel CLIA systems in the U.S. by major market players raises the growth of the chemiluminescence immunoassay market. Major market players like Beckman Coulter Inc., Abbott Laboratories, Roche, Siemens Healthineers, Inova Diagnostics Inc., Ortho Clinical Diagnostics, etc. uplift the market’s reputation.
The legal frameworks including International agreements like the International Health Regulations (IHR), and preparedness and response policies and plans accelerates the demand for immunoassays like CLIA in the U.S. healthcare market. Moreover, research and development including novel innovations in vaccines, treatments, and diagnostics highlight the outstanding efforts of scientists for the betterment of the U.S. population and people across the North America region.
The National Health Systems contribute to the healthcare infrastructure of every country by responding to health emergencies. The funding, financing, and investments from multilateral organizations, governments, and private sectors are supportive to public health efforts and emergency response. The global and regional organizations like the WHO provide guidance, leadership, and resources. The surveillance and early warning systems at the National, regional, and global level help to collect, share, and analyze data
• The U.S. Government Global Health Security Strategy (GHSS) 2024 helps to strengthen and adapt public health, domestic health care, emergency preparedness, and response to threats. It aligns with national strategies, directives, and commitments like the National Security Memorandum (NSM).
• The National Biodefense Strategy and Implementation Plan of the U.S. works to counter biological threats, achieve global health security, and enhance pandemic preparedness.
Asia Pacific is anticipated to be the fastest-growing region in the chemiluminescence immunoassay market during the forecast period due to the huge population base and the rising incidence of chronic and infectious diseases. The rising demand for diagnostic testing in this region drives the growth of this market. The promising government initiatives to support healthcare infrastructure accelerate the market’s growth.
Moreover, the Asian Infrastructure Investment Bank, Asian Development Bank, and Islamic Development Bank provided co-financing to the Indonesia Health Systems Strengthening Project which is a US$ 4.3 billion investment approved in December 2023. This project was designed to enhance the availability of functional equipment in public health facilities. The World Bank provides a strong analytical support to Pacific Island Health ministries. The World Bank also provides its assistance to governments for building health systems with human capital, protect against future pandemics, etc.
• In May 2024, the World Bank planned to invest in health to establish human capital, protect human lives, and promote economic resilience by supporting to the East Asia and Pacific regions.
• The World Bank supports Indonesia’s efforts to boost the supply of medical care professionals through a Universal Health Coverage Development Policy Plan to overcome shortages of medical doctors and barriers to accessing medical care.
Chemiluminescence Immunoassay Market Segments Analysis:
Application Analysis
The endocrine segment dominated the chemiluminescence immunoassay market due to a wide range of test and product offerings by chief and local manufacturers. The introduction of new tests for diagnosing several endocrine disorders raises the demand for the endocrine segment in the market. The applications of CLIA technology in addressing complex conditions related to the endocrine system accelerate the growth of this segment in the market.
The oncology segment is anticipated to be the fastest-growing in the chemiluminescence immunoassay market due to the increased mortality rate due to cancer and related conditions. The rising awareness of early cancer detection in developing as well as developed countries boosts the growth of the oncology segment in the market.
Product Analysis
The consumables segment dominated the chemiluminescence immunoassay market due to the increased demand for consumables including stains and reagents. The rising demand for stains or reagents is observable in fields like endocrinology, disease analysis, and therapeutic drug monitoring.
The instruments segment is expected to grow at the fastest rate in the chemiluminescence immunoassay market due to a wide range of automated instruments used in high-volume testing settings. The wide adoption of medical instruments in large hospitals, and research institutes is offering efficiency and accuracy in clinical workflows. The growing efforts of the leading companies to develop and launch advanced CLIA systems lead to the growth of this segment.
End User Analysis
The hospital segment dominated the chemiluminescence immunoassay market due to the rising need for chemiluminescence immunoassay solutions in hospitals. A large number of hospital visits and the rising number of infectious diseases and cancer drives the growth of this segment.
The growing number of hospitalization cases due to pandemic situations boosts the need for chemiluminescent immunoassay solutions. The applications of automated CLIA analyzers in sectors like oncology, diagnostics, therapeutic drug monitoring, etc. drive the growth of this segment in the market.
The pharmaceutical and biotechnology companies segment is anticipated to be the fastest-growing in the chemiluminescence immunoassay market during the forecast period due to the well-established healthcare infrastructure. The wide utilization of highly sensitive and specific CLIA technology solutions raises the demand for this segment in the market.
The application of CLIA technology as an ideal tool for the detection of biomarkers associated with several diseases boosts the growth of this segment. The use of CLIA technology in research, development, and manufacturing of diagnostic kits and reagents raises the demand for this segment in the market.
Browse More Insights from Precedence Research
• Immunoassay Market: The global immunoassay market size is estimated at USD 35.57 billion in 2024 and is anticipated to reach around USD 56.2 billion by 2034, expanding at a CAGR of 4.68% from 2024 to 2034.
• Automated Immunoassay Analyzers Market: The global automated immunoassay analyzers market size was valued at USD 19.44 billion in 2023 and is anticipated to reach around USD 74.31 billion by 2033, expanding at a CAGR of 14.35% from 2024 to 2033.
• Pharmaceutical Drug Delivery Market: The global pharmaceutical drug delivery market size is estimated at USD 1.97 trillion in 2024 and is anticipated to reach around USD 3.18 trillion by 2034, expanding at a CAGR of 4.90% between 2024 and 2034.
• Esoteric Testing Market: The global esoteric testing market size is estimated at USD 33.50 billion in 2024 and is anticipated to reach around USD 92.57 billion by 2034, expanding at a CAGR of 10.70% from 2024 to 2034.
• Automated Analyzers Market: The global automated analyzers market size is estimated at USD 8.64 billion in 2024 and is anticipated to reach around USD 9.27 billion by 2034, expanding at a CAGR of 7.30% between 2024 and 2034.
• Enzyme-Linked Immunosorbent Assay Testing Market: The global enzyme-linked immunosorbent assay (ELISA) testing market size accounted for USD 2.27 billion in 2024 and is predicted to reach around USD 4.19 billion by 2034, growing at a CAGR of 6.32% from 2024 to 2034.
• Drug Discovery Market: The global drug discovery market size is accounted for USD 65.84 billion in 2024 and is anticipated to reach around USD 158.74 billion by 2034, expanding at a CAGR of 9.20% between 2024 and 2034.
Competitive Landscape and Major Breakthroughs in the Chemiluminescence Immunoassay Market
The chemiluminescence immunoassay market continues to evolve rapidly and showcases remarkable advancements in 2023 and 2024 with a dynamic competitive landscape. Major players such as Ortho Clinical Diagnostics, Abbott Laboratories, Immunodiagnostic Systems, etc. hold a dominating position in the chemiluminescence immunoassay market. These companies are utilizing their vast resources and expertise to provide promising immunodiagnostic techniques and high-throughput screening assays.
What is Going Around the Globe?
• The Government of Japan initiated efforts to accelerate action to help people fight against antimicrobial resistance in the Asia Pacific region and these efforts are co-organized by WPRO and SEARO.
• The Australian Government, the Department of Industry, Science, and Resources initiated the medical science co-investment plan to present investment opportunities for industries and government to utilize the strength and high economic potential of Australia.
Segments Covered in the Report:
By Product
• Consumables
• Instruments
o Automated
o Semi-automated
• Software & Services
By Application
• Cardiology
• Therapeutic Drug Monitoring
• Oncology
• Endocrinology
• Autoimmune Disease
• Infectious Disease
• Others
By End User
• Clinical Laboratories
• Hospitals
• Pharmaceutical & Biotechnology Companies
• Others
By Region
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa
Thanks for reading you can also get individual chapter-wise sections or region-wise report versions such as North America, Europe, or Asia Pacific.
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