CHEMILUMINESCENCE IMMUNOASSAY MARKET ANALYSIS
Global chemiluminescence immunoassay market is estimated to be valued at USD 13.11 Bn in 2024 and is expected to reach USD 20.50 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 6.6% from 2024 to 2031.
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The market trends driving 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 are witnessing increased adoption rate especially in hospitals and diagnostic laboratories, thus, driving the chemiluminescence immunoassay market growth.
Market Driver – 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 healthcare experts and researchers, chronic diseases have now overtaken infectious illnesses as the major cause of mortality worldwide. 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. CLIA tests play a pivotal role in monitoring liver function, screening for hepatitis and other infectious agents that could lead to liver diseases. CLIA is also a preferred diagnostic methodology for endocrinological conditions like hyperthyroidism due to its high sensitivity. Growing geriatric population prone to age-related illnesses has also boosted demand for such assays. Due to rising chronic disease prevalence worldwide, healthcare providers are incorporating more chemiluminescence immunoassays in their practice to facilitate improved patient management.
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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. . According to the data published by the United Nations, non-communicable diseases and healthcare needs of an ageing global population will rise substantially in the future. COVID-19 pandemic witnessed exponential increase in infectious disease testing worldwide using CLIA platforms. This further underscores the necessity of rapid, automated and high-throughput CLIA technology for quality diagnostic services.
Key Takeaways from Analyst:
Global chemiluminescence immunoassay market growth is driven by increasing prevalence of chronic and infectious diseases that boosts demand for diagnostic tests using CLIA technology. The advanced capabilities of CLIA in performing a wide range of tests from a small sample volume can also boost its adoption.
North America dominates the market due to well-established healthcare systems and rising healthcare spending in the region. However, Asia Pacific is poised to be the fastest growing regional market due to improving access to healthcare facilities and growing healthcare expenditure in developing countries of China and India.
High instrument costs can hamper the market growth, however, ongoing technological advancements focusing on developing portable and affordable CLIA analyzers can drive the market growth. Favorable regulatory guidelines and financial support for high-throughput CLIA testing offer opportunities for manufacturers to enter developing markets.
Market players are actively engaging in new product launches, collaborations and acquisitions to strengthen their presence. Development of assays for detecting novel disease biomarkers can boost demand for CLIA immunoassays.
Market Challenges: Presence of alternative technologies
The presence of alternative techniques for immunoassays can hamper the global chemiluminescence immunoassay market growth. Technologies like fluorescence immunoassay and enzyme-linked immunosorbent assay (ELISA) are well-established alternatives to chemiluminescence immunoassay. Fluorescence immunoassay uses fluorescent probes instead of chemiluminescent substances for detection. It provides strong signals, high sensitivity, and allows detecting multiple analytes simultaneously by using different fluorescent dyes. ELISA is also a popular immunoassay technique that employs enzymes for signal generation instead of chemiluminescence. Both fluorescence and ELISA methods are faster, simpler to perform, and more cost-effective as compared to chemiluminescence immunoassay. The widespread adoption of these alternative technologies by clinical laboratories and hospitals can restrict the potential customer-base expansion of chemiluminescence immunoassay. For example, according to a 2019 report published by the World Health Organization (WHO), around 70% of clinical microbiology laboratories in low and middle-income countries mainly rely on ELISA and rapid diagnostic tests rather than chemiluminescence immunoassay for detecting infectious diseases due to their lower cost and simpler operation. The preference for alternative cost-effective techniques is significantly hampering the sales and marketing opportunities of chemiluminescence immunoassay analyzers/reagents globally.
Market Opportunities: Launch of advanced CLIA diagnostic technologies
The launch of advanced chemiluminescence immunoassay (CLIA) diagnostic technologies provide a great opportunity to drive global chemiluminescence immunoassay market 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. ECLIA systems utilize advanced signal amplification methods to enable detection of smaller concentrations of target analytes with high precision. This enhanced sensitivity of ECLIA allows detection of biomarkers at early disease stages, facilitating early diagnosis and treatment. Nano-immune technology employs the use of nanomaterials like quantum dots and gold nanoparticles in CLIA. The nanomaterial tags offer increased stability and brightness of chemiluminescence signals. This improves assay sensitivity for low abundance analytes. Microfluidic CLIA systems miniaturize the analytical process on a single microchip utilizing only minute volumes of samples and reagents. The higher surface area to volume ratio allows for rapid reaction kinetics and analysis of multiple samples on the same chip in an automated, high-throughput and cost-effective manner.
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By Product Type - Reagents segment dominates
In terms of product type, reagents segment is estimated to contribute the highest market share of 58.1% in 2024, 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. These enable accurate measurement of drug metabolites, which helps physicians customize therapy based on an individual's metabolic rates. This personalized approach enhances treatment efficacy while avoiding toxic effects. Reagents are also driving the large usage of chemiluminescence immunoassays in disease screening, monitoring disease progression, and assessing treatment responses in various therapeutic areas.
By Application - Therapeutic drug monitoring segment dominates
In terms of application, therapeutic drug monitoring segment is estimated to contribute the highest market share of 30.12% in 2024, owing to pressing need for optimizing pharmacotherapy. Therapeutic Drug Monitoring (TDM) utilizes assays like 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 given how factors like 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. TDM guided dosing is indispensable for drugs with narrow therapeutic indices where blood concentrations must be accurately maintained, to minimize toxicity risks. It is highly relevant for immunosuppressants, anti-cancer agents, and psychotropic medications. TDM has been proven to improve clinical outcomes, reduce hospitalization risks and healthcare costs associated with suboptimal drug response or toxicity issues. Rising geriatric population on complex multi-drug regimens, growing need for individualized medicine approaches, and increased chronic disease prevalence have amplified the clinical importance of TDM. This boosts demand for high-throughput, sensitive and accurate assays like chemiluminescence immunoassays to facilitate widespread adoption of TDM practices.
By Sample Type - Oncology being a major diagnostic area
In terms of sample type, blood segment is estimated to contribute the highest market share of 40% in 2024, owing to its universal suitability as a diagnostic sample across disease areas. However, within this segment, oncology dominates as a clinical application area driving significant blood-based testing needs. Cancer poses a huge disease burden worldwide and impacts millions lives annually. Timely and accurate diagnosis and monitoring treatment responses are critical to improving patient outcomes and healthcare savings. Chemiluminescence immunoassays utilizing blood-based tumor markers play a pivotal role in cancer screening, diagnosis, prognosis assessment, and surveillance following therapy. These assays offer high sensitivity for detecting extracellular circulating tumor biomarkers like 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.
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North America dominates the global chemiluminescence immunoassay market with an estimated market share of 41.2% in 2024, 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. The presence of major pharmaceutical and life sciences companies has also augmented the regional market growth. Favorable regulatory environment and healthcare reimbursement policies have facilitated wider uptake of chemiluminescence immunoassay systems in the region.
Asia Pacific is witnessing the fastest growth and has emerged as the most lucrative regional market. 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. Expansion of private healthcare sector and increasing medical tourism are also favoring regional market growth.
Chemiluminescence Immunoassay Market Report Coverage
| Report Coverage | Details | ||
|---|---|---|---|
| Base Year: | 2023 | Market Size in 2024: | US$ 13.11 Bn |
| Historical Data for: | 2019 to 2023 | Forecast Period: | 2024 to 2031 |
| Forecast Period 2024 to 2031 CAGR: | 6.6% | 2031 Value Projection: | US$ 20.50 Bn |
| Geographies covered: |
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| Companies covered: |
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. |
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*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.
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About Author
Abhijeet Kale
Abhijeet Kale is a results-driven management consultant with five years of specialized experience in the biotech and clinical diagnostics sectors. With a strong background in scientific research and business strategy, Abhijeet helps organizations identify potential revenue pockets, and in turn helping clients with market entry strategies. He assists clients in developing robust strategies for navigating FDA and EMA requirements.
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