Chemiluminescence Immunoassay Market Report 2025

The chemiluminescence immunoassay market size has grown strongly in recent years. It will grow from $13.63 billion in 2024 to $14.85 billion in 2025 at a compound annual growth rate (CAGR) of 8.9%. The growth in the historic period can be credited to the increasing emphasis on high-sensitivity detection techniques, the expanding integration of chemiluminescence assays with point-of-care testing devices, rising demand for multiplex assay capabilities, growing use of chemiluminescence in oncology diagnostics, and the increasing prevalence of infectious diseases.

The chemiluminescence immunoassay market size is expected to see strong growth in the next few years. It will grow to $20.64 billion in 2029 at a compound annual growth rate (CAGR) of 8.6%. The growth in the forecast period can be attributed to increasing demand for personalized medicine, greater adoption of digital health technologies, rising investments in healthcare infrastructure, expanding applications in infectious disease diagnostics, and growth in automated central laboratory environments. Key trends during this period include advancements in automated immunoassay platforms, development of multiplex chemiluminescence immunoassay technologies, innovations in point-of-care diagnostic solutions, integration of AI for result interpretation, and the expanding use of chemiluminescence immunoassays in personalized medicine.

The increasing prevalence of infectious diseases is expected to drive growth in the chemiluminescence immunoassay market in the coming years. Infectious diseases are illnesses caused by harmful microorganisms such as bacteria, viruses, fungi, or parasites, which can spread directly or indirectly between individuals. The rise in antimicrobial resistance is contributing to this trend, as it diminishes the effectiveness of common treatments, allowing infections to persist and spread. Chemiluminescence immunoassays support infectious disease diagnosis by providing highly sensitive and specific biomarker detection, enabling early and accurate identification of pathogens. These assays help reduce diagnostic delays, improve patient management, and enhance treatment outcomes. For instance, in February 2024, the UK Health Security Agency reported that tuberculosis cases in England rose to 4,850 in 2023, up 10.7% from 4,380 cases in 2022. Therefore, the increasing prevalence of infectious diseases is boosting demand for chemiluminescence immunoassays.

Key players in the chemiluminescence immunoassay market are developing advanced products, such as high-performance chemiluminescence immunoassay analyzers, to improve diagnostic accuracy, increase throughput, and deliver faster results across a variety of clinical applications. These analyzers automatically detect and measure light emitted during chemical reactions to identify specific biomarkers with precision. For example, in July 2023, Fapon Biotech Inc., a China-based biotechnology company, launched the Shine i8000/9000 analyzer. Designed for medium to large laboratories, it provides preliminary results within 10 minutes and offers high precision with a compact, user-friendly design. Key features include a 360-degree large-span display, one-touch bulk loading for reaction cups, a dual-tube backup substrate system, and automatic reaction cup disposal to minimize contamination. Its fully automated workflow reduces manual intervention, while advanced algorithms ensure consistent results, making it ideal for high-volume diagnostic settings.

In December 2023, Danaher Corporation, a US-based life sciences and diagnostics company, acquired Abcam Limited for approximately \$5.7 billion. The acquisition strengthens Danaher’s Life Sciences segment by leveraging Abcam’s validated antibodies, reagents, biomarkers, and assays to accelerate drug discovery and disease mapping, while allowing Abcam to operate independently. Abcam Limited is a UK-based life sciences company specializing in chemiluminescence immunoassay kits and reagents.

Major players in the chemiluminescence immunoassay market are F. Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Siemens Healthineers AG, Shenzhen Mindray Bio-Medical Electronics Co. Ltd., QuidelOrtho Corporation, Sysmex Corporation, Bio-Rad Laboratories Inc., Revvity Inc., DiaSorin S.p.A., Tecan Group Ltd., Euroimmun AG, Randox Laboratories Ltd., Autobio Diagnostics Co. Ltd., Wondfo Biotech Co. Ltd., Fujirebio Diagnostics Inc., Trivitron Healthcare Pvt. Ltd., Getein Biotech Inc., Fapon Biotech Inc., Diazyme Laboratories Inc.

North America was the largest region in the chemiluminescence immunoassay market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in chemiluminescence immunoassay market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the chemiluminescence immunoassay market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.

Chemiluminescence immunoassay (CLIA) is a biochemical technique used to detect and quantify specific molecules, such as proteins, hormones, or pathogens, by combining antigen-antibody interactions with a chemiluminescent signal. In this method, light generated during a chemical reaction is measured to determine the presence and concentration of the target analyte. It offers highly sensitive, specific, and rapid diagnostic testing for both clinical and research applications.

The main product categories in chemiluminescence immunoassay include analyzers, kits, and reagents. Analyzers are automated instruments designed to perform CLIA tests by detecting and measuring the emitted light during the reaction. These systems handle various sample types, such as blood, saliva, urine, and others, and employ different technologies, including chemiluminescence enzyme immunoassay (CLEIA), electrochemiluminescence immunoassay (ECLI), and microparticle chemiluminescence immunoassay. CLIA finds applications in therapeutic drug monitoring, oncology, cardiology, endocrinology, infectious diseases, autoimmune disorders, and more, serving a wide range of end users including hospitals, pharmaceutical and biotech companies, and clinical laboratories.

The chemiluminescence immunoassay market research report is one of a series of new reports that provides chemiluminescence immunoassay market statistics, including chemiluminescence immunoassay industry global market size, regional shares, competitors with a chemiluminescence immunoassay market share, detailed chemiluminescence immunoassay market segments, market trends and opportunities, and any further data you may need to thrive in the chemiluminescence immunoassay industry. This chemiluminescence immunoassay market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The chemiluminescence immunoassay market consists of revenues earned by entities by providing services such as high-sensitivity diagnostic testing, disease biomarker detection, clinical laboratory workflow optimization, and personalized healthcare diagnostics. The market value includes the value of related goods sold by the service provider or included within the service offering. The chemiluminescence immunoassay market also includes sales of immunoassay analyzers, control and calibration solutions, diagnostic consumables, and related accessories used for performing chemiluminescence-based diagnostic tests. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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