Rising Healthcare Investments In Diagnostic Technologies is Driving the Growth of the China Immunoassay Reagents and Devices Market

Immunoassay Reagents and Devices are specialized diagnostic tools that utilize antigen-antibody reactions to detect and quantify specific analytes in biological samples with high sensitivity and specificity. These systems combine immunoassay reagents, such as kits and buffers, with automated or semi-automated analyzers, POCT devices, and accessories to enable efficient and accurate diagnostics across clinical and research settings. Immunoassay platforms include techniques such as ELISA, CLIA, FIA, and rapid tests, facilitating the detection of biomarkers related to infectious diseases, cancer, endocrinology, and autoimmune disorders. Together, these reagents and devices represent a growing field of laboratory and point-of-care diagnostics, offering precise, rapid, and personalized testing options for various applications within China's evolving healthcare system, including disease screening, monitoring, and management.

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Data Bridge Market Research analyzes that the China Immunoassay Reagents and Devices Market is expected to reach USD 3.04 billion by 2032 from USD 1.88 billion in 2024, growing with a CAGR of 6.2% in the forecast period of 2025 to 2032.

Key Findings of the Study  

Increasing Prevalence of Chronic Diseases

The increasing prevalence of chronic diseases such as diabetes, cardiovascular conditions, cancer, and respiratory illnesses has emerged as a significant driver of growth in the immunoassay reagents and devices market. The global rise in chronic disease cases is largely attributed to factors such as aging populations, unhealthy lifestyles, poor dietary habits, and lack of physical activity. As these diseases require continuous monitoring and early diagnosis, there is an escalating need for advanced diagnostic tools, including immunoassay devices that can provide accurate, quick, and minimally invasive results. Immunoassays are essential in detecting specific biomarkers associated with chronic conditions like diabetes (e.g., HbA1c), heart disease (e.g., troponin), and cancer (e.g., CA-125). These tests not only help in early diagnosis but also in tracking disease progression and assessing the efficacy of treatments. Consequently, healthcare systems and patients are increasingly relying on these diagnostic technologies, driving demand for immunoassay reagents and devices. This trend is expected to continue as the burden of chronic diseases grows globally, especially in emerging markets with expanding healthcare infrastructure

Report Scope and China Immunoassay Reagents and Devices Market Segmentation

Segment Analysis

China immunoassay reagents and devices market is categorized into five notable segments which are based on the Product Type, Type, Platform, Application, and End User.

• On the basis of Product Type, the China immunoassay reagents and devices market is segmented into Immunoassay Reagents & Kits and Immunoassay Devices. The Immunoassay Reagents & Kits segment is further segmented into Chemiluminescence Immunoassays Kits and Reagents, ELISA Kits and Reagents, Rapid Test Kits and Reagents, Immunohistochemistry Assays Kits and Reagents, Bead-Based Immunoassays Kits and Reagents, Western Blot Kits and Reagents, Elispot Kits and Reagents, Radioimmunoassay Kits and Reagents, Microarray Immunoassays Kits and Reagents, Multiplex Microarray Assays Kits and Reagents, and Other Immunoassay Kits and Reagents. The Immunoassay Devices segment is segmented into Analyzers, Accessories and Consumables, and POCT Devices.

In 2025, the Immunoassay Reagents & Kits segment is expected to dominate the market

In 2025, the Immunoassay Reagents & Kits segment is expected to dominate the market with a market share of 67.75% due to their wide clinical and research application, growing demand for high-sensitivity testing, and the increasing need for early disease detection across hospitals and laboratories. The extensive use of ELISA and chemiluminescence-based reagents continues to drive demand across various diagnostic areas in China’s evolving healthcare landscape.

• On the basis of Platform, the China Immunoassay Reagents and Devices Market is segmented into Chemiluminescence Immunoassays (CLIA), Enzyme Immunoassay (EIA/ELISA), Fluorescence Immunoassays (FIA), Chromatographic Immunoassays, Immunohistochemistry, Radioimmunoassays (RIA), Turbidimetric Immunoassays, Microarray Immunoassays, Counting Immunoassays, and Others

In 2025, the Chemiluminescence Immunoassays (CLIA) segment is expected to dominate the market

In 2025, the Chemiluminescence Immunoassays (CLIA) segment is expected to dominate the market with a market share of 43.07% due to its high sensitivity, broad dynamic range, and faster turnaround times compared to conventional methods. CLIA platforms are widely adopted across hospitals and laboratories for detecting a wide range of analytes, supporting their growing use in clinical diagnostics and large-scale screening programs within China's healthcare system.

• On the basis of type, China Immunoassay Reagents and Devices Market is segmented into Laboratory Based, Point of Care. In 2025, the blood segment is expected to dominate the China Immunoassay Reagents and Devices Market with a market share of 73.27%
• On the basis of specimen type, China Immunoassay Reagents and Devices Market is segmented into blood, urine, saliva, and others. In 2025, the blood segment is expected to dominate the China Immunoassay Reagents and Devices Market with a market share of 72.24%.
• On the basis of Application, the China Immunoassay Reagents and Devices Market is segmented into Infectious Diseases, Cancer Biomarkers, Endocrinology, Bone and Mineral Disorders, Cardiology, Hematology and Blood Screening, Autoimmune Disorders, Toxicology, Neonatal Screening, Allergy Diagnostics, Gastrology, and Others. In 2025, the Infectious Diseases segment is expected to dominate the market with a market share of 25.50%
• On the basis of End User, the China Immunoassay Reagents and Devices Market is segmented into Hospitals, Clinical Laboratories, Pharmaceutical and Biotechnology Companies, Blood Banks, Research and Academic Laboratories, Ambulatory Care Centers, Nursing Homes, Home Healthcare Agencies, and Others. The Hospitals segment is further segmented into Public and Private. In 2025, the Hospitals segment is expected to dominate the market with a market share of 42.54%
• On the basis of Distribution Channel, the China Immunoassay Reagents and Devices Market is segmented into Direct Tender, Retail Sales, and Others. The Retail Sales segment is further segmented into Online and Offline. In 2025, the Direct Tender segment is expected to dominate the market with a market share of 72.51%

China Immunoassay Reagents and Devices Market Players

Data Bridge Market Research analyzes Hoffmann-La Roche Ltd, Siemens, Abbott Laboratories, Thermo Fisher Scientific Inc., and QuidelOrtho Corporation as the major market players of the market.

China Immunoassay Reagents and Devices Market Development

• In June 2025, Early results from the Phase I/II NXTAGE trial show promising outcomes for NXT007, Roche’s next-generation bispecific antibody for hemophilia A. The data indicate that NXT007 may achieve hemostatic normalization in patients without factor VIII inhibitors. These findings were presented by Chugai Pharmaceutical at the 2025 International Society on Thrombosis and Hemostasis (ISTH) Congress. NXT007 is designed to build on the clinical success of Hemlibra, another bispecific antibody therapy.
• In March 2025, The company received CE Mark approval in Europe for its Volt Pulsed Field Ablation (PFA) System, offering a new therapy option for treating abnormal heart rhythms such as atrial fibrillation. The single-catheter system delivers precise, high-energy electrical pulses to safely ablate targeted cardiac tissue, achieving pulmonary vein isolation in 99.1% of veins during clinical trials. Abbott has already commenced commercial PFA procedures in several EU countries and plans to expand deployment later this year.
• In February 2025, The Company new EVOS S1000 Spatial Imaging System allows researchers to generate high-quality data for spatial tissue proteomics, enabling detailed analysis of tissue microenvironments. The system utilizes advanced imaging techniques that involve surface analysis to study protein distribution and interactions within tissue samples.
• In August  2024, The company launched its VITROS Syphilis Assay for use on VITROS 3600, 5600, and XT 7600 systems in the U.S. This product launch is a significant development as it expands their infectious disease testing portfolio, offering timely and accurate diagnosis of syphilis. The impact is crucial for public health, especially given the rising incidence of syphilis in the U.S., enabling clinicians to respond quicker and more effectively to the epidemicto treat astigmatism during cataract surgery.
• In October 2024, BD has launched a new robotics solution to automate and standardize single-cell research, specifically for genomic sequencing. This collaboration with Hamilton integrates BD's automation-ready reagent kits, like the BD OMICS-One XT WTA Assay, with the Hamilton Microlab NGS STAR automated liquid handling platform. The aim is to streamline labor-intensive manual processes, reduce human error, and accelerate the generation of DNA libraries, ultimately enhancing consistency and efficiency in large-scale single-cell discovery studies.

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