China Immunoassay Reagents and Devices Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

China Immunoassay Reagents and Devices Market Size

• The China Immunoassay Reagents and Devices Market size was valued at USD 1.88 billion in 2024 and is expected to reach USD 3.04 billion by 2032, at a CAGR of 6.2% during the forecast period
• The market growth is primarily driven by increasing demand for early disease detection, the prevalence of chronic and infectious diseases, and advancements in immunoassay technologies, which have enhanced the accuracy, speed, and sensitivity of diagnostic testing.
• Additionally, expanding healthcare infrastructure, rising healthcare expenditure, and the adoption of automated and point-of-care testing solutions are contributing significantly to the market’s expansion across hospitals, diagnostic centers, and research laboratories.

China Immunoassay Reagents and Devices Market Analysis

• Immunoassay reagents and devices, essential tools for detecting and quantifying biological markers, are becoming increasingly vital in China's healthcare system due to their high sensitivity, accuracy, and ability to support early disease diagnosis in both clinical and research settings.
• The escalating demand for immunoassay solutions in China is primarily fueled by the rising prevalence of chronic and infectious diseases, growing awareness of preventive healthcare, and the increasing integration of automated and point-of-care diagnostic technologies.
• Immunoassay reagents & kits segment is expected to dominate the China Immunoassay Reagents and Devices Market with a market share of 67.75% in 2025, driven by their widespread use in hospitals, diagnostic laboratories, and academic research, as well as their ease of implementation across various testing platforms.

Report Scope and China Immunoassay Reagents and Devices Market Segmentation 

China Immunoassay Reagents and Devices Market Trends

Growing Government Support for Domestic Diagnostic Manufacturing

• The Chinese government’s increasing focus on strengthening domestic production of medical diagnostics and reducing dependence on foreign imports is a key trend shaping the China Immunoassay Reagents and Devices Market.
• For instance, in 2023, China’s National Health Commission emphasized the importance of accelerating the localization of key diagnostic technologies under its “Healthy China 2030” initiative, which aims to improve healthcare accessibility and innovation.
• This policy shift is driving increased funding, favorable regulations, and public-private partnerships to support the development and commercialization of homegrown immunoassay solutions.
• The government is also encouraging local companies to upgrade manufacturing capabilities and adopt international quality standards, further boosting the competitiveness of Chinese immunoassay product manufacturers.
• As a result, several domestic firms are entering the immunoassay space with affordable, high-performance devices and reagents tailored to local healthcare needs.
• This trend not only fosters innovation but also enhances supply chain resilience, improves access to diagnostics in rural and underserved regions, and positions China as a potential global hub for diagnostic exports in the future.

China Immunoassay Reagents and Devices Market Dynamics

Driver

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 China Immunoassay Reagents and Devices Market.  
• For instance, In Dec 2024, according to the World Health Organization (WHO), non-communicable diseases (NCDs) such as cardiovascular diseases, cancers, chronic respiratory diseases, and diabetes account for 71% of all global deaths. The WHO also stresses the need for early detection and effective management strategies to combat these rising health threats.
• 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.

Restraint/Challenge

Fragmented Market with Intense Low-Cost Competition Causing Pricing Pressure

• The Chinese immunoassay market includes a large number of small- to mid-sized domestic manufacturers offering low-cost reagents and devices. These players compete aggressively on price rather than innovation or quality.
• For instance, In 2024, China's centralized procurement policies significantly impacted the immunoassay market. Domestic brands, such as Mindray Medical, Antu Biotech, New Industry, and Wanfu Biotech, have increasingly dominated the biochemical diagnosis, blood diagnosis, and enzyme-linked immunoassay sectors, which are characterized by lower technical content. These sectors have largely completed domestic substitution, leading to a competitive landscape where domestic manufacturers offer more affordable options, thereby exerting downward pressure on prices
• The absence of significant mergers and acquisitions has prevented consolidation, resulting in a crowded marketplace with overlapping product portfolios and minimal differentiation.
• Fragmentation reduces the space for premium and specialized offerings, as customers (especially in public hospitals) are often driven by procurement cost rather than diagnostic accuracy or automation. The Chinese government’s national and provincial bidding systems prioritize lowest-cost bids in public hospitals, which account for a significant portion of healthcare delivery.
• This institutionalizes price wars and further compresses margins for all players.

China Immunoassay Reagents and Devices Market Scope

China Immunoassay Reagents and Devices Market is categorized into seven notable segments which are based on the product type, platform, type, specimen type, application, end user, and distribution channel.

• By Product Type

On the basis of product type, China Immunoassay Reagents and Devices Market is segmented into immunoassay reagents & kits and immunoassay devices. In 2025, the immunoassay reagents & kits segment is expected to dominate the China Immunoassay Reagents and Devices Market with a market share of 67.75%, driven by the increasing demand for early and accurate disease diagnosis, widespread adoption in hospitals and diagnostic laboratories, and the ease of use and high reliability of these kits in detecting a wide range of infectious and chronic conditions. Additionally, advancements in reagent formulation and automation-friendly designs are further enhancing their uptake across the healthcare sector.

The immunoassay reagents & kits segment is anticipated to witness the fastest growth rate from 2025 to 2032, fueled by the rising prevalence of chronic and infectious diseases, increasing demand for point-of-care testing, and ongoing innovations in assay sensitivity and specificity. Additionally, growing investments in healthcare infrastructure and the expanding use of immunoassays in personalized medicine and routine health screenings are expected to further accelerate segment growth.

• By Platform

On the basis of platform, 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 and witness the fastest CAGR the China Immunoassay Reagents and Devices Market, driven by its high sensitivity, wide dynamic range, and ability to deliver rapid and accurate results. The increasing adoption of automated CLIA systems in hospitals and laboratories, along with their suitability for large-scale testing and chronic disease monitoring, is further propelling the segment’s growth.

• By Type

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 and witness the fastest CAGR from 2025 to 2032 in the China Immunoassay Reagents and Devices Market, driven by its high reliability in detecting a wide range of biomarkers, including those related to infectious diseases, hormonal imbalances, and chronic conditions. The ease of sample collection, compatibility with various immunoassay platforms, and growing use in routine health checkups and disease screening are further contributing to the segment’s dominance.

• By Specimen Type

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 market and expected to witness the fastest CAGR from 2025 to 2032, driven by the widespread use of blood-based immunoassays for early disease detection, ongoing advancements in assay technologies, and increasing demand for minimally invasive, accurate diagnostic testing. Additionally, the rising prevalence of chronic and infectious diseases requiring regular monitoring through blood tests is fueling sustained growth in this segment.

• By Application

On the basis of application, 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 market and expected to witness the fastest CAGR from 2025 to 2032, driven by the rising prevalence of infectious diseases, increased public health initiatives for early detection and control, and growing demand for rapid and accurate diagnostic tools. Advances in immunoassay technologies enabling timely identification of pathogens and the need for efficient outbreak management further accelerate growth in this segment.

• By End User

On the basis of end user, 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, and by level into tier 3, tier 2, and tier 1 hospitals. In 2025, the hospitals segment is expected to dominate the market and expected to witness the fastest CAGR from 2025 to 2032, driven by the increasing number of hospital admissions, growing demand for advanced diagnostic services, and the expansion of healthcare infrastructure across China. Additionally, hospitals’ preference for automated and high-throughput immunoassay devices to support timely and accurate patient diagnosis is fueling growth in this segment.

• By Distribution Channel

On the basis of distribution channel, 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 market and expected to witness the fastest CAGR from 2025 to 2032, driven by increasing government and institutional procurement of immunoassay reagents and devices to ensure cost-effective and large-scale supply. Additionally, streamlined purchasing processes, long-term contracts, and rising investments in public healthcare infrastructure are accelerating growth in this segment.

China Immunoassay Reagents and Devices Market Regional Analysis

• North America dominates the China Immunoassay Reagents and Devices Market with the largest revenue share of 40.01% in 2024, driven by a growing demand for home automation and security, as well as increased awareness of smart home technology
• Consumers in the region highly value the convenience, advanced security features, and seamless integration offered by Immunoassay Reagents and Devicess with other smart devices such as thermostats and lighting systems.
• This widespread adoption is further supported by high disposable incomes, a technologically inclined population, and the growing preference for remote monitoring and control, establishing Immunoassay Reagents and Devicess as a favored solution for both residential and commercial properties.

China Immunoassay Reagents and Devices Market Insight

The China Immunoassay Reagents and Devices Market is fueled by the increasing prevalence of chronic and infectious diseases, which drive the demand for early and accurate diagnostic solutions. Rapid advancements in immunoassay technologies, including automation and enhanced sensitivity, have improved testing efficiency and reliability, further boosting market growth. Additionally, growing healthcare infrastructure, supportive government initiatives aimed at promoting domestic manufacturing, and rising awareness about preventive healthcare are key factors contributing to the expanding adoption of immunoassay reagents and devices across hospitals, diagnostic laboratories, and research institutions throughout China.  

China Immunoassay Reagents and Devices Market Share

The Immunoassay Reagents and Devices industry is primarily led by well-established companies, including:

• F. Hoffmann-La Roche Ltd (Switzerland)
• Siemens (Germany)
• Abbott Laboratories (U.S.)
• Thermo Fisher Scientific Inc. (U.S.)
• QuidelOrtho Corporation (U.S.)
• Bio-Techne (U.S.)
• BIOMRIEUX (France)
• DIASORIN S.P.A (Italy)
• Danaher (U.S.)
• Tosoh Bioscience LLC (Japan)
• Hipro Biotechnology Co., Ltd. (China)
• Agilent Technologies, Inc. (U.S.)
• Bio-Rad Laboratories, Inc. (U.S.)
• Sysmex (Japan)
• BD (U.S.)
• QIAGEN (Germany)
• Revvity (U.S.)
• SD Biosensor, INC (South Korea)

Latest Developments in China Immunoassay Reagents and Devices Market

• 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 initiated a new clinical trial focused on intravascular lithotripsy (IVL) to enhance treatment outcomes for patients with coronary artery disease. This innovative procedure uses sonic pressure waves to fracture calcium deposits in the coronary arteries, aiming to improve stent placement and blood flow. The trial highlights Abbott’s commitment to advancing minimally invasive cardiovascular technologies and addressing complex arterial conditions.
• 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 is acquiring Solventum’s Purification and Filtration business for USD 4.1 billion, strengthening its bioprocessing capabilities. The acquisition enhances its portfolio of filtration and purification technologies, which involve key surface analysis techniques to optimize material interactions in biologics and industrial applications.
• 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.

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