Domestic Chemiluminescence Immunoassay Replacement Accelerates as 900T/H High-Speed Analyzer Unlocks New Growth

Chemiluminescence has become the mainstream of global immunoassay diagnostics, owing to its advantages such as high sensitivity, wide linear range, long reagent shelf life, and broad clinical applications.

According to Deloitte’s report, “Current Status and Future Outlook of China’s Immunoassay Market,” the Chinese immunoassay market has maintained a 20% growth rate over the past five years, with its market size projected to reach RMB 52.4 billion in 2022. Among these, chemiluminescence immunoassay accounted for more than 85% of the immunoassay market share in 2022, with its market size exceeding RMB 40 billion.

As the market continues to evolve, the IVD industry, once characterized by unrestrained growth, is returning to rationality and beginning to reveal its underlying growth logic. Currently, China’s chemiluminescence market has formed a “4+5+N” competitive landscape. In this intensely competitive environment, the true survival rule for IVD companies is to stand out and gradually achieve high-quality domestic substitution.

At the recently concluded CACLP exhibition in Nanchang, multiple manufacturers launched high-speed chemiluminescence instruments. Among them, FAPON BIOTECH’s ultra-high-speed fully automated chemiluminescence immunoassay systems, Shine i8000/9000, attracted significant attention. With a single-unit throughput of up to 900 tests per hour (T/H) and a combined throughput of 3,600 T/H when four units are linked, the system delivers the first results within 10 minutes and achieves a coefficient of variation (CV) ≤3% for precision. These capabilities maximize laboratory workflow efficiency, setting a new benchmark for speed among domestic chemiluminescence systems.

As can be seen, domestic brands have taken the lead in instrument detection speed, ushering in a new wave of accelerated import substitution.

For a long time, importers have dominated the domestic chemiluminescence market, achieving a prolonged monopoly and placing immense competitive pressure on domestic manufacturers. In recent years, driven by factors such as the pandemic and healthcare insurance cost-containment measures, the pace of import substitution has accelerated significantly. The distinction between domestic and imported products has gradually blurred, with domestic brands even beginning to capture market share in large tertiary hospitals.

In the chemiluminescence immunoassay (CLIA) sector, instruments are the focal point of competition, with their technical performance primarily determined by the underlying technology platform and testing speed. Currently, CLIA technology platforms are mainly categorized into enzyme-linked chemiluminescence, direct chemiluminescence, and electrochemiluminescence. Among these, Roche’s electrochemiluminescence technology offers relatively stable detection sensitivity. Beckman, Siemens, Abbott, and most Chinese manufacturers predominantly utilize direct chemiluminescence and enzyme-linked chemiluminescence technologies.

In recent years, domestic chemiluminescence manufacturers have begun to exert significant effort. In terms of testing speed, high-speed models are currently the main focus of Chinese-made products. In 2018, Snibe launched the MAGLUMI X8 chemiluminescence device with a throughput of 600 tests per hour (T/H), which was the fastest model at the time. FAPON BIOTECH has now released the Shine i8000/9000 high-speed platform, achieving a single-unit testing speed of 900 T/H and a combined speed of 3,600 T/H when four units are linked together. This further breaks the record for single-unit testing speed, positioning it as a global leader.

Moreover, domestically produced instruments have also reached the international forefront in parameters such as sample positions, reagent positions, turnaround time, and testing pathways.

Since large chemiluminescence instruments in China are primarily used in large tertiary medical institutions, which have high demands for high throughput, high testing speed and large sample capacity are important criteria for tertiary hospitals when selecting equipment.

According to the product launch materials, the Shine i8000/9000 high-speed platform is designed for medium-to-large clinical laboratories. Its primary application scenarios include testing centers at large medical institutions, third-party medical laboratories, large-scale health examination centers, group testing centers in the livestock industry, and animal disease prevention and control centers, thereby meeting the urgent demand of medical laboratories for high-throughput testing instruments.

In addition to speed, sensitivity, linear range, and precision are also critical performance parameters for chemiluminescence. We look forward to more Chinese manufacturers launching outstanding products that achieve comprehensive leadership across all parameter dimensions.

Unlike the domestic substitution achieved in biochemical testing, the closed nature of chemiluminescence systems poses certain challenges to their replacement with domestically produced alternatives.

Currently, the sales model for in vitro diagnostic (IVD) equipment in China is predominantly based on the bundled sale of “instruments + reagents.” Equipment manufacturers provide testing instruments to end-user medical institutions and stipulate a committed purchase amount for reagents over a specified period, thereby driving subsequent reagent sales. While this marketing approach helps ensure customer stickiness to some extent, it also results in a more closed business model. Having entered the market earlier, international giants have achieved market monopoly ahead of domestic competitors.

Due to the wide range of chemiluminescence immunoassay (CLIA) tests, individual manufacturers often struggle to offer a comprehensive test menu. As a result, healthcare institutions typically need to deploy instruments from multiple vendors to ensure full test coverage, leading to additional costs and operational burdens. Therefore, there is a clear market demand for compatible, scalable, and comprehensive testing platforms.

To build an open-platform ecosystem for chemiluminescence, it is first necessary to create an instrument platform compatible with reagents from multiple vendors, a process that inevitably entails numerous challenges and difficulties. Given the diverse methodologies employed in chemiluminescence and the absence of unified industry testing standards, test results vary significantly across manufacturers. Consequently, ensuring quality and the traceability of test results is of paramount importance.

We have noted that the Shine i8000/9000 not only sets a new benchmark for single-unit testing speed but also serves as an open platform.

It is reported that, leveraging its core raw material advantages, FAPON BIOTECH has gradually expanded into reagent solutions and open instrument platforms, establishing foundational capabilities within the IVD open platform. It has created China’s first open IVD ecosystem platform, integrating services such as raw materials, testing platforms, reagent solutions, and CXO. This platform empowers upstream and downstream segments of the industry chain, facilitating the rapid development of IVD enterprises.

We believe that, within an open ecosystem, high-quality domestic substitution can be accelerated, thereby driving the rapid development of the IVD industry.

With the gradual implementation of tiered diagnosis and treatment systems and new healthcare infrastructure initiatives, a portion of the diagnostic demand from tertiary hospitals is being diverted to primary care facilities, driving sustained volume growth in the primary healthcare market. Given the cost sensitivity of this sector, domestically produced equipment is expected to see accelerated adoption, further expanding the market potential for Chinese-made chemiluminescence immunoassay systems.

However, the expansion of the chemiluminescence market and the significant potential for domestic substitution do not necessarily benefit every player in the industry. With the advancement of centralized procurement, the widespread outsourcing of hospital laboratory departments, the adoption of business models involving independent clinical laboratories (ICLs) and co-built regional testing centers with hospitals, and the implementation of DRG/DIP medical insurance payment methods, the profit margins for IVD distributors will continue to shrink.

Currently, early-stage manufacturers have basically completed instrument development and market deployment. Meanwhile, leading companies such as Mindray, Autobio, Wantai, Snibe, and Maccura continue to spare no effort in investing in reagent upgrades. Beyond these top-tier players, the vast majority of small and medium-sized IVD manufacturers possess only limited capabilities, making it difficult for them to meet end-user market demands. How can these companies become the significant “N” participants in the market and establish a firm foothold in the new round of competitive landscape?

To this end, some medium and large IVD distributors have chosen to transform into upstream manufacturers, leveraging the Medical Device Registrant system and industrial platforms to rapidly produce their own reagent brands, thereby retaining greater control over their operations. However, in the course of this transformation, IVD distributors generally face three major hurdles—R&D, production, and regulatory registration—making the process fraught with challenges.

Creating an open industry ecosystem and seeking broad-based collaboration across reagents, instruments, technologies, and total solutions represents a potential opportunity for small and medium-sized IVD manufacturers.

Based on this, FAPON BIOTECH has emphasized the advantages of its open-platform ecosystem for collaboration in the IVD industry. By integrating its own resources in technology, industry, and distribution channels, the company can offer partners a range of collaborative models, including high-quality raw materials, reagent development, innovative instruments, technology transfer, and comprehensive solutions.

For instance, although FAPON BIOTECH does not manufacture magnetic beads—a core raw material required for chemiluminescence immunoassays (CLIA)—it leverages over 20 years of accumulated expertise in the foundational R&D of antigens and antibodies, along with proven experience and technical capabilities in coupling bioactive raw materials to magnetic beads and comprehensive development of chemiluminescent reagents. By collaborating with strategic magnetic bead partners and integrating FAPON’s strengths, the company helps create more competitive products and technological solutions. This approach addresses the combined needs of midstream CLIA enterprises for performance, cost-effectiveness, and efficiency in reagent R&D, thereby achieving a triple-win outcome for chemiluminescence customers, magnetic bead partners, and FAPON BIOTECH.

A new industrial ecosystem platform featuring openness over closure, collaboration over competition, and symbiosis over dependency, achieving multi-party win-win outcomes., we can join hands with the industry to counter import monopolies, break through intra-industry involution and challenges posed by centralized procurement, truly achieve high-quality domestic substitution for chemiluminescence, propel more Chinese IVD enterprises to the center of global competition, and make precision diagnostic technologies more accessible.

Global competition is both ruthless and realistic. FAPON BIOTECH’s open ecosystem can drive collective industry growth and accelerate the rise of China-made IVD solutions. We also look forward to witnessing a thriving domestic IVD landscape characterized by mutual support and a proliferation of innovative products.