The Market for Flow Cytometry Is Experiencing Rapid Growth, With Sustainable Monoclonal Antibody (mAb) Development Capabilities Being Key

Flow cytometry plays an irreplaceable role in the analysis of basic scientific research and in the diagnosis and treatment of certain diseases.

 

Flow cytometry plays an irreplaceable role in the analysis of basic scientific research and in the diagnosis and treatment of certain diseases. It has high technological barriers in research and production, and can be applied to different detection needs by mounting various reagents on instruments, making it a platform technology that can sustainably develop a series of applications.

 

Flow cytometry refers to an efficient cell sorting technology that quantitatively analyzes and sorts cells, biological particles, and soluble biomolecules simultaneously in a rapid linear flow state.   It provides multi-parameter, high-precision, and fast quantitative analysis and sorting, enabling the determination of disease types and severity, including infections, tumors, and blood disorders.

 

Flow cytometry consists of two main components: flow cytometry reagents and flow cytometers.   Flow cytometry reagents bind specifically to cell surface markers using monoclonal antibodies (mAbs) labeled with fluorophores.   This involves critical steps such as cell line development, antibody purification, and fluorophore conjugation.   Due to the high specificity and affinity required for antibodies targeting antigen clusters on live cell surfaces, and challenges such as low yields and antibody aggregation, the production of flow cytometry reagents involves complex screening processes with low success rates and high costs.

 

Flow cytometers are devices used for automated analysis and sorting of cells based on the detection of fluorophores bound to cells.   Their development involves optics, electronics, fluid dynamics, immunology, and software, with high demands on the design and production of optical components and fluid control systems.

 

 

Despite the high barriers to entry compared to other immunological detection technologies, flow cytometry has accumulated a strong scientific research foundation over nearly a century of development and is expanding towards large-scale applications.   Flow cytometers can be adapted to different detection needs by using various reagents, making it a platform technology capable of continuous application development.

 

There is a significant disparity between domestic and foreign reagents in the reagent sector.   The reagent market is dominated by a few multinational companies such as BD, Beckman, and BioLegend, with domestic flow cytometry products accounting for less than 5% of the overall market in China, primarily due to weak capabilities in developing core mAb raw materials.   The stringent requirements for cell lines as sources of flow cytometry antibodies have limited domestic companies to a few cell lines obtained through academic collaborations, with ongoing challenges in funding, investment cycles, and research risks hindering the establishment of sustained cell line development capabilities.   As a result, most reagents used in the domestic market are imported from foreign companies in purified or labeled bulk forms, repackaged, and sold domestically.

 

High prices and ongoing price increases of imported products have squeezed profit margins for distributors, particularly after the implementation of Diagnosis Related Groups (DRG) and Drug Injection Policies (DIP), benefitting neither distributors nor hospitals.   Consequently, there is an urgent market demand in China for domestically produced flow cytometry reagents that offer good performance at reasonable prices.

 

There exists substantial unmet market demand for flow cytometry testing in China, with sufficient accumulated scientific research to support its widespread adoption.   The technology is at a turning point towards large-scale clinical applications.   Therefore, the time is ripe to invest in domestically produced alternatives for flow cytometry products, with a particular focus on the development of cell lines as raw materials, which is fundamental for companies seeking to establish themselves in this market.