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Policy-led High-quality Development of Domestic Mass Spectrometry Industry

2022-08-08

To promote the high-quality development of the domestic mass spectrometry industry, the state has consistently strengthened policy support in recent years. The Guideline for the Development of Key Generic Technologies in Industry clearly lists "mass spectrometry analysis and detection technology" as key generic technologies in the industry with characteristics of application basis, relevance, system, and openness, and prioritizes their development. The Classification of Strategic Emerging Industries lists "Experimental Analysis Instruments Manufacturing" into the "High-end Equipment Manufacturing Industry" industry category. The Work plan for Strengthening the ‘0 to 1’ basic research will strengthen the design and development of major scientific and technological infrastructure and high-end general scientific instruments, focusing on high-end general and professional research and development of major scientific instruments and equipment and engineering and industrialization research, and promote the rapid development of the industrialization of high-end scientific instruments and equipment. the "14th Five-Year Plan" clearly proposes to strengthen research, development and manufacturing of high-end scientific research instruments and equipment. In recent years, the Ministry of Science and Technology has continued to increase research and development investment in the mass spectrometry industry, and is collaborating with domestic first-class scientific research instrument enterprises. The Ministry aims to develop the layout for high resolution and tandem mass spectrometry in domestic fields that are lacking such technologies and is focused on diversified and high-end research and development directions.


Government procurement policy is expected to break the bottleneck of imported mass spectrometry. The positioning of mass spectrometry focuses on quality and light cost, which cannot be directly replaced by cost and efficiency advantages. In the domestic mass spectrometry market, 40% of the demand is met through government procurement, including hospitals, research institutes, government agencies, etc. In December 2021, the government passed the Science and Technology Progress Law, which clearly states that: 1) for scientific and technological innovative products and services, the government shall procure the same under the condition that their functions, quality, and other indicators meet the needs of government procurement; 2) if such products and services are put on the market for the first time, government procurement shall take the lead in purchasing them, and shall not restrict them on the basis of commercial performance; 3) if the products purchased by the government have yet to be studied and developed, they shall be implemented by ordering. In May 2021, the proportion requirements for government agencies (institutions) to purchase domestic medical devices and instruments were clearly stipulated, such as in the serial number 203 high-performance liquid chromatography tandem mass spectrometer audit, which recommended that the proportion of domestic products to be procured was 25%.



Since the 1980s, as foreign mass spectrometer manufacturers attracted most of the mass spectrometer talents in China to carry out sales and after-sales service of their mass spectrometer products, the development of the domestic mass spectrometer industry had almost come to a standstill. The research and development by domestic analytical instrument manufacturers in the mass spectrometer product field had entered a vacuum for nearly 20 years, and domestic manufacturers consistently lagged the international level in engineering design and comprehensive production processes. The research and development of mass spectrometry products with zero basic layout requires a cycle of about 8 to 10 years; it involves integrating multi-disciplinary talents and realizing the R&D breakthrough from theoretical design to engineering design, as well as comprehensive production processes. With the advent of the 21st century and the rapid growth of the mass spectrometer market, colleges and universities, scientific research institutes, and returned talents have accelerated the research and development of mass spectrometers domestically, making breakthroughs in the core technologies of mass spectrometry and core components such as mass analyzers, in recent years. In 2006, the first domestic commercial quadruple GC-MS instrument was launched, which marked the market entry of domestic mass spectrometry instruments.



At present, mainstream mass spectrometer categories have been commercialized, including single quadruple, ion trap, and time-of-flight mass spectrometry, and the autonomous and controllable production of triple quadrupole can be realized, with a coverage rate at the corresponding market end exceeding 80%. In July 2019, the first batch of 2011 National Special Project for Major Scientific Instrument and Equipment development (2011YQ060084) was completed. "The development of triple quadrupole tandem mass spectrometry system and its application in trace organic analysis (2011YQ060084)," completed the comprehensive acceptance. The project focuses on the national "Twelfth Five-Year Plan’s" scientific and technological development plan, and addresses the needs for high-throughput, high-sensitivity, and automatic detection of trace organics in complex systems through the development of a special project, the triple quadrupole tandem mass spectrometry system, an automated preprocessing devices, and other key components, and a trace organics analysis platform based on the triple quadrupole tandem mass spectrometry system. The project will develop an analysis platform based on the triple quadruple tandem mass spectrometry system, conduct research and application demonstration in the fields of proteomics, metabolomics, environmental and ecological toxicology, food safety, etc., and realize the localization and industrialization of the triple quadrupole tandem mass spectrometry system.


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