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Home > News > Pharma News > Domestic substitution is the most difficult one

Domestic substitution is the most difficult one

yaozh.com 2022-10-31

Although the high-end chip to form a neck, but for low-end products, our country still has the ability to solve, however, large-scale analysis and testing instruments and related software, the situation is completely different, once the overseas supply, scientific research will not be able to be carried out.

 

The CEO of a pharmaceutical company in Shanghai recently lamented that few of the analytical instruments used by pharmaceutical companies and hospitals are made in China. We should first develop and produce domestic alternatives to these instruments, such as dissolution meters, HPLC, GC, UV, LCMS, various particle size meters, rapid moisture meters, KF meters, leakage pressure meters, surface tension meters. The diaphragm valve, regulating valve and water trap used by pharmaceutical enterprises are imported; Temperature/humidity/flow/pH/conductivity meter/flow rate/pressure probe (Sensor), all are imported, all PLC controller is also imported. Looking forward to domestic temporary products!

 

The localization rate of scientific instruments is only about 5%, and the related application scenarios are not limited to biomedicine, involving nearly 70% of the national economy.

 

Among the TOP20 global instrument companies by market value in 2021, 12 are in the United States, and the top 4 are all American companies. Domestic scientific instruments listed companies, at a glance, weak, leading focus technology nearly a month up 45%, market value is still less than 20 billion yuan, the performance is a mess. Lebertyco launched its first self-developed mass spectrometer in May 2021, which is applied to the medical, pharmaceutical and semiconductor fields. It has not yet announced sales and performance has not improved.

 

From 2016 to 2019, among the more than 2 million scientific instruments purchased by the institutes affiliated to the Chinese Academy of Sciences, the proportion of domestic mass spectrometers, X-ray instruments, optical chromatographs, and optical displays was less than 1.5%, among which the domestic procurement rate of optical microscopes was 0. Domestic scientific instruments rarely sell more than 2 million yuan, while overseas brands are favored by the high-end market.

 

Time has not become the friend of domestic scientific instruments, and there is little progress in replacing imports.

 

According to the Instrument Information network, domestic scientific instruments are jammed in ten aspects.

 

The chromatographic

 

HPLC units such as infusion pump, autosampler, detector and international brands have a certain gap. High pressure sealing ring, high precision and high stability pressure sensor, high precision ball screw in HPLC high-pressure pump unit; Ultra-high pressure six-way valve, sampling needle, ultra-fine capillary tube in the autosampler unit; The technology of planar field grating, diode array photoelectric sensor and fiber flow cell in the detector unit is still a challenge for domestic enterprises. The key components of the thin-layer chromatograph basically rely on imports, including chips (especially digital-to-analog conversion chips), photomultiplier tubes for detectors, highly stable light sources, gratings, and operating systems, and some raw materials, moving parts, motors, and sensors are more dependent on imports.

 

Chromatography software that complies with regulations, has complete functions, and can be deployed on the network is basically blank in China.

 

Domestic chromatographic columns have a global market share of only 2% and a domestic market share of only 20%. At present, the fillers used in domestic chromatographic columns or the raw materials of microspheres for the production of fillers, silanization reagents and empty column tubes are mostly dependent on imports, and the column tubes and sieve plates related to chromatographic columns, especially those suitable for small particle size loading, are also mostly imported.

 

The high performance liquid chromatography (HPLC) instruments necessary for the development and production of liquid chromatography columns are mostly dependent on imports. These challenges prevent the industrial chain from becoming a closed loop, which seriously affects the process of high-end localization of chromatographic columns.

 

Mass spectrometry

 

Mass spectrometry such as Orbitrap, FT-ICR, IT-TOF, TOFTOF and Magnetic MS are basically blank in China.

 

ICP-MS of inductively coupled plasma mass spectrometer is almost 100% imported, and ICP-MS used in the semiconductor industry is completely dependent on imports.

 

spectrum

 

The core components of small Raman spectrometer and fiber spectrometer, including grating, CMOS high-performance detector and high-performance filter, are still dependent on imports. Laser tube internal light emitting chip, ARM chip, FPGA chip, high-performance AD chip are dependent on imports.

 

High resolution, wide spectrum Fourier infrared spectrometer and vacuum Fourier infrared are still domestic short plate at present. The core chip, part of the infrared detector and the wide-spectrum optical crystal may be jammed.

 

Experimental equipment for mechanical properties

 

New material testing equipment: composite material mechanical properties characterization test system; In the field of biomedicines, from orthopedics and dentistry to heart stents and valves, it is difficult for domestic devices to meet the requirements of relevant test standards. Some special new materials need to test the mechanical properties of materials in high temperature, high pressure, vacuum or corrosion environment. This kind of professional equipment is also mainly imported equipment.

 

Dynamic testing machine: strain fatigue system. Most of the fatigue test equipment in China can only do ordinary stress fatigue test at present. Multi-axis fatigue system. The main manufacturers of this kind of high-end testing machine are almost all European and American manufacturers and are the main products banned in our country.

 

Scanning electron microscopy (sem)

 

Why is the market share of domestic SEM so small that it is difficult to break through the technical barriers?

 

Zeng Yi, vice president of Shanghai Society of Microscopy, has put forward three reasons: the production of high-quality electronic optical systems is difficult, the planning of the detector in the lens is difficult, and the demand for low-voltage resolution is difficult to break.

 

The PCR instrument

 

PCR: Take the PCR instrument as an example, at present, some parts and components used in the gene amplification instrument such as MCU microcontroller, AD converter and other chips, semiconductor refrigeration chips are mostly imported devices, and have not been completely replaced by domestic.

 

Digital PCR: So far, more than 90% of the global digital PCR market share is in the hands of 1-2 imported brands. From the point of view of technology, the design and processing of optical and biological chips are the key technologies that have jammed in China in the past few years.

 

Laser particle size meter

 

Electronic components are the "fragile key part" of domestic scientific instruments. Laser particle size instrument to use the laser diode, part of the analog integrated circuit, single chip microcomputer, need to be imported.

 

Industrial design software

 

The industrial design software used in the product design process, For example, KEIL MCU microcontroller software Design platform, Altium Design PCB board design software, Solidworks structural design 3D software, and Photo Shop/Illustrator /CorelDRAW graphic design software are developed by foreign companies. There is no better domestic software to replace.

 

Laboratory equipment

 

Industry generally reflect the domestic parts of carbon dioxide concentration sensor, humidity sensor and built-in fan of pH sensors, security protection equipment, cell culture equipment of electromagnetic valve, pump, there is a different level or insufficient accuracy, linear range, narrow, or working poor stability, short service life, or the problem of weak gas tightness, running noise. If we want to ensure the quality of biological instruments, we need to spend several times or even dozens of times the cost to buy imported components.

 

Laboratory general equipment bottle washing machine is currently stuck in the neck of the main chip, memory, design software and control system software, high precision and high stability pressure sensor, temperature sensor, pharmaceutical grade valve, low head high flow circulation pump, there is no way to achieve domestic replacement.

 

Core components and components

 

High resolution grating of molecular spectrum, high performance electron multiplier, turbomolecular pump of mass spectrum, high precision mass analyzer, ultracentrifuge rotor and special precision sensors of various instruments rely heavily on imports.

 

The neck is jammed with chips, high-precision pumps, various valve bodies, magnetron, frequency conversion board, plunger rod, one-way valve, sealing ring, stepping motor, light source, grating, PMT, degging machine.

 

In the mass spectrometric quadrupole, ion source and other parts that need precision machining, the material selection and finishing technology level still have a gap compared with foreign countries.

 

In most areas of biotechnology, the home-grown alternatives that are being played out magnificently may not be seen in scientific instruments.

 

Domestic scientific instruments start not too late. Our country began to develop the transmission electron microscope from the early 1950s, and the first domestic transmission electron microscope was born in Shanghai Xinyue Instrument Factory in 1959.

 

However, in the later period of geopolitical easing, it is better to build than to buy, time is money, basic research is not taken seriously, independent research and development of scientific instruments lags behind, and forms a path dependence on overseas.

 

High performance liquid chromatography (HPLC) is used for more than 2000 kinds of detection in the Chinese Pharmacopoeia. If you want to choose the most important detection equipment in a pharmaceutical company, it is probably the HPLC.

 

HPLC has already been made in China, but it is hardly used by pharmaceutical companies. Some experts complain that many parameters in the Chinese pharmacopoeia are bound to imported equipment, only to say that they must be used, resulting in the delay of domestic scientific instruments and equipment.

 

The development of large-scale scientific instruments and equipment involves a large number of basic research, and is also related to many key high-end manufacturing technologies. It is a systematic project involving many interdisciplinary disciplines and requires scientists in various fields to work together to solve problems.

 

Domestic scientific instruments listed companies do not have a king, can not bear such a grand historical task. Concentrating technology research and development expenses in the first half of the year accounted for 22.7% of the revenue, has been used to eat milk strength, but only 300 million yuan.

 

In 2020, there were 4906 instrument enterprises in China, with an average income of about 150 million yuan per main business, low concentration and poor anti-risk ability. Private companies are only willing to do low-end, small products with fast capital return. The state-owned biomedical enterprises have basically not involved in the field of instruments and equipment and key reagents and consumables. Some domestic enterprises are providing spare parts services for overseas scientific instrument manufacturers, but the distribution is wide and the industrial chain has not been formed.

 

Last year, LAN Minbo, a professor at East China University of Science and Technology, called for a nation-wide system to promote the development of large-scale scientific instruments.

 

Domestic mainstream scientific instrument enterprises have layout in sample pre-processing, spectroscopy, chromatography, mass spectrometer, and their advantages lie in cost-effective and customized services. They have generally entered the critical period of volume expansion and achieved local breakthroughs.

 

The ICP-MS/MS of Focus Technology has been sold in the upstream of semiconductors and verified in chip manufacturing enterprises. Hundreds of special gas alarms have been domestically replaced in chip and panel manufacturing enterprises. Sequoias led investment subsidiary Spectrum Poly Medical, clinical mass spectrometry domestic substitution accelerated, liquid chromatography tandem mass spectrometry system had no domestic ability, import prices up to 2.5 million to 4 million yuan per unit. Spectrumpoly Medical liquid was approved to fill the gap of domestic liquid production.

 

LabMS 3000 mass spectrometer has realized the application of domestic ICP-MS in the chip production line of semiconductor industry for the first time. On this basis, we continue to develop ICP-MS-MS with higher precision, aiming to achieve the complete domestic replacement of triple quadrupole inductively coupled plasma mass spectrometry in the semiconductor and non-ferrous metal industries.

 

The single particle aerosol time-of-flight mass spectrometer represented by the SPAMS series products of Hexin Instrument is in line with many indicators of foreign companies, and its resolution is up to 1000+FWHM, and the innovative bipolar Z-type structure.

 

Wan Instrument science and technology in the development of online ion chromatography combined with advanced high efficiency and high stability ion chromatography technology, has reached the international advanced level; The intelligent ultra-high performance liquid chromatoscope under research overcomes the technology of ultra-high pressure linear motor pump, and the expected maximum working pressure and flow precision of the product even exceed the technical indicators of foreign brands on the market.

 

In the electronic measuring instrument industry, a few domestic enterprises, represented by Dingyang Technology, Puyuan Precision Electronics and Guwei Electronics, have reached the international advanced level in some fields and have the research and development and production capacity of related mid-end products.

 

Inch work, millimeter change.

 

Domestic scientific instrument manufacturers, there is still some room for growth in the long run, equipment discount loan can promote scientific instrument purchase orders, the first half of next year will be improved, but the logic of bigger and stronger still need to wait to build.

 

Compared with scientific instruments, domestic alternatives in medical devices are much smoother. Referring to the rebound process of the orthopedic track, the beta market of the medical device industry is sustainable after the cost control suppression is lifted or eased. The starting point of orthopedic rebound was roughly in sync with the landing time of artificial joint collection. After the marginal recovery of performance and the marginal improvement of spinal collection, the rebound time has reached half a year. Medicine rebound will also achieve plate rotation, today's medical service plate rose against the trend, leading Aier ophthalmology, Tongce medical, golden area medical is at the bottom of the range. China Securities Healthcare ETF(516790) is the perfect choice to cover these two high-boom sectors at the same time, with medical devices accounting for 70% and medical services accounting for 30%. Index FUND IS THE BEST set investment variety, can reflect the essence of medicine long cattle, the current market volatility is large, can insist on set investment, obtain long-term benefits.

Disclaimer: ECHEMI reserves the right of final explanation and revision for all the information.

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