Sichuan Provincial Pharmaceutical Enterprises Import And Export Alliance Held Its Second Sponsor Meeting
Group to go to sea Sichuan sets up a pharmaceutical enterprise import and export alliance
The Sichuan Pharmaceutical Enterprises Import and Export Alliance was formally established
The Sichuan Pharmaceutical Enterprises Import and Export Alliance held a communication and coordination meeting
Reform raw material management and encourage technological innovation-the "Regulations" escort the innovation and development of the industry
The heads of the Ministry of Justice, the State Administration of Market Supervision, and the Food and Drug Administration answer reporters’ questions on the Regulations on Supervision and Administration of Cosmetics
Notice of the Comprehensive Department of the State Food and Drug Administration on matters concerning the registration of licensed pharmacists in deeply impoverished areas such as "three regions and three states"
Notice of the Sichuan Provincial Drug Administration on Launching Special Rectification Actions for Drug Online Sales Violations
2020 Medical Device "Clear Network" Action Work Plan
Notice of the Office of the Sichuan Provincial Drug Administration on Issuing the Implementation Plan for the Quality Supervision and Sampling Inspection of Sichuan Pharmaceutical Packaging Materials in 2020
Notice of the Comprehensive Department of the State Drug Administration on Doing a Good Job in the Supervision and Administration of Drug Exports During the Period of Epidemic Prevention and Control
The General Administration of Market Supervision announced the "Measures for the Administration of Drug Registration" and "Measures for the Supervision and Administration of Drug Production"
The State Food and Drug Administration issued 5 standards including the "Basic Data Set for Drug Marketing Authorization Holders and Manufacturers"
Notice of the Comprehensive Department of the State Food and Drug Administration on Carrying out the Special Inspection Work of Nationally Organized Drug Centralized Procurement and Use
Development status and thinking of medical device industry in China
- Categories:Alliance News
- Time of issue:2021-11-18
Development status and thinking of medical device industry in China
- Categories:Alliance News
- Time of issue:2021-11-18
If a worker wants to do well, he must sharpen his tools first. As an important tool of modern medical treatment, medical devices play an extremely important role in disease prevention, diagnosis and treatment. They are the basic equipment in the construction of China's medical and health system. Their strategic position has been highly valued by countries all over the world.
At present, the market scale of China's medical device industry has reached 730 billion yuan and will continue to grow in the future. With the increasing demand for medical security, people put forward higher requirements for the construction of medical and health technology, products and system, including medical devices. This paper takes you to the field of medical devices in China to understand the current situation and future development trend of medical device industry.
01 overview of medical device industry
Medical devices refer to instruments, equipment, instruments, in vitro diagnostic reagents and calibrators, materials and other similar or related articles directly or indirectly used in human body, including required computer software; Its effectiveness is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or although it is involved in these ways, it only plays an auxiliary role.
Medical devices are mainly used for:
1. Diagnosis, prevention, monitoring, treatment or remission of diseases;
2. Diagnosis, monitoring, treatment, remission or functional compensation of injury;
3. Inspection, substitution, regulation or support of physiological structure or physiological process;
4. Life support or maintenance;
5. Pregnancy control;
6. Provide information for medical or diagnostic purposes by examining samples from the human body.
High end medical devices, including orthopedic fixed implant materials, artificial joints, intraocular lenses, implantable cardiac pacemakers, artificial heart valves (biological and mechanical valves), cardiovascular stents, interventional medical catheters and other polymer implant consumables, as well as large-scale diagnosis and treatment equipment, such as CT machines and nuclear magnetic resonance instruments. High end medical devices have the characteristics of wide variety, complex models and high price risk. Their quality and function directly affect the user's physical recovery and even life safety. Any potential risk may cause extremely serious consequences.
02 market scale of medical device industry
1. The global market is expected to maintain stable growth
In recent years, with the improvement of global residents' living standards and the enhancement of medical care awareness, the demand for medical devices has continued to grow. In 2020, the market scale of the global medical device industry was USD 477.4 billion, with a year-on-year increase of 5.63%. It is expected that the scale of the global medical device industry will reach nearly USD 600 billion by 2024, with a compound growth rate of 5.6% from 2017 to 2024. The industry is expected to maintain stable growth.
2. China's market has large development space and fast growth
The domestic medical device market will maintain a growth rate of 20%, with huge market space in the future. The proportion of per capita consumption of medical devices and drugs in China is only 0.35:1, which is far lower than the global average of 0.7:1, and even lower than the level of 0.98:1 in European and American developed countries. Because of the huge consumer group, the increasing demand for health and the active support of the government, the development space of China's medical device market is very broad.
China's medical device market has performed prominently in recent years. By 2020, the scale of China's medical device market was about 734.1 billion yuan, a year-on-year increase of 18.3%, close to four times the growth rate of global medical devices, and maintained at a high growth level. China has become the world's second largest medical device market after the United States. It is estimated that in the next five years, the average annual compound growth rate of the market scale in the device field will be about 14%, and will exceed trillion by 2023. From the comparison of medical device market scale and drug market scale, the global medical device market scale is roughly 33% of the global drug market scale, and the proportion in China is only 12%.
According to the statistics of flint creation data platform, by the end of December 2020, the number of national medical device manufacturers had reached 30047, an increase of 66.24% over the end of 2019. Among them, 15924 enterprises can produce class I products, 13813 enterprises can produce class II products and 2310 enterprises can produce class III products. From 2015 to 2019, China's medical device industry disclosed a total of 1733 investment cases, with a disclosed investment amount of 103.6 billion yuan. M & A is an important trend of China's medical device development in the future, which will promote the improvement of market concentration.
3. Focus on high-end, in vitro diagnosis, high-value consumables and imaging equipment are the most concerned key segments
From the top 10 segments of global medical devices, in vitro diagnosis is the largest segment in the current global medical device market. In 2018, the global in vitro diagnosis market sales reached US $52.6 billion, accounting for 13%, followed by cardiovascular, imaging, orthopedics, ophthalmology, etc. It is estimated that by 2022, in vitro diagnosis will continue to rank first in all segments with sales of US $70 billion. From the product structure of China's medical device market, imaging diagnostic equipment occupies the largest market share; The second is in vitro diagnosis, accounting for 14% of the market share; Low value consumables account for 13% of the market share; The remaining market share is occupied by cardiovascular, orthopedic and other devices. In terms of the market share of the segments, the segments with high market share are basically high-end medical devices with strong innovation, high R & D investment and relatively high industry barriers, such as molecular diagnosis and POCT sub domain products in in vitro diagnosis, stents, pacemakers and other implant intervention devices in cardiovascular field, Large imaging equipment in the imaging field and implantable high-value consumables in orthopedics and ophthalmology.
With the implementation of the national policy of encouraging innovative R & D and production of medical devices, localization of medical devices and import substitution, China's independently innovative medical devices will accelerate the emergence and realize the continuous breakthrough from the medium and low-end market to the high-end market. The subdivided fields dominated by in vitro diagnostic reagents, orthopedic medical devices, cardiovascular medical devices, medical imaging equipment and high-value consumables have become the focus of development encouraged by the state and industry investment.
03 analysis on the pattern of China's medical device industry
With the development of China's medical device industry, several medical device industry clusters and manufacturing development belts have been formed in China. The three regions of Guangdong, Hong Kong and Macao, the Yangtze River Delta and Beijing Tianjin Bohai Bay have become domestic medical device industry clusters. According to incomplete statistics, the total output value and total sales of medical devices in the three regions account for more than 80% of the national total. Because each region has different conditions, the three industrial clusters show different regional characteristics.
1. Guangdong Hong Kong Macao Dawan district (Shenzhen): highlight high-tech characteristics
Guangdong, Hong Kong and Macao Dawan district takes Shenzhen as the center, including Zhuhai, Guangzhou and other places. The development of medical devices in this region has experienced two stages. The first stage is the entrepreneurial stage: during this period, some entrepreneurs with adventurous spirit gathered here to engage in the R & D and production of new products; During this period, the state also invested heavily to establish several enterprises that had a great impact on the later development, such as Shenzhen Anke company; The electronic components, parts and related industries in Guangdong, Hong Kong and Macao Dawan district are relatively developed, and the price of electronic parts is relatively low; Electronic engineering engineers are gathered with advanced concepts and strong disassembly and design ability; The logistics industry is developed, and there are rich foreign products that can be used for reference. These characteristics make medical electronic products have a supporting processing foundation here and can develop rapidly.
Guangdong, Hong Kong and Macao Dawan district with Shenzhen as the center has obvious advantages in the R & D and production of comprehensive high-tech medical devices. Its main products include medical impact equipment such as monitor, ultrasonic diagnostic instrument and magnetic resonance instrument, as well as large-scale stereotactic radiotherapy equipment such as gamma knife and X knife, tumor hyperthermia equipment, etc. Among them, the total output value of Shenzhen medical device industrial zone is increasing at a rate of more than 30% every year, and the export trade is developing rapidly. Compared with other regions, the advantage of Shenzhen's medical device industry lies in its industrial foundation accumulated for many years in the fields of electronics, computer, communication and mechatronics. Shenzhen's modern medical device industry has gradually formed an intensive advantage by integrating its own high-tech achievements in these fields, coupled with the incentives of local government preferential policies, open mechanisms and markets.
In the past 30 years, Shenzhen medical device industry has developed rapidly. Now it has more than 600 medical device manufacturing enterprises and more than 1500 medical device operating enterprises, with an annual output value of more than 24 billion yuan and a product export proportion of more than 60%, becoming one of the most important medical device industry clusters in China. With the rapid rise of Shenzhen Special Economic Zone, Shenzhen has successfully completed the first industrial upgrading, and high-tech industry has become the core pillar of Shenzhen. In the late 1980s, the establishment of Shenzhen Anke High Tech Co., Ltd. marked the start of Shenzhen medical device industry dominated by high technology. Since then, a group of entrepreneurs have started a difficult entrepreneurial process in Shenzhen, and the best of them have grown into leading enterprises in the industry.
2. Bohai Rim region (Beijing, Tianjin and Hebei): the diagnosis and treatment industry cluster is eye-catching
The Bohai Rim region is mainly centered on Beijing, including Hebei Province and Tianjin. After entering the 21st century, with the rapid development of basic processing industry in other regions in China and the good development momentum of medical device industry around the Bohai Bay, including Tianjin, Liaoning and Shandong, one covers digital X-ray equipment (DR), magnetic resonance imaging system (MRI), digital ultrasound, medical accelerator, navigation and positioning equipment, respiratory anesthesia machine, orthopaedic equipment An enterprise group of cardiovascular equipment and other products is taking shape.
In the Bohai Bay Rim region, in addition to some large enterprises introduced, enterprises in the region can be divided into two categories:
One is the large enterprises with the background of state-owned enterprises. They have a certain industrial foundation, technology accumulation, scale advantages, large-scale production equipment and plants, etc. it was difficult for small and medium-sized enterprises to compete with them. However, because the state-owned enterprises are restricted by the system and mechanism, the innovation power of enterprises is not as good as that of private small and medium-sized enterprises.
The other is small and medium-sized innovative enterprises, which can usually seize the opportunity brought by technological upgrading, and make outstanding achievements in the field of digital medical equipment with the help of government policy support and their own scientific and technological capabilities. However, it is not easy to convert technical advantages into product advantages or brand advantages. Affected by many factors, enterprises that rely on technical advantages to enter the field of medical devices are facing severe challenges on how to achieve sustainable development.
The outward diffusion of R & D achievements with Beijing as the core is a prominent feature of the medical device industry around the Bohai Bay. Due to the high production cost in Beijing, many technical achievements have been transferred to other regions, especially to the Great Bay area of Guangdong, Hong Kong, Macao and the Yangtze River Delta. Tsinghua University, Peking University and Beijing University of Aeronautics and Astronautics have established branches in Shenzhen, and the Chinese Academy of Sciences has also established medical device research institutes in Shenzhen and Suzhou.
3. Yangtze River Delta: outstanding performance of small and medium-sized enterprises
The Yangtze River Delta is centered on Shanghai, including Zhejiang, Jiangsu, Anhui and other provinces. As we all know, Shanghai has a strong industrial foundation. In the era of planned economy, Shanghai medical device industry is regarded as the leader of China's medical device industry in terms of product quality and technology R & D.
The medical device industry cluster in the Yangtze River Delta has developed rapidly, with active small and medium-sized enterprises and obvious industrial characteristics. Disposable medical devices and medical consumables in the Yangtze River Delta account for more than half of the domestic market. Representative industries include ophthalmic equipment in Suzhou, medical ultrasound in Wuxi, microwave equipment and RF tumor hyperthermia equipment in Nanjing, MRI industry in Ningbo, etc. In addition to the high-tech medical device industry in Shanghai, the medical device industry cluster in the Yangtze River Delta has become an important base for medical device innovation, R & D and production in China.
The medical devices in the Yangtze River Delta, especially in Jiangsu and Zhejiang provinces, are also characterized by small and complete. The products include Ophthalmology, orthopedics, surgical instruments, disposable medical instruments and other aspects, basically covering the routine medical instruments required by the hospital. At present, the scale and output value of medical devices in the Yangtze River Delta account for the largest proportion in China. Jiangsu Province is the largest medical device production area in China. With the continuous promotion of the construction of scientific and technological innovation center in Shanghai, a number of emerging cutting-edge technologies and innovative products of medical devices have been introduced one after another, with broad development prospects.
04 comparison of medical device industry development between China and foreign countries
Development trend and thinking of medical device industry in the future
With the continuous progress of science and technology and the wide application of high and new technology in the field of medical devices, the development of medical devices has entered a new stage. Modern medical devices play an extremely important role in disease prevention, diagnosis and treatment. It is characterized by:
1. Technology integration
Medical device industry is a multi-disciplinary, knowledge intensive, capital intensive and technology integrated high-tech industry. With high scientific and technological content and strong innovation, it involves many disciplines such as medicine, computer, electronic information engineering, machining, biochemistry, automatic control and materials. It is one of the few industries with the most disciplines at present.
Many large-scale medical devices are the results of multi technology and multi-disciplinary cross integration, such as computed tomography (CT), MRI, emission computed tomography (ECT), positron emission computed tomography (PET), surgical robot, angiography machine, automatic biochemical analyzer and multi parameter and multi-functional bedside monitoring system, which are all comprehensive cross technology products.
2. Focus on supporting strategic emerging industries
With the progress of medicine and the continuous emergence of new technologies and new achievements, modern health undertakings have higher and higher requirements for medical equipment. Coupled with the fierce competition in the market, medical devices are highly sensitive to new technologies. Countries all over the world, especially developed countries, focus on supporting and developing medical devices as a strategic emerging industry.
3. High degree of automation and intelligence
With the development of computer and artificial intelligence technology, medical devices continue to develop in the direction of automation and intelligence. Automatic functions replace manual operation, and machine learning assistance even replaces manual diagnosis. For example, clinical testing has been replaced by large-scale testing equipment such as automatic biochemical analyzer and blood cell analysis system, The common characteristics of these equipment are: less samples and more inspection indicators.
Modern inspection equipment can automatically process and detect according to the set program, with accurate results and good repeatability. The emerging radiomics technology, through the method of machine learning, has been able to accurately locate and diagnose the lesion. Surgical robots and surgical navigation can achieve minimally invasive and accurate intervention, detection and surgical treatment.
4. High reliability and safety requirements
Medical devices act on human body, and their safety and effectiveness are directly related to human health and life safety. Therefore, it has very high requirements for its safety and effectiveness.
5. The quality continues to improve and the price gradually decreases
The application of advanced manufacturing technology and high-performance materials, large-scale automatic production and fierce competition in the market force manufacturers to constantly improve technology and reduce costs. Product performance and quality continue to improve, but the price gradually decreases.
6. Maintenance free design and one-time application
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