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Research Report on the Development of Medical Device Industry in China

Release time:

2018-08-08

The life cycle and industry size of the 1. industry.

Development History and Current Situation of Medical Device Manufacturing Industry in China in (I)

China's medical device market demand has continued to grow in recent years, and there is still much room for growth in the future. In recent years, the development and investment of China's medical device industry has been relatively active. The national strategic emerging industry policy orientation and the upgrading demand of domestic medical and health institutions will make the future medical device consumption market continue to grow.

In the past 13 years, the sales scale of China's medical device market has increased from 17.9 billion yuan in 2001 to 212 billion yuan in 2013. Excluding the influence of price factors, it has increased by 10.84 times in 13 years. According to the sample survey statistics of the Medical Devices Branch of the China Pharmaceutical (17.33,1.580,10.03) Materials Association, the national medical device sales scale in 2014 was about 255.6 billion yuan, up 43.6 billion yuan from 212 billion yuan in 2013, a growth rate of 20.57.

The consumption ratio of global medicine and medical devices is about 1:0.7, and developed countries such as Europe, America and Japan have reached 1: 1.02. The global medical device market has occupied 42% of the total scale of the international pharmaceutical market, and has the potential to expand. In 2014, the total size of China's medical device market is about 255.6 billion yuan, the total size of the pharmaceutical market is expected to be 1,332.6 billion yuan, the ratio of medicine and medical consumption is 1:0.19, and the ratio of medicine and medical consumption in 2013 is 1:0.2. It is expected that the future medical device market will still have a broad space for growth.

The number of medical device manufacturing enterprises in China is increasing year by year: 14337 in 2010, including 4015 first-class medical device manufacturing enterprises, 7906 second-class medical device manufacturing enterprises, 2416 third-class medical device manufacturing enterprises, and 1863 national and provincial key regulatory enterprises. By the end of November 2012, the number of medical device manufacturers nationwide had rapidly increased to more than 16000, with state-owned enterprises, foreign-funded enterprises, joint ventures and private enterprises accounting for 3%, 37% and 60% respectively. Among them, there are more than 200 enterprises with an output value of more than 100 million yuan; less than 20 enterprises with an output value of more than 1 billion million yuan, and foreign-funded enterprises and joint ventures account for the vast majority. Statistics in 2011 show that foreign investors and Hong Kong, Macao and Taiwan-invested enterprises constitute the main force of China's medical device industry, and their assets account for 43% of the total assets of China's medical device industry.

There are many domestic medical device manufacturing enterprises, and the market concentration is low. According to the geographical distribution, the domestic brand medical device industry in the eastern and southern coastal areas represented by Shanghai and Shenzhen presents the characteristics of "many, small, high and weak": first, there are many manufacturing enterprises. By the end of 2013, there were 15698 medical device manufacturing enterprises in China; the second is the small scale of enterprises, in 2013, the total output value of the medical device industry market was 212 billion yuan, with an average output value of about 13.5 million yuan per enterprise, an increase of 1.5 million yuan or 12.5 percent over the previous year. The third is the high concentration of products, with more than 3,500 kinds of medical device products, with an average of more than 10 registration certificates for each product. The fourth is relatively weak in technical level compared with internationally renowned brands. In recent years, with the continuous progress of China's technical level and the continuous enhancement of the manufacturing capacity of precision manufacturing and mechatronics equipment, China's medical device industry has developed rapidly.

From 2000 to 2012, the size of the medical device industry increased by an average of more than 20% per year. In 2012, the scale of my country's medical device market has exceeded 150 billion billion yuan, and China has become a major medical device producer in Asia and one of the top ten emerging markets for global medical devices. In the next few years, China will surpass Japan to become the world's second largest medical device market.

Generally speaking, medical device listed companies have certain scale advantages, but the industrial concentration is still not enough: in 2014, the annual sales revenue of 20 listed companies engaged in medical device production and operation is estimated to be 37.2 billion yuan, accounting for 14.55 of the total sales of the industry. From the perspective of geographical distribution, China's medical device industry is concentrated in the eastern and southern coastal areas. The Yangtze River Delta region represented by Shanghai and Jiangsu and the Bohai Bay region represented by Beijing are mainly to attract investment, with foreign-funded enterprises as the main body to form advantageous industrial clusters.

The Yangtze River Delta region has an absolute advantage in the country with disposable injections and infusion sets; CT machines represented by General Electric in Beijing have an absolute advantage; Shenzhen's medical device industry has grown from scratch, in just over 10 years, Has developed into an important manufacturing and processing base for my country's high-end medical device industry, medical imaging diagnostic equipment, patient monitors and other products also occupy a place in the international market, and the development momentum is strong.

(II) industry enterprise development space

According to the "2011 China Medical Device Industry Analysis and Development Prospect Forecast Report" released by Shangpu Consulting, it is estimated that by 2015, China's entire medical device and equipment market is expected to be nearly 340 billion yuan. At present, global medical devices account for 42% of the total size of the pharmaceutical market, while China's medical devices account for 14% of the total size of the pharmaceutical market, the market has great potential for development. According to the statistics of the Medical Device Branch of the China Medical Materials Association, as of December 2013, there were 15700 domestic companies holding medical device production licenses, of which more than 35 medical devices were listed at home and abroad. Domestic medical device registration certificate of medical devices 93,592 kinds, basically the same year-on-year, to obtain medical device registration certificate of imported medical devices 34,655 kinds.

my country implements a registration system for medical devices. The 2013 "Drug Administration Statistics" published by the State Food and Drug Administration in November 2014, the number of re-registration of Class I and Class II medical devices increased significantly that year. Among them, the number of Class I re-registrations was 3,738, up 36.47 percent from 2,739 the previous year. Class II re-registrations reached 5,801, up 75.79 percent from 3,300 the previous year.

China's policy orientation to promote the development of digital medical equipment and localization is very clear. According to the "Twelfth Five-Year" National Independent Innovation Capacity Building Plan issued by the State Council, the "Twelfth Five-Year" National Strategic Emerging Industry Development Plan issued by the Ministry of Industry and Information Technology, the "Twelfth Five-Year" Development Plan for the Pharmaceutical Industry, and the "Twelfth Five-Year" Science and Technology Development Plan issued by the Ministry of Science and Technology, advanced medical devices are important industries related to the national economy and people's livelihood, it is a key area of strategic emerging industries that my country vigorously develops and cultivates. During the "Twelfth Five-Year Plan" period, my country vigorously promotes the development of core components, key technologies, and the development of mid-to-high-end products of medical imaging equipment, and cultivates strong independent innovation capabilities. The backbone of the company will improve the level of localization of equipment and improve the international competitiveness of my country's medical device industry. The company's series of products are focused on the development of products.

Since 2014, the relevant national regulatory authorities have taken active measures to create a good development environment for the medical device industry: in 2014, the State Food and Drug Administration launched a five-month "five rectification" special action, focusing on the five behaviors of false registration and declaration of medical devices, illegal production, illegal operation, exaggerated publicity and use of unlicensed products, which effectively regulated the market, it is conducive to the healthy development of the medical device industry; in March 2015, the Ministry of Science and Technology issued the ''Digital Diagnosis and Treatment Equipment Key Special Implementation Plan (Draft for Comment) ''. From 2015 to 2020, the main tasks for the development of the medical device industry are major equipment Research and development, frontier and common technological innovation, application solution research, application demonstration and evaluation research.

After the promotion and development during the "Twelfth Five-Year Plan" period and the guidance and foreshadowing of domestic industrial policies, my country will further increase the policy and investment in the digital diagnosis and treatment equipment industry in the future. During the "Thirteenth Five-Year Plan" period, the digital diagnosis and treatment equipment industry will achieve breakthroughs and With harvest, domestic digital diagnosis and treatment equipment will continue to develop rapidly in the future.

Medical imaging diagnostic equipment belongs to medium and high-end medical equipment, which mainly provides important guarantee for clinical diagnosis and treatment, and also provides an important platform for clinical scientific research. Commonly used medical imaging diagnostic equipment includes: X-ray machine, magnetic resonance imaging (MRI) equipment, Computed tomography (CT) equipment, etc.

2014 is an important year for the transformation of the domestic medical imaging diagnostic equipment industry. Strong support at the national strategic level, the introduction of a series of new policies to promote domestic hospitals to use domestic equipment instead of imported equipment, coupled with their own technology, talent and capital accumulation, domestic medical imaging diagnostic equipment enterprises are facing major development opportunities. It is expected that in the next few years, the process of localization of medical imaging diagnostic equipment will accelerate, driving the rapid expansion of the market scale of domestic enterprises.

2. industry competition pattern and industry barriers

(I) industry competition pattern

According to the business scale and market share, the medical imaging diagnostic equipment manufacturers in the domestic market can basically be divided into three echelons, and the company is located in the second echelon. The first echelon is multinational medical device companies, including Philips, General Electric, Siemens, etc.; these companies have high R & D, integration and sales capabilities for software products and hardware equipment. In addition to covering major medical imaging diagnostic equipment, The product line has also made many achievements in other types of medical device products. At present, the first echelon of multinational medical device enterprises occupy China's medical imaging diagnostic equipment market is higher.

The second echelon is domestic excellent medical device enterprises including Lan Yun, An Jian Technology, Wandong Medical, Yu Yue, Meirui Medical, New Huangpu (12.30,-1.370,-10.02) and United Film Medical. The brands and technologies of such enterprises are becoming more and more mature, and their product quality and performance are comparable to those of imported equipment. They are welcomed by more and more medical units with high cost performance and high-quality after-sales service. They are the main competitors in the industry, and the products are changing from the analog era to digital. Our company is a digital product, and its comprehensive competitive strength ranks eighth in the selection catalogue of excellent domestic equipment.

The third echelon is mainly a large number of small-scale medical device manufacturers with weak technical capabilities, low-end products and weak competitiveness.

(II) industry entry barriers

New entrants to the medical device industry to achieve scale and compete with existing enterprises, there are mainly the following barriers:

1. Barriers to entry

Disposable medical device products cover Class I, Class II and Class III medical devices. The State Drug Administration implements a strict medical device manufacturing enterprise license and product registration system. New enterprises entering the industry need to pass the examination and approval of the provincial drug administration department and can only operate after obtaining the medical device manufacturing enterprise license and the medical device operating enterprise license, manufacturers in the industry must obtain a product registration certificate before they can produce and sell corresponding medical device products.

The audit requirements of medical device manufacturing enterprises are strict. Enterprises engaged in the production of Class II and Class III medical devices should have production equipment, sites and environments suitable for production requirements, and their production, quality and technical directors need to have qualified professional capabilities; in terms of medical device registration, enterprises applying for Class I medical device registration need to have qualified quality management capabilities and corresponding resource conditions, the full performance test report of the product should be provided, while the enterprises applying for the registration of Class II and Class III medical devices need to provide product technical reports, risk analysis reports, product performance self-test reports, clinical trial data and product registration test reports issued by medical device testing institutions. There are more stringent standards and management regulations in product trial production, registration inspection, clinical trials, registration declaration and other links.

Enterprises can only engage in the production of medical devices on the premise of meeting the requirements of the production environment, personnel quality, equipment configuration, etc., and the sales of various products need to complete a series of testing, analysis, clinical trials, and pass the premise of product registration, which has higher obstacles for new entrants.

2. Technical barriers

The medical device industry is a multi-disciplinary, knowledge-intensive, and capital-intensive high-tech industry. The industry products are high-tech products that integrate multiple disciplines such as medicine, biomechanics, medical materials, and machinery manufacturing. The accumulation of product know-how and the cultivation of scientific research and development ability is a long-term process, and the general enterprise can not be formed quickly in a short time. At the same time, the industry has extremely high requirements for the production environment, product manufacturing process and manufacturing equipment. The production and processing technology will directly determine the performance and use effect of the product, and directly affect the success rate of the operation. For most users, the main production equipment of the product is customized according to its own production process, and it is continuously optimized and improved in the long-term production process. It is difficult for enterprises that lack the required process equipment and long-term process technology experience to produce qualified products with stable quality.

3. Market channel barriers

The establishment of a nationwide sales network and after-sales service system requires a large amount of capital investment, and the maintenance of the sales and after-sales service network requires a large number of high-profit products as support; the bidding project conditions of the medical and health system are generally set high, requiring years of good Operating performance, product quality and a complete after-sales service network make it difficult for new entrants to enter the bidding market. Due to the characteristics of wide geographical coverage, high professionalism and scattered customers, companies in the industry generally adopt the business model of "distribution-oriented, direct sales-supplemented" to sell to end-users.

In addition to having certain financial strength and marketing ability, dealers also need to be able to provide professional services to end users and help doctors coordinate and solve the problems encountered in use. These dealers have basically carried out long-term and stable cooperation with the enterprises that have entered the industry in advance, and it is difficult for new enterprises to find a suitable dealer team in a short time.

In addition, the construction of a sound marketing network system requires not only a large amount of upfront capital investment, but also a long-term accumulated deep understanding and forward-looking grasp of the market, as well as the brand effect formed by constantly creating value for customers. New entrants can not cultivate strong marketing channels in a short time.

4. Talent barriers

The medical device industry is a high-tech industry. Medical device products integrate new technologies in various disciplines such as medicine, electronics, and automation control. Enterprises lacking technology and scientific research and development capabilities are difficult to enter. Core technical personnel need to have comprehensive knowledge of medicine, electronics, automation control, etc., as well as many years of practical experience in the same industry; sales personnel need to have knowledge of marketing, product performance, use and other aspects; these talents are difficult to train in a short period of time.

5. Financial barriers

The medical device industry is a high-investment industry. Without a certain scale of capital investment for product research and development and the establishment of sales and service networks, it is difficult for enterprises to survive in the market.

6. Brand Barriers

Medical devices are related to the life and health of users. Customers pay special attention to brands when choosing products. The brand effect accumulated by high-quality products for many years is an insurmountable obstacle for new entrants in the short term.

The relationship between the 3. industry and the upstream and downstream of the industry

The technological progress, enterprise growth and market expansion of the medical device industry are closely related to the upstream and downstream industries. Medical device products have high requirements for the quality of raw materials, and the demand for many varieties is complicated. The upstream of the medical device industry is materials, electronics, machinery, non-ferrous metals and other industries. The technological progress of the upstream industry will directly affect the technological trend of medical devices, such as upstream industry processing The manufacturing capacity determines the quality, technical level and cost of raw materials or semi-finished products.

The downstream of the medical device industry is mainly the final consumer, the product is directly used by consumers through hospitals and other medical institutions, consumer demand and consumption capacity determines the size of the market capacity, which affects and determines the market prospects and economic benefits of medical device products.

4. national regulatory regimes and policies for the industry

1, industry authorities, regulatory system and industry policies.

(1) Industry authorities and functions

The competent department of China's medical device industry is the State Food and Drug Administration. Its functions include: responsible for the draft of laws and regulations for the supervision and management of medical devices, formulating policy plans, formulating departmental regulations, and organizing the implementation, supervision and inspection; responsible for organizing the formulation and publication of medical Device standards, classification management systems, and medical device development, production, operation, and use quality management standards and supervision of implementation; responsible for the registration, supervision and inspection of medical devices, establish a monitoring system for adverse events of medical devices, and carry out monitoring and disposal work; responsible for formulating and organizing the implementation of the inspection system for the supervision and management of medical devices, and organizing the investigation and punishment of major violations. Establish a recall and disposal system for problematic products and supervise its implementation.

The State Food and Drug Administration is in charge of the supervision and administration of medical devices throughout the country, and the food and drug supervision and administration departments of local people's governments at or above the county level are responsible for the supervision and administration of medical devices in their respective administrative regions.

(2) Industry regulatory system

The medical device industry is one of the national key management industries. The National Development and Reform Commission is responsible for implementing industrial policies for the medical device industry, studying and formulating industry development plans, guiding industry restructuring and implementing industry management; the Ministry of Health is responsible for formulating health reform and development strategic objectives, plans, guidelines and policies, drafting laws and regulations related to medical devices Draft, formulate medical device regulations, and formulate relevant standards and technical specifications in accordance with the law; the State Food and Drug Administration is responsible for the administrative supervision and technical management of the development, production, circulation and use of medical devices.

China's medical device industry currently implements classified supervision and management. Supervision and management includes supervision of products, product use and supervision of medical device manufacturers. The purpose of product supervision is to verify the effectiveness of the product. Supervision of production enterprises aims to ensure stable and effective product quality, reflected in the audit of the quality management system of manufacturing enterprises, and regular review. China's review of medical device quality management system standards, the use of medical device industry standard YY/T 0287-2003 "medical device quality management system for regulatory requirements", the standard is equivalent to the ISO13485 "medical device quality management system for regulatory requirements".

A. Classified management of medical devices according to the degree of risk

① The first category is medical devices with low risk and regular management can ensure their effectiveness; ② The second category is medical devices with moderate risk and need strict control and management to ensure their effectiveness; ③ The third category is medical devices with high risk and need to take special measures to strictly control and manage to ensure their effectiveness.

B. Medical devices implement product filing and registration management system

The first category of medical devices shall be subject to product filing management, and the second and third categories of medical devices shall be subject to product registration management. The food and drug supervision and administration department that accepts the registration application shall make a decision according to the evaluation opinions of the technical evaluation institution. If it meets the effective requirements, it shall approve the registration and issue the "Medical Device Registration Certificate".

① For the filing of Class I medical device products, the filing person shall submit the filing materials to the food and drug regulatory department of the municipal people's government with districts; ② for the registration of Class II medical device products, the registration applicant shall submit the registration application materials to the food and drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located; ③ for the registration of Class III medical device products, the registration applicant shall submit the registration application materials to the food and drug regulatory department of the State Council.

C. Medical device manufacturers implement a filing and production licensing system

① For the production of Class I medical devices, the manufacturer shall file with the food and drug regulatory department of the municipal people's government with districts; ② For the production of Class II and Class III medical devices, the manufacturer shall apply for a production license from the food and drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government. The food and drug supervision and administration department shall conduct verification in accordance with the requirements of the medical device production quality management standards formulated by the competent department of the industry. For the production enterprises that meet the prescribed conditions, the license shall be granted and the "Medical Device Production License" shall be issued. Enterprises engaged in the production of Class II and Class III medical devices need to obtain the Medical Device Registration Certificate and the Medical Device Production License.Enterprises exporting medical devices shall ensure that the medical devices they export meet the requirements of the importing country (region). For the second type of medical device business, the operating enterprise shall file with the food and drug supervision and administration department of the municipal people's government with districts where it is located; for the third type of medical device business, the operating enterprise shall apply to the food and drug supervision and administration department of the municipal people's government with districts where it is located, and obtain the license for medical device business enterprise.

5. the favorable and unfavorable factors affecting the development of the industry

(I) favorable factors

1. Strong support of national policies

The national medium-and long-term development plan takes the medical device industry as a key development area, among which the 2006 "National Medium-and Long-term Science and Technology Development Plan Outline" was first written into the development of the medical device industry. With the enhancement of the country's economic strength, various types of scientific research or development funding projects (such as 863 plans, national key projects, industrialization projects, etc.), included in the medical materials and products related topics increased significantly. The country's huge investment in scientific research and development in the field of medical materials and products has greatly improved the technical level of the industry and shortened the product renewal cycle.

In 2011, the Ministry of Science and Technology issued the "Twelfth Five-Year Plan" for the Medical Device Technology Industry, which included "breaking through a number of common key technologies and core components, focusing on the development of a number of basic medical device products with independent intellectual property rights, high performance, high high quality, low cost and mainly relying on imports, to meet the needs of China's primary medical and health system construction and clinical regular diagnosis and treatment needs" into the overall goal of China's medical device development. In 2006, the State Council issued the "National Medium and Long-term Science and Technology Development Plan Outline (2006-2020)" as a guiding document for scientific and technological development, which included "breakthroughs in key medical devices and technical capabilities for industrial development" into the development goals, and "disease prevention and control The focus is moving forward, insisting on prevention first, combining health promotion with disease prevention, researching key technologies for prevention and early diagnosis, and significantly improving the ability of diagnosis and prevention of major diseases, the development of advanced medical equipment and the promotion of independent innovation of medical devices are included in the development thinking, requiring" focus on the development of new treatment and regular diagnosis and treatment equipment ".

2, the medical device market prospects are broad.

A large number of new technologies and materials are applied in the medical device industry, involving the cross integration of optics, electronics, ultrasound, magnetism, isotope, computer and other disciplines, including artificial materials, artificial organs, biomechanics, monitoring instruments, diagnostic equipment, imaging technology, information processing, image reconstruction and other technologies are the first to be applied in medical device products.

3, the downstream market prospects are broad.

With the launch of the Plan and implementation Plan for deepening the Reform of the Medical and Health system during the 12th five-year Plan period, the new medical system reform plan further emphasizes the public welfare nature of medical and health undertakings, and strives to speed up the improvement of the universal health insurance system, consolidate and improve the basic drug system and the new operation mechanism of grass-roots medical and health institutions, and actively promote the reform of public hospitals, we will make overall plans for the equalization of basic public health services, the allocation of medical and health resources, the management of medical services by social capital, the informatization of medical and health care, the production and circulation of drugs, and the medical and health supervision system.

According to the "Main Work Arrangements for Deepening the Reform of the Medical and Health System in 2013", the current basic medical insurance for urban employees, basic medical insurance for urban residents, and new rural cooperative medical care cover all urban and rural residents. The participation (combined) rate of the three basic medical insurances is stable at 95%. the above. The company's end customers are mainly hospitals at all levels, community or rural health service stations, local CDC and other medical and health service institutions. With the advancement of medical system reform, the development of my country's economy and the intensification of aging, the improvement and soundness of downstream industry customers will provide the company with greater market space.

(II) adverse factors

1. Competition of foreign enterprises

At present, the key biological and new material industrialization technology is fully mastered by several major foreign medical device companies such as General Motors and Philips. They have the advantages of a complete industrial chain from upstream material research and development to downstream industrial applications. In recent years, China's catch-up speed in this field is accelerating day by day, but at present, no domestic enterprise has the ability to fully grasp the control power in the field of upstream material research and development, and maintain the upgrading and innovation synchronized with the international. In addition, there is a significant gap between domestic enterprises and foreign manufacturers in terms of capital capacity and brand influence.

2. Threat of new entrants

The higher gross profit margin of medical device products and the huge market growth space will attract more domestic and foreign manufacturers to enter the industry, especially the powerful large enterprises, which can rely on their mature market experience and capital advantages to compare domestic companies. Public company manufacturers conduct mergers and acquisitions, thereby occupying or expanding their market share in the domestic medical device industry, and intensifying the intensity of market competition. In order to maintain the leading position in the industry, the existing manufacturers in the industry must increase investment in research and development, enhance the ability of independent innovation, constantly introduce new products, improve product lines, and expand financing channels. Only through capitalization and market-oriented standardized operation can they ensure their dominant position in market competition.

3, low value-added products, fierce competition

Although low value-added products have a certain international market share, they do not contribute much to the development of the industry. Many companies have become "manufacturing centers" in overseas markets, earning low manufacturing costs. In addition, in recent years, the domestic labor cost has been increasing, and the operating cost of medical device enterprises has been rising, which has brought severe challenges to the survival and development of many small and medium-sized enterprises. With the continuous standardization of the industry, some small and medium-sized medical device enterprises are facing the risk of being eliminated. In the international market, Chinese medical device companies have faced the situation that the low-cost advantage of Chinese manufacturing has gradually weakened or even disappeared; in the domestic market, the result of low-cost and low-price is fierce market competition, and the cost advantage of large-scale enterprises has gradually been reflected. Many small and medium-sized enterprises are facing survival and development problems.

4. Insufficient R & D capability and weak innovation capability

At present, most of the domestic medical device manufacturers lack technological innovation capabilities, poor research equipment and basic conditions, insufficient R & D investment, and weak ability to transform scientific and technological achievements. In the field of high-end medical equipment, there is no technology and strength to surpass multinational companies and domestic mainstream companies. Enterprises can only take the road of imitation and fight a price war.

Domestic medical equipment show strength, compound growth rate of more than 30%

71 kinds of medical equipment 2016 or strictly controlled by the state