Abstract: along with the continuously into the achievements of modern science, medical apparatus and instruments more role in the medical and health undertakings, become a big health industry one of the most active economic growth point. At present, with the great support the government's policy planning, China continued double-digit growth in medical equipment industry, high-end product independent research and development and production capacity gradually strengthened. From the point of development trend, the market demand potential is tremendous, supervision and management of the increasingly standardized, technology innovation drive, increasing industrial concentration, etc., will continue to promote the rapid development China's medical equipment industry.
After nearly 70 years of development, China's medical equipment industry has developed into a relatively complete product categories, to enhance innovation capability and market demand of sunrise industry.
The market for medical devices in China increased from 17.9 billion yuan in 2001 to 308 billion yuan in 2015, with an average annual growth rate of about 20 percent.
According to statistics, the proportion of global medical devices and medicine consumption in 2014 is about 0.7 to 1, while the developed countries such as Europe and the us have reached 1.02:1. Total is 255.6 billion yuan, China medical equipment market medical market total scale is expected to be $13, 32.6 billion, medical equipment and medical consumption ratio is 0.19:1, far lower than international level. As a result, there is still a lot of room for development in China's medical device market (see figure 1).
China is the world's second-largest market for high-end medical devices. For a long time, the highly intensive equipment such as MRI, CT, PET and CT has been monopolized by general electric, philips and Siemens. , according to "medical equipment in China" in 2016, general electric (ge) in CT, MRI and ultrasound imaging and nuclear medicine market share ranks the first of such equipment, philips in vascular ZaoYingJi, put two class equipment share ranks the first. The three multinationals monopolize 70 per cent of China's high-end medical equipment and less than 10 per cent of domestic equipment. But in some areas, domestic companies are emerging. Mindray medical ranked first in monitoring products share (58.0%), old Ken, xinhua medical disinfection device class share ranked first (41.4%) and second (17.8%).
"Twelfth five-year" period, from the perspective of the product structure of China's medical equipment market, imaging diagnostic devices occupy the largest market share, remained at about 40% in recent years, the proportion from the point of view in recent years, the development of the industry and continue to expand the trend; The second is all kinds of medical consumables, accounting for about 20% of the market. The market share of orthopedic and implanted medical devices is declining; The rest is mostly dental and other instruments.
During the 12th five-year plan period, the average growth rate of China's medical device industry was about 15 percent, higher than the national economic average for the same period. The health industry in developed countries accounts for 8 to 15 percent of GDP, while China is only 2 percent, and the development of the domestic medical device industry is in the long-term.
According to the ministry statistics, from January to September 2016, pharmaceutical and industrial enterprises above designated size 21 main business revenue of 03.414 billion yuan, up 10.09% from a year earlier, higher than the national overall industrial growth is 6.39%. In terms of segmentation, medical device growth was the second highest in the pharmaceutical industry (11.96%), after the processing of Chinese traditional Chinese medicine (12.45%). In each sub-industry, the profit growth of medical instruments and equipment manufacturing (20451 million yuan) was the fastest, growing by 36.63 percent. According to the Chinese medical device industry association, the total output value of the national medical device industry is more than 50 billion yuan in 2016 (see figure 2).
According to the national food administration of drug safety statistics, as of the end of November 2015, medical device manufacturing enterprise of the 14, 151, among them: a kind of 5, 080, 2 kinds of 9, 517, three kinds of 2, 614; There are 186, 269 medical devices operating enterprises in the whole country. As of August 2016, there were 98 923 valid medical instrument registrations in China, including 26 462 in one category and 54 496 in the second class (see figure 3). Data show that the upgrading of the medical device industry in recent years the pace of a solid, a number of small scale, low level repeated enterprises exit the market, the government's new, decentralization, travel light power a batch of advantage enterprises, through independent innovation and capital operation, expand product structure, marketing channels, and layout of the health industry.
Have sprung up in recent years, China's medical equipment industry a number of research and development ability is strong, high technical content of the representative enterprises, such as mindray medical, xinhua medical, diving medical, neusoft medical, market, weigao group, minimally invasive medical, Shanghai united shadow, etc. On the other hand, China's medical equipment industry overseas market share is very limited, the main export products for the OEM products, as well as the human cost is larger, such as massage instrument), production technology content is low (such as cotton, catheters), and other products. This situation further reveals the reality of the lack of core technology and core competitiveness of Chinese medical device manufacturers.
In the aspect of industrial competition, domestic enterprises occupy the middle and lower end of the market, and foreign enterprises occupy the high end of the market. In most areas, the foreign advanced medical equipment companies in technology and quality is well ahead of domestic enterprises, especially in medical imaging equipment, minimally invasive surgical instruments, high-end clinical inspection instruments, etc. Some areas with higher technical barriers. Domestic enterprises in such aspects as production costs, channel localization has great advantages, coupled with the low-end market itself is relatively low technical content, industry barriers to entry is relatively loose, so the domestic enterprises are mainly concentrated in the low-end market; At the same time, the part of the market that there are many manufacturers are low, product differentiation, industry concentration degree is low, low value-added products, product competitive situation.
According to China's customs statistics, the total import and export of Chinese medical devices increased from $226.56 billion in 2010 to $38.91 billion in 2016. Overall, China's medical device exports are still in the long term and the development space is relatively large (see figure 4).
In 2016, the import and export volume was $38.91 billion, up 1.1% from a year earlier. Imports amounted to $18.4 billion, up 6.28 percent year on year, leading to the import of pharmaceutical products. Exports were $20.5 billion, down 3.14% from a year earlier. The export structure adjustment will pay more attention to the transformation of quality and further optimize the export structure. In 2015, the hospital diagnosis and treatment equipment imports by $12 billion, exports of $9.7 billion, although is still a trade deficit with China, but the top of the charts of medical equipment products export amount (45.8%), and export proportion increase year by year. This analysis, the product achieves a certain level to replace level of similar products in the developed countries, compared with Europe and the United States similar products price advantage, in recognition of the emerging markets also gradually improve.
Medical equipment industry is a measure of a country's development in science and technology progress and national economic modernization level is one of the important indicators, therefore, paid attention to by all countries in the world for the development of medical equipment industry strategic position. In recent years, China has adopted a series of policies to support the development of the medical device industry, including planning and guiding measures.
"Made in China 2025" clear the new materials, biological medicine and high performance medical devices as one of the top ten areas of focus on development, put forward to improve the innovative ability of medical equipment and the level of industrialization, gradually get rid of the situation of high-end medical equipment imports. "" much starker choices-and graver consequences-in" national science and technology innovation plan "with particular emphasis on" much starker choices-and graver consequences-in "period will focus on development of digital medical equipment, and key technology in vitro diagnostic products, health promotion, health services, pensions assistive technology such as key technology. The "healthy China 2030" planning outline is put forward, and the next 15 years, will deepen the reform of the medical equipment distribution system, strengthening the medical equipment safety supervision, to strengthen the construction of high-end medical equipment innovation ability, promoting the localization of medical equipment.
At present, most of China's low-end domestic medical equipment quality and performance are quite close to import equipment, can meet the demand of most hospitals, some high-end domestic equipment high cost performance, can partly replace imported equipment.
"Twelfth five-year" layout of important progress has been made a series of major products, shortened with the international advanced level in the difference between high-end digital medical equipment, reserve a number of cutting-edge technology, digital medical equipment technology is advancing rapidly in China. Breakthroughs in core components and key technologies, and the development of core components such as X-ray detectors, ultrasonic probes, and PET detectors; Key technologies, such as new imaging, neural signal detection and analysis, etc. A breakthrough in PET digital technology. Part in the research and production of high-tech innovation projects are rapidly advancing, represented by mindray medical and Shanghai united shadow of high-end products production enterprise grow up rapidly, a group of close to or reached the international level products has gradually appeared and began to enter the market. In 2013, developed by tsinghua university, Beijing chi brain pacemaker to obtain registration certificate of production, to become China's first active implantable neural control devices, to enable China to become the world's second to the development and production and clinical application of brain pacemaker. In 2014, mindray medical successfully developed with international advanced level of high-end fully digital color doppler ultrasonic diagnostic equipment DC - 8, makes it possible to break the foreign monopoly high-end colour to exceed.
Technology constantly breakthroughs at the same time, some leading enterprises develop rapidly, the layout of the international market competition actively, the rapid growth of a batch of innovation enterprises, medical equipment industry clusters are rapidly rising. First create a domestic CT neusoft medical opens a branch to leaf in the field of large-scale medical equipment, has from CT, MRI and PET/CT of the eight series of products, covering radiation image, routine inspection, radiation therapy, and comprehensive health care solutions in the field of nuclear medicine three; The products such as the electrocardiograph and monitor are now in the country's 110,000 medical institutions and more than 95% of the three hospitals. Developed by xinhua medical oxygen generator, atomizer, sphygmomanometer, stethoscope, ultra mild oxygen valve market share reaches the domestic first, one oxygen generator product is up to the global sales first; Minimally invasive medical has and medtronic, Boston scientific's ability to compete and foreign leading companies, coronary stent products basically completed the localization, the proportion of domestic has reached more than eighty percent.
The key problems that restrict the development of medical device industry in China are summarized in the following aspects.
There are tens of thousands of Chinese medical device companies, but they are mostly small businesses. As of November 2016, China had more than 2,000 enterprises, according to the ministry of industry and information technology. From the point of enterprise scale, by the middle of 2016, in Shanghai and shenzhen stock exchange listed companies in China, the main business for the medical devices only 35, in the Hong Kong stock exchange listed eight, a total of 43. In 2015, the annual operating income of domestic listed medical devices was about 1.1 billion yuan. In 2014, j&j's revenues were $27.5 billion, compared with $1.2 billion for the country's largest medical-device enterprise, mairy. Their own small scale, technology, scale, brand competitiveness is relatively weak, r&d spending is limited, can't large-scale industrialization, make the product cost high profits thin, further lead to homogeneity of vicious competition.
From the point of medical equipment industry as a whole, their industry management more ministries, the national development and reform commission, planning commission, the food administration of drug safety and the ministry of commerce, ministry of industry, general administration of quality supervision, inspection and ministry of science and technology more ministries and commissions such as are promulgated in the industry related policy laws and regulations, the phenomenon of government departments for cross management for medical devices industry. The formulation of industry policies involves the food and drug administration, the national development and reform commission and the legislative affairs office of the state council; Safety regulations involve the NHFPC and the administration of food and drug administration; The production and development of the food and drug administration and the ministry of industry and information; The circulation channels are related to the food and drug administration and the ministry of commerce.
Many ministries and commissions of the bulls management has affected the efficiency of management of the industry, retarding the industry development, caused the comprehensive control, the disadvantages of poor overall planning, not only increased the waste of administrative resources, but also increased the burden, which affects the healthy development of the industry.
Along with the further refinement of division of labor and market more active, medical apparatus and instruments industry chain in extension was perfected and optimized at the same time, the medical equipment industry and the relationship between upstream and downstream industry more closely. Upstream of medical equipment industry to play a bigger role for the development of medical equipment industry, especially the upstream industries such as machinery, materials, electronics, directly affect the medical instrument technical direction. Compared with developed countries, the weak base of manufacturing industry in China has become an important constraint on the development of medical device industry.
Medical equipment is the product of multidisciplinary, comprehensive high and new technology, involves the mechanical, optical, electronic, information, materials and other disciplines, the product validation involves biological evaluation, animal experiments and clinical trials, experimental design and statistical analysis, and a series of biological and medical research, there is no grasp multi-disciplinary knowledge of high-end talent impossible high-end medical equipment research and development of innovation. At present, the main component of domestic medical devices is the sale, maintenance and registration of medical devices. Compared with the quantity and quality of professionals in the developed countries, China medical equipment research and development personnel and precision instrument manufacturing personnel have a gap, medical instrument design, structural engineers, medical electronic engineer and polymer research and development personnel lack of high-end talent, directly affect the improved medical equipment industry international competitiveness.
In the future, the development of medical devices in China is full of opportunities and challenges. Pressure from regulation and finance is a challenge to the industry, and demand traction and technological innovation are the driving force behind the industry.
The market for medical devices in China accounts for only about 10 percent of the world market share, far from the demand of 1.3 billion people. The improvement of the medical insurance system, the reform of the medical service system and the increasing demand of the people's medical care will surely propel the continued increase in the consumption of medical devices. With the new medical reform policy deepening, as well as the classification system of pilot and promote, rural township (town) health agencies will be a huge potential market of medical equipment. An aging population and rising living standards will promote the rapid development of medical device industries, such as in vitro diagnosis, orthopaedic and rehabilitation. China's medical device industry will also be in rapid development in the context of stimulating demand and steady economic growth.
In order to promote innovative development of medical devices, China has formulated and implemented a series of scientific and technological input programs. The science and technology plan including the 863 plan, the national 12th five-year medical equipment special emphasis, "twelfth five-year" science and technology support plan, "much starker choices-and graver consequences-in" national key research and development plan, etc., support domain objects involved in enterprises, universities, research institutes, etc., funding covers product research and development, the transformation of scientific and technological achievements, talents cultivation, construction of high and new technology industrialization, science and technology services, to promote medical equipment industry provides a good platform and basic technology innovation.
In 2014, the regulations on the supervision and administration of medical devices were approved by the executive meeting of the state council, and the newly revised regulations were also released. The new regulations embody the reform and innovation of the administrative supervision of medical devices, which marks a new stage in the supervision and management of Chinese medical devices. The regulations, rules and regulations, and the "normative documents" of the three levels of the regulatory system are improving.
Food administration of drug safety review of examination and approval system reform will gradually establish a review as the core technology support system, optimize the approval procedures for the review, continuously improving the quality and efficiency for examination and approval of the review, further enhance the ability to review the examination and approval of medical equipment, guarantee the public use machinery is safe and effective, and promote the healthy development of the medical equipment industry.
In addition, the medical instrument standard system construction, the medical instrument inspection institution supporting development, is speeding up with the international connection. Will present the focus of your regulation effort towards the medical apparatus and instruments from the pre-market review to post-marketing surveillance, from product quality to detect the trend of shift to check production quality system, will further standardize the medical equipment enterprises, development, production and business activities.
From the current China's medical equipment industry listed companies, although all aspects of production in the industry have improved, but is still in the less competitive in the international market, the market share of low status. According to statistics, 40 of the large medical equipment enterprise output value accounts for 20% of global medical device market, while China has about 1.4 medical device companies, production accounts for only about 10% of the global medical device market. Medical equipment industry has the characteristics of diversification, faster innovation, crossover, through their own strength to form large-scale production all kinds of difficulties, m&a is a kind of gain economies of scale and scope economy is fast and effective way. In addition, medical apparatus and instruments each segment of the market capacity is small, but very high professional barriers, in such aspects as research and development, promotion, after-sales service in various fields, have great difficulty between the high value of supplies, medical equipment, diagnostic reagents, and other fields, endogenous growth alone, medical equipment enterprises cannot complete rapid growth.
At present, the market segment control and m&a expansion has become the mainstream in the domestic medical instrument enterprise strategy layout ideas, take the lead in integrating positive expansion companies are more wants to become a winner for a long time. Miriel medical, wihg group, fish jump medical, and music healthcare have become the leading players through joint ventures and mergers and acquisitions. Minimally invasive medicine and xinhua medical treatment have become the best in the field of segmentation. Others are opening up overseas acquisitions to try to diversify internationally.
Medical equipment financing funds, listed companies use industry, foreign investment and other ways to speed up the pace of mergers and reorganization, constantly improve the level of industry organization, realize the scale, intensive management, will be the important trend of the industrial development.