First, the life cycle and industry scale of the industry
(1) Development history and current situation of China's medical device manufacturing industry
The demand for medical device market in China has continued to grow in recent years, and it is expected that there will still be room for growth in the future. In recent years, China's medical device industry development and investment are more active, the national strategic emerging industry policy guidance and the upgrading of domestic medical and health institutions' equipment will make the future medical device consumer market continue to grow.
In the past 13 years, the sales volume of China's medical device market has increased from 17.9 billion yuan in 2001 to 212 billion yuan in 2013. Excluding the impact of price factors, it has increased by 10.84 times in 13 years. According to the sample survey of the Medical Devices Branch of China Pharmaceuticals (17.33, 1.580, 10.03%), the national medical device sales volume in 2014 was about 255.6 billion yuan, an increase of 43.6 billion yuan over the 2013 revenue of 213 billion yuan. 20.57%.
The global consumption ratio of medicines and medical devices is about 1:0.7. The developed countries such as Europe, America and Japan have reached 1:1.02. The global medical device market has occupied 42% of the total size of the international pharmaceutical market, and it has expanded. In 2014, the total size of China's medical device market was about 255.6 billion yuan. The total size of the pharmaceutical market is estimated to be 133.26 billion yuan. The ratio of medicines to medical consumption is 1:0.19. The ratio of medicines to medical consumption in 2013 is 1:0.2. The device market still has a relatively large room for growth.
The number of medical device manufacturing enterprises in China has increased year by year: in 2010, there were 14,337, including 4015 medical device manufacturers, 7906 medical device manufacturers, and 2,416 medical device manufacturers, and national and provincial key enterprises. 1863 homes. As of the end of November 2012, the number of medical device manufacturers nationwide has rapidly increased to more than 16,000. State-owned enterprises, foreign-funded enterprises and joint ventures and private enterprises accounted for 3%, 37% and 60% respectively. Among them, there are more than 200 enterprises with an output value of over 100 million yuan; less than 20 enterprises with an output value of over 1 billion yuan, and foreign-invested enterprises and joint-venture enterprises account for the vast majority. 2011 statistics show that foreign and Hong Kong, Macao and Taiwan-invested enterprises constitute the main force of China's medical device industry, its assets accounted for 43% of the total assets of China's medical device industry.
There are many domestic medical device manufacturers, and the market concentration is low. According to geographical distribution, the domestic brand medical device industry in the east and south coastal areas represented by Shanghai and Shenzhen is characterized by “multiple, small, high and weakâ€: First, there are many production enterprises. By the end of 2013, there were 15,698 medical device manufacturers in China. The second is the small scale of enterprises. In 2013, the total output value of the medical device industry market was 221 billion yuan, and the average output value of each enterprise was about 13.5 million yuan. In the previous year, it increased by 1.5 million yuan and 12.5%. The third is high product concentration, more than 3,500 types of medical device products, and an average of more than 10 registration certificates for each product. The fourth is relatively weak relative to internationally renowned brands. . In recent years, with the continuous improvement of China's technical level and the continuous improvement of the manufacturing capabilities 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, China's medical device market has exceeded 150 billion yuan, and China has become one of Asia's top medical device manufacturers and one of the world's top ten emerging markets for medical devices. In the next few years, China will surpass Japan to become the world's second largest medical device market.
In general, 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 was estimated at 37.2 billion yuan, accounting for the total sales of the industry. 14.55% of the amount. 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 attracting investment and forming a dominant industrial cluster with foreign-funded enterprises as the main body. In the Yangtze River Delta, products such as disposable injection and infusion sets are dominant in the country; CT machines represented by General Electric Company in Beijing have an absolute advantage; Shenzhen's medical device industry has grown from scratch, in just over 10 years. It has developed into an important manufacturing and processing base for China's high-end medical device industry. Medical imaging diagnostic equipment, patient monitors and other products also have a place in the international market, and the development momentum is strong.
(II) Space for development of industrial enterprises
According to the 2011 China Medical Device Industry Analysis and Development Forecast Report released by Shangpu Consulting, it is estimated that by 2015, the entire medical instrument and equipment market in China is expected to be nearly 340 billion yuan. At present, medical devices in the world 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, and the potential for market development is huge. According to the statistics of the Medical Devices Branch of the China Pharmaceutical Materials Association, as of December 2013, there were 15,700 enterprises holding medical device production licenses in China, including more than 35 medical devices listed at home and abroad. There were 93,592 types of medical devices that obtained medical device registration certificates in China, which were basically the same as the same period of last year, and 34,655 imported medical devices that obtained medical device registration certificates.
China has a registration system for medical devices, and the 2013 “drug supervision statistics†announced 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 in the same year. Among them, the number of Class I re-registrations was 3,738, an increase of 36.47% over the previous year's 2,739; the Class II re-registration reached 5,801, an increase of 75.79% over the previous year's 3,300.
The policy orientation of promoting the development of digital diagnosis and treatment equipment and localization in China is very clear. According to the "12th Five-Year Plan for National Independent Innovation Capacity Building" issued by the State Council, the "Twelfth Five-Year National Strategic Emerging Industry Development Plan" issued by the Ministry of Industry and Information Technology, and the "Twelfth Five-Year Plan" for the Pharmaceutical Industry "The National "Twelfth Five-Year" Science and Technology Development Plan issued by the Ministry of Science and Technology, advanced medical equipment is an important industry related to the national economy and the people's livelihood, and is a key area of ​​strategic emerging industries that China vigorously develops and cultivates." During the Five-Year Plan period, China vigorously promoted the development of core components of medical imaging equipment, the development of key technologies, the development of high-end products, and the cultivation of key enterprises with strong independent innovation capabilities, improved the localization level of equipment, and improved the internationalization of China's medical device industry. Competitiveness. The company's various products are key development products.
Since 2014, the relevant state 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 carried out a five-month “five rectification†special action, focusing on rectification. Five kinds of behaviors such as false registration of medical devices, illegal production, illegal operation, exaggeration of publicity, and use of unlicensed products have effectively regulated the market and contributed to the healthy development of the medical device industry. In March 2015, the Ministry of Science and Technology issued the digital diagnosis and treatment. The special equipment implementation plan (draft for comments), from 2015 to 2020, the main tasks of the development of the medical device industry are major equipment R&D, cutting-edge and common technology innovation, application solution research, application demonstration and evaluation research. After the “Twelfth Five-Year Plan†period of promotion and localization of industrial policy guidance and preparation, China will further increase the policy and investment of the digital diagnosis and treatment equipment industry in the future. During the “13th Five-Year Plan†period, the digital diagnosis and treatment equipment industry will achieve breakthroughs. Harvest, the future domestic digital diagnosis and treatment equipment will continue to develop at a high speed.
The medical imaging diagnostic equipment belongs to the middle and high-end medical equipment , which 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 domestic medical imaging diagnostic equipment industry. Strong support from the national strategic level and the introduction of a series of new policies to promote domestic hospitals to replace imported equipment with domestically produced equipment, coupled with the accumulation of their own technology, talents and funds, domestic medical imaging diagnostic equipment companies are facing major development opportunities. It is expected that the process of localization of medical imaging diagnostic equipment will accelerate in the next few years, driving the rapid expansion of the domestic enterprise market.
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