The report shows that China's medical device industry has entered a new stage of high-end development

Medical Network December 20th news The manufacturing level of medical apparatus represents the industrial technology level of a country to a certain extent. In the past November, domestic medical apparatus shone on the international stage, whether it was the first China International Import Expo held in Shanghai at the beginning of the month, or the North American Radiology Annual Conference (RSNA), which ended in Chicago at the end of the month, representing the current cutting-edge technology trend of medical apparatus. The high-profile appearance of domestic large-scale high-end medical apparatus such as PET-CT and PET-MR is exciting.

　　After nearly 5 years of double-digit annual growth, what are the characteristics of my country's medical apparatus industry structure? Recently, the "China Medical apparatus Industry Development Report 2018" (hereinafter referred to as the "Report") released by the China Medical apparatus Industry Association, from Policy, innovation and other aspects are analyzed.

　　Industry Status

　　Whole decentralized, partially concentrated

　　Compared with drugs, the medical apparatus industry, which started late, has been in a situation of "multi-scattered" and insufficient innovation for many years. The "Report" pointed out that at present, my country's medical apparatus industry presents an overall scattered and partially concentrated competition landscape.

　　"Many companies are small in scale and cannot be industrialized on a large scale, resulting in high product costs and thin profits, which further leads to homogeneous competition," said the relevant person in charge of the China Medical Apparatus Industry Association.

　　According to statistics, in 2014, the output value of 40 large medical apparatus companies in the United States accounted for 20% of the global medical apparatus industry output value, while there were about 14,000 medical apparatus manufacturers in China during the same period, but the output value accounted for only 13%.

　　The medical apparatus industry has the characteristics of diversification, rapid innovation, and difficulty in crossing borders, and it is difficult for enterprises to form large-scale industries through their own strength. Therefore, mergers and acquisitions are one of the fastest and most effective ways to obtain economies of scale and economies of scope. In addition, many medical apparatus market segments have small capacity and high professional barriers, and enterprises cannot achieve rapid growth by relying on endogenous growth alone.

　　Accordingly, the report predicts that medical apparatus enterprises will speed up the pace of mergers and reorganizations through industrial funds, listing financing, the introduction of foreign capital and other means, continuously improve the level of industry organization, and achieve large-scale and intensive operation, which will be an important trend in the development of the industry in the next few years. trend.

　　In the three years from 2013 to 2015, there were 45, 69 and 80 M & A cases of medical apparatus in China respectively; there were 2, 8 and 15 transactions over $50 million respectively. This fully shows that the M & A in the medical apparatus industry is increasing year by year, and the scale of funds is also increasing. In 2017, there were 84 financing incidents in the medical apparatus industry, with a cumulative amount of nearly $1.6 billion.

　　The "Report" pointed out that after the development in recent years, although a number of representative enterprises such as Mindray Medical, Shanghai United Film, Xinhua Medical, Yuyue Medical, Neusoft Group, Lepu Medical, Weigao Group, and Minimally Invasive Medical have emerged in my country, most of the production enterprises with annual sales exceeding 100 million yuan are joint ventures and foreign-funded enterprises. The Japanese medical apparatus market has annual sales of 25 billion to 26 billion US dollars, of which there are only more than 60 main enterprises. Although there are more than 2,000 domestic enterprises that have obtained export certification qualifications, they are still dominated by small and medium-sized enterprises. In 2016, the market value of Lepu Medical exceeded 50 billion yuan, which is still far behind Johnson & Johnson and Medtronic.

　　Industrial structure

　　Build clusters and accelerate innovation

　　The reporter learned that with the development of my country's medical apparatus industry, the country has formed some medical apparatus industry clusters and manufacturing development belts, such as the Pearl River Delta, the Yangtze River Delta and the three major areas of the Beijing-Tianjin Rim Bohai Bay, and has become the three major local medical apparatus industry clusters.

　　According to incomplete statistics, the sum of the total output value and sales of medical apparatus in the three regions accounts for more than 80% of the national total. Because of different conditions, these three industrial clusters have obvious geographical characteristics. In addition, the Chengdu-Chongqing region centered on Chongqing and the Central China region centered on Wuhan are also emerging industrial clusters, featuring biomedical materials and implantable devices and tissue engineering.

　　On November 25, at the RSNA held in Chicago, a series of products representing the cutting-edge technology of medical apparatus were unveiled. Among them, the PET-MR independently developed by Chinese companies attracted everyone's attention and attracted many professional audiences to share in "Moments". This grand occasion.

　　The report shows that in terms of domestic medical apparatus innovation, my country's medical apparatus industry has basically formed a multi-disciplinary research and development system, and has entered a new stage of developing from mid-end products to high-end products, from small to large, from weak to strong. The domestic medical apparatus industry is also gradually forming a technological innovation system with enterprises as the main body, market-oriented, and a combination of production, learning, research and use.

　　"Report" analysis, in the face of highly homogeneous market competition, medical apparatus enterprises will continue to innovate, speed up product upgrades, and actively explore the development of new products. In terms of policy, after the implementation of the special approval procedure for innovative medical apparatus, the speed of listing of domestic innovative medical apparatus has been accelerated.

　　It is understood that since March 2014, the number of products that have entered the priority review has gradually increased each year. Up to now, more than 50 innovative products have been approved. In addition, with the advancement of the new medical reform, the hospital's income structure has changed, and the hospital's demand for mid-to-high-end domestic medical apparatus is gradually increasing. Provinces (autonomous regions and municipalities) have also successively introduced policies and measures to support the development of domestic medical apparatus. For example, in 2016 and 2017, Sichuan, Zhejiang, Hubei, Guangdong, Anhui, Hebei, Fujian, Liaoning and other provinces have successively explicitly encouraged the use of domestic medical equipment.

　　Industry goals

　　Improve standards and integrate with international standards

　　On November 28, the official website of the State Food and Drug Administration released the "Key Points and Judgment Principles for Clinical Trials of Medical Apparatus", which attracted attention in the industry, and everyone rushed to forward the study.

　　In fact, since the promulgation and implementation of the revised "Regulations on the Supervision and Administration of Medical Apparatus" in 2014, the accompanying regulatory documents have been released one after another, reflecting the concept of medical apparatus supervision science and highlighting the reform and innovation of medical apparatus supervision.

　　The "report" pointed out that in order to improve medical apparatus product standards and ensure quality, the state has successively established 24 medical apparatus-related technical standardization committees to be responsible for standard formulation and revision. Since my country became a member of the international standards organization (ISO) in the 1980s, the rate of international standards has reached nearly 80%, which has promoted the internationalization of medical apparatus product standards.

　　Medical apparatus inspection and testing institutions are the technical support units for medical apparatus supervision. According to the analysis of the "Report", there are dozens of nationally recognized medical apparatus inspection and testing institutions, which can basically meet the needs of medical apparatus testing and supervision and management in my country. In November 2015, the former State Food and Drug Administration organized and formulated the "Qualification Accreditation Conditions for Medical Apparatus Inspection Institutions", which further strengthened the management of medical apparatus inspection institutions and standardized the qualification accreditation of medical apparatus inspection institutions. The promulgation and implementation of this series of measures have made the supervision and management of my country's medical apparatus increasingly perfect and accelerated its integration with international standards.