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China's medical device industry development environment

                       
Update:04-08-2019
Summary:

Since the reform and opening up, the development of Chi […]

Since the reform and opening up, the development of China's medical device industry has attracted worldwide attention. Especially since the beginning of the 21st century, the industry as a whole has entered a stage of rapid growth. In the past five years, the number of medical institutions nationwide has steadily increased, and a large amount of medical infrastructure investment will be brought in the next few years, and medical device manufacturers will benefit. Beginning in 2014, the first responsibility of medical device manufacturers will be further implemented, and the quality and safety awareness and level of production enterprises will be significantly improved, thereby promoting the structural adjustment and industrial upgrading of the medical device industry, and enhancing the quality and safety of medical devices in China. .

I. Development of China's medical device industry

At present, China's medical device market has grown rapidly, and has become the third largest medical device market in the world after the United States and Japan. China has become a major region driving the growth of the global market. In the next few years, if we continue to maintain the current development speed, China will surpass Japan to become the world's second largest medical device market. Medical devices and drugs are two important means of medical treatment. The sales ratio of the developed countries is relatively close, while the sales of medical devices in China is about one-third of the sales of pharmaceuticals. This shows that China's medical device market has great potential. China's medical device market is active, the orientation of national policies and the upgrading of domestic medical and health institutions' equipment have made China a huge medical device consumer market. Under the background of the stimulation of market demand and the sustained and stable development of China's economy, China's medical device industry has developed rapidly. The important position in the pharmaceutical industry has become more and more prominent, and it is following the development path of “heavy equipment and light medicines” in developed countries. Of course, this still has a long way to go.

According to the statistics of the Ministry of Industry and Information Technology, the national medical device output value in 2012 was 139.86 billion yuan; according to the China Medical Device Industry Association, the output value exceeded 300 billion yuan. According to conservative estimates, the output value of medical devices will reach 450-500 billion yuan by 2015.

According to the statistics of the State Food and Drug Administration, as of the end of 2012, there were 15,348 production enterprises (4,370 in the first category, 8414 in the second category, and 2,564 in the third category). Among them, there are 829 national key supervision enterprises and 1175 provincial key supervision enterprises. Generally speaking, the development of China's medical device industry has the following characteristics:

1. Regional development is good

With the development of China's medical device industry, several medical device industry clusters and manufacturing development zones have been formed nationwide. The three major regions of the Pearl River Delta, the Yangtze River Delta and the Beijing-Tianjin-Hebei Bay have become the three major medical device industry clusters. According to incomplete statistics, the sum of the total output value of medical devices in the three major regions and the sum of sales accounted for more than 80% of the national total. Because of the different conditions, the three industrial clusters have obvious regional characteristics.

Shenzhen-centered Pearl River Delta (including Zhuhai, Guangzhou, etc.), research and development and production of comprehensive high-tech medical device products is its strengths, the main products are monitoring equipment, ultrasound diagnosis, MRI and other medical imaging equipment and gamma knife, X-knife Such large stereotactic radiotherapy equipment, tumor hyperthermia equipment, etc., directly reflect the new technology of modern medical equipment. The export of medical equipment in Shenzhen has developed rapidly, and the regional production output has increased by more than 30%. Shenzhen's industrial advantages lies in the fields of electronics, computers, communications, and mechatronics. The development of modern medical devices is a combination of high-tech achievements in these fields, resulting in intensive advantages, coupled with Shenzhen's preferential policies and mechanisms. The stimulation and cultivation of factors such as the market have enabled the medical device industry to flourish in Shenzhen.

In recent years, Beijing-centered Bohai Bay area (including Tianjin, Liaoning, Shandong) has developed rapidly, including DR, MRI, digital ultrasound, accelerators, computer navigation and positioning medical equipment, respiratory anesthesia machines, orthopedic equipment and A group of cardiovascular equipment manufacturing companies are taking shape. A group of small and medium-sized enterprises has risen rapidly. These enterprises have been established for a few years, but the output value is close to or even more than 100 million yuan. With the help of the government's attention and their own technological capabilities, they are more inclined to digital medical equipment. Although the power displayed in the market is not very prominent and strong, it has strong momentum and great potential.

Shanghai has a profound industrial base. Whether it is products or technology, Shanghai is the leader in China's medical device industry. The Yangtze River Delta region with Shanghai as the center (including Jiangsu and Zhejiang) is one of the three major medical clusters in China. This region is characterized by rapid industrial development, active SMEs, and distinctive regional characteristics. Its disposable medical devices and consumables The domestic market share is more than half. In addition, there are ophthalmological equipment like Suzhou, medical ultrasound in Wuxi, microwave in Nanjing, radiofrequency tumor hyperthermia, Ningbo MRI and Shanghai's comprehensive strength, which are relatively prominent.

In addition, the Chongqing-centered Chengdu-Chongqing area is also an emerging area featuring biomedical materials and implantable devices and tissue engineering.

2. Trade is in a surplus, but the growth rate of imports is obviously stronger than that of exports.

The slowdown in China's economic growth in 2013 is a change in the growth pattern brought about by the current economic transformation and upgrading and structural adjustment. Although the growth rate is lower than the previous double digits, this growth is more important towards a more balanced, higher quality and more sustainable trend. The trade situation of China's medical devices in 2013 is that imports are obviously stronger than exports, which is inseparable from the current trend of differentiation of various economies in the world, such as moderate employment in developed economies but limited economic growth, inflationary pressures and economic growth in emerging economies. The constraints of rapid relaxation and other difficulties have led to a decline in the overall demand for medical devices in the global economy, and how much has a certain impact on the foreign trade of medical devices in China.

China's medical equipment foreign trade in 2013:

According to China Customs data, in 2013, China's total medical equipment trade reached US$34.31 billion, an increase of 14.13% year-on-year, an increase of 1 percentage point over last year. Among them, the export value was US$19.335 billion, a year-on-year increase of 9.92%, a decrease of 2 percentage points from last year. The import value was US$ 14.975 billion, a year-on-year increase of 20.07%, an increase of 5.5 percentage points over the previous year; the trade surplus was US$ 4.36 billion, down 14.8% year-on-year.

3. Increased research and development investment

China's medical device industry has basically formed a multidisciplinary research and development system. China has begun to enter a new stage of developing from mid-range products to high-end products, from small to large, from weak to strong. However, the core technology of high-end products is basically controlled by large foreign companies. At present, the state has increased investment in medical device research and development. The domestic medical device industry only establishes a technological innovation system that is enterprise-oriented, market-oriented, combining production, learning, research and use, fully integrates social resources, and drives industry development with group advantages, so that it is possible to better internationally. Get closer and get faster.

4. The overall level of the industry is at a moderately lower level internationally.

The innovation capability of China's medical device enterprises has increased, but technological innovation and ability to transform results have been weak. Key components depend on imports, and high-end products are still based on imitation and improvement. China's market potential is huge, and scientific and engineering research in some fields has reached the international advanced level. Moreover, the world's medical device frontier industry has only started for more than 10 years, and China is very hopeful to approach and catch up with the international level.

5. Foreign brands and joint venture brands have an advantage in the high-end market

The high-end medical equipment market is still monopolized by developed countries. Currently, high-end products on the market, such as CT, MRI and other high-end medical imaging products, are from a few developed countries such as the United States and Japan. They are advanced in technology and are the leaders in the development of the global medical device industry.

Second, the problems in the development of the medical device industry

In the past few decades, China's medical device industry has made great progress, and a number of key enterprises such as Shenzhen Mindray and Shandong Xinhua have emerged, which can produce 47 major categories, more than 3,500 varieties, and more than 12,000 kinds of products. The basic needs of disease diagnosis and treatment in China. However, compared with developed countries, there are still large gaps, mainly in the following aspects: 1. The scale of China's medical device industry continues to expand, but compared with the world's medical device powers, the industry scale is still small, accounting for only the world market share. 7% is far from meeting the needs of the 1.3 billion people. 2. The technology and product innovation capability of medical devices in China is still insufficient. The production enterprises account for more than 90%, the number of R&D companies is small, and the original technology and original products are less. Although the number of patents increases rapidly, the number of core patents is small, and the product development level is low. Relatively low, there are many low-end products, and key components depend on imports. High-end products are still based on imitation and improvement, and there are almost no original products.

1. Less investment in R&D, low level of innovation, and low core technology

The main reason is that the combination of production, learning and research is not tight. The medical and academic circles cannot truly meet the needs of enterprises. The combination of research and development and clinical is not tight. Products and technologies cannot truly meet the needs of medical care. Innovation and knowledge output have no interest guarantee. Mechanism; R&D expenses, clinical trial costs, registration fees, and market development costs are too large. In addition, the innovation support system is relatively weak, and there is still no systematic R&D team and infrastructure, the innovation chain is incomplete, the R&D layout is still not perfect, and there are many shortcomings in capacity building.

The serious lack of R&D investment is manifested in the lack of historical accumulation of investment and the lack of investment in the current period. Technological innovation requires long-term investment in time, capital and intelligence. The technical innovation of medical devices is lower than that of biomedicine in terms of cycle and capital, but the technological innovation of core products also requires a large amount of long-term investment. At present, China's overall pharmaceutical industry R & D investment accounts for 1-2% of sales revenue (medical equipment is 3%), while the foreign average is 15-18% (medical equipment is more than 15%). The serious shortage of funds makes China far behind foreign countries in the research and development of innovative medical devices. At present, China's medical device enterprises mainly focus on imitation and improved design. The main reason for the lack of R&D investment is that the individual scale of biomedical and medical device industry in China is small. The output value of the 40 largest medical device companies in the US accounts for 20% of the global medical device industry output, while there are more than 15,000 medical devices in China. Enterprises, the output value only accounts for about 5% of the global medical device industry. The scale of the enterprise is small, and it is impossible to make large-scale industrialization, so that the product cost is high and the profit is thin, which further leads to the homogenization competition of the enterprise.

2. National brands are in a weak position in the market, and medical expenses are high.

At present, more than 70% of high-end medical devices are monopolized by foreign companies in the market, which also increases the problem of expensive medical treatment to a certain extent. For example, about 80% of the CT market in China's medical device field, 90% of the ultrasonic instrument market, 85% of the test instrument market, 90% of the magnetic resonance equipment, 90% of the electrocardiograph market, 80% of the high-end monitor market, 90% of the high-end physiological recorder market, 95% of pacemakers, etc. are monopolized by multinational companies. At present, from the bidding situation of big cities, foreign-funded enterprises have occupied more than 80% of the domestic high-end and large-scale medical device market, and GE's market share has reached 50% to 60%. It can be seen that the domestic market share of domestic brand medical devices is still relatively low, especially high-end imaging products and high-end consumables. Although it seems that domestically produced products are gradually expanding their overseas market share, the domestically produced products are mainly processed and traded, with medium and low grades. In addition to the need to improve industrial competitiveness and the need to upgrade product grades, there is also a very important factor. Because many companies are small in scale, anti-risk and management capabilities are weak, and they are unable to implement quality system certification in line with international standards. Such as standards, so most products are also difficult to enter the international market.

3. There is a problem with the division of labor and cooperation with other industries, and the international competitiveness is weak.

The division of labor between the medical device industry and other industries mainly refers to the close relationship between its upstream and downstream industries. This kind of industrial chain is guided by market demand and is an objective phenomenon. With the further refinement of the division of labor and the more active market transactions, the medical device industry chain will be refined and optimized while extending. The upstream industry of medical devices in China will play a greater role in restricting the development of the medical device industry, directly affecting the technological direction of medical devices, especially the basic industries of the country, such as materials, electronics, machinery, energy, etc. An important factor in its development. On the basis of ensuring quality and reducing costs, it is an important issue for domestic medical device companies to adopt the mode of professional collaboration and preferential selection as much as possible. However, the problem of poor interdisciplinary and cross-industry collaboration is also a hindrance to the development of China's medical device industry.

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