8 opportunities and 10 trends of medical device industry

With the development of society and economy, the medical device industry is also developing rapidly. So what opportunities and challenges are China's medical device enterprises facing?

Eight opportunities and challenges analysis and summary of the development of China's medical device industry at this stage, the opportunities and challenges can be summarized as follows:

1. National policy environment is conducive to industry development In 2017-2018, various policies were issued and implemented intensively, and good regulatory environment made the industry feel the arrival of "the best era"; in 2015, the policy proposed "combination of medical care and maintenance"; in 2016, the health China 2030 was issued, and the national health and health conference raised "healthy China" to national strategy; in 2017, the made in China 2025 was implemented to accelerate the implementation of the system from scratch The manufacturing power turns to the manufacturing power. In particular, the establishment of the evaluation and approval of innovative medical devices, the establishment of MAH system, etc., are of great benefit in terms of policies, and the industry is full of expectations for future development.

2. Continuous market expansion In the past five years, China's medical device industry has maintained a compound growth rate of about 15%. It is expected that in the next 10 years, the growth rate of China's medical device industry will maintain an average annual growth rate of more than 10%. The proportion of China's medical device and drug sales is now about 0.25:1, which is expected to be further improved in the future. In the "golden development period" of this round of medical devices, the goal of 1:1 in developed countries will be achieved or exceeded It's not the end of the world.

3. Since the new medical reform stimulated the rapid growth of middle and low-end devices and new medical reform, the market increment of middle and low-end medical consumables, POCT, grass-roots laboratories and the production and operation enterprises of devices have paid more and more attention to the grass-roots market, which has shown changes in the market. In 2018, the "upgrading" and "filling the gap" of equipment and consumables in the grass-roots medical market still become a trend.

4. Domestic independent and innovative instruments continue to emerge In recent years, the state has successively issued encouraging policies for domestic medical devices. Good policy incentives have encouraged the domestic medical device industry to develop rapidly. It can be predicted that in the next three to five years, a large number of domestic innovative medical device products will come out, and many medical behaviors will change due to the emergence of new technologies and new products.

5, one belt, one road and another, continues to increase. The data show that the change of international market demand and the policy of "one belt and one road" have led to unexpected results and good momentum. With the development of science and technology in China, the structure of "low value" will inevitably change.

6. The industry merger and reorganization accelerates the merger and reorganization in the circulation field represented by Guoyao, Shangyao, Jiuzhoutong, Ruikang pharmaceutical and other enterprises. The horizontal and vertical merger and reorganization of production enterprises are also in the ascendant, stirring the overall industry pattern. We have reason to believe that this trend will continue, and some regional leading enterprises will also join the merger and acquisition tide, cross-border merger and acquisition is on the rise.

7. According to the booming development of household devices, the market scale of household medical devices is about 75 billion yuan, with an annual growth rate of 25%. Diagnostic and monitoring instruments, such as traditional blood pressure monitor, blood glucose meter, stethoscope, etc., treatment equipment, such as family hemodialysis machine, rehabilitation equipment, such as medical beds, intelligent workstations, etc., have performed well, and there have been many new intelligent products based on Internet. In 2018, the state promulgated the Internet plus medical care related documents, which will promote Internet plus. The new products based on are on the market.

8. The rise of third party service It is estimated that the medical device service market will have a market capacity of 100 billion yuan; medical imaging, inspection, blood purification and pathology will still be the main areas of "third-party", medical asset management, overall maintenance solutions, cost packaging and other third-party service modes will be more and more, and emerging three-party intensive service modes such as logistics platform and disinfection will emerge.

Looking forward to the future ten development trends, the development of China's medical device industry presents ten significant development trends:

1. The medical device industry is outstanding in the new cycle of economic development. With the arrival of the new national economic cycle and the reform of the government's large-scale system, the responsibilities of various departments of the government have been redefined, and the responsibilities of various links such as R & D, registration, procurement, production, distribution, sales, quality and agency have also been repositioned in various policies. The pilot and implementation of MAH is to clarify the responsibilities of product holders from the perspective of "responsibility". The development of the industry is facing unprecedented opportunities.

2. With the implementation of Health China strategy and health China 2030, the big health industry will lead a new wave of economic development in China in the future, in which medical devices will play a huge role; in the future, the big health industry will face unprecedented opportunities and challenges, and the health industry based on "big health, big health and big medicine" is expected to become the national economy The fastest growing industry has become the pillar and new power of China's economic development.

3. Policies and industrial planning guide the concentration of medical device industry to improve. Merger and reorganization will intensify in the next 2-3 years, and the concentration will increase rapidly. The medical device industry as a whole is relatively scattered and will tend to be centralized in the future. With the implementation of policies such as "two ticket system", "yinggaizeng", "No. 94 document" and "industry rectification", as well as the higher requirements of the new GSP for enterprise procurement, acceptance, storage, distribution and other links, the industry integration will be intensified and the concentration will be rapidly improved in the next 2-3 years.

4. With the advancement of supply side structural reform in the medical industry, the "inventory" will be further cleared, new supply will bring new demand, and the industry will face great changes; after nearly two years of efforts, the pharmaceutical supervision system will actively solve the backlog of approvals, accelerate the approval of innovative devices, crack down on clinical trial data fraud, process consistency verification, etc., and eliminate zombie approvals for medical devices; increase flight Inspection efforts shall be made to eliminate backward production capacity with low technology level and high product repeatability as well as "small, scattered, poor and disorderly" business enterprises. Through "two ticket system" and GMP / GSP flight inspection, the old marketing mode was eliminated. From the supply side of reform, a unit of new supply can bring n units of new demand, will accelerate the progress of the industry.

5. The state's supervision on the industry is becoming more strict, and the enterprises that are not standardized will be eliminated, and the market environment of the industry will be gradually improved; a great deal of flight inspection will be carried out to eliminate the unhealthy trend of the industry. In 2018, more efforts were made to control policy compliance. Standardizing operation and finance became the test of traditional marketing mode, and the policy of combating monopoly, administrative intervention and commercial bribery continued to make efforts. We assert that compliance enterprises are the hope of the future, illegal enterprises will be gradually eliminated, and the industry environment will gradually improve.

6. New technology can create efficiency and save costs for medical service institutions and patients, and also enable medical device enterprises to play a broader role in prevention, diagnosis, treatment and nursing. We predict that in the next three to five years, the medical device industry will introduce a large number of innovative products, and traditional diagnosis and treatment will be fundamentally subverted.

7, "Internet plus" will be closely integrated with the medical device industry, and the information level of the whole industry will be generally promoted, so that the information of products can be traced back, and the whole process of medical device production and circulation can be supervised by means of information technology. With the coming of 5g era, Internet of everything will greatly improve the wide application of medical devices. At present, the information tracing mechanism, system, coding and so on in the field of medical devices are not perfect, and need to be further improved.

8. In the aspect of market and clinical application, it will give birth to a new mode of "drug + device integration". Drugs and devices play a synergistic role in the diagnosis and treatment of medical institutions and health care of patients. In recent years, some manufacturers have explored the integrated marketing mode of "integration of drugs and devices", and achieved success, such as Lepu medical, AstraZeneca, etc.; some pharmaceutical commercial enterprises have also found a breakthrough point in the development of devices, forming the mode of "common development of drugs and devices".

9. Capital helps the medical device industry develop step by step. Merger and reorganization in the field of international and domestic devices is in the ascendant. In 2018, capital will develop towards the direction of high-quality investment, giving unlimited power to the development of medical device enterprises.

10. AI application services will develop rapidly. There will be breakthroughs in artificial intelligence technology, medical robots, large-scale medical equipment, emergency rescue medical equipment, biological 3D printing technology and wearable equipment. In April 25, 2018, the opinions on promoting the development of Internet plus medical health (No. 26 of 2018) were issued by the general office of the State Council, and clearly stated: "promote Internet plus" AI application services. Research and develop the clinical diagnosis and treatment decision support system based on artificial intelligence, carry out the application of intelligent medical image recognition, pathological classification and multi-disciplinary consultation, and intelligent voice technology in a variety of medical and health scenarios to improve the efficiency of medical services; "strengthen the integration and application of clinical and scientific research data, support the research and development of medical and health-related artificial intelligence technology, medical robots, large-scale Medical equipment, emergency rescue medical equipment, biological 3D printing technology and wearable equipment, etc. From the policy level, it provides guarantee for the development of AI medicine.