With the further deepening of China's reform and opening up, social construction, economic construction and cultural construction have entered a new period of development. In this big social background, the public's demand for medical treatment is increasing gradually. The innovation and development of medical devices keep a fast and healthy trend, and the regulatory policy will be further improved.
In the past two years, the author has systematically studied the development of the medical device industry in China. By sorting out the development track and achievements of the medical device industry in the past 20 years, it is judged that the development of the medical device industry in China will enter a fast track in the next 10 years.
Eight Opportunities and Challenges
To analyze and summarize the current development of China's medical device industry, we can summarize the opportunities and challenges as follows:
1. National policy environment is conducive to industry development
The intensive promulgation and implementation of various policies from 2017 to 2018, the good regulatory environment has made the industry feel the arrival of the "good era"; the policy of 2015 put forward the "combination of health care" as the focus; the promulgation of "Healthy China 2030" in 2016, and the National Health and Health Conference upgraded "Healthy China" to a national strategy; Made-in-China 2025 was implemented in 7 years to accelerate the transition from a manufacturing power to a manufacturing power. In particular, the establishment of innovative medical device approval, MAH system and so on, has great advantages in policy, and the future development of the industry is full of expectations.
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 the growth rate of China's medical device industry will remain above 10% annually in the next 10 years. The proportion of sales of medical devices and drugs in China is about 0.25:1 at present. It is expected to further improve in the future. In this "golden period of development" of medical devices. ” It is not a fantasy for China to reach or exceed the target of 1:1 in developed countries.
3. New Medical Reform Stimulates the Rapid Growth of Middle and Low-end Instruments
Since the new health care reform, market increments in low and middle-end medical consumables, POCT, grass-roots laboratories and other fields, 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 "updating" and "filling the gap" of equipment and consumables in the grass-roots medical market remain the trend.
4. Continuous emergence of domestic innovative instruments
In recent years, the state has issued incentive 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 devices will come out, and many medical behaviors will be due to the emergence of new technologies and products. Change now.
5. Import and export continue to increase
Data show that changes in the international market demand and China's "one belt and one way" policy guidance have led to unexpected results in exports and good momentum. With the improvement of science and technology in China, the structure of "low value" will inevitably change.
6. Acceleration of Industry Mergers and Accelerations
Mergers and acquisitions in the circulation field, represented by enterprises such as Guoyao, Shangyao, Jiuzhou Tong and Ruikang Pharmaceuticals, have risen one after another. Horizontal and vertical mergers and reorganizations of enterprises are also in the ascendant, stirring up the overall industrial structure. We have reason to believe that this trend will continue, and some regional leading enterprises will join the merger and acquisition tide and cross-border. M&A is on the rise.
7. Vigorous Development of Household Appliances
Data show that the current market size of household medical equipment is about 75 billion yuan, with an annual growth rate of 25%. Diagnostic and monitoring instruments, such as traditional sphygmomanometer, blood glucose meter, stethoscope, etc., treatment equipment, such as family personal hemodialysis machine, rehabilitation equipment, such as medical beds, intelligent workstations and so on, have performed well, and there have been many new intelligent products based on the Internet. In 2018, the state promulgated "Internet + medical care". The relevant documents will promote the listing of new products based on "Internet +".
8. Accelerated rise of third-party services
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" service. There will be more and more third-party service modes such as medical asset management, overall maintenance solutions, cost packaging and other emerging logistics platforms, disinfection and so on. The tripartite intensive service model will also emerge.
Ten Development Trends in the Future
Looking forward to the future, there are ten significant trends in the development of China's medical device industry:
1. The medical device industry has shown remarkable performance in the new cycle of economic development. With the advent of the new national economic cycle, the government's ministerial reform has redefined the responsibilities of various government departments, and the policies have re-positioned the responsibilities of R&D, registration, procurement, production, distribution, sales, quality and agency. The pilot and implementation of MAH system for medical device Market license holders is to clarify the responsibility of product holders from the perspective of "responsibility". The development of the industry is facing unprecedented opportunities.
2. With the implementation of the Healthy China Strategy and Healthy 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, based on "big health, David students, big medicine". The basic medical and health industry is expected to become a fast-growing industry in the development of national economy, and become the pillar and new driving force of China's economic development.
3. Policy and industrial planning guide the medical device industry to improve its concentration. Mergers and reorganizations will intensify in the next 2-3 years, and the concentration will increase rapidly. The medical device industry is more dispersed and will tend to be centralized in the future. With the implementation of policies such as "two-vote system", "business increase", "No. 94" and "industry rectification", as well as the new version of GSP to make higher requirements on enterprise procurement, acceptance, storage, distribution and other links, the industry integration will intensify and the concentration will be in the next 2-3 years. It will be promoted rapidly.
4. With the advancement of the supply-side structure reform in the medical industry, it will further clear up the "inventory" and bring new demand to the new supply. The industry will face tremendous changes. After nearly two years of efforts, the drug regulatory system actively resolves the backlog of approval, speeds up the approval of innovative devices, cracks down on the falsification of clinical trial data, and verifies the process consistency. We should eliminate the approval documents for medical equipment zombies, intensify flight inspection, eliminate backward production capacity with low technical level and high product repeatability, and "small, scattered, poor and disorderly" business enterprises. Through the "two-vote system" and GMP/GSP flight inspection, the old marketing model will be eliminated. Reforming from the supply side, the new supply of one unit can bring new demand of N units, which will accelerate the progress of the industry.
5. The state's supervision of the industry is becoming more and more stringent. Non-standard enterprises are eliminated. The market environment of the industry will be gradually improved. Flight inspection will be vigorously carried out to eliminate unhealthy tendencies in the industry. In 2018, more efforts have been made to regulate policy compliance. Regulating operation and finance has become a test of the traditional marketing model. Policies of combating monopoly, administrative intervention and commercial bribery have continued to be vigorous. We affirm that compliance enterprises are the hope of the future. Illegal enterprises will be phased out and the industry environment will be gradually improved.
6. New technologies can create efficiency and save costs for medical service institutions and patients, and also enable medical device enterprises to play a more extensive role in prevention, diagnosis, treatment and care. 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 +" will be closely integrated with the medical device industry. 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 production and circulation of medical devices can be supervised by means of information technology. With the advent of 5G era, the interconnection of all things will greatly improve the wide application of medical devices. At present, the information traceability mechanism, system and coding in the field of medical devices are not perfect enough, and need to be further improved.
8. In the market and clinical application, a new model of "integration of drugs and devices" will emerge. Drugs and devices play a synergistic role in the diagnosis and treatment of medical institutions and patients'health care. 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 breakthrough points in the development of devices. It will become the mode of "Drug + Device Development Together".
9. Capital promotes the step-by-step development of the medical device industry. Mergers and reorganizations in the field of domestic and international devices are in the ascendant. In 2018, capital will develop in the direction of high-quality investment, giving unlimited impetus to the development of medical device enterprises.
10. AI application service will develop rapidly. Artificial intelligence technology, medical robots, large medical equipment, emergency rescue medical equipment, biological three-dimensional printing technology and wearable equipment will make breakthroughs. In April 25, 2018, the opinions on promoting the development of "Internet + medical health" (issued by the State Council [2018] 26) were issued by the general office of the State Council and clearly stated: "promoting the" Internet + "AI application service. Research and development of clinical diagnosis and treatment decision support system based on artificial intelligence, develop intelligent medical image recognition, pathological classification and multidisciplinary consultation, as well as intelligent voice technology application under various medical and health scenarios, improve the efficiency of medical services; "Strengthen the integration and sharing of clinical and scientific research data and application, support the development of medical and health phase." Artificial intelligence technology, medical robots, large medical equipment, emergency rescue medical equipment, biological three-dimensional printing technology and wearable equipment, etc. From the policy level, it provides guarantee for the development of AI medical treatment.
