In the past two years, the author has edited the "Blue Book of Medical Devices" to systematically study the development of the industry.Through the combing of the development track of China's medical device industry in the past 20 years and the achievements, we can judge that in the next 10 years,The development of China's medical device industry will enter the fast-track, ushered in the "golden development period", the regulatory policy will be further improved, and innovation and development will maintain a rapid and healthy situation.
Opportunities and Challenges
The national policy environment is conducive to the development of the industry. From 2017 to 2018, various policies were intensively introduced, and the party's 19th National Congress wrote the report on “Healthy China Strategy”.Innovative medical device review and approval speed has accelerated, and the registrant system has been continuously promoted. The huge policy and good regulatory environment have made the industry feel the "best time".
The market will continue to grow and expand. In the past five years, the compound growth rate of China's medical device industry has remained at around 15%. It is expected that the industry growth rate will remain above 10% annually in the next 10 years.At present, the sales ratio of medical devices and drugs in China is about 0.25:1. In this round of "golden development period" of medical devices, it is also promising that the future ratio will reach or exceed the target of 1:1 in developed countries.
The market increments in the areas of (instant inspection) and grassroots laboratories are obvious. Medical device production and operation enterprises are paying more and more attention to the grassroots market, and the market has changed.In 2019, the new medical reform policy at the grassroots level stimulated the rapid growth of low-end medical devices. Since the launch of the new medical reform, low-end medical consumables, POCT medical market, equipment and consumables “renewed” and “filling gaps” are still developing trends.
Domestically-made independent innovative medical devices have emerged. In recent years, the state has successively introduced incentive policies for domestic medical devices, and good policy incentives have encouraged the domestic medical device industry.It is foreseeable that in the next three to five years, a large number of domestically produced innovative medical device products will be available, and many medical behaviors will change due to the emergence of new technologies and new products.
The import and export of medical equipment continued to increase. The data shows that with the changes in the international market demand and the guidance of China's “One Belt, One Road” initiative, China's medical equipment exports are gaining momentum.And with the improvement of China's scientific and technological level, the product structure based on "low value" will also change.
。Industry mergers and restructuring will accelerate. In recent years, mergers and acquisitions represented by Sinopharm, Shanghai Pharmaceutical, Jiuzhoutong, Ruikang Medicine and other enterprises in the circulation field have been one after another. The horizontal and vertical mergers and acquisitions of production enterprises are also in the ascendant.This trend will continue in 2019, and some regional leading companies will also join the tide of mergers and acquisitions, cross-border mergers and acquisitions is on the rise.
Home medical equipment is booming. According to the data, the market size of China's home medical equipment is about 75 billion yuan, with an annual growth rate of 25%.Diagnostic monitoring instruments, such as traditional sphygmomanometers, blood glucose meters, stethoscopes, etc.; therapeutic equipment, such as home personal hemodialysis machines;Rehabilitation equipment, such as medical beds and smart workstations, have performed well, and many new intelligent products based on the Internet have emerged.
The rise of third-party services for medical devices is estimated to have a market capacity of 100 billion yuan in the medical device service market.Medical imaging, testing, blood purification, and pathology are still the main areas of “third-party”;Third-party service models such as medical asset management, maintenance solutions, and cost packaging will be more and more; emerging third-party intensive service models such as logistics platforms and disinfection will emerge.
Future trends
The industry is eye-catching in the new cycle of economic development. With the reform of state institutions, the responsibilities of various government departments are further clarified, and the various policies are responsible for the research, development, registration, procurement, production, distribution, sales, and agency of medical devices. It has also been re-clarified.The pilot and implementation of the medical device registrant system is to clarify the rights and responsibilities of product registrants from the perspective of “responsibility”, and the industry is facing unprecedented opportunities.
The medical device industry will play an important role in the development of the big health industry. With the implementation of the “Healthy China Strategy” and the “Health China 2030 Plan”,The big health industry will lead China's new wave of economic development. The medical and health industry based on “health, health, and medicine” is expected to become the fastest-growing industry in the development of the national economy.As a pillar and a new impetus for China's economic development, medical devices will play a huge role in it.
Policy and industry planning have led to increased concentration in the medical device industry. At present, the medical device industry is generally scattered. With the implementation of the “two-vote system” and “reform of the camp”,And the new version of GSP puts forward higher requirements for enterprise procurement, acceptance, storage, distribution, etc. In the next two to three years, mergers, restructuring, and integration will intensify, and industry concentration will increase rapidly.
New supply brings new demand, and the industry environment is gradually improving. With the advancement of the supply-side structural reform of the medical industry, the “inventory” of medical devices will be further cleared.The drug regulatory authorities are actively addressing the backlog of approvals, accelerating the review and approval of innovative medical devices, combating fraud in clinical trial data, and conducting consistency checks on production processes.At the same time, the state's supervision of the industry has become more stringent, increasing the intensity of flight inspections, eliminating backward production capacity with low technical level and high product repeatability, and operating enterprises of “small, scattered, poor, chaotic”.If the non-standard enterprises are eliminated, the industry market environment will gradually improve.
New technologies and new products are constantly emerging. New technologies can create efficiency and save costs for medical service organizations and patients. Medical device companies will play a greater role in prevention, diagnosis, treatment and care.In the next 3 to 5 years, the medical device industry will introduce a large number of innovative products, and traditional diagnosis and treatment will be subverted.
"Internet +" will be closely integrated with the medical device industry. The information technology can supervise the whole process of medical device production and circulation, and realize the traceability of product information.With the advent of the 5G era, “Internet of Everything” will greatly expand the application range of medical devices. In the market and clinical applications, a new "drug + medical device integration" model will be created.Drugs and medical devices play a synergistic role in the diagnosis and treatment of patients in medical institutions.In recent years, some manufacturers have succeeded in exploring the integrated marketing model of “pharmaceutical-integration”, such as Lepu Medical, AstraZeneca, etc.; some pharmaceutical commercial enterprises are also looking for breakthroughs in the development of medical devices, forming “drugs+” The mode of joint development of medical devices.
Artificial intelligence application services will develop rapidly, and breakthroughs will be made in artificial intelligence technology, medical robots, large medical equipment, emergency medical equipment, biological 3D printing technology and wearable devices.In April 18, 18, the "Opinions on Promoting the Development of "Internet + Medical Health" issued by the General Office of the State Council clearly stated:Advance the "Internet +" artificial intelligence application service, develop a clinical diagnosis and treatment decision support system based on artificial intelligence, carry out intelligent medical image recognition, pathological typing and multidisciplinary consultation, as well as intelligent voice technology applications in various medical health scenarios, improve medical care Service efficiency.Strengthen the integration and application of clinical and scientific research data, and support the development of artificial intelligence technology, medical robots, large medical equipment, emergency rescue medical equipment, biological 3D printing technology and wearable equipment in the field of medical health.From the policy level, it provides a guarantee for the development of artificial intelligence medical care. (Geng Hongwu Author: Tsinghua University Old Science and Technology Association Medical Health Research Center)