Medical device industry usher in "Golden Period of Development"

By sorting out the development track and achievements of China's medical device industry in the past 20 years, it can be judged that the development of China's medical device industry will enter the fast track in the next 10 years, ushering in the "golden period of development", further improving regulatory policies, and maintaining a rapid and healthy trend of innovative development.

Opportunities and Challenges

The national policy environment is conducive to the development of the industry. From 2017 to 2018, various policies were introduced in an intensive manner, and the "Healthy China Strategy" was included in the report at the 19th National Congress of the CPC. The speed of review and approval of innovative medical devices has been accelerated, and the pilot registrant system has been continuously promoted. The huge favorable policies and favorable regulatory environment have made the industry feel the arrival of the "* era".

The market will continue to grow and expand. In the past 5 years, the compound growth rate of China's medical device industry has been maintained at about 15%, and it is expected that the growth rate of the industry will keep at an average annual rate of more than 10% in the next 10 years. At present, the sales ratio of medical devices and drugs in China is about 0.25∶1. In the "golden development period" of this round of medical devices, it is very promising that this ratio will reach or exceed the goal of 1:1 in developed countries in the future.

The new medical reform policy has stimulated the rapid growth of middle and low-end medical devices. Since the launch of the new medical reform, the market increase of middle and low-end medical consumables, POCT (instant test), grassroots laboratories and other fields has been obvious, and the production and operation enterprises of medical devices have paid more and more attention to the grassroots market, which has shown the changes of the market. In 2019, in the primary medical care market, "upgrading" and "filling the gap" of equipment and consumables are still the development trends.

In recent years, the state has successively introduced policies to encourage domestic medical devices, and the domestic medical device industry is greatly encouraged by good policies and incentives. It can be predicted that in the next three to five years, there will be a large number of domestic innovative medical device products, and many medical behaviors will be changed due to the emergence of new technologies and new products.

The import and export of medical devices continues to increase. Data show that with the change of international market demand and the guidance of China's "One Belt And One Road" initiative, China's medical device export has a good momentum. And with the improvement of science and technology level in China, the product structure dominated by "low value" will also change.

Industry merger and reorganization will accelerate, in recent years, the circulation field to the national medicine, Shangyao, Jiuzhou Tong, Ruikang pharmaceutical and other enterprises as the representative of the merger and reorganization one after another, the production enterprise horizontal and vertical merger and reorganization is also in the ascendant. This trend will continue in 2019, and some regional leading enterprises will also join the m&a tide, and cross-border M&A is on the rise.

Domestic medical equipment is booming. Data show that the market size of domestic medical equipment in China 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. Therapeutic equipment, such as family personal hemodialysis machines; Rehabilitation devices, such as medical beds and intelligent workstations, have performed well, and many new intelligent products based on the Internet have emerged.

The rise of third-party medical device services, it is estimated that medical device services market will have a market capacity of 100 billion yuan. Medical imaging, examination, blood purification and pathology are still the main fields of "third party". There will be more and more third-party service modes such as medical asset management, overall maintenance solutions and cost packaging. Logistics platform, disinfection and other emerging third-party intensive service models will emerge.

Future development trend

The industry has a prominent performance in the new cycle of economic development. With the national institutional reform in place, the responsibilities of various government departments have been further clarified, and the responsibilities of medical device research and development, registration, procurement, production, distribution, sales, agents and other links have also been re-defined in various policies. The pilot and implementation of medical device registrant system is to clarify the rights and responsibilities of product registrants from the perspective of "responsibility", and the development of the industry is facing the opportunity of *.

The medical device industry will play an important role in the development of the great health industry. As "health China strategy" and the "healthy China 2030" planning outline of the implementation of, big health industry will be * a wave of economic development in our country, in order to "big health, health, medicine," on the basis of medical health industry is expected to become the industry is growing rapidly in the development of national economy, became the mainstay of China's economic development and new energy, medical apparatus and instruments will play an important role in it.

Policies and industrial planning guide the improvement of medical device industry concentration. At present, the medical device industry as a whole is relatively dispersed. With the implementation of policies such as "two-ticket system" and "replacing business tax with VALUE-ADDED tax", and the new VERSION of GSP puts forward higher requirements for enterprises' procurement, acceptance, storage, distribution and other aspects, merger, reorganization and integration will be intensified in the next two to three years, and the industry concentration will increase rapidly.

New supply brings new demand, and the industry environment is gradually improving. With the advance of supply-side structural reform in the medical industry, the "inventory" of medical devices will be further cleared. Drug regulators are working hard to eliminate the backlog of approvals, speed up the review and approval of innovative medical devices, crack down on the falsification of clinical trial data, and check the consistency of manufacturing processes. At the same time, the state has increasingly strict supervision over the industry, intensifying flight inspection, and eliminating backward production capacity with low technical level and high product repeatability as well as "small, scattered, poor and chaotic" operating enterprises. If non-standard enterprises are eliminated, the market environment of the industry will gradually improve.

New technologies and products are constantly emerging. New technologies can create efficiency and save costs for medical service institutions and patients. Medical device enterprises will play a greater role in prevention, diagnosis, treatment and care. In the next three to five years, the medical device industry will introduce a large number of innovative products, and the traditional diagnosis and treatment will be overturned.

"Internet +" will be closely combined with the medical device industry, and information means can supervise the whole process of the production and circulation of medical devices, so as to realize the traceability of product information. With the advent of the 5G era, the "Internet of everything" will greatly expand the application scope of medical devices. In the aspect of market and clinical application, it will give birth to a new model of "drug + medical device integration". Drugs and medical devices play a synergistic role in the diagnosis and treatment of medical institutions and the health protection of patients. In recent years, some manufacturers have successfully explored the integrated marketing model of "drug and device integration", such as LPL Medical, Astrazeneca, etc. Some medical commercial enterprises also seek a breakthrough point in the development of medical devices and form a "drug + medical devices" common development model.

Artificial intelligence application services will develop rapidly, and breakthroughs will be made in artificial intelligence technology, medical robots, large medical devices, emergency medical devices, biological 3D printing technology and wearable devices. 20 April 18 years, issued by The General Office of the State Council on promoting the development of the "Internet + medical health" opinions "clearly put forward: to promote" Internet + "artificial intelligence application service, research and development of clinical diagnosis and treatment decision support system based on artificial intelligence, intelligent medical image recognition, pathological classification and multidisciplinary consultation, as well as a variety of health care scenarios of intelligent speech technology, improve the efficiency of medical service; We will strengthen the integration, sharing and application of clinical and scientific research data, and support the research and development of artificial intelligence technologies, medical robots, large medical devices, emergency medical rescue medical devices, bio-3D printing technologies and wearable devices in the medical and health field. From the policy level for artificial intelligence medical development to provide a guarantee.