In recent years, China has introduced a series of policies and regulations, coupled with the domestic medical and health care institutions equipped with the demand for upgrading, to promote the development of China's medical equipment industry.
In 2014, China completed the revision of its mother law on medical devices, the Regulations on the Supervision and Administration of Medical Devices (the new regulations), and issued five departmental regulations and dozens of normative documents.
In 2015, the State Council issued "Made in China 2025", which clearly puts new materials, biomedicine and high-performance medical devices as one of the ten key areas of development, and puts forward the need to improve the innovation capacity and industrialization level of medical devices, focusing on the development of medical imaging equipment, medical robots and other high-performance diagnostic and therapeutic equipment, high-value consumables such as full-degradation vascular stents, and wearable, remote diagnostic and other mobile medical products. The main focus is on the development of medical imaging equipment, medical robots and other high-performance diagnostic and treatment equipment, high-value consumables such as fully degradable vascular stents, wearable, remote diagnostic and other mobile medical products.
In 2017, the "Opinions on Deepening the Reform of the Review and Approval System to Encourage Innovation in Drugs and Medical Devices" was released, and the new initiatives of the listed license holder system and the "two-invoice system" were launched, and the "Twelfth Five-Year Plan" was adopted, The release of the "13th Five-Year Plan" for medical device science and technology innovation will reshape the medical device market in China.
In 2018, China's medical device market size of about 530.4 billion yuan, an increase of 19.86%, 2014-2018 CAGR of about 20.2%, significantly exceeding the average growth rate of the global medical device market.
China has become the world's second largest medical device market after the United States. Compared to the global consumption ratio of medical devices to pharmaceuticals, which is about 1:1, China's medical device market still has a lot of room for development (the ratio of medical devices to pharmaceuticals is 0.3:1).
Overall, China's medical device industry is still in the lower middle level, but some high-end devices have begun or completed import substitution (such as high-end imaging equipment, cardiac stents, heart blockers, etc.).
The proportion of medical device enterprises in listed pharmaceutical and biological enterprises increased from 6.7% in 2009 to 17.4% in 2018, and the total market value of pharmaceutical and biological enterprises increased from 5.8% in 2009 to 15% in 2018.
In recent years, the medical device index has performed well in terms of market returns, second only to medical services in terms of valuation, and the concentration of the industry has increased significantly.
The brokerage research report pointed out that diagnostic imaging equipment, clinical testing equipment and reagents, orthopedic medical devices, cardiac and macrovascular interventional devices, etc. are important segments of the medical device industry, the market space is large, and the industry growth trend is good.
Diagnostic imaging equipment refers to the use of a variety of different media as a carrier of information, the internal structure of the human body is reproduced as an image of a variety of instruments, including X-ray photographic systems (traditional X-ray machine, digital photography DR, digital subtraction contrast machine DSA), magnetic *** vibration imaging system (MRI), ultrasound diagnostic systems, computed tomography (CT) and nuclear medicine equipment (PET. SPECT, PET-CT), and the use of the latest technology and technology to improve the quality of medical equipment, SPECT, PET-CT/MR), and so on.
Diagnostic imaging equipment has high technical barriers and is greatly influenced by technology and policy. At present, China's diagnostic imaging equipment industry is mainly occupied by foreign brands, while with the development of domestic technology in recent years, some large-scale equipment has a certain degree of import substitution ability.
2015-2017, China's diagnostic imaging equipment market size from 36.6 billion yuan to 49.9 billion yuan, the annual growth rate of more than 16%. It is expected that in 2021, China's imaging equipment market size will reach nearly 90 billion yuan.
More than 60% of China's medical imaging equipment market is occupied by overseas enterprises. In recent years, with the support of national policies, increased investment in research and development, and the continuous updating of technology, a number of high-quality medical imaging companies have emerged in China, such as Myriad Bio, United Medical, etc.
Clinical testing and diagnostic equipment market size has increased from 36.6 billion yuan to 49.9 billion yuan.
Clinical testing refers to a series of laboratory tests and test results provided by clinical laboratories (including hospital laboratories and laboratories, as well as independent clinical testing centers and laboratories) for clinical medicine, which are used for the diagnosis of diseases.
Clinical testing equipment and reagents industry mainly includes blood analysis, biochemical analysis, immunoassay and molecular diagnostics and other segments, plays an important role in the process of disease diagnosis.
The innovation of medical technology, the aging of the population, the improvement of the income level, and the improvement of the national health insurance system have driven the continuous growth of China's clinical testing equipment and reagents industry, and the market size of the industry has maintained a growth rate of 15%-20% from 2015 to 2017.
In 2017, China's clinical testing equipment and reagents market size of 55.2 billion yuan, a year-on-year growth of 19.8%, is expected to reach 114.3 billion yuan by 2021.
In recent years, China's clinical testing equipment and reagents industry has entered a period of rapid development, high-end clinical testing equipment relies on imports, low-end clinical testing equipment domestic products accounted for a large proportion.
Myriad Medical: The continuous increase in the company's cumulative installed capacity of instruments has led to the sale of supporting reagents, the company's chemiluminescence immunity reagents from the beginning of 2015 increased from 27 to 64 at the end of 2017, the company's sales of in vitro diagnostic reagents is growing rapidly. The market share of Myriad in China's blood analysis field has reached 20.7%, and the share of biochemical field has reached 13.2%.
Kewa Bio: The company's products cover a wide range of fields such as immunodiagnostics, molecular diagnostics and POCT. Its market share in molecular diagnostics in China is about 9%.
Daan Genetics: Its instrumentation products include fluorescence quantitative PCR instrument, nucleic acid extractor, automatic nucleic acid molecular hybridizer, etc. Its reagents include fluorescence quantitative PCR series products and time-resolved series products, etc. It has an 18% share in China's molecular diagnostic field. In China, it accounts for 18.8% in molecular diagnosis, 2.3% in biochemical analysis and 1.7% in immunodiagnosis.
AnTuBio: the leading immunodiagnostic company in China, with a market share of about 4% in 2017.
Orthopedic medical devices is one of the important sub-industries in the medical device industry. According to different physical structures, they can be divided into internal fixation and external fixation:
1) Internal fixation refers to joints, splints, screws, etc. implanted in the body;
2) External fixation mainly refers to external fixation frames, splints, bandages, plasters, etc., which are fixed outside the body. From the therapeutic point of view, orthopedic medical devices can be divided into trauma, spine, joints and other categories (such as surgery, neurosurgery, etc.).
Accelerated aging is one of the important reasons for the development of orthopedic medical devices. The elderly is the high incidence of osteoporosis, and osteoporosis is one of the most important causes of orthopedic diseases. China's population over 65 years old rose from 113 million in 2009 to 166 million in 2018, and the proportion of the total population increased from 8.5% to 11.9%.
It is expected that around 2050, the number of elderly people in China will reach a peak of 487 million, accounting for 34.9% of the total population.
In 2017, China's orthopaedic medical device market size reached 22.6 billion yuan, up 17.1% year-on-year, and it is expected that the size of the market will reach 40.1 billion yuan in 2021.
China's orthopedic medical device market is mainly monopolized by overseas enterprises. The dominant enterprises in China for spinal products are Johnson & Johnson and Medtronic, for joint products, there are Jiemai Bangmei, and for trauma products, there are Johnson & Johnson.
It is worth mentioning that some domestic advantageous enterprises seize the good time for the development of orthopaedic medical devices, and emerge in some areas, gradually seize the market share, such as spine category of Weigao Orthopaedics, Kelite, trauma category of the Dabo medical, etc.
The heart and the heart of the company are the most important products in China.
Cardiac and macrovascular interventional devices are mainly related to cardiovascular, cerebrovascular, peripheral vascular, electrophysiology, etc., and the sub-products mainly include vascular stents, artificial pacemakers, artificial valves, catheters, wires, balloons, etc.
The industry has entered into a new phase of development of cardiovascular and macrovascular interventional devices.
The industry has high barriers to entry, and most products are highly dependent on imports. Cardiac and large-vessel interventional devices are classified as Class III medical devices, with strict manufacturer licenses and product registration systems. The long research and development period, rapid market update, and the basic synchronization of domestic and overseas product launches have constituted important barriers to entry into the industry.
Except for coronary stents, whose technology development is more mature and whose import substitution has been basically completed, most of the cardiac and large-vessel interventional devices in China are still in the state of monopoly by foreign investors, and the major foreign giants are Medtronic, Cook, Abbott, Boston Scientific, etc.
The Chinese government's policy on cardiac and large-vessel interventional devices is based on the principle of "one country, two systems".
The China Cardiovascular Disease Report 2017 shows that there are 290 million people suffering from cardiovascular disease in China, including 13 million people suffering from stroke, 11 million people suffering from coronary heart disease, 5 million people suffering from pulmonary heart disease, 4.5 million people suffering from heart failure, 2.5 million people suffering from rheumatic heart disease, 2 million people suffering from congenital heart disease, and 270 million people suffering from high blood pressure.
Interventional therapy has become a major therapeutic means of treating cardiovascular diseases, with the increase of cardiovascular patients on the demand for interventional therapy, China's cardiac and macrovascular interventional device market size is expanding. 2017, China's cardiac and macrovascular interventional device market size of 43.6 billion yuan, is expected to reach 70.8 billion yuan in 2021.
Domestic enterprises, such as Lepu Medical, Wicresoft, JWT, and other high-quality enterprises in China's cardiac stent field accounted for a high proportion, but the competitiveness of the high-end market is still insufficient.
In the field of prosthetic valves and pacemakers, international brands such as Medtronic and Abbott/St. Jude occupy a high market share.
LPMC: In 2017, the company's pacemaker market share in the domestic market is about 11%, the stent market share is about 22% (of which the balloon stent is about 14%).
Wicresoft : In 2017, the company's market share of cardiac stents reached 23% in China.
The rapid development of modern medical imaging has changed medical imaging from an auxiliary means to the most important clinical diagnosis and differential diagnosis method in modern medicine. 2021, China's diagnostic imaging equipment market size is expected to reach 90 billion yuan, with an annual growth rate of 15%. The competitiveness of domestic enterprises Neusoft Medical and Myriad Medical is being strengthened.
It is expected that by 2021, China's clinical testing equipment and reagents market size will reach 114.3 billion yuan, with an average annual growth rate of more than 18%. Among them, the immunoassay field accounts for the largest proportion, and the molecular field and POCT field (point-of-care testing) are the fastest growing. China's domestic enterprises, Myriad Medical comprehensive competitiveness is stronger.
Orthopedic medical devices is one of the most important sub-sectors in the medical device industry, and is expected to maintain a growth rate of about 15% in the next few years. Along with the aging of spine and joints, the growth rate is relatively fast, but the technical reasons for import substitution of joints are relatively slow.
In recent years, some of the domestic advantageous enterprises to grasp the orthopedic medical equipment development opportunity, in some areas gradually accelerate to seize market share, such as spine class Weigao orthopedic, Kellettier, traumatic injuries class Dabo medical etc.
Heart and joints, the heart and joints, the heart and joints, the heart and joints.
Cardiac and vascular interventional devices belong to the third category of medical devices, industry barriers to entry is high, is expected to maintain the next few years more than 11% growth rate. Except for the more mature coronary stents, which have basically completed the import substitution, the production technology of high-end cardiac stents is insufficient, and the technology of artificial valves and artificial pacemakers is progressing slowly.
Domestic companies such as Leopold Medical, Wicresoft, and JWT have a great advantage in the field of cardiac stents in China.