2024 China’s medical manufacturing industry opens up to the outside world , Aokear will fully cooperate with you.
On September 7, the Ministry of Commerce, the National Health Commission, the State Drug Administration issued a notice on the pilot work of expanding opening up in the field of healthcare, which intends to allow the establishment of wholly foreign-funded hospitals (except for Chinese medicine, excluding mergers and acquisitions of public hospitals) in Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen, and all islands of Hainan; at the same time, the establishment of wholly foreign-funded hospitals in the China (Beijing) Pilot Free Trade Zone, China (Shanghai) At the same time, in China (Beijing) Pilot Free Trade Zone, China (Shanghai) Pilot Free Trade Zone, China (Guangdong) Pilot Free Trade Zone and Hainan Free Trade Port allows foreign-invested enterprises to engage in the development of human stem cells, gene diagnostics and therapeutic technology and technology applications for product registration and production. All products that have been registered for listing and approved for production can be used nationwide.
“Like the manufacturing sector, the service sector is being opened up more and more. The process is always moving forward, not backward.” Bai Ming said that in terms of the needs of the Chinese market, the people are attaching more and more importance to health with the advancement of aging and consumption upgrading, in which case the liberalization of the establishment of wholly foreign-owned hospitals and the opening up of medical institutions for the development and application of human stem cells, gene diagnosis and treatment technologies in specific regions can better meet the needs of the people for a better life. “According to this Notice, the scale and scope of liberalization is bigger and wider than before. Medical devices, cell and gene therapy and other areas are the current focus of the medical community focus on the key cutting-edge direction, has a huge market space, but in the past due to policy restrictions, this aspect of the investment potential has not been fully released. The entry of foreign investment is expected to bring more capital, technology and talent opportunities for China’s biotechnology development.
Aokeray, as a medical grade plastic fluorine material manufacturer, will help you to enter the Chinese market and solve the related supporting supply chain in perfect collaboration! China’s cardiovascular interventional medical device field is one of the most important directions of China’s pharmaceutical innovation.
In nearly 40 years of development, the field has made some progress and has entered the stage of rapid independent innovation and development. Even so, when compared with the international advanced level, China’s cardiovascular field innovation still has a big gap and needs to overcome many technical bottlenecks.
On September 8, the National Development and Reform Commission and the Ministry of Commerce issued the “Special Administrative Measures for Foreign Investment Access (Negative List) (2024 Version)” (hereinafter referred to as the “Negative List”), and the restrictive measures on foreign investment access in the field of manufacturing industry have been realized as “zero”.
However, with the continuous development of social aging, further improvement of clinical practice, policy dividends and other additions, it is expected that by 2025, China’s cardiovascular interventional device industry will reach 25-30 billion yuan. In the future, China’s cardiovascular interventional devices will move to new heights.
1 The market is quite large and the potential continues
Globally, population aging is becoming a common problem. It is expected that in 2030, the population aged 65 and above will occupy nearly 11% of the world’s total population.
According to authoritative sources, the current global cardiovascular interventional device market has reached US$48.3 billion. With the increasing number of patients suffering from coronary heart disease, heart failure, valvular disease, congenital heart disease, and cardiomyopathy in the coming years, the global cardiovascular medical devices market size is expected to reach USD 82.2 billion by 2026, at a CAGR of about 6.9% during the forecast period.
China has entered an aging society with increasing life expectancy since the implementation of family planning policy. From 2016 to 2020, the number of patients with cardiovascular diseases in China increased at a CAGR of 2.78%, from 22.7 million to 25.3 million, reaching approximately 26.7 million in 2022.
Accelerating aging society and high incidence of cardiovascular diseases among the elderly are driving the growth of the interventional devices market; improving clinical practice is contributing to the development of interventional device technology and industry growth; and the government has introduced a series of policies to support the interventional devices industry. These factors promote the healthy development of the industry and present great opportunities for the cardiovascular medical devices market.
China’s cardiovascular interventional devices market size reached 37.204 billion yuan in 2021. China’s cardiovascular interventional devices market is expected to reach 25-30 billion yuan by 2025, growing at a CAGR of 7%-9%. The market size will reach 140.179 billion yuan by 2030, growing at a CAGR of 15.88% during 2021-2030.
China Cardiovascular Interventional Devices Market Size Status and Forecast Analysis 2017-2030 Source: CICC International Consulting /
2 Leading Geese Demonstrating the Situation
Although China’s cardiovascular interventional device industry is relatively young, it is developing rapidly and its popularity is increasing significantly. Driven by policy and market factors, domestic medical device enterprises have entered the field of cardiovascular interventional devices and gradually realized technological breakthroughs, which has contributed to the rapid development of the domestic cardiovascular interventional device industry.
In recent years, China has gathered a number of enterprises in the field of cardiovascular interventional medical devices, such as Lepu Medical, Microtronic Medical, Huitai Medical, Bairen Medical, Maidi Peak, Huayin Teco, and Heart Pulse Medical, etc. These enterprises have successively launched a series of self-developed cardiovascular interventional devices. These enterprises have successively launched a series of self-developed products involving coronary stents, heart valves, coronary heart blockers and cardiac rhythm management, etc., some of which have reached the leading level at home and abroad.
Lepu Medical
Founded in 1999, LPMC is one of the earliest domestic manufacturers to enter the field of cardiovascular intervention, and also one of the leading enterprises in the field of pan-cardiovascular devices and consumables. The company has built up an advantage of branded generic drugs in cardiovascular drugs, which can form a synergistic effect with the sales of medical devices. In addition, LPMC holds a large number of patents and certifications. Currently, the company has become a leading high-end medical product industrial group in cardiovascular interventional diagnostic and treatment devices and equipment in China, providing major products in three segments: medical devices, pharmaceutical products, medical services and health management. Its representative products include NeoVas bioabsorbable stent (known as the “disappearing stent”), Vesselin drug balloon, Vesscide cutting balloon and so on.
Wicresoft
Wicresoft focuses on the cardiovascular field, with products covering cardiovascular and structural diseases, electrophysiology and rhythm management systems, aortic and peripheral vascular diseases, and cerebrovascular and neuromodulation sciences. Promoting the project of “Key Technology and Industrialization of Heart and Vascular Implantable Medical Devices”, we have developed 40 new technologies and 27 industrial platforms, some of which are the first of their kind in China. Some of these products are the first of their kind in China, such as the magnetic positioning three-dimensional calibration system and the coronary heart disease drug-targeted elution stent system (“Fire Eagle”). On March 31, Wicresoft announced its 2022 annual results, with revenues of approximately US$841 million, up 15.6% year-on-year. It mainly benefited from the growth of cardiovascular intervention and structural heart disease medicine, cardiac rhythm management and electrophysiology medicine, and orthopedic implantation and repair.
Huitai Medical
Huitai Medical is a high-tech enterprise focusing on the R&D, production and sales of electrophysiology and interventional medical devices, and has formed a business layout with complete coronary access and electrophysiology medical devices as the leading business, and peripheral vascular and neurological interventional medical devices as the key development direction. The company has the ability to form strong competition with foreign products, and its listed products include electrophysiology, coronary access and peripheral vascular interventional medical devices. According to its 2022 annual report, in 2022, Huitai Medical realized an operating revenue of RMB1,216,017,969.28, an increase of 46.74% over the same period of the previous year. The coverage and hospital admission penetration rate of vascular interventional products further improved, with the number of hospital admissions of the products increasing by more than 600 compared with the end of last year, and the overall number of hospitals covered by more than 3,000, representing a year-on-year growth of more than 20%. The company’s R&D investment in the past three years amounted to RMB71,899,400, RMB134,876,800 and RMB174,876,300 respectively, accounting for 15.00%, 16.28% and 14.38% of the operating income.
Bairen Medical
Bairen Medical is a leading domestic technology, focusing on the development and production of animal-derived implant interventional medical devices, high-tech enterprises, products used in heart valve replacement and repair, congenital heart disease implant interventional therapy and surgical soft tissue repair.2022 three-quarterly report, the company’s main revenue of 221 million yuan, an increase of 20.31% year-on-year; which the third quarter of 2022, the company’s main business in a single quarter revenue of 79.847 million yuan, up 35.52% year-on-year.
MediTop
Founded in 2005, MediTop develops high-quality equipment and consumables for cardiovascular diseases and provides total therapeutic solutions. The company has mastered core technologies in the fields of surgical atrial fibrillation treatment, interventional treatment of coronary heart disease, and biological tissue organ repair, which have filled the gaps in the treatment of related diseases both at home and abroad. The company puts forward the treatment concepts of “maternal-fetal screening, birth rescue treatment, lifelong intervention”, “simultaneous treatment of heart and brain, stroke intervention” and “anatomical correction, hemodynamic improvement” for the treatment of coronary artery disease, cardiac arrhythmia and valvular disease. The treatment concept of “anatomical correction and hemodynamic improvement”.
Our products include E-Clip “Left Ear Closure System” and Pul-Stent Pulmonary Stent.
China PulseTechHuaweitaike is a high-tech enterprise focusing on the research, development and application of innovative products and therapies in the field of vascular disease treatment, with its main business being the research, development, production and sales of medical device products in the fields of aortic, peripheral and coronary arteries, neurological interventions and pathways. Currently, Huawei has 8 marketed products and more than 20 products under research and development, including thoracic main and abdominal aortic coated stent systems. In April 2020, Huatai Pulse Technology’s Multi-branch Artificial Vascular Stent was granted special approval for “Innovative Medical Devices” by the Instrumental Review Center of the State Drug Administration of the People’s Republic of China, and is expected to be approved by the State Council of the People’s Republic of China in 2024, after completing the clinical trial.
Heartbeat MedicalFounded in 2012, Heartbeat Medical specializes in the research, development, production and sales of aortic and peripheral vascular interventional medical devices. The company’s product line covers a comprehensive range, and is at the head of the market in the vascular intervention field. At present, the company has launched 12 products, aortic stent products have covered the aortic arch, descending aorta, abdominal aorta and other application scenarios, and peripheral interventional products include bare stent for lower limb arterial lesions, bare balloon, medicated balloon, high-pressure balloon and so on. The company’s main business is showing strong growth, with a revenue CAGR of 42.74% from 2017-2021. Aortic stent is the company’s core product, occupying 82.64% of the company’s total revenue.In 2021, the company realized operating revenue of 685 million yuan, a year-on-year growth of 45.74%; from January to September 2022, the company’s revenue reached 664 million yuan, a year-on-year growth of 30.2%.
3 Difficulties are still there to scale the heightsIt is not difficult to see the momentum of the industry from the above. In addition, with the continuous progress of society, the public’s lifestyle and concepts have begun to change, and public health awareness is increasing, promoting the early screening of chronic diseases such as cardiovascular disease. This is also good news for related enterprises. However, cardiovascular interventional devices is a segmented field, high technical threshold, product variety, complex application scenarios, showing a “small but complex, high-end fine” characteristics. Domestic enterprises started late, industrial development is in a rapid rise, but has not yet entered the mature saturation stage.
In the field of coronary stents and coronary heart blockers, the maturity of technology is relatively high, and domestic substitution has been fully realized, which can compete with the international market. While in the field of cerebrovascular intervention, cardiac intervention valves, left ear blockers, electrophysiology and pacemakers, the technology level is relatively low, long-term dependence on imports, and it is difficult to change in the short term. This puts new demands on local enterprises. In addition, cardiovascular intervention is a relatively new and complex procedure that requires practitioners to have professional knowledge and training experience, although the establishment and promotion of standardized training programs by industry associations has led to an increasing number of qualified practitioners.
Based on the current industry situation, issues such as strengthening industry chain synergy and enhancing upstream and downstream linkage capabilities; accelerating breakthroughs in the research and development of key core technologies; and creating a good industry ecosystem, all require a quick response from the industry. In this way, promoting product research and development, upgrading product quality, expanding application fields, improving service level, realizing scale and improving competitiveness can achieve sustainable and healthy development and bring China’s cardiovascular interventional medical devices to a new peak.
