中国医疗器械行业的发展现状

医疗器械行业涉及医药、机械、电子、塑料等多个行业，是多学科、知识密集、资金密集的高新技术产业。高科技医疗器械的基本特征是数字化、计算机化，是现代化、高技术、多学科、跨领域的结晶，产品技术含量高，利润丰厚，因此是各大科技国家和国际大公司竞争的焦点。即使在行业整体毛利较低、投入不高的细分行业，也会不断出现技术含量较高的产品，并从中诞生一些盈利能力较强的公司，因此，行业总的趋势是高投入、高收益。

随着人们生活水平的不断提高，医疗器械的选择将更加先进，产品结构不断调整，功能更加多样化，市场容量不断扩大。

与欧美、日本等发达国家相比，我国医疗器械行业起步较晚，技术相对落后，市场以低端产品为主。但建国以来，我国医疗器械行业发展十分迅速，发展经历大致可分为三个阶段：

第一发展阶段： 

新中国成立至改革开放的30年间，我国医疗器械行业开始处于“萌芽”状态，经过不断探索，逐渐形成独立的产业。

第二阶段发展： 

改革开放至党的十八大召开的35年间，我国医疗器械行业持续高速发展，行业已走向成熟，产品种类更加齐全，技术创新能力不断提高，能够满足不同层次消费者的需求。

第三阶段发展： 

党的十八大以来，党和国家高度重视医疗器械发展，鼓励企业创新，优化监督管理体制，我国医疗器械产业正朝着国产化、高端化、品牌化、国际化方向发展。

新中国成立初期：仅有刀、剪、钳、车床、车床等传统产品生产企业和医疗器械维修生产企业70余家，从业人员不足2000人。

In the autumn of 1952, the first 200 mA x-ray machine in China named "GUOQING HAO" was successfully developed by Shanghai Medical Equipment Factory and Shanghai Precision Medical Equipment Factory, realizing zero development and manufacturing of medical imaging equipment in China. breakthrough.

In 1963, China's first A-type ultrasonic instrument that could be mass-produced was developed in Shantou, pushing the road of independent research and development of ultrasonic diagnostic equipment in China.

1964: "CTS-5"-the only type A medical ultrasound diagnostic product in the country was successfully developed in Shantou, and more than 30,000 units were sold in the following 20 years.

In 1965, China successfully developed the first generation of cage ball artificial heart valve, and on June 12 that year for clinical use, the successful implementation of China's first artificial heart valve replacement, marking China's valvular surgery has entered a new stage.

In 2013, Academician Ge Junbo's team completed the first fully degradable polylactic acid stent implantation independently developed by the Chinese people in China.

In 2014, MicroPort launched the world's first and only drug-eluting stent system-“Fire Eagle”, achieving a major technological breakthrough for local companies in the field of international cardiovascular disease treatment. With the continuous development of technology in recent years and the country's strong support for the cardiovascular field, the cardiovascular interventional device market has realized import substitution, of which the domestic market share of domestic products in the coronary stent market is more than 70%.

As one of the largest sub-industries in the medical device industry, orthopedic medical devices have also developed well in recent years. China's orthopedic implant market grew from 13.9 billion yuan in 2014 to 22.5 billion yuan in 2017. With the gradual promotion of import substitution, the market share of domestic enterprises is also increasing.

In the process of the innovation of the large-scale high-end equipment war, United imaging implements in a short time video equipment across the board to the full coverage and the core technology of the breakthrough, the independent research and development of products covering five major product lines, including nuclear magnetic resonance MRI, CT, DR, nuclear medical imaging, linear accelerator, etc.

In January 2014, MicroPort officially completed the acquisition of the joint reconstruction business and related assets of Wright Medical.

In September 2017, WEGO Group acquisition of Argon US for 5.6 billion yuan attracted widespread attention, which was seen as a continuation of a series of deals by Chinese companies seeking a foothold in the US healthcare sector.

From 2005 to 2010, the average annual compound growth rate (CAGR) of China's medical device industry was 27.4%. In 2010, the sales revenue of the medical device industry reached 110 billion yuan, ranking the second in the world. In 2011, it reached 135.41 billion yuan. In particular, the output and output value of some middle and low-end medical devices ranked first in the world.  In 2017, the size of China's medical device market was 523.3 billion yuan, an increase of 8.37% over the previous year. In 2018, the market size of China's medical device industry reached 530.4 billion yuan, and the compound growth rate (CAGR) of the domestic medical device market was 20.02% from 2014 to 2018, far higher than the global growth rate.

Although China's medical device industry has made some development, due to the backward manufacturing technology, the development of high-end medical devices is still far from the international level, and the market of high-end products mainly depends on imported products to meet. From the perspective of the consumption structure of medical devices, medical imaging, in vitro diagnosis, low-value consumables accounted for the highest proportion, a total of 43%. From the specific product segmentation, Ultrasonic Instruments, Magnetic Resonance Equipment, Electrocardiograph, High-End Physiological Recorder imports accounted for 90%. With the upgrading of consumption and technology and the strategic layout of the country, domestic medical device companies will realize the import replacement of high-end surgical consumables with higher added value and imaging diagnosis and treatment equipment. For a long time in the future, import substitution and globalization of domestic medical devices will be a major trend.

National policies also provide strong support for the medical device industry.

First, promote the expansion of the medical device industry from the strategic and policy perspective, and encourage enterprises to innovate and domesticate high-end products. We will encourage research and development, reform clinical management, speed up the review and approval and strengthen the life cycle management of medical devices to make way for high-quality and innovative medical devices. In 2017, the national development and reform commission made it clear that it would focus on supporting the development of five categories of medical devices, including imaging equipment, therapeutic equipment, in vitro diagnostic products, implant intervention products, and specialized technical service platform, to fill the gap in the domestic high-end medical device field and narrow the gap with the international advanced level.

二是在医改背景下，医院由重药品向规范化诊疗转变，在医院预算精细化管理背景下，优质国产设备的性价比优势凸显，医院对国产设备的认可度逐步提升。

三是随着分级诊疗政策的逐步完善和实施，基层医疗机构为医疗器械行业的增长提供了新的增长空间。目前，我国基层医疗机构医疗设备配备水平较低，缺口较大，基层医疗机构经费预算有限。