受新冠肺炎疫情影响，医疗器械各细分领域将迎来新一轮变革。其中，医用防护耗材、生命监护及支持类医疗器械两大领域具备突出发展潜力。
医用防护耗材
谨防后疫情时代需求下降
  医用防护耗材是防止传染性疾病传播重要的物资之一。结合我国各地出台的《医用耗材采购清单》以及国家卫健委出台的《新型冠状病毒感染的肺炎防控中常见医用防护用品使用范围指引（试行）》，可以将医用防护耗材分为口罩、医用防护服、医用护目镜、医用手套、医用防护帽、医用鞋套等。数据显示，我国医用防护耗材市场规模从２０１５年的３７３亿元增长到２０１９年的７５８亿元。受疫情影响，预计今年我国医用防护耗材市场规模将达到９０５亿元，年复合增长率１９％（见图１）。

全球医用防护耗材企业主要集中在欧美等发达国家和地区，中国、越南等国家和地区代工生产企业居多。新冠肺炎疫情防控中，医用防护耗材是重要的医疗器械之一。未来较长一段时间内，国际医用防护耗材市场仍存在一定的需求空间。与此同时，我国企业也应积极提高高端产品技术水平，采取有效措施抵御需求骤降风险。

国际产业特点：整体面临庞大的需求缺口

目前，国际上仍有不少国家和地区采取防疫隔离措施。根据世界卫生组织统计的数据，全球一线医务人员每月需要约８９００万个医用口罩、７６００万双医用手套、１６０万副护目镜。 疫情防控早期，部分国家和地区政府储备意识不足，并未将医用口罩、防护服等易耗品列为重点储备，医院也基于运营成本压力，对日常医疗需求较低、使用场景有限的医用防护服、护目镜实施“零库存”，致使疫情防控中，相关医用防护耗材面临庞大的需求缺口。各个国家和地区相继出台政策限制医用防护耗材及其原材料出口，并且积极对接我国企业采购相关物资。

国内产业特点：产能充足，但分布不均且产品偏中低端

我国医用防护耗材产能充足，相关生产企业近４００家（不含疫情防控期间应急获批的新增企业）。从生产企业地域分布看，基于上游原材料资源优势，目前，我国医用防护耗材产能主要集中在华东及华中地区，包括湖北、江苏、山东等省份。国内医用防护耗材生产企业规模小，行业集中度不高。 以医用口罩为例，熔喷布作为口罩的重要原材料，被称为医用外科口罩和Ｎ９５口罩的“心脏”，我国经营范围涉及熔喷布的企业主要集中在江苏、浙江和河南三省，这三省的熔喷布生产企业数量占全国总数的４９．０２％，而湖北省仅占到全国的４．０３％。我国有２万多家企业涉及口罩生产经营，但具有医用口罩生产资质的企业仅３４８家（不包含疫情防控期间应急获批的新增企业），且大多数为全球代工厂家，产品偏向中低端，能够生产Ｎ９５／ＫＮ９５口罩的企业只有５８家。

行业发展新趋势：未来或呈现过剩状态

早期新冠疫情蔓延速度快、波及范围广，诸多医用防护耗材企业及跨行业企业积极响应政府号召，扩产、转产医用防护耗材。根据天眼查数据，今年以来，全国超过３０００家企业经营范围新增口罩、防护服、护目镜等产品，其中不乏中石化、富士康、比亚迪、ＯＰＰＯ等跨行业企业。 未来，随着全球疫情防控形势好转，医用防护耗材需求将面临断崖式下降，随后很有可能出现产能过剩的情况。因此，医用防护耗材相关企业有必要时常关注国际疫情发展态势及相关产品需求情况，积极提升自身产品技术水平，采取有效措施抵御需求骤降风险，以免产能过剩。 生命监护及支持类医疗器械 发挥优势抢占国际市场 生命监护及支持类医疗器械通过对患者生理特征进行实时监控等，为医生提供信息及救治帮助。参考我国《新冠肺炎疫情防治急需医学装备目录》，生命监护及支持类医疗器械可以分为呼吸机、监护仪、体外膜肺氧合机（ＥＣＭＯ）、除颤仪、输液泵、测温仪等。数据显示，全球生命监护及支持类医疗器械市场规模增长稳定，预计２０２０年将达到２６２亿美元（见图２）。

随着经济发展、人口增长、社会老龄化程度提高，以及人们保健意识的不断增强，生命监护及支持类医疗器械市场快速扩大。总体来看，全球市场呈现外资品牌主导欧美市场及高端市场，中国企业主导亚、非、拉市场及中低端市场的格局。国际市场的参与者主要通过打造具备多元化功能模块的高端产品提升市场份额，国内市场中的内资企业则不断通过技术提升、进口替代等方式抢占市场空间。

国际产业特点：全球市场主要由国际知名综合型医疗器械公司占主导地位，部分细分领域也有隐形冠军企业重点参与
       目前，全球生命监护及支持类医疗器械市场主要由荷兰飞利浦、美国ＧＥ、美国美敦力、中国迈瑞、德国西门子等综合型医疗器械企业占据。但在部分细分领域中，相比于综合型医疗器械企业，该领域隐形冠军企业的市场占有率更高。以呼吸机为例，瑞典洁定（Ｇｅｔ ｉｎｇｅ）、瑞士哈美顿（Ｈａｍｉｌ ｔｏｎ Ｍｅｄｉｃａｌ）、德国德尔格等品牌在全球呼吸机市场中占主导地位。

国内产业特点：国产品牌利用政策优势实现技术突破与市场崛起，外资企业通过合资共建或专利授权的形式实现布局

我国生命监护及支持类医疗器械企业较多，主要集中于长三角及珠三角区域，但大部分企业规模较小，行业集中度较低。目前，我国市场上的高端监护仪、体外膜肺氧合机等高端产品，以及国产呼吸机中的传感器等核心部件仍然主要依赖进口。近年来，我国分级诊疗政策逐步落地，基层医疗器械市场不断扩容。在《优秀国产医疗设备产品目录》《增强制造业核心竞争力三年行动计划（２０１８－２０２０年）》等政策措施的东风之下，国产生命监护及支持类医疗器械在国内基层市场中的占比有所提高。此外，创新医疗器械特别审查通道的设置，激发了企业的创新热情，直接推动内资企业积极提升研发能力，突破先进技术壁垒，从源头上解决核心技术问题。

我国庞大的市场空间也吸引了众多外国生命监护及支持类医疗器械企业，但由于对我国市场了解不足及自身品牌定价偏高等原因，他们很难以自有品牌进入，往往通过与我国企业合资共建或者专利授权的方式实现布局。

行业发展新趋势：我国企业可抓住时机抢占国际市场

今年初，我国疫情防控形势严峻，防控相关医疗物资供应紧张。国外方面，欧盟相关文件显示，基于疫情形势日益严峻，传统医疗器械供应链只能满足约１０％的需求量。同时，很多品牌由于产品定位及价格较高，不适于各国政府大规模采购。因此，部分国家和地区倾向从我国企业，如迈瑞、宝莱特、理邦等采购医疗设备。

未来，随着疫情防控形势的好转，对生命监护及支持类医疗器械的刚性需求将日益减少。我国生命监护及支持类医疗器械企业需要进一步提升技术水平，紧抓各个国家和地区建立负压隔离病房及特种医院的契机积极布局，抢占国际市场空间。

通过对疫情影响及市场发展前景进行综合考量可以发现，呼吸机、监护仪和体外膜肺氧合机市场发展空间较大。后疫情时代全球构建防疫机制所释放的庞大市场，将促使生命监护及支持类医疗器械领域变身为“潜力股”。

作者：苏州生物医药产业园

来源：中国医药报

Affected by the novel coronavirus pneumonia, new changes will be brought to the medical devices. Among them, medical protective consumables, life monitoring and support medical devices have outstanding development potential.

Medical protective consumables

Beware of declining demand in post epidemic Era

Medical protective consumables are one of the most important materials to prevent the spread of infectious diseases. Novel coronavirus infection control and prevention of common clinical protective products in the prevention and control of medical devices are introduced in combination with the list of medical consumables purchased in China. The medical protective consumables can be divided into respirators, medical protective clothing, medical goggles, medical gloves, medical protective caps, medical shoes covers, etc. The data shows that the market scale of medical protective consumables in China has increased from 37.3 billion yuan in 2015 to 75.8 billion yuan in 2019. Affected by the epidemic situation, the market scale of medical protective consumables in China is expected to reach 90.5 billion yuan this year, with a compound annual growth rate of 19% (see Figure 1).

The global medical protection consumables enterprises are mainly concentrated in developed countries and regions such as Europe and the United States, and most of them are OEM manufacturers in China, Vietnam and other countries and regions. In the novel coronavirus pneumonia epidemic prevention and control, medical protection supplies are one of the most important medical devices. For a long time in the future, there is still a certain demand space in the international medical protection consumables market. At the same time, Chinese enterprises should also actively improve the technical level of high-end products and take effective measures to resist the risk of sudden drop in demand.

Characteristics of international industry: facing huge demand gap as a whole

At present, many countries and regions in the world still take measures to prevent and isolate epidemic diseases. According to the statistics of the World Health Organization, the global front-line medical staff need about 89 million medical masks, 76 million pairs of medical gloves and 1.6 million pairs of goggles every month. In the early stage of epidemic prevention and control, some countries and regions had insufficient awareness of reserves, and did not list medical masks, protective clothing and other consumables as key reserves. Hospitals also implemented "zero inventory" of medical protective clothing and goggles with low daily medical demand and limited use scenarios based on the pressure of operating costs, resulting in a huge demand gap for relevant medical protection consumables in epidemic prevention and control 。 Various countries and regions have issued policies to restrict the export of medical protection consumables and raw materials, and actively connect with Chinese enterprises to purchase relevant materials.

Domestic industry characteristics: sufficient production capacity, but uneven distribution and low-end products

The production capacity of medical protective consumables in China is sufficient, and there are nearly 400 related manufacturers (excluding the newly approved enterprises during the period of epidemic prevention and control). From the geographical distribution of production enterprises, based on the advantages of upstream raw material resources, at present, the production capacity of medical protection consumables in China is mainly concentrated in East China and central China, including Hubei, Jiangsu, Shandong and other provinces. The scale of domestic medical protection consumables production enterprises is small and the industry concentration is not high. Taking medical masks as an example, meltblown cloth, as an important raw material of masks, is called the "heart" of medical surgical masks and N95 masks. In China, the enterprises involved in meltblown fabrics are mainly concentrated in Jiangsu, Zhejiang and Henan provinces. The number of meltblown cloth manufacturers in these three provinces accounts for 49.02% of the total number of the whole country, while Hubei Province only accounts for 4.03% of the national total. There are more than 20000 enterprises involved in the production and operation of masks in China, but only 348 enterprises with medical mask production qualification (excluding the new enterprises approved for emergency approval during the epidemic prevention and control period), and most of them are global OEM manufacturers, and their products tend to be medium and low-end. Only 58 enterprises can produce N95 / kn95 masks.

New trend of industry development: surplus in the future

In the early stage, Xinguan epidemic spread rapidly and affected a wide range. Many medical protection consumables enterprises and cross industry enterprises actively responded to the call of the government to expand production and switch to production of medical protection consumables. According to Tianyan data, since this year, more than 3000 enterprises nationwide have added new products such as masks, protective clothing and goggles, including Sinopec, Foxconn, BYD and oppo. In the future, with the improvement of global epidemic prevention and control situation, the demand for medical protective consumables will face a cliff like decline, and then there is likely to be overcapacity. Therefore, it is necessary for enterprises related to medical protection consumables to pay close attention to the development trend of international epidemic situation and the demand of related products, actively improve their own product technology level, and take effective measures to resist the risk of sudden drop in demand, so as to avoid overcapacity. Life monitoring and support medical devices play an important role in seizing the international market. Through real-time monitoring of patients' physiological characteristics, life monitoring and support medical devices can provide information and help for doctors. Referring to the catalogue novel coronavirus pneumonia is urgently needed, the life monitoring and supporting medical devices can be divided into respirator, monitor, extracorporeal membrane oxygenator (ECMO), defibrillator, infusion pump, thermometer and so on. According to the data, the global market for life monitoring and support medical devices is growing steadily and is expected to reach US $26.2 billion in 2020 (see Figure 2).

With the economic development, population growth, the improvement of social aging, and the continuous enhancement of people's health care awareness, the market of life monitoring and support medical devices is expanding rapidly. On the whole, the global market shows that foreign brands dominate the European and American markets and high-end markets, while Chinese enterprises dominate the Asian, African, Latin American and middle and low-end markets. Participants in the international market mainly through the creation of