后疫情時代 我國醫(yī)用防護耗材、生命監(jiān)護及支持類醫(yī)療器械該如何發(fā)展？

受新冠肺炎疫情影響，醫(yī)療器械各細分領(lǐng)域?qū)⒂瓉硇乱惠喿兏铩Ｆ渲?，醫(yī)用防護耗材、生命監(jiān)護及支持類醫(yī)療器械兩大領(lǐng)域具備突出發(fā)展?jié)摿Α?br /> 醫(yī)用防護耗材
謹防后疫情時代需求下降
  醫(yī)用防護耗材是防止傳染性疾病傳播重要的物資之一。結(jié)合我國各地出臺的《醫(yī)用耗材采購清單》以及國家衛(wèi)健委出臺的《新型冠狀病毒感染的肺炎防控中常見醫(yī)用防護用品使用范圍指引（試行）》，可以將醫(yī)用防護耗材分為口罩、醫(yī)用防護服、醫(yī)用護目鏡、醫(yī)用手套、醫(yī)用防護帽、醫(yī)用鞋套等。數(shù)據(jù)顯示，我國醫(yī)用防護耗材市場規(guī)模從２０１５年的３７３億元增長到２０１９年的７５８億元。受疫情影響，預(yù)計今年我國醫(yī)用防護耗材市場規(guī)模將達到９０５億元，年復(fù)合增長率１９％（見圖１）。

全球醫(yī)用防護耗材企業(yè)主要集中在歐美等發(fā)達國家和地區(qū)，中國、越南等國家和地區(qū)代工生產(chǎn)企業(yè)居多。新冠肺炎疫情防控中，醫(yī)用防護耗材是重要的醫(yī)療器械之一。未來較長一段時間內(nèi)，國際醫(yī)用防護耗材市場仍存在一定的需求空間。與此同時，我國企業(yè)也應(yīng)積極提高高端產(chǎn)品技術(shù)水平，采取有效措施抵御需求驟降風(fēng)險。

國際產(chǎn)業(yè)特點：整體面臨龐大的需求缺口

目前，國際上仍有不少國家和地區(qū)采取防疫隔離措施。根據(jù)世界衛(wèi)生組織統(tǒng)計的數(shù)據(jù)，全球一線醫(yī)務(wù)人員每月需要約８９００萬個醫(yī)用口罩、７６００萬雙醫(yī)用手套、１６０萬副護目鏡。 疫情防控早期，部分國家和地區(qū)政府儲備意識不足，并未將醫(yī)用口罩、防護服等易耗品列為重點儲備，醫(yī)院也基于運營成本壓力，對日常醫(yī)療需求較低、使用場景有限的醫(yī)用防護服、護目鏡實施“零庫存”，致使疫情防控中，相關(guān)醫(yī)用防護耗材面臨龐大的需求缺口。各個國家和地區(qū)相繼出臺政策限制醫(yī)用防護耗材及其原材料出口，并且積極對接我國企業(yè)采購相關(guān)物資。

國內(nèi)產(chǎn)業(yè)特點：產(chǎn)能充足，但分布不均且產(chǎn)品偏中低端

我國醫(yī)用防護耗材產(chǎn)能充足，相關(guān)生產(chǎn)企業(yè)近４００家（不含疫情防控期間應(yīng)急獲批的新增企業(yè)）。從生產(chǎn)企業(yè)地域分布看，基于上游原材料資源優(yōu)勢，目前，我國醫(yī)用防護耗材產(chǎn)能主要集中在華東及華中地區(qū)，包括湖北、江蘇、山東等省份。國內(nèi)醫(yī)用防護耗材生產(chǎn)企業(yè)規(guī)模小，行業(yè)集中度不高。 以醫(yī)用口罩為例，熔噴布作為口罩的重要原材料，被稱為醫(yī)用外科口罩和Ｎ９５口罩的“心臟”，我國經(jīng)營范圍涉及熔噴布的企業(yè)主要集中在江蘇、浙江和河南三省，這三省的熔噴布生產(chǎn)企業(yè)數(shù)量占全國總數(shù)的４９．０２％，而湖北省僅占到全國的４．０３％。我國有２萬多家企業(yè)涉及口罩生產(chǎn)經(jīng)營，但具有醫(yī)用口罩生產(chǎn)資質(zhì)的企業(yè)僅３４８家（不包含疫情防控期間應(yīng)急獲批的新增企業(yè)），且大多數(shù)為全球代工廠家，產(chǎn)品偏向中低端，能夠生產(chǎn)Ｎ９５／ＫＮ９５口罩的企業(yè)只有５８家。

行業(yè)發(fā)展新趨勢：未來或呈現(xiàn)過剩狀態(tài)

早期新冠疫情蔓延速度快、波及范圍廣，諸多醫(yī)用防護耗材企業(yè)及跨行業(yè)企業(yè)積極響應(yīng)政府號召，擴產(chǎn)、轉(zhuǎn)產(chǎn)醫(yī)用防護耗材。根據(jù)天眼查數(shù)據(jù)，今年以來，全國超過３０００家企業(yè)經(jīng)營范圍新增口罩、防護服、護目鏡等產(chǎn)品，其中不乏中石化、富士康、比亞迪、ＯＰＰＯ等跨行業(yè)企業(yè)。 未來，隨著全球疫情防控形勢好轉(zhuǎn)，醫(yī)用防護耗材需求將面臨斷崖式下降，隨后很有可能出現(xiàn)產(chǎn)能過剩的情況。因此，醫(yī)用防護耗材相關(guān)企業(yè)有必要時常關(guān)注國際疫情發(fā)展態(tài)勢及相關(guān)產(chǎn)品需求情況，積極提升自身產(chǎn)品技術(shù)水平，采取有效措施抵御需求驟降風(fēng)險，以免產(chǎn)能過剩。 生命監(jiān)護及支持類醫(yī)療器械 發(fā)揮優(yōu)勢搶占國際市場 生命監(jiān)護及支持類醫(yī)療器械通過對患者生理特征進行實時監(jiān)控等，為醫(yī)生提供信息及救治幫助。參考我國《新冠肺炎疫情防治急需醫(yī)學(xué)裝備目錄》，生命監(jiān)護及支持類醫(yī)療器械可以分為呼吸機、監(jiān)護儀、體外膜肺氧合機（ＥＣＭＯ）、除顫儀、輸液泵、測溫儀等。數(shù)據(jù)顯示，全球生命監(jiān)護及支持類醫(yī)療器械市場規(guī)模增長穩(wěn)定，預(yù)計２０２０年將達到２６２億美元（見圖２）。

隨著經(jīng)濟發(fā)展、人口增長、社會老齡化程度提高，以及人們保健意識的不斷增強，生命監(jiān)護及支持類醫(yī)療器械市場快速擴大?？傮w來看，全球市場呈現(xiàn)外資品牌主導(dǎo)歐美市場及高端市場，中國企業(yè)主導(dǎo)亞、非、拉市場及中低端市場的格局。國際市場的參與者主要通過打造具備多元化功能模塊的高端產(chǎn)品提升市場份額，國內(nèi)市場中的內(nèi)資企業(yè)則不斷通過技術(shù)提升、進口替代等方式搶占市場空間。

國際產(chǎn)業(yè)特點：全球市場主要由國際知名綜合型醫(yī)療器械公司占主導(dǎo)地位，部分細分領(lǐng)域也有隱形冠軍企業(yè)重點參與
       目前，全球生命監(jiān)護及支持類醫(yī)療器械市場主要由荷蘭飛利浦、美國ＧＥ、美國美敦力、中國邁瑞、德國西門子等綜合型醫(yī)療器械企業(yè)占據(jù)。但在部分細分領(lǐng)域中，相比于綜合型醫(yī)療器械企業(yè)，該領(lǐng)域隱形冠軍企業(yè)的市場占有率更高。以呼吸機為例，瑞典潔定（Ｇｅｔ ｉｎｇｅ）、瑞士哈美頓（Ｈａｍｉｌ ｔｏｎ Ｍｅｄｉｃａｌ）、德國德爾格等品牌在全球呼吸機市場中占主導(dǎo)地位。

國內(nèi)產(chǎn)業(yè)特點：國產(chǎn)品牌利用政策優(yōu)勢實現(xiàn)技術(shù)突破與市場崛起，外資企業(yè)通過合資共建或?qū)＠跈?quán)的形式實現(xiàn)布局

我國生命監(jiān)護及支持類醫(yī)療器械企業(yè)較多，主要集中于長三角及珠三角區(qū)域，但大部分企業(yè)規(guī)模較小，行業(yè)集中度較低。目前，我國市場上的高端監(jiān)護儀、體外膜肺氧合機等高端產(chǎn)品，以及國產(chǎn)呼吸機中的傳感器等核心部件仍然主要依賴進口。近年來，我國分級診療政策逐步落地，基層醫(yī)療器械市場不斷擴容。在《優(yōu)秀國產(chǎn)醫(yī)療設(shè)備產(chǎn)品目錄》《增強制造業(yè)核心競爭力三年行動計劃（２０１８－２０２０年）》等政策措施的東風(fēng)之下，國產(chǎn)生命監(jiān)護及支持類醫(yī)療器械在國內(nèi)基層市場中的占比有所提高。此外，創(chuàng)新醫(yī)療器械特別審查通道的設(shè)置，激發(fā)了企業(yè)的創(chuàng)新熱情，直接推動內(nèi)資企業(yè)積極提升研發(fā)能力，突破先進技術(shù)壁壘，從源頭上解決核心技術(shù)問題。

我國龐大的市場空間也吸引了眾多外國生命監(jiān)護及支持類醫(yī)療器械企業(yè)，但由于對我國市場了解不足及自身品牌定價偏高等原因，他們很難以自有品牌進入，往往通過與我國企業(yè)合資共建或者專利授權(quán)的方式實現(xiàn)布局。

行業(yè)發(fā)展新趨勢：我國企業(yè)可抓住時機搶占國際市場

今年初，我國疫情防控形勢嚴峻，防控相關(guān)醫(yī)療物資供應(yīng)緊張。國外方面，歐盟相關(guān)文件顯示，基于疫情形勢日益嚴峻，傳統(tǒng)醫(yī)療器械供應(yīng)鏈只能滿足約１０％的需求量。同時，很多品牌由于產(chǎn)品定位及價格較高，不適于各國政府大規(guī)模采購。因此，部分國家和地區(qū)傾向從我國企業(yè)，如邁瑞、寶萊特、理邦等采購醫(yī)療設(shè)備。

未來，隨著疫情防控形勢的好轉(zhuǎn)，對生命監(jiān)護及支持類醫(yī)療器械的剛性需求將日益減少。我國生命監(jiān)護及支持類醫(yī)療器械企業(yè)需要進一步提升技術(shù)水平，緊抓各個國家和地區(qū)建立負壓隔離病房及特種醫(yī)院的契機積極布局，搶占國際市場空間。

通過對疫情影響及市場發(fā)展前景進行綜合考量可以發(fā)現(xiàn)，呼吸機、監(jiān)護儀和體外膜肺氧合機市場發(fā)展空間較大。后疫情時代全球構(gòu)建防疫機制所釋放的龐大市場，將促使生命監(jiān)護及支持類醫(yī)療器械領(lǐng)域變身為“潛力股”。

作者：蘇州生物醫(yī)藥產(chǎn)業(yè)園

來源：中國醫(yī)藥報

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