高值醫(yī)用耗材步入集采時(shí)代

高值醫(yī)用耗材全國(guó)集采將于本周四（１１月５日）落地。作為新品種，涉及微創(chuàng)醫(yī)療、樂(lè)普醫(yī)療等１２家公司的２７個(gè)產(chǎn)品。市場(chǎng)分析認(rèn)為，集采或重塑冠脈支架百億市場(chǎng)競(jìng)爭(zhēng)格局，這是國(guó)家層面對(duì)高值醫(yī)用耗材進(jìn)行集采，對(duì)于后續(xù)其他品種將帶來(lái)較強(qiáng)的示范效應(yīng)。未來(lái)集采常態(tài)化下，龍頭公司的創(chuàng)新主線邏輯將更為清晰。

百億市場(chǎng)格局或重塑

根據(jù)國(guó)家組織高值醫(yī)用耗材聯(lián)合采購(gòu)辦公室１０月中旬發(fā)布的《國(guó)家組織冠脈支架集中帶量采購(gòu)文件》（以下簡(jiǎn)稱集采文件），首年意向采購(gòu)總量逾１０７萬(wàn)個(gè)，本次冠脈支架集中帶量采購(gòu)周期為兩年。公開(kāi)資料顯示，我國(guó)一年要用掉約１５０萬(wàn)個(gè)冠脈支架，總費(fèi)用達(dá)１５０億元，僅這一個(gè)品種就占高值醫(yī)用耗材市場(chǎng)總額的１０％。

據(jù)了解，冠脈支架領(lǐng)域是我國(guó)血管介入器械中發(fā)展成熟的細(xì)分市場(chǎng)，也是我國(guó)高值醫(yī)用耗材領(lǐng)域進(jìn)口替代率較高的市場(chǎng)之一。醫(yī)械研究院數(shù)據(jù)顯示，２０１８年，國(guó)內(nèi)心臟支架行業(yè)約８０％的市場(chǎng)份額已被國(guó)產(chǎn)品牌占領(lǐng)，樂(lè)普醫(yī)療、微創(chuàng)醫(yī)療和吉威醫(yī)療（藍(lán)帆醫(yī)療子公司）三家國(guó)產(chǎn)心臟支架企業(yè)的合計(jì)占有市場(chǎng)份額５３％，美敦力、波士頓科學(xué)和雅培三家進(jìn)口品牌的市場(chǎng)份額合計(jì)為２７％。

《經(jīng)濟(jì)參考報(bào)》記者梳理集采文件發(fā)現(xiàn)，首年意向采購(gòu)量匯總表顯示，共涉及１２家公司的２７個(gè)品種。其中，進(jìn)口品牌包括波士頓科學(xué)的６個(gè)品種約１２．０６萬(wàn)個(gè)、雅培的６個(gè)品種約１０．８９萬(wàn)個(gè)、美敦力的３個(gè)品種約１０．６０萬(wàn)個(gè)。國(guó)產(chǎn)品牌方面，微創(chuàng)醫(yī)療憑借４個(gè)品種約３９．２２萬(wàn)個(gè)意向采購(gòu)量居首，占比３６．５％，樂(lè)普醫(yī)療、吉威醫(yī)療、桓晨醫(yī)療（信立泰子公司）分別涉及一個(gè)品種，意向采購(gòu)量分別為１２０５６０個(gè)、１００６９０個(gè)、２００７０個(gè)，占比分別為１１．２％、９．４％、１．９％。

根據(jù)集采文件，２７個(gè)意向采購(gòu)產(chǎn)品中，將有１０個(gè)入圍。按產(chǎn)品申報(bào)價(jià)由低到高的順序確定排名。

國(guó)信證券分析認(rèn)為，這一采購(gòu)量基本符合預(yù)期，各具體品種的意向采購(gòu)量基本符合現(xiàn)有市場(chǎng)格局。本次集采較低價(jià)中標(biāo)產(chǎn)品將獲得不少于１０％的待分配總量，其余產(chǎn)品按照醫(yī)療機(jī)構(gòu)報(bào)量和自主選擇決定用量，對(duì)于報(bào)量較高的品種，只要中標(biāo)即能獲得較高份額，“光腳者”若未能以較低價(jià)中標(biāo)，可能仍然難以獲得份額的大幅增量。

浩悅資本表示，冠脈支架市場(chǎng)過(guò)去實(shí)現(xiàn)了８０％的進(jìn)口替代，格局穩(wěn)定，此次全國(guó)性的帶量采購(gòu)可能重塑競(jìng)爭(zhēng)格局，可預(yù)見(jiàn)利好行業(yè)龍頭，行業(yè)集中度將進(jìn)一步提高，也有可能給予后來(lái)者彎道超車(chē)的機(jī)會(huì)。

龍頭公司創(chuàng)新主線日漸清晰

此次集采的價(jià)格競(jìng)爭(zhēng)無(wú)疑十分激烈。

根據(jù)集采文件要求，此次冠脈支架?chē)?guó)家集采將于１１月５日在天津開(kāi)標(biāo)，擬中選結(jié)果在公示無(wú)異議后，由聯(lián)合采購(gòu)辦公室進(jìn)行中選結(jié)果公布。根據(jù)集采文件，入圍產(chǎn)品符合以下條件之一的，獲得擬中選資格：一是申報(bào)價(jià)≤低產(chǎn)品申報(bào)價(jià)１．８倍的；二是申報(bào)價(jià)＞低產(chǎn)品申報(bào)價(jià)１．８倍，但低于２８５０元的。

值得注意的是，２８５０元的參考價(jià)與此前江蘇冠脈支架集采中，樂(lè)普醫(yī)療報(bào)出的鈷基支架價(jià)格相同，這也是江蘇冠脈支架試點(diǎn)集采的低談判價(jià)格。目前，國(guó)產(chǎn)冠脈支架的平均價(jià)格在萬(wàn)元左右，進(jìn)口支架約為１．５萬(wàn)至１．９萬(wàn)元。

以怎樣的價(jià)格中標(biāo)，將對(duì)中標(biāo)企業(yè)產(chǎn)生較大影響。國(guó)信證券認(rèn)為，這一競(jìng)價(jià)模式下，價(jià)格降幅可能比此前預(yù)期更大，參考藥品集采中標(biāo)結(jié)果，不排除企業(yè)采取成本加成模式進(jìn)行報(bào)價(jià)以力保中標(biāo)，可能對(duì)企業(yè)利潤(rùn)率帶來(lái)一定影響。

集采文件的發(fā)布引起市場(chǎng)強(qiáng)烈反應(yīng)。文件發(fā)布后的交易日（１０月１９日），醫(yī)療器械板塊領(lǐng)跌兩市，相關(guān)個(gè)股暴跌，樂(lè)普醫(yī)療、藍(lán)帆醫(yī)療、信立泰分別下跌８．８３％、３．８８％、５．２９％；港股市場(chǎng)上，微創(chuàng)醫(yī)療當(dāng)天跌幅達(dá)１１．９３％。

券商普遍認(rèn)為，隨著集采落地、政策不確定性出清，龍頭公司的創(chuàng)新主線邏輯將更為清晰。

興業(yè)證券認(rèn)為，短期來(lái)看，雖然產(chǎn)品價(jià)格可能會(huì)面臨一定沖擊，但進(jìn)口替代仍有望帶來(lái)以價(jià)換量的紅利。長(zhǎng)期來(lái)看，擁有自主創(chuàng)新能力、業(yè)務(wù)多元化布局，或是單一產(chǎn)品具有高技術(shù)含量和高附加值，在差異化競(jìng)爭(zhēng)中具有明顯優(yōu)勢(shì)的國(guó)產(chǎn)龍頭企業(yè)有望在行業(yè)洗牌中受益。

國(guó)開(kāi)證券分析師王雯表示，經(jīng)過(guò)多省市多輪試點(diǎn)后，國(guó)家層面首次對(duì)高值耗材進(jìn)行集采，為后續(xù)高值耗材類品種帶來(lái)較強(qiáng)的示范效應(yīng)。中長(zhǎng)期看，在單個(gè)產(chǎn)品價(jià)格體系面臨一定沖擊及重構(gòu)壓力下，企業(yè)整體研發(fā)和創(chuàng)新能力將尤為重要。此外，該集采規(guī)則有望在冠脈支架試點(diǎn)后推廣至高值耗材其他領(lǐng)域，如骨科、眼科等，中長(zhǎng)期更應(yīng)關(guān)注在研管線豐富、研發(fā)實(shí)力較強(qiáng)的龍頭企業(yè)。

來(lái)源：經(jīng)濟(jì)參考報(bào)

The "first order" of nationwide centralized purchase of high-value medical consumables will be launched on Thursday (November 5). As the first variety, the intended purchase volume of coronary stents in the first year is more than one million, involving 27 products of 12 companies such as minimally invasive medicine and Lepu medical. Market analysis shows that centralized procurement or reshaping the market competition pattern of 10 billion coronary stents is the first time that high-value medical consumables are intensively purchased at the national level, which will bring strong demonstration effect for other follow-up varieties. Under the normalization of centralized purchasing in the future, the main line logic of innovation of leading companies will be clearer.

10 billion market pattern or reshaping

According to the "procurement document of national organization of centralized coronary stent volume" (hereinafter referred to as "centralized procurement document") issued by the joint procurement office of high-value medical consumables of the state organization in mid October, the total amount of intended procurement in the first year was more than 1.07 million, and the procurement cycle of centralized coronary stent was two years. According to public data, about 1.5 million coronary stents will be used in China a year, with a total cost of 15 billion yuan. This kind of stent alone accounts for 10% of the total market value of high-value medical consumables.

It is understood that the field of coronary stent is the most mature market segment of vascular interventional devices in China, and also one of the markets with the highest import substitution rate in the field of high-value medical consumables in China. According to the data of medical equipment research institute, in 2018, about 80% of the market share of domestic cardiac stent industry has been occupied by domestic brands. The total market share of three domestic cardiac stent enterprises, namely Lepu medical, minimally invasive medical and giver medical (a subsidiary of bluesail medical), has a total market share of 53%. The market share of Medtronic, Boston science and Abbott is 27 ％。

The reporter of economic reference daily sorted out the centralized purchasing documents and found that the first year's purchase intention summary table showed that 27 varieties of 12 companies were involved. Among them, there are about 120600 imported brands from Boston science, 108900 from Abbott and 106000 from Medtronic. In terms of domestic brands, minimally invasive medicine ranked first in terms of purchase intention with 4 varieties of about 392200, accounting for 36.5%. Lepu medical, Jiwei medical and Huanchen medical (a subsidiary of xinlitai) respectively involved one variety, with the intention to purchase 120560, 100690 and 20070, accounting for 11.2% and 9.2% respectively ４％、１．９％。

According to the centralized purchase documents, 10 of the 27 products intended to be purchased will be shortlisted. The ranking is determined according to the order from low to high, the lowest is the first, the second is the second, and so on.

According to Guoxin Securities Analysis, this purchase volume is basically in line with expectations, and the intended purchase volume of specific varieties basically conforms to the existing market pattern. The lowest price bid winning products of this centralized purchase will obtain no less than 10% of the total amount to be allocated, and the remaining products will be used according to the volume quoted by the medical institutions and determined by their own choice. For the varieties with higher volume, as long as they win the bid, they can obtain a higher share. If "barefoot" fails to win the bid at the lowest price, it may still be difficult to obtain a substantial increase in the share.

Haoyue capital said that the coronary stent market had achieved 80% import substitution in the past, and the pattern was stable. This nationwide procurement with volume may reshape the competition pattern. It can be predicted that it will benefit the industry leader, further increase the industry concentration, and may also give latecomers the opportunity to overtake in a curve.

The main innovation line of leading companies is increasingly clear

There is no doubt that the price competition is very fierce.

According to the requirements of centralized procurement documents, the national centralized procurement of coronary stents will be opened in Tianjin on November 5. The results of the proposed selection will be announced by the joint procurement office after the publicity and no objection. According to the centralized purchase documents, the shortlisted products that meet one of the following conditions will be eligible for selection: one is that the application price is less than 1.8 times of the lowest product application price; the other is that the application price is more than 1.8 times of the lowest product application price, but less than 2850 yuan.

It is worth noting that the reference price of 2850 yuan is the same as that of cobalt based stent quoted by Lepu medical in Jiangsu Province, which is also the lowest negotiation price of Jiangsu Province. At present, the average price of domestic coronary stents is about 10000 yuan, and that of imported stents is about 15000-19000 yuan.

How to win the bid at what price will have a great impact on the winning enterprises. Guoxin Securities believes that under this bidding mode, the price drop may be greater than previously expected. Referring to the bidding results of centralized purchasing of drugs, it is not ruled out that enterprises should adopt the cost plus mode to quote in order to win the bid, which may have a certain impact on the profit margin of enterprises.

The release of centralized purchasing documents caused strong market reaction. On the first trading day (October 19) after the release of the document, the medical device sector led the decline in the two markets, and the related stocks plummeted. Lepu medical, lanfan medical and xinlitai fell by 8.83%, 3.88% and 5.29% respectively; in the Hong Kong stock market, minimally invasive medical fell by 11.93% on the same day.

Securities companies generally believe that with the implementation of centralized mining and the clearing of policy uncertainty, the main line logic of innovation of leading companies will be clearer.

Societe Generale Securities believes that in the short term, although product prices may face a certain impact, but import substitution is still expected to bring a price for volume dividend. In the long run, domestic enterprises with independent innovation capability, diversified business layout, or single product with high technology content and high added value have obvious advantages in differentiated competition