高值医用耗材全国集采将于本周四（１１月５日）落地。作为新品种，涉及微创医疗、乐普医疗等１２家公司的２７个产品。市场分析认为，集采或重塑冠脉支架百亿市场竞争格局，这是国家层面对高值医用耗材进行集采，对于后续其他品种将带来较强的示范效应。未来集采常态化下，龙头公司的创新主线逻辑将更为清晰。

百亿市场格局或重塑

根据国家组织高值医用耗材联合采购办公室１０月中旬发布的《国家组织冠脉支架集中带量采购文件》（以下简称集采文件），首年意向采购总量逾１０７万个，本次冠脉支架集中带量采购周期为两年。公开资料显示，我国一年要用掉约１５０万个冠脉支架，总费用达１５０亿元，仅这一个品种就占高值医用耗材市场总额的１０％。

据了解，冠脉支架领域是我国血管介入器械中发展成熟的细分市场，也是我国高值医用耗材领域进口替代率较高的市场之一。医械研究院数据显示，２０１８年，国内心脏支架行业约８０％的市场份额已被国产品牌占领，乐普医疗、微创医疗和吉威医疗（蓝帆医疗子公司）三家国产心脏支架企业的合计占有市场份额５３％，美敦力、波士顿科学和雅培三家进口品牌的市场份额合计为２７％。

《经济参考报》记者梳理集采文件发现，首年意向采购量汇总表显示，共涉及１２家公司的２７个品种。其中，进口品牌包括波士顿科学的６个品种约１２．０６万个、雅培的６个品种约１０．８９万个、美敦力的３个品种约１０．６０万个。国产品牌方面，微创医疗凭借４个品种约３９．２２万个意向采购量居首，占比３６．５％，乐普医疗、吉威医疗、桓晨医疗（信立泰子公司）分别涉及一个品种，意向采购量分别为１２０５６０个、１００６９０个、２００７０个，占比分别为１１．２％、９．４％、１．９％。

根据集采文件，２７个意向采购产品中，将有１０个入围。按产品申报价由低到高的顺序确定排名。

国信证券分析认为，这一采购量基本符合预期，各具体品种的意向采购量基本符合现有市场格局。本次集采较低价中标产品将获得不少于１０％的待分配总量，其余产品按照医疗机构报量和自主选择决定用量，对于报量较高的品种，只要中标即能获得较高份额，“光脚者”若未能以较低价中标，可能仍然难以获得份额的大幅增量。

浩悦资本表示，冠脉支架市场过去实现了８０％的进口替代，格局稳定，此次全国性的带量采购可能重塑竞争格局，可预见利好行业龙头，行业集中度将进一步提高，也有可能给予后来者弯道超车的机会。

龙头公司创新主线日渐清晰

此次集采的价格竞争无疑十分激烈。

根据集采文件要求，此次冠脉支架国家集采将于１１月５日在天津开标，拟中选结果在公示无异议后，由联合采购办公室进行中选结果公布。根据集采文件，入围产品符合以下条件之一的，获得拟中选资格：一是申报价≤低产品申报价１．８倍的；二是申报价＞低产品申报价１．８倍，但低于２８５０元的。

值得注意的是，２８５０元的参考价与此前江苏冠脉支架集采中，乐普医疗报出的钴基支架价格相同，这也是江苏冠脉支架试点集采的低谈判价格。目前，国产冠脉支架的平均价格在万元左右，进口支架约为１．５万至１．９万元。

以怎样的价格中标，将对中标企业产生较大影响。国信证券认为，这一竞价模式下，价格降幅可能比此前预期更大，参考药品集采中标结果，不排除企业采取成本加成模式进行报价以力保中标，可能对企业利润率带来一定影响。

集采文件的发布引起市场强烈反应。文件发布后的交易日（１０月１９日），医疗器械板块领跌两市，相关个股暴跌，乐普医疗、蓝帆医疗、信立泰分别下跌８．８３％、３．８８％、５．２９％；港股市场上，微创医疗当天跌幅达１１．９３％。

券商普遍认为，随着集采落地、政策不确定性出清，龙头公司的创新主线逻辑将更为清晰。

兴业证券认为，短期来看，虽然产品价格可能会面临一定冲击，但进口替代仍有望带来以价换量的红利。长期来看，拥有自主创新能力、业务多元化布局，或是单一产品具有高技术含量和高附加值，在差异化竞争中具有明显优势的国产龙头企业有望在行业洗牌中受益。

国开证券分析师王雯表示，经过多省市多轮试点后，国家层面首次对高值耗材进行集采，为后续高值耗材类品种带来较强的示范效应。中长期看，在单个产品价格体系面临一定冲击及重构压力下，企业整体研发和创新能力将尤为重要。此外，该集采规则有望在冠脉支架试点后推广至高值耗材其他领域，如骨科、眼科等，中长期更应关注在研管线丰富、研发实力较强的龙头企业。

来源：经济参考报

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