中药配方颗粒,要大放开了?!

2018-01-27 遥望 华泰证券

根据华泰证券数据,中药饮片市场集中度将进一步提高,小饮片厂在未来几年面临彻底退出市场。中药配方颗粒市场需求持续释放,预计今年有望有条件的放开生产限制,打破6家企业的垄断局面。

根据华泰证券数据,中药饮片市场集中度将进一步提高,小饮片厂在未来几年面临彻底退出市场。中药配方颗粒市场需求持续释放,预计今年有望有条件的放开生产限制,打破6家企业的垄断局面。

▍小饮片厂被迫退出

从整体上看,在药品零加成背景下,中药饮片维持 25%加成,满足医生利益,市场需求继续扩张。新版 GMP 与国家飞行检查淘汰小产能、提升行业集中度,康美药业等龙头公司受益,中小企业彻底退出市场。








饮片大行业,小企业

得益于纳入 2009 版基药目录,中药饮片发展迅速。根据工信部数据,2011-2016 年市场规模复合增速达 18%,2016 年行业规模逼近 2000 亿元。而由于行业准入壁垒低,行业格局呈现小、散、乱,龙头公司 2016 年市占率不足 5%。



分散格局有望缓慢聚合

监管缺失导致饮片行业以低标准运行,药材质量饱受医师诟病。2014 年新版 GMP 颁布,企业为满足新规投入千万级技术改造费用,小产能淘汰,市场初步整理,抽检合格率从 2013 年的 64%上升至 2016 年的 77%,行业格局得以改善。



▍中药颗粒垄断被打破

市场持续扩容

我国中药配方颗粒行业发展迅速,市场规模从 2010 年的 15 亿元增长到 2015 年的 82 亿元(CAGR 达 40%)。




目前,我国尚未放开配方颗粒的生产销售,市场上仅有 6 家企业(5 家上市公司)具备全国性的生产销售牌照。同时政府要求6 家企业负责医院配送。中药配方颗粒自 2001 年纳入中药饮片管理以来,一直受到严格限制。

2018年有望打破垄断

从使用端来看,政府原先要求医院未经批准不得使用,后逐渐允许二级以上的中医院可备案使用。



从生产端来看,2015 年底,国家药监总局发布《中药配方颗粒管理办法(征求意见稿)》中表示,拟全面放开配方颗粒的生产、使用限制,但对企业提出较高要求(上游完全可溯源、负责医院用药配送)。

预计关于中药配方颗粒的新政于2018 年推出,解除生产限制但维持使用限制(不允许基层使用)。



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  1. [GetPortalCommentsPageByObjectIdResponse(id=1991526, encodeId=3d7319915269a, content=<a href='/topic/show?id=dfc92252167' target=_blank style='color:#2F92EE;'>#中药配方颗粒#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22521, encryptionId=dfc92252167, topicName=中药配方颗粒)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8b48400, createdName=rgjl, createdTime=Fri Apr 06 10:52:00 CST 2018, time=2018-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=283672, encodeId=43cc2836e24e, content=谢谢了.学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=30331616752, createdName=txqjm, createdTime=Wed Jan 31 00:07:36 CST 2018, time=2018-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282446, encodeId=5e9728244602, content=好好好好好好好好, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/29/bbc5cc0eed9b8d17623d2fd49dbdf19a.jpg, createdBy=79522135794, createdName=yjs木玉, createdTime=Sat Jan 27 07:29:33 CST 2018, time=2018-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282407, encodeId=eea528240e19, content=了解了解.继续关注, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Sat Jan 27 04:52:17 CST 2018, time=2018-01-27, status=1, ipAttribution=)]
  2. [GetPortalCommentsPageByObjectIdResponse(id=1991526, encodeId=3d7319915269a, content=<a href='/topic/show?id=dfc92252167' target=_blank style='color:#2F92EE;'>#中药配方颗粒#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22521, encryptionId=dfc92252167, topicName=中药配方颗粒)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8b48400, createdName=rgjl, createdTime=Fri Apr 06 10:52:00 CST 2018, time=2018-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=283672, encodeId=43cc2836e24e, content=谢谢了.学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=30331616752, createdName=txqjm, createdTime=Wed Jan 31 00:07:36 CST 2018, time=2018-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282446, encodeId=5e9728244602, content=好好好好好好好好, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/29/bbc5cc0eed9b8d17623d2fd49dbdf19a.jpg, createdBy=79522135794, createdName=yjs木玉, createdTime=Sat Jan 27 07:29:33 CST 2018, time=2018-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282407, encodeId=eea528240e19, content=了解了解.继续关注, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Sat Jan 27 04:52:17 CST 2018, time=2018-01-27, status=1, ipAttribution=)]
    2018-01-31 txqjm

    谢谢了.学习

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1991526, encodeId=3d7319915269a, content=<a href='/topic/show?id=dfc92252167' target=_blank style='color:#2F92EE;'>#中药配方颗粒#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22521, encryptionId=dfc92252167, topicName=中药配方颗粒)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8b48400, createdName=rgjl, createdTime=Fri Apr 06 10:52:00 CST 2018, time=2018-04-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=283672, encodeId=43cc2836e24e, content=谢谢了.学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=30331616752, createdName=txqjm, createdTime=Wed Jan 31 00:07:36 CST 2018, time=2018-01-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282446, encodeId=5e9728244602, content=好好好好好好好好, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/08/29/bbc5cc0eed9b8d17623d2fd49dbdf19a.jpg, createdBy=79522135794, createdName=yjs木玉, createdTime=Sat Jan 27 07:29:33 CST 2018, time=2018-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=282407, encodeId=eea528240e19, content=了解了解.继续关注, beContent=null, objectType=article, channel=null, level=null, likeNumber=48, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Sat Jan 27 04:52:17 CST 2018, time=2018-01-27, status=1, ipAttribution=)]
    2018-01-27 yjs木玉

    好好好好好好好好

    0

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    2018-01-27 1dd8c52fm63(暂无匿称)

    了解了解.继续关注

    0