2019上半年血液制品批签发研究报告.pptx

,2019上半年血液制品批签发研究报告,2019年07月,核心观点 （行业评级：推荐）, 2019H1血制品批签量增速放缓，全年仍有望达到浆量增速。,总量达到为3501万瓶（标化），较去年仅同期上涨4.87%，不及市场对整体浆量提升10%-15%的速度。一方面，上半年报批产品通常占比较低、波动较大；另一方面，受到年初上海新兴事件影响，批签速度有所放缓。预计全年仍有望匹配浆量增速。, 主力品种白蛋白小幅提升5.73%，进口品种出现短暂下滑。国产维持良好势头，维持高增长（24.11%），进口产品出现小幅下滑（-5.8%）。,主要进口品牌CSL和Grifols阶段性小幅下滑，拉低整个板块增速。国产替代趋势尚不显著。, 静丙需求尚未激发，批签延续下滑趋势。或受限于生产企业认为市场需求尚未被提振，2019H1批签量继续下滑9.72%。龙头企业天坛、泰邦,和华兰批签量和市占率提升明显。, 狂免和破免提升显著，批签量分别提升8.18%和72.51%。破免提升显著主要系天坛生物大幅放量，2019H1已超过去年整年水平，市占率赶超,泰邦和华兰。, 八因子首次出现增速下滑。生产企业较少，绿十字和华兰生物同比减少8.5万瓶、12万瓶，分别下滑40%和30%，难掩泰邦提升。, 纤原逆转下降趋势，泰邦生物快速放量。博雅表现稳定，2019H1提升1.12%，泰邦自2018年进军纤原，2019H1已超过去年总数。, 去库存事件已基本消散，需求回归常态。国内白蛋白增速已超过市场预期浆量增速，2017-2018年龙头企业注重拓展渠道、学术推广，白蛋,白需求稳健释放，库存已基本出清，价格有望稳定。静丙相比于海外市场仍然处于低位，国内需求仍有待激发。, 龙头企业表现优异。龙头企业白蛋白和静丙品种均有较大幅度提升，有望支撑2019年业绩释放。,注：（1）为方便对比，本文批签发量统计已进行标化处理。采用规格为：白蛋白为10g，静丙为2.5g，狂免、乙免、VIII因子、PCC为200IU，破免为250IU，纤原为0.5g,注：（1）为方便对比，本文批签发量统计已进行标化处理。采用规格为：白蛋白为10g，静丙为2.5g，狂免、乙免、VIII因子、PCC为200IU，破免为250IU，纤原为0.5g（2）数据来源：结合中检院和七个地方所数据。（3）本文更新至2019.7.10,核心观点 （行业评级：推荐） 投资建议：库存积压事件已消散，需求回归常态。建议买入血液制品+疫苗板块业绩稳健华兰生物；增持重组归来龙头，生产效率逐步改善，产能和品种有望双提升的天坛生物。 风险提示：行业监管风险、生产安全性风险。表 ：2019H1血液制品批签发情况,2018,2018H1,2019H1,H1同比%,人血白蛋白人血白蛋白免疫球蛋白肌注免疫球蛋白静注免疫球蛋白狂犬免疫球蛋白破伤风免疫球蛋白乙肝免疫球蛋白凝血因子凝血酶原复合物(PCC)人凝血因子VIII人纤维蛋白原,45,737,57645,737,57625,235,177639,56310,509,4098,423,0513,433,6752,229,4803,525,265978,8521,666,850879,563,20,162,82720,162,82711,537,625208,1914,941,6094,123,2031,359,840904,7831,669,008532,963810,381325,664,21,317,76921,317,76912,251,618187,1844,461,0424,460,3582,345,832797,2031,439,383352,732662,840423,811,5.73%5.73%6.19%-10.09%-9.72%8.18%72.51%-11.89%-13.76%-33.82%-18.21%30.14%,2019H1批签发分产品情况, 人血白蛋白 免疫球蛋白 凝血因子,重点公司批签发跟踪,目录,x 10000,总体血制品：批签增速有所放缓，产品格局较为稳定 2019H1血液制品批签量有所放缓，总批签量为3501万瓶（标化），较去年同期上涨5.73%。 上海新兴事件后，中检院批签要求更为严格，批签速度有所放缓，预计全年增速仍有望在下半年回升。 从产品来看，白蛋白仍然占据主导地位，产品格局较为稳定。白蛋白2131.78万瓶（60.9%），免疫球蛋白类12225.16万瓶（35.0%），凝血因子类143.94万瓶（3.5%）图.2012-2019H1血液制品批签发情况,10.65%,12.81%,19.45%,11.18%,0%,10%,15%,20%,25%,0,7.58%20004.87%5%10001.29%,40003000,5000,6000,80007000,2012,2013,2014,2015,2016,2017,2018,2019H1,白蛋白类,免疫球蛋白类,4124,4177,4622,凝血因子类6701,6229,5214,yoy7450,3501,x 10000,白蛋白：国产供应稳定，进口出现短暂下滑 2019H1人血白蛋白批签发为2131.78万瓶，较2018H1小幅提高5.73%。 进口批签供应出现一定程度下滑。其中进口、国产分别为1171.44万瓶（54.95%）、960.34万瓶（45.05%），进口下滑5.8%，国产保持增长势头，增速达24.11%。 上半年进口产品波动较大、批签收紧，进口比例表现在低位，国产替代趋势仍有待观测。,图.白蛋白批签发情况,图.白蛋白批签发-季度走势,52.02%,42.88%,40.27%,43.41%,43.61%,43.54%,40.22%,45.05%,47.98%,57.12%,59.73%,56.39%,56.46%,59.78%,54.95%,0%,4%2%,8%6%,14%12%10%,20%18%16%,0,1000500,20001500,350030002500,500045004000,2012,2013,2014,2015,2016,2017,2018,2019H1,国产,进口,yoy,3236.1156.59%,3812.47,4070.93,4573.76,2131.78,2160.80,2427.16,2764.04,1000,300200,600500400,900800700,1000,国产,进口,万瓶,图.白蛋白产品批签格局,白蛋白：进口仍为主导，国产天坛生物提升显著 进口白蛋白仍占据主导地位。上半年进口比例虽表现为略有下滑，预计全年比例仍将维持在55%以上。 天坛生物提升显著。重组完成后，内部生产效率逐步提升。2019H1批签量已经超过2018年的62.81%,同比增速达到33.83%，批签市占率提升至11.73%，白蛋白龙头地位稳固。 泰邦生物、上海莱士、华兰生物、博雅生物表现稳定。,52.02%,42.88%,40.27%,43.41%,43.61%,43.54%,40.22%,45.05%,47.98%,57.12%,59.73%,56.59%,56.39%,56.46%,59.78%,54.95%,10%0%,30%20%,60%50%40%,80%70%,2012,2013,2014,2015,2016,2017,2018,2019H1,图.进口VS国产白蛋白批签发占比情况国产VS进口国产100%90%,进口,x 10000,x 10000,x 10000,x 10000,进口白蛋白：主力CSL和Grifols上半年有所缩减,图.CSL-人血白蛋白-批签发情况,图. Octapharma-人血白蛋白-批签发情况,图. Grifols-人血白蛋白-批签发情况,图. Baxalta-人血白蛋白-批签发情况,30%20%10%0%-10%-20%-30%,70%60%50%40%,80%,8006004002000,12001000,1400,43.3%2012,48.5%2013,45.8%2014,42.8%2015,46.3%2016,55.4%2017,50.6%2018,2019,H1,H2,H1 同比增速%,40%20%0%-20%-40%-60%-80%,120%100%80%60%,140%,4003002001000,700600500,800,43.3%2012,48.5%2013,45.8%2014,42.8%2015,46.3%2016,55.4%2017,50.6%2018,2019,H1,H2,H1 同比增速%,43.3%,48.5%,45.8%,42.8%,46.3%,55.4%,50.6%,-100%,50%0%-50%,150%100%,200%,0,25020015010050,450400350300,500,2012,2013,2014,2015,2016,2017,2018,2019,H1,H2,H1 同比增速%,55.9%,47.8%,43.8%,58.7%,52.2%,60.1%,35.4%,-40%,20%10%0%-10%-20%-30%,60%50%40%30%,70%,0,20015010050,350300250,400,2012,2013,2014,2015,2016,2017,2018,2019,H1,H2,H1 同比增速%, 2018年底，Grifols的AMBAR研究显示血浆置换与人血白蛋白20%的联合使用能延缓中度AD患者疾病进展，海外应用扩容，需求景气度有所提,升, Baxalta战略提升中国白蛋白市场重要性，上半年度已经完成去年全年,约88.2%，预计今年批签量有望翻倍,x 10000,x 10000,x 10000,x 10000,x 10000,x 10000,国产白蛋白：天坛、泰邦提升显著,图.天坛生物-人血白蛋白-批签发情况,图.上海莱士-人血白蛋白-批签发情况,图.华兰生物-人血白蛋白-批签发情况,图.泰邦生物-人血白蛋白-批签发情况,图.博雅生物-人血白蛋白-批签发情况,图.振兴生化-人血白蛋白-批签发情况,45.6% 42.5% 45.6%,47.0%,39.1%,47.4%,42.2%,-30%,-10%-20%,30%20%10%0%,40%,0,10050,250200150,300,2012,2013,2014,2015,2016,2017,2018,2019,H1,H2,H1 同比增速%,-20%-40%,60%40%20%0%,80%,500,250200150100,300,35.3% 34.2% 47.9%2012 2013 2014,38.3%2015,38.5%2016,57.6%2017,39.6%2018,2019,H1,H2,H1 同比增速%,-20%-40%,60%40%20%0%,80%,100500,350300250200150,400,51.8%2012,39.6% 61.2% 48.2% 44.3%2013 2014 2015 2016,43.2% 44.9%2017 2018,2019,H1,H2,H1 同比增速%,45.0% 39.2%,51.4% 50.0% 44.7%,53.1%,31.5%,-40%,0%-20%,60%40%20%,80%,0,302010,8070605040,90,2012,2013,2014,2015,2016,2017,2018,2019,H1,H2,H1 同比增速%,35.9%,49.2%,22.4%,56.5%,31.7% 29.0%,45.1%,-100%,-60%,60%20%-20%,100%,0,302010,8070605040,90,2012,2013,2014,2015,2016,2017,2018,2019,H1,H2,H1 同比增速%,-0.1-0.2-0.3,0.50.40.30.20.10,0.6,500,250200150100,300,44.6%2012,66.8%2013,5.4%2014,44.0%2015,45.6% 52.4% 39.6%2016 2017 2018,2019,H1,H2,H1 同比增速%,注：泰邦生物2015年H1增速为2049%，波动较大，予以省略显示,x 10000,x 10000,静丙：需求端尚未激发，批签延续下滑趋势 2019H1批签发延续下滑趋势。静丙受限于市场尚未打开，近年批签量较为稳定。2018年批签量1050.94万瓶，出现近年来首次下滑（-9.72%）。2019H1继续扩大下滑趋势，批签量446.10万瓶，同比下滑9.72%。 预计全年批签水平同去年将基本持平，需求量相较国际水平差异较大，仍有较大提升空间。通过学术教育、市场教育来提升对静丙的认识，扩容需求，是静丙的必经之路。,630.23,553.70,650.31,871.39,1072.87,1086.50,1050.94,446.10,0%-10%-20%,20%10%,30%,40%,400.00200.000.00,800.00600.00,1000.00,1200.00,2012,2013,2014,2015,2016,2017,2018,2019H1,图. 2012-2019H1静丙批签发情况静注免疫球蛋白,同比%,100500,200150,250,350300,图.静丙季度批签发走势400,静丙：天坛、泰邦、华兰占比持续提升,图.静丙批签发格局, 天坛生物静丙地位稳固，重组后批签市占率显著提升，2019H1达到28.16%。整体市场下滑趋势下，仍有,12.20%的批签量增速。, 白蛋白市场竞争激烈，龙头血液制品公司的推广扩渠道、推产品的重心逐步转向静丙。, 泰邦生物、华兰生物批签量、市占率提升，上海莱士、博雅生物、振兴生化下降。,x 10000,x 10000,x 10000,x 10000,x 10000,x 10000,图.天坛生物-静丙-批签发情况,图.泰邦生物-静丙- 生 批签发情况 球蛋白批签发量,图.上海莱士-静丙海 批签发情况 疫球蛋白批签发量,-,图.博雅生物-静丙 生 -物-签 注 发 免情 球 况 蛋白批签发量,批静 疫,图.振兴生化-静丙 生批签发情况 蛋白批签发量,静丙：龙头企业提升，振兴生化波动较大,50%40%30%20%10%0%-10%-20%-30%-40%,60%,706050403020100,80,60.7%39.3%2012,50.5%49.5%2013,40.3%59.7%2014,51.7%48.3%2015,68.2%31.8%2016,47.2%52.8%2017,60.1%39.9%2018,2019H1,博雅,H1,H2,同比yoy,万,200%150%100%50%0%-50%-100%,180160140120100806040200,50.1%49.9%2013,47.2%52.8%2016,46.3%53.7%2018,2019H1,泰邦 物-静注免疫,H193.2%6.8%2014,H253.4%46.6%2015,同比yoy45.9%54.1%2017,万43.1%56.9%2012,60%50%40%30%20%10%0%-10%-20%-30%,300250200150100500,54.3%45.7%2013,52.1%47.9%2016,57.9%42.1%2018,2019H1,天坛生物-静注免疫球蛋白批签发量,H136.4%63.6%2014,H248.7%51.3%2015,同比yoy52.3%47.7%2017,万54.9%45.1%2012,100%80%60%40%20%0%-20%-40%,180160140120100806040200,68.4%31.6%2013,59.3%40.7%2016,50.3%49.7%2018,2019H1,图.华兰生物-静丙 兰批签发情疫球蛋白批签发量,-生物-静注免况 华,H153.3%46.7%2014,H250.7%49.3%2015,同比yoy38.2%61.8%2017,万66.7%33.3%2012,80%60%40%20%0%-20%-40%-60%-80%-100%,100%,50403020100,60,47.1%52.9%2012,37.5%62.5%2013,79.9%20.1%2014,54.0%46.0%2015,63.3%36.7%2016,45.2%54.8%2017,38.9%61.1%2018,2019H1,静 疫,H1,H2,同比yoy,万,40%30%20%10%0%-10%-20%-30%-40%-50%,50%,160140120100806040200,180,57.4%42.6%2012,62.6%37.4%2013,51.7%48.3%2014,46.6%53.4%2015,65.5%34.5%2016,56.5%43.5%2017,56.0%44.0%2018,2019H1,上 莱士-静注免,H1,H2,同比yoy,万,x 10000,图.肌丙-批签发格局,图.肌丙-批签发情况,肌丙：批签发继续收窄，莱士为主要企业 批签量体量较小，继续收窄。肌丙批签发量较小，近5年每年批签发多为不足100万瓶，2018年全年批签发仅有63.96万瓶，2019H1批签发18.72万瓶，同比下滑-10.09%，供应收窄显著。 上海莱士占据绝对优势：2019H1仅有3家企业有批签发，上海莱士后发制人，快速占据76.57%。,157.27,64.38,97.96,63.96,-37.56% 41.93-73.34%,142.46%156.1053.56%,-37.25%,-34.71%18.72,-100%,-50%,0%-10.09%,150%100%50%,200%,0,50,100,250200150,300,2012,2013,2014,2015,2016,2017,2018,2019H1,肌丙，300mg，批签发,肌注免疫球蛋白,yoy,万251.88,0,50,100,150,200,250,华兰生物博晖创新,上海莱士,远大蜀阳卫光生物泰邦生物,振兴生化,300千,2019H1,2018,x 10000,x 10000,x 10000,x 10000,肌丙：上海莱士提升，其他企业均大幅减少,2.30,1.10,51.97,16.59,69.30 6216.88%,-25.01%,-68.08%,-1000%,0%,3000%2000%1000%,5000%4000%,7000%6000%,0,10,403020,6050,8070,2012,2013,2014,2015,2016,2017,2018,2019H1,万,6.36,5.62,10.45,2.95,-11.57%,11.40 9.07% 10.86-4.74%,23.85 119.53%,-83.42%,-100%,50%0%-50%,150%100%,0,2015105,3025,2012,2013,2014,2015,2016,2017,2018,2019H1,万,4.62,7.31,13.71,14.33,0%,20%,60%40%,80%,120%100%,0,2,864,1210,1614,2012,2013,2014,2015,2016,2017,2018,2019H1,万,15.22,4.00,4.65,1.43,-80%,-10%-20%-30%-40%-50%-60%-70%,0%,30%20%10%,0,40302010,6050,2012,2013,2014,2015,2016,2017,2018,2019H1,万52.97,图.博晖创新-肌丙-批签发情况博晖创新-肌注免疫球蛋白,图.上海莱士-肌丙-批签发情况上海莱士-肌注免疫球蛋白,图.泰邦生物-肌丙-批签发情况泰邦生物-肌注免疫球蛋白,图.华兰生物-肌丙-批签发情况华兰生物-肌注免疫球蛋白,x 10000,389.98,图.破免-批签发情况,破免：19H1来势汹涌，同比增长72% 2018年基数较低，2019H1增量显著。2019H1批签发已达234.58万瓶，同比增长72.51%。 华兰批签量有所下滑，天坛、莱士、泰邦等均有所上升。 天坛生物提升显著，2019H1已超过去年一年总量，市占率提升接近翻倍。,343.37,234.58,0%-20%-40%,80%60%40%20%,150100500,2012,2013,2014,2015,2016,2017,2018,2019H1,破免，250IU，批签发图.破免-批签发情况,破伤风免疫球蛋白280.44212.94 202.96,yoy406.97,450 万400350 322.76300250200,x10000,x10000,x 10000,70.27,15.10,破免：19H1华兰下滑过半，天坛、泰邦、莱士翻倍,24.54%24.44,-38.20%,139.98%43.15 19.07%36.24,125.61191.09%92.03-26.74%,23.58-54.79%,-100%,250%200%150%100%50%0%-50%,0,14012010080604020,2012,2013,2014,2015,2016,2017,2018,2019H1,万19.62,图.华兰生物-破免-批签发情况华兰生物-破伤风免疫球蛋白,61.00,75.69,64.93%,106.53%,40%20%0%-20%-40%-60%-80%,120%100%80%60%,50403020100,807060,45.082013,43.00-4.61%2014,41.85%2015,24.07%2016,24.62-67.47%2017,40.612018,28.542019H1,万,图.上海莱士-破免-批签发情况上海莱士-破伤风免疫球蛋白,10.44 -90.32%,51.65%15.83,127.13351.67%71.5077.81%,93.08-26.78%,63.82-31.43%,177.44%50.49,-150%,400%350%300%250%200%150%100%50%0%-50%-100%,0,14012010080604020,2012,2013,2014,2015,2016,2017,2018,2019H1,万107.87,图.泰邦生物-破免-批签发情况泰邦生物-破伤风免疫球蛋白,43.06-43.75%,49.8815.82%,40.39-19.02%,34.31-15.05%,96.21%67.32,49.85-25.95%,96.12%,-60%,120%100%80%60%40%20%0%-20%-40%,0,908070605040302010,2012,2013,2014,2015,2016,2017,2018,2019H1,万76.55,图.天坛生物-破免-批签发情况.天坛生物-破伤风免疫球蛋白,38.15%,48.46%,20%0%-20%-40%-60%,60%40%,6050403020100,908070,2012,51.47644.7576-13.05%-35.61%2013 2014,53.105738.44-14.12%2015 2016,38.6452 37.509926.0308-50.98%2017 2018 2019H1,万79.9458,图.远大蜀阳-破免-批签发情况远大蜀阳-破伤风免疫球蛋白,x 10000,图.乙免-批签发情况,图.乙免-批签发情况,乙免：2019H1批签发出现下滑 2019H1下滑明显：过往提升速率月稳定在10%左右，2018年批签发已达到222.95万瓶，2019H1批签量为79.72万瓶，同比2018年的高基数，下滑11.89%。 远大蜀阳仍维持龙头地位，上海莱士提升显著。,246.44,156.15,79.72,-8.62% 140.62,-42.94%,14.33%,178.52 185.59 3.96%,20.13%222.95,-40%-50%,-30%,0%-11.89%-10%-20%,30%20%10%,500,200150100,300250,2012,2013,2014,2015,2016,2017,2018,2019H1,乙免，200IU，批签发,乙肝免疫球蛋白11.04%,yoy,万269.69,46.81,21.66,乙免：远大蜀阳下滑但仍占据龙头，天坛、莱士大幅提升,16.10-55.67%,27.96%20.60,54.89%31.91,35.2010.29%,39.9713.56%,28.23-29.37%,-80%,80%60%40%20%0%-20%9.78-37.15% -40%-60%,0,45403530252015105,2012,2013,2014,2015,2016,2017,2018,2019H1,万36.33,图.华兰生物-乙免-批签发情况华兰生物-乙肝免疫球蛋白,40.15-14.23%,26.90-33.00%,11.04-58.95%,166.81%32.2929.469.60%,34.958.24%,24.8655.89%,-100%,200%150%100%50%0%-50%,0,5045403530252015105,2012,2013,2014,2015,2016,2017,2018,2019H1,万,图.天坛生物-乙免-批签发情况.天坛生物-乙肝免疫球蛋白,8.12,6.64,11.69-17.69%,130.41%15.29-18.26%,41.64%4.56,-40%,140%120%100%79.80%60%40%20%0%-20%,0,252015105,2012,2013,2014,2015,2016,2017,2018,2019H1,万14.21,图.泰邦生物-乙免-批签发情况泰邦生物-乙肝免疫球蛋白,24.61,45.09,46.88,47.06,20.59,91.94%47.23,-4.54%,55.4122.90%,-15.39%,0.39%,68.2344.97%,-46.89%,-60%,-40%,0%-20%,100%80%60%40%20%,0,10,3020,8070605040,2012,2013,2014,2015,2016,2017,2018,2019H1,万,图.远大蜀阳-乙免-批签发情况远大蜀阳-乙肝免疫球蛋白,14.49,35.60,21.18,-61.54%,14.29-1.38%,33.6330.94135.32%,-8.00%,15.06%,-40.51%,210.61%19.93,-100%,-50%,50%0%,250%200%150%100%,0,5,1510,4035302520,2012,2013,2014,2015,2016,2017,2018,2019H1,万37.68,图.上海莱士-乙免-批签发情况上海莱士-乙肝免疫球蛋白,x 10000,图.狂免-批签发情况,图.狂免-批签发格局,狂免：高增速之后，2019H1有所放缓 高增速之后，2019H1有所放缓。2017、2018年狂免批签发分别为511.42万瓶、842.31万瓶，增速高达51.18%、64.70%，2019H1批签发44.60万瓶，同比增速放缓，仅为8.18%。 狂免批签发企业较多，竞争激烈，格局变动较大。2019H1振兴生化、远大蜀阳和上海莱士批签占比较高。,381.58,469.27,413.60,338.28,511.42,842.31,446.04,-20%-40%-60%,40%20%0%,80%60%,3002001000,600500400,900800700,2012,2013,2014,2015,2016,2017,2018,2019H1,狂免，200IU，批签发,狂犬免疫球蛋白645.46,