醫(yī)療健康行業(yè)市場(chǎng)分析報(bào)告

醫(yī)療健康行業(yè)市場(chǎng)分析報(bào)告2021年7月??1897192019461950s1960s19891993200020022009至今結(jié)合域：特異性地與神經(jīng)細(xì)胞膜結(jié)合進(jìn)入細(xì)胞催化域：術(shù)前去除動(dòng)態(tài)皺紋水解突觸前膜上的SNAP25蛋白，降低其活性術(shù)前瘦臉輕鏈（50kD）重鏈（100kD）N端C端催化域易位域結(jié)合域動(dòng)態(tài)皺紋表皮乙酰膽堿囊泡乙酰膽堿囊泡真皮神經(jīng)元神經(jīng)元細(xì)胞膜皮下組織肌肉纖維突觸間隙收縮區(qū)域表皮真皮肌肉細(xì)胞肌肉細(xì)胞細(xì)胞膜皮下組織肌肉纖維乙酰膽堿肉毒素被放松的肌肉1）正常狀態(tài)的神經(jīng)肌肉接點(diǎn)2）注射肉毒素后的神經(jīng)肌肉接點(diǎn)-研新究藥申臨請(qǐng)床FDA&IRB會(huì)）審查臨1.I期臨床試驗(yàn)確定安全性提申交請(qǐng)新藥FDA&IRB藥品上市床進(jìn)試行驗(yàn)2.II3.III員會(huì)）審查-1.I期臨床試驗(yàn)確定明確藥品分類提指定責(zé)任人申請(qǐng)人進(jìn)行安全性為明確責(zé)任，每種藥品必信提息交文產(chǎn)件品EMA審查臨床試驗(yàn)交新藥申請(qǐng)EMA審查藥品上市須指定責(zé)任人，責(zé)任人需為在歐盟內(nèi)的自然人或法人。2.II有效性3.III患者試驗(yàn)責(zé)任人需要隨時(shí)更新產(chǎn)品信息及臨床試驗(yàn)情況-藥1.向藥品審評(píng)中心國(guó)臨家床藥批監(jiān)件局發(fā)申請(qǐng)1.省局進(jìn)行臨床試驗(yàn)現(xiàn)場(chǎng)核查，并抽取送省藥檢院藥1.CDE技術(shù)審評(píng)品2.申請(qǐng)人補(bǔ)充材料審審（如需）查評(píng)3.向國(guó)家技術(shù)中心1.申請(qǐng)人接國(guó)提交申請(qǐng)省級(jí)審查省級(jí)藥學(xué)及動(dòng)物實(shí)驗(yàn)室現(xiàn)場(chǎng)核查，并抽取3批樣品送省藥檢院省品審審查評(píng)（CDE現(xiàn)認(rèn)受核查，并場(chǎng)證抽取3批樣品生家產(chǎn)藥批監(jiān)件局發(fā)藥品上市床試驗(yàn)人級(jí)2.CDE進(jìn)審2.核查通過后，申請(qǐng)人核中查心送省藥檢院中3.申請(qǐng)人補(bǔ)充材料心（如需）行臨及省藥檢院分別向提中及申請(qǐng)人下發(fā)生產(chǎn)心現(xiàn)場(chǎng)核查通知查2.核查報(bào)告遞交CDE交申報(bào)材料和檢驗(yàn)報(bào)告提中藥心品許做可出決行定政決藥1.CDE150日之內(nèi)）國(guó)家藥監(jiān)局需在20日內(nèi)做出行政許可決定；20日內(nèi)不能做出決定的，經(jīng)主管局批準(zhǔn)可延長(zhǎng)10日。交申請(qǐng)定送達(dá)由NMPA受理和舉報(bào)中心將品上市審審2.申請(qǐng)人補(bǔ)充材料（需在4個(gè)月之內(nèi)按照通行政許可決定送達(dá)查評(píng)知要求一次性完成補(bǔ)充材料）-申請(qǐng)人進(jìn)行臨床試驗(yàn)初KFDA（韓國(guó)藥品監(jiān)督管理局）審小組訪談1.成立初審小組，根據(jù)申請(qǐng)人提交的材料與申請(qǐng)人進(jìn)行訪談KFDA提交申請(qǐng)藥品上市初審需要全程記錄詳細(xì)的臨床試驗(yàn)數(shù)據(jù)和生產(chǎn)日志終審2.回復(fù)結(jié)果??75%50%25%45.45%46.28%47.17%52.83%48.01%49.39%50.50%54.55%53.72%51.99%50.61%49.50%治療用醫(yī)美用???????200160120(美元十億元)5.5%2.7%2.9%3.4%肉毒素注射玻尿酸注射脫毛1059779897579747.7%826475606759605546.1%52475449光子嫩膚非手術(shù)減脂非手術(shù)皮膚緊致其他8331.7%0201420152016201720182019手術(shù)類非手術(shù)類012%0282512%（美元十億元）43（美元十億元）9.8%338.5%35244010.8%37228.9%8.6%7.3%30218.2%8%4%0%-4%219.3%8%3219208.8%258.6%1818287.4%235.9%4%0%-4%4.2%4.2%3.9%-2.7%1.0%-3.3%201520162017201820192024E201520162017201820192024E市場(chǎng)規(guī)模同比增速市場(chǎng)規(guī)模同比增速???814%10%6%610%6%（美元億元）35.3（美元億元）3433.36.2%31.9325.8%5.5%5.6%5.3%31.14.9%10.729.730.14.3%9.828.64.1%10.227.411.911.37.4%9.62%9.18.14.4%4.1%2%3.8%3.8%3.3%2.9%2.1%-2%-6%-10%-2%-6%-10%-2.1%-5.6%0020162017201820192022E2024E市場(chǎng)規(guī)模同比增速20162017201820192022E2024E市場(chǎng)規(guī)模同比增速50020%15%10%5%（萬例）80%60%40%20%0%67%56%48%49%50%47%33%33%37%26%46730%20%00%肉毒素玻尿酸醫(yī)美療程數(shù)滲透率中國(guó)美國(guó)歐洲韓國(guó)日本巴西03.0%,13.0%,4.0%,86.0%,1716.0%,4818.0%,5115.0%,1515.0%,427.0%,2172.0%,20265.0%,1957.0%,2179.0%,23年Dysport2018年DysportXeominBOTOXXeominMeditoxin其他??4503602701809020%15%10%5%6.0%,0.53883287.0%,0.6)28028534835331.0%,2.8Dysport8.0%,0.7Xeomin0%Meditoxin（粉毒）Nabota（綠毒）其他22.0%,2.026.0%,2.40????肉毒素分子XTRACT肉毒素分子純化技術(shù)，去除復(fù)合蛋白：???SAKURA1(Daxi40SAKURA2(Daxi40GL-1Dysport500GL-3Dysport300BOTOX50皺紋改善程????202019982005200620102012199319952009先95-99歲90-94歲85-89歲80-84歲75-79歲70-74歲65-69歲60-64歲0.84.216.13.514.33.5%12.3%37.837.940.416.8%66.5689389.9106.8128.82020-25歲25-30歲30-35歲35185.613955-59歲208.550-54歲45-49歲40-44歲201.6191.9207.9214.7210.7190.9216.8218.627.4%35-39歲30-34歲25-29歲20-24歲15-19歲10-14歲5-9歲197.5173.3187.1168.3162.3154.9153.9153.3128.9117.5115.997.4118.7109.892.30-4歲40.0%03.0%5.0%10.0%0Botulax()MeditoxinNabota40.0%7.0%35.0%60%40%20%0%60%48%36%24%12%0%51%3.2,43.0%2.7,35.0%3.6,43.0%3.2,38.2%42%43%43%2.2,42.0%40%2.4,40.0%2.0,33.3%31%30%29%1.4,26.7%0.5,9.5%23%0.8,13.3%0.6,7.0%0.7,8.4%0.4,4.8%201620172018Nabota2019201220132014201520162017201820192020BMxBotulax（白毒）韓國(guó)市場(chǎng)市占率Ⅲ11.4%其他：0.7%0.7%肉毒素：32.7%20.1%66.6%5.3%5.0%手術(shù)-身體和四肢57.4%手術(shù)-頭面部手術(shù)-胸部非手術(shù)-注射非手術(shù)-面部年輕化非手術(shù)-其他12010080604020011240%32%24%16%8%10080604020048%40%32%24%16%8%（人民幣億元）33.3%（人民幣億元）39.1%37.1%9123.0%8034.5%38.2%746025.0%30.2%6126.5%3433.1%32.4%51454823.1%21.3%3519.6%282427211813106.3%2020E9.6%2020E0%0%20162017201820192021E增速2022E2023E2024E20162017201820192021E增速2022E2023E2024E市場(chǎng)銷售額市場(chǎng)銷售額201510540.9%23.9%42.4%22.0%45%按銷量計(jì)算按銷售額計(jì)算（人民幣億元）33.6%31.1%28.5%20.3%25%5%6.78.39.54.75.53.64.36.82.73.50-15%2018衡力增速20142015BOTOX201