全球医药产业研究与发展的最新趋势

《全球医药产业研究与发展的最新趋势》由会员上传分享，免费在线阅读，更多相关内容在教育资源-天天文库。

1、全球医药产业研究与发展的最新趋势胡江滨美中药协(SAPA)北京,20041报告内容全球制药界新药开发最新概况新药开发值得注意的走向Projectin-licensing项目引进LifeCycleManagement(LCM)产品周期的管理OutsourcingWhatWhyand(How)?2223236249285296297308337364396010020030040050060019921993199419951996199719981999200020012002p2003pGlobalpharmaceut

2、icalsales(US$billion)4204450100200300400500600Yearp=projectionSource:Salesdatafor1992-2001suppliedbyIMSHealth全球药品销售1992-2003p30608010012014016018020019921993199419951996199719981999200020012002pYearIndexedvalues(1992=100)全球研发费用全球新药上市研发时间(3yearmovingaverage)全球销售全

3、球销售，研发费用及研发时间和新药上市1992-2002p4ResearchLateDevelopmentEarlyDevelopmentRegulatoryassessmentCommercial-isationPre-clinicalevaluationClinicalevaluation2.9yrs1.5yrs5.7yrsUSFDA:1.0yrsEMEA:1.3yrsJapaneseMHLW:1.4yrsDuration(median)Attrition(Numberofcompoundsenteringstage

4、percompoundlaunched)911新药R&D的过程TargetdiscoveryAssaydevelopmentLeaddiscoveryLeadoptimisation511%16%44%79%0%10%20%30%40%50%60%70%80%90%100%FirsthumandosetoMarket临床一期FirstpatientdosetoMarket临床二期FirstpivotaldosetoMarket临床三期Submissiontomarket申报Successrate新药上市的成功机率68%

5、13%40%77%34%46%76%88%0%10%20%30%40%50%60%70%80%90%100%FirsthumandosetomarketFirstpatientdosetomarketFirstpivotaldosetomarketSubmissiontomarketSuccessrateChemicalentitiesBiotechSuccessratetomarketbyproducttype7Terminationreasonswereprovidedfor498ofthe538NASsforwh

6、ichdevelopmentwasterminatedbetween1999and2001.新药开发失败的原因1999-20018目前新药开发遇到的困境R&D成本和风险不断提高Pipelinesbecomingthinner新药项目越来越少Increasingcostsforpromotion新药上市的费用越来越高Shorterproductlifecycles新药产品周期不断缩短Risinggenericexposure非专利药抢占市场越来越早9面对上述的挑战，国际制药界采取了些什么对策？10NewTrendsinD

7、rugDevelopment目前的新走向Nowtheclassicdrugdiscoverymodelissupplementedby传统的新药开发模式由下面两种方式进行补充Projectin-licensing项目引进LifeCycleManagement(LCM)产品周期的管理Outsourcing11Manyblockbusterdrugsareexternallysourced许多重磅炸弹都是从其它公司引进的。DrugLicenseeLicensorLaunched2002sales(mioUSD)PaxilG

8、SKNovoNordisk19912,055PravacholBMSSankyo19902,266FosamaxMerckGentili19932,250LipitorPfizerWarnerLamb19977,972CelexaForestLabsLundbeck19981,45112Revenuesfromin-licensi