全球醫(yī)藥產(chǎn)業(yè)與發(fā)展的最新趨勢

全球醫(yī)藥產(chǎn)業(yè)研究與發(fā)展的最新趨勢胡江濱美中藥協(xié)(SAPA)北京,20041報告內(nèi)容全球制藥界新藥開發(fā)最新概況新藥開發(fā)值得注意的走向Projectin-licensing

項目引進(jìn)LifeCycleManagement(LCM)

產(chǎn)品周期的管理Outsourcing

WhatWhyand(How)?2223236249285296297308337364396010020030040050060019921993199419951996199719981999200020012002p2003pGlobalpharmaceuticalsales(US$billion)4204450100200300400500600Yearp=projectionSource:Salesdatafor1992-2001suppliedbyIMSHealth全球藥品銷售

1992-2003p30608010012014016018020019921993199419951996199719981999200020012002pYearIndexedvalues(1992=100)全球研發(fā)費(fèi)用全球新藥上市研發(fā)時間(3yearmovingaverage)全球銷售全球銷售，研發(fā)費(fèi)用及研發(fā)時間和新藥上市1992-2002p4Research

LateDevelopmentEarlyDevelopmentRegulatoryassessmentCommercial-isationPre-clinicalevaluationClinicalevaluation2.9yrs1.5yrs5.7yrsUSFDA:1.0yrsEMEA:1.3yrsJapaneseMHLW:1.4yrsDuration(median)Attrition(Numberofcompoundsenteringstagepercompoundlaunched)911新藥R&D的過程TargetdiscoveryAssaydevelopmentLeaddiscoveryLeadoptimisation511%16%44%79%0%10%20%30%40%50%60%70%80%90%100%FirsthumandosetoMarket臨床一期FirstpatientdosetoMarket臨床二期FirstpivotaldosetoMarket臨床三期Submissiontomarket申報Successrate新藥上市的成功機(jī)率68%13%40%77%34%46%76%88%0%10%20%30%40%50%60%70%80%90%100%FirsthumandosetomarketFirstpatientdosetomarketFirstpivotaldosetomarketSubmissiontomarketSuccessrateChemicalentitiesBiotechSuccessratetomarketbyproducttype7Terminationreasonswereprovidedfor498ofthe538NASsforwhichdevelopmentwasterminatedbetween1999and2001.新藥開發(fā)失敗的原因1999-20018目前新藥開發(fā)遇到的困境R&D成本和風(fēng)險不斷提高Pipelinesbecomingthinner

新藥項目越來越少Increasingcostsforpromotion新藥上市的費(fèi)用越來越高Shorterproductlifecycles

新藥產(chǎn)品周期不斷縮短Risinggenericexposure 非專利藥搶占市場越來越早9面對上述的挑戰(zhàn)，國際制藥界采取了些什么對策？10NewTrendsinDrugDevelopment目前的新走向Nowtheclassicdrugdiscoverymodelissupplementedby傳統(tǒng)的新藥藥開發(fā)模式式由下面兩兩種方式進(jìn)進(jìn)行補(bǔ)充Projectin-licensing項目引進(jìn)LifeCycleManagement(LCM)產(chǎn)品周期的的管理Outsourcing11Manyblockbusterdrugsareexternallysourced許多重磅炸炸彈都是從從其它公司司引進(jìn)的。。DrugLicensee Licensor Launched2002sales(mioUSD)Paxil GSK NovoNordisk19912,055Pravachol BMS Sankyo 19902,266FosamaxMerck Gentili19932,250LipitorPfizerWarnerLamb19977,972Celexa ForestLabs Lundbeck19981,45112Revenuesfromin-licensingareincreasing…引進(jìn)項目的的產(chǎn)品銷售售正在不斷斷提高Shareofrevenuesfromin-licensingTop10pharmacos*Classifiedproductsaccountforover70%ofprescriptionrevenuesSource:Analystreports;annualreports;Pharmaprojectsdatabase;literaturesearch;McKinseyanalysis13WhyLicensein/PartneringTocomplementin-houseR+Defforts對公司本身身R&D的補(bǔ)補(bǔ)充充Tohedgeagainstunexpectedproductfailureordisappointingcommercialperformance以防防不不可可預(yù)預(yù)期期的的產(chǎn)產(chǎn)品品失失敗敗或或者者不不佳佳的的商商業(yè)業(yè)業(yè)業(yè)績績Increasingvalueofdevelopmentandmarketedproductsthrougharrangementswiththirdparties聯(lián)和和開開發(fā)發(fā)和和銷銷售售14項目目引引進(jìn)進(jìn)包包括括哪哪些些方方面面In-licensing/Partneringforglobaldevelopment項目目引引進(jìn)進(jìn)與與聯(lián)聯(lián)合合開開發(fā)發(fā)Discovery/ResearchPlatformcollaborations研究究平平臺臺的的合合作作Newdrugdeliverytechnologies新的的給給藥藥劑劑型型Co-marketing,co-promotion聯(lián)合合銷銷售售Manufacturingrelationships15項目目引引進(jìn)進(jìn)案案例例1999-200216CompetitorsforagivenlicensingdealPercentofrespondentsCompetitionforDealsIsAlsoIncreasing5yearsagoFewerthan33to55to8TodaySource:McKinseysurvey17CrossFunctionalDealTeamStandardProcessesandTeamWorkResearchandDevelopmentMarketingLegalFinancePatentPreselectionInitial

EvaluationFullEvaluationNegotiation18DueDiligenceObtainandreviewsourcedocumentationtoprovideareliableevaluationofthe:ScientificrationalePreclinicalSafetyDrugmetabolismandpharmacokineticsChemicalandpharmaceuticaldevelopmentClinicalefficacyandsafetyRegulatoryfilabilityPatentstatus19LargeNumberofOpportunitiesEvaluatedforEveryDealClosed110Contacts65EarlyAssessments17InitialEvaluations9DueDiligences3Neogtiations1DealClosed20NewTrendsinDrugDevelopment目前的新走向Nowtheclassicdrugdiscoverymodelissupplementedby傳統(tǒng)的新新藥開發(fā)發(fā)模式由由下面兩兩種方式式進(jìn)行補(bǔ)補(bǔ)充Projectin-licensing項目引進(jìn)進(jìn)LifeCycleManagement(LCM)產(chǎn)品周期期的管理理Outsourcing21AugmentinClaritinZestrilNeurontinFloventCipro-floxacinProcritLovenoxDuragesicDiflucanZocorPravacholZithromaxZoloftActosAmbienPaxilNeupogenNorvascFosamaxEffexorRisperdalSereventLevaquinAciphexPrevacklCeliceptTopamaxGemzarAriceptSingulairAdvair/Seretide*OnlydrugswithrevenuesofmorethanUS$100millionperyearareincluded.WhyLifeCycleManagement?今后十年年內(nèi)專利利過期的的新藥22LifeCycleManagementincludeProlonged/ModifiedreleasedosageformsFixedcombinationwithotherdrugsEnhancedbioavailabilityNewdrugdeliveryprinciplesTargetedorsite-specificdrugdelivery23GlobalDrugDeliveryMarket,2001TotalDrugDeliverySystemsMarket=$42.9billionsOralInhalationTransdermalParenteralOtherTotalPharmaceuticalMarket=$350billions2430%11%32%19%40%26%0%10%20%30%40%50%60%70%80%90%100%MajorcompaniesOthercompaniesAveragepercentageofR&Dexpenditurebycompanyallocatedtolineextensions199719992001各大公司司用于LCM方面的研研發(fā)費(fèi)用用25SuccessStoryofLCMTheCardizemStory26Wellbutrin:GrowthofaBlockbuster$millionNCEexclusivityexpires:2004PKhalf-life:21hours8daystoreachsteady-stateplasmalevelWellbutrin(buproprionHCl)Story(GSK)WellbtrinSRintroducedWellbtrinXLapproved27WhyDevelopFixedCombinationProducts?NewpatentprotectionSynergisticeffectsBettertherapyPatientcompliancePatientconvenienceAttractivemarket28NewTrendsinDrugDevelopment目前的新走向Nowtheclassicdrugdiscoverymodelissupplementedby傳統(tǒng)的新新藥開發(fā)發(fā)模式由由下面兩兩種方式式進(jìn)行補(bǔ)補(bǔ)充Projectin-licensing項目引進(jìn)進(jìn)LifeCycleManagement(LCM)產(chǎn)品周期期的管理理Outsourcing29Outsourcing為什么要要Outsourcing?CapacityManagement人力資源源的調(diào)控控Technology/Specificexpertise新技術(shù)Strategic戰(zhàn)略上的的考慮Costcontrol控制成本本Deadline時間30新藥研發(fā)發(fā)的費(fèi)用用分布200131010203040506019971998199920002001USANon-coremarketsGermanyUKFranceJapanSourceofpatientsforclinicaltrials1997-2001YearenrolmentcompletedPercentageoftotalpatientsrecruited325.47.47.99.313.30.02.04.06.08.010.012.014.0Respiratory(151)Anti-infectives(222)Cardiovascularsystem(174)Nervoussystem(383)Anti-cancer(342)Mediandurationofenrolmentperiod(months)Impactoftherapeuticareaonenrolmentperiod(n)=numberofclinicalstudies3322%0%5%10%15%20%25%30%CMCoutsourcingexpenditureasapercentageoftotalCMCexpenditure(average)18%0%5%10%15%20%25%30%AveragepercentageofR&DFTEsworkinginCMCOutsourcingofCMC12%0%5%10%15%20%25%30%AveragepercentageofR