全球医药产业研究与发展的趋势课件

全球医药产业研究与发展的最新趋势1全球医药产业研究与发展的最新趋势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Outsourcing

WhatWhyand(How)?2全球医药产业研究与发展的最新趋势223236249285296297308337364396010020030040050060019921993199419951996199719981999200020012002p2003pGlobalpharmaceuticalsales(US$billion)4204450100200300400500600Yearp=projectionSource:Salesdatafor1992-2001suppliedbyIMSHealth全球药品销售

1992-2003p3全球医药产业研究与发展的最新趋势0608010012014016018020019921993199419951996199719981999200020012002pYearIndexedvalues(1992=100)全球研发费用全球新药上市研发时间(3yearmovingaverage)全球销售全球销售，研发费用及研发时间和新药上市1992-2002p4全球医药产业研究与发展的最新趋势Research

LateDevelopmentEarlyDevelopmentRegulatoryassessmentCommercial-isationPre-clinicalevaluationClinicalevaluation2.9yrs1.5yrs5.7yrsUSFDA:1.0yrsEMEA:1.3yrsJapaneseMHLW:1.4yrsDuration(median)Attrition(Numberofcompoundsenteringstagepercompoundlaunched)911新药R&D的过程TargetdiscoveryAssaydevelopmentLeaddiscoveryLeadoptimisation5全球医药产业研究与发展的最新趋势11%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6全球医药产业研究与发展的最新趋势8%13%40%77%34%46%76%88%0%10%20%30%40%50%60%70%80%90%100%FirsthumandosetomarketFirstpatientdosetomarketFirstpivotaldosetomarketSubmissiontomarketSuccessrateChemicalentitiesBiotechSuccessratetomarketbyproducttype7全球医药产业研究与发展的最新趋势Terminationreasonswereprovidedfor498ofthe538NASsforwhichdevelopmentwasterminatedbetween1999and2001.新药开发失败的原因1999-20018全球医药产业研究与发展的最新趋势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全球医药产业研究与发展的最新趋势面对上述的挑战，国际制药界采取了些什么对策？10全球医药产业研究与发展的最新趋势NewTrendsinDrugDevelopment

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Outsourcing11全球医药产业研究与发展的最新趋势Manyblockbusterdrugsareexternallysourced

许多重磅炸弹都是从其它公司引进的。

Drug Licensee Licensor Launched 2002sales (mioUSD)Paxil GSK NovoNordisk 1991 2,055Pravachol BMS Sankyo 1990 2,266Fosamax Merck Gentili 1993 2,250Lipitor Pfizer WarnerLamb 1997 7,972Celexa ForestLabs Lundbeck 1998 1,45112全球医药产业研究与发展的最新趋势Revenuesfromin-licensingareincreasing…

引进项目的产品销售正在不断提高

Shareofrevenuesfromin-licensing

Top10pharmacos*Classifiedproductsaccountforover70%ofprescriptionrevenuesSource:Analystreports;annualreports;Pharmaprojectsdatabase;literaturesearch;McKinseyanalysis13全球医药产业研究与发展的最新趋势WhyLicensein/Partnering

Tocomplementin-houseR+Defforts

对公司本身R&D的补充

Tohedgeagainstunexpectedproductfailureordisappointingcommercialperformance

以防不可预期的产品失败或者不佳的商业业绩

Increasingvalueofdevelopmentandmarketedproductsthrougharrangementswiththirdparties

联和开发和销售

14全球医药产业研究与发展的最新趋势项目引进包括哪些方面In-licensing/Partneringforglobaldevelopment

项目引进与联合开发Discovery/ResearchPlatformcollaborations

研究平台的合作Newdrugdeliverytechnologies

新的给药剂型Co-marketing,co-promotion

联合销售Manufacturingrelationships15全球医药产业研究与发展的最新趋势项目引进案例1999-2002

16全球医药产业研究与发展的最新趋势CompetitorsforagivenlicensingdealPercentofrespondentsCompetitionforDealsIsAlsoIncreasing5yearsagoFewerthan33to55to8TodaySource:McKinseysurvey17全球医药产业研究与发展的最新趋势CrossFunctionalDealTeamStandardProcessesandTeamWorkResearchandDevelopmentMarketingLegalFinancePatentPreselectionInitial

EvaluationFullEvaluationNegotiation18全球医药产业研究与发展的最新趋势DueDiligenceObtainandreviewsourcedocumentationtoprovideareliableevaluationofthe:ScientificrationalePreclinicalSafetyDrugmetabolismandpharmacokineticsChemicalandpharmaceuticaldevelopmentClinicalefficacyandsafetyRegulatoryfilabilityPatentstatus19全球医药产业研究与发展的最新趋势LargeNumberofOpportunitiesEvaluatedforEveryDealClosed110Contacts65EarlyAssessments17InitialEvaluations9DueDiligences3Neogtiations1DealClosed20全球医药产业研究与发展的最新趋势NewTrendsinDrugDevelopment

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Outsourcing21全球医药产业研究与发展的最新趋势AugmentinClaritinZestrilNeurontinFloventCipro-floxacinProcritLovenoxDuragesicDiflucanZocorPravacholZithromaxZoloftActosAmbienPaxilNeupogenNorvascFosamaxEffexorRisperdalSereventLevaquinAciphexPrevacklCeliceptTopamaxGemzarAriceptSingulairAdvair/Seretide*OnlydrugswithrevenuesofmorethanUS$100millionperyearareincluded.WhyLifeCycleManagement?

今后十年内专利过期的新药22全球医药产业研究与发展的最新趋势LifeCycleManagement

includeProlonged/ModifiedreleasedosageformsFixedcombinationwithotherdrugsEnhancedbioavailabilityNewdrugdeliveryprinciplesTargetedorsite-specificdrugdelivery23全球医药产业研究与发展的最新趋势GlobalDrugDeliveryMarket,2001TotalDrugDeliverySystemsMarket=$42.9billionsOralInhalationTransdermalParenteralOtherTotalPharmaceuticalMarket=$350billions24全球医药产业研究与发展的最新趋势30%11%32%19%40%26%0%10%20%30%40%50%60%70%80%90%100%MajorcompaniesOthercompaniesAveragepercentageofR&Dexpenditurebycompanyallocatedtolineextensions199719992001各大公司用于LCM方面的研发费用25全球医药产业研究与发展的最新趋势SuccessStoryofLCMTheCardizemStory26全球医药产业研究与发展的最新趋势Wellbutrin:GrowthofaBlockbuster$millionNCEexclusivityexpires:2004PKhalf-life:21hours8daystoreachsteady-stateplasmalevelWellbutrin(buproprionHCl)Story(GSK)WellbtrinSRintroducedWellbtrinXLapproved27全球医药产业研究与发展的最新趋势

WhyDevelopFixedCombinationProducts?

NewpatentprotectionSynergisticeffectsBettertherapyPatientcompliancePatientconvenienceAttractivemarket28全球医药产业研究与发展的最新趋势NewTrendsinDrugDevelopment

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Outsourcing29全球医药产业研究与发展的最新趋势Outsourcing为什么要Outsourcing?CapacityManagement人力资源的调控Technology/Specificexpertise新技术Strategic战略上的考虑Costcontrol控制成本Deadline时间30全球医药产业研究与发展的最新趋势新药研发的费用分布200131全球医药产业研究与发展的最新趋势010203040506019971998199920002001USANon-coremarketsGermanyUKFranceJapanSourceofpatientsforclinicaltrials

1997-2001YearenrolmentcompletedPercentageoftotalpatientsrecruited32全球医药产业研究与发展的最新趋势5.47.47.99.313.30.02.04.06.08.010.012.014.0Respiratory(151)Anti-infectives(222)Cardiovascularsystem(174)Nervoussystem(383)Anti-cancer(342)Mediandurationofenrolmentperiod(months)Impactoftherapeuticareaonenrolment

period(n)=numberofclinicalstudies33全球医药产业研究与发展的最新趋势22%0%5%10%15%20%25%30%CMCoutsourcingexpenditure