Mckinsey方法论产品生命周期管理

CONFIDENTIALPharmaceuticalLife

CycleManagement(LCM)ClientworkshopJune2001Today´sdiscussion * FootnoteSource: SourceKeyelementsofLifeCycleManagementThoughtsonhowtoorganizeforLCMKeyissues1LifeCycleManagementLifeCycleManagementislargely

aboutbuildingbrandsovertime–

byincrementalinvestmentsinvaluecreatingactivitiestomaximize

thevalueofacompoundObjectiveBuildingabusinessbasedonagreatproductidea/brand–notjustlaunchaninnovationMindset2LCMrequiresacommercialmindsetSettingambitionlevelShape

theproductShape

themarketShapethecompany3LCMrequiresacommercialmindsetSettingambitionlevelShape

theproductEarlycrossfunctionalagreementonvisionfortheproduct(targetlabel)InvestwithaventurecapitalistmindsetDeliveragainsttimelineFocusonwhatisimportantContinuouslyenhancecompetitivedifferentiationClinicaldevelopmententirelyfocusedonvaluecreation

(e.g.,mostimportantindications)4LCMrequiresacommercialmindsetSettingambitionlevelShape

themarketShapethemarketearly

andactivelyClearandconsistentmessagesincommunication/PRstrategiesRecognizeregionaldifferencesinkeymarketsClearandbroadperspectiveonresourcesrequiredtoshapethemarketEnsuretightlinkbetweenR&Dstrategyandmarketstrategy5LCMrequiresacommercialmindsetSettingambitionlevelShapethecompanyHaveaconsistentandtransparentcommercializationprocessMarketleadingwhereitreallymattersStrongmotivationamongemployees

tobringproducttomarketPartnership/

communicationsacrossfunctions/teams/MCsTimelytrainingofallrelevantemployees6LCMrequiresacommercialmindsetSettingambitionlevelEarlycrossfunctionalagreementonvisionfortheproduct(targetlabel)InvestwithaventurecapitalistmindsetDeliveragainsttimelineFocusonwhatisimportantContinuouslyenhancecompetitivedifferentiationClinicaldevelopmententirelyfocusedonvaluecreation(e.g.,mostimportantindications)HaveaconsistentandtransparentcommercializationprocessMarketleadingwhereitreallymattersStrongmotivationamongemployeestobringproducttomarketPartnership/

communicationsacrossfunctions/teams/MCsTimelytrainingofallrelevantemployeesShapetheproductShapethemarketearly

andactivelyClearandconsistentmessagesincommunication/PRstrategiesRecognizeregionaldifferencesinkeymarketsClearandbroadperspectiveonresourcesrequiredtoshapethemarketEnsuretightlinkbetweenR&DstrategyandmarketstrategyShape

themarketShapethecompany7ThelifecyclecanbedividedintothreephasesActionsoftentakenyearsearlier!YearOverallambitions0–4GainmarketshareEstablishmarketRapidsalesramp-up5–10ExpandmarketGainmarketshare11+MinimizeimpactofgenericsDevelopandlaunchline-extensionsTypicalindustrycurvePotentialcurvewithactiveLCMPhaseLaunchExtendSustain8Bestpracticetargetsfor”launch”phaseAmbitionsRapidgrowthinmarketshare(x%byyear4)Establishoverallmarket(fromytozbillionUSD)Rapidsalesrampup(a%ofyear4salesinyear2)AlignandanchortargetswithentireorganizationShapetheproductRapidlaunchacrossallmarketsProductlabel/positioning/brandingisconsistentanddifferentiatedCompetitormovesandstrategiesassessedandimplicationstaken–

inadvanceLCMstrategy/positioningovertimeisclearlyidentifiedShapethemarketEstablishKOLnetworkandbuildbaseforongoingrelationshipPricingstrategybalancesneedforquickapproval/penetrationandestablishingfavorablelong-termpositionMarketingmixandfocusonkeyinfluencerstoreachambitionClinical“shareofvoice”andpublicationlevelsofsufficientmagnitudeandqualityShapethecompanyCompetitiveinvestmentlevelacrossmarkets(e.g.,xperpatient)Transitionglobalteamroleandcomposition;Educate,exciteandalignlocalteamsandsalesforceCreateandmaintainmasterplanningchartoflaunchactivitiesNegotiatepossiblealliances/co-promotionarrangementtooptimizegeographicalcoverage9SelectingtherightlabelrequiresaclearambitionExampleofambitionlevelstaircaseKeyinputintolabelWhatlabelisneededtogettothenextstep?Productname,

projectnameProductvisionCompetitiveenvironmentMainpatientandcustomergroupsandtheirkeyunmetneedsPricingstrategyKeyclaimsforlaunchGo/nogoRelativevalueRouteofadministrationDosingregimenLabelindication(s)LaunchdateKeyissuesNogoMinimallyacceptedlevelGet“fairshare””ClassleaderExpandthemarket10Trendtowardscompressedlaunchschedules–caseexample:Pfizer* Numberinparenthesesdenotesfirstlaunchdateworldwide** Includesforecastsbecausetimehorizonextendspast1998Source: FDA;pinksheets;10-K;MorganStanleyanalystreport(7/98);McKinseyanalysisWorldwidesalesUSDbillionsLipitor**(withWL)ZoloftViagra**NorvascYearsafterlaunchLipitor(97)Norvasc(90)Viagra(98)Zoloft(90)YearsafterlaunchNumberofcountries*11MarketinginvestmentbecomingmoreaggressiveLipitorPravacholCumulativeUSdetailsThousandsYearsfromlaunchYearsfromlaunchSource: SalesanddetailsfromScottLevinUSCumulativeUSsalesUSDmillionsLipitor(1997)Pravachol(1991)Projected12TrackresultsagainstsegmentbottlenecksDevelopscorecardtoevaluate

resultsfrommarketingsolutionsFocusmessageandspend

oneliminatingbottlenecksDevelopmarketingsolutionsandevaluate

eachbasedonabilitytoresolvebottleneck,easeofimplementationandcostIdentifywhichdriverscanresolve

thebottleneck(s)Howtoincreaseawareness,inducetrial,retainpatientsandphysicians,etc.?Identifykeybottlenecksformostattractiveconsumer/prescribersegments

Evaluatewhereinthepurchasefunnelmajorbottle-necksexistforhigh-valuepatientsandphysiciansManylargepharmaco’sarestillintheprocessofadoptingthistoolDynamicmarketingmodel123413PhysicianisawareofnewdrugPhysicianconsidersnewdrugPhysiciandifferen-tiatesnewdrugfromolddrugPhysiciantriesnewdrugPhysicianendorsesnewdrugsforpatientswithunresolvedsymptomsPhysicianendorsesnewdrugforallolddrugusersFew,ifany,

unmetneedsNolong-term

safetyprofileBelievesthatnewdrugefficacyisnotsignificantlysuperiortothatofolddrugLackofsamplesLackofexperiencewithnewdrug;prefertrueandtesteddrugNewdrugisnotonmanyformularies/physiciandoesnotwanttodealwithMCOcallbacksPhysiciandoesnotwanttoswitchpatientwhoisstableonolddrugNotallpatientsrespondwelltonewdrugNewdrugisnotonmanyformulariesNewdrugdoesnothavefullrangeofindicationsExampleofphysiciandecisionfunnelBottle-necksILLUSTRATIVEEXAMPLE14PublicationvolumeisimportantindifferentiatingdrugproductsSource: Citedreferencesciencedatabase,variousmarketing/salesdatabaseandpublicationsDiovan(Novartis)launchedin1994oneyearafterCozaar(Merck)withahigherefficacyandbettertolerateddrug;however,Cozaarwasabletoleveragea5––32xgreaterpublicationvolumetobeatDiovanSalesUSDmillionsCozaarDiovan0250500750100019929394959697982Q99Cozaar202204206201992939495969798DiovanNumberofcitationsCorrelationbetweendrugsalesandpublications15MasterplanningchartToplevelmilestonesEXAMPLEProcessDiseaseorientatedUpdateddiseaseorientatedFinaldiseaseorientatedInitialprojectspecific––staircaseRefinedbasedonmarketresearchandtrialresults––staircaseFinalpre-launchOnlyifissues/LCM*MS1MS2TG1MS4TG2TG3TG4MS8GlobalmarketingTargetlabelPositioningBranding*UpdatedannuallyBroadinitialUpdatedasCDiselectedUpdatedbasedondevelop-mentstudiesandfocusgroupswithKOLsFinalpre-launchbasedonmarketresearchandclinicaltrialsRepositionifnecessaryInitialverypreliminaryUpdatedbasedonmarketresearchandfocusgroupsFinalpre-launchbasedoninputfrommarketsandtrialsRebrandedonlyinunusualsituationsCoverskeydimensionsProductdevelopmentGlobalmarketingProductsupplyPatentsEtc.Toplevelmilestonesandmoredetailedactivities16Bestpracticetargetsfor””extend”phaseAmbitionsMaximizegrowthoffranchiseovertimethroughshareandmarketgrowthShapetheproductDeliverstudiestoevolveproductpositioningandrespondtocompetitiveandmarketshifts–focusonincrementalsalesEvolvetheproduct(e.g.,drugdeliverymethods)andaddvalue-addedofferings(e.g.,diagnosissupport)Pursuelocalclinicalstudiesbalancingneed/demandsoflocalmarketswithdiminishingreturnsofglobalpositioningShapethemarketEvolvemarketingmixandfocusovertimeAppropriatelyfocusKOLactivitiestomaintainnetworkandrespondtonewcompetitorsIncreasethesizeofthemarketthroughinvestmentstobroadenusageandenhancediagnosisSecureoptimalgeographicalcoveragebyalliances/co-promotionShapethecompanyDevelopandretainproductteamsonglobalandlocallevelEnsuresalesforceincentivesdriveevolutionofexistingprescribersandconversionofnewprescribers17ExamplesofproductextensionsPatientbasedinnovationSafety/tolerabilityprofileLineextensionsPharmaco––economicFurther/expandedindicationsNewindication18ExamplesofproductextensionsWaystocreateproductextensionDescriptionExamplesNewindicationIdentifyingdiseases/symptomcurrentlypoorly/nottreatedanddevelopingnovelproductsProscar(Merck)Captopril(BMS)Reo-Pro(Centocor)Acculane(Roche)LineextensionsAdaptingproducttoavoid/delaygenericcompetitionVoltarol(Geigy)Amoxil(SB)ProcardiaXL(Pfizer)Safety/tolerability

profileFocusingproductdevelopment/marketingonaddressingsafelyissueswithincumbenttherapiesIstin/Norvasc(Pfizer)Cardizem(HMR)Zantac(GW)PharmacoeconomicDefiningp-economicprofilebye.g.,redefiningclinicalendpointsforcompetitiveadvantageRocephin(Roche)IPA/GUSTO(Genentech)Dipravan(AstraZeneca)Patient-basedInnovatingaroundthespecificneedofpatientsEasi-Breathe(3M)Novopen(NovoNordisk)Menorest(RPR)Further/expandedindicationsExpandingrelevantpatientpopulationbyredefiningdiseasesofbytreatingadditionaldiseases(formulationcombinations)Fosamax(Merck)Mevacor(Merck)Coreg(BM)Wellbutrin/Zyban(GW)19CapturingbenefitsofcontinuedresearchSource:UKofficeofHealthEconomics/MarketletterJune13,200125-40%ofsalesoftopsellingdrugsinUK/USAareforindicationsdiscoveredonlyafterthedrugswerelaunched20ImpactofnewindicationsExperienceshowsSubstantialspillovereffectsfrombeingfirstcompanytolaunchindicationFirstmovercangetupto10%moremarketshareevenwhereoff-labelexistsThefollower––runningthesameindications–usuallyisnotabletoimprovehismarketpositionExampleofpossibleindicationsforSSRIsMajordepressionPreventionofrelapseofdepressionPremenstrualdysphoricdisorderAnxiety–generalandpanicattacksObsessivecompulsivedisordersEatingdisorders–anorexiaandbulimiaSubstanceabuseSocialphobiaWherecancompanygainsharebypioneeringindications?Wherecancompanyleverageclasseffect?DISGUISEDEXAMPLE21SustainedresultswithproactiveLifeCycleManagement–exampleVoltarenSource:IMS"Patentlife"extended10yearsafterexpirythroughproactiveproductre-launchesUSD1billionglobalsalesin1997SalesinGermanyDEMMillionsPatentexpiryGelSustainedreleaseSuppositoryPlainGlobalmarketsharePercent199394959697198283848586878889909192930408012016022IncreasingchallengetomaintainKOLnetworkdemandsfocusSponsoredSupportedCharacterization“Thoughtleaders””ProvidecriticaldataPrescribersMarketingmeasuresScientificeventsinitiatedbycompanyInvolvementinsalesforcetraining“Influencers””Heavilyinvolvedinteaching“Followers”Commandvastmajority

ofprescriptionsVeryheterogeneousandvolatilelimitedunderstanding“Laggards””LagbehindnewtherapydevelopmentsSpecialcompanyeventstoleverageOPLs,e.g.,““Semi-Annualupdate””forheavyprescribersSalesforcevisitsInformationusingmarketingmeasuresotherthansalesforcecontactOPLHighprescribersLowprescribers23RetainingandmotivatingtoptalentoveryearsrequiresmorethanmoneyGreattasksDifferentiatedcompensationHightotalcompensationFreedomandautonomyJobhasexcitingchallengesCareeradvancementandgrowthGreatproductCompensationValuesandcultureWellmanagedproductCompanyhasexcitingchallengesStrongperformance24Bestpracticetargetsfor””sustain”phaseAmbitionsMaintainmarketshareandprofitlevelsaslongaspossibleShapetheproductIdentifyandinvestinleverstoextendlifecycleShapethemarketReviewpricingasakeylevertomeasureproductvalueExtendsalesandmarketingactivityShapethecompanyRampupexcitementandonlocalteamstoextendthefranchiseShiftcompositionofglobalteamtomeetdemandsofsustaininglifecycleAddressinternalbarrierstosustainingfranchise255keycompetitiveleverstomaximizelatelifecycleNPVMaximize

remainingsalesIncreasesalesspendingImprovesaleseffectivenessIncreasemarketspendingImprovemarketingeffectivenessAttainadditionalindicationsCreateproductextensionsMigratetonewproprietaryproductsExclusiveproductenhancements/extensions”New”versionsofproductParsethemarketDefendsalesexclusivityLitigateManageregulatoryaffairsTakecompetitiveactionsCompetein

genericmarketProduceowngenericPartnerwithgenericsMaximizecontributionMigratetoOTCTransferownershipLicenseTradeSellKeyleversPossibleactions26InternalbarrierstoaddresslifecycleextensionsPossibleresponseDeterminewhichgenericcompetitorsarelikely

toenterStudycaseexamplesUsescenariomodelingtoquantifyimpactandassesspotentialopportunityRecognitionofthe

threatandopportunityNewproductbiasResourcecapacityconstraintsEstablishmoresophisticatedrisk/rewardmeasuresFocusontotalproductopportunityratherthanannualbudgetingforin-lineproductsLCMrevenuesimportanttosustainingperformancethrough”droughts”OutsourcetheLCMworktoconservein-houseresources,e.g.,transferringownership27Non-traditionalskillsneededinlateLifeCycleManagementTraditionalFocus:Thisyear’sprofitplanRequiredFocus:NPVofassetClinicaldevelopmentRegulatoryaffairsSales/marketingClinicaldevelopmentRegulatoryaffairsSaleseffectivenessLicensingandacquisitioning/partneringDealstructure,negotiation

andalliancemanage-

mentLitigationstrategyandtacticsProductteamProductteam28Today´´sdiscussionKeyelementsofLifeCycleManagementThoughtsonhowtoorganizeforLCMKeyissues29DesignprinciplesDrivelifecyclemanagementaroundthemajorplanningevents(earlyonmilestonesandlaterinannualplanningcycle)CreateclearrolesandresponsibilitiesbetweenglobalandmarketsDocumentlifecyclemanagementthinkinginasimpledocumentthatpotentiallyisbroaderthanthebusinessplandocument30FocusareasandearlyrecommendationsClarifydecision-makingaroundLCMMakeLCM-plananintegralpartoftollgatedecisionsMakeLCMplanningpartofannualportfoliomanagementprocessDefinerolesandresponsibilitiesDefinewhohaswhatresponsibilitiesDefinethecompanylifecycleplanUpgradetheLCM-plantoarealannualstrategydocumentforpostlaunchDefinethecompanyLCM-plan(alignedwithmarkets)OrganizeforcreationandmanagementoftheLCM-planClarifyleadership–commercialversustechnicalCreateastanding/recurringLCMsub-teamincludingkeymarketsMakeLCMapriorityinannualplanningDefinetheroleinannualplanningDefinethecompanyminimumstandardLinkbudgetstoLCMplanning31LifecyclethinkingshouldbepartoftheearlydevelopmenttollgatedecisionsChoiceoffirstindicationTargetlabelassessmentPreliminarytargetTargetlabelevolutionovertimePatent/IPstrategyChoiceofCDandbackupRoughlifecyclevisionFuturedevelopmentactivitiesEvolutionofpositioningUpdatedtargetlabelassessmentStaircaseDevelopmentprojectplanforproposedscenarioScopeScaleInvestmentforspeedUpdatedLCMplanAgreedvisionwithmarketsFuturedevelopmentinitiativesEvolutionofpositioningFuturemarketinginitiativesUpdateddevelopmentprojectplanforproposedscenarioEnsuresupplyUpdatedtargetlabelassessmentFinal“launch”targetlabelUpdatedLCMplanILLUSTRATIVEPre-CDCDnominationProofofconceptApprovaltolaunch32AgoodLCMplanconsidersabroadrangeofstrategicinitiativesWhatisrequiredtoreachvision/objectives?Marketing

andsalesClinicaldevelopmentOtherMarketpenetrationprogramsGlobalpositioningandcoordinationprogramsNewmarketing/salesapproachesNewclaims/indicationsLineextensionsRepositioningofotherclassesProductionandlogisticsimprovementprogramRenegotiateallianceagreementEXAMPLE33CreatequalitystandardoverallandwithintheLCMplanExamplesDecisionsshouldbebasedonadeeperlevelofinsightintooverallmarketsituationthanwhatresidesinanysinglemarketAvoiddoing““alittleofeverything””Avoidmismatchbetweenglobalandlocalambition.BeclearonoverallstrategicdirectionEachplanshouldincreasethefuturevalueofproductbasedondefiningessentialactivitiesforproductgrowthEnsurethatinitiativesfocusonbothdevelopmentandmarketingleversacrosstimeUseinnovativetoolsandframeworktopushthinking

(e.g.,““wargames””,strategicstaircasesetc)ILLUSTRATIVE34Lifecycleplan––annualportfolioreviewpostlaunchChapterContentQualityguideline1.ExecutivesummaryOutlineplanforthebrandExplaintheoverallLCMstrategyandperformanceobjectivesDescribethe3–5mainissuesthatmaysignificantlyaffecttheproductsuccessLayoutactionstoresolveissuesDoestheexecutivesummaryclearlyandconciselyarticulatehowtheproductwillwininthemarketplaceandovercomeanysignificantchallenges?2.Deci