2026年全球医药研发动向报告-150位行业领导者洞见-

GlobalR&DinsightsinpharmaceuticalsContents42T33™uncertaintyhasbecomethedominantbackdropfordrug445TMethodologyandsample•Web-based,quantitativesurn=89Small/Mid-sizeco•Locations:U.S.,Can•Dates:JulytoAugust2025•SurveyLength:~20minutes•Surveyvendor/Samplesource:LifeScienceRespondents^•JobLevel:Directororhi-Pre-trial/preclinicaldevelopment-Clinicaldevelopment-Peri-/post-approval/registries/HEOR-Quality/Regulatory-Businessservices(finance,procurement/purchasing,-Executivemanagement/C-level6PrimaryPrimaryFunctionalAreaClinicalDevelopment44%ExecutiveManagement/C-level20%Peri-/Post-approval/Registries/HEOR16%QualityandRegulatory10%Pre-trial/PreclinicalDevelopment10%JobJobLevel/RolePresident/C-Level15%Director64%DirectorOfficeOfficeLocation52%30%Asia:18%30%Asia:18%10%5%3%5%US/CanadaEuropeAsiaAustraliaMiddleEast/IndiaDrugDevelopmentDrugDevelopmentModalitiesOrganizationTypeSmall/Midspendlessthan41%59%n=61n=89spendof$1BiologicsNovelsmallmoleculedrugsGenetherapies CelltherapiesVaccinesGenericsmallmoleculedrugsNucleicacidtherapiesBiosimilarsDiagnostics66%60%37%32%29%19%16%14%AveragenumberofAveragenumberofmodalities:7Sampleprofileoverview:CustomersegmentsLarge(A)Small/Mid(B)54%B37%37%27%A19%10%8%11%9%13%11%ClinicaldevelopmentExecutive/C-levelPeri-/Post-approval/QualityandRegulatoryPre-trial/PreclinicalmanagementRegistries/HEORdeLarge(A)Small/Mid(B)President/C-levelVicePresidentDirector8%President/C-levelVicePresidentDirector8%21%70%19%21%60%Large(A)Small/Mid(B)24% 10%24% 34%27%MiddleEast/India 34%27%Asia56%49%56%49%US/CanadaAvg.#Modalities87%B72%BSmall/Mid(B)4.02.152%52%39%46%B46%B39%31%27%31%17%B26%B26%B26%B26%B10%9%8%6%BiologicsNovelsmallmoleculedrugstherapiestherapiesmoleculedrugsNucleicacidtherapiesBiosimilarsDiagnostSmall/Mid=annualR&Dspendlessthan88•Therisingcostofclinicaltrialsisthetopchallengefollowedbypatientrecruitmentandthechangingregulatorylandscape.•Small/Mid-sizeenterprisesc%ofRespondentsRisingcostofclinicaltrialsPatientrecruitmentinclinicaltrialsNavigatingthechangingregulatorylandscapeIncreasingcomplexityofclinicaltrialsMacroenvironment/economicuncertaintyCROpartnershipdynamics55%39%35%31%27%27%•Focusing•FocusingonsurrogatInsightsfrominterviewswithsponsorsInnovativetrialdesignshelpExamplesandreasonsforinnovativetrialdesignprovidedbysponsorsduringin-depthinterviews:•Testingacrossmultipleindicationsatonc•Usinginvestigator-initiatedtrialstoquicklygetproof-of-conceptandengagewithregulatoryauthoritiestostreamlinetrials9Tsubsidiariesunlessotherwisespecified.10DeeperlookattwokeychallengesClinicaldevelopmenttimelinesforoverhalfoforganizations,45%indicatetheirclinicaltimelineshaveincreasedcomparedtoChangeinTimelinetoProduceaDrugComparedtoTwoYearsAgo(fromfirst-in-humantrialsthroughregulatorysubmission)uLengtheneduNochangeuShortened45%45%27%28%Trialcomplexitystemsprimarilyfrominternalfactorswithincompaniesandregulatoryrequirements–with•SponsorstakemultiplefacomplextrialdesignsPrimarySourceDrivingIncreasingClinicalTrialComplexityInternalRegulatorybodies(drugdevelopmentRegulatorybodies44%37%28%31%51%39%44%37%28%31%TotalLargeSmall/MidGoalsandstrategiesTimelinevs.CostAgreementwithStatements口口Stronglyagree口AgreeX%=Agree/StronglyAgreeAcceleratingdrugdevelopmenttimelinesisthetoppriorityofmyorganization 47%37%84%Managingcostsisthetoppriorityofmyorganization72%43%29%StrategiesCurrentlyPursuingEffortstomaximizeassetvalueReprioritizationofassetportfoVendorrationalizationPatient-centricityNewapproachestoinvestment/funding0%10%20%30%40%50%60%70%simultaneouslyaccelerateTotalLargeSmall/MidHeighteneduncertaintyrightdirection,40%areconcernedaboutthedirectionoftheindustry.Navigatingthechangingregulatorylandscthe11thtothirdmostcommonchallenge.environment/economicuncertaintyranksamongthetopissuesconfrontingpharmacompanies–particudrugdevelopers.impactoncorporatedrugdevelopmentprograms–particularlyandalterationstofederalgranPatient-focusedstrategiesSeveralofthetopstrategiespincludingafocusonmaximizingareprioritizingassetportfolios,andreducingtheirnumberofvendors.insponsors’relationshipswithCROs.Mancompaniesarewrestlingwith,andfewerthanhalftrustCROstoworkinsponsors’bestinterest.Withpatientrecruitmentatopchallenge,itfollowsthatcommongoalsofpatient-focusedparticipationKeyfactorsconsiderthemostimportantfactorsforimprovingReducingtheReducingthenumberofrequiredclinicalvisitscommunicationwithpatientsisclearProvidingpatient-friendlytechnologyandappsReducingthedurationofSuccessAlthoughsponsorsemployrecruitmentstrategies,threemorethanmodestsuccessinSuccessinAchievingGoalsofPatient-focusedStrategiesSlightly/NotsuccessfulVery/Extremelysuccessful13%Very/ExtremelysuccessfulSomewhat63%successfulSomewhatAI/MLinclinicaldevelopmentVirtuallyallpharmacompaniesareusingAI/ML,andthedepthandbreadthofAI/MLinitiativesisalreadyconsiderable.initiatives.Themostcommonapplic•Operations•Medical/scientificwriting•DrugdiscoveryanddesignBarriersThemainfactorsimpedi•Trust/reliabilityofAIpredictions•Integrationwithexistin•LimitedexpertiseandtrainingresourcesBenefits•MoreaccuratepredictivemodelImpactFormanyitistoosoontoknowtheoverallimpactofAI/MLoncosts,timelines,orclinicaltrialcomplexity.Howeveramongthosewhoseprogramsareestablishedenoughtoseeresults,indicationsimpactingdrugdevelopmenttimelinesbutcouldbeaddingtotheoverallcomplexity.TheuseofvariousoutsourcingmodelsremainsTheuseofvariousoutsourcingmodelsremainsconsistentwithpreviousyearsintermsoftheallocationofcurrentclinicalwork.OutsourcingmodelShareofcurrentclinicalworkInsourcing/temporarystaffingActivitiesMostLikelytoOutsourceClinicallaboratoryanddiagnosticservicesPatientrecruitmentSitesupportClinicaldatamanagementClinicaltrialmanagement-FSO/end-to-endtrialsupportClinicalmonitoring/Clinicaloperationsmanagement67%65%32%67%65%35%59%59%59%59%59%59%22%25%33%Small/Mid-sizeenterprisesuseFSOtoagreaterextent(42%)whileLargecompaniesoptforClinicallaboratoryanddiagnosticservicesalongwithpatientrecruitmentarethetopdrugdevelopmentactivitieslikelytobeoutsourced,consistentwithfindingsfrom2024.InsightfrominterviewswithsponsorsInsightfrominterviewswithsponsorsRegardlessofsize,thetopclinicalcostofclinicaltrials,patientrecruitment,theregulatorylandscape,andincreasingtrialcomplexity.•SignificantlymoreLargecompaniesarechallengedbymacroenvironment/economicuncertaintyandfeasibility/siteselection,whilelackoffundingisabiggerproblemformoreSmall/Mid-sizeorganizations.YearoveryearNavigatingthechangingregulatorylandscapeisnowthirdin2025,upfrom11thinPharmaceuticalCompanies’BiggestChallenges(Challengesselectedby20%+amongTotalorwithsignificantsectordifferences*)TotalSmall/TotalRisingcostofclinicalRisingcostofclinicaltrials49%58%Patientrecruitmentinclinicaltrials39%mm33%44%Navigatingthechangingregulatorylandscape35%mm34%mm36%Increasingcomplexityofclinicaltrials31%mm33%29%^Macroenvironment/economicuncertaintymm27%mm34%B21%21%^CROpartnershipdynamicsmm27%mm26%27%^Managingmultipledrugdevelopmentvendors(CROs,CDMOs)23%20%26%Maximizingassetvalue/ROImm22%mm28%mm18%Elongatedstudystartuptimemm22%mm21%mm22%Findingappropriatescientific/therapeuticexpertiseinvendorsmm22%mm21%mm22%UsingAIinclinicaldevelopment21%mm28%mm17%Talent/staffshortagesmm21%20%21%21%Lackoffundingmm21%mmmm8%29%A21%Bmm13%8%Feasibilityand21%Bmm13%8%Lettersindicatestatisticallysignificantdifferencebetweengroupsatthe90%confidencelevelBase=allrespondents:Total:n=150;Large:n=61,Small/Mid:n=89Q.Whatarethebiggestchallengesyourorganizationiscurrentlyfacing?Pleaseselectyourtop5biggestchallenges.(^=addedin2025)=drawsattention*SeeAppendixforcompletedetailDeeperdive:ClinicaldeChangesinclinicaldevelopmenttimelines•Morethan40%ofsponsorsindicatetheirclinicaldevelopmenttimelinesarelongerthantheyweretwoyearsago.•LargesponsorsaremorelikelytohaveecyclesthantheirSmall/Mid-sizecounterparts.YearoveryearChangeinTimelinetoProduceaDrugComparedto2YearsAgoNote:Note:Nooneindicatedtheirtimelineshaveshortenedby24+monthsLengthenedby:S24+months12to23monthsLengthenedby:S24+months12to23months12to23months27%22%30%10%16%14%24+months38%B28%34%26%20%21%29%29%29%29%45%40%40%49%49%Lettersindicatestatisticallysignificantdifferencebetweengroupsatthe90%confidencelevelBase=allrespondents(excluding‘Notsure’)Total:n=140;Large:n=58,Small/Mid:n=82Q.Comparedtotwoyearsago,howhastheaveragetimelinetoproduceadrug(fromfirst-in-humantrialsthroughregulatorysubmission)changedatyourorganization?16Deeperdive:ClinicaldeReasonsforincreasingdrugdevelopmenttimelinesProtocolcomplexity,difficultieswithpatientrecruitment/enrollment,andregulatoryrequirements/submissionsarethetopfactorsresponsibleforlongerdrugdevelopmenttimelines.•Directionally,LargecompaniesaremorelikelytocsponsorsaremoreapttoindicateregulatoryrequirementFactorsResponsibleforLengtheningDrugDevelopmentTimTotalLarge(A)Small/Mid(B)60%50%40%30%20%10%0%PoorpatientretentionDifficultieswithpatientrecruitmentandenrollmentIPmanufacturing/supplyPoorpatientretentionDifficultieswithpatientrecruitmentandenrollmentIPmanufacturing/supplyissuesSupplychainorotherlogisticalissuesStudymodificationsSiteavailabilitySitesadoptingandmanagingmultipleRegulatoryrequirementsandsubmissionstechnologyplatforms=notablyhigher=notablyhigherthantheothersegmentBase=experiencinglongerdrugdevelopmenttimelinescomparedtotwoyearsago.Total:n=63;Large:n=23,Small/Mid:n=40Q.(NEW)Youindicatedthatdrugdevelopmenttimelinesarelengthening.What,inyourexperience,ismostresponsiblefordrivinglongertimelines?Pleaseselectuptotworesponses.TacticsusedtoreducedrugdevelopmenttimelinesImplementinginnovativetrialdesignsisthemostcommontacticforreducingdrugdevelopmenttimelinesforbothLargeandSmall/Mid-sizecompanies,followedbyincreasingoutsourcingandutilizingAI/ML.•Directionally,Small/Mid-sizesponsorsaremorelikelytoreduceprotocolcomplexitytoshortentimelinesthantheirLargecompanycounterparts.TakingStepsRegulaStepstoReduceDrugDevelopmentTakingStepsRegulaTotalLarge(A)Small/Mid(B)97%Averagenumberstrategies:2.62.52.697%60%50%40%30%20%10%0%Increasebudgets/incurhighercostsUtilizeAI/MLImplementinnovativeIncreasebudgets/incurhighercostsUtilizeAI/MLImplementinnovativetrialdesignsIncreaseoutsourcingReduceprotocolcomplexityUsemorecomplexprotocolsclinicaltrial=notablyhigherthantheothersegmentNostatisticallysignificantdifferencesbetweengroupsatthe90%confidencelevelBase=allrespondents:n=150;Large:n=61,Small=notablyhigherthantheothersegmentQ.(NEW)Whatstepsdoesyourorganizationregularlytaketoreducedrugdevelopmenttimelines?Pleaseselectallthatapply.Deeperdive:ClinicaltrialcomplexityDriversofincreasingclinicaltrialcomplexityOverall,trialcomplexityisdrivenequallybyinternalfactorsandregulatoryrequirements,butLargecompaniesputmoreweightoninternalconsiderationswhileSmall/Mid-sizeorganizationsassigngreaterweighttoregulato•Directionally,Small/Mid-sizesponsorsaremorelikelytoreduceprotocolcomplexitytoshortentimLargecompanycounterparts.PrimarySourcesDrivingtheIncreasingComplexityofClinicalTrialsTotalLarge(A)Small/Mid(B)60%50%40%30%20%10%0%InternalRegulatorybodiesCROsSitesOther(drugdevelopmentorganization)Lettersindicatestatisticallysignificantdifferencebetweengroupsatthe90%confidencelevelBase=allrespondents.Total:n=150;Large:n=61,Small/Mid:n=89Q.(NEW)Whatistheprimarysource,inyourexperience,drivingtheincreasingcomplexityofclinicaltrials?RationaleforcomplextrialdesignsThedecisiontouseamorecomplextrialdesignis•Regulatoryfeedbackandoveralltrialcostsaretopconsiderationswhendecidingtousemorecomplextrialdesigns,followedbypatientrecruitmentandretention,timetotrialcompletion,anddataquality/integrity.70%60%50%40%30%20%10%0%FactorsConsideredWhenDecidingUseofMoreComplexTrialDesignsAveragenumberfactorsconsidered:5.25.45.0LargecompaniesaremorelikelythanSmall/Mid-sizesponsorstoconsiderfrequencyofprotocoldeviationsanddevelopment/lifecyclemanagementstrategies.InvestigatorandsitesatisfactionFrequencyofadverseeventsTimetotrialcompletionDataqualityandintegrityNumberInvestigatorandsitesatisfactionFrequencyofadverseeventsTimetotrialcompletionDataqualityandintegrityNumberofprotocolamendmentsOveralltrialcostcollection/evidenceneedsAdherencetotrialtimelinesPatientcomplianceandadherenceRegulatoryfeedbackPatientrecruitmentandretentionratesdeviationsmanagementstrategiesLettersindicatestatisticallysignificantdifferencebetweengroupsatthe90%confidencelevelBase=allrespondents(excludingNone/Notsure):n=143;Large:n=58,Small/Mid:n=85Q.(NEW)Whichofthefollowingfactorsareconsideredbyyourorganizationwhendecidingtousemorecomplextrialdesigns?Pleaseselectallthatapply.19Deeperdive:ClinicaltrialcomplexityBenefitsofcomplexclinicaltrialdesignsObtainingmorerobustorbetterdataoutcomesisthemostcommonlymentionedrationalethatmakescomplextrialdesignsworthwhile,followedbyreducedtimelinesandmoreopportunitiestogatherdata.•ComparedtotheirLargecounterparts,Small/Mid-sizecompaniesaresomewhatmoreinclinedtocitetheabilitytoaddressmorequestionsasafactorthatjustifiescomplexprotocols.JustificationFactors(numberofmentions)TotalLargeSmallMorerobust/betterdataoutcomes8Moreopportunitiestogatherdata9Improvedregulatorycomp8Abilitytoaddressmorequestionsaboutthedrug/indication45957“WewanttoensurethatwemaximizeopportunitiestocollectCurrentstrategiesEffortstomaximizeassetvalue,portfolioreprioritizationandvendorrationalizationaretopstrategiesusedbysponsors.•ManyLargecompaniesarealsoactivelyworkingonpatient-centricityandRWD/RWEinitiatives.•MaximizingassetvalueremainsthetopstrategicfocusforSmall/Mid-sizecompaniesandhasgrownfStrategiesCurrentlyPursuedbyPharmaceuticalCompaniesTotalLarge(A)Small/Mid(B)70%60%50%40%30%20%10%0%Averagenumberstrategies70%60%50%40%30%20%10%0%B23233BGreateruseofRWD/RWEStrategiestoreducesiteburdenEffortstomaximizeassetvalueRisk-basedcontractswithGreateruseofRWD/RWEStrategiestoreducesiteburdenEffortstomaximizeassetvalueRisk-basedcontractswithvendorsMergersandacquisitionsSustainabilityeffortsReprioritizationofproduct/assetportfolio^VendorrationalizationPatient-centricityPatientdiversityLettersindicatestatisticallysignificantdifferencebetweengroupsatthe90%confidencelevelBase=allrespondents(excludingNone/Notsure):n=148;Large:n=61,Small/Mid:n=87Q.Whichspecificstrategiesarebeingpursuedcurrentlybyyourorganization?Pleaseselectallthatapply.(^=addedin2025)=directionallyhigherthantheothersegmentYearoveryear20242025TotalLargeSmall/Mid42%47%38%29%33%26%Sustainabilityeffortshavealsodropped,mostnotablyamongM&AeffortsaredownamongStateoftheindustryIndustrydirectionrightdirection,asizeableminorityindicatetheyhaveconcerns.Innovation•Viewsaboutinnovationinthedrugdevelopmentindustryaremixed–althoughmostbelAgreementwithStatementsRegardingtheDrugDevelopmentIndustry口口Stronglyagree口口AgreeX%=Agree/StronglyAgreeIndustryIndustryDirection41%26%15%Innovation54%41%13%12%12%49%61%Base=allrespondents:n=150Q.(NEW)Howmuchdoyouagreeordisagreewitheachofthefollowingstatements?23%23%47%69%Competingpriorities:Timelinesvs.cost•Whilebothtimelineaccelerationandcostmanagementarehighorganizationalpriorities,acceleratingdevelopmenthastheedgewithnearlyhalfofparticipantsstronglyagreeingthisistheirProtocolcomplexity•Interestingly,altprotocolsaremorecomplexthannehalfalsoindicatecomplexproobjectives–indicatingthethornynatureofthisissue.AgreementwithStatementsRegardingtheDrugDevelopmentIndustry口口Stronglyagree口口AgreeX%=Agree/StronglyAgreeTimelinevsTimelinevsCost72%43%29%ProtocolComplexity71%53%18%47%47%37%84%Base=allrespondents:n=150Q.(NEW)Howmuchdoyouagreeordisagreewitheachofthefollowingstatements?26subsidiariesunlessotherwisespecified.22TStateoftheindustryPatientexperiencedata•Thereisbroadagreementthatpatientexperiencedataisessential.•WhilemanysponsorssomewhatcautiousabouttheimpactCROsmayhaveontheirinfluencewithintheircompanies.AgreementwithStatementsRegardingtheDrugDevelopmentIndustry口口Stronglyagree口口AgreeX%=Agree/StronglyAgreePatientPatientExperienceDatanotcriticaltoclinicaltrialsucce17%13%CROs37%27%9%31%31%51%82%Base=allrespondents:n=150Q.(NEW)Howmuchdoyouagreeordisagreewitheachofthefollowingstatements?11%11%36%47%ImpactofchangesinU.S.healthcarSponsorsanticipatethatmanaffecttheirdrugdevelopmentprograms.•Chiefamongtheirconcernsaretariffs,regulatorychanges,staffingattheFDA,NIHandCDC,andalterationstofederalgrantandloanprograms.ImpactofChangesinU.S.HealthCareSystemonCorporateDrugDevelopmentProgramsuVeryNegativeuSomewhatNegativeuNoImpactuSomewhatPositiveuVeryPositChangingU.S.regulaChangestoU.S.federalgrantandloanprogrStaffingchangesatNIH,CDCU.S.withdrawalfromtheWHORollingbackU.S.policiestolimitthecostofprescriptiondrugsChangestoU.S.vaccineandinfectiousdiseasepolicyIncreasedemphasisonchronicdiseaser0%10%20%30%40%50%60%70%80%90%100%Base=allrespondents.Total:n=150Q.(NEW)HowwillthefollowingchangesorproposedchangestotheUnitedStates’healthcaresystemimpactyourorganization’sdrugdevelopmentprograms?ImpactofchangesinU.S.healthcarAnticipationissimilaramongbothLargeandSmall/Mid-sizesponsorsthattariffs,U.S.regulatorycha•ThoseatLargecompaniesaremoreliresultofchangestovaccine/infectiousdiseasepolicy.ImpactofChangesinU.S.HealthCareSystemonCorporateDrugDevelopmentProgramsLarge(A)BChangingU.S.regulatoryChangestoU.S.fedeBARollingbackU.S.policiesChangestoU.S.vaccineandinfBIncreasedemphasisonchronicdisB0%20%40%60%80%100%0%20%40%60%80%100%Lettersindicatestatisticallysignificantdifferencebetweengroupsatthe90%confidencelevelBase=allrespondents.Large:n=61;Small/Mid-size:n=89Q.(NEW)HowwillthefollowingchangesorproposedchangestotheUnitedStates’healthcaresystemimpactyourorganization’sdrugdevelopmentprograms?25TPatientstrategygoalspatientparticipationarethetopgoalsofpatient-focusedstrategiesforbothLargeandSmall/Mid-sizecompanies.•Comparedto2024,somewhatfewerindicatethatstrengtheningrelationshipswithphysicianswhoservemorediversepatientsisakeygoalfortheirpatientYearoveryearKey:%Ranked#1%RankedTop3TotalGoalsofPatient-FocusedStrategiesSmall/Mid(B)33%58%36%52%31%62%15%53%18%51%13%55%15%52%15%56%15%49%Strengthenrelationshwhoservemoredive11%39%10%41%12%38%9%37%10%41%8%34%12%36%10%36%13%36%Strengthenconnectiontothec18%16%7%19%=drawsattentionImprovingpatientexperienceSponsorsindicatethatpatient-friendlytech/apps,reducingthenumberanddurationofvisits,andclearcommunicationareamongthemostimportantwaystoimprovepatients’experience.•ShorteningstudyvisitsisparticularlynotedbyLargecompaniesasimportant.MostImportantFactorstoImprovePatientExperienceUseofpatient-friendlytechnologyandapps35%32%36%30%38%B35%34%20%30%Facilitatingonlinepatientcommunities8%10%7%TotalLarge(A)Useofpatient-friendlytechnologyandapps35%32%36%30%38%B35%34%20%30%Facilitatingonlinepatientcommunities8%10%7%ReducingthenumberofrequiredclinicvisitsReducingthedurationofstudyvisits27%Clearcommunicationwithpatientsmm27%23%Remotevisitoptions25%mm30%22%Patientsupportand