生物制药创新领域重拾发展动力

GlobalTrendsinR&D2025 ProgressinRecapturingMomentuminBiopharmaInnovation MARCH 2025 Introduction Thelifesciencesinnovationecosystemhascontinuedtoevolveandexpandasindustryadaptstoacomplexanddynamicrangeofgeopolitical,technologicalandsocialuncertainties,andinvestmentcontinuestoflowintothesector. Innovativesciencehasalsogrowninparallel,asevidencedbyanincreasingproportionofnoveltherapeuticmodalitiesinclinicaltrialsandbyinnovativeproductsreceivingregulatoryapprovalandreachingpatients—withmultipleimportantcellandgenetherapydrugshavingachievedrecentsuccess,alongsidenewoptionsforhistoricallychallengingindications.Despitetheseadvances,improvingtheefficiencyofR&Dremainsanimportantobjectiveforbiopharmaceuticalcompaniesandsignificantopportunitiesexisttoreducemedicinedevelopmenttimesandincreaseprobabilitiesofsuccess. ThisreportassessesthetrendsinR&Dfunding,clinicaltrialactivity,andnewdrugapprovalsandlaunches.Italsoexaminestheefficiencyandproductivityofclinicaldevelopment,usingarefreshedClinicalProgramProductivityIndex,whilealsoprovidinginsightsoncontributingfactorsandenablers.Operationallyaddressablecycletimecomponentsareinvestigatedbyexaminingclinicaltrialtimelinesinthebroadercontextofatypicalmedicinedevelopmentprogram,demonstratingcriticalwithin-andbetween-trialcomponentsthatcanbetargetedtoacceleratedevelopment.Thecontinuedsignificanceofemergingbiopharmacompaniesandofgeographicalshiftsinclinicaltrialactivityarerevisitedthroughout. TheresearchincludedinthisreportwasundertakenindependentlybytheIQVIAInstituteforHumanDataScienceasapublicservice,withoutindustryorgovernmentfunding.Theanalyticsinthisreportare basedonproprietaryIQVIAdatabasesand/orthird-partyinformation.Noproprietarysponsortrialinformation ispresented. ThecontributionstothisreportfromTaskinAhmed,LucyHaggerty,SrinidhiBC,TanyaBhardwaj, ChrisBamford,RachaelFones,JuliaKern,BhagyashreeNawar,UrvashiPorwal,JamiePritchett,anddozensofothersatIQVIAaregratefullyacknowledged. FindOutMore IfyouwishtoreceivefuturereportsfromtheIQVIAInstituteforHumanDataScienceorjoinourmailinglist,visitiqviainstitute.org. MURRAYAITKEN ExecutiveDirector IQVIAInstituteforHumanDataScience REFERENCINGTHISREPORT Pleaseusethisformatwhenreferencingcontentfromthisreport: Source:IQVIAInstituteforHumanDataScience.GlobalTrendsinR&D2025:Progressinrecapturingmomentuminbiopharmainnovation.March2025.Availablefromwww.iqviainstitute.org ©2025IQVIAanditsaffiliates.Allreproductionrights,quotations,broadcasting,publicationsreserved.Nopartofthispublicationmaybereproducedortransmittedinanyformorbyanymeans,electronicormechanical,includingphotocopy,recording,oranyinformationstorageandretrievalsystem,withoutexpresswrittenconsentofIQVIAandtheIQVIAInstitute. GlobalTrendsinR&D2025:ProgressinRecapturingMomentuminBiopharmaInnovation TableofContents Overview2 R&Dfunding5 Clinicaltrialactivity14 Newdrugapprovalsandlaunches36 Clinicaldevelopmentproductivity51 Productivityenablers72 Notesonsources86 Methodologies87 References89 Abouttheauthors90 AbouttheInstitute92 Overview R&DFUNDING Biopharmafundinglevelsinthepastyearcontinuedtoincreasefollowingthepost-pandemicreboundof2023,withgrowthcontributionscomingfromIPOs,follow-onfunding,andotherpublicandprivatesources.Excludingthe2020and2021heightsseenduringthepandemic,fundingreacheda10yearhighof$102Bnin2024 —asubstantialincreaseonthe2023figureof$71Bn. Incontrast,thevolumeofR&Ddealsbetweenpharmaceuticalcompaniesdeclinedin2024,continuingthedownwardtrendthatbeganin2022.Morethanhalfofthe1,016dealsmadein2024werebetweenemergingbiopharma(EBP)companies,withthemajorityoftheremainderinvolvingEBPdealswithlargercompanies. Partnershipsbetweenlargercompaniesremainedrelativelyrare,accountingforjustoveroneintenR&Ddeals.ThevolumeofM&Adealsalsodeclinedbetween2023and2024,butthemedianvalueofthesedealsincreaseddramaticallyfrom$153Mnto$405Mn,withabouthalfofthe2024dealsinthe$1Bnto$5Bnrange.MostinternationalR&DM&AandlicensingdealsinvolvingaChina-headquarteredcompanywerefocusedoutwards(71of73deals),withaninternationalpartneracquiringorin-licensingR&DfromChina,andtherelativeimportanceoftheseoutwardChinadealshasbroadlyincreasedovertime. TotalR&Dexpenditureoflargepharmaceuticalcompaniescontinuedtoincreasein2024,bothinabsoluteterms(reaching $190Bn,upfrom$163Bnin2023)andasapercentageofsales,exceeding25%forthefirsttime. TotalR&Dexpenditureoflargepharmaceuticalcompaniescontinuedtoincreasein2024,bothinabsoluteterms(reaching$190Bn,upfrom$163Bnin2023)andasapercentageofsales,exceeding25%forthefirsttime. CLINICALTRIALACTIVITY Thetotalvolumeofclinicaltrialstartsstabilizedin2024aftertheyear-on-yeardeclinesseenin2022and2023,reaching5,318—anumberremarkablysimilartothe5,316pre-pandemiccountin2019andslightlyabovethe5,302totalof2023.Theshort-term volatilityintroducedbyCOVID-19trialssince2019hasbeenpartlycounterbalancedbyincreasingtrialsfromChina-headquarteredcompaniesandrecentupliftsfromEBPandlargercompanies,especiallyinPhaseI. EBPcompaniescontinuedtoaccountforamajorityoftrialstarts,upfrom56%in2019to63%in2024,alth