2024年全球新药研发趋势_市场营销策划_2024年市场报告-3月第4周_【2024研报】重点报告_.docx

inR&D2024FEBRUARY2024三三IQVIAINSTITUTEFORHUMANTASCIENCEGlobalTrends+ACTIVITY,PRODUCTIVITY,ANDENAB1.ERSIntroductionBiomedicaladvancesaretransforminghealthcareglobally.Themulti-stakeholderecosystemthatenablesthisprogresshasbeenbuffetedbytheglobalCOVID-19pandemicandisresettingandrefocusingonfutureopportunitiestoadvancetheunderstandingofhumanbiologyanddisease,discoveranddevelopnewtherapeutics,andprovideevidenceoftheclinicalvalueoftheseinnovationsforindividualpatients,populations,andhealthsystems.Byallofthetraditionalmetrics,includingfundinglevels,numbersoftrialstarts,druglaunches,R&Dsuccessrates,andmanyothers,itisClearthatindustryandinvestorscontinuetoseetremendousvalueinthevastarrayofongoingresearchprogramsaroundtheworld.Thisreportassessesthetrendsinnewdruglaunchesandtheoverallnumberofinitiatedclinicaltrials.ItalsoprofilesthestateofR&DfundingandtheactivityofcompaniesOfdifferenttypes.TheresultsofresearcharecomparedtotheinputeffortinaClinicalDevelopmentProductivityIndex.ThenotableaccelerationandadaptabilityoftheinnovationecosystemisexaminedintermsOfseveralenablersofR&Dproductivity,includingtherelationshipbetweenshorteningtrialdurationsandthe'whitespace,withinclinicaldevelopmenttimelinesthathavebeenreducingforsomediseasesandincreasingforothers.TheresearchincludedinthisreportwasundertakenindependentlybytheIQVIAInstituteforHumanDataScienceasapublicservice,withoutindustryorgovernmentfunding.TheanalyticsinthisreportarebasedonproprietaryIQVIAdatabasesand/orthird-partyinformationandarenotderivedfromproprietarysponsortrialinformation.ThecontributionstothisreportfromMohitAgarwal,TaskinAhmed,ChrisBamford,VaibhavBhalotia,TanyaBhardwaj,1.ucyHaggerty,JuliaKern,BhagyashreeNawar,UrvashiPorwal,TanushreeThakur,anddozensofothersatIQVIAaregratefullyacknowledged.FindOutMoreIfyouwishtoreceivefuturereportsfromtheIQVIAInstituteforHumanDataScienceorjoinourmailinglist,visitiqviainstitute.org.MURRAYAITKENExecutiveDirectorIQVIAInstituteforHumanDataScienceREFERENCINGTHISREPORTPleaseusethisformatwhenreferencingcontentfromthisreport:Source:IQVIAInstituteforHumanDataScience.GlobalTrendsinR&D2024:Activity,Productivity,andEnablers.February2024.Availablefrom©2024IQVIAanditsaffiliates.Allreproductionrights,quotations,broadcasting,publicationsreserved.Nopartofthispublicationmaybereproducedortransmittedinanyformorbyanymeans,electronicormechanical,includingphotocopy,recording,oranyinformationstorageandretrievalsystem,withoutexpresswrittenconsentofIQVIAandtheIQVIAInstitute.OverviewR&Dfunding4Clinicaltrialactivity12Newdrugapprovalsandlaunches29Clinicaldevelopmentproductivity40Productivityenablers58Notesonsources73Methodologies74References75Abouttheauthors76AbouttheInstitute78OverviewR&DFUNDINGR&Dfundinglevelshavereboundedin2023afterasteepdeclinefromthepeakseenin2020-21.Whilethenumberofdealshasfallen,highprofileandhighvaluedealsindicaterobustinterestfrominvestorsandinnovatorsinthenextgenerationoftherapies.Biopharmafundinglevelsreboundedto$72Bnin2023,upfrom$61Bnin2022,althoughstillwellbelowthelevelsin2020-21.M&Aactivityjumpedto$140Bnfrom$78Bnin2022,whilemediandealvaluedippedforthesecondyear.TheleadingdealandM&Aactivityareasrelatedtoantibodydrugconjugatesaccountedfor47%ofdisclosedM&Adealsvaluedover$2Bnand85%oflargeoncologydeals.DealsinvolvingChina-basedcompaniesremainedsignificantandAldealsmorethandoubled.R&Dexpenditurereportedbylargepharmacorporationstotaledarecord$161Bnin2023,anincreaseofalmost50%since2018,andhistoricallyhighat23.4%ofnetsalesforthosecompanies.C1.INICA1.TRIA1.ACTIVITYTrialstartshaveslowedtobelowpre-pandemiclevels,reflectingfewerCOVID-19activityandshiftingresearchpriorities.Clinicaltrialstartsdeclined15%in2023comparedtotheprioryearandweredown22%from2021whichincludedthepeakofCOVID-19-relatedtrialactivity.ThethreemaindriversaccountingfortheslowdownwerefewerCOVID-19trialstarts,fewernon-COVID-19startsbylargercompanies,andfewerbyemergingbiopharmacompanies.TrialstartsfromChina-headquarteredcompanieshaverisento28%oftrialstarts,upfrom3%adecadeago,andanincreasingproportionofChinesecompanieshavehadinternationaltrialstartscontrastedwiththedomestic-onlyactivityofmostfirms.Thetopfourdiseasesintermsoftrialstartsoncology,immunology,metabolic/endocrinology,andneurology一accountfor79%oftrialstartsanddeclinedlessthanotherdiseases.Rarediseasetrialactivityremainshighandslowedlessthantrialsfocusedonlargerpopulations.ThediseasefocusofrarediseaseresearchispredominatelyinoncologywhilediseaseswithlargerpopulationsstudyawidervarietyOfdiseases.Noveloncologymechanisms,especiallycellandgenetherapies,ADCsandmulti-specificantibodies,haverisento25%ofoncologytrials.Industrysponsoredcellandgenetherapytrialshavemorethantripledoverthelastdecadewhilenon-industryhavegrown5%.CART-celltherapyclinicalresearchisfocusedononcology,whileotherdiseasesmaybenefitfromothercellandgenemodalities.Obesityclinicaltrialsin2023wereup68%from2022andhavenearlydoubledwhencomparedtofiveyearsago