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1、inR&D2024FEBRUARY2024三三IQVIAINSTITUTEFORHUMANTASCIENCEGlobalTrends+ACTIVITY,PRODUCTIVITY,ANDENAB1.ERSIntroductionBiomedicaladvancesaretransforminghealthcareglobally.Themulti-stakeholderecosystemthatenablesthisprogresshasbeenbuffetedbytheglobalCOVID-19pandemicandisresettingandrefocusingonfutureopport

2、unitiestoadvancetheunderstandingofhumanbiologyanddisease,discoveranddevelopnewtherapeutics,andprovideevidenceoftheclinicalvalueoftheseinnovationsforindividualpatients,populations,andhealthsystems.Byallofthetraditionalmetrics,includingfundinglevels,numbersoftrialstarts,druglaunches,R&Dsuccessrates,an

3、dmanyothers,itisClearthatindustryandinvestorscontinuetoseetremendousvalueinthevastarrayofongoingresearchprogramsaroundtheworld.Thisreportassessesthetrendsinnewdruglaunchesandtheoverallnumberofinitiatedclinicaltrials.ItalsoprofilesthestateofR&DfundingandtheactivityofcompaniesOfdifferenttypes.Theresul

4、tsofresearcharecomparedtotheinputeffortinaClinicalDevelopmentProductivityIndex.ThenotableaccelerationandadaptabilityoftheinnovationecosystemisexaminedintermsOfseveralenablersofR&Dproductivity,includingtherelationshipbetweenshorteningtrialdurationsandthewhitespace,withinclinicaldevelopmenttimelinesth

5、athavebeenreducingforsomediseasesandincreasingforothers.TheresearchincludedinthisreportwasundertakenindependentlybytheIQVIAInstituteforHumanDataScienceasapublicservice,withoutindustryorgovernmentfunding.TheanalyticsinthisreportarebasedonproprietaryIQVIAdatabasesand/orthird-partyinformationandarenotd

6、erivedfromproprietarysponsortrialinformation.ThecontributionstothisreportfromMohitAgarwal,TaskinAhmed,ChrisBamford,VaibhavBhalotia,TanyaBhardwaj,1.ucyHaggerty,JuliaKern,BhagyashreeNawar,UrvashiPorwal,TanushreeThakur,anddozensofothersatIQVIAaregratefullyacknowledged.FindOutMoreIfyouwishtoreceivefutur

7、ereportsfromtheIQVIAInstituteforHumanDataScienceorjoinourmailinglist,visitiqviainstitute.org.MURRAYAITKENExecutiveDirectorIQVIAInstituteforHumanDataScienceREFERENCINGTHISREPORTPleaseusethisformatwhenreferencingcontentfromthisreport:Source:IQVIAInstituteforHumanDataScience.GlobalTrendsinR&D2024:Activ

8、ity,Productivity,andEnablers.February2024.Availablefrom2024IQVIAanditsaffiliates.Allreproductionrights,quotations,broadcasting,publicationsreserved.Nopartofthispublicationmaybereproducedortransmittedinanyformorbyanymeans,electronicormechanical,includingphotocopy,recording,oranyinformationstorageandr

9、etrievalsystem,withoutexpresswrittenconsentofIQVIAandtheIQVIAInstitute.OverviewR&Dfunding4Clinicaltrialactivity12Newdrugapprovalsandlaunches29Clinicaldevelopmentproductivity40Productivityenablers58Notesonsources73Methodologies74References75Abouttheauthors76AbouttheInstitute78OverviewR&DFUNDINGR&Dfun

10、dinglevelshavereboundedin2023afterasteepdeclinefromthepeakseenin2020-21.Whilethenumberofdealshasfallen,highprofileandhighvaluedealsindicaterobustinterestfrominvestorsandinnovatorsinthenextgenerationoftherapies.Biopharmafundinglevelsreboundedto$72Bnin2023,upfrom$61Bnin2022,althoughstillwellbelowthele

11、velsin2020-21.M&Aactivityjumpedto$140Bnfrom$78Bnin2022,whilemediandealvaluedippedforthesecondyear.TheleadingdealandM&Aactivityareasrelatedtoantibodydrugconjugatesaccountedfor47%ofdisclosedM&Adealsvaluedover$2Bnand85%oflargeoncologydeals.DealsinvolvingChina-basedcompaniesremainedsignificantandAldeals

12、morethandoubled.R&Dexpenditurereportedbylargepharmacorporationstotaledarecord$161Bnin2023,anincreaseofalmost50%since2018,andhistoricallyhighat23.4%ofnetsalesforthosecompanies.C1.INICA1.TRIA1.ACTIVITYTrialstartshaveslowedtobelowpre-pandemiclevels,reflectingfewerCOVID-19activityandshiftingresearchprio

13、rities.Clinicaltrialstartsdeclined15%in2023comparedtotheprioryearandweredown22%from2021whichincludedthepeakofCOVID-19-relatedtrialactivity.ThethreemaindriversaccountingfortheslowdownwerefewerCOVID-19trialstarts,fewernon-COVID-19startsbylargercompanies,andfewerbyemergingbiopharmacompanies.Trialstarts

14、fromChina-headquarteredcompanieshaverisento28%oftrialstarts,upfrom3%adecadeago,andanincreasingproportionofChinesecompanieshavehadinternationaltrialstartscontrastedwiththedomestic-onlyactivityofmostfirms.Thetopfourdiseasesintermsoftrialstartsoncology,immunology,metabolic/endocrinology,andneurology一ac

15、countfor79%oftrialstartsanddeclinedlessthanotherdiseases.Rarediseasetrialactivityremainshighandslowedlessthantrialsfocusedonlargerpopulations.ThediseasefocusofrarediseaseresearchispredominatelyinoncologywhilediseaseswithlargerpopulationsstudyawidervarietyOfdiseases.Noveloncologymechanisms,especially

16、cellandgenetherapies,ADCsandmulti-specificantibodies,haverisento25%ofoncologytrials.Industrysponsoredcellandgenetherapytrialshavemorethantripledoverthelastdecadewhilenon-industryhavegrown5%.CART-celltherapyclinicalresearchisfocusedononcology,whileotherdiseasesmaybenefitfromothercellandgenemodalities.Obesityclinicaltrialsin2023wereup68%from2022andhavenearlydoubledwhencomparedtofiveyearsago