2024年全球新药研发趋势

GlobalTrendsinR&D2024 ACTIVITY,PRODUCTIVITY,ANDENABLERS FEBRUARY 2024 Introduction Biomedicaladvancesaretransforminghealthcareglobally.Themulti-stakeholderecosystemthatenablesthisprogresshasbeenbuffetedbytheglobalCOVID-19pandemicandisresettingandrefocusingonfutureopportunitiestoadvance theunderstandingofhumanbiologyanddisease,discoveranddevelopnewtherapeutics,andprovideevidenceoftheclinicalvalueoftheseinnovations—forindividualpatients,populations,andhealthsystems.Byallofthetraditionalmetrics,includingfundinglevels,numbersoftrialstarts,druglaunches,R&Dsuccessrates,andmanyothers,itisclearthatindustryandinvestorscontinuetoseetremendous valueinthevastarrayofongoingresearchprogramsaroundtheworld. Thisreportassessesthetrendsinnewdruglaunchesandtheoverallnumberofinitiatedclinicaltrials.ItalsoprofilesthestateofR&Dfundingandtheactivityofcompaniesofdifferenttypes.TheresultsofresearcharecomparedtotheinputeffortinaClinicalDevelopmentProductivityIndex.ThenotableaccelerationandadaptabilityoftheinnovationecosystemisexaminedintermsofseveralenablersofR&Dproductivity,includingtherelationshipbetweenshorteningtrialdurations andthe‘whitespace’withinclinicaldevelopmenttimelinesthathavebeenreducingforsomediseasesandincreasingforothers. TheresearchincludedinthisreportwasundertakenindependentlybytheIQVIAInstituteforHumanDataScienceasapublicservice,withoutindustryorgovernmentfunding.TheanalyticsinthisreportarebasedonproprietaryIQVIAdatabasesand/orthird- partyinformationandarenotderivedfromproprietarysponsortrialinformation. ThecontributionstothisreportfromMohitAgarwal,TaskinAhmed,ChrisBamford,VaibhavBhalotia,TanyaBhardwaj,LucyHaggerty,JuliaKern,BhagyashreeNawar,UrvashiPorwal,TanushreeThakur,anddozensofothersatIQVIAaregratefullyacknowledged. FindOutMore IfyouwishtoreceivefuturereportsfromtheIQVIAInstituteforHumanDataScienceorjoinourmailinglist,visitiqviainstitute.org. MURRAYAITKEN ExecutiveDirector IQVIAInstituteforHumanDataScience REFERENCINGTHISREPORT Pleaseusethisformatwhenreferencingcontentfromthisreport: Source:IQVIAInstituteforHumanDataScience.GlobalTrendsinR&D2024:Activity,Productivity,andEnablers.February2024.Availablefromwww.iqviainstitute.org ©2024IQVIAanditsaffiliates.Allreproductionrights,quotations,broadcasting,publicationsreserved.Nopartofthispublicationmaybereproducedortransmittedinanyformorbyanymeans,electronicormechanical,includingphotocopy,recording,oranyinformationstorageandretrievalsystem,withoutexpresswrittenconsentofIQVIAandtheIQVIAInstitute. GlobalTrendsinR&D2024:Activity,Productivity,andEnablers Overview2 R&Dfunding4 Clinicaltrialactivity12 Newdrugapprovalsandlaunches29 Clinicaldevelopmentproductivity40 Productivityenablers58 Notesonsources73 Methodologies74 References75 Abouttheauthors76 AbouttheInstitute78 Overview R&DFUNDING R&Dfundinglevelshavereboundedin2023afterasteepdeclinefromthepeakseenin2020-21.Whilethenumberofdealshasfallen,highprofileandhighvaluedealsindicaterobustinterestfrominvestorsandinnovators inthenextgenerationoftherapies.Biopharmafundinglevelsreboundedto$72Bnin2023,upfrom$61Bnin2022,althoughstillwellbelowthelevelsin2020-21. M&Aactivityjumpedto$140Bnfrom$78Bnin2022,whilemediandealvaluedippedforthesecondyear.TheleadingdealandM&Aactivityareasrelatedtoantibodydrugconjugatesaccountedfor47%ofdisclosedM&Adealsvaluedover$2Bnand85%oflargeoncologydeals.DealsinvolvingChina-basedcompaniesremainedsignificantandAIdealsmorethandoubled.R&Dexpenditurereportedbylargepharmacorporationstotaledarecord$161Bnin2023,anincreaseofalmost50%since2018,andhistoricallyhighat23.4%ofnetsalesforthosecompanies. CLINICALTRIALACTIVITY Trialstartshaveslowedtobelowpre-pandemiclevels,reflectingfewerCOVID-19activityandshiftingresearchpriorities.Clinicaltrialstartsdeclined15%in2023comparedtotheprioryearandweredown22%from2021whichincludedthepeakofCOVID-19-relatedtrialactivity.ThethreemaindriversaccountingfortheslowdownwerefewerCOVID-19trialstarts,fewernon-COVID-19starts bylargercompanies,andfewerbyemergingbiopharmacompanies.TrialstartsfromChina-headquarteredcompanieshaverisento28%oftrialstarts,upfrom3%adecadeago,andanincreasingproportionofChinesecompanieshavehadinternationaltrialstartscontrastedwiththedomestic-onlyactivityofmostfirms. Thetopfourdiseasesintermsoftrialstarts—oncology,immunology,metabolic/endocrinology,andneurology—accountfor79%oftrialstartsanddeclinedlessthanotherdiseases.Rarediseasetrialactivityremainshighandslowedlessthantrialsfocusedonlargerpopulations.Thediseasefocusofrarediseaseresearchispredominately inoncologywhilediseaseswithlargerpopulationsstudyawidervarietyofdiseases.Noveloncologymechanisms,especiallycellandgenetherapies,ADCsandmulti-specificantibodies,haverisento25%ofoncologytrials.Industrysponsoredcellandgenetherapytrialshavemorethantripledoverthelastdecadewhilenon-industryhave grown5%.CART-celltherapyclinicalresearchisfocusedononcology,whileotherdiseasesmaybenefitfromothercellandgenemodalities. Obesityclinicaltrialsin2023wereup68%from2022andhavenearlydoubledwhencomparedtofiveyearsago,including124dru