Citeline-Pharma-R&D-Annual-Review-2014

1IanLLoydSenIordIrector,PharmaProjectS/PIPeLIneanddataIntegratIoncitelinePharmar&dannualreview20142WelcometoCiteline’s2014reviewoftrendsinpharmaceuticalR&D.Forovertwentyyears,I’vebeentakinganannuallookatthestateofthepharmanation,freezingthepipelineintimeandcomparingittosimilardatapointsinpreviousyears.BylookingatourinformationoncommercialdrugR&Doverseveralyears,I’veidentifiednewtrends,raisedalarmbellsatworrisomesigns,orbangedthedrumfortheindustry’ssuccesses.Inthisarticle,wewillbeseeinghowthepipelineattheverystartof2014haschangedinthepasttwelvemonths,andlookingforpointersastowhatthenewyearmightbring.Here,we’llbeconcentratingonthepipelineasawhole.I’llbeaddingmythoughtsastotheindustry’ssuccessstoriesoftheyearjustpassedwhenweissueourreviewof2013’sNewActiveSubstancelaunchesasasupplementtothisreport,atthebeginningofMarch2014.totalsizeofpipeline–up,upandaway!Solet’sdivestraightinwiththealwayshotly-anticipated‘headlinefigure’fortheyear–thetotalsizeoftheglobalpipeline.Citeline’sdruginformationservice,Pharmaprojects/Pipeline,herecountsapipelinedrugasasingleentityorprojectwhichissomewhereonitsjourneyfrompreclinicaldevelopmentthroughtomarketlaunch.Itdoesalsoincludedrugswhicharealreadycommerciallyavailablebutarecontinuingindevelopmentforfollow-onindicationsorforadditionalmarkets.Andthisyear,thenewsisstriking.With11,307drugscurrentlyinR&D,thepipelinehasswollenbyawhopping7.9%.AlookatFigure1,whichshowstheequivalentfigureforeveryyeargoingbackto2001,highlightswhythispercentageincreaseisremarkableinmorethanoneway.Firstly,leavingasidetheanomalousincreaseseeninfrom2007to2008wheretheriseishugelyflatteredbythemergingofdrugdatafromouroriginaldatabasewiththatfromthethennewly-acquiredCitelinedatabaseofclinicaltrials(Trialtrove),thisisbyFigure1.TotalR&DPipelineSizebyYear2001-20145995619864166994736074067737921796059737971310452104791130702000400060008000100001200020012002200320042005200620072008200920102011201220132014Source:Pharmaprojects®Pipeline®,January20143Source:Pharmaprojects®Pipeline®,January2014Figure2.PipelineByDevelopmentPhase51061446188969315879920102548415412011744170951074740100020003000400050006000PreclinPhaseIPhaseIIPhaseIIIPre-regRegisteredLaunchedSuspended20132014somedistancethebiggestannualincreaseinnumberseverseen.It’salsotheheftiestinpercentagetermsinadecade,sincethe9.0%seenfrom2003to2004.Thishoweveronlyrepresentedajumpof578drugs–thisyear’srisewasofalmostoneandahalftimesasmany.Buttheexpansionisalsoinsharpcontrasttothechangeseenlastyear,whichwasalmostflat.Infact,itseemsthatthecurious‘step-wise’progressionofpipelinegrowthisundergoinganothercycle.Therearenointernalchangesineditorialprocedurethisyearwhichcanexplainthissuddenupwardstrajectory,soweareforcedtoconcludethatthereisgenuinegrowthintheindustry’spipeline,perhapstingedwithgreaterdisclosurefromthepharmaceuticalcompanies.Ifthelatterisabigfactorhere,wewouldexpectbiggerincreasesattheearlierstagesofdevelopmentwherepublicationofcompounddataismorediscretionary,solet’smovetobreakthepipelinedownbydevelopmentstage.the2014pipelinebyphase–increasesacrosstheboardThefirstthingtonotewhenweexamineFigure2,whichlooksatthenumbersofdrugsateachglobaldevelopmentstatusbothnowandayearago,isthattherearemoredrugsateveryactivedevelopmentstatusnow.Butthispatternofincreaseisindeednotuniform.WhilethenumberofdrugsatPhaseIandPhaseIIclinicaltrialshasincreasedby6.6and6.5%,respectively,thoseatthePreclinicalstageofdevelopmenthavegrowntheirnumberby7.4%.Thiswouldindicatethatasmallpartofthepipelinesizegrowthcouldhavecomefromincreaseddisclosure,orbetterdetectiononourpart,butthatthemajorityoftheincreaseislikelygenuineorganicgrowth.Indeed,thePhaseIIIfigurerosebythesamepercentageasthePreclinicalone.Interestingly,thebiggestgrowthisseenwiththeLaunched(butstillActive)drugs–up16.7%.Thisissurelyevidenceofcompaniesincreasinglywringingmorefromtheirsuccessfuldrugsbycontinuingtodevelopthempost-marketingforadditionalindications.4RegularreadersoftheCitelinePharmaR&DAnnualReviewsmayrecallthatlastyear,alarmbellsweresoundingatthePhaseIfigure,whichhadshownadeclineforthefirsttimeever.Happily,thisappearstohavebeensomethingofablip,withthe2014numbermorethanrecovering.Similarly,afterflattishdataatPhaseIIandPhaseIIIin2013,thisyearseesaresumptionofgrowth,withthedataforPhaseIIlookingparticularlyimpressive.ThenumbersofdrugsinPhaseI,IIandIIIhaveinfactgrownbyaformidable45.3,47.9and66.9%,respectively,overthestudyperiod,andeightyearsisreallynotthatlongatime.Thisisallmightilyencouraging.Asalways,aquicknoteabouttheseeminglycounterintuitivefactthatthePhaseIIfigurealwaysexceedsthatforPhaseIfigure,whenclearlydrugsdropoutofdevelopmentbetweenthetwophases.Thisisaneffectproducedbythesnapshotnatureofthedata:becausedrugsspendfarlesstimepassingthroughPhaseI,atanyonetime,moreareundergoingthemuchlongerPhaseIItrials.Thestatisticswhichareusuallyofmostinterestherearethosesurroundingtheclinicalphasesofdevelopment,inmanywaysthe‘beatingheart’ofthepipeline.It’sherethatthemostcluesastotheoverallhealthoftheindustryinthecomingyearscanbegarnered,soit’swor