IMS Health生物类似药市场分析报告

WHITEPAPERIMSHEALTHBIOSIMILARSANDNON-ORIGINALBIOLOGICSSearchingforTerraFirmaintheBiosimilarsandNon-OriginalBiologicsMarketInsightsfortheComingDecadeofChangeAUTHORS:SARAHRICKWOODANDSTEFANODIBIASEIMSHEALTHBIoSIMILARSAndnon-oRIgInALBIoLogIcSIMSHEALTHAcknowledgements•ThecontributionstothisreportofAlanSheppard,JamieMcQuade,RobertHaigh,DonalCumiskeyandmanyothercolleaguesatIMSHealtharegratefullyacknowledged.Weareenteringanerawithgreatpotentialforchangeinthebiosimilarsmarket,markedbytheLoEofmanyoftheworld’sleadingbiologics,andforeshadowedbyanumberof“firsts”inwhatisbeingbroughttomarket,bywhom,andwhere.IntroductionIntheglobalbiosimilarsandnon-originalbiologicsmarket,thesandsareshiftingunderfoot.It'stimeforallstakeholderstore-examinethepresentenvironmentandre-setexpectationsforthefuture.WithinthefirstthreeyearsfollowingthecreationofaregulatorypathwayforbiosimilarsintheEU,biosimilarsforthreemoleculeswereintroduced:somatropin(totreatgrowthfailure),erythropoietin(totreatanemia)andfilgrastim(toboostwhitebloodcellcountsafterchemotherapy).Fromthatpointon-until2013-nonewmoleculesenteredthebiosimilarsmarketintheEUandnonewerelaunchedintheU.S.forlackofabiosimilarapprovalpathway.Withuptakeontheexistingbiosimilarsbeingverymeasured,itwasaperiodofrelativecalm—borderingonstasis—inmaturemarkets.Thereare,however,severalindicationsthatthestatusquoisabouttochange—perhapsdramatically.Considerthat:•Thefirstofanewwaveofmonoclonalantibody(mAb)biosimilars—treatingchronicconditionsinthelargestareasofbiologicspend—hasrecentlybeenapprovedintheEU.•TheEuropeanMedicinesAgency(EMA)permittedindicationextrapolationintheaboveapproval…andthebiosimilaritselfisproducedbyanunexpectedsource:aSouthKoreanfirm.•Anon-originalversionoffilgrastim,anequivalentofthebiosimilarversionsoffilgrastimalreadyavailableinEurope,hasbeenapprovedformarketingintheU.S.andisexpectedtolaunchbeforetheendof2013.•Forthefirsttime,abiosimilarhaseclipsedanoriginatorproductinvolumeshareinEurope.•Severalimportantandverylargebiologictherapyareasarefacinglossofexclusivity(LoE)inthenextfewyears,includingmonoclonalantibodyoncologics,moderninsulins,andanti-tumornecrosisfactormonoclonalantibodies(anti-TNFmAbs).With2013beingsuchapivotalyear,itappearsthatthebiosimilarmarketofthenextdecadewillbestrikinglydifferentfromthatofthepastsevenyears.WhileMulti-NationalCorporations(MNCs)havefocusedtheireffortsonmaturemarkets,localplayersinemergingmarketshavebeeninsertingthemselves,littlebylittle,intothenon-originalbiologicsarena.Bynow,thisparallelmarketdevelopment,sometimesbackedbygovernment,iswellunderway,andthestageissetforgreatchange.IMSHEALTHBIoSIMILARSAndnon-oRIgInALBIoLogIcS1SEARCHINGFORTERRAFIRMAINTHEBIOSIMILARSANDNONCORIGINALBIOLOGICSMARKETIMSHEALTH2IMSHEALTHBIoSIMILARSAndnon-oRIgInALBIoLogIcSTheGlobalBiologicsMarketOverthepast30years,biologicshavebeenthedarlingsofthepharmaceuticalindustry,withsalesgrowingattwicetherateofthemarketasawhole.Theglobalbiologicsmarketreachednearly$170billioninsalesvaluein2012,accountingfor18percentoftheoverallmarket.Andfiveofthetop10globalproductsintermsofsalesvolumearebiologics,upfromjusttwoin2008.AscanbeseeninFigure1,theU.S.takesthelion'sshare(49percent)oftheglobalbiologicsmarketvalueandgenerateshalfofthesalesvaluegrowthaswell.TheEUaccountsfor22percentofthemarket'ssalesvalueand14percentofitsvaluegrowth.Incontrast,emergingmarketsrepresentjustasliverofthesalespie,with7.5percentshare.Thus,biologicsmarketgrowthisstilllargelydrivenbymaturemarkets.Thisisverydifferentfromwhatweseeinthepharmaceuticalmarketasawhole,wheregrowthislargelydrivenbypharmergingmarkets.CLASSIFICATIONOFBIOLOGICSWithinIMSMIDAS®,biosimilarsarethosebiologicsthatarenon-originalcopiesofinnovativebrandsandthathavebeenapprovedformarketingviaadedicatedregulatorypathway,suchashasbeencreatedintheEU,U.S.,andJapan.Non-originalbiologics(NOBs)arethosecopiesofinnovativebrandsthathavenotbeenapprovedthroughsuchadedicatedpathway.Typically,theyareintroducedinemergingmarkets.TYPEdEScRIPTIonTARgETEXAMPLETrueInnovatorBio-bettersBiosimilarsnonoriginalBiologics•Disruptivetechnologies,bigadvancesinefficacy•Efficacy/safetyimprovements•Affordablehighquality•Lessstringentcomparability•Newdrugagainstnewtarget•Drugaimingatcopyinnovator•Focusonpatientaccess,EMs•Clinicallyequivalenceandcomparabilitytooriginators•Sametargetbutdifferentiated(e.g.Betterefficacy,safety,administration)BiologicsoriginalsnonoriginalsABiosimilarbyAnyOtherName…Tosupportconsistentanalysesacrossgeographies,therapies,andmanufacturers,IMSHealthhasestablishedanindustry-verifiedcategorizationofbiologics.Althoughnoteveryproductfitsneatlyintotheseclassifications,theschemaappliesinmostinstances.REdITUXTMInFLEcTRATMPEgASYS®EYLEA®3Whilebiologicproductperformancehas,ofcourse,beenawelcomeboontoinnovatormanufacturers,ithasputextremepressureonalreadystrainedhealthcarebudgets.Biologicsareamongthemostexpensivepharmacotherapiesavailable,andrationalizingtheirusehasbeenanongoingchallengeforpayers.Shouldlessexpensivealternativestobiologicsbecomeavailable,andbeacceptedbyphysicians