2014年医药产业“兵器谱”出炉，十大畅销药横扫世界

2015年2月17日讯/生物谷BIOON/--古龙曾经说过，有人的地方就有江湖。如果把医药产业比作纷乱的江湖，各大医药公司比作一位位绝世高手，那么这些生物医药公司旗下的畅销药物可谓是这些"高手"们的神兵利器。因此，每年的畅销药物排行榜也就成为了"江湖中人"关注的重中之重。最近，分析人士统计出了2014年生物医药产业销售额最高的十大药物。这十种药物的销售总额达到了惊人的830亿美元之多，更引人瞩目的是其中的生物制药占据了七种之多。其中的前三甲分别是艾伯维公司的Humira、吉利德公司的Sovaldi以及强生和默沙东公司共有的Remicade，而Humira以及Sovaldi的年销售额均突破了100亿美元，分别达到了125亿美元和108亿美元之多。而这远远不是结束，预计到2020年这两种药物的销售额将分别上升至147亿美元和166亿美元以上。而按照药物的适应症进行归类，治疗癌症的药物占据了排行榜中的六席，此外治疗糖尿病的药物有两种上榜，分别是赛诺菲的Lantus和默沙东的Januvia。可以说，这些畅销药物已经成为了这些生物医药巨头占据生物医药市场领导地位的杀手锏。
不过，这些生物医药公司也都有着各自的远虑近忧。资料显示，2014年的十大畅销药中又数种都即将失去专利保护。这也意味着这些药物将面临着来自各个仿制药的强烈竞争。以此次的榜首--艾伯维公司的Humira--为例，尽管这一药物已经为艾伯维带来了数以百亿计的收益，但是随着仿制药的围攻，Humira的销售峰值预计将从2017年的160亿美元跌落至2022年的60亿美元。另一方面，随着美国政府医疗改革的进程，美国医保体系中药物价格过高的问题已经遭到了美国政府和民众的猛烈抨击。以吉利德公司的Sovaldi为例，这种治疗丙肝药物于2013年十二月上市后，因为其极其明显的疗效迅速席卷美国市场。然而Sovaldi每疗程的价格高达84000美元（即每片药物1000美元），不仅让人想起中国的一句俗话"十个劫道的不如一个买药的"。而FDA和美国的政府部门也紧急出台了多种政策旨在控制今后的新药价格。这两方面的问题都将对未来生物医药市场产生极大的影响。
正所谓江山代有才人出。在生物医药市场，没有人会是永远的赢家。今天的畅销药或许在明天就会被新的药物所取代。只有不断保持警惕和锐意进取才能保证在这个竞争激烈的领域立足。
本文系生物谷原创编译整理，欢迎转载！转载请注明来源并附原文链接。谢谢！
详细英文报道：
Itisnowonderthatbiosimilarbullsareemerging.The10biggestsellingpharmaceuticalproductsin2014generatedcombinedsalesof$83billion,ofwhich$60billionwasgeneratedbysevenbiologicdrugs,mostofwhichwillloseexclusivityforkeypatentsbytheendofthedecade.
Thevalueofthiscommercialopportunityhaslongbeentoutedbybiosimilardevelopersand,ofcourse,onlyrepresentsonepartoftheequation.Boththedevelopmentandregulatoryenvironmentscontinuetoprovideamultitudeofchallenges,whileconvincingphysiciansandpatientstousebiosimilarsattheexpenseofheavilyentrenchedbrandsislikelytoprovethemostdifficultchallengeofall-theflipsidetothepotentialdemiseoftheseproductsistheirimpressivelongevityinthemarket.
However,anintensificationofthedebatearoundpricingintheUSdrugmarketandconcertedregulatorymomentumfromtheFDAinthepastfewmonthswillframethislistofbest-sellingmedicinesinaslightlydifferentlighttopreviousyears,whentheprospectofsignificantbiosimilarerosionappearedjustthatlittlebitlesstenable.
Inanotetoinvestorspublishedlastweek,CitianalystsledbyAndrewBaumhavetakenthemostbullishstanceyetonthebiosimilarsopportunity;oneheadlinegrabbingconclusionfromCitisresearchisthatsalesofAbbViesanti-TNFtherapyHumirawilldeclinefromapeakof$16billionin2017to$6billionby2022.
Therestoftheanalystcommunityareyettoreachthesameconclusion;consensusforecastssourcedfromBloombergindicatehealthysalesof$14.8billionforHumirain2020,whileitshouldbenotedthatCitisoutlookisnotalldoomandgloom;costsavingssourcedfromtheuseofbiosimilarswillbeusedtofunduptakeofnoveltherapies,withBaumamongthemostbullishabouttheimmuno-oncologymarketamonghispeers.
TheCitioutlookispartlybasedonthenotionofUSpharmacybenefitmanagers-empoweredbytheirsuccessinthehepatitisCmarket-targetingtheanti-TNFclassforrapidadoptionofbiosimilars.ItisCelltrionsbiosimilarversionoftheanti-TNFRemicade-whichistobeassessedbyanFDAAdCompanelnextmonth-thatmayprovidethefirstopportunityforCitisscenariotoplayout.
ConsensusforecastssuggestingthatRemicadesaleswilldeclinetoaround$7.6billionby2020illustratetheJohnson&JohnsonandMerck&Co.-marketedproductasbeingthemostexposedtodirectbiosimilarcompetition.NotonlycouldCelltrionsproductfeasiblybeapprovedbytheFDAlaterthisyear,butisalreadyclearedinEuropeandonthevergeoflaunchinginsomeoftheregionslargestmarkets(PhysicianViewsPollResults:Letthegamesbegin-RemicadebiosimilarfreetodebutinEU5markets).
SanofisbasalinsulinproductLantusisalsosettofacebiosimilarcompetition(fromEliLilly)inEuropethisyear,althoughaforecastdeclineinsalesoverthenextfiveyearsprimarilyreflectsamorechallengingUSpriceenvironment,lossofsharetocompetitorsandtheswitchingofpatientstoSanofisToujeofranchise,whichisexpectedtogainFDAapprovallaterthisyear.
MirroringSanofisToujeostrategyitisnotsurprisingthatsuccessorproductstothreeotherdrugsonthelisthavelaunchedinthepastfewyears.RochehassoughttoreduceitstoplinetoexposurefrombiosimilarcompetitionbylaunchingGazyvaasamootedsuccessortoRituxanwithPerjetaandKadcylapositionedasfollow-onstoHerceptin(withthisstrategyamixedsuccessfollowingpublicationoftheMARIANNEdatainDecember).
GlaxoSmithKlinehassoughttomaintainleadershipoftheasthmaandCOPDmarketsviathelaunchesofBreoElliptaandAnoroEllipta.WhileAdvairhaslostshareoverthepastyearintheUSduetopricingdynamics,however,bothBreoandAnorohaveunderwhelmedsincelaunch.Asaresult,emphasisisbuildingonatriplecombinationtherapyinPhaseIIIdevelopmentbutAdvairlookswellsettoremainthebiggestsellingrespiratorydrugofalltime.AkeypointofdebateiswhetherAdvairwillfacegenericcompetitionintheUSnextyear;consensussuggestsnot,butthisisapotentialblackswaneventinwaitingfortheUKplayer.
ThefinalwordmustgotoGileadSciencesSovaldihepatitisCfranchise,whichgeneratedsalesof$10.3billionin2014,astaggeringperformancefollowingfirstlaunchinDecember2013.FactoringinsalesofHarvoni(acombinationofSovaldiwithledipasvir),franchiserevenuesswellto$12.4million(HarvonionlylaunchedinDecember2014).
Sovaldi/Harvonihasnotonlyemergedasthefastestdruglaunchofalltime,butacontroversialproductthathasstirredmuchofthecurrentdebatearoundUSdrugpricing.WhetherthefranchisecanovertakeHumiraandPfizersLipitorasthebiggestsellingremainstobeseen,butconsensusindicates2020salesofaround$16billion.

医药网新闻