1新药研发绪论

122121“”96%96%3““??””“”““””43-10,000(III)I100-300(II)5R&D11--22~100~100~10011-15YearsI001515551010IIIII65000/5-61-21-2IIIIII31-212-155,000-10,00051138318802197519872000PhRMA20037TOTALDRUGDEVELOPMENTTIMEFROMSYNTHESISTOAPPROVAL8.1DevelopmentTime(Years)8(90%)9%oftotalR&Dcosts70-110250-370180-25090-120870-1,350240-280230-250BasicResearchcostsDiscoverycostsPreclinialcosts1Non-clinicaloutsourcing2Clinicaldevelopmentcosts3Clinicalout-sourcing4Clinicalgrants40-70FDAfilingcosts2,000-2,900Total4139451110224•Research=30%•Development=70%30-100ClinicalMaterialcosts100Developmentspendingisgrowingfasterthanresearchspending:12%vs.9%CAGRCostofresearchactivities10--------28.3%28.3%--------5.8%(1/3(1/3))5.8%((9.9%)9.9%)--------12%12%--------19.1%19.1%--------9.2%9.2%((41.3%41.3%11R&D1220032003R&DR&D2003R&D()(%)2003(%)35.5135001250050050077PFIZER45,9503,910555116,775.00113192JOHNSON&JOHNSON41,8627,19721248,263.001983114GLAXOSMITHKLINE35,0517,35019142,918.602155193NOVARTIS24,8645,01636449,317.001942205ROCHEGROUP23,2132,2821101048,097.402004222MERCK22,4866,83122340,587.502256239BRISTOL-MYERSSQUIBB20,8943,10675627,471.002959248AVENTIS20,1622,1511141135,666.602437254ABBOTTLABORATORIES19,6812,75388826,715.3030110269ASTR12AZENECA18,8493,03678723,573.0032211330WYETH15,8512,0511181231,031.902738433ELILILLY12,5832,56196921,678.1033512142004500165001520022003FDA78721821200432™1619961996200120011996200161,93361,46491,1521576817.51,21726.555474.58617R&DR&D30306660601.31.388171788→→141418‰‰3355‰‰4/54/5‰‰10103319“”20#21WorldPopulationWesternEuropeNorthAmericaJapanOther(Africa,Australia)“”“DevelopingMarkets”2223GlobalGrowthto2006–DrivenbytheUS2001200120062006ROW17%USA49%Japan15%19%17%10%ROW14%USA59%3900USD390billion6300USD630billionPharmaMarket24MajorChallengesFacingtheIndustry•Highlycompetitivemarketplace•Publicandpoliticalpressure•Deficitofbreakthroughproductsinpipelines•Decliningmarketexclusivityperiods•Globaldevelopmentstrategies•Scientificandtechnologicaladvances•Changingregulatoryenvironment•RapidlyrisinginR&Dcosts25R&DbyGeographicAreaUSA79.1%Europe13.5%ROW5.0%Japan2.4%ROWCanada:1.0Mexico:0.6Australia:0.2Asia:0.2Africa:0.1Unspecified:2.8ROWCanada:1.0Mexico:0.6Australia:0.2Asia:0.2Africa:0.1Unspecified:2.8Ethicalpharmaceuticals(PhRMAmembers):300Totalspend:30BNUSD2620102728•10••29Top102003()(%)((LipitorLipitor))1031031414((ZocorZocor))6161--44((ZyprexaZyprexa))48481313((NorvascNorvasc))454577ErypoErypo40401313((PrevacidPrevacid))404000((NexiumNexium))38386262((PlavixPlavix))37374040((SeretideSeretideEvohalerEvohaler))//37371111(Zoloft)(Zoloft)34341414PhIIC3031⎯32•••“”•33Me-too34Me-too75941000NCE76%Me-too3536¾¾¾¾¾37¾¾38¾198619937.57.5ProscarCefiximeSinemet39¾¾“”“”40¾41¾¾425120()2007820——145%250%360%199410%20002025%43200544Y“”YY45““””“”4647¾¾10010015%15%95%95%¾¾2010201040040090%90%48FDAFDAANDA123ANDA4ANDA18018049•50“”12“”“”1994513200191920011020029320047520199420145152•“”•GSK“”“”•53•“”••••542.2.77357735700700GMPGMP5071507120042004663030GMPGMP3237323764641587158724724755—56573.3.584.4.“”59/60$0$10$20$30$40$50$6019971998199920002001Billions$0$1$2$3$4$5$6$7$8$9$10BillionsTotalR&DSpendingOutsourcedR&DReutersBusinessInsight,PharmaceuticalR&DOutsourcingStrategies,200261$47$50$59$68$79$91$9$11$14$19$26$36$0$20$40$60$80$100$120$140200120022004200620082010BillionsIn-houseR&DOutsourcedR&DReutersBusinessInsight,PharmaceuticalR&DOutsourcingStrategies,2002625.5.1.51.56364•10050%•13%•200040%1999l/3200560%TechnologyCatalystsInternational65•20001330•20082000•200040%662000200520002005/1.561.682.232.418.3016.4311.8020.5410.7312.9721.4625.9322.8132.6938.0254.4911.4218.2116.3226.020.851.061.702.123.316.495.6710.822.844.014.055.736.569.1415.1122.871.703.564.268.9170.08106.24120.62179.84677.7.DDTDDTDDT200520057007002002200246146168…90400010%15%69••19991•7011001100200320036000600071••••••••7273DDTDDT748.8.FDAFDA:InnovationorStagnation?March200475[2004]8276::§--§“me-too--§--1.5,§--§