全球醫(yī)藥產(chǎn)業(yè)研究與發(fā)展的趨勢課件

1、全球醫(yī)藥產(chǎn)業(yè)研究與發(fā)展的最新趨勢胡江濱美中藥協(xié) (SAPA)北京, 20041全球醫(yī)藥產(chǎn)業(yè)研究與發(fā)展的最新趨勢1報告內(nèi)容全球制藥界新藥開發(fā)最新概況新藥開發(fā)值得注意的走向Project in-licensing項目引進(jìn)Life Cycle Management (LCM)產(chǎn)品周期的管理OutsourcingWhat Why and (How) ?2報告內(nèi)容全球制藥界新藥開發(fā)最新概況2223236249285296297308337364396010020030040050060019921993199419951996199719981999200020012002p2003pGlobal ph

2、armaceutical sales (US$ billion)4204450100200300400500600Yearp = projectionSource: Sales data for 1992-2001 supplied by IMS Health全球藥品銷售 1992-2003p32232362492852962973083373643960608010012014016018020019921993199419951996199719981999200020012002pYearIndexed values (1992 = 100)全球研發(fā)費(fèi)用全球新藥上市研發(fā)時間 (3 yea

3、r moving average)全球銷售全球銷售，研發(fā)費(fèi)用及研發(fā)時間和新藥上市1992-2002p4060801001201401601802001992199Research Late DevelopmentEarly DevelopmentRegulatory assessmentCommercial-isationPre-clinical evaluationClinical evaluation2.9yrs1.5yrs5.7yrsUS FDA: 1.0 yrsEMEA: 1.3 yrs Japanese MHLW: 1.4 yrsDuration(median)Attrition(N

4、umber of compounds entering stage per compound launched)911新藥 R&D 的過程Target discoveryAssay developmentLead discoveryLead optimisation5Research Late Early Regulatory11%16%44%79%0%10%20%30%40%50%60%70%80%90%100%First human dose toMarket臨床一期First patient dose toMarket臨床二期First pivotal dose toMarket臨床三期

5、Submission to market申報Success rate新藥上市的成功機(jī)率611%16%44%79%0%10%20%30%40%50%68%13%40%77%34%46%76%88%0%10%20%30%40%50%60%70%80%90%100%First human dose tomarketFirst patient dose tomarketFirst pivotal dose tomarketSubmission to marketSuccess rateChemical entitiesBiotechSuccess rate to market by product t

6、ype78%13%40%77%34%46%76%88%0%10%20Termination reasons were provided for 498 of the 538 NASs for which development was terminated between 1999 and 2001.新藥開發(fā)失敗的原因 1999-20018Termination reasons were provi目前新藥開發(fā)遇到的困境R&D成本和風(fēng)險不斷提高Pipelines becoming thinner新藥項目越來越少Increasing costs for promotion新藥上市的費(fèi)用越來越高S

7、horter product life cycles新藥產(chǎn)品周期不斷縮短Rising generic exposure非專利藥搶占市場越來越早9目前新藥開發(fā)遇到的困境9面對上述的挑戰(zhàn)，國際制藥界采取了些什么對策？10面對上述的挑戰(zhàn)，國際制藥界采取了些什么對策？10New Trends in Drug Development目前的新走向Now the classic drug discovery model is supplemented by傳統(tǒng)的新藥開發(fā)模式由下面兩種方式進(jìn)行補(bǔ)充Project in-licensing項目引進(jìn)Life Cycle Management (LCM)產(chǎn)品周期的管

8、理Outsourcing11New Trends in Drug DevelopmentMany blockbuster drugs are externally sourced許多重磅炸彈都是從其它公司引進(jìn)的。DrugLicenseeLicensorLaunched 2002 sales(mio USD)PaxilGSKNovo Nordisk19912,055PravacholBMSSankyo19902,266FosamaxMerckGentili19932,250LipitorPfizerWarner Lamb19977,972CelexaForest LabsLundbeck1998

9、1,45112Many blockbuster drugs are extRevenues from in-licensing are increasing引進(jìn)項目的產(chǎn)品銷售正在不斷提高Share of revenues from in-licensingTop 10 pharmacos* Classified products account for over 70 % of prescription revenuesSource: Analyst reports; annual reports; Pharmaprojects database; literature search; McK

10、insey analysis13Revenues from in-licensing areWhy License in/ PartneringTo complement in-house R+D efforts對公司本身R& D 的補(bǔ)充To hedge against unexpected product failure or disappointing commercial performance以防不可預(yù)期的產(chǎn)品失敗或者不佳的商業(yè)業(yè)績Increasing value of development and marketed products through arrangements wit

11、h third parties聯(lián)和開發(fā)和銷售14Why License in/ PartneringTo 項目引進(jìn)包括哪些方面In-licensing/Partnering for global development 項目引進(jìn)與聯(lián)合開發(fā)Discovery/Research Platform collaborations研究平臺的合作New drug delivery technologies新的給藥劑型Co-marketing, co-promotion聯(lián)合銷售Manufacturing relationships15項目引進(jìn)包括哪些方面15項目引進(jìn)案例 1999-2002 16項目引進(jìn)案例

12、 1999-2002 16Competitors for a given licensing dealPercent of respondentsCompetition for Deals Is Also Increasing5 years agoFewer than 33 to 55 to 8TodaySource: McKinsey survey17Competitors for a given licensCross Functional Deal TeamStandard Processes and Team WorkResearch and DevelopmentMarketingL

13、egalFinancePatentPreselectionInitialEvaluationFull EvaluationNegotiation18Cross Functional Deal TeamStanDue DiligenceObtain and review source documentation to provide a reliable evaluation of the:Scientific rationalePreclinical SafetyDrug metabolism and pharmacokineticsChemical and pharmaceutical de

14、velopmentClinical efficacy and safetyRegulatory filabilityPatent status19Due DiligenceObtain and reviewLarge Number of Opportunities Evaluated for Every Deal Closed110 Contacts65 Early Assessments17 Initial Evaluations9 Due Diligences3 Neogtiations1 Deal Closed20Large Number of Opportunities New Tre

15、nds in Drug Development目前的新走向Now the classic drug discovery model is supplemented by傳統(tǒng)的新藥開發(fā)模式由下面兩種方式進(jìn)行補(bǔ)充Project in-licensing項目引進(jìn)Life Cycle Management (LCM)產(chǎn)品周期的管理Outsourcing21New Trends in Drug DevelopmentAugmentinClaritinZestrilNeurontinFloventCipro-floxacinProcritLovenoxDuragesicDiflucanZocorPrava

16、cholZithromaxZoloftActosAmbienPaxilNeupogenNorvascFosamaxEffexorRisperdalSereventLevaquinAciphexPrevacklCeliceptTopamaxGemzarAriceptSingulairAdvair/Seretide*Only drugs with revenues of more than US $100 million per year are included. Why Life Cycle Management ?今后十年內(nèi)專利過期的新藥22AugmentinNeurontinProcrit

17、ZocorLife Cycle Management includeProlonged/Modified release dosage formsFixed combination with other drugsEnhanced bioavailabilityNew drug delivery principlesTargeted or site-specific drug delivery23Life Cycle Management include2Global Drug Delivery Market, 2001Total Drug Delivery Systems Market =

18、$42.9 billionsOralInhalationTransdermalParenteralOtherTotal Pharmaceutical Market = $350 billions24Global Drug Delivery Market, 230%11%32%19%40%26%0%10%20%30%40%50%60%70%80%90%100%Major companiesOther companiesAverage percentage of R&D expenditure by company allocated to line extensions199719992001各

19、大公司用于LCM方面的研發(fā)費(fèi)用2530%11%32%19%40%26%0%10%20%30%4Success Story of LCMThe Cardizem Story26Success Story of LCMThe CardizWellbutrin: Growth of a Blockbuster$millionNCE exclusivity expires: 2004PK half-life: 21 hours8 days to reach steady-state plasma levelWellbutrin (buproprion HCl) Story (GSK)Wellbtrin

20、 SRintroducedWellbtrin XLapproved27Wellbutrin: Growth of a BlockbWhy Develop Fixed Combination Products?New patent protectionSynergistic effectsBetter therapyPatient compliancePatient convenienceAttractive market28Why Develop Fixed CombinationNew Trends in Drug Development目前的新走向Now the classic drug

21、discovery model is supplemented by傳統(tǒng)的新藥開發(fā)模式由下面兩種方式進(jìn)行補(bǔ)充Project in-licensing項目引進(jìn)Life Cycle Management (LCM)產(chǎn)品周期的管理Outsourcing29New Trends in Drug DevelopmentOutsourcing為什么要 Outsourcing?Capacity Management 人力資源的調(diào)控 Technology/Specific expertise 新技術(shù)Strategic 戰(zhàn)略上的考慮Cost control 控制成本Deadline 時間30Outsourcin

22、g30新藥研發(fā)的費(fèi)用分布 200131新藥研發(fā)的費(fèi)用分布 200131010203040506019971998199920002001USANon-core marketsGermanyUKFranceJapanSource of patients for clinical trials 1997-2001Year enrolment completedPercentage of total patients recruited320102030405060199719981999200025.47.47.99.313.30.02.04.06.08.010.012.014.0 Respiratory (151) Anti-infectives (222) Cardiovascular system(174) Nervous system (383) Anti-cancer (342)Median duration of enrolment period (months)Impact of therapeutic area on enrolment period(n) = number of clinical studies 335.47.47.99.313.30.02.04.06.08.22%0%5%10%15%20%25%30%CMC o