全球醫(yī)藥產(chǎn)業(yè)研究與發(fā)展趨勢

1、全球醫(yī)藥產(chǎn)業(yè)研究與發(fā)展趨勢報告內(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工程引進(jìn)Life Cycle Management (LCM)產(chǎn)品周期的管理OutsourcingWhat Why and (How) ?2223236249285296297308337364396010020030040050060019921993199419951996199719981999200020012002p2003pGlobal pharmaceutical sales (US$ billion)4204450100200300400500600Year

2、p = projectionSource: Sales data for 1992-2001 supplied by IMS Health全球藥品銷售 1992-2003p30608010012014016018020019921993199419951996199719981999200020012002pYearIndexed values (1992 = 100)全球研發(fā)費用全球新藥上市研發(fā)時間 (3 year moving average)全球銷售全球銷售，研發(fā)費用及研發(fā)時間和新藥上市1992-2002p4Research Late DevelopmentEarly Developme

3、ntRegulatory assessmentCommercial-isationPre-clinical evaluationClinical evaluation2.9yrs1.5yrs5.7yrsUS FDA: 1.0 yrsEMEA: 1.3 yrs Japanese MHLW: 1.4 yrsDuration(median)Attrition(Number of compounds entering stage per compound launched)911新藥 R&D 的過程Target discoveryAssay developmentLead discoveryLead

4、optimisation511%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Submission to market申報Success rate新藥上市的成功機率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 tomarke

5、tFirst pivotal dose tomarketSubmission to marketSuccess rateChemical entitiesBiotechSuccess rate to market by product type7Termination 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 1999-20018目前新藥開發(fā)遇到的困境R&D本錢和風(fēng)險不斷提高Pipelines becomin

6、g thinner新藥工程越來越少Increasing costs for promotion新藥上市的費用越來越高Shorter 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)行補充Project in-licensing工程引進(jìn)Life Cycle

7、 Management (LCM)產(chǎn)品周期的管理Outsourcing11Many 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 LabsLundbeck19981,45112

8、Revenues from in-licensing are increasing引進(jìn)工程的產(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; McKinsey analysis13Why License in/ Partn

9、eringTo complement in-house R+D efforts對公司本身R& D 的補充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 with third parties聯(lián)和開發(fā)和銷售14工程引進(jìn)包括哪些方面In-licensing/Partnering for globa

10、l development 工程引進(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工程引進(jìn)案例 1999-2002 16Competitors for a given licensing dealPercent of respondentsCompetition for Deals Is Also Increasing5 years agoFew

11、er than 33 to 55 to 8TodaySource: McKinsey survey17Cross Functional Deal TeamStandard Processes and Team WorkResearch and DevelopmentMarketingLegalFinancePatentPreselectionInitialEvaluationFull EvaluationNegotiation18Due DiligenceObtain and review source documentation to provide a reliable evaluatio

12、n of the:Scientific rationalePreclinical SafetyDrug metabolism and pharmacokineticsChemical and pharmaceutical developmentClinical efficacy and safetyRegulatory filabilityPatent status19Large Number of Opportunities Evaluated for Every Deal Closed110 Contacts65 Early Assessments17 Initial Evaluation

13、s9 Due Diligences3 Neogtiations1 Deal Closed20New 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)行補充Project in-licensing工程引進(jìn)Life Cycle Management (LCM)產(chǎn)品周期的管理Outsourcing21AugmentinClaritinZestrilNeurontinFloventCipro-floxacinProcritLovenoxDura

14、gesicDiflucanZocorPravacholZithromaxZoloftActosAmbienPaxilNeupogenNorvascFosamaxEffexorRisperdalSereventLevaquinAciphexPrevacklCeliceptTopamaxGemzarAriceptSingulairAdvair/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22Li

15、fe Cycle Management includeProlonged/Modified release dosage formsFixed combination with other drugsEnhanced bioavailabilityNew drug delivery principlesTargeted or site-specific drug delivery23Global Drug Delivery Market, 2001Total Drug Delivery Systems Market = $42.9 billionsOralInhalationTransderm

16、alParenteralOtherTotal Pharmaceutical Market = $350 billions2430%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各大公司用于LCM方面的研發(fā)費用25Success Story of LCMThe Cardizem Story26Wellbutrin

17、: Growth of a Blockbuster$millionNCE exclusivity expires: 2004PK half-life: 21 hours8 days to reach steady-state plasma levelWellbutrin (buproprion HCl) Story (GSK)Wellbtrin SRintroducedWellbtrin XLapproved27Why Develop Fixed Combination Products?New patent protectionSynergistic effectsBetter therap

18、yPatient compliancePatient convenienceAttractive market28New 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)行補充Project in-licensing工程引進(jìn)Life Cycle Management (LCM)產(chǎn)品周期的管理Outsourcing29Outsourcing為什么要 Outsourcing?Capacity Management 人力資源的調(diào)控 Techn

19、ology/Specific expertise 新技術(shù)Strategic 戰(zhàn)略上的考慮Cost control 控制本錢Deadline 時間30新藥研發(fā)的費用分布 200131010203040506019971998199920002001USANon-core marketsGermanyUKFranceJapanSource of patients for clinical trials 1997-2001Year enrolment completedPercentage of total patients recruited325.47.47.99.313.30.02.04.06.08.010.012.014.0 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 3322%0%5%10%15%20%25%30%CMC outsourci