全球制药行业外包情况分析报告-培训课件外文版2024.5印度仿制药

INDUSTRIES

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MARKETSOutsourcinginthepharmaceuticalindustryCHAPTER

01OverviewRevenueoftheworldwidepharmaceuticalmarketfrom2001to2022(inbillionU.S.dollars)Pharmaceuticalmarket:worldwiderevenue2001-20221,6001,4001,2001,0001,4821,4501,3121,2781,204.81,135.11,115.71,073.11,063.6993.8963.2

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20223Description:Theglobalpharmaceuticalmarkethasexperiencedsignificantgrowthinrecentyears.For2022,thetotalglobalpharmaceuticalmarketwasestimatedat1.48trillionU.S.dollars.Thisisaonlyaslightincreasefrom2021whenthemarketwasvaluedat1.42trillionU.S.dollars.Thepharmaceuticalmarketplaysakeyroleinhowpeoplegetmedicationsandwhatpeoplepayformedication.However,somemarketsarebetterforpharmaceuticalcompaniesthanothers.

ReadmoreNote(s):WorldwideSource(s):IQVIATotalglobalspendingonpharmaceuticalresearchanddevelopmentfrom2014to2028(inbillionU.S.dollars)TotalglobalpharmaceuticalR&Dspending2014-20283503002503022962892812722622492442111942001501005018517116115114502014201520162017201820192020202120222023*202420252026202720284Description:In2022,researchanddevelopmentspendinginthepharmaceuticalindustrytotaledsome244billionU.S.dollarsglobally.Forcomparison,R&Dexpenditurestotaled137billiondollarsin2012.PharmaceuticalR&Dincludesallstepsfromtheinitialresearchofdiseaseprocesses,thecompoundtestingoverpre-clinical,andallclinicaltrialstages.Atacertainpointintheprocess-mostlyduringthepre-clinicalphase-agovernmentalauthorityisinvolvedtooverview,regulate,andultimately[...]

ReadmoreNote(s):Worldwide;asofAugust2023;*Allvaluesareprojectedfrom2023on.ReadmoreSource(s):EvaluateLeading50globalpharmaceuticalcompaniesbyprescriptionsalesandR&Dspendingin2022(inbillionU.S.dollars)Top50pharmaceuticalcompanies-RxsalesandR&Dspending2022Sales/spendinginbillionU.S.dollarsResearchanddevelopmentspending20

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6001070809010012.38Pfizer(U.S.)AbbVie(U.S.)91.36.4456.1814.14Johnson&Johnson(U.S.)Novartis(Switzerland)Merck&Co.(U.S.)Roche(Switzerland)BristolMyersSquibb(U.S.)AstraZeneca(UK)Sanofi(France)50.179.0950.0849.6311.8414.7847.9145.4210.029.57.166.344.74.974340.3538.25GSK(UK)Takeda(Japan)GileadSciences(U.S.)29.6926.625Description:Thetop50pharmaceuticalcompaniesbyprescriptionsalesin2022-andtheirresearchanddevelopment(R&D)spending-includedbignamessuchasPfizer,Novartis,andAbbVie.Duringthatyear,Pfizer'sRxsaleswereapproximately91billiondollars.Thus,theAmericanpharmagiantwasboththelargestpharmaceuticalcompanybasedonpurepharmarevenueworldwideandthethirdrankedpharmaceuticalcompanybasedonR&Dspending.Pfizerspent12.38billionU.S.dollarson[...]

ReadmoreNote(s):WorldwideSource(s):Evaluate(EvaluatePharma);PharmaceuticalExecutive;Varioussources(companydata)Distributionofin-houseandoutsourcingservicesexpenditureintheglobalpharmaceuticalmarketfrom2014to2023Globalpharmaceuticalmarketin-housevsoutsourcingservicesshare2014-2023OutsourcingIn-house120%100%80%60%40%20%0%50.7%53.2%55.8%58.3%60.5%63.5%62.3%63.7%66.3%65.2%49.3%2023*46.8%2022*44.2%2021*41.7%2020*39.5%2019*36.5%201737.7%201836.3%201633.7%201434.8%20156Description:Throughoutthegivenperiod,thepercentageofin-housespendingisexpectedtodecreasefrom66.3percentin2014toalmost51percentin2023.Thisstatisticshowsthepercentdistributionofin-houseandoutsourcingservicesexpenditureintheglobalpharmaceuticalmarketfrom2014to2023.ReadmoreNote(s):Worldwide;asofMarch2019;*Forecasted.ReadmoreSource(s):Frost&Sullivan;HKExnewsSelectactivitiesoutsourcedbybiopharmaceuticalcompaniesasof2022Selectactivitiesoutsourcedbybiopharmaceuticalcompanies2022Percentageofcompanies0%10%20%30%40%50%60%70%80%90%87%100%Analyticaltesting:otherbioassaysTesting:toxitytesting79%76%73%ValidationservicesTesting:productcharacterizationTesting:celllinestabilityContractresearch(laboratory)Testing:lotrelease67%66%65%64%Fill/finishoperationsPlantmaintenanceservicesTesting:hostcellproteinanalysisGMPtraining64%64%63%7Description:Accordingtoastudyfrom2022,whenaskedaboutoutsourcingatleastsomeactivities,some87percentofbiopharmaceuticalmanufacturersnamedanalyticaltestingofotherbioassaysasthemaincategoryforoutsourcing.Thisstatisticshowsselectactivitiesoutsourcedbybiopharmaceuticalcompanies,asof2022.ReadmoreNote(s):Worldwide;asofApril2022Source(s):BioPlan;BioprocessOnlineCHAPTER

02CROsTotalenterprisevalueofselecttopcontractresearchorganizationsasof2022(inmillionU.S.dollars)Enterprisevalueoftopcontractpharmaresearchorganizations2022TotalenterprisevalueinmillionU.S.dollars10,000

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25,00005,00030,00035,00040,00045,00050,00049,34855,000IQVIAHoldingsInc.LaboratoryCorporationofAmericaHoldingsICONPublicLimitedCompany26,82620,267CharlesRiverLaboratoriesInternational,Inc.MedpaceHoldings,Inc.14,2896,855SyneosHealth,Inc.6,6369Description:Thisstatisticshowsthetotalenterprisevalueoftoppharmaceuticalcontractresearchorganizations(CROs)asofDecember31,2022.Atthistime,U.S.-basedcompanySyneosHealthInc.hadaTEVofsome6.6billionU.S.dollars.

ReadmoreNote(s):Worldwide;asofDecember31,2022Source(s):HarrisWilliams;S&PCapitalIQLeadingglobalcontractresearchorganizations(CROs)basedon2022revenue(inmillionU.S.dollars)Leadingglobalcontractresearchorganizationsbasedonrevenue2022RevenueinmillionU.S.dollars5,000

10,0000ThermoFisherScientific*15,00020,00025,00022,511LaboratoryCorp.ofAmericaHoldings(incl.Covance)IQVIA(QuintilesIMSHoldings)14,87714,410IconPublicLimitedCorp.7,741WuxiApptec**6,1005,393SyneosHealthCharlesRiverLaboratoriesInternational,Inc.3,976ParexelInternationalCorp.**MedpaceHoldings,Inc.2,5001,46010Description:In2022,theleadingcontractresearchorganizationsworldwideincludedLaboratoryCorporationofAmericaHoldings,ThermoFisherScientific,andIQVIA.Thesecondrankedcompany,LaboratoryCorporationofAmericaHoldingshadnearly15billionU.S.dollarsinrevenueduringthatyear.Comparatively,thefirstrankedcompanyThermoFisherScientific,whichrecentlyacquiredPharmaceuticalProductDevelopment(PPD),generated22.5billionU.S.dollarsinrevenuethroughitsclinical[...]

ReadmoreNote(s):Worldwide;*OnlyLaboratoryProducts&BiopharmaServicessegment.**Estimated.ReadmoreSource(s):VarioussourcesGlobalcontractresearchorganization(CRO)marketin2023and2028(inbillionU.S.dollars)CROmarketsizeworldwideforecast202814012010080127.376.660402002023(estimated)2028(projected)11Description:For2023,itisestimatedthattheglobalCROmarketwillreachsome77billionU.S.dollarsworldwide.Thisstatisticshowsthemarketsizeofcontractresearchorganizations(CROs)globally2023andaforecastfor2028,inbillionU.S.dollars.

ReadmoreNote(s):Worldwide;asofFebruary2023Source(s):MarketsandMarketsLargestdealsincludingcontractresearchorganizations(CROs)asof2023(inmillionU.S.dollars)Topcontractresearchorganizationtransactiondealsuntil2023DealvalueinmillionU.S.dollars5,000

10,0000ThermoFisher(PPD)15,00020,00025,00020,881ICON(PRAHealthSolutions)12,277Investmentconsortium(SyneosHealth)7,374IQVIA(Q2Solutions)TrileyBidco(Clinigen)*1,9001,590875CharlesRiverLabs(CognateBioServices)CharlesRiverLabs(MPIResearch)Eurofins(Covance)800670545510Inotiv(Envigo)*CharlesRiverLabs(Citoxlab)12Description:AsofMay2023,ThermoFisher'sacquisitionofPPDhasbeenthelargestM&Adealincludingcontractresearchorganizations,valuedataround21billionU.S.dollars.Thisstatisticshowsthelargestdealsincludingcontractresearchorganizations(CROs),basedonvalue.ReadmoreNote(s):Worldwide;asofMay2023Source(s):GlobalData;S&PCapitalIQ;CHAPTER

03CDMOs/CMOsTotalenterprisevalueofselectcontractdevelopmentandmanufacturingorganizationsasof2022(inmillionU.S.dollars)Valueofselectcontractpharmamanufacturingcompanies202250,00046,00845,00040,00035,00030,00025,00020,00015,00010,0005,00036,35434,7628,1002,8170SamsungBiologicsCo.,Ltd.LonzaGroupAGWuXiAppTecCo.,Ltd.Catalent,Inc.SiegfriedHoldingAG14Description:Thisstatisticdepictsthetotalenterprisevalueofselectcontractdevelopmentandmanufacturingcompanies,asofDecember31,2022.Atthispoint,CatalentInc.hadatotalenterprisevalueofsome8.1billionU.S.dollars.Acontractdevelopmentandmanufacturingorganization(CDMO)isabletotakeoversomepartsofapharmaceuticalcompany,whichcouldincludeanyservicefromdrugdevelopmenttodrugmanufacturing.ReadmoreNote(s):Worldwide;asofDecember31,2022Source(s):HarrisWilliams;S&PCapitalIQContractdevelopmentandmanufacturingorganization(CDMO)marketforecastworldwidefrom2020to2030(inbillionU.S.dollars)CDMOmarketsizeworldwideforecast2020-2030250223.5208.4194.420015010050181.2169157.6140.8139.6132.3124115.502020202120222023202420252026202720282029203015Description:Thisstatisticshowsthesizeofthe(pharmaceutical)contractdevelopmentandmanufacturingorganizations(CDMOs)marketworldwide,projectedfortheperiodfrom2020to2030.By2030,theglobalCDMOmarketisexpectedtoexceed220billionU.S.dollars.ReadmoreNote(s):Worldwide;asofMay2023Source(s):Alvarez&Marsal;GrandViewResearch;VarioussourcesContractdevelopmentandmanufacturingorganization(CDMO)marketforecastworldwidefrom2020to2030,bytype(inbillionU.S.dollars)CDMOmarketsizeworldwideforecastbytype2020-2030API/bulkdrugsDrugproductmanufacturing(incl.dosage&formulationdevelopment)Packaging2502001501005027.354.725.650.623.946.922.320.940.219.537.743.417.333.217.132.716.215.214.127.231.229.279.62021141.52030132.32029123.62028115.52027108100.9202590.389.884.974.202020202220232024202616Description:Thisstatisticshowsthesizeofthe(pharmaceutical)contractdevelopmentandmanufacturingorganizations(CDMOs)marketworldwide,projectedfortheperiodfrom2020to2030.By2030,theglobalCDMOmarketisexpectedtoexceed220billionU.S.dollars.ReadmoreNote(s):Worldwide;asofMay2023Source(s):Alvarez&Marsal;GrandViewResearch;VarioussourcesShareofcontractdevelopmentandmanufacturingorganizations(CDMOs)worldwidebymodalityandregionasof2022ShareofCDMOsworldwidebymodalityandregion2022SmallmoleculesLargemolecules92%Advancedtherapies100%90%80%70%60%50%40%30%20%10%0%88%83%79%69%63%50%41%33%NorthAmericaEuropeAsia17Description:Thisstatisticshowsthedistributionoftheleadingglobal(pharmaceutical)contractdevelopmentandmanufacturingorganizations(CDMOs),accordingtoa2022study,bymodalityandregion.InEurope,some41percentofleadingCDMOswereinvolvedinthedevelopmentand/ormanufacturingofadvancedtherapies.ReadmoreNote(s):Worldwide;asof2022;150majorCDMOsSource(s):Strategy&Shareofcontractdevelopmentandmanufacturingorganizations(CDMOs)worldwidebyvaluechainserviceandregionasof2022ShareofCDMOsworldwidebyvaluechainserviceandregion2022DevelopmentDrugsubstance84%DrugproductPackaging100%90%80%70%60%50%40%30%20%10%0%92%92%74%70%70%69%67%65%62%58%48%NorthAmericaEuropeAsia18Description:Thisstatisticshowsthedistributionoftheleadingglobal(pharmaceutical)contractdevelopmentandmanufacturingorganizations(CDMOs),accordingtoa2022study,byservicealongthevaluechainandregion.InEurope,84percentofleadingCDMOswereinvolvedinthedevelopmentofdrugs.ReadmoreNote(s):Worldwide;asof2022;150majorCDMOsSource(s):Strategy&CHAPTER

04CDMOdealsLeadingCDMOcompaniesbasedonnumberofM&Adealsbetween2017and2021TopCDMOcompaniesbynumberofM&Adeals2017-2021Numberofacquisitions40Catalent(U.S.)26810121214CharlesRiverLaboratoriesInternational(U.S.)ThermoFisherScientific(U.S.)LonzaGroupAG(Switzerland)WuXiApptech(China)9887EurofinsScientific(Netherlands)DelpharmHolding(France)Evotec(Germany)654DanaherCorp.(U.S.)33PiramalEnterprises(India)20Description:Thisstatisticshowstheleading(pharmaceutical)contractdevelopmentandmanufacturingorganizations(CDMOs)worldwidebasedonnumberofM&Adealsbetween2017and2021.Inthisperiod,U.S.-basedCatalentwastheleadingcompany,actingin12dealsworldwideasacquirer.ReadmoreNote(s):WorldwideSource(s):EY-Parthenon;S&PCapitalIQ;VarioussourcesNumberofCDMOmergerandacquisitiondealsworldwidefrom2012to2021NumberofCDMOmergerandacquisitiondealsworldwide2012-2021100938990807060504030201007776686563443930201220132014201520162017201820192020202121Description:ThisstatisticshowsthenumberofM&Adealsinthe(pharmaceutical)contractdevelopmentandmanufacturingorganization(CDMO)industryworldwidefrom2012to2021.In2021,therewere68M&AtransactionsintheCDMOmarket.ReadmoreNote(s):WorldwideSource(s):EY-Parthenon;S&PCapitalIQ;VarioussourcesValueofCDMOmergerandacquisitiondealsworldwidefrom2012to2021(inbillionU.S.dollars)ValueofCDMOmergerandacquisitiondealsworldwide2012-2021454035302520154222161211910587530201220132014201520162017201820192020202122Description:ThisstatisticshowsthevalueofM&Adealsamong(pharmaceutical)contractdevelopmentandmanufacturingorganizations(CDMOs)worldwidefrom2012to2021.In2021,dealsintheCDMOindustrypeakedtoabout42billionU.S.dollars.

ReadmoreNote(s):WorldwideSource(s):EY-Parthenon;S&PCapitalIQ;VarioussourcesNumberofCDMOmergerandacquisitiondealsworldwidebetween2017and2021,bycountryNumberofCDMOmergerandacquisitiondealsworldwidebycountry2017-2021120971008060402001715141412119887443323Description:ThisstatisticshowsthedistributionofthenumberofM&Adealsinthe(pharmaceutical)contractdevelopmentandmanufacturingorganization(CDMO)industryworldwidebetween2017and2021,bycountry.Inthatperiod,97CDMOM&AtransactionstookplaceintheUnitedStates.ReadmoreNote(s):WorldwideSource(s):EY;EY-Parthenon;VarioussourcesValueofCDMOmergerandacquisitiondealsworldwidebetween2017and2021,bycountry(inbillionU.S.dollars)ValueofCDMOmergerandacquisitiondealsworldwidebycountry2017-2021ValueinbillionU.S.dollars010203040506070UnitedStatesSwitzerlandSweden66.284.743.36DenmarkUnitedKingdomBelgiumIndia1.481.341.310.75GermanyChinaSouthKoreaCanada0.730.710.460.430.310.190.170.16ItalyFranceIrelandIsrael24Description:ThisstatisticshowsthedistributionofthevalueofM&Adealsinthe(pharmaceutical)contractdevelopmentandmanufacturingorganization(CDMO)industryworldwidebetween2017and2021,byregion.Forthatperiod,internalCDMOM&AtransactionsintheUnitedStateswerevaluedatover66billionU.S.dollars.ReadmoreNote(s):WorldwideSource(s):EY;EY-Parthenon;VarioussourcesCHAPTER

05TrendsPercentageofpreferredoutsourcingmodelsinclinicaldevelopmentamongbiopharmaceuticalcompaniesworldwideasof2023,bycompanysizePreferredoutsourcinginclinicaldevelopmentamongbiopharmacompaniesbysize2023Full-serviceFunctionalserviceprovider(FSP)HybridOther120%100%80%60%40%20%0%6%8%10%22%26%31%27%27%26%41%39%37%TotalLargeSmall/mid26Description:Accordingtoasurveyconductedin2023,nearly40percentofsurveyedbiopharmaexecutivesstatedthatthefull-servicemodelisthepreferredoutsourcingmodelfortheirclinicaldevelopmentwork.Thisstatisticdescribesthedistributionofpreferredoutsourcingmodelsinclinicaldevelopmentamongbiopharmaceuticalcompaniesworldwide,bythesizeofthecompany.ReadmoreNote(s):Worldwide;MarchandApril2023;150executives;respondentsfromlargecompanies:n=65,fromsmall/mid:n=85Source(s):LifeScienceStrategyGroup;ThermoFisher(PPD)Percentageofoutsourcingmodelsinclinicaldevelopmentamongbiopharmaceuticalcompaniesworldwideasof2023,bycompanysizeOutsourcinginclinicaldevelopmentamongglobalbiopharmacompaniesbysize2023Insourcing/temp.staffHybridFunctionalserviceprovider(FSP)Full-service120%100%80%60%40%20%0%35%38%40%27%22%26%23%25%23%17%13%11%TotalLargeSmall/mid27Description:Accordingtoasurveyconductedin2023,38percentofbiopharmaexecutiveswhosecompaniesareoutsourcingstatedthatthefull-servicemodelistheircurrentoutsourcingmodelofclinicaldevelopmentwork.Thefull-servicemodelwasmorecommonamongsmallandmid-sizedcompanies(40percent)thanamonglargecompanies(35percent).Thisstatisticdescribesthedistributionofoutsourcingmodelsinclinicaldevelopmentamongbiopharmaceuticalcompaniesworldwide,bysize[...]

ReadmoreNote(s):Worldwide;MarchandApril2023;150executives;respondentsfromlargecompanies:n=65,fromsmall/mid:n=85Source(s):IndustryStandardResearch;ThermoFisher(PPD)Likelihoodofoutsourcingselectdrugdevelopmentactivitiesinthenext2yearsamongbiopharmaceuticalcompaniesworldwideasof2023Likelihoodofoutsourcingdrugdevelopmentactivitiesbybiopharmacompanies2023PercentageofrespondentsExtremelylikely20%Verylikely30%0%10%40%50%60%70%80%PatientrecruitmentClinicallaboratoryanddiagnosticservicesClinicaltrialmanagementRWD/RWE39%42%35%30%28%31%36%31%Medicalwriting25%23%20%22%20%21%20%33%34%36%