日本制药工业市场前景及投资研究报告-培训课件外文版2024.4

POLITICS

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SOCIETYPharmaceuticalindustryinJapanCHAPTER

01OverviewDistributionofglobalpharmaceuticalmarketrevenuefrom2010to2022,byregionGlobalpharmaceuticalmarket-revenuedistribution2010-2022,byregionNorthAmerica(U.S.,Canada)Europe*Africa,Asia&Australia**ChinaJapanLatinAmerica60%50%40%30%20%10%0%20102011201220132014201520162017201820192020202120224Description:In2022,theNorthAmericanregionaccountedforoverhalfofthepharmaceuticalmarketrevenueworldwide.Since2010,NorthAmerica`srevenuesharehasincreasedby10percent,whileJapan`ssharehasdecreasedbynearlysixpercent.

ReadmoreNote(s):WorldwideSource(s):EFPIA;IQVIANumberofmedicaldrugmanufacturingplantsinJapanin2021,byproductionvalueNumberofmedicaldrugmanufacturingplantsJapan2021,byproductionvalue2502001501005023820017216314912271660Under1millionJPY

1tolessthan5millionJPY5tolessthan10

10tolessthan50

50tolessthan100

100tolessthan

500milliontoless

1billionJPYandmillionJPY

millionJPY

millionJPY

500millionJPY

than1billionJPY

moreMonthlyproductionvalueonaverage5/statistics/1223235/japan-number-drug-manufacturing-plants-by-production-valueIn2021,therewere238drugmanufacturingplantsinJapanwithamonthlyproductionvalueofonetolessthanfivemillionJapaneseyen.Inthesameyear,163manufacturersreportedadrugproductionvalueofonebillionyenandmoreonaverage.ReadmoreNote(s):Japan;2021;manufacturesthathadmanufacturedgoodsduringtheperiodSource(s):MHLW(Japan)VolumeshareofgenericsintheprescriptiondrugmarketinJapanfrom2005to2022VolumeshareofgenericsinprescriptiondrugmarketJapan2005-202285%75%65%55%79%79%78.3%76.7%72.6%65.8%56.2%46.9%45%35%25%39.9%201135.8%200934.9%200732.5%2005201320152017201820192020202120226Description:ThevolumeshareofgenericsintheJapaneseprescriptiondrugsmarketstoodataround79percentasofSeptember2022,upfromabout32.5percentin2005.ThehealthministryinJapandidnotmeetthesetgoalofgenericdrugusageof80percent,whichwastobeachievedbySeptember2020.ReadmoreNote(s):Japan;2005to2022;asofSeptemberSource(s):JPWA;MHLW(Japan)MedianapprovaltimeofnewdrugsinJapanfrom2003to2022,byproducttype(inmonths)MedianapprovaltimeofnewdrugsJapan2003-2022,bytypeAllproductsPriorityreveiwproductsStandardreviewproducts302625.2125201510521.719.321.720.121.618.821.320.617.820.119.118.917.915.715.513.112.912.611.911.710.9108.810.810.910.89.810.91110.99.98.810.61010.6810.58.26.610.41100.

110.28.410.189.98.19.87.99.79.69.459.28.78.47.95.802002

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2021

2022YearforNewDrugApplication(NDA)7Description:In2022,themedianapprovaltimeofnewdrugsinJapanwasabout5.8months,indicatingasignificantdecreasecomparedtorecentyears.Thatyear,ittookaround5.8monthsforproductsinthelistofstandardreviewstobeapproved,includingacceleratedapprovalproducts.ReadmoreNote(s):Japan;2003to2022;productsthatwereapprovedfrom2003to2022Source(s):JapanPharmaceuticalManufacturersAssociation;PMDACHAPTER

02ProductionProductionvalueofpharmaceuticaldrugsinJapanfrom2012to2021(intrillionJapaneseyen)ProductionvalueofpharmaceuticaldrugsJapan2012-20211099.499.269.1886.986.896.916.756.72765432106.596.6220122013201420152016201720182019202020219Description:ThetotalproductionvalueofmedicaldrugsinJapanamountedtoapproximately9.2trillionJapaneseyenin2021,adecreasefromaround9.3trillionyeninthepreviousyear.Prescriptiondrugsrepresentthestapleproductsofthemedicaldrugmarket,accountingforalmost92percentoftheannualproductionvalue.ReadmoreNote(s):Japan;2012to2021Source(s):MHLW(Japan)DistributionofthepharmaceuticaldrugproductionvalueinJapanfrom2012to2021,bytypeShareofdrugproductionvalueJapan2012-2021,bytypePrescriptiondrugsOthermedicines10.6%120%100%8.7%8.5%8.2%10.2%89.8%10.2%89.8%10.9%89.1%11.1%11.4%88.6%201610.6%89.4%80%60%40%20%0%91.3%91.5%91.5%88.9%89.4%20122013201420152017201820192020202110Description:In2021,prescriptionmedicinesinJapanaccountedforaround92percentofthetotaldrugproductionvalueinJapan.Therestofapproximatelyeightpercentwasgeneratedbyothermedicinessuchasover-the-counter(OTC)medicinesandhouseholdmedicines,whicharestoredandkeptathome.ReadmoreNote(s):Japan;2012to2021Source(s):MHLW(Japan)DistributionofthepharmaceuticaldrugproductionvalueinJapanin2021,bymaintherapeuticcategoryofdrugsShareofdrugproductionvalueJapan2021,bycategoryShareofproductionvalue4%

6%0%2%8%10%12%14%16%OtheragentsaffectingmetabolismAntineoplastics14.6%14.1%CentralnervoussystemagentsCardiovascularagents10.2%9.8%BloodandbodyfluidagentsBiologicalpreparations6.7%6.1%5.9%DigestiveorganagentsExtracorporealdiagnosticagentsDermatologicpreparationsSensoryorganagents5%4.6%3.2%3%Hormones(includingantihormones)TraditionalChinesemedicinesChemotherapeutics2.1%2%11Description:In2021,otheragentsaffectingmetabolismaccountedforthelargestsharewitharound14.6percentofthetotaldrugproductionvalueinJapan.Thatyear,theproductionvalueoftheseagentsformetabolismamountedtoapproximately1.3trillionJapaneseyen.ReadmoreNote(s):Japan;2021Source(s):MHLW(Japan)DistributionofthepharmaceuticaldrugproductionvalueinJapanin2021,bydrugformShareofdrugproductionvalueJapan2021,bydrugformProductionvalueshare10%

15%

20%0%5%25%30%35%40%45%44.5%50%TabletsInjectablesolutionsCapsules15.6%6.2%5%3.6%3.1%2.2%TopicalsolutionsPowdersandgranules,etcInjectablepowdersPlasters,cataplasmsanddermatologicpastesOintmentsandcreams2.1%1.8%OralliquidpreparationsAerosols0.3%Pills

0.1%Suppositories

0.1%Others15.4%12Description:In2021,theproductionvalueoftabletsaccountedforthelargestsharewith44.5percentofthetotalproductionvalueinthepharmaceuticalindustryinJapan.Injectablesolutionsfollowedat15.6percent.ReadmoreNote(s):Japan;2021Source(s):MHLW(Japan)ProductionvalueofprescriptiondrugsinJapanfrom2012to2021(intrillionJapaneseyen)ProductionvalueofprescriptiondrugsJapan2012-20211098.668.488.43876.266.196.1766.015.875.876543210201220132014201520162017201820192020202113Description:In2021,theproductionvalueofprescriptiondrugsinJapanamountedtoapproximately8.4trillionJapaneseyen,adecreaseofabout0.6percentcomparedtothepreviousyear.Theproductionvalueofover-the-counterdrugsreachednearly749billionyenin2021.ReadmoreNote(s):Japan;2012to2021Source(s):MHLW(Japan)CHAPTER

03SalesWholesalevalueofpharmaceuticalproductsinJapanfromfiscalyear2015to2021(intrillionJapaneseyen)WholesalevalueofpharmaceuticalsJapanFY2015-2021109.239.128.98.928.938.98.79876543210201520162017201820192020202115Description:Inthefiscalyear2021,thewholesalevalueofpharmaceuticalproductsinJapanamountedtoapproximately8.9trillionJapaneseyen,increasedfromaround8.7trillionyeninthepreviousfiscalyear.Prescriptiondrugsaccountedfor96percentofoverallpharmaceuticalwholesalesinthenationinfiscal2021.ReadmoreNote(s):Japan;fiscalyear2015to2021;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyearSource(s):Crecon;JPWAWholesalesvalueofpharmaceuticalsinJapaninfiscalyear2021,bycategory(inbillionJapaneseyen)WholesalesvalueofpharmaceuticalsJapanFY2021,bycategoryWholesalesvalueinbillionJapaneseyen02,0004,0006,0008,00010,00012,00014,000Medicalprescriptiondrugs(includinggenericdrugs)Genericdrugs12,121.791,059.31Rawmaterialsandother586.78InVitroDiagnostics(IVD)reagentsOver-the-counterdrugs499.59314.8216Description:Inthefiscalyear2021,medicalprescriptiondrugswerethelargestcategorywithregardtothewholesaleofpharmaceuticalsinJapan,accountingforasalesvalueofapproximately12.1trillionJapaneseyen.Thatyear,thetotalwholesalevalueofpharmaceuticalsatpharmaceuticalwholesalecompaniesinJapanamountedtoaround13.5trillionyen.ReadmoreNote(s):Japan;fiscalyear2021;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyear;excluding9companiesthatdonothavesalesfiguresforpharmaceuticalwholesaleSource(s):MHLW(Japan);StatisticsBureauofJapanDistributionofethicalpharmaceuticalsandover-the-counter(OTC)medicationwholesalesinJapanfromfiscalyear2012to2021ShareofprescriptionandOTCdruginwholesaleJapanFY2012-2021PrescriptionOver-the-counter(OTC)120%100%80%60%40%20%0%3.7%3.8%3.9%3.8%4.2%4.4%4.4%4.4%4.1%4%96.3%96.2%96.1%96.2%95.8%95.6%95.6%95.6%95.9%96%201220132014201520162017201820192020202117Description:Inthefiscalyear2021,prescriptiondrugsaccountedforthemajorityoftotalpharmaceuticalwholesalesinJapan.OTCdrugsaccountedforfourpercentofpharmawholesalesinthesameyear.

ReadmoreNote(s):Japan;fiscalyear2012to2021;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31Source(s):Crecon;JPWASalesvalueofmedicineofpharmaceuticalmanufacturersandsellersinJapaninfiscalyear2021,byproducttype(inbillionJapaneseyen)PharmasalesvalueofmanufacturersandsellersJapanFY2021,byproducttypeSalesvalueinbillionJapaneseyen02,0004,0006,0008,00010,00012,00014,000Medicalprescriptiondrugs(includinggenericdrugs)Genericdrugs11,625.771,290.391,069.91InVitroDiagnostic(IVD)reagentsOver-the-counterdrugs(includinghomemedications)Rawmaterialsandothers674.56322.24Homemedications

6.4418Description:Infiscalyear2021,medicalprescriptiondrugswerethelargestproducttypewithregardtothesalesvalueofmedicineofJapanesepharmaceuticalmanufacturersandsellers,accountingforasalesvalueofapproximately11.6trillionJapaneseyen.Thatyear,thetotalsalesvalueofmedicineofpharmaceuticalmanufacturersandsellersamountedtoaround13.7trillionyen,includingoverseassales.ReadmoreNote(s):Japan;fiscalyear2021;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyear;excluding28companiesthathavenotenteredpharmaceuticalsalesbyproducttype;includingoverseassalesSource(s):MHLW(Japan);StatisticsBureauofJapanSalesvalueofmedicineofpharmaceuticalmanufacturersandsellersfromJapaninfiscalyear2021,bysalesregion(inbillionJapaneseyen)PharmasalesvalueofmanufacturersandsellersJapanFY2021,bysalesregionSalesvalueinbillionJapaneseyen01,0002,0003,0004,0005,0006,0007,0008,0009,00010,000JapanAmericas8,682.543,484.16Europe1,256.85Asia(excludingJapan)Others824.04767.1919Description:Inthefiscalyear2021,JapanwasthelargestregionwithregardtothesalesvalueofmedicineofJapanesepharmaceuticalmanufacturersandsellers,accountingforasalesvalueofapproximately8.7trillionJapaneseyen.Thatyear,thetotalsalesvalueofmedicineofpharmaceuticalmanufacturersandsellersamountedtoaround15trillionyen.ReadmoreNote(s):Japan;fiscalyear2021;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyear;excluding21companiesthathavenotenteredpharmaceuticalsalesbyregionSource(s):MHLW(Japan);StatisticsBureauofJapanCHAPTER

04SalesofprescriptiondrugsSalesvalueoftheprescriptiondrugmarketinJapanfrom2003to2022(intrillionJapaneseyen)PrescriptiondrugmarketsizeJapan2003-20221210.9410.6

10.6310.6310.610.5210.3410.379.989.85109.489.558.858.878.258.057.757.7864207.27.062003

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2021

202221Description:In2022,theJapaneseprescriptiondrugmarketwasvaluedatmorethan10.9trillionJapaneseyen,thehistoricallyhighestvalue.Themarketsizeexpandedbynearlyfourtrillionyenthroughoutthepasttwodecades.

ReadmoreNote(s):Japan;2003to2022Source(s):IQVIADistributionofprescriptiondrugsalesinJapanfromfiscalyear2012to2021,bychannelShareofprescriptiondrugsalesJapanFY2012-2021,bychannelLargesizedhospitalsSmallandmediumsizedhospitalsClinicsPharmaciesanddrugstores120%100%80%60%40%20%0%51.3%52%52.6%52.8%52.6%52.1%51.6%51.7%51.5%53.5%16.3%5.7%16.2%5.6%15.6%5.4%16.8%5.8%19.8%6.9%19.8%6.7%18.8%6.6%17.9%6.1%17.8%6%18%6.3%26.5%201926.6%202027.5%202125.3%201821.9%201221.5%201322.1%201422.3%201523.2%201623.6%201722Description:Inthefiscalyear2021,with51.5percent,themajorityofpharmaceuticalproductsinJapanweresoldatdrugstoresandpharmacies.Large-sizedhospitalsrecordedashareofaround27.5percentintheoverallpharmaceuticalsales,thehighestamongmedicalservicefacilitiesinthecountry.ReadmoreNote(s):Japan;fiscalyears2012to2021;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31;largesizehospitals=over200beds;smallandmediumsizedhospitals=20-199beds;clinics=lessthan20bedsSource(s):Crecon;JPWAAnnualsalesvalueofleadingprescriptiondrugsinJapaninfiscalyear2022(inbillionJapaneseyen)SalesvalueofleadingethicaldrugsJapanFY2022SalesvalueinbillionJapaneseyen80

1000204060120140160180OpdivoKeytrudaLixianaTakecabVecluryTagrissoAzilva152.44128.31116.47111.89109.84109.488.5687.42EyleaSamscaAvastin85.8285.6823Description:Inthefiscalyear2022,OpdivowastheleadingmedicamentinJapan,reachingasalesvalueofapproximately152.4billionJapaneseyen.ReadmoreNote(s):Japan;fiscalyear2022;theJapanesefiscalyearstartsApril1ofthestatedyearandendsMarch31ofthefollowingyear;NHIpricebasisSource(s):IQVIACHAPTER

05InternationaltradeValueofpharmaceuticaldrugimportstoJapanfrom2012to2021(intrillionJapaneseyen)ValueofimportedpharmaceuticaldrugstoJapan2012-20214.54.03.54.023.953.443.193.153.083.042.883.02.52.01.51.00.50.02.822.75201220132014201520162017201820192020202125Description:In2021,thevalueofpharmaceuticaldrugimportstoJapanamountedtooverthreetrillionJapaneseyen,representinganincreasefromapproximately2.9trillionyeninthepreviousyear.

ReadmoreNote(s):Japan;2012to2021Source(s):MHLW(Japan)ValueofpharmaceuticaldrugexportsfromJapan2012to2021(inbillionJapaneseyen)ValueofexportedpharmaceuticaldrugsfromJapan2012-2021600500400300200563.15512.55442.54189.192018175.742016166.912017153.51137.622012129.692013126.0520141000201520192020202126Description:In2021,thevalueofJapanesepharmaceuticaldrugexportsamountedtoapproximately563billionJapaneseyen,aroundatenpercentincreasefromthepreviousyear.

ReadmoreNote(s):Japan;2012to2021Source(s):MHLW(Japan)ValueofpharmaceuticaldrugimportstoJapanin2021,byregion(inbillionJapaneseyen)ValueofimportedpharmaceuticaldrugstoJapan2021,byregionImportvalueinbillionJapaneseyen0100200300400500600700800UnitedStatesGermanySwitzerlandIreland688.32634.36377.83207.74186.45167.43132.81125.29106.1479.62UnitedKingdomBelgiumFranceCanadaItalySouthKoreaOthers333.327Description:In2021,thevalueofpharmaceuticaldrugsimportedtoJapanfromtheUnitedStatesamountedtoaround688.3billionJapaneseyen.ImportsfromGermanyrankedsecondwithanamountworthabout634.4millionyen.

ReadmoreNote(s):Japan;2021Source(s):MHLW(Japan)ValueofpharmaceuticaldrugexportsfromJapanin2021,byregion(inbillionJapaneseyen)ValueofexportedpharmaceuticaldrugsfromJapan2021,byregionExportvalueinbillionJapaneseyen020406080100120140160SwitzerlandUnitedStatesofAmericaChina146.61139.577.73Taiwan25.8424.24SouthKoreaNetherlandsAustralia9.098.517.89GermanyHongKongItaly6.545.69Others111.5128Description:In2021,theleadingrecipientcountryforpharmaceuticaldrugexportsfromJapanwasSwitzerland,withanexportvalueofapproximately146.6billionJapaneseyen.TheUnitedStatesofAmericafollowedwithavalueofcloseto140billionyen.

ReadmoreNote(s):Japan;2021Source(s):MHLW(Japan)CHAPTER

06ExpenditureResearchanddevelopment(R&D)expenditureasashareofsalesofpharmaceuticalmanufacturingcompaniesinJapanfromfiscalyear2015to2021R&DspendingofpharmaceuticalcompaniesinrelationtosalesJapanFY2015-202114%11.93%12%10%8%11.1%11.05%10.04%10.08%10.06%9.68%6%4%2%0%201520162017201820192020202130Description:Inthefiscalyear2021,Japanesepharmaceuticalcompaniesspentaround10.06percentofsalesonresearchanddevelopment(R&D),downfromaround12percentinfiscal2015.PharmaceuticalcompaniesinJapanspentatotalofaround1.4trillionJapaneseyenonR&Dinfiscal2021.ReadmoreNote(s):Japan;fiscalyear2015to2021;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyearSource(s):MinistryofInternalAffairsandCommunications(Japan)Researchanddevelopment(R&D)expendituresinthepharmaceuticalmanufacturingcompaniesinJapanfromfiscalyear2015to2021(inbillionJapaneseyen)R&DspendingofpharmaceuticalcompaniesJapanFY2015-20211,6001,457.71,465.31,404.71,398.61,351.61,4001,2001,00080060040020001,339.21,321.6201520162017201820192020202131Description:Inthefiscalyear2021,Japanesecompaniesinthepharmaceuticalmanufacturingindustryspentatotalofaround1.4trillionJapaneseyenonresearchanddevelopment(R&D).Thisequaledaround10percentofthetotalsalesintheindustryduringthatyear.ReadmoreNote(s):Japan;fiscalyear2015to2021;JapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31Source(s):e-Stat(Japan);MinistryofInternalAffairsandCommunications(Japan)Researchanddevelopment(R&D)expendituresofleadingpharmaceuticalmanufacturersinJapaninfiscalyear2021(inbillionJapaneseyen)R&DexpenditureofleadingpharmaceuticalmanufacturersJapanFY2021ExpenditureinbillionJapaneseyen0100200300400500600TakedaPharmaceuticalCompanyLimitedDaiichiSankyoCompany,LimitedAstellasPharmaInc.526.09260.23246.01232.3OtsukaHoldingsCo.,Ltd.EisaiCo.,Ltd.171.74ChugaiPharmaceuticalCo.,Ltd.MitsubishiTanabePharmaCorporationSumitomoDainipponPharmaCo.,Ltd.OnoPharmaceuticalCo.,Ltd.Shionogi&Company,LimitedKyowaKirinCo.,Ltd.137.396.994.975.967357.68SantenPharmaceuticalCo.,Ltd.NipponShinyakuCo.,Ltd.26.3822.8632Description:Inthefiscalyear2021,TakedaPharmaceuticalspentaround526billionJapaneseyenonresearchanddevelopment(R&D),thehighestamountamongleadingpharmaceuticalmanufacturersinJapan.DaiichiSankyofollowedwitharound260billionyenofR&Dexpenses.ReadmoreNote(s):Japan;fiscalyear2021;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyearSource(s):JapanPharmaceuticalManufacturersAssociation;SPEEDAAdvertisingexpenditureofthepharmaceuticalandmedicalindustrythroughtraditionalmediainJapanfrom2013to2022(inbillionJapaneseyen)AdexpensesofthepharmaceuticalsindustryJapan2013-202218016014012010080152.65149.92147.45147.38148.32146.47144.11138.63135.9128.856040200201320142015201620172018201920202021202233/statistics/826125/japan-advertising-expenses-pharmaceutical-industryTheadvertisingexpensesofthepharmaceuticalandmedicalindustrythroughtraditionalmediainJapanamountedtoabout128.5billionJapaneseyenin2022.Thisrepresentedadecreaseofalmosttenbillionyencomparedtothepreviousyear.

ReadmoreNote(s):Japan;2013to2022;expensesthroughnewspapers,magazines,TV,andradio;excludingsatellitemediarelatedspendingSource(s):DentsuCHAPTER

07ApprovalandpatentNumberofpharmaceuticalproductsapprovedbythePharmaceuticalsandMedicalDevicesAgency(PMDA)inJapaninfiscalyear2022,bytypeNumberofpharmaceuticalproductsapprovedbyPMDAJapanFY2022,bytypeNumberofapprovedproducts01,0002,0003,0004,0005,0006,000TotalPrescriptiondrugs(generics)Quasi-drugs5,3061,9171,906BTCandOTCdrugs*725Prescriptiondrugs(newdrugs)Invitrodiagnostics57318535Description:Inthefiscalyear2022,approximately1.9thousandgenericprescriptiondrugswereapprovedbythePharmaceuticalsandMedicalDevicesAgency(PMDA)inJapan,while573newdrugswereapproved.Newdrugsrefertomedicaldrugsthatareclearlydifferentfromexistingdrugsintermsofactiveingredients,ethicalcombination,administration,indication,dosageforms,ordosage.PMDAfunctionsasaregulatoryagencyforpharmaceuticalproductsandmedicaldevices,working[...]

ReadmoreNote(s):Japan;fiscalyear2022;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyear;*BCT:behind-thecounter,OCT:over-the-counter.

ReadmoreSource(s):PMDANumberofprescriptiondrugsapprovedbythePharmaceuticalsandMedicalDevicesAgency(PMDA)inJapanfromfiscalyear2015to2022,bytypeNumberofprescriptiondrugsapprovedbyPMDAJapanFY2015-2022,bytypePrescriptiondrugs(newdrugs)Prescriptiondrugs(generics)4,0003,5003,0002,5002,0001,5001,0005003,2353,1923,0962,5602,2642,3991,9321,91757957755657351548142946802015201620172018201920202021202236Description:Inthefiscalyear2022,thenumberofprescriptiondrugsapprovedbythePharmaceuticalsandMedicalDevicesAgency(PMDA)inJapanamountedtoaround2.5thousandintotal.Thatyear,around1.9thousandgenericprescriptiondrugswerenewlyapproved.PMDAfunctionsasaregulatoryagencyforpharmaceuticalproductsandmedicaldevices,workingwithJapan'shealthministry.ReadmoreNote(s):Japan;fiscalyear2015to2022;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyearSource(s):PMDANumberofnewdrugsapprovedbythePharmaceuticalsandMedicalDevicesAgency(PMDA)inJapanfromfiscalyear2014to2022NumberofnewdrugsapprovedbyPMDAJapanFY2014-2022PartiallychangedNew700600500400300200100012610813710312614213115510946545345344038936233732032620142015201620172018201920202021202237Description:Inthefiscalyear2022,atotalof573newdrugswereapprovedbythePharmaceuticalsandMedicalDevicesAgency(PMDA)inJapan,108ofwhichwerenewlyappliedandapproved.Newdrugsrefertomedicaldrugswhichareclearlydifferentfromexistingdrugsintermsofactiveingredients,ethicalcombination,administration,indication,dosageforms,ordosage.PMDAfunctionsasaregulatoryagencyforpharmaceuticalproductsandmedicaldevices,workingwithJapan'shealthministry.ReadmoreNote(s):Japan;fiscalyear2014to2022;theJapanesefiscalyearstartsonApril1ofthestatedyearandendsonMarch31ofthefollowingyearSource(s):PMDANumberofpatentsownedinthepharmaceuticalindustryinJapanin2022,bytypeNumberofpatentsinthepharmaceuticalindustryJapan2022,bytypeNumberofpatentapplications3,00001,0002,0004,0005,0006,0007,000Unusedcases6,384Actively-usedcases5,85938Description:Asof2022,atotalofapproximately12.2thousandpatentsweregrantedinthepharmaceuticalindustryinJapan.About6.4thousandcasesofwhichwerenotactivelyusedeitherforthein-houseproductionorforlicensesthataresoldtoothercompanies.Thatyear,theutilizationrateofthepatentsownedintheindustryamountedtoaround47.9percent.ReadmoreNote(s):Japan;2022Source(s):JapanPatentOfficeBusinessenterpriseswhichfiledthehighestnumberofpharmaceuticalpatentapplicationsattheJapanPatentOfficein2022CompanieswiththehighestnumberofpharmaceuticalpatentapplicationsJapan2022Numberofpatentapplications05101520253035404550KobayashiPharmaceuticalCo.,Ltd.SantenPharmaceuticalCo.,Ltd.KaoCorporation44323130RohtoPharmaceuticalCo.,Ldt.ToyoShinyakuCo.,Ltd.NovartisAG(Switzerland)2828LionCorporation24NationalUniversityCorp.OsakaUniversityHisamitsupharmaceuticalCo.,Ltd.Institutnationaldelasanteetdelarecherchemedicale(France)KurarayNoritakeDentalCo.,Ltd.RegeneronPharmaceuticalsInc.(USA)TaishoPharmaceuticalCo.,Ltd.22212120201939Description:In2022,KobayashiPharmaceuticalsappliedfor44pharmaceuticalpatentsinJapan,whichwasthehighestnumberofapplicationsbyanindividualcompanyduringthatyear.NovartisAGtoppedamongforeignbusinessenterprises,intotalfiling28pharmaceuticalpatentapplicationsduringthemeasuredtimeperiod.ReadmoreNote(s):Japan;2022Source(s):JapanPatentOfficeCHAPTER

08LeadingcompaniesTotalassetsofleadingpharmaceuticalcompaniesinJapanasofMarch2023(inbillionJapaneseyen)TotalassetofmajorcompaniesinpharmaceuticalindustryJapan2023TotalassetsinbillionJapaneseyen02,0004,0006,0008,00010,00012,00014,00013,957.7516,000TakedaPharmaceuticalCompanyLimitedOtsukaHoldingsCo.,Ltd.*DaiichiSankyoCompany,LimitedAstellasPharmaInc.3,102.722,508.892,456.521,869.76ChugaiPharmaceuticalCo.,Ltd.*ShionogiCo.,Ltd.1,311.81,263.351,134.74941.49EisaiCo.,Ltd.SumitomoDainipponPharmaCo.,Ltd.TaishoPharmaceuticalCo.,Ltd.KyowaKirinCo.,Ltd.*939.8841Desc