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23DIRECTORYOFSINGAPOREPROCESS&CHEMICALSINDUSTRIES2023/2024thedecisionprovedcontroversialTheadministrationhadsidesteppeditsownpanelofoutsideadviserswhonotedclinicaltrialshadfailedtoprovethedrugseffectivenessAccordingtoPharmaceuticalsTechnologyTheapprovalwasbasedonclaimsthatthedrugled toareductioninamyloidplaquesin thebrainHowever Alzheimers diseaseis a complexillnessanditscauseandpathophysiologyarepoorlyunderstoodAduhelmisbothcostlyandcommonlyproducessideeffectsOfthe37drugsFDAapprovedin202220drugswereforpatientswithfewornoexistingtreatmentoptionsincluding•Acidsphingomyelinasedeficiency(Niemann-PickdiseasetypeABA/B)aninheriteddiseasethataffectsthebodysabilitytometabolisefat;•Generalisedpustularpsoriasisararelife-threateningskindisease;•Obstructivehypertrophiccardiomyopathyadiseaseinwhichtheheartmusclethickens;•Metastaticorunresectableuvealmelanomaararecancerthatdevelopsinapartoftheeyecalledtheuvea;and•HepatorenalsyndromeaformofimpairedkidneyfunctioninpeoplewithadvancedliverdiseaseAsforcompanieswhichgainedapprovalsBristolMyersSquibbreceivedthreeapprovals-thehighestnumber-eachwithpeaksalespotentialintheUS$4billionrangefollowedbybiotechcompanybluebirdbiowithtwogenetherapiesSkysonaandZyntegloIntermsofimpactFiercePharmaexpectsEliLillysMounjarotobeagamechangerfordiabetesandobesitypatientswhileAlnylamsAmvuttrausedtotreatnervedamagecausedbyhereditarytransthyretin-mediated(hATTR)amyloidosisandJohnson&JohnsonsandLegendBiotechsCarvyktihavethepotentialtobeblockbustershATTRamyloidosisisrareandAmvuttraisdesignatedasanorphanmedicinewhileCarvyktiisusedtotreatadultswithmultiplemyelomaacancerof thebonemarrowaftertheyhavesufferedarelapseSlowingGrowthInPharmaR&DTheR&Dpipelineremainedflatin2022with6147productsinactivedevelopmentfromPhaseI toregulatorysubmission just2%higheroverthelasttwoyearsIQVIAsuggestedthattheslowinggrowthsincethepandemicbegancouldbeduetodelaysindevelopmentactivitybecauseofthemultipledisruptionssince2020causedbyCOVID-19andthenewvariantsInitsGlobalTrendsinRandD2023IQVIAsaidproductsfromChina-headquarteredcompanieshadincreasedaccountingfor15%oftheR&Dpipelinein2022upfrom2%in2007whileEuropessharehaddeclinedoverthesameperiodfrom31%to23%USsharehadremainedrelativelystableatabove40%Oncologyremainedthefocusaccountingfor38%ofpharmaR&DItgrewby105ÊGRoverthelastfiveyearsAndR&DfundingincludinginitialpublicandsecondaryofferingsandventurecapitalinvestmenttotalledUS$608billionin2022justabovethe2019levelaftertwoyearsofheightenedinvestmentCollectivelythelargestpharmaceuticalcompaniesspentoverUS$138billiononR&Din2022up17%from2021Atotalof64novelactivesubstances(NASs)werelaunchedin2022adeclinefromthemorethan80launchedineachofthepriortwoyearswithoncologyneurologyandimmunologyaccountingforincreasingsharesofnewlaunchesGoingforwardThroughworkingwithindustrypartnersSingaporeisbeefingupitscapabilitiesInDecember2022aconsortiumcalledBiologicsPharmaInnovationProgrammeSingapore(BioPIPS)wasformedtoboostitsbiologicmanufacturingcapabilityInitiatedbytheAgencyforScienceTechnologyandResearch(A*STAR)withthesupportoftheEDBtheconsortiumbrings togetherSingaporesresearchecosystemincludingtheNationalUniversityofSingaporeNanyangTechnologicalUniversityandSingaporeInstituteofTechnologyandglobalpharmagiantsGSKSanofiandTakedatoleverageresearchandinnovation
