2022中國生命科學與醫(yī)療行業(yè)現(xiàn)狀及展望

2022中國生命科學與醫(yī)療行業(yè)現(xiàn)狀及展

望

德勤(Deloitte)發(fā)布了《2022年全球生命科學行業(yè)展望報

告》。

盡管過去一年生命科學行業(yè)的估值參差不齊，但該行業(yè)

的基本表現(xiàn)和前景是樂觀的。許多公司的增長受到

COVID-19療法的推動。隨著生命科學公司繼續(xù)轉(zhuǎn)型，德

勤預(yù)計該行業(yè)將進一步增長。部分公司(尤其是那些工

作方式受限的公司)正在擺脫疫情的影響，采用數(shù)字優(yōu)

先模式。隨著數(shù)字化轉(zhuǎn)型加速生命科學價值鏈的每個環(huán)

節(jié)，那些在疫情前就進行了大量數(shù)字投資的企業(yè)正中受

益。2022年，有遠見的領(lǐng)導(dǎo)者將繼續(xù)推動投資于長期的

戰(zhàn)略數(shù)字目標——使用自動化、智能工廠和人工智能來

變革制造業(yè)，并使用新技術(shù)來建立供應(yīng)鏈彈性。

不確定的時期將需要對企業(yè)敏捷性做出更大的承諾。虛

擬和混合工作的新世界需要靈活性，在不久的將來，大

多數(shù)生命科學公司仍需適應(yīng)新規(guī)范和競爭激烈的人才格

局。重新構(gòu)想以企業(yè)和工作文化為重點的工作是CEO的

戰(zhàn)略重點，滿足人們的需求以及以人為本的工作場所體

驗變得至關(guān)重要。

在過去兩年，生命科學領(lǐng)域和利益相關(guān)方開展了前所未

有的合作。為了患者的利益，每個人都被動員起來，包

括世界各地數(shù)字化共享研究的監(jiān)管機構(gòu)。在接下來的一

年里，更多以患者為中心、共同創(chuàng)造的體驗將不斷發(fā)展，

使患者在整個旅程和決策過程中成為更平等的合作伙

伴，并幫助生命科學提供更好、更個性化的結(jié)果。德勤

預(yù)計由患者推動的臨床試驗將更加多樣化。

2022年，數(shù)據(jù)驅(qū)動的科學家們將憑借新的見解來源和真

實世界的證據(jù)，解決曾經(jīng)被認為難以解決的疾病問題。

COVID-19疫苗和細胞和基因背后的mRNA技術(shù)療法等

科學突破在未來有許多潛在的用例。為加快COVID-19

疫苗和治療產(chǎn)品而采用的新工藝現(xiàn)在也被用于加快其他

藥物和治療的開發(fā)。隨著企業(yè)面臨更嚴格的信息披露和

新的全球標準，ESG預(yù)計將在2022年繼續(xù)處于前沿和中

心地位。

監(jiān)管機構(gòu)、投資者和客戶將密切關(guān)注生命科學的進展。

在未來的一年里，預(yù)計生命科學領(lǐng)袖們將重點關(guān)注該部

門的實質(zhì)性ESG因素，如藥品的獲取、藥品定價、環(huán)境

可持續(xù)性、健康和種族平等以及領(lǐng)導(dǎo)力的多樣性。這種

變化將持續(xù)至2022年及以后。許多生命科學公司都經(jīng)歷

了增長，并且擁有更強大的資產(chǎn)負債表來進行投資。有

了大量的數(shù)據(jù)收集和分析工具做基礎(chǔ)，生命科學公司將

大規(guī)模采用數(shù)字化。

2022GlobalLifeSciencesOutlook|Digitalizationatscale:Deliveringonthepromiseofscience

Contents

Introduction

AcceleratingR&DproductivityandindustrycoIlabora

Transformingthepatientexperience

Transformingthetalentexperience

Regulatory:Masteringexternalforces

Thedigitalenterpriseatscale:ACEOimperativefor2

Future-proofingmanufacturingandsupplychains

Environmental,Social,andGovernance(ESG):Anothe

Contacts

Learnmore

Endnotes

2022GlobalLifeSciencesOutlook

Introduction

Whilevaluationsforthelifesciencessectornthispastyearhavebeenmixed,theunderl-

sectorishealthy.Wesawmanycompanies'growthbuoyedbyCOVID-19therapeutics,an

fairlyimmunetosomeofthepandemicimpactsinitiallyfeared(e.g.,slowdowninpatient

anticipatefurthergrowthintheindustryaslifesciencescompaniescontinuetotransforr

Somecompanies,especiallythosewithlimitedlegacywaysofworking,arecomingoutof

modelandchallengingnormsacrosstheirenterprise.Thosethatmadesignificantdigital

arebenefittingfromtheirboldvisionasdigitaltransformationaccelerateseverypartofrl

visionaryleaderswillcontinuetodriveinvestmentsfocusedonlong-term,strategicdigits

smartfactories,andartificialintelligencetotransformmanufacturingandusingnewtech

resilience.

Uncertaintimeswillrequireagreatercommitmenttoenterpriseagility.Thenewworldof

flexibility,andmostlifesciencescompanieswillstillbeadjustingtonewnormsandahigh

nearfuture.ReimaginingworkwithafocusoncorporateandworkingcultureisaCEOstr

ofhumans—andhuman-centeredexperienceintheworkplace—hasneverbeenmoreir

Thelast【woyearsofthepandemicsawunprecedentedcollaborationacrosslifesciences

wasmobilizedintheinterestofpatients,includingregulatoryagenciesaroundtheworld

nextyear,morepatient-centric,co-createdexperienceswillevolvetomakepatientsmon

throughouttheirjourneysandhelplifesciencesdeliverbettermorepersonalizedoutcor

clinicaltrialsdrivenbypatientsandagreaterfocusonhealthequity,enabledbydecentre

In2022,data-drivenscientists,armedwithnewsourcesofinsightsandreal-worldevider

diseasesthatwereoncethoughtintractable.2Scientificbreakthroughs,likethemRNAtec

vaccinesandcellandgenetherapies,havemanypotentialuse-casesforthefuture.Ther

COVID-19vaccinesandtherapeuticproductsarenowalsobeingappliedtospeedupthe

treatments—andcompaniescannotrevertbacktooldways.

2022GlobalLifeSciencesOutlook|Digitalizationatscale:Deliveringonthepromiseofscience

AcceleratingR&Dproducti

industrycollaboration

2022GlobalLifeSciencesOutlook|Digitalizationatscale:Deliveringonthepromiseofscience

Impactontimelines

Whilesomeworriedthatlifesciencescompanieswouldseeanegativeimpactontimelin<

morebullishaboutthedegreeofchangelifesciencescompaniesweregoingtoembrace

Atlarge,timelinesdidrftchange.

Whataretypicaltimelines?ResearchconductedbyCowenanalyzedtheperformanceof'

overmorechan15,000clinicaltrialsacrossfivecategories.Thetimeperiodanalyzedwas

?Pipelinepace:Averagetimetoreachapproval,almost5years

?Recruitingspeed:Averagedmetoenrollpatientsinrnals,almost19months

?R&Defficiency(2016-2021):AverageR&Dspendperactivetrial,US$35million,US$66rr

reflectaproclivitytoin-bcenselatestageassets)

?Trialpush-ours:Averagepercentageoftrialsnotdelayed,52%

?Delayduration:Averagechangeinprimarycompletionrace,57-daydelay4

Ifwelookattheresultsforrecruitingspeed,(seefigure1盧forexample,thedatashowhe

companyandtherapeuticarea.Whileitmaytakeonlyabout4monchstoenrollhealthyp

monthstoenrollparticipantsforstudiesconcerningulcersandthegastrointestinaltract

Figure1:Trialrecruitingspeedbycompanyandtherapeuticarea,2012-2021

Weightedaverageenrollmenttimeinmonthsbycompany(left)andbytherapeuticarea(right)

HealthyParticipinti

CCV1O19

BoneDisease

InfecxiousOseese

Diabetes^bBsiry

Hepatibs

Dermatology

Respiratory

PainManagement

WomerfsHearth

LiverDisease

Opthalmrtqgy

Carcfrcvasajlar/ftenal

CNS

RheurMnflammArnrruno

Non-Mafigrenthem

MS

Aizneimers

Ocher

2022GlobalLifeSciencesOutlook

Overall,theleadingcompaniesaveragedabout19monthstoenrollpatients,andthebes

leadingtherest—wasNovoNordisk,withaphase-weightedaverageof9.6months.Howt

oncologytrialswasatailwind.Theaverageoncologytrialtook27.6monthstoenroll,com

months.Second-placeGlaxoSmithKline(GSK)andthird-placeEliLillyalsohadhmicedexp

PharmaR&Drecruitingtimelineswerenotsloweddownbythepandemic.However,clinic

arebackontrack.3Wherewedidseeshortenedtimelines,companiesarekeentoreplica

Deloitte'sanalysisofR&Dcycletimesfor15leadingpharmaceuticalcompaniesshowsth,

was6.64yearsin2019,followedbyanincreaseto7.14yearsin2020,a7-yearhigh.Asligb

years-adecreasedrivenbytheexpeditedcompletionofstudiesforCOVID19therapies

Someacceleratedpathsforimprovingproductivityincludefocusingoncontinueddigital

andworkingintandemandacrossgeographieswithregulatorsforearlierapprovals.10

Returnonpharmaceuticalinnovation

Deloittehasbeentrackingreturnonpharmaceuticalinnovationsince2010.Upuntil202(

adecade-longdeclineinR&Dproductivity.Butin2021,Deloitte^analysisof15largepha

significantuptickforthecohort'sinternalrateofreturn(IRR)—7%,upfrom2.7%in2020.

emergencyapprovalsplayedasignificantroie.Excludingthoseassets,theprojectedIRR?

Figure2:UptickinR&Dreturnsforbiopharmacohortfor2021

15biopharmacompanieswereanalyzedbyDeloitte

R&Dreturnshaveseenalargeuptickin2021

IRRisthehighestithasbeensince2014

2022GlobalLifeSciencesOutlook|Digitalizationatscale:Deliveringonthepromiseofscience

Pharmaceuticalcompaniesexpecttoadvancescientificbreakthroughsandmanufacture

productsinanefforttofulfillunmetneedsandstayaheadofthecompetition.In2021,th

costtodevelopanassetforthisgroup,includingthecostoffailure,decreasedUS$70mil

from2020,toapproximatelyUS$2billion.Thisdecreaseismainlyduetotheincreaseintl

numberofassetsinthelare-stagepipelineforthecompaniesanalyzed.In2021,thegrou

242late-stageassets,anincreasefrom210in2020.'2

Wecan'trever:toouroldways

TrackingR&Dspend

DrugDiscovery&DevelopmentanalyzedtheR&Dspendforleadingpharmaceuticalcom

thetop15companiesrangedfromalmostUS$4billiontomorethanUS$13.5billionfortl

apercentageofrevenue,IncyteledtheindustrywithanR&DspendofUS$2.2billionthai

revenue.RegeneronPharmaceuticalsspentalmostUS$2.4billiononR&D,or32.19%ofn

WhenallocatingR&Dspendforanasset,apharmaceuticalcompanyisofteninfluencedt

?Anticipatedlifetimeglobalrevenuesfromthenewdrug

?Expectedcoststodevelopthedrug

?Policiesandprogramsinfluencingsupplyofanddemanaforprescriptiondrugs16

?Pressuretoinnovate17

Pharmaceuticalcompaniesfacegreaterpressuretoinnovatebecauseofthetime-lirrutec

drugs.Whenapatentexpires,companiesexpecttotakeabighittosalesfromgenericsc

Figure3:Pharmacompanies'totalR&Dspendin2020

CompanyUSDfor20：

1Merck$13,558,00。。

2RochePharmaceuticals(divisionofRocheGroup)$12,164,234,7

2022GlobalLifeSciencesOutlook|Digiraiizaxionatscale:Deliveringonthepromiseofscience

Establishingnewnorms

Investii

Revampingtheclinicaltrialmodel

Accelerat

ChangesbroughtaboutasaresultoftheCOVID-19pandemicaredeliveryi

shapinganewerainclinicaltrials.Restrictivenormsandoutdateddemand4

processesarefallingaway.Withdigitalandvirtualtools,constraintslabofthe

suchasgeographyandset'businesshours'arenolongerbarrierstoplatform:

participation.Researchersarefindingnewwaystobringmorepeoplesupports

intotrialsthroughnewmodelschatareadaptive,decentralized,andtorapidl)

hybrid.Participantsexpectmorepersonalizedcareandreal-timeDeloitte5

access,nomatterwheretheyare.20fromlarg

billionan

Remotemonitoringandremotevisitsweretopstrategiesforkeeping

Asia.Sur、

clinicaltrialsopenduringthepandemic.21Researchshowsthatthere

currently

weremorestudystaresacrosstheboardbytheendof2021thanever

(71%).Ar

before,withanincreaseofalmost18%from2020to2021,including

nextfive

morenon-COVIDtrials.Oncologysawthebiggestincreaseatalmost

AR/VR(1<

1,300trialinitiationsin2021,a23%increase.22Twoyearsafterthe

forthela

pandemicstarted,morethan7,000clinicaltrialshadbeeninitiated

relatedtoCOVID-19intheNIHClinicalTrialsdatabase(seefigure4).23

Figure4.TotalnumberofclinicaltrialsrelatedtoCOVID-19vaccinesandtreatmentsasofJw

1,990

Complete

7f299

2022GlobalLifeSciencesOutlook|Digitalizationatscale:Deliveringonthepromiseofscience

Tufts*studyfinds5xto14

trialsinvestment

ArecentstudyfromtheTuftsC

comparedpublishedbenchmar

morethan150decentralizedtri.

studyreportsthat,onaverage,?

withreducedclinicaltrialtimelir

example,decentralizedphase2

thantraditionaltrials,anetben，

investmentrequired;phase3w

Improvingaccesstotrialsandtechnology

CVSHealthexpands;

throughhybridtrials

locations

Decentralizedtrialsandremotemonitoringmay

CVSHealthClinicalTrial!

addressconvenienceanddiversepopulationsin

distantlocations,butunderservedandminoritythepandemicwiththegoe

acrossthecommunitiesit

populationsarestilllikelytoexperiencedisparities.For

industry,CVSHealthhelpf

example,accesstobroadband,caregivers,andhome

COVID19vaccinesandtre

healthcare,maypresentachallenge.33

modelandscreeningprot(

Notalltrialscanbefullydecentralized.Hybridtnals,volunteersforCOVID19v<

thatalsoreachpatientsthroughthecommunitywherestudiesclosetowherethe

theylive,areanothergrowingsolution.34Researchers

Bycreatingamoreefficier

shouldbeawareofthelogisticaldifficultiesthat

somenecessarym-personproviderinteractionsandretentionandresearcheff

trialexperiencebenefitsp

laboratorytestsmayposeforsomepariticipants.

researchorganizations,ar

Forexample,somemayfacetravelconstraints(eg,

focusedonscalingthreec

accessandcost),nonacceptanceofjobabsencesfor

clinicaltrialdelivery,andr

studyactivities,andmobilitychallengesduetomedical

comorbidities.35

2022GlobalLifeSciencesOutlook

In2021,PhRMAandtheDeloitteUSCenterforHealthSolutionsconducted,is

O'c1dincludingasurveywith31PhRMAsmembercompaniesandaw(

withmorethan500stakeholdersfrommorethan150organizations.ThesurveyofPhRk

membersshowed61%ofrespondentshavedefinedgoalsandobjectivestoenhanceclin

trialdiversity,andallrespondentshaveorareplanningcoaddresstrialaccessissues(see

Figure5:PhRMAmembercompaniessurveyonclinicaltrialdiversity

Percentageofrespondentswithdefinedgoalsandobjectives

forincreasingclinicaltrialdiversity

|Wehavedefinedgoalsandobjectives,dentifiedbestpractices,

andbeguntoincorporatetheseacrosssomeofourtrials

.Wehavedefinedgoalsandobjectivesandworkingtoidentify

bestpractices

■Weareworkingondefiningourgoalsandobjectives

Note:N-31PhRMAmembercompanies

Allrespondentshaveorareplanningtoaddresstrialaccessissuesandareconsideringtheneed

diversepopulationsinclinicaltrialdesign

Wearetakingspecificmeasurestoaddresstrialaccessissues(e.g.rtransportationcosts,eventsch

remote/decentrahzeddatacollection,patentappsanddataaccess,etc,)

Weareconsideringtheneedsofdiversepopulationsinclinicaltriadesign(eg.takingapatientcei

toprotocoldesignandincorporatingpatenrinput)

71%

Wearedentifyingsiteswherediversepatientsmaybelocated,dentifyinghealthcareprovidersth

orunderrepresentedpopulations,andcollaboratngwthinvestigatorstoaddressthegoalsofenrc

71%

Weareenhancingeducationontheroleofclinicaltrialsthroughoutthemedicalcommunity

2022GlobalLifeSciencesOutlook|Digitalizationatscale:Deliveringonthepromiseofscience

MostsurveyedPhRMAmembercompaniesidentifiedareastoaddressinternallytoenha

legacyprocessesandsystems,dataondemographicsofdiseasebyrace/ethnicity,andp，

strategieswereidentifiedforenhancingclinicaltrialdiversityandarediscussedintheES

Evolutionofreal-worldevidence

Amountandtypesofdatarapidlyaccelerating

Lifesciencescompaniesstriveforconsistent,regulatory-qualityclinical

trialdatatoprovetheeffectivenessoftreatments,andresearchersare

expectedtogather,analyze,andcuratemanystreamsofstructuredVerani

andunstructureddata.TheamountofdatabeingcollectedbydigitalRWEfc

healthtechnologies—telemedicine,mobiledevices,wearables,andother

sensor-basedrechnologies—israpidlyacceleratingduetodecentralizedVerana

trialsandremotemonitoring.41real-wo

likethe

Inadditiontoclinicaldata,genomicinformationandimprovementsinAmerica

technology—likeAlandquantumcomputing—areevolvingthewayUrologii

lifescienceorganizarionsapproachdrugdiscoveryanddevelopment.andhea

Real-worlddata(RWD)andreal-worldevidence(RWE)collectedtodayforinsig

havethepotentaltobetterinformclinicaltrialdesign/executionandsystems

deliverinsightsneverbeforethoughtpossible.InDeloittersannualTheirpc

surveyofC-suirebiopharmaleaders,100%identifiedRWEasstrategicallyAltoau

important.42drugan

speedin

Attheendof2021,theUSFoodandDrugAdministration(USFDA)issued

recently

draftguidanceforusingdigitalhealthtechnologiestoacquiredata

Johnsor

remoteiyfromparticipantsmclinicaltrials.Inadditioncosponsorsarid

investigators,deveiopersandmanufacturershavetheopportunityto

benefitbyreviewingthisguidance.44

Selectingdigitaltoolsforbetterclinicaltrials

Whenselectingdigitalandvirtualtoolsforclinicalinvestigations,sponsorsshouldensure

sufficienttosupporttheiruseandinterpretabilityinthestudy.Datatransmissionwithm.

agreementsshouldbedesignedtosecuredatacolSectedandtransmitted.45

Gettingbetterdatafromdevicesinclinicaltrials:

2022GlobalLifeSciencesOutlook

ThroughAl&ML,lifesciencescompanieshavealsobeenabletoselectinvestigatorsand

wellaspredictthe.Tperformance.5'

LessonsfromtheCOVID-19experience

In2022,biopharmacompaniesarelookingtoapplysomeofthemoresuccessfulCOVID-

design,andexecutestudiesmoreefficientlyby:

?Enablingat-nskdevelopmentforhigh-priorityprograms,allowingthemtobypasscerta

?Expandingcollaborativedialoguewithregulators,usingdata-shannginfrastrutureand

?Limitingthenumberofrelevantendpoints,tostreamlinetriaiprotocoidesign

?Enablingtherapidassessmentanddevelopmentoftherapieswithmasterprotocolsan

?Acceleratingtheuseofdigitaltechnologies,forconductingdecentralizedandhybridsti

recruitingdiversestudypopulations,andremotelycoilecdngdataandmonitoringpati€

Duringthepandemic,irbecamebothdifficultandpotentiallydangerousforsomeclinical

AccordingtoBadhriSrinivasan,headofglobaldevelopmentoperationsforNovartis,hist

asin-homenursingprogramsordirecttopacientshipmentsoftheirstudymedication.

prefer,regardlessofrestrictions,andmanytrialsiteshavenowexpandedtheircapabilitit

Therefore,weneedtoprioritizebuildingassessmentofdecentralizedclinicaltria!elemer

NewtherapeuticmodalitiesarethefutureofR&Dproductiv

Highlyanticipatedbiopharmaresearch

Thescienceoftherapeuticsismaturingwithnewandcompellingmodalities.Scientistsar

oncethoughtintractable.54Technologyandscienceareconverging,andthemodalitylan<

disease,smallmolecules,biologies,andproteintargetstogeneticdisorders,Antisense0

andnuclecacidtargets,accordingtoAnabellaVillalobos,PhD,seniorvice-presidentatBi

Villalobossaysthatproteindegradersareanemergingtherapeuticmodality助owingen(

degradation(TPD)tacklesdisease-causingprovensthathavehistoricallybeenhighlycha

smallmolecules.Inihefuture,thismodalityisexpectedtoexpandtheuseofubiquitinlig

andmovebeyondoncology.57

Dr,JayBradneroversees5600scientistsand325discoveryprogramsover8diseaseare;

forBiomedicalResearch(NIBR).58Hesaysthatitisironicthatreturnsarediminishingwhe

2022GlobalLifeSciencesOutlook

Unprecedentedcollaboration

Growingglobalecosystem

Duringthepandemic,manylifesciencescompaniesrhachadbeencompetirorscametog

addresstheurgentneedfortreatments,vaccines,diagnostics,andmedicaldevices(see,

inotherotherindustries,alsojoinedtheefforttohelpfillrawmaterialsshortages,digitali

process,andenhancemanufacturingathighcapacitiesatdifferentlocationsworldwide.6

Figure7:Lifesciences'globalcollaborations

UnitedKingdomChinaSwitzerlandIndia

ProductionscaleofProductionscaleofProductionscale-upofClinicaltrialsai

J&JvaccineSputnikVvaccineHGCO19.Indiasfirstscale-upofCovi

mRNAvaccine

.Johnson&Johnson.USA?DrReddyrsGeciova.India?AstraZeneci

DrugandvacaneLaboratoriesB4o(herapeuticscoaddressOxford.UK

LScompanyhfe-chreacen?ngdiseasesSc?ence-led.?

btopharmace

.HDTBiotech

BiologicalE.India?Russia'sCOVID19business

Corporation.Seattle

Firstprivare-sectofSpumikV

Saence-ted?nnovauve

t>olog<alpfoduccs

biopharmaceuocaibus，Mss

companymIndia

DevelopmentandClinicaltrialsinEUandUS;ActiveingredientfortheR&D'licensea

productionandproductionscale-upofCOVID-19Modernsvaccineisresearchtech,

ofavaccinePfizermRNAvaccineproducedinSwitzerlandtherapeut

Novavax,US.BioNTech.Germany.Moderna.US.Elilily,US

NextgenerationDrugsandvaccineDrugsandva

mnmunocherapyLScompanydevelopmem

powerhouse

.Pfizer.USCbugai.Japa

DrugandvaccineAnooodyen^

LScompanytechnologyI

R&D—formofconsortium

XOVIDR&Dalliance****USCOVIDR&DconsortiumPhRMA

LifesciencecompaniescollaboracePharm^ceupcalResearchand

coaeceleracetherapiesandManufacturers<rfAmenca

)AMGEN.Takeda.JP

vaccineforCOV1D-.19representsUSleading：

USDrugand.._.^novacrvebiopnaffvnKeut?c^lOIAGlobal

DfugLSvaccme.researchcompaniesdevotedDruglnfonr

companyLScompanyAdvancedMed.calTechnologytod,scovefingandAssocauon

Assocac-on-cheworld'sdevelgng島⑹