2022中国生命科学与医疗行业现状及展望

2022中国生命科学与医疗行业现状及展

望

德勤(Deloitte)发布了《2022年全球生命科学行业展望报

告》。

尽管过去一年生命科学行业的估值参差不齐，但该行业

的基本表现和前景是乐观的。许多公司的增长受到

COVID-19疗法的推动。随着生命科学公司继续转型，德

勤预计该行业将进一步增长。部分公司(尤其是那些工

作方式受限的公司)正在摆脱疫情的影响，采用数字优

先模式。随着数字化转型加速生命科学价值链的每个环

节，那些在疫情前就进行了大量数字投资的企业正中受

益。2022年，有远见的领导者将继续推动投资于长期的

战略数字目标——使用自动化、智能工厂和人工智能来

变革制造业，并使用新技术来建立供应链弹性。

不确定的时期将需要对企业敏捷性做出更大的承诺。虚

拟和混合工作的新世界需要灵活性，在不久的将来，大

多数生命科学公司仍需适应新规范和竞争激烈的人才格

局。重新构想以企业和工作文化为重点的工作是CEO的

战略重点，满足人们的需求以及以人为本的工作场所体

验变得至关重要。

在过去两年，生命科学领域和利益相关方开展了前所未

有的合作。为了患者的利益，每个人都被动员起来，包

括世界各地数字化共享研究的监管机构。在接下来的一

年里，更多以患者为中心、共同创造的体验将不断发展，

使患者在整个旅程和决策过程中成为更平等的合作伙

伴，并帮助生命科学提供更好、更个性化的结果。德勤

预计由患者推动的临床试验将更加多样化。

2022年，数据驱动的科学家们将凭借新的见解来源和真

实世界的证据，解决曾经被认为难以解决的疾病问题。

COVID-19疫苗和细胞和基因背后的mRNA技术疗法等

科学突破在未来有许多潜在的用例。为加快COVID-19

疫苗和治疗产品而采用的新工艺现在也被用于加快其他

药物和治疗的开发。随着企业面临更严格的信息披露和

新的全球标准，ESG预计将在2022年继续处于前沿和中

心地位。

监管机构、投资者和客户将密切关注生命科学的进展。

在未来的一年里，预计生命科学领袖们将重点关注该部

门的实质性ESG因素，如药品的获取、药品定价、环境

可持续性、健康和种族平等以及领导力的多样性。这种

变化将持续至2022年及以后。许多生命科学公司都经历

了增长，并且拥有更强大的资产负债表来进行投资。有

了大量的数据收集和分析工具做基础，生命科学公司将

大规模采用数字化。

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卢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岛⑹