DECEMBER202

4Digital

HealthTrends

2024IMPLICATIONSFORRESEARCHANDPATIENT

CAREDigitalhealthcompanieshavefacedheadwindsoverthepastfewyears.Startupshaveseenreducedfundinginflowswhilecompanieswithapprovedproductshavestruggledtogrowrevenueandexpandtheiruserbase.Somehavegonebankrupt.However,innovationhasremainedstrongandnewdigitalhealthproductstodiagnose,treatandremotelymonitorpatientsarenowlaunchingintoamorematureglobalmarketplacewithanexpandingnumberofapprovaland

reimbursementpathwaysthatofferimprovedchancesoffuturesuccess.Developersarealsocombiningindividualproducttypesinto“solutions”withbothpatientandphysician-facinginterfacesthatincreasethecaseforhealthsystemadoption.Intheresearchspace,biopharmacompanieshavebeenusingwearablesensorsanddigitalmeasuresindrugtrialstobetterunderstanddrugbenefitsandreducerisk.Thisreportexaminestrendsacrossvarioussegmentsofthedigitalhealthmarket,whicharebecomingincreasinglydefined.Weexaminedigitaldiagnosticsalongsidematuringtherapeuticproductsegmentslikedigitaltherapeutics(DTx)anddigitalcare(DCs)andlookatconsumerappsandnon-prescriptiondigitaltherapeuticsthataimtoreducehealth

symptoms.Wealsoexaminehowlifesciencescompaniesarestrategicallydeployingwearablesensorsandotherpatientmonitoringtoolsin

research.WhilepastIQVIAInstitutedigitalhealthreportshavefocusedmostlyonconsumer-facingdigitalhealthtechnologies,thisreportalsoexploresprovider-focusedsolutions,likedigitaldiagnostics,clinicaldecisionsupporttools,remotepatientmonitoringtools

andAI-informeddigitalplatformsthatarenowhelpingprovidersgloballyimproveoutcomesforpatientswithchronicdiseases.Forthefirsttime,wealsoexaminetheuptakeofthesesolutionsinthemarketplacedrawingonvariousIQVIAdata

sources.Afollow-uptothisreport,tobereleasedinearly2025,willthenlookacrosssegmentstoexaminehowbusinessstrategiesareshiftinginthepursuitofrevenue,thepathwaysdigitalproductsaretakingtoreachthemarketandgainreimbursement,andhowpayerevidencerequirementsandgovernmentpoliciesareshiftinggloballyandmayinfluence

adoption.ThestudywasproducedindependentlybytheIQVIAInstituteforHumanDataScienceasapublicservice,withoutindustryorgovernmentfunding.ThecontributionstothisreportofSalma

Ajraoui,OliverBailey,KateBennet,AnnaExenberger,MatthewHackenberg,MichaelKrupnick,NadeaLeavitt,BrianLovinguth,ChristopherLudwig,NicholasMageras,SaraPawley,MaximilianPeters,CovadongaFernándezdelPozo,TapanRaval,BrindaSriskantha,ErikaSzewkies,AinhoaUribarrenanddozensofothersatIQVIAaregratefully

acknowledged.FindOut

MoreIfyouwishtoreceivefuturereportsfromtheIQVIAInstituteforHumanDataScienceorjoinourmailinglist,visit

.MURRAY

AITKENExecutive

DirectorIQVIAInstituteforHumanData

ScienceIntroductionDigitalHealthTrends2024:ImplicationsforResearchandPatient

CareREFERENCINGTHIS

REPORTPleaseusethisformatwhenreferencingcontentfromthis

report:Source:IQVIAInstituteforHumanDataScience.DigitalHealthTrends2024:ImplicationsforResearchandPatientCare.December2024.Availablefrom

?2025IQVIAanditsaffiliates.Allreproductionrights,quotations,broadcasting,publicationsreserved.Nopartofthispublicationmaybereproducedortransmittedinanyformorbyanymeans,electronicormechanical,includingphotocopy,recording,oranyinformationstorageandretrievalsystem,withoutexpresswrittenconsentofIQVIAandtheIQVIA

Institute.Tableof

ContentsOverviewThe

landscape

of

digital

healthConsumerapp

trendsDigital

therapeutics

and

their

use

in

careSensor-baseddigital

measuresDigital

diagnostics

and

other

health

assessment

toolsUptake

and

use

of

digital

health

technologiesNoteson

sourcesMethodologyReferencesAbouttheauthorsAboutthe

Institute2611244452687778808990OverviewTHELANDSCAPEOFDIGITAL

HEALTHWhilethepasttwoyearshavebeenchallengingformanyplayersinthedigitalhealthfield,theyhavealsoyieldedmanynewproductsthatbettermeettheneedsofstakeholdersandaremorecommerciallyviable.Asthescopeofdigitalhealthcontinuestoexpand—fueledbyadvancesintechnologyandartificialintelligence

—andmoredefinedsegmentsofinnovationhaveemerged,developershavealsobeencombiningtheseindividualproducttypesinto“solutions”withbothpatientandphysician-facinginterfaces.Theirapplicationsnowspanthefullpatientjourney.Bothdigitaltherapiesandnewhealthassessmenttoolslikedigitaldiagnosticsoffertospeedcareandclose

caregapstoimprovehealthoutcomes,arebetterfittingintoexistingcarepathways,andareestablishingsustainablebusinessmodelsthatwillbringbenefitstomoresegmentsofpatientsandhealthsystems.CONSUMERAPP

TRENDSSinceappstoresfirstemergedin2008,over1millionconsumerdigitalhealthappshavebeen

created.However,twothirdsoftheseappsarenolongermarketed.Amidthecycleofappcreationandelimination,thetoplinenumberofconsumerhealthappshasremainedabove300,000since2017and

337,000arecurrentlyavailable.Moreproactiveremovaloflow-qualityappsandfewernewappreleasesonGooglePlayhaveledappnumberstodeclineby4%since

2021.Disease-specificappscontinuetogrowinnumber,withmanysupportingmentalhealthandpatientswithdiabetesandcardiovasculardiseases.

Recently-launchedappsalsohelpthosewithvisualimpairments,auditoryissuesanddermatologicconditions.Withincreasedcompetitioninmostcategoriesandcontinuedcommercialheadwinds,newhealthappentrantsfacechallengestogrowanddifferentiatethemselvesinthemarket.Evenforhighqualityappsuptakeisrelativelyslow.Whilesomenotableconsumerappsattain420,000installsonaverageafterfiveyears,diseasemanagementappsseeonlyabout90,000installs,althoughnewerappsappeartobegrowingmorequickly.Appswithstrongerclinicalevidencehaveseenhigherrates

ofuseandmorerapiduptake,indicatingthatevidencegenerationisnowincreasinglyimportantforconsumeradoptionandcommercialsuccess.AstheFDAunwindsCOVID-19emergencyuseauthorizations,somenon-prescriptiondigitaltherapeuticsthathadbeenavailabletoconsumerstosupportmentalhealthhavebeenrequiredtoundergoregulatoryapprovalasprescriptionproducts.Atthesametime,somediseasemanagementappswithdemonstratedhealthbenefitsarenowusedexclusivelywithindigitalcareprogramsforcommercial

reasons.Bothtrendshavecauseddirectconsumeraccesstohigh-qualityhealthappstodisappearastheyshifttogatedcommercialmodelswithnocash-pay

options,suchthatthepromiseofdigitalsolutionstodemocratizehealthhasdiminished.However,thistrendmaygraduallyreverseifmoreprescriptiondigitaltherapeuticsare

abletoswitchtoover-the-counter

dispensing.2|DigitalHealthTrends2024:Implicationsfor

ResearchandPatientCareBothdigitaltherapiesandnewhealthassessmenttoolslikedigitaldiagnosticsoffertospeedcareandclosecaregapstoimprovehealthoutcomes,arebetterfittingintoexistingcarepathways,andareestablishingsustainablebusinessmodels

that

will

bring

benefits

to

more

segments

of

patients

and

health

systems.DIGITALTHERAPEUTICSANDTHEIRUSEIN

CAREOver360software-basedtherapeutictoolsarenowcommerciallyavailablewithsomeproductsavailabletoconsumerswithorwithoutaprescriptionandothersusedbyproviderstoenhanceclinicalanddigitalcare.Asregulatoryandreimbursementpathwaysproliferateandproofofclinicalutilityandcostsavingsincrease,digitaltherapeuticsintendedforpatientuseathomehavenotablygrowninnumberwith140grantedmarketaccessthroughnationalregulatoryandreimbursementpathways.Asofearly2024,42werealsoavailableasnon-prescriptiondigitaltherapeutics—manydirectlyavailabletopatientsforself-management—and222digitaltherapieswerecommerciallyavailableforusebyprovidersintheirclinicsorwithindigitalcare

programs.Asdevelopershaveprogressedtheirglobalcommercializationstrategies,somedigitaltherapeuticsarenowavailableinmultiplegeographies.GermanycontinuestoleadintheapprovalandreimbursementofDTxwith56patient-facingprescription

digitaltherapeuticscurrentlygrantedreimbursement,followedbytheUnitedStateswhere37areavailable(46includingoutpatientdosingapps).IntheUnitedKingdom

20havebeenendorsedforusebyNICEalongwithothertherapeuticdigitallyenabled

therapies.Since2021,87digitaltherapeuticshavegainednewapprovalsormarketaccessglobally.RecentlyapprovedDTxincludeappstotreatvisualimpairmentsandchronicdiseaseslikediabetesandhypertension,thoughmentalhealthstillpredominatesasafocus.ThetypesandmechanismsofactionforDTxhavealsoexpandedbeyondwidelyusedcognitivebehavioral

therapyapps.Theuseofbiofeedbackandvirtualrealityhavegrown,aidinginmusculoskeletalandneurologicalrehabilitation,treatingvisualimpairments,reducingvarioustypesofpain,andaddressingPTSDandphobiasthroughexposuretherapies.Somehavegained

FDAbreakthroughdevicedesignationhavingshownpotentialtoaddressunmetmedicalneedsthroughnonpharmacologicaltreatments.WithagrowingnumberofDTxincorporatingvirtualcarewraparoundstoovercomeprovideradoptionissues,digitalcareisbecomingthepredominantchannelfortheuseofdigitaltherapeuticsandover180

digitalcareprogramsarenowcommerciallyavailable.Patientdemandforobesitydrugshasdrivenpayerendorsementofdigitalcareweightmanagementprograms,someofwhichusemobileappstoshiftbehaviorpriortoinitialdruguseorencourageadherence.Somecountriesalsoappeartopreferdigitaltherapiesbeusedwithintheboundsoftraditionalcare,as“blendedtherapies”,resultingindigitaltherapeuticsbeingmarketedasastandaloneDTxinonecountrybutasadigitalcaresolutionin

another.Throughtheuseofdigitalsensorsandwearables,nuancedaspectsofhealthandpatientexperiencearebecomingtraceableandmeasurableindailylife.Inpatientcareandinclinicaldevelopmentprogramsforinnovativemedicines,sensor-basedmeasures,includingdigitalbiomarkersandclinicaloutcomeassessments,areprovingvaluabletoremotelymonitorpatients,demonstratetheeffectsoftherapeuticinterventionsandtrack

outcomes.

|

3Digitaltherapeuticsintendedforpatientuseathomehavenotablygrowninnumber

with140grantedmarket

accessthroughnationalregulatory

andreimbursement

pathways.SENSOR-BASEDDIGITAL

MEASURESLifesciencescompanieshaveincorporateddigitalmeasuresintotheirclinicaltrialsandhaveinvestedinthecreationandvalidationofnewdigitalendpoints,withsomeevenbuildingmolecule-to-marketdigitalstrategiesthatoverlaytheirdrugdevelopment

programs.Byofferinghigherqualityofdatacapture,moreconsistentmeasurementsandincreasedsensitivitythantraditionalmethods,somedigitalendpointshaveoptimizedclinicaldevelopment,allowingtrialsponsorstoreduceclinicaltrialenrollmentandtheyfurtherpromisetoreducetrialdurationandtheneedforpatientstotraveltotrial

sites.TheFDAandEMAhavealsobeguntoapprove(or“qualify”)digitalendpointsforuseinclinicaltrials,withthefirstonesusingwearablestoassessCOPD,Duchennemusculardystrophyandatrialfibrillation.Whilesomedigitalendpointsmayeventuallyreplaceexistingmethods,othersmayserveasobjectivemeasuresalongsidemoresubjectiveclinicaloutcomeassessmentswithincombinationendpointstogiveaclearerpictureofpatient

experience.DIGITALDIAGNOSTICSANDOTHER

HEALTHASSESSMENT

TOOLSSoftware-baseddevicesthatprocesssignalsfromsensorshaverapidlyopenednewroutestoassessdiseaserisk,speeddiagnosisandmonitorpatienthealthandatleast103suchdigitaldiagnosticsarenowcommerciallyavailable.Conditionsnowdetectableusingthesetoolsincludeautismspectrumdisorders,sleepapnea,atrialfibrillation,skincancers,epilepsy

andsepsis,amongothers.Manyofthesedevicesareenabledbyartificialintelligenceandmachinelearning,andintheUnitedStates,around75oftheseAI/MLenabledmobileandpoint-of-caretoolshavebeenapprovedbytheFDA.ThisfitsinwithinabroaderdevelopmenttrendtowardsusingAItoimprovediagnosticequipmentandas

ofJune2024801distinctAI/MLenableddevices—mostlylarge-footprintradiologyequipmentorimageanalysissoftwareusedinhospitals—hadreceived

approval.UsingAI,algorithms,imagematchingandotherapproaches,mobilehealthassessmenttoolsspanthepatientjourneywithconsumer-facingappshelpingtoidentifypotentialcausesofsymptoms,consumerwearablesscreeningundiagnosedpatientsforsignsofdisease,anddigitaldiagnosticsenablingproviderstodiagnoseandmonitorpatientsremotely.Digitalsolutionsthatspeedandimprovediagnosisnotablyoffertoexpandthepopulationrecognizedtorequiretreatmentandallowforearlyintervention.Amongthese,riskscreeningtoolsbuiltonconsumersmartphonesandwearablesoffergreat

abilitytospeeddiagnosisanddemocratizehealthassessmentbyreachingglobalpatientpopulationsandwhentheyprovideanegativeresult,mayreducethenumberofpatientsunnecessarilyreferredtospecialist

care.4|DigitalHealthTrends2024:Implicationsfor

ResearchandPatientCareUsingAI,algorithms,image

matchingandotherapproaches,mobilehealthassessmenttoolsspanthepatientjourneywithconsumer-facingappshelpingtoidentifypotential

causesofsymptoms,consumerwearablesscreeningundiagnosedpatientsforsigns

of

disease,

and

digital

diagnosticsenablingproviderstodiagnoseandmonitorpatients

remotely.Remotepatientmonitoringtoolssuchaswearablesandsymptom-trackingappsarebeingcombinedintobroaderclinical“platform”solutionsforproviderstomonitordiseaseprogressionorresponsetotherapy,detectrecurrenceandevenpredictfuturehealthchangestotriagepatientsingreatestneedofcare.Thishasenabledthecreationofhospital-at-homesolutionsthatcontinuouslydetectandpredict

adverseevents,therebyspeedingpatientdischargefromhospitalsettingsandimprovingqualityoflifeforpatientsbeingtreatedwithadvancedtherapiesandmedicineswithhigherrisk

profiles.Thelinebetweenconsumergradedevicesandclinicalgradedeviceshasalsobeguntoblurasmedicaldevicecompaniesdevelopconsumerwearablesaimedatwellnessandlifestyleoptimizationandconversely,medical-gradesensorsbegintobeaddedtoconsumerproducts,makingin-homehealthandchronicconditionmanagementincreasinglyapartofdailylife.UPTAKEANDUSEOFDIGITALHEALTH

TECHNOLOGIESTheuseofdigitaltechnologiescanbeexaminedinvariouswaysbasedonhowtheyare

prescribed,dispensed,distributed,billed,andreimbursed.Multipledatasourcesshowthatpatientsandhealthsystemsareincreasinglyrelyingoninnovativedigitalsolutionstoclosecaregapsacrossthepatientjourney,withmorerapidgrowthinsomegeographiesthan

others.Digitaltoolsarealsobeingusedtocareforpatientswithabroadrangeofdiseases,butnotablyforhigh-riskchronicconditions,includinghypertension,diabetes,heartfailure,andsleep

disorders.Theuseofdigitalhealthassessmenttoolsforremotepatientmonitoringandmanagementhasgrownmostrapidly,drivingsomecountriesto

establishreimbursementpathways.IntheUnitedStates,providerbillingforremotephysiologicalmonitoring

increasedfive-foldinthepastthreeyears,anduseofnewcodesforremotetherapeuticmonitoringnearlyquadrupledintheyearendingSeptember2023.Appsforobesityandweightmanagementhavegainedsignificantuse,witharound1.5millioninstallsonaverage,althoughmentalhealthappsaremorewidelyavailableandcollectivelyaremorewidelyusedthanweightmanagement

apps.Musculoskeletaldigitalcaresolutionsarenotablygainingtractionintheemployerbenefitmarket,withchargedmedicalclaims

growing.UseofdigitaltherapeuticshasbeengrowinginGermany,whilecommercializationchallengesintheUnitedStateshavecontributedtotheinsolvencyofsomecompanies.ManyearlyentrantsintotheU.S.marketwithpharmacy-dispensedDTxarenolongerinbusinesstoday—theiruptakenotablylimitedbylackofreimbursementforcingpatientstopayoutofpockettoreceiveaccess.However,thenewcohortofDTxenteringamorematuremarketmayfarebetter.InGermany,where56digitaltherapeuticsarecurrently

eligibleforreimbursementandtheDiGAdirectorydoublesasacentralizedrepositoryofclinicalevidenceoneachtoinformproviders,prescriptionvolumehasbeenincreasingoverall.Multipledatasourcesshowthatpatientsandhealthsystemsareincreasinglyrelyingoninnovativedigitalsolutionstoclosecaregapsacrossthepatientjourney,with

morerapidgrowthinsomegeographiesthan

others.

|

56|DigitalHealthTrends2024:Implicationsfor

ResearchandPatientCareThelandscapeofdigital

health+Thepasttwoyearshavemarkedaperiodofretrenchmentindigitalhealth,withsomeestablishedcompaniesbecominginsolvent

andmanyshiftinganddiversifyingtheirbusinessmodelsto

survive.+Afteranearcontinuousdeclineindigitalhealthventure

funding

since

early

2021,

a

Q2

2024

increaseoffershopeforarebound,althoughthenumberofdigital

health

deals

remain

at

its

lowest

since

2019.1,2+Inatypicalinnovationcycleaftersuchperiodsof

disillusionment,

new

products

come

to

marketthatbettermeetthe

needsofstakeholdersandare

more

commercially

viable

—

just

as

we

see

nowwithdigitalhealthproductsevolvingtobetterfitintoexistingcare

pathways.+

The

scope

of

digital

health

continues

to

expandwith

more

defined

segments

of

innovation

anddeveloperscombiningtheseindividual

producttypesinto“solutions”withbothpatientandphysician-facing

interfaces.+Digitalsolutionsnowassistpatientandphysiciansacrossthefullpatientjourneyfrompreventativeself-caretoriskassessment,triage,diagnosis,treatment,

and

monitoring

—

offering

to

acceleratethisjourneyandimprove

outcomes.+Physician-focusedsolutionsareakeyareaofinterest

to

life

sciences

companies

and

includetoolstosupportclinicaldecision-makingandremotelymonitorpatientoutcomesinclinicalresearchand

care.INVESTMENTINDIGITAL

HEALTHDigitalhealthcanbedefinedinmanyways.TheFDAdescribesdigitalhealthtechnologies(DHTs)broadlyas“systemsthatusecomputingplatforms,connectivity,software,and/orsensors,forhealthcareandrelateduses.”4Inthisreport,wefocusmorenarrowlyontheuseofmobiledevices(suchasmulti-usesmartphones,tablets,virtualrealitydevices,consumer

wearables,andin-homevirtualassistants)intendedtoimprovehealth,alongwiththeirassociatedapps,biometricsensors,connecteddevices,analyticalgorithms,andsoftware

platforms.Thevalueofmobiletoolsderivesfromtheirabilitytoextendpatientcareandhealthassessmentbeyondtheirtraditionalsettingsintothehome,tothepoint-of-careortoprimarycaresettings.Theyarenowusedacrossthepatienthealthjourneyfordiseasediagnosis,prevention,symptommanagement,therapy,andmonitoring.Todelivertheirbenefits,theymayrecordandanalyzedataincludingbiometricmeasuresofhealth,communicateinformation,anddeliverhealthinterventions(sometimesasgamesandvisualexperiences)andtherebyinfluenceanindividual’shealthbehaviorsordiseaseself-management,oraprovider’sclinical

decision-making.Asiscommonintheworldofemergingtechnologiesandinnovation,aninitialperiodofexcitementandhighexpectationisoftenfollowedbyaperiodofretrenchmentwheresomecompaniesfailandthemoodofstakeholderslevelsofforturnspessimistic.3Overthepastfewyears,asregulatoryandcommercialpathwaysevolved,adiversearrayofnewdigital

healthtechnologiesandproductsenteredthemarket.However,attainingsuccessinthatyoungmarkethasnotbeenstraightforward,andevengroundbreakingcompaniesindigitaltherapeuticssuchasPearTherapeuticshavegonebankrupt,ashasBabylonfordigitalcare,Kiioformusculoskeletalcare,andBetterTherapeutics(whosediabetesdigitaltherapeuticwaslaunchedmonthspriortoitsdemise).Others,includingAkili,struggledtoturnaprofit,andsought“strategicbusinessalternatives”5orhavebeenacquired,dampeningthemoodsignificantlyandimpacting

funding.Indeed,thepasttwo-and-a-halfyearshaveseencontinuousdeclinesinthenumberofdigitalhealthdealsandtotaldigitalhealthinvestmentcloseto2019levels(Exhibit1).1,2FollowingapeakperiodpostCOVID-19wherehealthcarerapidlydigitizedand2021annualventurefundingroseto$59.3Bn,itthenfelltohalfthat,or$22.8Bn,in2023withfewerdealsandlower

average

|

7dealsizes.1,2AlthoughtoplinequarterlyfundingandnumberofdigitalhealthdealsremainedatrecentlowsasrecentlyasQ12024,thesecondquarterhasofferedhopeforarebound,showinghighertotalfundingandhigheraveragedealvalues.2Outsideoftheventurecapitallandscape,lifesciencescompanieshavecontinuedtoinvestindigitalhealthinwaysthatwillinfluencebothpatientcareandresearch.Physician-focusedsolutionsthatsupportdiagnosticandtherapeuticdecision-makinghavebeenakeyareaofinterest,however,investmentsspanapplications.Theyincludetheuseofsensorstocapturedigitalendpointsindrugdevelopmenttrials,thedevelopmentofdigitaltherapeuticstoimprovepatienthealth,digital

healthassessmenttoolstosupportandacceleratediagnosis(andtreatment),andremotepatientmonitoringtoolstohelpcliniciansandinvestigatorsimprovepatient

outcomes—alldiscussedindifferentsectionsof

thisreport.Finally,morepositivenewscomesfromtypicalphasesofthe“innovationcycle.”Followingperiods

ofdisillusionmentwithhotnewtechnologiesandlessonslearned,newproductstypicallycometomarketthatbettermeettheneedsofstakeholdersandaremorecommerciallyviable.Inthecaseofdigital

health,developersnowbetterunderstandmarketpitfallsandareincreasingtheirappealwith

next-generationproducts.Physicians,havinggainedpriorexposure,arealsolikelytobetterunderstandhownewproductscanfitintoorimprovetheirbusinessandpatient

care.3Alreadyweareseeingproductdevelopersgravitatetoalternatebusinessmodelswithclearercommercialprospectsandlowerregulatoryandreimbursementbarriers.Thisenablesthemtoobtainrevenueearlierintheirlifecyclewhiletheyrefinetheirproductsovertime.Theyarealsohorizontallyandverticallyintegratingwithothercompaniestobuildsuitesofproductsthatfitbetterintoexistingcarepath