Deep dive: Emerging Technology in Healthcare and Medicine · 2016-11-14 · genomics, nanomedicine,...
Transcript of Deep dive: Emerging Technology in Healthcare and Medicine · 2016-11-14 · genomics, nanomedicine,...
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NOVEMBER13,2016
DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
Inthisreport,weexaminesomeofthe latesttechnology inhealthcare,suchasgeneeditingandgenetherapy,personalgenomics, nanomedicine, organs-on-chips, regenerativemedicineandothertrends,suchaswearabletechnologyandrobotics.Thesearesomekeyfindings:
1) TheglobaldigitalhealthcaremarketwasworthUS$60.8billion in 2013, and is estimated to grow to US$135.9billion in 2017 and reach nearly US$233.3 billion in2020.
2) There are some 4,000 diseases linked to geneticdysfunction.Conventionaldrugsdonotwork forabout75%ofcancer(ageneticdisease)patients,onaverage.
3) The global nanomedicine market was worth US$248billion in 2014, and is projected to grow at a CAGR of16.3%toreachUS$528billionin2019.
4) The market for organs-on-chips was worth someUS$31.5 million in 2015, and growth is expected tosurgeataCAGRof70%by2020.
5) New developments in healthcare must solve theproblems that patients and healthcare professionalsface regularly, in order to become economically viableandsuccessful.
6) Theyalsoneedtogetthroughthelongstagesofclinicaltrialsandgainregulatoryapprovalsfaster,inordertobeavailabletothemassmarket.
D E B O R A H W E I N S W I G M a n a g i n g D i r e c t o r ,
F u n g G l o b a l R e t a i l & T e c h n o l o g y d e b o r a h w e i n s w i g @ f u n g 1 9 3 7 . c o m
U S : 6 4 6 . 8 3 9 . 7 0 1 7 H K : 8 5 2 . 6 1 1 9 . 1 7 7 9
C N : 8 6 . 1 8 6 . 1 4 2 0 . 3 0 1 6
Deep dive: Emerging
Technology in Healthcare and
Medicine
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NOVEMBER13,2016
DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
TABLEOFCONTENTS
EXECUTIVESUMMARY 3
INTRODUCTION 4
DIGITALHEALTHCARE:SOONTOBEAUS$136BILLIONMARKET 5
1.GENEEDITINGANDGENETHERAPY 6
WHYISITIMPORTANT? 7THECURRENTSTATEOFGENETHERAPY 7THEOUTLOOK 9
2.PERSONALGENOMICS 10
WHYISITIMPORTANT? 10THECURRENTSTATEOFPERSONALGENOMICS 11THEOUTLOOK 12
3.NANOMEDICINE 12
WHYISITIMPORTANT? 13THECURRENTSTATEOFNANOMEDICINE 14THEOUTLOOK 15
4.ORGANS-ON-CHIPS 16
WHYISITIMPORTANT? 16THECURRENTSTATEOFORGANS-ON-CHIPS 17THEOUTLOOK 17
5.REGENERATIVEMEDICINE 18
WHYISITIMPORTANT? 18THECURRENTSTATEOFREGENERATIVEMEDICINE 18THEOUTLOOK 19
6.OTHERTRENDS 20
WEARABLESANDTHESMART,HEALTHYHOME 20THERISEOFTHE“-BLES”—EMBEDDABLES,INGESTIBLESANDHEARABLES 21AIANDVRINTHEOT 21ROBOTICSANDHEALTH 21
KEYTAKEAWAYS 22
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NOVEMBER13,2016
DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
EXECUTIVESUMMARY
Inthisreport,weexaminesomeofthelatesttechnologyinhealthcareandexplorehowthiscantransformthefieldasweknowit.Wewilllookatthefollowingemergingtechnologicaldevelopmentsinhealthcare:geneeditingand gene therapy, personal genomics, nanomedicine, organs-on-chips andregenerativemedicine,aswellasothertrends,suchaswearabletechnologyandrobotics.
Gene editing/gene therapy: Gene editing or gene therapy involves theintroductionofnewgenes,usuallyintotheareaofthebodymostaffected,toreplacemissingordefectiveones.Therearesome4,000diseaseslinkedtogeneticdysfunction,accordingtotheAmericanMedicalAssociation.
Personal genomics: This is the sequencing and analysis of an individual’sDNA, to identify his or her various hereditary traits and the likelihood ofbeing prone to developing certain conditions or disorders. Conventionaldrugsdonotworkforabout75%ofcancerpatients,onaverage.
Nanomedicine: Nanomedicine is the application of nanotechnology formedicaluse.TheglobalnanomedicinemarketwasworthUS$248.3billionin2014andisprojectedtogrowataCAGRof16.3%toreachUS$528.3billionin2019.
Organs-on-chips: These are tiny laboratory-synthesized cells placed on achiptoemulatetheworkingsofhumanorgans.Themarketfororgans-on-chipswasworthsomeUS$31.5million in2015,andgrowth isexpectedtosurgeataCAGRof70%throughto2020.
Regenerativemedicine: Regenerativemedicine is an interdisciplinary fieldthataimstorestorethefunctionandformofdegeneratedcells,tissuesandorganstotheirformerororiginalstate.TheregenerativemedicinesmarketisestimatedtobeworthsomeUS$17.1billionby theendof2016,andtogrowataCAGRof23.7%throughto2021,atwhichtimeitisexpectedtobewortharoundUS$49.4billion.
While these tech developments all look very promising, they need to beabletoachievethreethingstocommercializequicklyandhaveameaningfulimpact: 1) they must solve problems that patients and healthcareprofessionals face regularly; 2) they need to be affordable to the massmarket;and3)theyneedtogetthroughthelongstagesofclinicaltrialsandgainregulatoryapprovalsfaster.
Source:Shutterstock
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DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
INTRODUCTION
Modernhealthcareandtechnologyhavealwaysbeenintertwined.Fromtheinventionofbasicsurgicaltoolssuchasscalpelsandprobesinthe1800stothe exceptionally sophisticated health equipment in use today, scientists,technologistsandinnovatorsquestforlife-savingcreationsisneverending.
Inthisreport,weexaminesomeofthelatesttechnologyinhealthcare,andexplorehowthiscantransformthefieldasweknowit.
Wewilllookatthefollowingemergingdevelopmentsinhealthcare:
1. Geneeditingandgenetherapy
2. Personalgenomics
3. Nanomedicine
4. Organs-on-chips
5. Regenerativemedicine
6. Othertrends,suchaswearabletechnologyandrobotics.
First, we offer an overview of the size and composition of the digitalhealthcaremarket.
Source:Shutterstock
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DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
DIGITALHEALTHCARE:SOONTOBEAUS$136BILLIONMARKET
Health technology, as theWorld Health Organization describes it, is “theapplication of organized knowledge and skills in the form of devices,medicines, vaccines, procedures and systems developed to solve a healthproblemand improvequality of lives.”Digital healthcare, a part of healthtechnology,involvestheuseofinformationandcommunicationsystems,toaddressapatient’shealth conditions. TheglobaldigitalhealthcaremarketwasworthUS$60.8billion in2013, according tomanagement consultancyArthurD.Little.ThefirmestimatesthiscouldincreasetoUS$135.9billionin2017andreachnearlyUS$233.3billionin2020.
Figure1.GlobalDigitalHealthMarketSize(2013-20,USDBil.)
EHRisElectronicHealthRecords;EMRisElectronicMedicalRecords.Source:ArthurD.Little/GSMAIntelligence/AlliedMarketResearch/Accenture/IHS/MarketsandMarkets
Withintheoveralldigitalhealthmarket:
• Telehealth is expected to be the fastest-growing segment, with aCAGR of 46%. This segment comprises medical devices andcommunication technology to monitor patients, including videoconsultationswithphysicians,whichwediscussedextensivelyinourpreviousreport,TheUberificationofHealthcare.
• Mobilehealth,anotherpromisingsegment,isexpectedtogrowataCAGR of 36%.Mobile apps and services are categorized under thissegment. The wireless health segment includes handheld devicesandsensors,andisexpectedtogrowataCAGRof23%.
• Electronichealthrecords(EHR)andelectronicmedicalrecords(EMR)arealreadyestablishedsegments,sotheseareexpectedtogrowataslowerCAGRof6%.
0.4 4.5 6.36.424.2
55.9
20 24.8 29.123.8
59.7
103.2
10.122.6
38.9
60.8
135.9
233.3
0
50
100
150
200
250
2013 2017* 2020*
Telehealth MobileHealth EHR/EMR WirelessHealth Other** Total
TheglobaldigitalhealthcaremarketwasworthUS$60.8billionin2013.ThisisexpectedtoincreasetoUS$135.9billionin2017andreachnearlyUS$233.3billionin2020.
Telehealthisexpectedtobethefastest-growingsegment,withaCAGRof46%.MobilehealthisexpectedtogrowataCAGRof36%.
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NOVEMBER13,2016
DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
Manyservicesbasedaroundtheabovesegmentsindigitalhealthhavebeenin existence for at least a decade now, with the growth in mobile andcommunication technology developing these further. There are, however,several innovations thatcombineelementsof the information technology,biotechnologyandpharmaceuticalsectors.
Biotechnology is the manipulation of biological processes to obtain theoptimum benefits from them, and the transfer of the process totechnological equipment and applications. Based on the data of 1,174global,publicbiotechcompaniesonS&PCapitalIQ’sdatabase,wecalculatethat the industry generatednearlyUS$152billion in revenue in 2015.WeexpectthistogrowataCAGRof16.2%tosomeUS$177billionbytheendof2016,andtonearlyUS$323billionby2020.
Ofcourse,notallofthesecompanies’coreofferingsareforhumanhealthandmedicalcare,assomecreateproductsandsolutionsforagricultureandanimal healthcare. And there are also several companies that createproductsandsolutionsforusebyhumans,animalsandplants.
Thesubsequentsectionsofthisreportconsiderourfiveemergingthemesinhealthcare.
1. GENEEDITINGANDGENETHERAPY
Genes are microscopic components of human, animal or plant cells thatimparthereditary characteristics to theoffspringof theparent.GenesaremadeupofDNAandactasinstructionstomakeproteins.Somegenesmaybe structured differently from regular, normally-functioning genes, whichcausehealthconditionsordiseasesinalivingorganism.
Geneeditingorgenetherapyinvolvestheintroductionofnewgenes,usuallyintotheareaofthebodymostaffected,toreplacemissingordefectiveones.
Source:Shutterstock
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DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
Gene editing or gene therapy involves the introduction of new genes,usually into the area of the body most affected, to replace missing ordefectiveones.
Whyisitimportant?
Thereare some4,000diseases linked togeneticdysfunction,according totheAmericanMedicalAssociation.SomeofthepossiblediseasesthatgenetherapycanaddressareAIDS,cancer,cardiovasculardisease,arthritis,andParkinson’s and Alzheimer’s diseases. The figure below shows theconditionsbeingaddressedbyclinicaltrials.
Figure2.Global:GeneTherapyClinicalTrialsbyCondition(throughtoFeb2016)
Source:TheJournalofGeneMedicine,JohnWileyandSonsLtd.
Geneeditingalsoformsanimportantpartofresearchstudies.Scientistsareusing this method to observe the effects of altering the genes of livingorganisms,ontheirregularfunctionsandbehavior.
TheCurrentStateofGeneTherapy
Scientists performed the first successful gene therapy treatment in 1990.Sincethen,therehavebeenmanyclinicaltrialsbutveryfewhavemadeittoadvancedstages.Clinical trialsareconductedamongagroupofpeople todetermine if a treatment is safe and effective. They are regulated bygovernmentandareconductedinaseriesofsteps,calledphases,witheachintendedtoansweraseparateresearchquestion.
Belowisasummaryofthevariousphasesinclinicaltrials,asoutlinedbytheUSFoodandDrugAdministration(FDA).
64%
8%2%2%
8%
1%10%
2% 1%2%
Cancer
CardiovascularDiseases
GeneMarking
HealthyVolunteers
InfecmousDiseases
InflammatoryDiseases
MonogenicDiseases
NeurologicalDiseases
OcularDiseases
Others
Glybera,adrugtotreatlipoproteinlipasedeficiency(LPLD),araregeneticdisorder,launchedinGermanyin2015atamarketpriceofaboutUS$1.4millionpercourseoftreatment.
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DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
Figure3.SummaryofClinicalTrialPhasesintheUS
PhaseI PhaseII PhaseIII PhaseIV
SizeofTrialGroup 20-100healthyvolunteersorpeopleafflictedwiththeconditionforwhichthedrughasbeendeveloped.
Severalhundredvolunteersthatareaffectedwiththecondition.
Afewhundredtoabout3,000volunteersthatareaffectedwiththecondition.
Severalthousandvolunteersaffectedbythecondition.
Periodoftrialandobservation
Severalmonths Severalmonthstotwoyears
Onetofouryears N/A
Mainpurposeoftrial Totestthesafetyofthedrugadministeredandthedosagethatcanbeadministered.
Totesttheeffectivenessofthedrugsandgainadeeperunderstandingoftheside-effects.
Tomonitortheeffectivenessofthedrugandanyadversereactionsitmayhaveonalargergroupofsubjects,overalongerterm.
ThisstageofobservationisconductedaftertheFDAhasapprovedthemarketingofthedrug.ThemainpurposeistomonitortheeffectsoveranevenlargergroupandoveralongerperiodoftimethanforPhaseIIItrials.
Proportionofdrugsthatprogresstonextstage
Approx.70% Approx.33% Approx.25-30% N/A
Source:USFDA
Somedrug trialsmay involvemultiple stages, forexample,one stagemaybetotestthehighestdosethatissafe,whilethenextstagemaybetotesttheeffectivenessofthedrug.ThesearesometimesdenotedasPhaseI/IIorPhase II/III. When a trial is conducted only on an individual patient, toinvestigate how he or she may respond to treatment and test theeffectivenessofthedrug,itiscalledaSingleSubjecttrial.
Medicines and treatments need to pass these phases in clinical trials inordertobemadeavailabletothemassmarketandsellsuccessfully.AsofFebruary2016 (the latestdate forwhichdata is available), very few trialshad reachedadvancedstages in theUS, sowemaystillbea longwayoffbeforeweseegenetherapyusedinregularclinicalpractice.
Source:Shutterstock
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NOVEMBER13,2016
DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
Figure4.Global:GeneTherapyClinicalTrials,byStage
Source:TheJournalofGeneMedicine,JohnWileyandSonsLtd.
However, in 2012, the EuropeanMedicines Agency (EMA), the regulatoryauthority for the European Union, approved a gene therapy drug calledGlybera for the treatment of lipoprotein lipase deficiency (LPLD), a raregenetic disorder. The drug formally launched in Germany in 2015 at amarketpriceofaboutUS$1.4millionpercourseoftreatment,andhassincebeenusedtotreatonlyonepatient.
UniQure, the firm thatdevelopedGlybera,hasnot foundmuchsuccess ingaining regulatoryapprovalelsewhere.And,perhaps,unsurprisingly,giventhe price tag, it has come under the scrutiny of cost-effectivenesswatchdogsinGermany.
The EMA approved a second gene therapy drug, called Strimvelis, forchildren suffering with Adenosine Deaminase Severe Combined ImmuneDeficiency(ADA-SCID),anultra-raregeneticdisorderthatonaveragejust15childrenarebornwithinEuropeeachyear.IndustrygiantGlaxoSmithKline,thedeveloperof thedrug, receivedmarketingauthorization inMay2016,and is selling theone-time treatmentdrug forUS$665,000withamoney-backguarantee.
TheOutlook
Aside from UniQure and GlaxoSmithKline, which appear to be the onlycompanies thathave so far received regulatoryapproval forgene therapytreatments, there is no clear market leader yet. New entrants face thehurdleofovercomingthehighpricetagthedrugsarelikelytocarry.
57.6%
20.3%
17.1%
1.0%3.7% 0.1%
0.2%
PhaseI
PhaseI/II
PhaseII
PhaseII/III
PhaseIII
PhaseIV
SingleSubject
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DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
Conditionssuchascancerare,toalargeextent,uniquetoapatient’sgeneticmakeup,andconventionaltreatmentsdonotworkforabout75%ofpatients,onaverage.
2. PERSONALGENOMICS
Personalgenomicsisthesequencingandanalysisofanindividual’sDNA,toidentifyhisorhervarioushereditarytraitsandlikelihoodofbeingpronetodevelopingcertainconditionsordisorders.
WhyisitImportant?
Genes hold awealth of information about people’s unique characteristicsandtheirlineage.Aperson’sgenesmaybeabletoprovideanindicationofcommon physical and psychological traits associated with ancestry, thehealth conditions and illnesses that run in the family, and the things oneshoulddotostayhealthy.
Personalizedmedicine, a branch ofmedicine that treats people based ontheir genetic sequence, aims to increase the accuracy of diagnosis andtreatmentforsomeconditions,asthedrugstypicallyusedfortheconditionmaybeineffectiveintreatingthem.
Conditions such as cancer are, to a large extent, unique to a patient’sgeneticmakeup.Conventionaldrugsdonotworkforabout75%ofpatients,onaverage,accordingtoaresearchpaperpublishedinthejournalTrendsinMolecular Medicine, which analyzes the responses of patients to drugs,basedontheirgenetics.
By knowing how a patient will respond to certain drugs based on theirgeneticsbeforehand,throughpersonalizedmedicine,doctorswillbeabletodiagnose and treat the illness more effectively. They will not have toprescribe the typicalmedication to thepatientbasedonhisorherhealthhistoryandconditions,andthenfindanalternativetreatmentshouldtherebeanadversereaction.
Moreover, personalized medicine can enable a preventive approach tohealthcare by identifying conditions a person is susceptible to, throughgenome tests. The person may then be able to make healthy lifestylechangesortakeacourseofaction,suchastreatment,inadvance,toavoidtheconditionaltogether.
Figure5.PercentageofPatientsforWhomaTreatmentisIneffectiveonAverage
Source:BrianB.Spear,MargoHeath-Chiozzi,JeffreyHuff,ClinicalTrendsinMolecularMedicine
38%
40%
43%
50%
70%
75%
Anm-Depressants
AsthmaDrugs
DiabetesDrugs
ArthrimsDrugs
Alzheimer'sDrugs
CancerDrugs
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DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
Initsnascentyearsoftheearly2000s,thecostofsequencingahumangenomewasaroundUS$300million,butnowabasicdirect-to-consumertestcanbedoneforaslittleasUS$199.
TheCurrentStateofPersonalGenomics
Technological advancements in genome research have grown at a fasterpace thanwhatwasdeclaredbyMoore’s Law (an ideaadvocatedby Intelco-founder Gordon Moore that the capacity of computer processorsdoubles every two years). In its nascent yearsduring theearly 2000s, thecostofsequencingahumangenomewasaroundUS$300million,butnowithasbecomefarmoreaccessibletothegeneralpublicandcanbedoneforaslittleasUS$199forabasicdirect-to-consumertest.
The table below shows the dramatic fall in the price of a single genomesequence,from2001to2015.
Figure6.Global:CostofaSingleGenomeSequence(2001-15)
Date Costpergenome
2001 US$95,263,071.92
2005 US$13,801,124.19
2010 US$29,091.73
2015 US$1,245.00
Source:NationalHumanGenomeResearchInstitute
Attheexorbitantcosts in itsearlydays,genomesequencingwasavailableonlyforresearchortotheultra-wealthy,butthedrasticfallinprice,duetotechnological advancement, has led to several direct-to-consumercompaniesformingasaresult.
We have listed some of the popular genomics profiling companies in thefollowing table, to provide examples of the services they provide and theapproximatecost.
Figure7.ProfileofPersonalGenomicsCompanies
CompanyInformationProvidedbytheTest
Method Cost
23andme Ancestry,healthandwellness,andtraitsreports
Thecompanysendsthecustomeratubetocollectsalivaandaself-addressedenvelope/boxtoreturnthesample.Customersneedtoregisteronlinewithafewpersonaldetailsandthebarcodeonthetube.Resultsaremailedtothecustomerinafewweeks.
US$99foranancestryreport,US$199forareportonancestryandhealth.
Color Cancerriskprofile Ordersneedtobeplacedthroughaphysician.Similarmethodas23andme’s,forcollection.
US$249
Counsyl Healthprofileforfamilyprepandidentifyinginheriteddisorders
Counsylneedstheapprovalofaphysicianbeforesendingakittocustomers.Similarmethodas23andme’s,forcollection.
Costsvarybasedonthetypeofscreeningchosenandtheadditionalservicesrequested.
Source:Companyreports
Attheexorbitantcostsinitsearlydays,genomesequencingwasavailableonlyforresearchortotheultra-wealthy.
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DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
TheglobalnanomedicinemarketwasworthUS$248.3billionin2014andisprojectedtogrowataCAGRof16.3%toreach$528.3billionin2019.
Thereareseveralothercompaniesthatprovideservicessimilartotheonesabove,withvaryingprice ranges. Thereareeven some thatprovidemorespecific information on a health condition and how a patient may betreated.
TheOutlook
Whilemany find such in-depth analysis of their genetic profile fascinatingandhelpful, thereareotherswhofeel that it isunnecessarytoknowlittleinformation without adequate detail and without the knowledge tounderstand it.Forexample,knowingthatone’sDNA isa likelycarrierofadiseaseorthatone’sDNAmakeshimorhersusceptibletoacertainkindofillnessmaycauseunwarrantedworryandpanic,asanaveragepersonwithno medical knowledge may not understand the implications of theinformationgiventothem.
3. NANOMEDICINE
Nanomedicine is the application of nanotechnology for medical use.Nanotechnologyinvolvestheengineeringanduseofminiaturemachines—ones that are at an atomic ormolecular level. Inmoreprecise terms, the“nano-” prefix is used to signify a measure equivalent to one billionth.Nanoparticlesareinvisibletothehumaneye.
Source:Shutterstock
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DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
WhyisitImportant?
Expertsviewnanomedicineasapossiblesolutiontotheproblemsposedbytraditionalmethods of drug delivery, i.e. the passage of a drug through apatient’sbody to safelyandeffectivelydeliver thedesiredeffect. Inmanycases,adrugmaynotbeeffectivelyabsorbedbythebodyandmayevenbeeliminatedfromthebodybeforeitcanachievetheintendedpurpose.
Nanotechnologyallowsgreatercontroloverthepathadrugtakesonceitisingested. Thedrug is placed in a carrieror ananoparticle that ismadeofmaterial suitable to attach easily to the affected area or organ. Once itreachestherightdestination,thedrugisdispensedfromthecarrier.
Another application for nanomedicine is to visualize and detect tumorsfromMRIscans.Withthismethod,thepatientisinjectedwithnanoparticlesand an MRI scan is done. If the area of the body has a tumor, thenanoparticles will not be absorbed and show up as bright spots, helpingdoctorstodetectthepresenceofatumor.
Anewerapplicationthatisbeingtestedfornanotechnologyisthedeliveryof cancer drugs through nanorobots, or nanobots as they are commonlycalled.Conventionalcancertreatmentssuchasradiationorchemotherapydonot justdestroythecancerouscells,butaffecthealthycellsaswell.Onthe other hand, nanobots will actively seek out cancer cells and releasedrugsonlywhentheyreachthosecells.
Source:Shutterstock
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DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
ThemarketfornanomedicinesforcancerwasworthsomeUS$75.4billionin2014,andisexpectedtogrowataCAGRof13.2%throughto2019,whenitwillbeworthaboutUS$140.2billion.
TheCurrentStateofNanomedicine
Thefirstnano-drugwasapprovedbytheFoodandDrugAuthority(FDA)intheUS in 1995, and since then, severalmorehavebeen approvedby theAmerican regulatory body and a few by the Japanese and Europeanregulatorybodiesaswell.
This number continues to grow as doctors, scientists and researchersformulate additional methods to treat existing and new conditions. Theglobal nanomedicine market was worth US$248.3 billion in 2014, and isprojected to grow at a CAGR of 16.3% to reachUS$528.3 billion in 2019,accordingtomarket-researchfirmResearchandMarkets.
Themarket fornanomedicines forcancerwasworthsomeUS$75.4billionin2014,andisexpectedtogrowataCAGRof13.2%throughto2019,whenitwillbeworthaboutUS$140.2billion,thefirmsaid.
The next largest sub-market is for nanomedicines that address conditionsrelatedtothecentralnervoussystem.ResearchandMarketsestimatedthistobeUS$50.3billionin2014,andtogrowataCAGRof15.4%toUS$102.9billionin2019.
Figure8.EstimatedGlobalNanomedicinesMarketSize(2014-19,USDBil.)
Source:ResearchandMarkets
Accordingtoa2012medicalresearchpaper,themajorityofnanomedicinesdeveloped up to 2011 were for cancer, with a larger proportion in aninvestigativestage,whiletherestwereincommercialuse.Thefigurebelowdepicts an approximate number of nanomedicine products developed bytheconditiontobetreated,astheywere listedontheUSclinicaltrials.govdatabaseatthetimeofresearch.
50.3 58.0 67.0 77.3 89.2 102.975.4 85.4 96.6 109.4 123.8 140.2
248.3288.8
335.8
390.6
454.3
528.3
2014 2015 2016 2017 2018 2019
NanomedicinesfortheCentralNervousSystem NanomedicinesforCancer NanomedicinesMarket
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DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
Withthe2016NobelPrizeinchemistryawarded“forthedesignandsynthesisofmolecularmachines,”nanotechnologyanditsvariousapplicationsinthefieldsofmedicineandhealtharelikelytodrawfurtherresearchandinterestinthenearfuture.
Figure9.MedicalUsesforApprovedandLikelyNanomedicineDrugs
*Approximatenumbersin2012.Source:TheBigPictureonNanomedicine:TheStateofInvestigationalandApprovedNanomedicineProducts,Elsevier
TheOutlook
NanobotsandparticlesforMRIimagingcontinuetobeinstagesofresearchand clinical trials, and getting them past regulatory approval is still acomplextask.Gainingapprovalformedicinesisinitselfanarduousprocess,and to obtain it for the technology and robotsmay be a differentmatteraltogether.
Thetechnologyalsoneedstoberefinedtoalevelthatitcanbeautomatedand relied on to the extent that it will not fail, as having machinessuspendedwithinahumanbody,withno realpurposecouldhaveseriousimplications.
And while some of this technology is being developed with the idea oftreating a particular condition, there are other likely treatments beingdevelopedatafasterpacethatmightrendertheformerredundant.
However, with the 2016 Nobel Prize in chemistry awarded to threescientists “for the design and synthesis of molecular machines,”nanotechnology and its various applications in the fields ofmedicine andhealtharelikelytodrawfurtherresearchandinterestinthenearfuture.
0102030405060708090
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Infecmou
sDise
ases
Hepamm
s
Anesthem
cs
CardiovascularDiso
rders
Immun
eDisorders
Endo
crine/Exocrene
Diso
rders
Degene
ramveDisorders
Others
Commercial Invesmgamonal
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DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
4. ORGANS-ON-CHIPS
Organs-on-chips are tiny laboratory-synthesized cells placed on a chip toemulate the workings of human organs. This invention involves a multi-disciplinary field called microfluidics that unites engineering, physics,chemistry, biology and nanotechnology. Components of these chips aresmall,butnotallasminuteasnanoparticles,andtheyalsoserveadifferentfunction.Wethereforeconsiderthemtobeaseparatesegment.
WhyisitImportant?
Organs-on-chipsfacilitateawiderapplicationofpre-clinicaldrugtrialsthatnormallyemployanimalsubjectsintheirstudy,andarenotatreatmentinthemselves. Many times the drugs may not have the same effect onhumans as they do on animals, because the toxicity tolerance is differentforboth.
Syntheticorgans that function,behaveand respond justashumanorgansdocanprovidemoreinsightfulobservationsfromdrugtrials.Anadvantagethat the chip-sized organs have over large ones is that they are lesscomplex,withfewervariablestocontrol,requirelesshardwaresupportandtechnician time to keep themalive, and are thusmore convenient to runtestson.Creatinga largerorganmodel involvessynthesizingmorecells tobuild it, and will require a higher quantity of drugs to run tests, whichultimatelymaynotbecost-effective.
Chip organ technology can help researchers progress faster with thedevelopment ofmedicines and vaccines, and foster cheaper and efficientpharmaceutical,drugandcosmetictesting.
Source:Shutterstock
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NOVEMBER13,2016
DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
TheCurrentStateofOrgans-On-Chips
HarvardUniversity’sWyssInstituteforBiologicallyInspiredEngineeringhasbeenapioneer in chiporgan technology, andhas so fardeveloped lungs,heartsandintestinesonchips.Itaimstocreatetendifferenthumanorganson chips and link them together throughaprogrammedapparatus that ismeanttomimicafullyfunctionalhumanbody.
TheMuseum ofModern Art, New York, and the London DesignMuseumhave even awardedWyss Institute’s organ-on-a-chip with “Design of TheYear”inamovetocurbanimaltestingandpromotemoreethicaldrugandcosmeticstrials.
PharmacompanyAstraZenecaaloneusedabout182,000animalsforglobalresearchin2015,andthisisdownfromthe408,000itusedin2010.Manyothershavealsobeentakingactiontoreducethenumberofanimalsusedfor testing, due to animal welfare groups prompting for hard regulationagainst it. Chiporgan technology can turnout tobea suitable alternativeshouldharderlawsorconsumersentimentmakeanimaltestingtougher.
TheOutlook
Research and Markets estimated the market for organs-on-chips to beworth some US$31.5 million in 2015, and expects growth to surge at aCAGRof70%throughto2020.Asthistechnologyisstillverynewandalsosincethereareonlyahandfulofcompanies (someofwhichareuniversityspin-outs thathaveagreementswithpharmacompanies), thedemand forchiporgantechnologyisexpectedtogrowatarapidpace.
Themarketfororgans-on-chipswasanestimatedUS$31.5millionin2015,andgrowthisexpectedtosurgeataCAGRof70%throughto2020.
PharmacompanyAstraZenecaaloneusedabout182,000animalsforglobalresearchin2015,andthisisdownfromthe408,000itusedin2010.
Source:Shutterstock
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NOVEMBER13,2016
DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
5. REGENERATIVEMEDICINE
Wediscussedregenerativemedicineinthecontextofanti-aginginoursixthreport in the Silvers Series; readers can find that report on our website,FungGlobalRetailTech.com.Here,welookatthebroaderapplicationsofthetechnology.Regenerativemedicine isan interdisciplinaryfieldthataimstorestore the function and formof degenerated cells, tissues andorgans totheirformerororiginalstate.
WhyisitImportant?
In2015,therewerejust15,068organdonors—theycontributedto37,910organ transplants—while the number of Americans that needed an organtransplantwasasubstantial119,926.Theabilitytocreatenewcellswhichcan then go on to form full organs that functionwithin a human body isbeing viewed as a likely solution to address the acute organ shortageproblembeingfacedglobally.
Tissueengineering,asphereofregenerativemedicine, involves implantinghumancells into scaffoldsmadeofbiologicalor synthesizedmaterial, inacontrolledenvironment.Damagedtissuesandorganscanberepairedwiththeuseoftheseengineeredtissues,whicharebeingappliedextensivelyinorthopedicsurgery,abdominalsurgeryandgastrointestinalsurgery.
TheCurrentStateofRegenerativeMedicine
Research company Markets and Markets estimates the regenerativemedicinesmarketwillbeworthaboutUS$17.1billionbytheendof2016,andgrowataCAGRof23.7%throughto2021whenitwillstandatUS$49.4
Source:Shutterstock
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NOVEMBER13,2016
DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
billion. Currently, there are several players that are making products forjointandbonereconstructivesurgeries.
A growing global senior population is likely to bolster the number ofpatients with musculoskeletal conditions, such as arthritis, for whomengineeringproductslikebonegraftscanbeused.
Advancements in technology have provided a boost to stem cell researchandgenetherapy,andmanyofthesolutionsbeingdevelopedunderthesebranchesofregenerativemedicinearestillintheclinicaltrialsstage.
TheOutlook
Technology is one aspect that can boost the progress of regenerativemedicinebutinmanymarketsgovernmentregulationsalsoplayakeyrolein theway the field advances. For example, Japan has specific policies inplace that accelerate the approval of products and treatments inregenerativemedicine.
Japan institutedaspecial forumtobring innovativecompanies inthefieldtogether, and formulated policies to attract foreign companies to set upshop in the country.Of course, Japanalsohas an agingpopulation and islooking for ways to address problems that may arise as a result of thisgrowing demographic. However, it gives Japan a first-mover competitiveadvantage in the field, and perhaps other countries can draw someinspirationfromit,ontheapproachtodeveloplocalemergingtechnology.
Source:Shutterstock
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NOVEMBER13,2016
DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
6. OTHERTRENDS
Apart from themajor technologies listed earlier, there are several othersthat are already being used extensively and have almost become the“norm”inclinicalpractice.Webrieflyoutlinethesebelow.
WearablesandtheSmart,HealthyHome
Themarket for smart devices has grownexponentially in the last decade,andbytheendof2016,researchfirmGartnerpredictsthattherewillbeatleast6.4billionconnecteddevices,up from4.9billionat theendof2015,andexpects thenumber to reach at least 20billion connecteddevices bytheendof2020.
The rise in general health and fitness consciousness has furthered thedemandforwearabletrackersanddevices,andthis issettogrowfurther,with big-brand technology companies, sports brands, fashion brands andthelikeunveilingtheirownversionsofsmartbands,watches,eyewearandsmartphoneapplications.
Butwearableshavegoneastepfurthertohelptrackthehealthandsafetyof agingand infirmpeople. Sensorsplacedaround thehomeareenablingseniorsandpeoplewithvarioushealthconditionstoliveindependently,byconnectingsmarthomedevicesandthewearerofthesmarttrackerwitharemote caregiver. Smart home systems can help remind a person to taketheirmedicationortoturnoffthestoveorassistwithothersimpletasks,orevencallforhelpduringanemergency.
Therewere4.9billionconnecteddevicesattheendof2015,anditisexpectedthattherewillbeatleast20billionconnecteddevicesbytheendof2020.
Source:Shutterstock
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NOVEMBER13,2016
DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
TheRiseofthe“-bles”—Embeddables,IngestiblesandHearables
Healthtrackersarenotjustwearableanymore,butcanalsobeembeddedinto the skin, swallowed through a smart pill or even placed in the earthrough smart headphones. These are expected to track vital healthinformation more discreetly and even deliver results more efficiently, asphysicianswillhavemoreknowledgeofpatientinformationandcontrolthewayconditionsaretreated.
AIandVRintheOT
As technology advances, so does the alphabet soup of innovations, butabbreviations aside, artificial intelligence (AI) and virtual reality (VR) areplaying substantial roles in the operating theatre (OT) and assistingsurgeonswithprocedures.Watson,thecognitiveAI fromtechfirmIBM, isable to read a patient’s symptoms and sift through heaps of data fromclinical studies, medical books, patient records and other information, tohelp doctors diagnose their patients with seemingly rare or complicatedconditions.
VRishelpingphysiciansandsurgeonslookatorgansandareasofthebodyinmoredetailthaneverbefore,whichcanhelpthemdeliverbetterresultswithtreatmentstheydispenseandprocedurestheycarryout.
RoboticsandHealth
Anothermuch talked-about innovation is the use of robots in healthcare.We did discuss tiny robots in the earlier section on nanotechnology, butlarge, life-size robots carrying out various tasks may be a common sighteventually. Robots that assist with surgery, or robotic nurses that helppatients sit up or walk, or care robots that provide companionship to
Healthtrackersarenotjustwearableanymorebutcanalsobeembeddedintotheskin,swallowedthroughasmartpill,orevenplacedintheearthroughsmartheadphones.
Source:Shutterstock
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NOVEMBER13,2016
DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
patients in hospitals and residents in care homes, are a few examples oftheirapplications.
Thedevelopmentanduseofroboticarmsandlegsarealsointhepipelineasanalternativetoprostheticlimbs,astheycanprovidemorestrengthandflexibilityinmovement.
KEYTAKEAWAYS
There seem to be near-endless possibilities for the applications oftechnologyinmedicineandhealthcare.Butforanynewmedicaltechnologyinnovation to be successful, it must solve problems that patients andhealthcareprofessionalsfaceregularly.Itneedstobeabletocurediseasesthatdonotyethavecures,orprovidemoreeffectiveresultsthanpreviouslyusedproceduresandtraditionalmedicine.
Many new cures and procedures, such as gene therapy and personalizedgenesequencing,tendtohaveveryhighpricesandareunaffordabletothelargemajority.Companiesthatdevelopthesesolutionsneedtofindawayto recuperate the investmentmadeandcommercialize theproductsatanaffordablepriceandnarrowthetimeittakesformass-marketadoption.
Another deterrent to commercializing developments that provide fastercures and treatments are the long stages of clinical trials and gainingregulatoryapprovals.Untilcompaniesareabletosolvetheissueoflengthyapproval stages and affordable pricing, no matter how effective a newinnovation is, it may be a long time before these technologies canmakemeaningfulimpactsonthosewhoneedit.
Thereseemtobenear-endlesspossibilitiesfortheapplicationsoftechnologyinmedicineandhealthcare.Butforanynewmedicaltechnologyinnovationtobesuccessful,itmustsolveproblemsthatpatientsandhealthcareprofessionalsfaceregularly.
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NOVEMBER13,2016
DEBORAHWEINSWIG,MANAGINGDIRECTOR,FUNGGLOBALRETAIL&[email protected]:917.655.6790HK:852.6119.1779CN:86.186.1420.3016Copyright©2016TheFungGroup.Allrightsreserved.
DeborahWeinswig,CPAManagingDirectorFungGlobalRetail&TechnologyNewYork:917.655.6790HongKong:852.6119.1779China:[email protected]
JohnMercerSeniorAnalyst
SwaroopraniMuralidharResearchAssistant
HONGKONG:8thFloor,LiFungTower888CheungShaWanRoad,KowloonHongKongTel:85223004406LONDON:242-246MaryleboneRoadLondon,NW16JQUnitedKingdomTel:44(0)2076168988NEWYORK:1359Broadway,9thFloorNewYork,NY10018Tel:6468397017FungGlobalRetailTech.com