Globalvaccinemarket

GlobalVaccineandImmunizationResearchForum
AmieBatson
ChiefStrategyOfficer,PATH
March2016

PATH/EricBecker
Agenda

Overviewofglobalvaccinemarket
Demand
Supply
Financing
Vaccinedevelopmentandvaccinemarkets
Productlifecycle
 Demand criticalfactors

Epidemiology:
Globalandlocal;
Individualandcommunity

Perceivedsafety vaccine
hesitancy
Perceivedvalueformoney
Fitwithdeliverysystem

PATH/GabeBienczycki
 Demand growingmarket

VaccineMarketGrowth VaccineMarketShare2014
40 (US$ApproximateValue)
PerceivedSafety
35 33
vaccinehesitancy
30 28
Perceivedvaluefor
25 UMICS
money 23%
$(Billions)

20 17
Epidemiology:Global
15 LMICs
andlocal 8%
10 HICs
6
Fitwithdeliverysystem 65% LICs
5
4%
0

Source:GlobalVaccineMarketModelpreliminaryroutineimmunizationmarketvalueanalysis,March2016
 Globalvaccinemarkets

GAVI/UN

MIC/LMIC
PUBLIC

US/EUROPE/JAPAN

MIC/LMIC
PRIVATE

Note:OnlynonPAHOcountrieswith>250,000annualbirthcohortincluded.
Source:WorldBankGNI2013,UNPDPopulationProspects2012Edition,GAVIWebsite,September2014
 Globalvaccinemarkets

GAVI/UN
POOLEDPROCUREMENT
MIC/LMIC
Characteristicstofit
indeliverysystem
PUBLIC
Valueformoney

US/EUROPE/JAPAN
Vaccinehesitancy

MIC/LMIC
PRIVATE

Note:OnlynonPAHOcountrieswith>250,000annualbirthcohortincluded.
Source:WorldBankGNI2013,UNPDPopulationProspects2012Edition,GAVIWebsite,September2014
 Supply

Regulatory
requirements:
nationalandWHOPQ
Predictabilityof
demand
Reliabilityandscaleof
production

PATH/Satvir Malhotra
 Vaccinemanufacturers
100% Developing country vaccine manufacturers

90% 21
Other CNBG
Serum
Instituteof
80% India

Global export
4
SanofiPasteur Parastatal
70% Emerging actors
12 global actors
MSD
BioFarma
60%
13 Merck LGLS
InstitutePasteur
deDakar BioM BioE
50% Panacea

17 Pfizer Walvax
40%
Butantan SKChemicals
Razi Innovax
30%
SanofiPasteur
National

Local BBIL
Niche
20%
Birmex Incepta
33
GlaxoSmithKline Biovac
10%
/Novartis Arabio

0%
State-owned Privately held
Shareofmarketvalue
Source:MiloudKaddar,WHO,GlobalVaccinesMarketFeaturesandTrendsPresentation.Geneva,2012;GAVIwebsite,October2014; PATHanalysis
Scalemattersinvaccinemanufacturing:larger
productioncanhelpdrivedownunitcosts.

Indicative cost per dose manufactured

OECD
12M doses

Gavi
57M doses
Illustrativeonly
*Assuming80%
coverage

Manufacturing volume

Source:UnitedNations,DepartmentofEconomicandSocialAffairs,PopulationDivision(2015).WorldPopulationProspects:The2015Revision,customdataacquiredviawebsite.
 Financing

Perceivedvaluefor
moneybymarket
Tieredpricing
Perceivedreliability
andtimelinessof
payor

PATH/JoleneBeitz
TheGAVI/UNICEFprocurementhasdoubledinvaluein
thelast5yearsalone.
UNICEFcontracts(200114)

Source:
UNICEFpublic
data
AscountriestransitionfromGaviandODA,vaccineswillbe
increasinglyfinancedbydomesticbudgets.
Gavitransitions20152030
Demand(numberofdoses)

Source:PATHGlobalVaccinesMarketModel.Providedforillustrativepurposesonly.
AscountriestransitionfromGaviandODA,vaccineswillbe
increasinglyfinancedbydomesticbudgets.
Gavitransitions20152030
Demand(numberofdoses)

Source:PATHGlobalVaccinesMarketModel.Providedforillustrativepurposesonly.
AscountriestransitionfromGaviandODA,vaccineswillbe
increasinglyfinancedbydomesticbudgets.
Gavitransitions20152030
Demand(numberofdoses)

Source:PATHGlobalVaccinesMarketModel.Providedforillustrativepurposesonly.
 VaccineDevelopment whymarketsmatter
Demandandfinancingdepends
oncharacteristicsofvaccine
Fitwithdeliverysystemand
schedule
Valueformoney

Significantinvestment

PATH/AmyMacIver
Investmentsinvaccinedevelopmentandproductionare
significant.Theexpectedmarketsizeisacriticalfactor.

Licensureandproduction
Decision capital
Investment$million

Gate

Decision PhaseIII
Gate

PhaseI&II
Preclinical

Time(years)

*AllcostssourcedfromLight,DonaldW.,JonKimAndrus,andRebeccaN.Warburton."Estimatedresearchanddevelopmentcosts of rotavirusvaccines." Vaccine 27.47(2009):66276633,updatedto2016USD

 Productlifecycle
Earlymarket
Productlaunch Maturity
penetration

Number of
1 12 Several
products

Product capacity Low Medium High

Yieldandlearning
Cost/unit High Relativelyhigh
curvegains

Competitive
Tiers(High/middle Multipletiers
Price High
income) Lowest tierfor
thepoorest

PATH/AmyMacIver
Changinglandscape 2006

Source:
UNICEFpublicdata
Changinglandscape 2007

Source:
UNICEFpublicdata
Changinglandscape 2008

Source:
UNICEFpublicdata
Changinglandscape 2009

Source:
UNICEFpublicdata
Changinglandscape 2010

Source:
UNICEFpublicdata
Changinglandscape 2011

Source:
UNICEFpublicdata
Changinglandscape 2012

Source:
UNICEFpublicdata
 Changinglandscape 2013
This image cannot currently be display ed.

Source:
UNICEFpublicdata
 Changinglandscape 2014
This image cannot currently be display ed.

Source:
UNICEFpublicdata
 Hibvaccineintroduction:high andlowincomemarkets
100%
Percentageofcountriesthathave

90%
universallyintroducedvaccine

80%

70% Highincome markets

60%

50%

40% ~10+years
30%

20%
Lowincomemarkets
10%

0%
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

Yearssincefirstintroduction

Source:InternationalVaccineAccessCenter(IVAC),VaccineInformationManagementSystem(VIMS)GlobalVaccineIntroductionReport,December2015.JohnsHopkins
BloombergSchoolofPublicHealth.
 PCVvaccineintroduction:high andlowincomemarkets
100%
Percentageofcountriesthathave

90%
universallyintroducedvaccine

80%

Highincome markets
70%

60%

50%

40%
~5years
30%

20% Lowincomemarkets
10%

0%
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Yearssincefirstintroduction

Note:LimitedprojectionsareavailableforPCVintroductioninhighincomecountries
Source:InternationalVaccineAccessCenter(IVAC),JohnsHopkinsBloombergSchoolofPublicHealth.VaccineInformationManagementSystem(VIMS)GlobalVaccineIntroductionReport,December2015.
 Newvaccinesarereachingchildrenindevelopingcountries
muchmorerapidly.
100%
Percentageofcountriesthathave

90%
universallyintroducedvaccine

80%

70%

60%

HibHIC
50%
HibLIC

40% PCVHIC
PCVLIC
30%

20%

10%

0%
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26

Yearssincefirstintroduction
Note:LimitedprojectionsareavailableforPCVintroductioninhighincomecountries
Source:InternationalVaccineAccessCenter(IVAC),JohnsHopkinsBloombergSchoolofPublicHealth.VaccineInformationManagementSystem(VIMS)GlobalVaccineIntroductionReport,December2015.
 TieredpricingenabledGAVIcountriestoaccessPCVearlierin
theproductslifecycles

$120.00 PCVpriceandvolumebyMarket2015

$100.00

USA
2015AVERAGEPRICEPERDOSE

$80.00 OtherHICs

UMICs
$60.00
LMICs

Gavi
$40.00

$20.00

$
1M
7M
13M
19M
25M
31M
37M
43M
49M
55M
61M
67M
73M
79M
85M
91M
97M
103M
109M
115M
121M
127M
133M
139M
145M
151M
157M
163M
169M
175M
181M
187M
193M
199M
205M
211M
217M
223M
229M
SHAREOFDEMAND

Source:GlobalVaccinesMarketModel,March2016
 Pricetiering hasalsobeencriticalinacceleratingaccessto
rotavirusvaccines.
RotavirusvaccinepriceandvolumebyMarket2015

$60.00

$50.00
USA
2015AVERAGEPRICEPERDOSE

OtherHICs
$40.00
UMICs

$30.00 LMICs

Gavi
$20.00

$10.00

$
1M
4M
7M
10M
13M
16M
19M
22M
25M
28M
31M
34M
37M
40M
43M
46M
49M
52M
55M
58M
61M
64M
67M
70M
73M
76M
79M
82M
85M
88M
91M
94M
97M
100M
103M
106M
109M
SHAREOFWASTAGEADJUSTEDDEMAND

Source:GlobalVaccinesMarketModel,March2016
 Vaccineswithoutadualmarketfaceotherchallenges.
MeningitisAvaccinewasdevelopedthroughapublicprivate
partnership.
DEMAND:AfricanMOHsrequest This image cannot currently be display ed.

conjugateMenAvaccineavailableat
~$0.50/dose
DEVELOPMENTANDSUPPLY:PATH
WHOpartnershipwithSerumInstitute
ofIndia,FDA,NIH,andothers
FINANCING:BMGFinvest$75million;
govtsanddonorspurchasedoses
Vaccineavailableonmarketin2010;
TODAY 235millionpeopleprotected
By2020,expecttoprotect~400
million
Thechallenges managingtheviciouscycle:

Uncertaintyabout
demandleadsto
limitedinvestments Demand
incapacity
Lowcapacity
resultsinlimited
supplywhich
createsshortages
Supply andkeepsprices
relativelyhigh
Higherpricesraise
questionsabout
Financing
valueformoneyand
increaseuncertainty
aboutdemandand
financing
Thechallenges creatingavirtuouscycle:
Appropriatelysized
capacityincreases
efficiencyof
Financing production benefit
Lowercoststranslate fromeconomiesof
intoaffordableprices scaleandsupplyall
fordifferentmarkets Supply markets
stimulatingdemand

Demand Reliabledemandleadsto
investmentinadequate
capacityandefficiently
managedproduction
ot currently be display ed.

Thankyou!
www.path.org

This image cannot currently be display ed.

PATH/GabeBienczycki
 Globalvaccinemarkets

GAVI/UN
POOLEDPROCUREMENT
MIC/LMIC
Characteristicstofit
indeliverysystem
PUBLIC
Value formoney

US/EUROPE/JAPAN
Vaccinehesitancy

MIC/LMIC
PRIVATE

Note:OnlynonPAHOcountrieswith>250,000annualbirthcohortincluded.
Source:WorldBankGNI2013,UNPDPopulationProspects2012Edition,GAVIWebsite,September2014