Global vaccine market
Global Vaccine and Immunization Research Forum
Amie BatsonChief Strategy Officer, PATHMarch 2016
PATH/Eric Becker
Agenda
• Overview of global vaccine market• Demand• Supply• Financing
• Vaccine development and vaccine markets• Product life‐cycle
Demand – critical factors
• Epidemiology: •Global and local; • Individual and community
• Perceived safety – vaccine hesitancy
• Perceived value for money• Fit with delivery system
PATH/Gabe Bienczycki
Demand – growing market
• Perceived Safety –vaccine hesitancy
• Perceived value for money
• Epidemiology: Global and local
• Fit with delivery system
Source: Global Vaccine Market Model preliminary routine immunization market value analysis, March 2016
6
17
2833
0
5
10
15
20
25
30
35
40
$ (Billions)
Vaccine Market Growth
UMICS23%
LMICs8%
LICs4%
HICs65%
Vaccine Market Share 2014(US$ Approximate Value)
Global vaccine markets
Note: Only non‐PAHO countries with >250,000 annual birth cohort included. Source: World Bank GNI 2013, UNPD Population Prospects 2012 Edition, GAVI Website, September 2014
MIC/LMICPRIVATE
US/EUROPE/JAPAN
GAVI/UN
MIC/LMICPUBLIC
Global vaccine markets
Note: Only non‐PAHO countries with >250,000 annual birth cohort included. Source: World Bank GNI 2013, UNPD Population Prospects 2012 Edition, GAVI Website, September 2014
MIC/LMICPRIVATE
US/EUROPE/JAPANVaccine hesitancy
GAVI/UNPOOLED PROCUREMENT
• Characteristics to fit in delivery system
• Value for money
MIC/LMICPUBLIC
Supply
PATH/Satvir Malhotra
• Regulatory requirements: national and WHO PQ
• Predictability of demand
• Reliability and scale of production
Vaccine manufacturers
33
17
13
12
4
21
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Share of market value
Other
Sanofi‐PasteurMSD
Merck
Pfizer
Sanofi‐Pasteur
GlaxoSmithKline/Novartis
Source: Miloud Kaddar, WHO, “Global Vaccines Market Features and Trends” Presentation. Geneva, 2012; GAVI website, October 2014; PATH analysis
State-owned Privately held
Developing country vaccine manufacturers
BioE
Innovax
BBIL
Parastatalglobal actors
Local
Emerging actors
Niche
Nat
iona
lG
loba
l exp
ort
Serum Institute of India
LGLS
CNBG
BioFarma
BioM
Butantan
Institute Pasteur de Dakar
Birmex
Biovac
Walvax
SK Chemicals
Panacea
Incepta
Arabio
Razi
Scale matters in vaccine manufacturing: larger production can help drive down unit costs.
Illustrative only
Indi
cativ
e co
st p
er d
ose
man
ufac
ture
d
Manufacturing volume
Source: United Nations, Department of Economic and Social Affairs, Population Division (2015). World Population Prospects: The 2015 Revision, custom data acquired via website.
Gavi57M doses
OECD12M doses
*Assuming 80% coverage
Financing
PATH/Jolene Beitz
• Perceived value for money by market
• Tiered pricing• Perceived reliability and timeliness of payor
The GAVI/UNICEF procurement has doubled in value in the last 5 years alone.
Source: UNICEF public data
UNICEF contracts (2001‐14)
Demand (num
ber o
f doses)
As countries transition from Gavi and ODA, vaccines will be increasingly financed by domestic budgets.
Source: PATH Global Vaccines Market Model. Provided for illustrative purposes only.
Gavi transitions 2015‐2030
Demand (num
ber o
f doses)
As countries transition from Gavi and ODA, vaccines will be increasingly financed by domestic budgets.
Source: PATH Global Vaccines Market Model. Provided for illustrative purposes only.
Gavi transitions 2015‐2030
Demand (num
ber o
f doses)
As countries transition from Gavi and ODA, vaccines will be increasingly financed by domestic budgets.
Source: PATH Global Vaccines Market Model. Provided for illustrative purposes only.
Gavi transitions 2015‐2030
Vaccine Development – why markets matter
PATH/Amy MacIver
• Demand and financing depends on characteristics of vaccine • Fit with delivery system and
schedule• Value for money
• Significant investment
Investments in vaccine development and production are significant. The expected market size is a critical factor.
*All costs sourced from Light, Donald W., Jon Kim Andrus, and Rebecca N. Warburton. "Estimated research and development costs of rotavirus vaccines." Vaccine 27.47 (2009): 6627‐6633, updated to 2016 USD
Time (years)
Investmen
t $ m
illion
PreclinicalPhase I & II
Phase III
Licensure and production capital
Decision Gate
Decision Gate
Product life‐cycle
Product launch Early market penetration Maturity
Number of products 1 1‐2 Several
Product capacity Low Medium High
Cost/unit High Relatively high Yield and learning curve gains
Price High Tiers (High/middle income)
Competitive‐ Multiple tiers‐ Lowest tier for
the poorest
PATH/Amy MacIver
Changing landscape ‐ 2006
Source: UNICEF public data
Changing landscape ‐ 2007
Source: UNICEF public data
Changing landscape ‐ 2008
Source: UNICEF public data
Changing landscape ‐ 2009
Source: UNICEF public data
Changing landscape ‐ 2010
Source: UNICEF public data
Changing landscape ‐ 2011
Source: UNICEF public data
Changing landscape ‐ 2012
Source: UNICEF public data
Changing landscape ‐ 2013This image cannot currently be displayed.
Source: UNICEF public data
Changing landscape ‐ 2014This image cannot currently be displayed.This image cannot currently be displayed.
Source: UNICEF public data
Hib vaccine introduction: high‐ and low‐income markets
Source: International Vaccine Access Center (IVAC), Vaccine Information Management System (VIMS) Global Vaccine Introduction Report, December 2015. Johns Hopkins Bloomberg School of Public Health.
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
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
Percen
tage of cou
ntrie
s that h
ave
universally introd
uced
vaccine
Years since first introduction
High‐income markets
Low‐income markets
~10+ years
PCV vaccine introduction: high‐ and low‐income markets
Source: International Vaccine Access Center (IVAC), Johns Hopkins Bloomberg School of Public Health. Vaccine Information Management System (VIMS) Global Vaccine Introduction Report, December 2015.
Note: Limited projections are available for PCV introduction in high‐income countries
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
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
Percen
tage of cou
ntrie
s that h
ave
universally introd
uced
vaccine
Years since first introduction
High‐income markets
Low‐income markets
~5 years
New vaccines are reaching children in developing countries much more rapidly.
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
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
Percen
tage of cou
ntrie
s that h
ave
universally introd
uced
vaccine
Years since first introduction
Hib HIC
Hib LIC
PCV HIC
PCV LIC
Note: Limited projections are available for PCV introduction in high‐income countriesSource: International Vaccine Access Center (IVAC), Johns Hopkins Bloomberg School of Public Health. Vaccine Information Management System (VIMS) Global Vaccine Introduction Report, December 2015.
Tiered pricing enabled GAVI countries to access PCV earlier in the products lifecycles
Source: Global Vaccines Market Model, March 2016
$‐
$20.00
$40.00
$60.00
$80.00
$100.00
$120.00
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
2015
AVE
RAGE PR
ICE PER DO
SE
SHARE OF DEMAND
USA
Other HICs
UMICs
LMICs
Gavi
PCV price and volume by Market 2015
Price tiering has also been critical in accelerating access to rotavirus vaccines.
Source: Global Vaccines Market Model, March 2016
$‐
$10.00
$20.00
$30.00
$40.00
$50.00
$60.00
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
2015
AVE
RAGE PR
ICE PER DO
SE
SHARE OF WASTAGE‐ADJUSTED DEMAND
USA
Other HICs
UMICs
LMICs
Gavi
Rotavirus vaccine price and volume by Market 2015
This image cannot currently be displayed.
Vaccines without a dual market face other challenges. Meningitis A vaccine was developed through a public private partnership.
• DEMAND: African MOHs request conjugate Men A vaccine available at ~$0.50/dose
• DEVELOPMENT AND SUPPLY: PATH‐WHO partnership with Serum Institute of India, FDA, NIH, and others
• FINANCING: BMGF invest $75 million; gov’ts and donors purchase doses
• Vaccine available on market in 2010; TODAY – 235 million people protected
• By 2020, expect to protect ~ 400 million
The challenges – managing the vicious cycle:
Financing
Demand
Supply
Uncertainty about demand leads to limited investments in capacity
Low capacity results in limited supply which creates shortages and keeps prices relatively high
Higher prices raise questions about value for money and increase uncertainty about demand and financing
Financing
Demand
Supply
The challenges – creating a virtuous cycle:
Reliable demand leads to investment in adequate capacity and efficiently managed production
Lower costs translate into affordable prices for different markets stimulating demand
Appropriately sized capacity increases efficiency of production ‐ benefit from economies of scale and supply all markets
ot currently be displayed.
PATH/Gabe Bienczycki
Thank you!www.path.org
This image cannot currently be displayed.
Global vaccine markets
Note: Only non‐PAHO countries with >250,000 annual birth cohort included. Source: World Bank GNI 2013, UNPD Population Prospects 2012 Edition, GAVI Website, September 2014
MIC/LMICPRIVATE
US/EUROPE/JAPAN• Vaccine hesitancy
GAVI/UNPOOLED PROCUREMENT
• Characteristics to fit in delivery system
• Value for money
MIC/LMICPUBLIC