the growing market for amoxicillin dispersible tablets - home page | unicef · the growing market...
TRANSCRIPT
Copenhagen, Denmark
September 23, 2014
Opportunity Assessment for Potential Manufacturers
THE GROWING MARKET FOR
AMOXICILLIN DISPERSIBLE TABLETS
TABLE OF CONTENTS
1. Overview/background
2. Market size and demand
3. Market trends
1. Overview/background
2. Market size and demand
3. Market trends
Pneumonia is the number one killer of children under five. Most demand resides in Africa and SE Asia
Notes:1) Child Survival Call to Action, Ending Preventable Child Deaths Summary Roadmap Version 1, June 14, 2012
2) Global Burden of Childhood Diarrhea and Pneumonia Christa L. Fischer Walker, et al, Lancet Series, April 12, 2013
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Number of Under-Five Deaths by Cause of Mortality1
2010
Pneumonia
Diahhrea
Malaria
Preterm Complications
Intrapartum Events
All other
Un
de
r-fi
ve d
ea
ths
(20
10
)
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Under-five Pneumonia Deaths by Geography2
2013
Africa
South and
Southeast Asia
Eastern Mediterranean
Western Pacific
The Americas
Europe
Loca
tion
of u
nd
er-five
pn
eu
mo
nia
de
ath
s(20
13
)
Under-five deaths Under-five deaths due to pneumonia
Lancet Series on Childhood Pneumonia
and Diarrhoea launched on April 12,
2013
Lancet series focused on opportunities in
treating childhood pneumonia
Global momentum and support for ending preventable deaths from childhood pneumonia
WHO/UNICEF: Ending preventable child
deaths from pneumonia and diarrhoea
by 2025
The integrated Global Action Plan for
Pneumonia and Diarrhoea (GAPPD)
UN Commission on Life Saving
Commodities
Global coordinated effort to scale up
priority commodities, including
Amoxicillin DT
Recent events highlighting global focus:Just a few of the partners with ongoing global
support for scale-up of Amoxicillin DT:
WHO and others continue to support global advocacy around the use of Amoxicillin DT
Revised WHO classification and treatment of
pneumonia in children at health facilities:
• Advocacy Brief
• Policy Brief
• Evidence Summary
Significant advocacy work is well underway
around pneumonia treatment:
www.worldpneumoniaday.org
Coming Soon
Rapid scale up of quality, affordable, and dependable supply of Amoxicillin DT is needed
1.1M2 children die
annually
97M1 cases of
childhood
pneumonia annually
Need for supply to
grow rapidly in the
coming years
WHO defines the
optimal treatment
as Amoxicillin DT
• Most cases occur in
just 10 low and middle
income countries
• Estimates show as
many as 80% of all
children go untreated
or incorrectly treated
with antibiotics
• Most common
antibiotic in use is
Cotrimoxazole
• Many cases are
undiagnosed or
incorrectly diagnosed
• Pneumonia is the
number one killer of
children under five
• Technical guidance
from the WHO has
defined the optimal
treatment as child
friendly amoxicillin in
250mg dispersible
tablets (DT)
• To meet this growing
demand, new quality
manufacturers are
needed
• Requirements:
— Speed to scale-up
— High quality
— Price
— Supply security
Amoxicillin Dispersible Tablets (DT)
250mg
The need:
• Child friendly, simple dosing, effective
• No cold-chain requirement
The benefit:
Notes: 1) Estimates by John Snow, Inc
2) Committing to Child Survival: A Promise Renewed Report, Progress Report 2013, UNICEF
Dispersible Tablet Benefits2:
• Cheaper than its equivalent oral suspension
• Facilitates and simplifies Community Case Management (CCM) and greater dosage
accuracy compared to OS (which has to be manually measured and mixed)
• No refrigeration/cold-chain needed
• Come in appropriate strengths and pack sizes to meet the needs of CHWs,
caregivers, and children
• Are packaged for easy dispensing and inventory management—course of
treatment is one or multiple blister strips and light weight
• Do not have to be split to get the correct dosage
Dispersible Tablet Benefits2:
• Cheaper than its equivalent oral suspension
• Facilitates and simplifies Community Case Management (CCM) and greater dosage
accuracy compared to OS (which has to be manually measured and mixed)
• No refrigeration/cold-chain needed
• Come in appropriate strengths and pack sizes to meet the needs of CHWs,
caregivers, and children
• Are packaged for easy dispensing and inventory management—course of
treatment is one or multiple blister strips and light weight
• Do not have to be split to get the correct dosage
WHO recommends treating childhood pneumonia with Amoxicillin. Dispersible tablets are the optimal formulation.
AgePneumonia in low HIV
prevalence areas
Pneumonia in high HIV
prevalence areasSevere pneumonia
Severe pneumonia with
danger signs
<2 months 1st dose antibiotic, referral to health facility for supportive therapy
2 – 12
months
1 Amoxicillin 250mg tablet /
twice a day / 3 days
1 Amoxicillin 250mg tablet /
twice a day / 5 days
1 Amoxicillin 250mg tablet /
twice a day / 5 days
1st dose antibiotic, referral to
health facility for supportive
therapy
12 – 59
months
2 Amoxicillin 250mg tablets /
twice a day / 3 days
2 Amoxicillin 250mg tablets /
twice a day / 5 days
2 Amoxicillin 250mg tablets /
twice a day / 5 days
1st dose antibiotic, referral to
health facility for supportive
therapy
WHO’s New Pneumonia Treatment Guidelines for Case Management1
Notes: 1) Qazi, Shamim, Management for Pneumonia in Developing Countries, WHO, Geneva, June 2013.
2) Amoxicillin Dispersible Tablets (DT): Product Profile, Availability and Guidance UNICEF Supply Division July 2013.
Amoxicillin Products:
• Caps
• Tablets
• Oral Suspension (OS)
• *Dispersible Tablets*
Amoxicillin Products:
• Caps
• Tablets
• Oral Suspension (OS)
• *Dispersible Tablets*
The global health community is facilitating scale up of Amoxicillin DT by addressing all bottlenecks
Trigger /
Information
Gathering
Assessment
Management
Antibiotics
Choice
The Treatment Process Leverage Points being addressed by
the global health community
Trigger/Information Gathering:• Demand generation campaigns to raise
awareness of signs of pneumonia and
importance of seeking care
Evaluation and Diagnosis:• Training and education for caregivers
• New diagnostic technologies and protocols
being developed
Treatment Options:• WHO recommends Amoxicillin DT
• Global advocacy for inclusion on countries’
Essential Medicine Lists and Standard
Treatment Guidelines
Amoxicillin choice:• WHO recommends Amoxicillin DT
• Global advocacy for inclusion on countries’
Essential Medicine Lists and Standard
Treatment Guidelines
1
3
Mother
contacts CHW/
Pharmacist
Timer, etc
(fever + fast
breathing)
Child not there
– mother
describes
Less severe
pneumonia
Severe
pneumonia
RDT blood test
Anti-fever
meds
Inject.
antibioticsAntibiotics
1
2
Amoxicillin
DT (250mg)
Amoxicillin
(other
formulations)
4
5
Cotrimoxizole
Classification
OxygenAnti-
malarials
Nothing
(get rest
and feed)
Other non-
opitmal (Cipro,
etc.)
Malaria
3
4
5
Visual and
verbal
diagnosis
2
Mother
unaware and
does nothing
TABLE OF CONTENTS
1. Overview/background
2. Market size and demand
3. Market trends
1. Overview/background
2. Market size and demand
3. Market trends
Up to 71 million cases of suspected childhood pneumonia may not currently receive antibiotics
27 28 28 29 29 30 30
71 72 73 75 76 77 79
97.799.5 101.4 103.3 105.2 107.2 109.2
-
20
40
60
80
100
120
2014 2015 2016 2017 2018 2019 2020
Untreated Treated Total
Ca
ses
of
Ch
ildh
oo
d P
ne
um
on
ia (
M)
Suspected childhood pneumonia cases in 50 low/middle income
countries1 (2014 – 2020)
See
ne
xt pa
ge
for d
eta
il
*
*Note: Treatment rates estimated using a combination of the latest DHS, MICS or NFHS data – depending on what was available for each
country. In some cases, like India, antibiotic usage may be higher and the size of the “untreated” population may be an overestimate.
Notes: 1) Estimates by John Snow, Inc for the 49 Every Woman, Every Child countries + India
2) Updated August 2014 with 2010 CHERG estimates of incidence of clinical pneumonia (published 2013) - Using latest DHS/MICS estimates of
those children 5 and under receiving antibiotics for treatment of ARI
10 focus countries account for 77% of all untreated suspected childhood pneumonia cases
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
-
5
10
15
20
25
30
35
40
Ind
ia
Nig
eri
a
Pa
kist
an
Ba
ng
lad
esh
De
m R
ep
ub
lic o
f…
Eth
iop
ia
Ta
nza
nia
Afg
ha
nis
tan
Ug
an
da
Ke
nya
Vie
tna
m
Ye
me
n
Nig
er
Mo
zam
biq
ue
Mya
nm
ar
Bu
rkin
a F
aso
Ma
da
ga
sca
r
Co
te d
'Ivo
ire
Ma
li
Gh
an
a
Ne
pa
l
Ma
law
i
Ch
ad
Za
mb
ia
Sen
eg
al
Uzb
eki
sta
n
Gu
ine
a
Rw
an
da
Be
nin
Ca
mb
od
ia
Som
alia
De
m R
ep
ub
lic o
f K
ore
a
Bu
run
di
Zim
ba
bw
e
Ha
iti
Sie
rra
Le
on
e
To
go
Lib
eri
a
Eri
tre
a
Lao
PD
R
Ce
ntr
al A
fric
an
…
Ta
jiki
sta
n
Pa
pu
a N
ew
Gu
ine
a
Ma
uri
tan
ia
Kyr
gyz
Re
pu
blic
Ga
mb
ia (
Th
e)
Gu
ine
a-B
issa
u
Co
mo
ros
Solo
mo
n I
sla
nd
s
Sao
To
me
an
d P
rin
cip
e
Untreated
Treated
Ch
ildh
oo
d p
ne
um
on
ia c
ase
s (M
)
tre
ate
d a
nd
un
tre
ate
d
Pareto of childhood pneumonia in 50 low/middle income countries1 (2014)
Total = 97M cases
All 50 countries: 97M 71M
10 focus countries: 74M 55M
All 50 countries: 97M 71M
10 focus countries: 74M 55M
Total cases Untreated
See next pages for some
detailed demand estimates
74% of all
untreated
cases
Notes: 1) Estimates by John Snow, Inc for the 49 Every Woman, Every Child countries + India
2) Updated August 2014with 2010 CHERG estimates of incidence of clinical pneumonia (published 2013) - Using latest DHS/MICS estimates of
those children 5 and under receiving antibiotics for treatment of ARI
*
*Note: Treatment rates estimated using a combination of the latest DHS, MICS or NFHS data – depending on what was available for each
country. In some cases, like India, antibiotic usage may be higher and the size of the “untreated” population may be an overestimate.
The 10 focus countries for global scale-up of Amoxicillin DT have strong demand growth
5.2 5.3 5.5 5.6 5.713.5 13.9 14.3 14.7 15.114.6 15.0 15.5 16.0 16.418.9 19.4 19.9 20.5 21.019.2 19.8 20.5 21.1 21.8
35.1 36.0 37.0 38.0 39.0
37.3 38.2 39.2 40.2 41.2
69.8 70.7 71.5 72.4 73.2
74.8 76.2 77.6 78.9 80.4
96.197.1
98.299.3
100.4
0
50
100
150
200
250
300
350
400
450
20142 20152 20162 20172 2018
India
Pakistan
Bangladesh
Nigeria
DRC
Uganda
Kenya
Tanzania
Afghanistan
Ethiopia
384392 399 407
414M
Potential childhood pneumonia Amox DT demand in
10 focus countries1,2,3,4,5 (2014 – 2018)
Po
ten
tia
l de
ma
nd
fo
r A
mo
xD
T
(MM
)
Notes: 1) Estimates by John Snow, Inc
2) Countries included: India, Nigeria, DRC, Pakistan, Ethiopia, Tanzania, Uganda, Bangladesh, Kenya, Niger
3) Scale up scenario increases base year (2013) coverage by population growth and 3% annual increase in treatment coverage to 2017
4) Low treatment coverage estimates for India (13%) likely underestimate treatment figures
5) Assumes 20 tablets per course; this over-estimates for children under age 1 who require 10 tablets, likely off-set by use for other conditions
5-year total demand in 10 focus countries: ~2B tablets5
*Bangladesh not shown
Ten priority countries account for majority of
potential Amox DT demand
Orders for Amoxicillin DT through UNICEF have seen strong growth
0
2
3
11
15 MM
0
2
4
6
8
10
12
14
16
2010 2011 2012 2013 2014
DT OS
UNICEF Procurement:
Amoxicillin DT and Amoxicillin Oral Suspension (number of treatments)
Eq
uiv
ale
nt
tre
atm
en
ts f
or
on
e y
ea
r o
lds
(MM
)
CAGR = 128%
All high-burden countries either already have, or are in process of updating national guidelines to Amox DT
Amox DT recommended as 1st- or 2nd-line
treatment in national guidelines?
Yes
In progress
Country
• Bangladesh
• DRC
• Niger
• Pakistan
• Tanzania
• Uganda
• Ethiopia
• India
• Kenya
• Nigeria
TABLE OF CONTENTS
1. Overview/background
2. Market size and demand
3. Market trends
1. Overview/background
2. Market size and demand
3. Market trends
Economic growth in developing countries is increasing demand for pharmaceutical products
$335.0
$245.0
$97.0
$113.0
$53.0
$15.0
4%4%
5%
9%
15%
9%
0%
2%
4%
6%
8%
10%
12%
14%
16%
$0
$50
$100
$150
$200
$250
$300
$350
$400
Co
mp
ou
nd
An
nu
al G
row
th R
ate
(CA
GR
, 20
10
–2
01
4)
20
10
Ma
rke
t Si
ze (
$B
)
Global Pharmaceutical Market (2010)1,2
Value and Growth Rate by Region
Notes: 1) “Market Report: World Medical Device Market,” Acmite Market Intelligence
2) IMS via Investment Fund for Health in Africa
3) FSG Social Impact Consultants, Shared Value: Competing By Saving Lives, 2012.
4) World Bank, Data Bank (data.worldbank.org)
+225%
Demand growth in Africa for healthcare
commodities will be among the strongest
in the world in the next decade
Pharmaceutical spending in Africa
expected to reach $30B by 2016 and $45B
by 20203
+173%
Per capita healthcare spending increase
for the decade ending in 20114:
In Africa
In South Asia
Additional areas of growth for amoxicillin will keep the market strong
•Many pneumonia vaccines are in testing and are currently being rolled out. While they will certainly have an impact on the prevalence of pneumonia, they are still in their early stages of use and a need for treatment will remain.
Vaccines for pneumonia
•Many organizations and multi-national medical technology companies are actively developing and testing new diagnostic tools for childhood pneumonia. New successful innovations will likely increase the demand for amoxicillin treatment.
Difficult diagnosis
•Competition from alternative products remains, including cotrimoxizole. The WHO, however, recommends amoxicillin as the first line and secondary response to cases of pneumonia and severe pneumonia.
Competition from competitive products
•New research1 shows the potential benefits for integrating antibiotics (including amoxicillin) into fighting severe childhood malnutrition. This would likely further increase the size of the Amoxicillin market.
New research in malnutrition treatment
•Amoxicillin DT is a growing secondary treatment choice for newborn sepsis. This would likely further increase the size of the Amoxicillin market.
Treatment of newborn sepsis
Notes: 1) Grady, Denise. “Malnourished Gain Lifesaver in Antibiotics.” The New York Times. Jan. 30, 2013. Web. July 22, 2013.
2) Trehan, Indi et al. “Antibiotics as Part of the Management of Severe Acute Malnutrition“ The New England Journal of Medicine.
January 31, 2013. Web. July 22, 2013.
Market Trend Implication for Amoxicillin global market
R4D has successfully applied market dynamics strategies to improve access to various life-saving commodities
• Focuses on increasing global access to high-quality and affordable life-saving products
for the poor.
• The team has more than three decades of collective experience working with
stakeholders across the global value chain – manufacturers, major donors, and
country level stakeholders – to develop and shape markets for health, nutrition, and
sanitation in Africa, Asia, and Latin America.
Malaria bed net market: Drove
strategies to save $600M to protect
300M additional people
Lifesaving products for women and
children: Partnered with UN
Commission on global market
strategies to save millions of lives
Neglected diseases: Actively worked
with suppliers to support a 10x drug
production increase
HIV/AIDS drugs: Designed Market-
shaping Strategy to save $520M on
AIDS drugs
Global malaria diagnostic market:
Potentially increase impact delivered
from donor allocated funds by 400%
Global micronutrient market:
Strategies can reach 34M low-income
children who require access to critical
nutrition products.
R4D’s Market
Dynamics team
R4D’s Market Dynamics team is launching a 3-year BMGF-funded project to scale up access to amox DT
Project goal:
Identify and address
barriers preventing the
scale-up of amox DT
• Share global forecasts with grounding in country-level data
• Assist suppliers in prioritizing key market actions – e.g. Increases in capacity depending on market needs
• Provide market transparency – e.g. tender calendars for high-volume markets – to assist manufacturers in efficient operations
• Help secure effective, affordable, and sufficient supply of amoxicillin DT
Supplier-level
• Gather amox DT demand forecasting and procurement volumes and pricing data across high-burden countries
• Support increased public sector amox DT volumes and access in one focus geography and two lighter touch geographies
• Serve as national champion in key geographies – including amox DT registration, inclusion in guidelines, securing of financing, and procurement.
Country-level
• Support resource mobilization for amox DT
• Help develop strategies with donors which incorporate private sector scale-up
Global-level
“USAID is committed to scaling up the use of Amoxicillin DT for the treatment of
childhood pneumonia – the number 1 killer of children under-five – in our effort
to end preventable maternal and child deaths.”
- David Milestone, USAID
Both USAID and the Bill & Melinda Gates Foundation are actively supporting the scale-up of Amoxicillin DT
“Increasing the availability of Amoxicillin DT and ensuring its widespread use a
the first line treatment for childhood pneumonia is the cornerstone of the
Pneumonia team’s treatment strategy”
- Rasa Izadnegahdar, Bill & Melinda Gates Foundation
Resources
This information was prepared by:
• USAID, Center for Accelerating Innovation and Impact
• Results for Development Institute
• UNICEF and UNICEF Supply Division
• Bill & Melinda Gates Foundation
For more information, contact:
• Kanika Bahl, Results for Development – [email protected]
• Francisco Blanco, UNICEF Supply Division – [email protected]
• Rasa Izadnegahdar, Gates Foundation – [email protected]
• Cammie Lee, Results for Development – [email protected]
• David Milestone, USAID – [email protected]
• David Muhia, UNICEF Supply Division – [email protected]
References:
• http://www.unicef.org/supply/
• http://everywomaneverychild.org/component/content/article/1-about/305-
amoxicillin-product-profile-
This information was prepared by:
• USAID, Center for Accelerating Innovation and Impact
• Results for Development Institute
• UNICEF and UNICEF Supply Division
• Bill & Melinda Gates Foundation
For more information, contact:
• Kanika Bahl, Results for Development – [email protected]
• Francisco Blanco, UNICEF Supply Division – [email protected]
• Rasa Izadnegahdar, Gates Foundation – [email protected]
• Cammie Lee, Results for Development – [email protected]
• David Milestone, USAID – [email protected]
• David Muhia, UNICEF Supply Division – [email protected]
References:
• http://www.unicef.org/supply/
• http://everywomaneverychild.org/component/content/article/1-about/305-
amoxicillin-product-profile-