the growing market for amoxicillin dispersible tablets - home page | unicef · the growing market...

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



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





1st dose antibiotic, referral to

health facility for supportive

therapy

12 – 59

months

2 Amoxicillin 250mg tablets /






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



3. Market trends



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

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an

da

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nya

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tna

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me

n

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biq

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ar

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rkin

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ire

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pa

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law

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ad

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ia

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eg

al

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eki

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n

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ine

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an

da

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nin

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mb

od

ia

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alia

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m R

ep

ub

lic o

f K

ore

a

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run

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bw

e

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iti

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rra

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e

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go

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eri

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tre

a

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R

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ntr

al A

fric

an

…

Ta

jiki

sta

n

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pu

a N

ew

Gu

ine

a

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uri

tan

ia

Kyr

gyz

Re

pu

blic

Ga

mb

ia (

Th

e)

Gu

ine

a-B

issa

u

Co

mo

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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



3. Market trends



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-

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