Transcript What makes a manufacturer produce medicines at

UNITAID
IAS 2013
Examining the paediatric
antiretroviral market
landscape and factors
relating to product adoption
Emma Hannay
Kuala Lumpur, Malaysia
July 1st, 2013
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What makes a manufacturer produce
medicines at the lowest possible price?
• You know what products are preferred
• You have the adequate technical know-how to
produce and needed regulatory approvals
• There are other manufacturers to compete with
• You can make an adequate return in the
market
• You have a forecast of future demand to plan
manufacturing
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The donor Paediatric market is relatively
concentrated, with 3 major manufacturers
2011 Paediatric Donor ARV market value
By manufacturer, $ million
100%=$36m USD
$4 (12%)
$19
(52%)
*Based on data sets of major purchasers (UNITAID, SCMS, Global Fund)
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$8 (21%)
Hetero
Mylan
Bristol
Ranbaxy
Merck
Glaxo
Abbott
Aurobindo
Cipla
Matrix
Global Fund has become major
purchaser of Paediatric ARVs
FDC volume by purchaser*
2008
2011
Projected 2013
onwards
ABC 60mg / 3TC 30mg
3TC 30mg / d4T 6mg
S. Africa
25%
SCMS
/Other
20%
3TC 60mg / d4T 12mg
3TC 30mg / ZDV 60mg
3TC 30mg / NVP 50mg / d4T
6mg
3TC 60mg / NVP 100mg / d4T
12mg
GFATM
3TC 30mg / NVP 50mg / ZDV
60mg
LPV 100mg / RTV 25mg
0%
UNITAID
20% 40% 60% 80% 100%0%
20% 40% 60% 80% 100%
SCMS
*Based on data sets of major purchasers (UNITAID, SCMS, Global Fund)
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Global Fund
55%
Made up of
more than
50 national
purchasers
The paediatric market is smaller
than adults….
Value of Paedatric ARV donor market
$ millions
2005
79%
2008
44%
2011
31%
21% 19
56%
69%
Single/liquid
34
+11%
pa
36
FDC
Adult 1st
Line 2011
Source: Waning et al, BMC Paediatrics, 2010; UNITAID analysis
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Trends 2013 onwards
• Volumes driven by
epidemiology, diagnosis
rates, treatment guidance
• Value impacted by
treatment guidance, price
• Falling volumes may
impact attractiveness to
manufacturers
520
…and is also highly fragmented
ABC+3TC+LPV/r
Under 3 years
• ABC+3TC 60/30 tab
• ABC 20 mg/ml liquid
• 3TC 10 mg/ml liquid
• ABC 60 mg disp
scored tab
• 3TC 30 mg disp tab
• LPV/r 80/20 mg/ml
liquid
AZT+3TC+LPV/r
Under 3 years
• AZT+ 3TC 60/30 mg
tab
• 3TC 10 mg/ml liquid
• AZT 10 mg/ml liquid
• 3TC 30 mg disp tab
• AZT 60 mg tab
• LPV/r 80/20 liquid
ABC+3TC+EFV
3 to 10 years old
• ABC + 3TC 60/30 tab
• ABC+ 3TC 600/300
tab
• ABC 60 mg disp
scored tab
• 3TC 30 mg tab
• EFV 100 mg tab
• EFV 200 mg scored
tab
• EFV 600 mg double
scored tab
Preferred 1st-line regimen for children implies at least 2 or 3 formulations per day,
and multiple options are available in the market  not yet a full-regimen FDC.
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Recently formed mechanisms
increase insight into market volumes
• Transparency on volumes and orders of great
importance in pediatrics – due to low volume, choppy
orders
• Coordination of global procurement assisted by the
Global Fund Paediatric Antiretroviral Procurement
Working Group, formed in 2011
– Consists of major purchasers and procurers (GF,
PFSCM, VPP, CHAI, UNICEF, MSF, UNITAID)
– Aggregates demand, recent coordinated orders
– Consistent communication with suppliers
– Assistance in forecasting
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What concerns should we have going
forward from a market perspective?
• maintain market conditions to ensure children
Defend gains
remain on treatment
• Risk of fragmentation if volumes drop and new
products introduced – could increase prices or
increase delivery times
Expand
treatment
• continue to increase access, when need may
flatline or decrease
• Develop new ways to identify more HIV+ children
• Address growing requirements for 2nd line as
children spend longer on treatment
• Continue to stimulate development and market
entry of new products
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UNITAID has a special interest
paediatric HIV treatment
• Pediatric treatment is a specific Strategic
Objective in new 2013-2016 strategy
• Since 2005, the UNITAID funded CHAI project
to increase access through volume aggregation,
price negotiation, commodity purchase, market
intelligence and demand creation
• New grants with 2012 directed call on
Paediatric HIV treatment – DNDi project, and
potential for further investment
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Call for Letters of Intent
UNITAID's 2013 Call is open to interventions supporting any of
the 6 Strategic Objectives outlined in UNITAID's Strategy 20132016, with emphasis on interventions focused on treatments
for HIV/AIDS, TB and malaria.
Additional details can be found at unitaid.org/calls
Closing date for submissions is 22 September, 2013
The Market Share
• Latest news in global
health markets for HIV,
TB, malaria
• Published 44 times a
year
unitaid.org/
themarketshare
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Thank you!
Particular thanks for their input to: Brenda
Waning, Carmen Perez Casas, Patrick
Alyward, Ian Warden
[email protected]
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