1. Abstract #: WEAD0203
Estimating the size of the pediatric ARV market in 27 low- and middle-income countries (LMICs) through 2025 as PMTCT initiatives continue to succeed
Vineet R. Prabhu, Shaun McGovern, Paul Domanico
PRESENTED AT THE 9TH IAS CONFERENCE ON HIV SCIENCE - PARIS, FRANCE

2. Conflict of Interest
No conflicts of interest to declare

3. The paradox we face in addressing pediatric HIV
Ensure best pediatric ARV formulations available
End
pediatric HIV
Directional sense of evolution of CLHIV population needed to understand future need for formulations and commercial considerations

4. Pediatric ARV market much smaller than adult market
2015 Figures for “generic accessible” LMICs
Unlike the adult market, new infections are dropping significantly with PMTCT, and older children are “ageing out”
Note: “Generic-accessible” denotes countries where global generic manufacturers can register and supply a large proportion of that country’s ARV volume needs Source: CHAI ARV Market Report, 2016

5. “Super Fast-Track Targets” aim to reduce the number of children living with HIV/AIDS (CLHIV) even further
START FREE
Eliminate new HIV infections among children by reducing the number of children newly infected to less than 40,000 by 2018 and 20,000 by 2020.
STAY FREE
Ensure counselling and prevention services for adolescents etc.
AIDS FREE
Provide 1.6 million children (0-14 years) and 1.2 million adolescents (15-19) living with HIV with antiretroviral therapy by Provide 1.4 million children (0-14) and 1 million adolescents (15-19) with HIV treatment by 2020
Even if not met on schedule, these ambitious targets will have a strong (positive) effect on the pediatric population living with HIV

6. Several challenges in estimating the pediatric population in need of various new ARV formulations
Lack of reliable data!
Age and weight band distributions in country
Line of therapy breakdown
Regimen breakdown
Formulation breakdown
Others….

7. Global Figures (2016 estimates)*
Thinking about the overall size of CLHIV population as it inevitably declines…
Global Figures (2016 estimates)*
2011
2012
2013
2014
2015
Total PLHIV; Children ages 0-14
2,100,000
2,000,000
1,900,000
1,800,000
New Infections; Children age 0-14
270,000
230,000
200,000
160,000
150,000
YoY % drop in new infections
-15%
-13%
-20%
-6%
AIDS-related deaths; Children age 0-14
170,000
140,000
120,000
110,000
-12%
-7%
-14%
-8%
*2017 estimates are slightly higher but directionally similar
As new infections (+) and deaths (-) decrease, “ageing out” will be a major factor in the decline of this population
Source: UNAIDS AIDSInfo Database, accessed March 2017; revised estimates became available July 2017

8. Modelling the population by tracking age cohorts
New Infections (decreasing)
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Age 0
Age 1
Age 2
Age 3
Age 4
Age 5
Age 6
Age 7
Age 8
Age 9
Age 10
Age 11
Age 12
Age 13
Age 14
Mortality
(decreasing)
“Aging out”

9. Provisional age-specific breakdown for estimated CLHIV ( ) were provided by UNAIDS for 27 high-volume countries
27 Countries
Benin
Lesotho
Swaziland
Botswana
Liberia
Togo
Burkina Faso
Malawi
Uganda
Burundi
Mozambique
United Republic of Tanzania
Cambodia
Myanmar
Cameroon
Nigeria
Viet Nam
Côte d’Ivoire
Papua New Guinea
Zambia
Ethiopia
Rwanda
Zimbabwe
Kenya
Senegal
Lao PDR
South Africa
In 2015, these 27 countries represented 77% of global CLHIV burden, and 85% within LMICs
Note: The estimates provided by UNAIDS are modelled and provisional. The data do have limitations in accuracy especially at the individual country level.

10. Assumptions used 27 country Age 0 cohort; 2015 64,075
Per UNAIDS provisional estimates
Super fast-track targets for “Start Free” met?
(scenarios for decline in age 0 cohort)
On time (aggressive)
2 yrs late (moderate)
Status quo (conservative)
Annual ped. new infections drop per “Status Quo”
(i.e. if Start Free targets not met) 8%
( CAGR was -14%; was -10%)
Ped. (age 0-14) mortality (global); 2015
110,000
Per UNAIDS
27 country contribution to global ped. mortality; 2015
77%
(84,700)
Total CLHIV in 26 countries was 77% of global, 85% of GA LMICs in 2015)
Annual ped. mortality drop
( CAGR was -10%; was -8%)
Note: For modelling purposes, the 20,000 new infections of the “Start Free” targets are attributed entirely to the 27 countries even though the targets are global
Total projected mortality assumed to be equally distributed across the age groups each year

11. Scenarios lead to different implied new infection rates
Implied new infections and mortality for 27 countries with assumptions used
Number of Children
Note: For modelling purposes, the 20,000 new infections of the “Start Free” targets are attributed entirely to the 27 countries even though the targets are global
Total projected mortality assumed to be equally distributed across the age groups each year

12. Scenarios suggest between 350-500K CLHIV by 2025 in 27 high burden LMICs
Pediatric population (ages 0-14) living with HIV in 27 high-burden LMICs
CLHIV ages (‘000s)
(Status Quo)
(“Stay Free” met by 2022)
(“Stay Free” met by 2020)

13. Weight band distribution of CLHIV (ages 0-14) in 27 high-burden LMICs by scenario: skewing heavier
(a) Aggressive scenario
(b) Moderate scenario
(c) Conservative scenario
Note: Age to weight conversions as per Doherty K et al. (2014) BMC Health Serv Res. 14:201

14. Limitations
Analysis based on 2015 figures; revised UNAIDS estimates are now available suggesting higher number of CLHIV than previously thought
Country level estimates provided by UNAIDS are modelled and provisional; limitations in accuracy
Model simplifies new infections by attributing only to age 0 cohort; transmission through breast feeding may occur at older ages
Overestimates younger age and lower weight bands in outer years
Model simplifies annual mortality by distributing evenly across ages 1-14
Current distribution by age is not well known

15. Conclusions
Overall number of CLHIV (age 0-14) will decline as PMTCT efforts continue to succeed
CLHIV population will increasingly skew towards older and heavier children, especially as ART coverage increases and mortality declines
Variance in scenarios of overall population may be greater than variance likely with different ART coverage, 2L migration, or market share scenarios
Demand for pediatric formulations for the lowest weight bands will likely reduce over time
Careful consideration will need to be given to post-regulatory commercial sustainability of newer desired pediatric formulations
Innovative financing mechanisms may be needed
These estimates are not meant to be definitive, but do provide a frame of reference

16. Acknowledgements
Mary Mahy (UNAIDS)
CHAI colleagues
Funders