Page 0 UNITAID  Melbourne, Australia 2014 Overview of paediatric antiretroviral market : is market in shape to enable achieving targets? Carmen Pérez Casas IAS 2014

Page 1 Access to ART for children still limited Children represent 10% of total HIV burden, –3.4 million children live with HIV Global ART coverage is currently 23% (36% for adults) −Less than 1 in 4 children in need of ART receive it –792,000 on treatment New targets (90*90*90) seek to multiply almost by 3,5 the number of children receiving ART… Or up to 4,3 times more on ART if we target for them all!

Page 2 Identified barriers to scale-up paediatric treatment Inadequate political commitment Insufficient financial resources Policy challenges Insufficient innovation: –in diagnostic technologies –in paediatric HIV medicines –in paediatric treatment delivery Stigma and discrimination

Page 3 $45M Donor-funded sales by stock keeping unit, 1 July 2012 – 1 July 2013 $1,009M … and confined to poor nations A small and fragmented market

Page 4 With multiple options... 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 1 st -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.

Page 5 … with multiple options, Five products make up 76% of sales value 3TC/ZDV/NVP 30/60/50mg accounted for 41% sales value Donor-funded sales by pediatric product, 1 July 2012 – 1 July 2013

Page 6.. and very concentrated from supply side * Herfindahl Hirshman index is a commonly used measure of market concentration. When assessing mergers and anti-trust issues, US Department of Justice considers a market with an HHI > 2500 to be highly concentrated Donor-funded sales by pediatric product, 1 July 2012 – 1 July 2013 top 12 Product Sales (2012, millions) # mfgs meeting QA criteria Market Share of top firm Market Share of top two firms Herfindahl Hirschman Index 3TC/NVP/ZDV 30/50/60mg $ %99% 7,329 EFV 200mg $ %94% 5,263 ABC/3TC 60/30mg $ %96% 4,890 NVP 10mg/ml $ %100% 5,142 LPV/r 80/20mg/ml $ %100% 9,269 3TC/ZDV 30/60mg $ %64% 2,854 ABC 20mg/ml $ %94% 7,584 LPV/r 100/25mg $ %100% 5,005 3TC/NVP/d4T 60/100/12mg $ % 10,000 ZDV 10mg/ml $ %95% 7,922 3TC 10mg/ml $ %96% 8,291 EFV 50mg $ %98% 7,186

Page 7.. and very concentrated from supply side Donor-funded sales by pediatric product, 1 July 2012 – 1 July 2013 top products

Page 8 What prompts timely development and production of most adequate products? Knowledge on which products and formulations are preferred Adequate technical know-how and enabling IP landscape to produce and sell Clear regulatory pathways to follow for timely approval Possibility of making an adequate return in a competitive market A forecast of future demand to plan manufacturing

Page 9 Great need but … No incentives Great challenges Collaboration

Page 10 Cameroon C.A.R. D.R.C. Congo Uganda Kenya Tanzania Mali Mauritania Niger Egypt Funders Procurers Observers Paediatric ARV Procurement Working Group Procurement Consortium Partnership of funders, procurers & technical bodies collaborating to improve the supply of paediatric ARVs

Page 11 Cameroon C.A.R. D.R.C. Congo Angola Uganda Kenya Tanzania Egypt All stakeholders Partnership to accelerate the development of adequate formulations for all children

Page 12 Thank you! Particular thanks to Patrick Aylward, UNITAID consultant