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*WHO Towards Universal Access Reports

Market dynamics of paediatric ARV formulations July 17 th , 2011 CHALLENGES IN THE DEVELOPMENT AND PROCUREMENT OF PAEDIATRIC ARV FORMULATIONS Rome, Italy. Over the past 6 years we have seen tremendous growth and improvement in the marketplace for pediatric ART. Market Changes.

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*WHO Towards Universal Access Reports

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  1. Market dynamics of paediatric ARV formulations July 17th, 2011CHALLENGES IN THE DEVELOPMENT ANDPROCUREMENT OF PAEDIATRIC ARV FORMULATIONSRome, Italy

  2. Over the past 6 years we have seen tremendous growth and improvement in the marketplace for pediatric ART Market Changes Pediatric HIV Patients on ART* • Dramatic improvement in treatment coverage • Though still lower than adult coverage (28% vs 36%) • Better treatment options • >30 pediatric formulations, of which: • 7pediatric-strength FDCs • 8 dispersible formulations 1 in 4 children in need 1 in 12 children in need *WHO Towards Universal Access Reports

  3. Still the size and the fragmented nature of the pediatric ARV market make it inherently risky and difficult to sustain compared to adults Further fragmented into sub-groups by age and weight bands The pediatric market is relatively small (~356,000 patients) Risk in the Pediatric Market Patients on Treatment (in millions)* 6M Almost 15X more adults are on ARV treatment than pediatric patients *WHO Towards Universal Access Reports

  4. Still the size and the fragmented nature of the pediatric ARV market make it inherently risky and difficult to sustain Slow transition to new products further fragments volumes Further fragmented into sub-groups by age and weight bands The pediatric market is relatively small (~355,000 patients) Risk in the Pediatric Market VS Pediatric Product Procurement AZT 50 mg/5 ml AZT 100 mg AZT/3TC 60/30 mg AZT/3TC/NVP 60/30/50 mg AZT 300 mg AZT/3TC 300/150 mg AZT/3TC/NVP 300/150/200 mg Adult Product Procurement AZT 300 mg AZT/3TC 300/150 mg AZT/3TC/NVP 300/150/200 mg *WHO Towards Universal Access Reports

  5. Low volume orders create supply challenges for national programs UNITAID-CHAI Pediatric Project Volumes Pooling volumes has a large impact South Africa 23% • Suppliers have volume minimums to manufacture known as batch sizes • Groupingmanylow volume orderscreates a mechanism to meet minimum batch sizes 10% UNITAID 67% • Pooled procurement across 40 beneficiary countries • Countries moving to new funder 2010- end 2012 *Genericaccessible countries exclude China, Mexico, Argentina, South Africa and Brazil

  6. National programs and global stakeholders are partnering together to ensure a smooth transition to new funders • Vast majority of UNITAID’s pediatric ARV commodity funding is expected to transition to The Global Fund • GFATM Board endorsed a Market Shaping Strategy 1 • Coordinated Procurement • Aglobal pediatric ARV formulary list is under development • National efforts to focus procurement on newer products that offer adherence advantages 2 • Product Consolidation

  7. Challenges facing the pediatric market are considerable but surmountable Zambia Minister of Health and the WHO Country Representative celebrating the introduction of AZT and ABC pediatric FDCS in June 2011 Together we can secure the pediatric market and ensure pediatric HIV patients continue to be able to access optimal treatment options

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