VACFA 2014 Pharma Vaccines Diagnostics Manufacturers Multinats - PowerPoint PPT Presentation

VACFA 2014

Pharma Vaccines Diagnostics Manufacturers Multinats and small and Small number of large Some multinats,large medium players producers number of small & medium players >90% of value held by <15 manufacturers Mandatory except for Largely absent Role of regulatory mandatory agency complimentary WHO PQ Mandatory for purchase by Mandatory for Mandatory for global global initiatives purchase by UN purchases but only 2 agencies products listed in 2011 Product pricing at Moderate ;most end user High; often mediated High; plus additional cost prices are related to taxes and s of purchase and source in relation through national mark-ups maintenance of test to access purchasing or global equipment and service initiatives ( GAVI) Integral to new products; New technology and Intellectual Integral to new Property generic production possible products, most EPI constituents components and more likely to be products no longer often patent protected produced have patents Barrier is know-how rather than patents Limited therapeutic High for some products; Market New vaccines competition competition during patent life; produced by limited lower for some neglected generics play major role in large producers; older diseases reducing price vaccines have competing producers Mixed centralized; local OTC High product based Route of market Centralised purchasing segmentation ;limited by govts or purchasing entities central purchasing

Procurement of vaccines for Low income countries Unicef procures vaccines for countries: GNP <$1520 per capita In SADC e.g.Lesotho,DRC,Angola,Malawi,Mozambique Zimbabwe Countries UNICEF procures on behalf of All Vaccines Part of the Vaccines Based on 2008 Forecasts received by UNIICEF

Tiered market Western Markets W Europe, USA, Japan Self Purchasing Upper Middle Income Brazil, Russia, South Self Purchasing Countries Africa, Turkey, Middle East Countries Lower Middle Income Congo ( brazzaville), Graduating Countries Angola, Ghana etc. Low Income Lesotho, Tanzania, GAVI/UNICEF Countries Kenya, DRC etc.

Developing Regions birth cohort and the proportion of vaccine manufacturers Region Birth cohort No of Vaccine manufacturers Africa 47m ? 3 Asia 61m >20 Latin America 10,7m 4

UNICEF Annual Report 2011

GAVI Supply

GAVI Supply

Developing Country Manufacturers Middle East & Africa Asia Pacific Latin America DCVMN

Journey is Long

Challenges in Vaccine Development Overview of the development of a vaccine against rotavirus developed by Wyeth.

BIOVAC Middle East & Africa Asia Pacific Latin America DCVMN

Platforms and Technologies UPSTREAM DOWNSTREAM Technology Formulation Fermentation Cell Culture Biopharming Purification Conjugation [Adjuvant Platforms technologies] Mammalian Purification Purification Transgenic PS-Protein Aluminium- Insect cell Transient Plant cell Emulsion- Bacterial Protein Protein Protein- Technologies based based Yeast Oral cell PS Cross-cutting Analytical Method Development Technology Platforms Microbial Immunological Chemical Cross-cutting Knowledge Biosafety Preclinical Clinical Non Technical Management Platforms 19 PS: Polysaccharide

Vaccine Value Chain Backward Integration Strategy Product BIOVAC Institute Candidates Government Biotech Co’s Universities WHO etc Donor Org Ag Manufacture Operations Outsourced Outsourced Platform Formulation F & F F & F L, P, W, D L, P, W, D Labeling, Packaging, Warehousing, Distribution

Biovac API Production Formulation Packaging Filling

Conclusion • Vaccine Manufacturing Capability – takes long to develop ( patience!) – Takes deep pockets – Has risks But………….. – Is absolutely essential where • there is the largest burden of vaccine preventable diseases ( Africa!) • biggest population growth ( africa!) However needs a direct link with sound, long term procurement practises