VACFA 2014 Pharma Vaccines Diagnostics Manufacturers Multinats - - PowerPoint PPT Presentation

vacfa 2014
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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


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VACFA 2014

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Pharma Vaccines Diagnostics

Manufacturers Multinats and small and medium players Small number of large producers >90% of value held by <15 manufacturers Some multinats,large number of small & medium players Role of regulatory agency Mandatory except for complimentary mandatory Largely absent WHO PQ Mandatory for purchase by global initiatives Mandatory for purchase by UN agencies Mandatory for global purchases but only 2 products listed in 2011 Product pricing at source in relation to access Moderate ;most end user prices are related to taxes and mark-ups High; often mediated through national purchasing or global initiatives ( GAVI) High; plus additional cost s of purchase and maintenance of test equipment and service Intellectual Property Integral to new products; generic production possible and more likely to be produced Integral to new products, most EPI products no longer have patents Barrier is know-how rather than patents New technology and constituents components

  • ften patent protected

Market competition Limited therapeutic competition during patent life; generics play major role in reducing price New vaccines produced by limited large producers; older vaccines have competing producers High for some products; lower for some neglected diseases Route of market Mixed centralized; local OTC Centralised purchasing by govts or purchasing entities High product based segmentation ;limited central purchasing

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Countries UNICEF procures on behalf of

All Vaccines Part of the Vaccines

Based on 2008 Forecasts received by UNIICEF

Unicef procures vaccines for countries: GNP <$1520 per capita In SADC e.g.Lesotho,DRC,Angola,Malawi,Mozambique Zimbabwe

Procurement of vaccines for Low income countries

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Tiered market

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

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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

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UNICEF Annual Report 2011

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GAVI Supply

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GAVI Supply

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Latin America Middle East & Africa Asia Pacific

Developing Country Manufacturers

DCVMN

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Journey is Long

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Challenges in Vaccine Development

Overview of the development of a vaccine against rotavirus developed by Wyeth.

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Latin America Middle East & Africa Asia Pacific

BIOVAC

DCVMN

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Platforms and Technologies UPSTREAM

Fermentation Bacterial Yeast Cell Culture Mammalian cell Insect cell Plant cell Biopharming Transgenic Transient

DOWNSTREAM

Purification PS Purification Protein Purification Conjugation PS-Protein Protein- Protein Formulation [Adjuvant technologies] Aluminium- based Emulsion- based Oral

Analytical Method Development

Microbial Immunological Chemical Technology Platforms Technologies Cross-cutting Technology Platforms

PS: Polysaccharide

Knowledge Management Biosafety Preclinical Clinical Cross-cutting Non Technical Platforms

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Vaccine Value Chain

Biotech Co’s Universities etc Ag Manufacture Formulation

L, P, W, D

BIOVAC Institute

Product Candidates

Government WHO Donor Org

F & F F & F

L, P, W, D

Labeling, Packaging, Warehousing, Distribution

Outsourced Outsourced Platform Operations

Backward Integration Strategy

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Biovac

Packaging Filling API Production Formulation

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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