Investment opportunities in the health sector in Europe, focussing on Germany Dr. Simone Breitkopf, BPI Dr. Rudolf Schosser, Consultant

World Pharma Market by Regions 2007 European Pharmaceutical market: 213,1 billion US$ Source: IMS World Review 2008

Europe: Central and Regional  27 countries  493 Mio. population  Pharmaceutical market: 213,1 billion US$  Administration  Legislation  Pharmaceutical regulations  Marketing authorization  Different health care systems  Different health insurance and reimbursement systems Very complex environment!

German Pharmaceutical Market  pharmaceutical companies  395 biotech companies  Pharmaproduction: 26,2 billion EURO  R&D-Expenditure: 5,8 billion EURO  Turnover in German Pharmacy Market (22,8 billion EURO): 17,7 billion EURO Rx-Products 2,9 billion EURO „pharmacy only“-Products Source: BPI-Pharma-Daten 2008

Exports and Imports of Pharmaceuticals in Germany YearImportExport Mill. Euro+/- %Mill. Euro+/- % , , , , , , , , , , , , , , , , Source: German Federal Statistical Office (Destatis), 2008

Price structure Source: BPI-Pharma-Daten

Healthcare Sector in Germany 90% of the population is insured in about 220 statutory health insurances (GKV). About 10% of the population is insured by 50 private health insurances. GKV-Expenditure: 153,6 billion EURO Medicinal Products: 25,6 billion EURO (16,7 %)

Generics market in Germany Growing market Highly competitive Complex reimburse- ment situation Opportunities for Indian pharmaceutical companies?!

Growing Number of Chronic Diseases Source: WHO % of population

Growing OTC Market Covering pharmacy-only products, freely available products and general health products OTC sales trends in 2007 dominated by pharmacy-only products with 82.0% of the market. Every fifth non-prescription product sold at pharmacies is not pharmacy-only (percentage sales: 18.3%).

Market entry in Germany …  is a rough cruise  requires professionalism  and strong local partners e.g. BPI e.V. and BPI-Service GmbH knowledgeable consultants and service providers

Shortening time to market Sequential approach Decision to explore market entry Decision to enter market Subsidiary established Launch of product(s) Market entry researchEstablish subsidiaryObtain marketing authorization + build up infrastructure (in case of greenfield approach) Parallel approach Decision to explore market entry Decision to enter market Subsidiary established Launch of product(s) Market entry researchEstablish subsidiary Obtain marketing authorization + (optional) build up infrastructure

You need … …a local team in which each member knows exactly what has to be done at the right time in the right order

You need … …a crew which is highly motivated and aligned to the goal of bringing your drug onto the market

You need … ….to avoid unnecessary collisions and get the ship safely to the harbor of destination (= marketing authorization and reimbursement) ….a captain …a navigator and …a helmsman….

Thank you for your attention