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European Market Entry Strategies: Impact of Regulations, Pricing, Reimbursement, Parallel Trade and Generics Post-Accession

Introduction

Europe remains an attractive market to launch pharmaceutical products in because centralized regulatory ruling allows for immediate access to 15 member states. Although EU expansion to 25 countries does offer even greater market opportunities, the timely implementation of harmonized regulatory and intellectual property laws within these accession countries remains the limiting factor for success. 

Scope

Reviews the impact of EU drug authorization, pricing, reimbursement, parallel trade and generics post-accession 

Identifies a framework for market entry, including an optimal country-by-country product launch sequence for the EU15 states 

Evaluates the current issues and changes impacting pricing and reimbursement within each EU15 member state 

Benchmarks the current market entry practices used across Europe in terms of either the partnering or go-it-alone routes 

Report Highlights

Provides a detailed insight into impacting factors affecting EU drug authorizations, pricing, reimbursement, parallel trade and generics pre- and post-accession. 

Reviews the current issues impacting pricing and reimbursement within each EU15 member state, thereby, providing an optimal country-by-country product launch sequence framework for successful entry into the EU. 

Analyzes the results of Datamonitor’s European Market Entry Strategies 2003 Survey covering 35 pharmaceutical companies in the US, Europe and Japan. The data includes opinions and inference relating to best practice from senior business development, regulatory and international affairs, licensing, and sales and marketing executives. 

Reasons to Purchase

Allows your organization to be fully aware of factors impacting the pharmaceutical industry before and after accession in the EU 

Identify which EU member states should be targeted first for a successful market launch with reference to their key pricing and reimbursement policies 

Benchmark which market entry strategy is best suited for your organization in terms of either the partnering, go-it-alone or acquisition routes 

April 2004, 213 pages 

Publisher: Datamonitor Market and Sales Reports 

To order go to this URL: http://www.bioportfolio.com/cgi-bin/acatalog/Datamonitor_Market_and_Sales.html#a573

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