欧州のジェネリック医薬品およびバイオシミラー市場における価格および償還動向

Abstract

This Frost & Sullivan research service titled Pricing and Reimbursement Issues for Generics & Biosimilars Markets in Europe provides a detailed analysis of various issues affecting pricing and reimbursement decisions of generics in Europe. The study includes an overview of cost-containment measures such as reference pricing, parallel trade, generic substitution, patient co-payments and reimbursement. Certain key issues such as the EU accession, the Roche/Bolar provision, data exclusivity and marketing authorisation applications are also discussed.

Table of Contents

1. Executive Summary

• 1. Executive Summary
  • 1. Executive Summary

2. Glossary of Terms

• 1. Important Terms
  • 1. Definitions

3. Research Methodology

• 1. Methodology Of Research
  • 1. The "12 Step" Market Engineering Research Methodology and Process

4. Introduction

• 1. Overview
  • 1. Market Analysis
  • 2. Scope and Objectives
  • 3. Pricing and Reimbursement
  • 4. The Biosimilars Opportunity

5. Key Trends

• 1. Pharmaceutical Cost-containment Measures
  • 1. Reference Pricing
  • 2. Parallel Trade
  • 3. Generic Substitution
  • 4. Patient Co-payments and Reimbursement
• 2. Political/Legal/Regulatory Issues
  • 1. Impact of EU Accession
  • 2. The Roche/Bolar Provision
  • 3. Data Exclusivity and Marketing Authorisation Applications

6. Country-wise Policy Analysis

• 1. Group I
  • 1. Denmark
  • 2. Germany
  • 3. The Netherlands
  • 4. The United Kingdom
• 2. Group II
  • 1. Austria
  • 2. Belgium
  • 3. France
  • 4. Italy
  • 5. Portugal
  • 6. Spain
• 3. Group III
  • 1. Central and Eastern Europe (CEE)

7. Market Participants

• 1. Market Players
  • 1. List of Generics Market Participants
  • 2. List of Biosimilars Market Participants

8. Strategic Recommendations

• 1. Recommendations to Market Participants
  • 1. Strategic Suggestions

9. Decision Support Databases

• 1. DSDs
  • 1. Total Healthcare Expenditure
  • 2. Pharma R&D Expenditure

List of Figures

Chapter 4

• Generics Market: Market Share of Generics by Value and Volume (Europe), 2004

Chapter 5

• Generics Market: Country-wise Policy on Generic Substitution (Europe), 2006
• Generics Market: Average Time Required for Pricing and Reimbursement Approvals (Europe), 2004

Chapter 7

• Generics Market: List of Key Market Participants (Europe), 2006
• Biosimilars Market: List of Key Market Participants (Europe), 2006