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Reportlinker Adds Pharmaceutical Pricing, Reimbursement and Parallel Trade 2006

NEW YORK, Nov. 10 /PRNewswire/ -- announces that a new market research report is available in its catalogue.

Pharmaceutical Pricing, Reimbursement and Parallel Trade 2006

Despite their diversity, global healthcare systems are increasingly converging in the need and desire to contain costs of healthcare, and especially those associated with pharmaceuticals. At the same time, Big Pharma are having to contend with a dearth of invention, patent expirations, and increased generic competition, among other factors undermining their profits. In this environment, the importance of market access strategies, especially in terms of pricing, reimbursement and parallel trade are rapidly gaining prominence.

Pharmaceutical and Biotech Market Entrance Strategies examines the key issues that need to be addressed by pharmaceutical and biotechnology companies alike in order to successfully achieve return on investment. The American, European and Japanese markets are undergoing constant harmonisation changes, which are leading to a globalisation of operating procedures and state intervention in healthcare and drug cost containment. This trend has an important impact on the overall environment facing the drug and biotechnology industry - on the one hand, facilitating access to a wider patient base but, on the other, raising the stakes of key pricing and reimbursement decisions.

Pricing can no longer be considered separate to reimbursement, while parallel trade threatens to undermine companies' wider regional efforts to achieve the best price for their products. Lifecycle management issues increasingly involve tailor-made medicines, pharmacogenomics and similar disciplines, as well as greater co- operation within the industry and outside its boundaries. This report examines these issues in great detail and helps the reader navigate this increasingly complex field.

Pharmaceutical and Biotech Market Entrance Strategies provides the following:

An overview of major market access strategies

In-depth information regarding the pricing environments of the American, European and Japanese pharmaceutical markets, comparing and contrasting their major features with a view to securing the best approach

In-depth information regarding reimbursement environments and market strategies that are most suitable for a particular market

Overview of parallel trade, including major responses to the threat by all relevant players

Overview of lifecycle management, identifying key factors for successful product placement over time

Examination of Latin American experience in terms of pricing strategies and lessons that can be learned globally

Who should buy this report?

Companies wishing to examine the most current pricing and regulatory environments in major global markets, including different cost-containment strategies used by governments and purse-holders.

Companies interested in understanding the impact and implications of parallel trade, with a view to minimising disadvantages to their products.

Companies interested in understanding the wider opportunities and challenges in the American, Japanese and European markets.

Pharmaceutical and biotech companies wishing to identify both the threats to products in these markets as well as the variety of profit maximisation strategies outlined in this report.

Table of Content

1 Executive Summary, Report Objectives and Scope

1.1 Executive Summary

1.2 Report Objectives and Scope

2 Introduction

2.1 Pharmaceutical and Biotechnology Industries: Brothers in Need

Case Study: Biotech-Biotech Take-Over Deal - Amgen and Immunex

2.1.1 Pipeline Problems

2.1.2 Big Pharma's Image under Attack

2.1.3 The Secret Price of Drugs

2.2 Biotechnology as an Equal Partner

2.2.1 Risk Management Strategies for Biotech Firms

2.2.2 Biotech in Europe

Case Study: The European Biotechnology Patents Directive

2.2.3 The One That Can: Amgen, the Most Successful Biotech Company

3 Key Issues Affecting Global Pharmaceutical and Biotechnology Industries

3.1 Pharmaceuticals: Strength in Numbers

3.2 Pharmaceuticals: The Medical Needs/Financial Means Gap

3.3 Pharmaceuticals: The Public Voice

3.4 Pharmaceuticals: Big Names in Pharma Business

3.5 Biotechnology: What's Hot and What's Not

3.6 Key Markets: The US, Japan, Europe

3.6.1 The Awesome Threesome: The US

3.6.2 The Awesome Threesome: Japan

3.6.3 The Awesome Threesome: The EU

4 Market Entrance Strategies - General Overview

Minority equity investment



Partnerships and R&D partnering

Niche market launches

New blockbuster therapy

Me-too drugs

Not launching or delaying launches

Marketing and promotion

Full reimbursement versus lower prices or restrictions on prescribing

Launching without reimbursement

Sequence of launch


Orphan drug status


Price corridors

Generic market entry

Patent extension, data exclusivity and market protection

Prescription to OTC switching

Case Study: Biotechnology Commercialisation Agreement - Innovex and CVT

Case Study: Launching Without Reimbursement - Aricept

Case Study: AstraZeneca and Atherogenics Licensing Deal

Case Study: Aspreva and Rare Disease Research

Acquisition Case Study: Novartis and Lek

Case Study: the US - Pfizer and Pharmacia Merger

Case Study: Europe: Aventis and Sanofi-Synthelabo Merger

Case Study: Japan: Daiichi and Sankyo Merger

Case Study: Supplementary Protection Certificates and Data Exclusivity in Europe

5 An Introduction to Pricing and Reimbursement

5.1 The Basics of Pricing

5.2 Elements of Pricing

5.3 Strategic Pricing

5.4 Pharmacogenomics and Pricing Ramifications

Case Study: Pharmacogenomics in the UK's NHS

6 Pricing/Reimbursement in the US

6.1 US Healthcare System - Overview

6.2 Medicare

6.3 Medicaid

6.4 Federal Healthcare Budget

6.5 Recent Developments

6.6 Pricing in the US

6.6.1 Price-Fixing

6.6.2 State-Specific Pricing Policies Price Controls in Maine Florida's Medicaid Drug Rebates

6.7 Pricing in the US: Market Entrance Strategies

6.8 Reimbursement in the US: Present Climate and Conditions

6.9 Reimbursement in the US: Market Entrance Strategies

7 Pricing/Reimbursement in Japan - Overview

7.1 Pricing in Japan

7.2 Pricing in Japan: Market Entrance Strategies

7.3 Reimbursement in Japan: Present Climate and Conditions

7.4 Reimbursement in Japan: Market Entrance Strategies

8 Pricing in the EU: Present Climate and Conditions - Overview

8.1 Price Controls

8.1.1 Supply Side

8.1.2 Demand Side

8.2 EU Enlargement

8.3 Pricing in Europe: Market Entrance Strategies

8.4 Reimbursement in the EU: Present Climate and Conditions - Overview

8.5 Reimbursement Strategies

8.6 Reimbursement in Europe: Market Entrance Strategies

8.7 Pricing/Reimbursement in Select EU Countries

8.7.1 Pricing in the UK

8.7.2 Reimbursement in the UK

8.7.3 Pricing in France

8.7.4 Reimbursement in France

8.7.5 Pricing in Germany

8.7.6 Reimbursement in Germany

8.8 Pricing and Reimbursement in Other EU Countries

8.8.1 Pricing and Reimbursement - Spain

8.8.2 Pricing and Reimbursement - Italy

8.8.3 Pricing and Reimbursement - Greece

8.8.4 Pricing and Reimbursement - Portugal

8.8.5 Pricing and Reimbursement - Poland

8.8.6 Pricing and Reimbursement - Hungary

8.8.7 Pricing and Reimbursement - The Czech Republic

9 Parallel Trade

9.1 Definition

9.2 Reasons for Parallel Trade

9.2.1 The Cost-Cutting Rationale

9.2.2 Principles of Free Trade

9.2.3 Disparate Regulatory and Intellectual Property Environments

9.3 Who Benefits from Parallel Trade?

10 Parallel Trade in the US: Canadian Re-importation

10.1 Re-importation into the US - The Desire to Save

10.2 Re-Importation into the US - Patent Rights

10.3 Re-Importation into the US - Legislative Support

10.4 Reasons for Parallel Trade from Canada

10.5 Company Opposition

10.6 State Actions

10.7 Patients' Involvement

10.8 FDA Response

10.9 Potential Savings

11 Parallel Trade in Europe

11.1 Single Market and Parallel Trade

11.2 EU PT Market Figures

11.3 EU Enlargement

11.4 Parallel Trade and EU Enlargement

11.5 Parallel Trade and the Euro

11.6 How to Stop Parallel Trade

11.7 Legal Examples of Parallel Trade Disputes

11.7.1 Pharmaceutical Repackaging: Aventis' Insuman

11.7.2 Repackaging: Boehringer Ingelheim & Others v. Swingward and Dowelhurts

11.7.3 Trademarks: Pharmacia & Upjohn SA v. Paranova A/S

11.7.4 Market Authorisation Withdrawal: Ferring v. Eurim-Pharm and Paranova

11.7.5 Common Origin: Germany v. Kohlpharma

11.7.6 Stock Management: Bayer and Adalat

11.8 A Single European Price?

Case Study: Single European Price for Merck's Crixivan

12 Regional Lessons for Pharmaceutical Pricing

12.1 Regional Pricing: Latin American Examples

13 Conclusion: The Lessons Learnt

13.1 Pricing - Global Lessons

13.2 Reimbursement - Essential Market Access Factor

13.3 R&D - Continued Need for Innovation

13.4 Globalisation of the Pharmaceutical Market

13.5 Future Considerations

13.5.1 Development of New Markets

Case Study: Bird Flu

13.5.2 Discoveries in Technology and Genetics

13.5.3 Bioterrorism, New Diagnostics

13.5.4 Lifecycle Management

13.6 Closing Remarks


List of Tables

Table 2.1 Total and On-Patent Drug Revenues for Selected Organisation for Economic Co-Operation and

Development (OECD) Countries

Table 2.2 Total and Off-Patent Drug Revenues for Selected OECD Countries

Table 2.3 Key Off-Patent Drugs

Table 2.4 World's Largest Biotech Companies by Sales, 2005

Table 2.5 World's Largest Healthcare Companies by Sales of Biotech Products, 2003

Table 2.6 Amgen's Financial Statement Figures

Table 3.1 Big Pharma by Sales

Table 3.2 Top Products, October 2005

Table 3.3 Retail Medicine Sales by Main Markets, 12 Months to November 2005

Table 3.4 Promotional Expenditure in Select EU Countries, 2003

Table 4.1 FDA Orphan Drugs - Products Designated as Orphan Drugs, September 2005 to December 2005

Table 6.1 OECD Health: Spending and Resources (2003 Figures)

Table 6.2 US Online Advertising Spending by Major Industry Category as a % of Total Online Ad Spending

Table 6.3 Marketing and R&D Costs by Major Pharmaceutical Companies, 2003

Table 8.1 Pharmaceutical Sales and Growth by Value

Table 8.2 European Reference Pricing Situation

Table 8.3 Overview of Supply-Side Pricing and Reimbursement in the Old EU

Table 8.4 Overview of Demand-Side Pricing and Reimbursement in the Old EU

Table 8.5 Estimated Pharmaceutical Market Value by Country, 2005

Table 9.1 Parallel Trade Benefits and Threats

Table 11.1 Savings Achieved by PT in Select EU Countries

Table 11.2 Share of Parallel Imports as % of Total Pharmaceutical Market, 1998, 2000, 2002

Table 11.3 Share of Parallel Imports as % of Total Pharmaceutical Market, 1997, 1999

Table 11.4 National Policies Regarding Parallel Import Drugs in Europe, 2004

Table 11.5 Pros and Cons of Single and Decentralised Pricing Strategies 2002

Table 12.1 Antiretroviral Therapy Coverage in the Developing Countries, December 2002

List of Graphs

Graph 2.1 Average R&D Expenses of Major Pharmaceutical Companies in Japan and the US

Graph 3.1 Geographical Breakdown of Retail Medicine Sales by Main Markets

Graph 3.2 Pharmaceutical Sales in the New EU

Graph 4.1 European Price Corridor Strategy

Graph 8.1 Main EU Markets, 2004

Graph 11.1 Average Pharmaceutical Price per Tablet, 19 Leading Molecules

Graph 11.2 Shortcomings of a One-Price Policy

Graph 12.1 Cumulative Number of Reported HIV/AIDS Cases in the WHO European Region

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Pharmaceutical Pricing, Reimbursement and Parallel Trade 2006

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    CONTACT:  Nicolas Bombourg
    US: (805)652-2626
    Intl: +1 805-652-2626

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