Biopharma Quarter: Key Trends and Events of the Fourth Quarter of 2008

Published by: Decision Resources

Published: Mar. 30, 2009 - 48 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Introduction

Events Perspective

On the Political Front: Focus on Themes of the U.S. Elections

Expanded Access

Cost Containment

Cost-Effective, Quality Care

Support for Innovation

On the Economic Front: Quantifying the Impact of the Recession

On the Approvals Front: Latisse Became the Latest Entry in the Lifestyle Drugs Category

On the International Front: Focus on Chinese Pharma Manufacturing

Deals Perspective

Deals by Company

Deal Type

Acquisitions

Collaborations and Licensing

Deals by Therapeutic Area—Oncology Focus

Product Deals

Generics Perspective: Pro-Generics Governments Boost the Generics Industry

Increased Big Pharma Involvement in Generics

U.S. Biosimilars Guidelines Delayed—For Now

FDA Clampdowns—A Reaction to the Heparin Fiasco?

Generic Plavix Reaches European Market Early Through a Legal Loophole

Japanese Generics Market Starts to Open

Strategy Perspective: Global Economic Crisis Is a Prelude to Greater Challenges for Biopharma

Biotech Sector: Cash Crunch, Company Crashes, and a Cull

Pharma Sector: Missing a Master Plan for Necessary Transformation

Pending Challenges for the Industry

Tables

1. Targets of Select Key Cost-Containment Measures in the Major Markets

2. Select PGx-Based Diagnostic Tests

3. Select Companies Working on Stem Cell Technologies and Therapies

4. Select Drugs in Development for Autism

5. Worldwide 2007 Sales of Select “Lifestyle” Drugs

6. Leading Domestic and Multinational Pharmaceutical Companies in China

7. Key Fourth-Quarter Findings of Decision Resources’ Emerging Markets Research and Analysis

8. Company Dealmaking Activity, Q4 2008

9. Select Big Pharma Acquisitions, Q4 2008

10. Select Big Pharma Collaborations, Q4 2008

11. Select Big Pharma Licensing, Q4 2008

12. Select Fourth Quarter Oncology Deals, 2008

13. Biosimilar Agents in the European Union and the United States

14. Generic Expansion into Japan, Q4 2008

Figures

1. Qualitative Assessment of Implications of U.S. Healthcare Reform for Biopharma

2. Healthcare Statistics in the United States Versus Select Nations That Provide Universal Health Insurance

3. Year in Review: Market Sector Stock Indices

4. Impact of Cost of Care on Access to Care in the United States Versus Select Nations That Provide Universal Health Insurance

5. Fourth-Quarter 2008 U.S. Drug Approval Tallies and Highlights

6. Volume of Pharma and Biotech Deals, 2006-2008

7. Pharma and Biotech Deals Valued Over $100MM, 2006-2008

8. Largest Deals of Q4 2008, by Value

9. Therapeutic Area Focus of Deals, Q4 2008

10. Product Dealmaking Activities Between Companies, Q4 2008

11. Phase of Development of 54 Inlicensed Products, Q4 2008

12. Categories of Inlicensed Products, Q4 2008

13. Most Important Issues and Labeling Requirements for Regulatory Authorities

14. Extensive Layoffs in the Pharmaceutical Industry, 2007-2008

Expert Commentaries

Prospects for Improved Access to Innovative Medicines in the United Kingdom

Outlook for Foreign Pharma in the Face of China’s New Patent Law

Gilding Lilly? A Look at the ImClone Acquisition

Biosimilars in Japan: The Threat Level Is Low

Abstract

• There's a new administration in Washington. What are the prospects for expanded care? What are the targets of cost-containment? How do administration policies present opportunity for the biopharma industry?
• Healthcare is generally regarded as a stable industry in a down economy, but biopharma is feeling the effects of the global recession. How is access to healthcare changing? How is access to funding changing? How are biopharma companies affected, and how are they adjusting their general business and dealmaking strategies?
• Spectrum has advised the industry to adapt to inevitable changes in the industry. What are the promising strategies and new directions for biopharma companies? How can companies turn challenges into opportunities?

• Events: political change in the United States and United Kingdom, effects of the economy on the industry's fortunes, new moves on the lifestyle drugs landscape, new competitive considerations in the emerging market of China.
• Dealmaking: deal type, deal value, deal focus, most active companies, therapeutic areas.
• Generics: related deals, biosimilars, Big Pharma participation, early competition for clopidogrel, opening of the Japanese market.
• Strategy: the varied affect of the economy on biotechs versus Big Pharma; new imperatives in the response to the economy; new scrutiny of Big Pharma responses to generic competition.
• Expert commentaries: generics industry perspectives, strategy perspectives, U.K. policy news perspective, Japanese biosimilar industry news perspective, Chinese intellectual property news perspective, Lilly's fourth-quarter dealmaking strategy perspective.

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