Biopharma Quarter: Key Trends and Events of the Third Quarter of 2009
Decision Resources, Inc, December 2009, Pages: 37
The rules of the game in healthcare are changing. Although U.S. healthcare reform has yet to coalesce, the European Union is cracking down on generics shipments, stirring up controversy about trade rules and counterfeit drugs, and ratcheting up its oversight of antitrust laws, launching an investigation into purported agreements between a pharma company and generics manufacturers to keep generic alternatives off the market. Companies are looking outside of their traditional strongholds and toward new opportunities in emerging geographical markets, niche diseases, and targeted approvals.
Questions Answered in This Report
- Healthcare reform initiatives in the United States and related global moves toward cost-containment intensified in the third quarter. What is the outlook for U.S. healthcare reform as the issue becomes more heated? What are the implications for the generics drug business? How do these changes shape the emerging personalized medicine business model? How must pharma companies adapt to become winners in a new marketplace?
- Dealmaking activity increased slightly in the third quarter of 2009 relative to the prior quarter. Which companies were most active? What trends in dealmaking illustrate company strategies?
- Emerging geographical markets are of great interest to makers of branded and generic pharmaceuticals. How are companies gaining access to these markets? What are some of the challenges of reaching these markets?
- The 2006 U.S. approval of a vaccine against human papillomavirus, for use in young girls with the goal of warding off HPV and consequent cervical cancer, was controversial. How has that vaccine been received?
What events have occurred since that initial approval? How are commercial dynamics related to this marketplace evolving?
Scope
- Events: Genetic testing, personalized medicine, companion diagnostics, testing uptake; Genzyme’s troubles; HPV vaccine approvals; HIV vaccine development.
- Dealmaking: Companies, deal values, historical comparisons, trends, technologies, products.
- Generics: Watson expands, Wockhardt contracts; EU generic shipment seizures; legislative defi nition loopholes; EC antitrust investigations; U.K. generic substitution plans.
- Healthcare reform: Rational scenarios; winners and losers; size, scale, and focus of companies before and after reform.
Executive Summary
Strategic Considerations
Stakeholder Implications
Introduction
Events Perspective
The Genetic Testing Component of Personalized Medicine—Who Is Passing and Who Is Failing?
Genzyme: Will the King of Rare Diseases Lose Its Throne?
HPV Vaccine Developments: Gardasil vs. Cervarix
AIDS Vaccine Breakthroughs: Therapeutic and Prophylactic Possibilities
Deals Perspective
Dealmaking Initiatives in Emerging Markets
M&A Activity Energized
Notable Product Deals
Therapy-Area Deals
Technology Deals
Generics Perspective: Contracts, Controversy, Confl ict, and Competitiveness
Buying and Selling in the Industry
EU Seizes Indian Generics in Transit and Fuels Controversy
European Commission Investigates the Activities of Servier
Sanofi ’s Generic Problems Multiply
U.K. Plans for Generic Substitution Delayed
Strategy Perspective: Healthcare Reform and the Future of Pharma
The Pharma Factor
Rational Scenarios
Ramifi cations for Pharma
Winners
Losers
Decision Time
Key Strategic Issues
Scale and Size
Focus
The Bottom Line
Tables
1. HER2 Tests on the Market
2. Diagnosed Incident Cases, by Stage, of Cervical Cancer in the Major Pharmaceutical Markets,
2008 and 2013
3. Diagnosed Incident Cases of HIV Infection in the Major Pharmaceutical Markets, 2008 and 2013
4. Top Company Dealmaking Activity, Q3 2009
5. Select Deals by Therapeutic Area, Q3 2009
6. Select Stem Cell Deals, Q3 2009
7. Select Foreign Acquisitions by U.S. Generics Companies
8. Recent EMEA Generics Approvals
9. Blockbusters Facing Patent Expiry in 2010
Figures
1. Select Product/Franchise Shares of Genzyme Revenue, 2008
2. Number of Third-Quarter Deals, 2006-2009
3. Number of Deals Valued at More than $100 Million in the Third Quarter of Each Year, 2006-2009
4. Number of Deals with a Focus on Emerging Markets, 2009
5. Select Mergers and Acquisitions Valued at More than $250 Million, Q3 2009
6. Select Product Deals Valued at More than $100 Million, Q3 2009
7. Percentage of Deals by Therapeutic Area, Q3 2009
8. Percentage of Deals by Technology, Q3 2009
9. Number of Deals with a Focus on Stem Cell Technology, Q3 2009
10. Healthcare Statistics in the United States vs. Select Nations
Abbott
- Abbott Molecular
- Acino Pharma
- Acorda Therapeutics
- Addrenex Pharmaceuticals
- Adolor
- Agendia
- Agilent Technologies
- Alcon
- Algeta
- Amgen
- Arrow
- ArunaA Biomedical
- AstraZeneca
- AstraZeneca
- Aurora Health Care
- Bayer
- Becton Dickinson
- Biogen Idec
- BioGenex
- BioLineRX
- BioMedica Life Sciences
- Biovail
- Boehringer Ingelheim
- BRAHMS
- Brainstorm Cell Therapeutics
- Bristol-Myers Squibb
- Catalyst Biosciences
- Celera
- Cellular Dynamics International
- Chugai
- Cipla
- Clinical Data
- CombinatoRx
- Crucell
- Daiichi Sankyo
- Dainippon Sumitomo Pharma
- Dako
- Danaher
- Department of Health and Human Services
- Dream Pharma
- Duke University’s Center for Genomic Medicine
- Dura
- Eisai
- Elan
- Eli Lilly
- Endo Pharmaceuticals
- ESBATech
- Evalve
- EyeCyte
- Facet Biotech
- Genentech
- GeneWorks
- Genomic Health
- GENova Biotherapeutics
- Genzyme
- GlaxoSmithKline
- Global Solutions for Infectious Diseases
- HCS
- Hexal
- Hisamitsu Pharmaceuticals
- Horizon Discovery
- Ikaria
- ImmunoCellular Therapeutics
- Indiana University
- International AIDS Vaccine Initiative
- Intervet/Schering-Plough Animal Health
- Invitrogen
- Johns Hopkins University
- Johnson & Johnson
- Krka
- Laboratory Corporation of America
- LEO Pharma
- Life Technologies
- LifeHealth
- Lindopharm
- Lonza Group
- Lundbeck
- Lupin
- Matrix
- MDS
- Meda
- Medarex
- Medicis Pharmaceutical
- MedImmune
- Mental Health Research Institute of Melbourne
- Merck & Co.
- Merial
- Millipore
- Molecular Insight Pharmaceuticals
- Monogram Biosciences
- Mova
- Mylan
- Nanotherapeutics
- NIAID
- Niche Generics
- Norpharm Regulatory Services
- Novartis
- Noven Pharmaceuticals
- Novo Nordisk
- Nycomed
- Opexa Therapeutics
- Oscient Pharmaceuticals
- Ovation Pharmaceuticals
- Patheon
- Peplin
- Pfi zer
- Pfi zer China
- Pharmathen
- Portola Pharmaceuticals
- Procter & Gamble
- Prostrakan Group
- Protalix
- Protea Biosciences
- Protein Production Services
- PTC Therapeutics
- Purdue Pharma
- Qualimed
- Ratiopharm
- Revance
- Roche
- Sandoz
- Sanofi Pasteur
- Sanofi -Aventis
- Santhera Pharmaceuticals
- Schering-Plough
- Sepracor
- Sequenom
- Servier
- Shanghai Institutes for Biological Science
- Shantha Biotechnics
- Shire
- Siemens Healthcare Diagnostics
- Solvay
- TAD
- Teva
- Theraclone Sciences
- Thermo Fisher Scientifi c
- Torrey Pines Institute
- Transcept Pharmaceuticals
- Trubion Pharmaceuticals
- Unichem Laboratories
- Vanda Pharmaceuticals
- Varian
- Ventana Medical Systems
- Veridex
- Vetoquinol
- Vical
- Visiogen
- Vysis
- Warner Chilcott
- Watson
- Wockhardt
- ZymoGenetics
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