SPI Infoamtion

Table of Contents

Executive summary

Key challenges
Key opportunities
Analysis of the top 10 global pharma companies
Pfizer
GlaxoSmithKline
Merck and Co.
Roche
The future

Chapter 1 Key challenges

Summary
Introduction
Challenges facing R&D

Falling R&D productivity
Late stage pipeline attrition
Economic pressures
Regulatory hurdles

Competition from generics

Patent challenges
Biosimilars

Impact of challenges on pharma and its responses

Restructuring of R&D operations
Outsourcing sales
Mitigation strategies for genericization

Chapter 2 Key opportunities

Summary
Introduction
Opportunities

Biotech still growing
New emerging markets

Asia

Demise of the blockbuster drug and emergence of the nichebuster
New technologies to boost niche drugs

Biomarkers
Theranostics

Drug repositioning

Chapter 3 Analysis of the top 10 global pharma companies

Summary
Introduction
Top 10 companies

Product mix (small molecule/biologic)
Therapy area mix

Growth in oncology drugs

Geography of product sales

Asia
South America

R&D profiles
Growth strategies

Chapter 4 Pfizer

Summary
Introduction
Is bigger better?
Challenges

Patent expiration of Lipitor
Torcetrapib
Exubera

Strategy

New CEO
Job cuts and plant closures
New opportunities for global growth

Pipeline
Opportunities in emerging markets
Reducing costs where possible

Looking to Biotech

Mergers and acquisitions

Encysive Pharmaceuticals
Serenex
Coley Pharmaceutical
CovX

Pipeline

Sutent
Lyrica

Chapter 5 GlaxoSmithKline

Summary
Introduction
Challenges

Generic competition

Seretide/Advair
Avandia
Wellbutrin
Zofran
Imigran

Lack of therapy area diversification

Business Strategy

Financial Strategy
GSK's new strategic priorities
Recently marketed products

Tykerb
Cervarix

Mergers and acquisitions

Sirtris Pharmaceuticals
Reliant Pharmaceuticals
Domantis Ltd

Pipeline

Bosatria (mepolizumab)
Ofatumumab
Zunrisa/Rezonic

Chapter 6 Merck & Co.

Summary
Introduction
Challenges

Vioxx
Generic competition

Zocor
Fosamax
Cozaar/Hyzaar

Vaccines

Gardasil
Manufacturing problems

5 year strategy

Cost cutting measures
Boosting revenue
Utilizing emerging markets

Licensing
Mergers and acquisitions

NovaCardia
Sirna Therapeutics
Abmaxis
GlycoFi

Pipeline

telcagepant
Cordaptive/Tredaptive

Chapter 7 Roche

Summary
Introduction
Challenges
The networked pharma model
Current strategy

Mergers and acquisitions

Arius Research
Mirus Bio Corporation
Piramed Limited
Alnylam Pharmaceuticals

Roche and Genentech

Pipeline

Ocrelizumab
Omnitarg

Chapter 8 The future

Summary
Introduction
Future growth
Biotech partnerships and acquisitions
Pipeline
Personalized medicine

Predictive medicine
Pharmacogenomics
Molecular diagnostics
Biomarkers

Chapter 9 Appendix

Primary research methodology
Index

List of Figures
Figure 1.1: Number of NMEs and BLAs approved by the US FDA
Figure 1.2: Pharma R&D spend 2004 . 2009e
Figure 1.3: Biotech R&D spend
Figure 1.4: Biotech funding
Figure 1.5: Drug patent expiries in the US, 2008-2012
Figure 1.6: Barr Pharmaceuticals Paragraph IV patent challenges
Figure 1.7: Estimated Last Patent Expiry Dates of Selected Proteins
Figure 1.8: Global Expenditure on R&D and Contract Research
Figure 2.9: Biotech drugs in development by therapeutic category*
Figure 2.10: Market share of blockbuster drugs (%), global.
Figure 3.11: Competitive dynamics of the top 10 companies, 2006-7
Figure 3.12: Molecule type by company type, 2006-7
Figure 3.13: Therapy area analysis, 2006-7
Figure 3.14: Competitive dynamics of the leading cancer drugs, 2007
Figure 3.15: Sales by geography, 2006-7
Figure 3.16: Percentage of developmental products in each phase of clinical development
Figure 3.17: Number of products in clinical development
Figure 3.18: Therapeutic focus of the leading pharmaceutical companies' R&D portfolios
Figure 5.19: GSK sales by therapy area, 2007
Figure 6.20: Aligning sales teams around customers
Figure 6.21: New commercial models, more effective and efficient
Figure 7.22: The networked pharma model
Figure 7.23: Roche's pipeline by phase and type
Figure 7.24: Roche's pipeline by partnerships
Figure 8.25: What is your prediction of the annual growth rates in the following sectors in the next 5-10 years? a) Pharma
Figure 8.26: What is your prediction of the annual growth rates in the following sectors in the next 5-10 years? Biotech
Figure 8.27: In the next 5-10 years how will the number of alliances between the following sectors change?
Figure 8.28: In order to improve R&D productivity, how will the number of deals in the following categories change in the next 5-10 years?
Figure 8.29: Please rate how attractive a move into each of the following sectors would be.
Figure 9.30: Which is your principal activity?

List of Tables
Table 1.1: Drug safety concerns, 2007
Table 1.2: Total generic sales in the US/5EU ($m), 2007
Table 2.3: Global biotech leading therapy classes 2007
Table 2.4: Recent pharma acquisitions of biotech companies
Table 2.5: Sales in 7MM and pharmerging markets ($m), 2003-07
Table 2.6: Sales in key Asian markets ($m), 2003-07
Table 2.7: Market share of blockbuster drugs, global.
Table 2.8: Sales contributions ($m) to the top 10 companies from their 5 leading products, 2007
Table 2.9: FDA NME drug approvals, Jan .August 2008
Table 2.10: Breakdown of R&D investment in 2005
Table 3.11: Total pharma sales of the top 10 corporations ($m), 2003-7
Table 3.12: Top 10 branded pharmaceuticals, 2006-7
Table 3.13: Total pharma sales, top 20 molecule analysis
Table 4.14: Pfizer's acquisitions and divestments 2005-2008
Table 4.15: Pfizer's Pipeline Phase 2, 2008
Table 4.16: Pfizer's Pipeline, Phase 3 and filed
Table 4.17: Pfizer's projected submission, 2010-2012
Table 5.18: GSK's M&A activity 2005-2008
Table 5.19: GSK's phase 3 pipeline 2008
Table 6.20: Merck's M&A activity 2005-2008
Table 6.21: Merck's Pipeline 2008
Table 7.22: Roche's M&A activity 2005-2008
Table 7.23: Roche's pipeline, phase 3 and filed, 2008,
Table 7.24: Roche's oncology pipeline, phase 3 and filed, 2008