The US Pharmaceutical Market Outlook To 2014: Market trends, leading players and forecasts

Table of Contents

Executive summary

• The US market outlook - An overview
• The US healthcare system
• Healthcare reforms
• The pharmaceutical industry in the US
• Key players in the US pharmaceutical market

Chapter 1 - Scope and methodology

• Scope
• Methodology

Chapter 2 - The US market: an overview

• Summary
• Introduction
• Obama

• The macroeconomic setting
• An economy in recession

• Population profile

• Disease burden

Chapter 3 - The US healthcare system

• Summary
• Introduction
• Overview of the US healthcare system

• Structure

• Financing healthcare - pricing and reimbursement
  • Drug pricing
  • Parallel imports in the US pharmaceutical market
  • Reimbursement of drugs
  • Formularies as a cost containment measure
  • Tiered co-payment as a cost containment measure
  • Step therapy as a cost containment measure

• Health insurance
  • The Medicaid program
  • The Medicare program
  • Employment-based insurance

• Regulatory environment - Patent protection
  • Hatch Waxman Act
  • Litigation under Paragraph IV
  • Market exclusivity
  • Pediatric extension
  • Orphan drugs

Chapter 4 - Healthcare reforms

• Summary
• Introduction
• Where does the healthcare dollar go?

• Obama' s healthcare reforms
• Universal coverage
  • Massachusetts healthcare reform
  • The proposed plan of the Obama administration
  • The Building Blocks approach
• Disease management
• FDA reforms
• Industry reforms
  • Impact on individual drug companies
  • Drug costs

Chapter 5 - The pharmaceutical industry in the US

• Summary
• Introduction
• Key industry trends, events and issues
  • Slew of patent losses
  • The impact of the economic slowdown on biotech
  • Big pharma Biotech alliances to strengthen drug pipelines

• Trends in generics usage and licensing

• Therapy area analysis
• Analysis of leading sub-therapy areas
  • Nervous System
  • Cardiovascular system
  • Alimentary tract and metabolism
  • Antineoplastic and immunomodulating agents
  • General anti-infectives (systemic)
• Sub-therapeutic categories analysis

• Therapy area sales forecast

• Leading brands
• Key brands analysis
  • Lipitor
  • Nexium
  • Plavix
  • Seroquel
  • Aranesp

• Leading brands sales forecast

• The US biotechnology market
• An eventful year
• Different classes of biologics
  • Monoclonal antibodies
  • Growth factors
  • Hormones
  • Fusion proteins
  • Cytokines
• Key players in the biotech market
• Key products in the biotech market
  • Enbrel
  • Aranesp
  • Neulasta
  • Avastin
• Follow-on Biologics
• Biotech funding

• The US generics industry
• Leading generic companies
• Leading generic products
  • Fentanyl
  • Amlodip
  • DuoNeb
• Key issues and trends
  • At risk launches to remain a key feature
  • Value added generics

Chapter 6 - Key players in the US pharmaceutical market

• Summary

• Introduction

• Leading companies

• The shrinking pharma space
• Roche - Genentech - a 20 year history
• Pfizer - Wyeth - Adding stability
• Merck - Schering-Plough - A strategic fit?
• Gilead - CV Therapeutics - A bid to diversify
• Are other pharma majors following suit?

• Detailed analysis of leading US pharmaceutical market players
• Pfizer
  • Overview
  • Sales focus by leading drug classes
  • Sales focus by leading brands
  • Pfizer' s pipeline focus
  • Axitinib
  • Apixaban
  • SWOT analysis
  • Strengths
  • Weaknesses
  • Opportunities
  • Threats
• GlaxoSmithKline
  • Overview:
  • Sales focus by leading drug classes
  • Sales focus by leading brands
  • GSK' s pipeline focus
  • Arzerra/HuMax-CD20
  • SWOT analysis
  • Strengths
  • Weaknesses
  • Opportunities
  • Threats
• Johnson & Johnson
  • Overview:
  • Sales focus by leading drug classes
  • Sales focus by leading brands
  • J&J' s pipeline focus
  • Xarelto
  • Golimumab
  • SWOT analysis
  • Strengths
  • Weaknesses
  • Opportunities
  • Threats
• Amgen
  • Overview:
  • Sales focus by leading drug classes
  • Sales focus by leading brands
  • Amgen' s pipeline focus
  • Vectibix
  • Denosumab
  • SWOT analysis
  • Strengths
  • Weaknesses
  • Opportunities
  • Threats
• Roche-Genentech
  • Overview:
  • Sales focus by leading drug classes
  • Sales focus by leading brands
  • Roche-Genentech' s pipeline focus
  • Ocrelizumab
  • SWOT analysis
  • Strengths
  • Weaknesses
  • Opportunities
  • Threats
• Gilead
  • Overview:
  • Sales focus by leading drug classes
  • Sales focus by leading brands
  • Gilead' s pipeline focus
  • Elvitegravir
  • SWOT analysis
  • Strengths
  • Weaknesses
  • Opportunities
  • Threats
• Teva-Barr
  • Overview:
  • Sales focus by leading drug classes
  • Sales focus by leading brands
  • SWOT analysis
  • Strengths
  • Weaknesses
  • Opportunities
  • Threats
• Sandoz
  • Overview:
  • Sales focus by leading drug classes
  • Sales focus by leading brands
  • SWOT analysis
  • Strengths
  • Weaknesses
  • Opportunities
  • Threats

• Leading companies sales forecast

Chapter 7 - Appendix

• IMS Data
• Anatomical Therapeutic Classification (ATC)
  • C: Cardiovascular system
  • N: Nervous system
  • A: Alimentary tract and metabolism
  • L: Antineoplastic and immunomodulating agents
  • J: General anti-infectives systemic
  • R: Respiratory system
  • M: Musculo-skeletal system
  • G: Genito-urinary system and sex hormones
  • B: Blood and blood forming organs
  • D: Dermatologicals
  • T: Diagnostic agents
  • H: Systemic hormonal preparations
  • S: Sensory organs
  • V: Various

• Licensing status as per IMS Health
• Original brand
• Other brand
• Licensed brand
• Patent N/A brands
• Unbranded/ generic product

• Glossary

• Index

List of Figures

• Figure 2.1: GDP growth, 2002- 2007
• Figure 3.2: US healthcare providers by ownership status
• Figure 3.3: Key stakeholders of the US healthcare system
• Figure 3.4: Factors affecting drug pricing in the US
• Figure 3.5: Breakup of health insurance coverage in the US, 2007
• Figure 4.6: Breakup of US healthcare expenditure, 2006
• Figure 5.7: Comparative performance of global pharmaceutical markets, 2006- 07
• Figure 5.8: Sales of pharmaceutical products in US by license type,
• Figure 5.9: Top 10 sub-therapeutic categories of CNS disorders market by sales, 2007
• Figure 5.10: Top 10 sub-therapeutic classes of the cardiovascular market by sales, 2007
• Figure 5.11: Top 10 sub-therapeutic categories of the alimentary tract and metabolism market sales, 2007
• Figure 5.12: Top 10 sub-therapeutic categories of the antineoplastic and immunomodulating agents market by sales, 2007
• Figure 5.13: Top 10 sub-therapeutic categories of the anti-infectives market by sales, 2007
• Figure 5.14: Top 10 sub-therapeutic categories of the US market by sales, 2007
• Figure 5.15: Share of categories of biologics in the over all US biologics market, 2007 (%)
• Figure 5.16: The complementary needs and challenges facing biotech and pharma
• Figure 5.17: Key US patent expirations, 2008- 14
• Figure 5.18: Sales erosion of Ambien and Toprol XL on the arrival of first generics
• Figure 6.19: Pfizer' s US market sales by therapy area ($m), 2007
• Figure 6.20: Pfizer' s SWOT analysis
• Figure 6.21: GSK' s US market sales by therapy area ($m), 2007
• Figure 6.22: Launch of different Triptans in the US market
• Figure 6.23: GSK' s SWOT analysis
• Figure 6.24: J&J' s US market sales by therapy area ($m), 2007
• Figure 6.25: J&J' s SWOT analysis
• Figure 6.26: Amgen' s growth trajectory ($m), 1992- 2008
• Figure 6.27: Amgen' s US market sales by therapy area ($m), 2007
• Figure 6.28: Amgen' s SWOT analysis
• Figure 6.29: Roche- Genentech' s US market sales by therapy area ($m), 2007
• Figure 6.30: Roche-Genentech' s SWOT analysis
• Figure 6.31: Gilead' s US market sales by therapy area ($m), 2007
• Figure 6.32: Gilead' s SWOT analysis
• Figure 6.33: Teva-Barr' s US market sales by therapy area ($m), 2007
• Figure 6.34: Teva-Barr' s SWOT analysis
• Figure 6.35: Sandoz' s US market sales by therapy area ($m), 2007
• Figure 6.36: Sandoz' s SWOT analysis

List of Tables

• Table 2.1: US key demographic indicators
• Table 2.2: Forecast epidemiology of different types of cancer, 2008- 2014
• Table 2.3: Forecast epidemiology of cardiovascular disorders, 2008- 2014
• Table 2.4: Forecast epidemiology of autoimmune disorders, 2008- 2014
• Table 2.5: Forecast epidemiology of CNS disorders, 2008- 2014
• Table 2.6: Forecast epidemiology of skin disorders, 2008- 2014
• Table 2.7: Forecast epidemiology of metabolic disorders, 2008- 2014
• Table 5.8: Big pharma and Biotech alliances in 2007- 08
• Table 5.9: US pharmaceutical market by therapy area sales, 2007
• Table 5.10: US pharmaceutical market therapy area sales forecast ($m), 2007- 14
• Table 5.11: Top 10 brands of the US pharmaceutical market, 2007
• Table 5.12: Key trial results for Lipitor
• Table 5.13: Top 10 brands of the US pharmaceutical market, sales forecast 2007- 14
• Table 5.14: Key players of the US biotech market, 2007
• Table 5.15: Key products in the US biotech market, 2007
• Table 5.16: Key players in the US generics market, 2007
• Table 5.17: Key products in the US generics market, 2007
• Table 6.18: Top 10 companies of the US pharmaceutical market, 2007
• Table 6.19: Relative importance of the US pharma market, 2004-2008
• Table 6.20: Pfizer' s leading brands in the US pharmaceutical market, 2007
• Table 6.21: An overview of axitinib
• Table 6.22: An overview of apixaban
• Table 6.23: GSK' s leading brands in the US pharmaceutical market, 2007
• Table 6.24: An overview of HuMax-CD20
• Table 6.25: GSK' s deals and alliances in 2008
• Table 6.26: J&J' s leading brands in the US pharmaceutical market, 2007
• Table 6.27: An overview of Xarelto
• Table 6.28: An overview of Golimumab
• Table 6.29: Amgen' s leading brands in the US pharmaceutical market, 2007
• Table 6.30: An overview of Vectibix
• Table 6.31: Key ongoing Vectibix clinical trials
• Table 6.32: An overview of denosumab
• Table 6.33: Roche-Genentech' s leading brands in the US pharmaceutical market, 2007
• Table 6.34: An overview of Ocrelizumab
• Table 6.35: Gilead' s leading brands in the US pharmaceutical market, 2007
• Table 6.36: An overview of elvitegravir
• Table 6.37: Teva-Barr' s leading brands in the US pharmaceutical market, 2007
• Table 6.38: Sandoz' s leading brands in the US pharmaceutical market, 2007
• Table 6.39: Top 10 companies of the US pharmaceutical market, sales forecast 2007- 14