A. Executive Summary

B. The Global Pharmaceutical Industry – A Brief Profile
B.1 Industry Definition
B.2 Product Characterization
B.2 Industry Overview
B.3 Industry Forecast

C. TRIPS and the Global Pharmaceutical Industry
C.1 Introduction
C.2 Product Patents and Prices of Medicines
C.3 Product Patents and Research and Development
C.4 Patents and Technology Transfer
C.5 Flexibility in the Agreement
C.6 TRIPS and the Developing Countries
C.7 Issues for the United States

D. Offshoring in the Pharmaceutical Sector
D.1 Introduction
D.1.1 What is Offshoring?
D.1.2 Analyzing the Pharma Value Chain
D.1.3 Employment Scenario of the Pharmaceutical Industry
D.1.4 Why Offshore?
D.1.5 Primary Offshoring Locations
D.2 Offshoring of R&D
D.2.1 Looking at India
D.2.2 Looking at China
D.2.3 Growth Factors
D.2.4 Challenges & Barriers to Offshoring R&D
D.3 Offshoring of Pharmaceutical Manufacturing Processes
D.3.1 Overview
D.3.2 Looking at Biologics Manufacturing
D.3.3 Looking at Secondary Manufacturing
D.3.4 Growth Factors
D.3.5 Challenges & Barriers to offshoring Manufacturing Processes
D.4 Effect of Offshoring on US Economy
D.5 Effect of Offshoring on US Labor Market

E. Analyzing the Pharmaceutical Industry in the US
E.1 Overview of Health Statistics
E.2 Determining the Market Size
E.3 Geographic Distribution
E.3 Industry Segments
E.3.1 Generics
E.3.2 Prescription Drugs
E.3.3 Drug Delivery

F. International Competition and Economic Trends in the US Pharma Industry
F.1 Overall Changes in the Industry
F.2 Consolidation
F.3 Modifications in Geographical Concentrations
F.4 Global Trade and Competition

G. Key Trends in the Pharmaceutical Sector Supply Chain
G.1 Restructuring of the Supply Chain
G.2 Decline of Market Share and Margins
G.3 Decreased Access to Newer Drugs

H. Overall Market Trends

I. Barriers and Challenges in the US Pharma Sector

J. Strategies for Market Entry

K. Analyzing the Industry through PEST Framework
K.1 Political Features
K.2 Economic Features
K.3 Social Features
K.4 Technological Features

L. Analyzing the Industry through Porter's Five Forces Business Strategy Framework
L.1 Bargaining Power of Buyer
L.2 Bargaining Power of Suppliers
L.3 Competitive Rivalry in the Industry
L.4 Threat of New Entrants
L.5 Threat of Industry Substitution
L.6 Conclusion

M. Research and Development
M.1 Economics of Innovation
M.2 R&D Process
M.3 New Medicines under Development
N.4 Treatments for Rare Diseases
N.5 Case Study – Personalized Medicines
N.6 Patent Incentives & Cooperation in the Industry

O. Patents in the US Pharmaceutical Industry
O.1 Introduction
O.2 Brief Profile of the Hatch Waxman Provisions
O.3 Patent Protection Regime for Branded Drugs
O.3.1 How to Extend the Exclusivity
O.3.2 Limitations on Multiple 30 Month Stays
O.3.3 Medicare Amendments
O.3.4 Changes in the Medicare Rx Drug Improvement Act
O.4 Looking at Offensive Patenting
O.5 Looking at Defensive Patenting
O.6 Conclusion

P. Impact of the Hatch-Waxman Act on the US Pharmaceutical Industry
P.1 History
P.2 Increasing Demand for Generics
P.3 1984 Hatch Waxman Act
P.4 Expanding the Act
P.5 Impact of the Hatch Waxman Act
P.6 Proposed Changes to the Act
P.7 Conclusion

Q. Analyzing the Role of the Federal Drug Agency

R. Government Proposals Affecting the US Pharma Industry

S. Industry Outlook

T. Leading Players
T.1 Pfizer
T.2 GlaxoSmithKline
T.3 Merck & Company
T.4 AstraZeneca
T.5 Amgen
T.6 Eli Lilly & Company
T.7 Johnson & Johnson
T.8 Novartis
T.9 Bristol Myers Squibb
T.10 Wyeth

U. Appendix

V. Glossary of Terms