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Pharmaceutical Industry in the United States

  • January 2013
  • -
  • Aruvian's R'search
  • -
  • 240 pages

Over the past decade, pharmaceutical companies have pushed the scientific envelope, working at the cellular and molecular levels to dramatically advance the treatment of disease.

Between 1995 and 2005, more than 300 new drugs, biologics, and vaccines that prevent and treat over 150 conditions were approved by the FDA.3 The FDA also gave the go-ahead for numerous new indications for previously approved medicines, allowing physicians to tailor treatment strategies to meet a patient’s individual disease status, past medication history, side effect tolerance, and preferences.

The US pharmaceutical industry is a highly globalized industry, dominated by multinational companies that engage in significant business activity in many countries and whose products are distributed and marketed worldwide. The industry has undergone dramatic structural changes over the past few decades, with the rise of the biotechnology sector, substantial growth in demand driven by demographics and substitution away from other therapeutic modalities such as surgery, and increased competition from globally active generic manufacturers.

The pharmaceutical industry is under mounting scrutiny because of rapidly increasing expenditures for drugs in the United States. Drug expenditures are now the fastest-growing component of health care costs, increasing at the rate of about 15 percent per year. They account for about eight percent of health care spending, and at their current rate of increase, they will soon surpass spending for physicians' services and, for many health maintenance organizations (HMOs), the costs of hospitalization.

Aruvian's R'search brings you a complete analysis of the Pharmaceutical Industry in the United States. The report covers a brief profile of the global pharmaceutical industry, the TRIPS agreement and the effect of the agreement on the US pharmaceutical industry, offshoring in the pharmaceutical industry, economic trends in the industry, competition in the industry, and key trends in the pharmaceutical supply chain in the United States.

The report also analyzes the US pharmaceutical industry through two frameworks – a PEST analysis and a Porter’s Five Forces Business Strategy analysis. The report also looks at strategies for market entry, impact of the Hatch-Waxman Act, and the role of the government in the industry.

Complete with a comprehensive section on the research and development going on in the US pharmaceutical industry, Aruvian’s latest research is a collection of all you need to know about the US Pharmaceutical Industry.

Table Of Contents

Pharmaceutical Industry in the United States
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 RandD
D.2.1 Looking at India
D.2.2 Looking at China
D.2.3 Growth Factors
D.2.4 Challenges and Barriers to Offshoring RandD
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 and 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 RandD Process
M.3 New Medicines under Development
N.4 Treatments for Rare Diseases
N.5 Case Study - Personalized Medicines
N.6 Patent Incentives and 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 and Company
T.4 AstraZeneca
T.5 Amgen
T.6 Eli Lilly and Company
T.7 Johnson and Johnson
T.8 Novartis
T.9 Bristol Myers Squibb
T.10 Wyeth

U. Appendix

V. Glossary of Terms

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