Summary

The US represents one of the world's largest economies. The country's per capita income and spending are rated among the highest in the world. On the back of rapidly growing consumer spending on branded products, total healthcare spending of the US reached up to an estimated value of around US$ 2.5 Trillion in 2009, which appears very high when compared to the population. The government is now emphasizing to minimize the healthcare spending by using generics drugs and promoting other low cost healthcare. This has created huge opportunities in the country's generics industry.

The US generics market is anticipated to grow at a CAGR of around 8.8% during 2010-2013, says our recent research report "Booming US Generic Drug Market". Currently, the market growth is largely fuelled by the emergence of new products as patents of branded drugs are getting expired, and the trend is likely to continue over the next 3-4 years also. Anticipating the future growth, big pharma players are making deals with some generics manufactures from the Asian countries, like India, to access their products and market them in the US. This trend will emerge more strongly during our forecast period, providing opportunities to the local players to widen their product portfolios.

Although several challenges, such as price erosion and litigations from branded manufacturers, may hamper the growth, the overall growth prospects of the market remain good. In this regard, our report provides rational analysis of various factors which will drive the generics market in the US over the forecast period.

The report also provides extensive information on the country's generics market, besides discussing the emerging trends like contract manufacturing and biogenerics. Thus, it provides valuable information to pharmaceutical & generics companies and investors looking to enter this market. Facts and figures regarding market size, growth, share, regulatory environment and trends in technology development have been thoroughly analyzed in the report to provide clients a comprehensive overview of the market.

Table of Contents

1. Analyst View
2. Research Methodology
3. Macroeconomic Environment
3.1 Macroeconomic Indicators
3.2 Population
3.3 Demographics
3.4 Healthcare Expenditure
3.5 Healthcare Infrastructure
3.6 Disease Statistics
4. Market Overview
5. Market Drivers
5.1 Patent Expiries of Key Drugs
5.2 Favorable Political Environment
5.3 Increasing Trends of Prescribing Generics Drugs
5.4 Ageing Population
6. Industry Performance and Forecast to 2013
6.1 Branded vs Generics
6.2 Generics Drugs Market
6.2.1 By Value
6.2.2 By Volume
7. Market Potential of Generics Drugs in Key Therapies Segments
7.1 Lipid Regulators
7.2 Antipsychotics
7.3 Angiotensin II receptor
7.4 Anti Depressants
7.5 Human Insulin
7.6 Proton Pump Inhibitors
8. Regulatory Environment
8.1 Drug Efficacy Study Implementation (DESI) Program
8.2 Hatch-Waxman Act
8.3 Patent Infringement Litigations
8.4 Para IV & the 180-day Marketing Exclusivity
8.5 FDA Requirements
8.6 Generic Initiative for Value & Efficiency (GIVE)
9. Emerging Market Trends
9.1 Biogenerics
9.2 Contract Manufacturing
9.3 Drugs Delivery
9.4 Retail Pharmacy
10. Industry Restraints
10.1 Lawsuits
10.2 Entry Barriers
10.3 Price Erosion and Depleting Margins
10.4 Authorized Generics
11. Key Players
11.1 Teva Pharmaceuticals
11.2 Watson Pharmaceuticals, Inc.
11.3 Mylan Laboratories Inc.
11.4 Pfizer Inc.
11.5 Sandoz Inc. (Novartis)

List of Figures:

Figure 3-1: Nominal GDP (Trillion US$), 2007-2009
Figure 3-2: Forecast for Nominal GDP (Trillion US$), 2010-2012
Figure 3-3: Consumer Price Index (%), 2007-2009
Figure 3-4: Forecast for Consumer Price Index (%), 2010-2012
Figure 3-5: Foreign Direct Investment (Billion US$), 2007 & 2008
Figure 3-6: Population (Million), 2007-2009
Figure 3-7: Forecast for Population (Million), 2010-2012
Figure 3-8: Life Expectancy (Years), 2007-2009
Figure 3-9: Forecast for Life Expectancy (Years), 2010-2012
Figure 3-10: Population Breakup by Age Group (%), 2007-2009
Figure 3-11: Forecast for Population Breakup by Age Group (%), 2010-2012
Figure 3-12: Healthcare Spending (US$ per Head), 2007-2009
Figure 3-13: Forecast for Healthcare Spending (US$ per Head), 2010-2012
Figure 3-14: Breakup of Healthcare Spending by Sponsor (%), 2009
Figure 3-15: Number of Doctors (per '000 Population), 2007-2009
Figure 3-16: Forecast for Number of Doctors (per '000 Population), 2010-2012
Figure 3-17: Number of Hospital Beds (per '000 Population), 2007-2009
Figure 3-18: Forecast for Number of Hospital Beds (per '000 Population), 2010-2012
Figure 3-19: Breakup of Leading Causes of Death (%)2007
Figure 5-1: Comparison of Number of Receipts and Approval of ANDA Applications (FY 2007 to FY 2009)
Figure 5-2: Number of Prescriptions Dispensed in Generic Drugs Market (Million), 2008 & 2009
Figure 5-3: Forecast for Population of Age above 65 Years (Million), 2010-2012
Figure 6-1: Share of Branded and Generics Drugs in Pharma Market (2008 & 2009)
Figure 6-2: Generics Drugs Market (Billion US$) 2008-2013
Figure 6-3: Share of Generics and Branded Drugs in Pharma Market (By Sales Value), 2009
Figure 6-4: Share of Generics and Branded Drugs in Pharma Market (By Sales Volume), 2009
Figure 8-1: Generic Drugs Approval Process
Figure 9-1: Global-Biogenerics Market (Billion US$), 2007 & 2011
Figure 9-2: Forecast for Share of Biogenerics Market by Drugs Type (2016)
Figure 9-3: Global-Contract Manufacturing Market (Billion US$), 2009-2013
Figure 10-1: Relationship between Generic Drugs Price and Number of Generic Competitors

List of Tables:

Table 3-1: Number of Deaths due to Leading Causes (2007)
Table 5-1: Blockbuster Drugs Going Off-patent Globally (2010 to 2012)
Table 7-1: Top Therapeutic Categories by Sales (Billion US$), 2008
Table 7-2: Patent Expiry of Key Lipid Regulators
Table 7-3: Patent Expiry of Key Antipsychotic Drugs
Table 7-4: Patent Expiration of Key Angiotensin II receptor
Table 7-5: Patent Expiration of Key Antidepressants Drugs
Table 9-1:  Patent Expiry Dates for Biopharmaceuticals
Table 11-1: Teva Pharmaceuticals-Strengths & Weaknesses
Table 11-2: Watson Pharmaceuticals, Inc.-Strengths & Weaknesses
Table 11-3: Mylan Laboratories Inc.-Strengths & Weaknesses
Table 11-4: Pfizer Inc.-Strengths & Weaknesses
Table 11-5: Sandoz Inc. (Novartis)-Strengths & Weaknesses