The US represents the world’s largest market for generic drugs with unbranded generics accounting for more than 50% prescriptions and 10% sales out of the total pharmaceutical market in 2006. The market is driven by several factors, including lower costs, a favorable political environment, and rapidly increasing ageing population.
The top 10 players in the US presently occupy more than 70% of the generic market, with Teva, Sandoz (Novartis) and Mylan leading the market. However, the huge potential and growth of this market is also attracting several Asian and Eastern European players. Thus, competition in this market is expected to heat up in future making the market extremely price sensitive.
Although several challenges, such as price erosion and litigations from branded manufacturers, may hamper growth, the overall growth prospects of the market are good. The market is expected to get a strong boost with the patent expiry of several blockbuster drugs in the next five years and also with the launch of biogenerics (expected in around 2010). Overall, the unbranded generic market is expected to continue its double-digit growth rate between 2007 and 2011 and generate revenues worth more than US$ 69 Billion by 2011.
Key Findings
Unbranded generics grew faster than branded drugs, biotech drugs and branded generics between 2004 and 2006.
The sales volume of drugs in the pharmaceutical market is being driven strongly by the sale of generics.
The Hatchman-Waxman Act was a major boost to the generic business in the US.
The patent expiry of key biotech drugs is creating opportunities for biogenerics.
Generic substitution of branded drugs resulted in estimated savings of US$ 10.2 Billion in the US in 2006.
Unbranded generics are expected to occupy more than 19% of the US pharmaceutical market by 2011.
Key Issues & Facts Analyzed
Evaluation of past, current and future market trends
Discussion about the size and growth of the market
Market evaluation by segments
Analysis of healthcare indicators
Future prospects of the generic market
Analysis of various challenges and opportunities for the industry
Profile discussion of key players in this sector
Key Players Analyzed
This section provides the overview, key facts, and financial information of prominent players in the US generic market, such as Teva Pharmaceutical Industries Limited, Sandoz Inc., Mylan Laboratories Inc., Watson Pharmaceuticals, Inc. and Actavis Group hf.
Research Methodology Used
Information Sources
Information has been sourced from books, newspapers, trade journals, and white papers, industry portals, government agencies, trade associations, monitoring industry news and developments, and through access to more than 3000 paid databases.
Analysis Methods
The analysis methods include ratio analysis, historical trend analysis, linear regression analysis using software tools, judgmental forecasting, and cause and effect analysis.
Table of Content
1. Analyst View
2. Global Generic Drugs Market
2.1 Market Size & Growth
2.2 By Region
3. United States Generic Drugs Market
3.1 Most Potential Generic Drugs Market
3.2 Market Size & Growth
3.2.1 Pharmaceutical Market
3.2.1.1 By Therapeutic Category
3.2.1.2 By Drugs Category
3.2.1.2.1 Branded Drugs
3.2.1.2.2 Branded Generics
3.2.1.2.3 Unbranded Generics
3.2.1.3 Unbranded Generics witnessing Fastest Growth
4. Regulatory Environment
4.1 Drug Efficacy Study Implementation (DESI) Program
4.2 Hatch-Waxman Act
4.3 Patent Infringement Litigations
4.4 Para IV & the 180-day Marketing Exclusivity
4.5 FDA Requirements
4.6 Generic Initiative for Value & Efficiency (GIVE)
5. Industry Analysis
5.1 Driving Forces
5.1.1 Huge Cost Savings
5.1.2 Patent Expiries
5.1.3 Favorable Political Environment
5.1.4 Ageing Population
5.1.5 Large Uninsured Population
5.1.6 Obesity
5.2 Opportunities
5.2.1 Patent Expiry of Key Drugs
5.2.2 Biogenerics
5.2.3 Contract Manufacturing
5.2.4 Drugs Packaging
5.2.5 Drugs Delivery
5.3 Challenges
5.3.1 Lawsuits
5.3.2 High Entry Barriers
5.3.3 Price Erosion & Depleting Margins
5.3.4 Authorized Generics
6. Future Outlook (2007-2011)
6.1 Driving & Restraining Forces
6.2 Sales
7. Competitive Landscape
7.1 Market Share of Key Players
7.2 Profile of Key Players
7.2.1 Teva Pharmaceutical Industries Limited
7.2.2 Watson Pharmaceuticals, Inc.
7.2.3 Mylan Laboratories Inc.
7.2.4 Sandoz Inc.
7.2.5 Actavis Group hf
8. Supporting Databases
8.1 Macroeconomic Indicators
8.2 Population
8.3 Demographics
8.4 Healthcare Expenditure
8.5 Healthcare Infrastructure
8.6 Major Causes of Mortality
List of Table
Table 3-1: US - Retail Pharmaceutical Market by Therapeutic Category (in Million US$), 2006
Table 5-1: US - Actual & Potential Cost Savings from Using Generic Drugs by Therapy Area (in Billion US$), 2005
Table 5-2: US - Estimated & Potential Cost Savings from Using Generic Drugs by Therapy Area (in Billion US$), 2006
Table 5-3: US - Blockbuster Drugs Expected to Lose Exclusivity (2007-2009)
Table 5-4: US - Patent Expiry Dates for Biopharmaceuticals
Table 7-1: US - Sales* of Top 10 Players in Generic Drugs Market (in Million US$), 2005
Table 7-2: US - Number of Prescriptions*
Table 7-3: US - Sales** of Top 10 Players in Generic Drugs Market (in Million US$), 2007*
Table 7-4: US - Number of Prescriptions**
Table 7-5: Teva Pharmaceutical Industries Limited - Key Financials (in Million US$), 2004-2006
Table 7-6: Watson Pharmaceuticals, Inc. - Key Financials (in Million US$), 2004-2006
Table 7-7: Sandoz Inc. - Key Financials (in Million US$), 2005 & 2006
Table 7-8: Actavis Group hf - Key Financials (in Million Euro), 2004-2006
List of Charts
Figure 2-1: Global - Generic Drugs Market (in Billion US$), 2006 & 2010F
Figure 2-2: Global - Pharmaceutical Market (in Billion US$), 1999-2006
Figure 2-3: Global - Unbranded Generic Drugs Market (in Billion US$), 2001-2006 & 2010F
Figure 2-4: Global - Share of Unbranded & Branded Generics in Generic Drugs Market (%), 2006 & 2010F
Figure 2-5: Global - Breakup of Unbranded Generic Drugs Market by Region (%), 2006
Figure 3-1: Global - Top Unbranded Generic Drugs Market (in Billion US$), 2006
Figure 3-2: Global - Top Pharmaceutical Markets (in Billion US$), 2006
Figure 3-3: Global - Per Capita Drugs Consumption of Top Pharmaceutical Markets (in US$), 2006
Figure 3-4: US - Number of Prescriptions for Pharmaceutical Market (in Billion), 2004-2006
Figure 3-5: US - Pharmaceutical Market (in Billion US$), 2002-2006
Figure 3-6: US - Prescriptions Breakup for Pharmaceutical Market by Drug Category (%), 2006
Figure 3-7: US - Sales Breakup of Pharmaceutical Market by Drug Category (%), 2006
Figure 3-8: US - Share of Prescriptions for Branded Drugs in Pharmaceutical Prescriptions (%), 2002-2006
Figure 3-9: US - Number of Prescriptions for Branded Drugs (in Billion), 2005 & 2006
Figure 3-10: US - Share of Branded Drugs Sales in Pharmaceutical Market (%), 2002-2006
Figure 3-11: US - Branded Drugs Market (in Billion US$), 2002-2006
Figure 3-12: US - Share of Prescriptions for Branded Generic Drugs in Pharmaceutical Prescriptions (%), 2002-2006
Figure 3-13: US - Number of Prescriptions for Branded Generic Drugs (in Billion), 2005 & 2006
Figure 3-14: US - Share of Branded Generic Drugs Sales in Pharmaceutical Market (%), 2002-2006
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