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Generic Drugs

Booming US Generic Drug Market

 

Publication Date August 2009
Publisher RNCOS
Product Type Report
Pages 70
ISBN Number not applicable
Product Code RCS00307

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Summary

The growth of generics markets in the US is in full swing. Realizing its importance in minimizing the healthcare cost, government is also taking initiative to promote this market. Over the past ten years (1999-2008), the generic drugs have saved US$ 734 Billion for the American healthcare system. With patents of several blockbuster drugs expiring in next 3-4 years, generic drugs sector of the US presents a promising and availing opportunity for big pharma players from Europe, Asia and other regions to invest.

The US generics market is forecasted to grow at a CAGR of around 9.2% during 2010-2012, says our recent research report Booming US Generic Drug Market. Currently, the market is characterized by the emergence of new products as patents of branded drugs are getting expired. This trend is likely to continue in next few years. Anticipating the future growth, big pharma players are making deals with some generics manufactures from Asian countries, like India, to access their products and market them in the US.

We have discovered that generics market is expected to grow more strongly due to global economic downturn. The people are buying more generic products in order to cut their healthcare cost. 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 this market segment over the forecasted period.

The report also provides extensive information on the generics market in the US, 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. Analysis and statistics regarding market size, growth, share, regulatory environment and trends in technology development have been thoroughly analyzed to provide clients a comprehensive overview of the market.

Contents

  • 1. Analyst View
  • 2. Global Generic Drugs Market
  • 3. US Generic Drugs Market
    • 3.1 Pharmaceutical Market
      • 3.1.1 Branded Drugs
      • 3.1.2 Generic Drugs
  • 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. Emerging Market Trends
    • 5.1 Patent Expiries of Key Drugs
    • 5.2 Huge Cost Savings
    • 5.3 Biogenerics
    • 5.4 Contract Manufacturing
    • 5.5 Drugs Packaging
    • 5.6 Drugs Delivery
    • 5.7 Favorable Political Environment
    • 5.8 Ageing Population
  • 6. Growth Inhibitors
    • 6.1 Lawsuits
    • 6.2 Entry Barriers
    • 6.3 Price Erosion and Depleting Margins
    • 6.4 Authorized Generics
  • 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 Pfizer
  • 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 Figures:
    • Figure 2-1: Global Generic Drugs Market (Billion US$), 2007-2009
    • Figure 2-2: Global Pharmaceutical Market (Billion US$), 2007-2009
    • Figure 3-1: Per Capita Drugs Sales in Top Pharmaceutical Markets (US$), 2007
    • Figure 3-2: Prescriptions Dispensed in Pharmaceutical Market (Billion), 2007-2009
    • Figure 3-3: Pharmaceutical Market (Billion US$), 2007-2009
    • Figure 3-4: Forecast for Pharmaceutical Market (Billion US$), 2010-2012
    • Figure 3-5: Share of Generic and Branded Drugs Prescriptions (2008)
    • Figure 3-6: Share of Generic and Branded Drugs Sales (2008)
    • Figure 3-7: Share of Branded Drugs Prescription in Pharmaceutical Market (2007-2009)
    • Figure 3-8: Prescriptions Dispensed in Branded Drugs Market (Million), 2007-2009
    • Figure 3-9: Share of Branded Drugs Sales in Pharmaceutical Market (2007-2009)
    • Figure 3-10: Branded Drugs Market (Billion US$), 2007-2009
    • Figure 3-11: Forecast for Branded Drugs Market (Billion US$), 2010-2012
    • Figure 3-12: Share of Generic Drugs Prescriptions in Pharmaceutical Market (2007-2009)
    • Figure 3-13: Prescriptions Dispensed in Generic Drugs Market (Million), 2007-2009
    • Figure 3-14: Share of Generic Drugs Sales in Pharmaceutical Market (2007-2009)
    • Figure 3-15: Generic Drugs Market (Billion US$), 2007-2009
    • Figure 3-16: Forecast for Generic Drugs Market (Billion US$), 2010-2012
    • Figure 3-17: Forecast for Share of Branded and Generic Drugs Sales (2010-2012)
    • Figure 3-18: Forecast for Share of Branded and Generic Drugs in Growth of Pharmaceutical Market (2009 to 2012)
    • Figure 4-1: Generic Drugs Approval Process
    • Figure 4-2: Median Approval Time for ANDA Originals (Months), 2004-2007
    • Figure 5-1: Product Development Time for Branded and Generic Drugs (Years)
    • Figure 5-2: Average Retail Price of Branded and Generic Drugs (US$), 2008
    • Figure 5-3: Price Comparison of Various Branded and Generic Blood Pressure Drugs (US$)
    • Figure 5-4: Breakup of Savings from Generics in Healthcare System (%), 1999 to 2008
    • Figure 5-5: Global Biogenerics Market (Billion US$), 2007 & 2011
    • Figure 5-6: Forecast for Share of Biogenerics Market by Drugs Type (2016)
    • Figure 5-7: Global Contract Manufacturing Market (Billion US$), 2008-2012
    • Figure 5-8: Comparison of Number of Receipts and Approval of ANDA Applications (2005-2007)
    • Figure 5-9: Share of State and Others Financing in Pharma Market (2006)
    • Figure 5-10: Forecast for Population of Age above 65 Years (Million), 2010-2012
    • Figure 6-1: Relationship between Generic Drugs Price and Number of Generic Competitors
    • Figure 8-1: Nominal GDP (Trillion US$), 2007-2009
    • Figure 8-2: Forecast for Nominal GDP (Trillion US$), 2010-2012
    • Figure 8-3: Consumer Price Index (%), 2007-2009
    • Figure 8-4: Forecast for Consumer Price Index (%), 2010-2012
    • Figure 8-5: Foreign Direct Investment (Billion US$), 2007 & 2008
    • Figure 8-6: Population (Million), 2007-2009
    • Figure 8-7: Forecast for Population (Million), 2010-2012
    • Figure 8-8: Life Expectancy (Years), 2007-2009
    • Figure 8-9: Forecast for Life Expectancy (Years), 2010-2012
    • Figure 8-10: Population Breakup by Age Group (%), 2007-2009
    • Figure 8-11: Forecast for Population Breakup by Age Group (%), 2010-2012
    • Figure 8-12: Healthcare Spending (US$ per Head), 2007-2009
    • Figure 8-13: Forecast for Healthcare Spending (US$ per Head), 2010-2012
    • Figure 8-14: Breakup of Healthcare Spending by Sponsor (%), 2007
    • Figure 8-15: Number of Doctors (per '000 Population), 2007-2009
    • Figure 8-16: Forecast for Number of Doctors (per '000 Population), 2010-2012
    • Figure 8-17: Number of Hospital Beds (per '000 Population), 2007-2009
    • Figure 8-18: Forecast for Number of Hospital Beds (per '000 Population), 2010-2012
    • Figure 8-19: Breakup of Leading Causes of Death (%), 2006
  • List of Tables:
    • Table 3-1: Top Therapeutic Categories by Sales (Billion US$), 2008
    • Table 5-1: Blockbuster Drugs Going Off-patent Globally (2010 to 2012)
    • Table 5-2: Patent Expiry Dates for Biopharmaceuticals
    • Table 7-1: Top 10 Players by Sales in Pharmaceutical Market (Billion US$), 2008
    • Table 7-2: Top 10 Players by Prescriptions Dispensed in Generic Drugs Market (Million), 2008
    • Table 8-1: Number of Deaths due to Leading Causes (2006)