成長著しい米国のジェネリック医薬品市場

Abstract

The research report, "Booming US Generic Drug Market", by RNCOS, the leading market research company, is an exhaustive analysis of the US generic market. The report does a thorough investigation of both the drivers as well as restraints impacting the market, and the factors that distinguish the US from other generic markets of the world.

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 Contents

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 Figures:

• 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
• Figure 3-15: US - Branded Generic Drugs Market (in Billion US$), 2002-2006
• Figure 3-16: US - Share of Prescriptions for Unbranded Generic Drugs in Pharmaceutical Prescriptions (%), 2002-2006
• Figure 3-17: US - Number of Prescriptions for Unbranded Generic Drugs (in Billion), 2005 & 2006
• Figure 3-18: US - Share of Unbranded Generic Drugs Sales in Pharmaceutical Market (%), 2002-2006
• Figure 3-19: US - Unbranded Generic Drugs Market (in Billion US$), 2002-2006
• Figure 3-20: US - Breakup of Unbranded Generic Drugs by Formulation Type (%), 2005
• Figure 3-21: US - Sales Growth of Various Pharmaceutical Sectors (%), 2003-2006
• Figure 3-22: US - Share of Branded, Branded Generics & Unbranded Generics in Growth of Pharmaceutical Market (%), 2006
• Figure 4-1: US - Generic Drugs Approval Process
• Figure 4-2: US - Median Approval Time for ANDA Originals (in Months), 2000-2006
• Figure 5-1: US - Product Development Time for Generic & Branded Pharmaceuticals (in Years)
• Figure 5-2: US - Average Retail Price of Branded & Generic Drugs (in US$), 2006
• Figure 5-3: US - Price Comparison of Various Branded & Generic Blood Pressure Drugs (in US$), 2004
• Figure 5-4: US - Average Copayments for Generic Drugs, Preferred Branded Drugs & Non-preferred Branded Drugs (in US$), 2000 & 2004
• Figure 5-5: US - Sales Value of Drugs Loosing Patent Protection (in Billion US$), 2003-2006
• Figure 5-6: US - Comparison of Receipts & Approval of ANDA Applications (in Numbers), 2000-2006
• Figure 5-7: US - Share of State & Other Financing in Pharmaceutical Market (%), 2006
• Figure 5-8: US - Number of Medicare Beneficiaries (in Million), 1970 to 2030F
• Figure 5-9: US - Savings for Medicare from Drugs going Generic (in Billion US$), 2006-2010F
• Figure 5-10: US - Population of Age above 65 Years (in Million), 2001-2006
• Figure 5-11: US - Relative Per Capita Spending on Drugs by Age Group (%)
• Figure 5-12: US - Number of Uninsured People (in Million), 2001-2006E
• Figure 5-13: US - Obese* Population in Age Group 20-74 (%), 1960-1962 to 1999-2002**
• Figure 5-14: US - Relative Medication Cost due to Obesity, Smoking & Overweight (%)
• Figure 5-15: US - Forecast for Breakup of Biogenerics Market by Drugs Type (%), 2016
• Figure 5-16: Global - Contract Manufacturing Market (in Billion US$), 2001, 2006E & 2010F
• Figure 5-17: US - Relationship between Generic Drugs Price & Number of Generic Competitors (%)
• Figure 6-1: US - Population of Age above 65 Years (in Million), 2007-2011F
• Figure 6-2: US - Forecast for Number of Uninsured People (in Million), 2007-2011
• Figure 6-3: US - Forecast for Pharmaceutical Market (in Billion US$), 2007-2011
• Figure 6-4: US - Forecast for Branded Drugs Market (in Billion US$), 2007-2011
• Figure 6-5: US - Forecast for Branded Generic Drugs Market (in Billion US$), 2007-2011
• Figure 6-6: US - Forecast for Unbranded Generic Drugs Market (in Billion US$), 2007-2011
• Figure 6-7: US - Forecast for Penetration of Branded, Branded Generics & Unbranded Generics (%), 2007-2011
• Figure 6-8: US - Forecast for Share of Branded, Branded Generics & Unbranded Generics in Growth of Pharmaceutical Market (%), 2006 to 2011
• Figure 8-1: US - Nominal GDP (in Trillion US$), 2001-2006
• Figure 8-2: US - Nominal GDP (in Trillion US$), 2007-2011F
• Figure 8-3: US - Consumer Price Index (%), 2001-2006
• Figure 8-4: US - Consumer Price Index (%), 2007-2011F
• Figure 8-5: US - Foreign Direct Investment (in Billion US$), 2005 & 2006
• Figure 8-6: US - Population (in Million), 2001-2006
• Figure 8-7: US - Population (in Million), 2007-2011F
• Figure 8-8: US - Life Expectancy (in Years), 2001-2006E
• Figure 8-9: US - Life Expectancy (in Years), 2007-2011F
• Figure 8-10: US - Population Breakup by Age Group (%), 2001-2006
• Figure 8-11: US - Population Breakup by Age Group (%), 2007-2011F
• Figure 8-12: US - Healthcare Spending (in US$ per Head), 2001-2006E
• Figure 8-13: US - Healthcare Spending (in US$ per Head), 2007-2011F
• Figure 8-14: US - Breakup of Healthcare Payments by Source (%), 2005
• Figure 8-15: US - Number of Doctors (per ‘000 Population), 2001-2006E
• Figure 8-16: US - Number of Doctors (per ‘000 Population), 2007-2011F
• Figure 8-17: US - Number of Hospital Beds (per ‘000 Population), 2001-2006E
• Figure 8-18: US - Number of Hospital Beds (per ‘000 Population), 2007-2011F
• Figure 8-19: US - Breakup of Leading Causes of Death (%), 2005
• Figure 8-20: US - Number of Deaths due to Leading Causes, 2005
• Figure 8-21: US - Forecast for Breakup of Leading Causes of Death (%), 2030

List of Tables:

• 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* of Top 10 Players in Generic Drugs Market (in Million), 2005
• Table 7-3: US - Sales** of Top 10 Players in Generic Drugs Market (in Million US$), 2007*
• Table 7-4: US - Number of Prescriptions** of Top 10 Players in Generic Drugs Market (in Million), 2007*
• Table 7-5: Teva Pharmaceutical Industries Limited - Key Financials (in Million US$), 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