US Generic Drug Market - Industry Trends, Competitive Landscape, Opportunities and Outlook



The US generic drug market has witnessed a transformation over the last three decades. From less than 20% of the total prescriptions, generic drugs now account for the majority of the total prescriptions dispensed in the United States. During 2010-2015, the US generic drug market grew at a CAGR of more than 11% and currently represents a multibillion dollar industry. The biggest catalyst of this industry is the significantly lower price of generics compared to branded drugs. Although generics are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price. This has enabled governments and third-party payers to save billions of dollars in healthcare expenditures and resulted in lower copayments for patients. Other factors such as patent expiration of blockbuster innovator drugs, ageing population and an increasing prevalence of chronic diseases have also acted as catalysts for this market.

The report entitled “US Generic Drug Market - Industry Trends, Competitive Landscape, Opportunities and Outlook” provides a comprehensive insight into the historical and current trends as well as the future prospects of the generic drug market in the United States. This study serves as an exceptional tool to understand the sales trends, volume trends, growth, key segments, competitive structure, regulations, major manufacturer, major distributors, top drugs, manufacturing requirements, opportunities and future prospects of the US generic drug market. This report can serve as an excellent guide for manufacturers, consultants, researchers, marketing strategists and all those who plan to foray into the US generic drug market in any form.

 

What We Have Achieved in This report?

  • Historical, current and future sales trends in the US generic drug market?
  • Historical, current and future prescription trends in the US generic drug market?
  • Performance of the US generic drug market compared to the US pharmaceutical market?
  • Performance of the US generic drug market compared to other major generic drug markets?
  • Structure of the US generic drug market?
  • Competitive landscape in the US generic drug market?
  • Top US generic drug manufacturers and their market shares?
  • Distribution of generic drugs in the US?
  • Top US generic drug distributors and their market shares?
  • Most prescribed generic drugs in the US?
  • Pricing analysis of generic drugs?
  • Value chain analysis of generic drugs in the US?
  • Regulations in the US generic drug market?
  • Manufacturing process of generic drugs?
  • Machinery and raw material requirements for manufacturing generic drugs?
  • Key success and risk factors in the US generic drug market?

1 Research Methodology and Market Definitions
2 Report Summary
3 US Generic Drug Market - Introduction
    3.1 What are Generic Drugs?
    3.2 Unbranded and Branded Generics
    3.3 Authorized Generics
    3.4 Commoditized and Specialty Generics
4 Why is the US Generic Drug Market so Lucrative
    4.1 Patent Expiry of Blockbuster Drugs
    4.2 Significant Price Differential between Generics and Innovator Drugs
    4.3 Savings for the Government and Third Party Payers
    4.4 Incentives for Dispensing and Prescribing Generic Drugs
    4.5 Reimbursement and Lower Copayments
    4.6 Biosimilars
5 Global Generic Drug Market
    5.1 Current and Historical Market Trends
    5.2 Market Breakup by Country: The United States Represents the World’s Biggest Market
    5.3 Market Forecast
    5.4 Most Prescribed Generic and Branded Drugs
6 US Generic Drug Market
    6.1 US Pharmaceutical Market – Current, Historical and Future Market Trends
    6.2 US Pharmaceutical Market - Share of Branded and Generic Drugs
    6.3 US Generic Drug Market - Current, Historical and Future Volume Trends
    6.4 US Generic Drug Market - Current, Historical and Future Sales Trends
    6.5 US Generic Drug Market - Market Breakup by Segment
7 US Generic Drug Market- Competitive Landscape
    7.1 US Generic Drug Market - Competitive Structure
    7.2 US Generic Drug Market - Sales Breakup of Key Players
    7.3 US Generic Drug Market - Volume Breakup of Key Players
    7.4 US Generic Drug Market - Most Prescribed Generic Drugs
    7.5 US Generic Drug Market - Market Breakup by Distribution
    7.6 US Generic Drug Market - Pricing Dynamics
8 US Generic Drug Market - Value Chain Analysis
    8.1 Research and Development
    8.2 Manufacturing
    8.3 Marketing and Distribution
9 Regulations in the US Generic Drug Industry
    9.1 Overview of Pharmaceutical Regulations
    9.2 Drug Applications
    9.3 Patents and Market Exclusivity
    9.4 Regulatory Requirements for Generic Drugs
    9.5 The Hatch-Waxman Act
    9.6 Certifications
    9.7 Other Important Considerations
10 US Generic Drug Market: Key Success Factors
11 US Generic Drug Market: Road Blocks
12 Requirements for Setting Up a Generic Drug Manufacturing Plant
    12.1 Manufacturing Process
    12.2 Raw Material Requirements
    12.3 Machinery and Infrastructure Requirements
13 US Generic Drug Market - Key Company Profiles
    13.1 Teva
    13.2 Mylan
    13.3 Actavis
    13.4 Sandoz
    13.5 Sun Pharma
    13.6 Par Pharmaceuticals
    13.7 Endo Pharmaceuticals
    13.8 Lupin Pharmaceuticals
    13.9 Dr Reddy’s
    13.10 Hospira

 

List of Figures

Figure 3 1: Structure of the Pharmaceutical Industry
Figure 3 2: Classification of Generic Drugs
Figure 4 1: US: Patent Expiry Exposure (in Billion US$), 2009-2018
Figure 4 2: US: Savings from Generic Drugs (in Billion US$), 2005-2015
Figure 5 1: Global: Generic Drug Market: Sales Value (in Billion US$), 2010-2015
Figure 5 2: Global: Generic Drug Market: Sales Volume (in Billion Units), 2010-2015
Figure 5 3: Global: Generic Drug Market: Sales Value Breakup by Country (in %), 2015
Figure 5 4: Global: Generic Drug Market: Sales Volume Breakup by Country (in %), 2015
Figure 5 5: Global: Generic Drug Market Forecast: Sales Value (in Billion US$), 2016-2021
Figure 5 6: Global: Generic Drug Market: Sales Volume (in Billion Units), 2016-2021
Figure 6 1: US: Pharmaceutical Market: Sales Volume (in Billion Units), 2010-2015
Figure 6 2: US: Pharmaceutical Market: Sales Value (in Billion US$), 2010-2015
Figure 6 3: US: Pharmaceutical Market Forecast: Sales Value (in Billion US$), 2016-2021
Figure 6 4: US: Pharmaceutical Market: Sales Volume (in Billion Units), 2016-2021
Figure 6 5: US: Pharmaceutical Market: Sales Volume Breakup of Branded and Generic Drugs (in %), 2010 and 2015
Figure 6 6: US: Pharmaceutical Market: Sales Value Breakup of Branded and Generic Drugs (in %), 2010 and 2015
Figure 6 9: US: Generic Drug Market: Sales Volume (in Billion Units), 2010-2015
Figure 6 10: US: Generic Drug Market Forecast: Sales Volume (in Billion Units), 2016-2021
Figure 6 7: US: Generic Drug Market: Sales Value (in Billion US$), 2010-2015
Figure 6 8: US: Generic Drug Market Forecast: Sales Value (in Billion US$), 2016-2021
Figure 6 11: US: Generic Drug Market: Market Breakup by Segment (in %), 2010-2015
Figure 7 1: US: Generic Drug Market: Sales Share of Top Players (in %), 2015
Figure 7 2: US: Generic Drug Market: Volume Share of Top Players (in %), 2015
Figure 7 3: US: Generic Drug Market: Volume Share by Distribution (in %), 2015
Figure 7 4: US: Generic Drug Prices as a Percentage of Branded Drug Prices – Based on Number of Competitors
Figure 8 1: US: Generic Drug Market: Value Chain Analysis

 

List of Tables

Table 4 1: US: Sales and Patent Expiry of Major Drugs Expected to Lose Patent Protection (in Billion US$)
Table 4 2: US: Price Differential between Generics and Innovator Drugs (in %)
Table 5 1:  Sales Volume and Growth in Major Markets, 2015
Table 5 2: Volume Performance of Top Generic Drugs (in Million Prescriptions), 2015
Table 5 3: Global: Branded Drug Market: Volume Performance of Top Branded Drugs (in Million Prescriptions), 2015
Table 7 1: Sales Performance of Top Players (in Billion US$), 2015
Table 7 2: Volume Performance of Top Players (in Billion Units), 2015
Table 7 3: US: Generics Market: Volume Performance of Top Generic Drugs (in Million Prescriptions), 2015
Table 9 1: US: Overview of Pharmaceutical Regulations


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