US Generics Market Report and Outlook

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US Generics Market: Industry Trends, Competitive Landscape, Opportunities and Outlook

Copyright Š 2015 International Market Analysis Research & Consulting (IMARC). All Rights Reserved

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US Generics Market: Industry Trends and Opportunities A number of factors have catalyzed the strong growth in the US generics market. This includes their low costs, drug patent expiries, cost savings for governments’ and payers’, lower copayments for patients, ageing population and an increasing prevalence of chronic diseases.

The United States represents the world’s biggest market for generic drugs. Over the past three decades, the acceptance and use of generics in the United States has changed markedly. This transformation has been catalyzed by a number of factors. The continuous expiration of drug patents, rising aging population, increasing prevalence of chronic diseases and continuous efforts by governments and health care service providers to control their healthcare expenditures have enabled generics to represent a multibillion dollar industry in the United States.

The report entitled “US Generics Market: Industry Trends, Competitive Landscape, Opportunities and Outlook” represents an in-depth analysis on the historical, current and future trends in the US generics market. This research report serves as an exceptional tool to understand the drivers, sales trends, prescription trends, market structure, competitive landscape, regulations, key players, key drugs, manufacturing and the outlook of the US generics market. This report can serve as an excellent guide for investors, researchers, consultants, marketing strategists and all those who want to gain an insight into the US generics market in any form.

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Key Questions Answered in This Report?

• • • • • • • • • • • • • •

What are generic drugs and how are they different from branded drugs?

How have the US generics market performed in recent years?

How have generics performed compared to branded drugs?

What were the total sales and prescriptions for generics in the US? Who are the key players in the US generics market and how have they performed?

What is the structure of the US generics market?

Which are the most prescribed generics in the US? What is the pricing mechanism of generics in the US? What is the value chain of generics in the US? What are the regulations for generics in the US? How are generics distributed in the US? How are generics manufactured?

What are the raw material and machinery requirements to manufacture generics?

What are the drivers and challenges in the US generics market?

Table of Contents

1 Research Methodology and Market Definitions 2 Report Summary 3 US Generics Market - Introduction 3.1 What are Generics?

3.2 Unbranded and Branded Generics 3.3 Authorized Generics

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US Generics Market

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3.4 Commoditised and Specialty Generics 4 Why is the US Generics 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 Generics 4.5 Reimbursement and Lower Copayments 4.6 Biosimilars 5 Global Generics 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 6 US Generics Market 6.1 US Pharmaceutical Market - Current and Historical Market Trends 6.2 US Pharmaceutical Market - Share of Branded and Generic Drugs 6.3 US Generics Market - Current and Historical Sales Trends 6.4 US Generics Market - Current and Historical Volume Trends 6.5 US Generics Market - Market Breakup By Segment 7 US Generics Market- Competitive Landscape 7.1 US Generics Market - Competitive Structure 7.2 US Generics Market - Sales Breakup of Key Players 7.3 US Generics Market - Volume Breakup of Key Players 7.4 US Generics Market - Most Prescribed Generic Drugs 7.5 US Generics Market - Market Breakup By Distribution 7.6 US Generics Market - Pricing Dynamics

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8 US Generics Market - Value Chain Analysis 8.1 Research and Development 8.2 Manufacturing 8.3 Marketing and Distribution 9 Regulations in the US Generics Industry 9.1 Overview of Pharmaceutical Regulations 9.2 Drug Applications 9.3 Patents and Market Exclusivity 9.4 Regulatory Requirement For Generics 9.5 The Hatch-Waxman Act 9.6 Possible Certifications 9.7 Other Important Considerations 10 US Generics Market: Key Success Factors 11 US Generics 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 Market - Key Company Profiles 13.1 Teva 13.2 Mylan 13.3 Actavis 13.4 Sandoz 13.5 Sun Pharma 13.6 Par Pharmaceuticals

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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 Generics Figure 4 1: United States: Patent Expiry Exposure (in Billion US$), 2009-2018 Figure 4 2: United States: Savings From Generic Drugs (in Billion US$), 2004-2014 Figure 5 1: Global: Generics Market: Sales Value (in Billion US$), 2010-2014 Figure 5 2: Global: Generics Market: Sales Volume (in Billion SU), 2010-2014 Figure 5 3: Global: Generics Market: Sales Value Breakup By Country (in %), 2014 Figure 5 4: Global: Generics Market: Sales Volume Breakup by Country (in %), 2014 Figure 5 5: Global: Generics Market Forecast: Sales Value (in Billion US$), 2015-2020 Figure 5 6: Global: Generics Market: Sales Volume (in Billion SU), 2015-2020 Figure 6 1: US: Pharmaceutical Market: Sales Volume (in Million Prescriptions), 2010-2014 Figure 6 2: US: Pharmaceutical Market: Sales Value (in US$ Billion), 2010-2014 Figure 6 3: US: Pharmaceutical Market: Sales Volume Breakup of Branded and Generic Drugs (in %), 2010 & 2014 Figure 6 4: US: Pharmaceutical Market: Sales Value Breakup of Branded and Generic Drugs (in %), 2010 & 2014 Figure 6 5: US: Generics Market: Sales Value (in Billion US$), 2010-2014 Figure 6 6: US: Generics Market Forecast: Sales Value (in US$ Billion), 2015-2020

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Figure 6 7: US: Generics Market: Sales Volume (in Million Prescriptions), 2010-2014 Figure 6 8: US: Generics Market Forecast: Sales Volume (in Million Prescriptions), 2015-2020 Figure 6 9: US: Generics Market: Market Breakup by Segment (in %), 2010-2014 Figure 7 1: United States: Generics Market: Sales Share of Top Players (in %), 2014 Figure 7 2: United States: Generics Market: Volume Share of Top Players (in %), 2014 Figure 7 3: United States: Generics Market: Volume Share by Distribution (in %), 2014 Figure 7 4: United States: Generic Drug Prices as a Percentage of Branded Drug Prices – Based on Number of Competitors (in Billion US$) Figure 8 1: United States – Generics Market – Value Chain Analysis List of Tables Table 4 1: United States: Sales and Patent Expiry of Major Drugs Expected to Lose Patent Protection (in Billion US$), 2016-2020 Table 5 1: Global - Generics Market: Sales, Volume and Growth of Major Markets, 2014 Table 7 1: United States: Generics Market: Sales Performance of Top Players (in US$ Million), 2014 Table 7 2: United States: Generics Market: Volume Performance of Top Players (in Million Prescriptions), 2014 Table 7 3: United States: Generics Market: Volume Performance of Top Generic Drugs (in Million Prescriptions), 2014 Table 9 1: United States: Overview of Pharmaceutical Regulations

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