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US Generic Drug Market: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2019-2024

The US generic drug market reached a value of US$ 103.8 Billion in 2018, at a CAGR of 12.1% during 2011-2018. Generics are off-patented drugs that are bioequivalent to branded medications in terms of dosage, strength, quality, form, effect, intended use, side effects, and route of administration. In the US, generic drugs have witnessed a substantial rise in production as they are less expensive than branded drugs and do not require extensive research and testing. Additionally, the introduction of generic medicines has helped in sustaining the healthcare system of the country with improved patient access and generating savings for taxpayers, employers and insurance providers. Moreover, the market is currently experiencing significant growth due to a rise in the prevalence of chronic diseases across the region, such as cardiovascular diseases, diabetes, Alzheimer’s disease, and Parkinson’s disease.

US Generic Drug market Report

Market Drivers:

In recent years, there has been a rise in the number of generic-drug approvals across the US supported by the implementation of the Drug Competition Action Plan of the FDA that aims towards the elimination of barriers faced by the generic-drug manufacturers. Furthermore, to enhance the generic-drug development and approval process, the US Food and Drug Administration (USFDA) has reauthorized the Generic Drug User Fee Amendments in 2017. The GDUFA II allows the collection of user fees from generic-drug manufacturers to provide the FDA with additional resources for generic-drug reviews. Other than this, the Government has introduced several programs for offering incentives to physicians and pharmacists to promote generic substitution in the nation. Besides, numerous brand-name drugs are set to lose their patent protection in the near future which will have a positive effect on the generic drugs market in the country. According to IMARC Group, the US generic drug market is expected to reach US$ 190.4 Billion by 2024, at a projected CAGR of 10.6% during 2019-2024.

Breakup by Segment:

  • Unbranded
  • Branded


The market has been segmented into unbranded and branded generics. Currently, unbranded generics exhibit a clear dominance in the market, holding the majority of the market share.

Breakup by Therapy Area:

  • CNS
  • Cardiovascular
  • Dermatology
  • Genitourinary/Hormonal
  • Respiratory
  • Rheumatology
  • Diabetes
  • Oncology

US Generic Drug Market By Therapy Area

The market has been categorized on the basis of various therapy areas which mainly include CNS, cardiovascular, dermatology, genitourinary/hormonal, respiratory, rheumatology, diabetes and oncology.

Breakup by Drug Delivery:

  • Oral
  • Injectables
  • Dermal/Topical
  • Inhalers


On the basis of drug delivery methods, oral drugs represent the largest segment as they are convenient for the patients and requires minimal or no medical assistance. Oral drug delivery method is followed by injectables, dermal/topical and inhalers.

Breakup by Distribution Channel:

  • Hospital Pharmacies
  • Retail Pharmacies


On the basis of distribution channels, the market is dominated by hospital pharmacies which account for the majority of the generic drug sales in the region.

Competitive Analysis:

The market is characterized by the presence of manufacturers who compete in terms of quality and prices. Some of the leading players operating in the market are:

  • Teva
  • Mylan
  • Actavis
  • Sandoz
  • Sun Pharma
  • Par Pharmaceuticals
  • Endo Pharmaceuticals
  • Lupin Pharmaceuticals
  • Dr Reddy’s
  • Hospira


Key Questions Answered 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   Preface
2   Scope and Methodology

    2.1    Objectives of the Study
    2.2    Stakeholders
    2.3    Data Sources
        2.3.1    Primary Sources
        2.3.2    Secondary Sources
    2.4    Market Estimation
        2.4.1    Bottom-Up Approach
        2.4.2    Top-Down Approach
    2.5    Forecasting Methodology
3   Executive Summary
4   US Generic Drug Market - Introduction

    4.1 What are Generic Drugs?
    4.2 Unbranded and Branded Generics
    4.3 Authorized Generics
    4.4 Commoditized and Specialty Generics
5   Why is the US Generic Drug Market So Lucrative
    5.1 Patent Expiry of Blockbuster Drugs
    5.2 Significant Price Differential between Generics and Innovator Drugs
    5.3 Savings for the Government and Third-Party Payers
    5.4 Incentives for Dispensing and Prescribing Generic Drugs
    5.5 Reimbursement and Lower Co-payments
    5.6 Biosimilars
 6  Global Generic Drug Market
    6.1 Market Performance
        6.1.1    Volume Trends
        6.1.2    Value Trends
    6.2 Market Breakup by Country
    6.3 Market Forecast
    6.4 Most Prescribed Generic and Branded Drugs
7   US Generic Drug Market
    7.1 US Pharmaceutical Market Performance
        7.1.1    Volume Trends
        7.1.2    Value Trends
        7.1.3    Market Breakup by Type
        7.1.4    Market Forecast
    7.2 US Generic Drug Market Performance
        7.2.1    Volume Trends
        7.2.2    Value Trends
        7.2.3    Market Breakup by Segment
        7.2.4    Market Breakup by Therapy Area
        7.2.5    Market Breakup by Drug Delivery
        7.2.6    Market Breakup by Distribution Channel
        7.2.7   Market Forecast
8   Market Breakup by Segment
    8.1 Unbranded Generics
        8.1.1 Market Trends
        8.1.2 Market Forecast
    8.2 Branded Generics
        8.2.1 Market Trends
        8.2.2 Market Forecast
9   Market Breakup by Therapy Area
    9.1 CNS
        9.1.1 Market Trends
        9.1.2 Market Forecast
    9.2 Cardiovascular
        9.2.1 Market Trends
        9.2.2 Market Forecast
    9.3 Dermatology
        9.3.1 Market Trends
        9.3.2 Market Forecast
    9.4 Genitourinary/Hormonal 
        9.4.1 Market Trends
        9.4.2 Market Forecast
    9.5 Respiratory
        9.5.1 Market Trends
        9.5.2 Market Forecast
    9.6 Rheumatology 
        9.6.1 Market Trends
        9.6.2 Market Forecast
    9.7 Diabetes
        9.7.1 Market Trends
        9.7.2 Market Forecast
    9.8 Oncology
        9.8.1 Market Trends
        9.8.2 Market Forecast
    9.9 Others
        9.9.1 Market Trends
        9.9.2 Market Forecast
10  Market Breakup by Drug Delivery
    10.1 Oral
        10.1.1 Market Trends
        10.1.2 Market Forecast
    10.2 Injectables   
        10.2.1 Market Trends
        10.2.2 Market Forecast
    10.3 Dermal/Topical
        10.3.1 Market Trends
        10.3.2 Market Forecast
    10.4 Inhalers
        10.4.1 Market Trends
        10.4.2 Market Forecast
11  Market Breakup by Distribution Channel
    11.1 Retail Pharmacies
        11.1.1 Market Trends
        11.1.2 Market Forecast
    11.2 Hospital Pharmacies
        11.2.1 Market Trends
        11.2.2 Market Forecast
12  US Generic Drug Market - SWOT Analysis
    12.1 Overview
    12.2 Strengths
    12.3 Weaknesses
    12.4 Opportunities
    12.5 Threats
13  US Generic Drug Market - Value Chain Analysis
    13.1 Research and Development
    13.2 Raw Material Procurement
    13.3 Manufacturing
    13.4 Marketing 
    13.5 Distribution
    13.6 End-Consumer
14  Pricing Mechanism and Profit Margins at Various Levels of the Supply Chain
15  Porter’s Five Forces Analysis

    15.1 Overview
    15.2 Bargaining Power of Buyers
    15.3 Bargaining Power of Suppliers
    15.4 Degree of Rivalry
    15.5 Threat of New Entrants
    15.6 Threat of Substitutes
16  US Generic Drug Market- Competitive Landscape
    16.1 US Generic Drug Market - Competitive Structure
    16.2 US Generic Drug Market - Breakup of Key Players
    16.4 US Generic Drug Market - Most Prescribed Generic Drugs
    16.5 US Generic Drug Market - Market Breakup by Distribution
    16.6 US Generic Drug Market - Pricing Dynamics
17  Regulations in the US Generic Drug Industry
    17.1 Overview of Pharmaceutical Regulations
    17.2 Drug Applications
    17.3 Patents and Market Exclusivity
    17.4 Regulatory Requirements for Generic Drugs
    17.5 The Hatch-Waxman Act
    17.6 Certifications
    17.7 Other Important Considerations
18  US Generic Drug Market: Key Success Factors
19  US Generic Drug Market: Road Blocks

20  Requirements for Setting Up a Generic Drug Manufacturing Plant
    20.1 Manufacturing Process
    20.2 Raw Material Requirements
    20.3 Raw Materials Pictures
    20.4 Land and Construction Requirements 
    20.5 Machinery and Infrastructure Requirements
    20.6 Machinery Pictures
    20.7 Plant Layout
    20.8 Packaging Requirements 
    20.9 Utility Requirements 
    20.10 Manpower Requirements
21  US Generic Drug Market - Key Company Profiles
    21.1 Teva
    21.2 Mylan
    21.3 Actavis
    21.4 Sandoz
    21.5 Sun Pharma
    21.6 Par Pharmaceuticals
    21.7 Endo Pharmaceuticals
    21.8 Lupin Pharmaceuticals
    21.9 Dr Reddy’s
    21.10 Hospira    


List of Figures

Figure 1: Structure of the Pharmaceutical Industry
Figure 2: Classification of Generic Drugs
Figure 3: US: Patent Expiry Exposure (in Billion US$), 2010-2019
Figure 4: US: Savings from Generic Drugs (in Billion US$), 2007-2018E
Figure 5: Global: Generic Drug Market: Sales Value (in Billion US$), 2011-2018
Figure 6: Global: Generic Drug Market: Sales Volume (in Billion Standards Units), 2011-2018
Figure 7: Global: Generic Drug Market: Sales Value Breakup by Country (in %), 2018
Figure 8: Global: Generic Drug Market: Sales Volume Breakup by Country (in %), 2018
Figure 9: Global: Generic Drug Market Forecast: Sales Value (in Billion US$), 2019-2024
Figure 10: Global: Generic Drug Market Forecast: Sales Volume (in Billion Standards Units), 2019-2024
Figure 11: US: Pharmaceutical Market: Sales Volume (in Million Prescriptions), 2011-2018
Figure 12: US: Pharmaceutical Market: Sales Value (in Billion US$), 2011-2018
Figure 13: US: Pharmaceutical Market: Sales Volume Breakup of Branded and Generic Drugs (in %), 2011 and 2018
Figure 14: US: Pharmaceutical Market: Sales Value Breakup of Branded and Generic Drugs (in %), 2011 and 2018
Figure 15: US: Pharmaceutical Market Forecast: Sales Volume (in Million Prescriptions), 2019-2024
Figure 16: US: Pharmaceutical Market Forecast: Sales Value (in Billion US$), 2019-2024
Figure 17: US: Generic Drug Market: Sales Volume (in Million Prescriptions), 2011-2018
Figure 18: US: Generic Drug Market: Sales Value (in Billion US$), 2011-2018
Figure 19: US: Generic Drug Market: Breakup by Segment (in %), 2011-2018
Figure 20: US: Generic Drug Market: Breakup by Therapy Area (in %), 2011-2018
Figure 21: US: Generic Drug Market: Breakup by Drug Delivery (in %), 2011-2018
Figure 22: US: Generic Drug Market: Breakup by Distribution Channel (in %), 2011-2018
Figure 23: US: Generic Drug Market Forecast: Sales Volume (in Million Prescriptions), 2019-2024
Figure 24: US: Generic Drug Market Forecast: Sales Value (in Billion US$), 2019-2024
Figure 25: Generic Drug Market: Price Structure (US$/Ton)
Figure 25: US: Generic Drug Market: SWOT Analysis
Figure 26: US: Generic Drug Market: Value Chain Analysis
Figure 27: US: Generic Drug Market: Pricing Mechanism and Profit Margins at the Various Levels of the Supply Chain
Figure 28: US: Generic Drug Market: Porter's Five Forces Analysis
Figure 29: US: Generic Drug Market: Unbranded Generics (in Million Prescriptions), 2011 & 2018
Figure 30: US: Generic Drug Market Forecast: Unbranded Generics (in Million Prescriptions), 2019-2024
Figure 31: US: Generic Drug Market: Branded Generics (in Million Prescriptions), 2011 & 2018
Figure 32: US: Generic Drug Market Forecast: Branded Generics (in Million Prescriptions), 2019-2024
Figure 33: US: Generic Drug Market: CNS (in Million US$), 2011 & 2018
Figure 34: US: Generic Drug Market Forecast: CNS (in Million US$), 2019-2024
Figure 35: US: Generic Drug Market: Cardiovascular (in Million US$), 2011 & 2018
Figure 36: US: Generic Drug Market Forecast: Cardiovascular (in Million US$), 2024
Figure 37: US: Generic Drug Market: Dermatology (in Million US$), 2011 & 2018
Figure 38: US: Generic Drug Market Forecast: Dermatology (in Million US$), 2019-2024
Figure 39: US: Generic Drug Market: Genitourinary/Hormonal (in Million US$), 2011 & 2018
Figure 40: US: Generic Drug Market Forecast: Genitourinary/Hormonal (in Million US$), 2019-2024
Figure 41: US: Generic Drug Market: Respiratory (in Million US$), 2011 & 2018
Figure 42: US: Generic Drug Market Forecast: Respiratory (in Million US$), 2019-2024
Figure 43: US: Generic Drug Market: Rheumatology (in Million US$), 2011 & 2018
Figure 44: US: Generic Drug Market Forecast: Rheumatology (in Million US$), 2019-2024
Figure 45: US: Generic Drug Market: Diabetes (in Million US$), 2011 & 2018
Figure 46: US: Generic Drug Market Forecast: Diabetes (in Million US$), 2019-2024
Figure 47: US: Generic Drug Market: Oncology (in Million US$), 2011 & 2018
Figure 48: US: Generic Drug Market Forecast: Oncology (in Million US$), 2019-2024
Figure 49: US: Generic Drug Market: Others (in Million US$), 2011 & 2018
Figure 50: US: Generic Drug Market Forecast: Others (in Million US$), 2019-2024
Figure 51: US: Generic Drug Market: Orals (in Million US$), 2011 & 2018
Figure 52: US: Generic Drug Market Forecast: Orals (in Million US$), 2019-2024
Figure 53: US: Generic Drug Market: Injectables (in Million US$), 2011 & 2018
Figure 54: US: Generic Drug Market Forecast: Injectables (in Million US$), 2019-2024
Figure 55: US: Generic Drug Market: Dermal/Topical (in Million US$), 2011 & 2018
Figure 56: US: Generic Drug Market Forecast: Dermal/Topical (in Million US$), 2019-2024
Figure 57: US: Generic Drug Market: Inhalers (in Million US$), 2011 & 2018
Figure 58: US: Generic Drug Market Forecast: Inhalers (in Million US$), 2019-2024
Figure 59 US: Generic Drug Market: Retail Pharmacies (in Million US$), 2011 & 2018
Figure 60: US: Generic Drug Market Forecast: Retail Pharmacies (in Million US$), 2019-2024
Figure 61: US: Generic Drug Market: Hospital Pharmacies (in Million US$), 2011 & 2018
Figure 62: US: Generic Drug Market Forecast: Hospital Pharmacies (in Million US$), 2019-2024
Figure 63: US: Generic Drug Market: Sales Breakup of Top Players (in %), 2018
Figure 64: US: Generic Drug Market: Volume Share of Top Players (in %), 2018
Figure 65: US: Generic Drug Market: Volume Share by Distribution (in %), 2018
Figure 66: US: Generic Drug Prices as a Percentage of Branded Drug Prices – Based on Number of Competitors
Figure 67: US: Generic Drug Market: Detailed Process Flow
Figure 68: US: Generic Drug Market: Raw Material Requirements
Figure 69: US: Generic Drug Market: Plant Layout
Figure 70: US: Generic Drug Market: Packaging Requirements


List of Tables

Table 1: US: Sales and Patent Expiry of Major Drugs Expected to Lose Patent Protection (in Billion US$)
Table 2: US: Expenses of Generic and Branded Drug Manufacturers (in %)
Table 3: Global: Generic Drug Market: Volume Performance of Top Generic Drugs (in Million Prescriptions)
Table 4: Global: Branded Drug Market: Volume Performance of Top Branded Drugs (in Million Prescriptions)
Table 5: US: Generic Drug Market: Sales Performance of Top Players (in Billion US$), 2018
Table 6: US: Generic Drug Market: Volume Performance of Top Players (in Billion Units), 2018
Table 7: US: Generics Market: Volume Performance of Top Generic Drugs (in Million Prescriptions), 2018
Table 8: US: Overview of Pharmaceutical Regulations
Table 9: US: Generic Drug Market: Land and Construction Requirements
Table 10: US: Generic Drug Market: Machinery and Infrastructure Requirements
Table 11: US: Generic Drug Market: Utility Requirements
Table 12: US: Generic Drug Market: Manpower Requirements
 

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