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United States Generic Drug Market: By Segment: Unbranded Generic, Branded Generic; By Therapy Area; By Drug Delivery; By Distribution Channel: Retail Pharmacies, Hospital Pharmacies; Regional Analysis; Historical Market and Forecast (2015-2025); Market Dynamics; Competitive Landscape; Industry Events and Developments

United States Generic Drug Market Outlook

The United States generic drug market reached a value of about USD 116.5 billion in 2019. The market is further expected to grow at a CAGR of 12% in the forecast period of 2020-2025 to reach a value of approximately USD 230 billion by 2025. 

The United States is the world's largest regional market for generic drug. That can be due to the thorough evaluations made by various regulatory bodies to ensure optimal quality during the manufacturing process of such products, further assisting the development of generic drugs in the country.

Generic medicines have seen a significant increase in production in the United States as they are less costly than branded drugs, and do not require extensive research and testing. Additionally, the advent of generic drugs has helped support the country's healthcare system by enhancing the patient quality and generating savings for taxpayers, employers, and insurance companies. Moreover, the market is currently experiencing a rapid growth due to a rise in the incidences of chronic disease across the world, such as cardiovascular diseases, Alzheimer's disease, diabetes, and Parkinson's disease.

 

Properties and Applications

Generic drugs are medicines that give the same active ingredients and therapeutic impact as a branded counterpart. Such medications are available in different forms, e.g., oral, topical, intramuscular, intravenous, or inhalant. They do not require marketing due to their marketed equivalents' established safety and efficiency profile. Such products can only be launched after the patent expiration of related brand-name drugs. 

The generic drug industry includes the following segments:

  • Unbranded 
  • Branded 

Unbranded generics currently hold the largest market share within the country.

On the basis of the therapy area, the industry is divided into:

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

On the basis of drug delivery, the industry is segregated into oral, injectables, dermal/topical, inhalers, and others. Oral drugs represent the largest market segment owing to their convenience.

On the basis of the distribution channel, the industry is bifurcated into retail pharmacies and hospital pharmacies. Hospital pharmacies dominate the generic drug market. 

 

Market Analysis 

In the recent years, there has been an increase in the number of generic drug approvals across the U.S. driven by the FDA's Drug Competition Action Plan to remove obstacles faced by generic-drug manufacturers. Moreover, the U.S. Food and Drug Administration (USFDA) re-authorised the Generic Drug Consumer Fee Reforms in 2017 to improve the generic-drug production and approval process. GDUFA II permits generic-drug manufacturers to give user fees and provide the FDA with extra resources for generic-drug reviews. Other than this, the government has launched many programs to facilitate physicians and pharmacists to promote generic substitution in the country. Additionally, in the near future, several brand-name medicines will lose their patent rights, which will have a positive impact on the generic drug market in the United States.

 

Competitive Landscape 

The report gives a detailed analysis of the following key players in the United States generic drug market, covering their competitive landscape, capacity, and latest developments like mergers, acquisitions, and investments, expansions of capacity, and plant turnarounds:

  • Teva Pharmaceuticals USA, Inc.
  • Sandoz Inc.
  • Sun Pharmaceutical Industries Ltd.
  • Lupin Pharmaceuticals, Inc.
  • Par Pharmaceutical
  • Endo Pharmaceuticals
  • Others

The comprehensive EMR report provides an in-depth assessment of the industry based on the Porter's five forces model along with giving a SWOT analysis. 

1    Preface
2    Report Coverage – Key Segmentation and Scope
3    Report Description

    3.1    Market Definition and Outlook
    3.2    Properties and Applications
    3.3    Market Analysis
    3.4    Key Players
4    Key Assumptions
5    Executive Summary

    5.1    Overview
    5.2    Key Drivers
    5.3    Key Developments
    5.4    Competitive Structure
    5.5    Key Industrial Trends
6    Snapshot
    6.1    Global
    6.2    United States
7    Industry Opportunities and Challenges
8    Global Generic Drug Market Overview

    8.1    Key Industry Highlights
    8.2    Global Generic Drug Historical Market (2015-2019) 
    8.3    Global Generic Drug Market Forecast (2020-2025)
    8.4    Global Generic Drug Market by Region
        8.4.1    Market Share
            8.4.1.1    North America
            8.4.1.2    Europe
            8.4.1.3    Asia Pacific
            8.4.1.4    Latin America
            8.4.1.5    Latin America
9    United States Pharmaceuticals Market Overview
    9.1    Key Industry Highlights
    9.2    United States Generic Drug Historical Market (2015-2019) 
    9.3    United States Generic Drug Market Forecast (2020-2025)
    9.4    United States Generic Drug Market by Type
10    United States Generic Drug Market Analysis
    10.1    Key Industry Highlights
    10.2    United States Generic Drug Historical Market (2015-2019) 
    10.3    United States Generic Drug Market Forecast (2020-2025)
    10.4    United States Generic Drug Market by Segment
        10.4.1    Unbranded Generic
            10.4.1.1    Market Share
            10.4.1.2    Historical Trend (2015-2019)
            10.4.1.3    Forecast Trend (2020-2025)
        10.4.2    Branded Generic
            10.4.2.1    Market Share
            10.4.2.2    Historical Trend (2015-2019)
            10.4.2.3    Forecast Trend (2020-2025)
    10.5    United States Generic Drug Market by Therapy Area
        10.5.1    CNS
            10.5.1.1    Market Share
            10.5.1.2    Historical Trend (2015-2019)
            10.5.1.3    Forecast Trend (2020-2025)
        10.5.2    Cardiovascular
            10.5.2.1    Market Share
            10.5.2.2    Historical Trend (2015-2019)
            10.5.2.3    Forecast Trend (2020-2025)
        10.5.3    Dermatology
            10.5.3.1    Market Share
            10.5.3.2    Historical Trend (2015-2019)
            10.5.3.3    Forecast Trend (2020-2025)
        10.5.4    Genitourinary/Hormonal 
            10.5.4.1    Market Share
            10.5.4.2    Historical Trend (2015-2019)
            10.5.4.3    Forecast Trend (2020-2025)
        10.5.5    Respiratory
            10.5.5.1    Market Share
            10.5.5.2    Historical Trend (2015-2019)
            10.5.5.3    Forecast Trend (2020-2025)
        10.5.6    Rheumatology 
            10.5.6.1    Market Share
            10.5.6.2    Historical Trend (2015-2019)
            10.5.6.3    Forecast Trend (2020-2025)
        10.5.7    Diabetes
            10.5.7.1    Market Share
            10.5.7.2    Historical Trend (2015-2019)
            10.5.7.3    Forecast Trend (2020-2025)
        10.5.8    Oncology 
            10.5.8.1    Market Share
            10.5.8.2    Historical Trend (2015-2019)
            10.5.8.3    Forecast Trend (2020-2025)
        10.5.9    Others
    10.6    United States Generic Drug Market by Drug Delivery
        10.6.1    Oral
            10.6.1.1    Market Share
            10.6.1.2    Historical Trend (2015-2019)
            10.6.1.3    Forecast Trend (2020-2025)
        10.6.2    Injectables   
            10.6.2.1    Market Share
            10.6.2.2    Historical Trend (2015-2019)
            10.6.2.3    Forecast Trend (2020-2025)
        10.6.3    Dermal/Topical
            10.6.3.1    Market Share
            10.6.3.2    Historical Trend (2015-2019)
            10.6.3.3    Forecast Trend (2020-2025)
        10.6.4    Inhalers
            10.6.4.1    Market Share
            10.6.4.2    Historical Trend (2015-2019)
            10.6.4.3    Forecast Trend (2020-2025)
        10.6.5    Others
    10.7    United States Generic Drug Market by Distribution Channel
        10.7.1    Retail Pharmacies
            10.7.1.1    Market Share
            10.7.1.2    Historical Trend (2015-2019)
            10.7.1.3    Forecast Trend (2020-2025)
        10.7.2    Hospital Pharmacies
            10.7.2.1    Market Share
            10.7.2.2    Historical Trend (2015-2019)
            10.7.2.3    Forecast Trend (2020-2025)
11    Market Dynamics
    11.1    SWOT Analysis
        11.1.1    Strengths
        11.1.2    Weaknesses
        11.1.3    Opportunities
        11.1.4    Threats
    11.2    Porter’s Five Forces Analysis
        11.2.1    Supplier’s Power
        11.2.2    Buyers Power
        11.2.3    Threat of New Entrants
        11.2.4    Degree of Rivalry
        11.2.5    Threat of Substitutes
    11.3    EMR’s Key Indicators for Demand
    11.4    EMR’s Key Indicators for Price
12    Value Chain Analysis
13    Regulations in the US Generic Drug Industry

    13.1    Overview of Pharmaceutical Regulations
    13.2    Drug Applications
    13.3    Patents and Market Exclusivity
    13.4    Regulatory Requirements for Generic Drugs
    13.5    The Hatch-Waxman Act
    13.6    Certifications
    13.7    Other Important Considerations 
14    Requirements for Setting Up a Generic Drug Manufacturing Plant
    14.1    Manufacturing Process
    14.2    Raw Material Requirements
    14.3    Land and Construction Requirements 
    14.4    Machinery and Infrastructure Requirements
    14.5    Machinery Pictures
    14.6    Plant Layout
    14.7    Packaging Requirements 
    14.8    Utility Requirements 
    14.9    Manpower Requirements
15    Competitive Landscape
    15.1    Market Structure
    15.2    Key Players’ Market Share
    15.3    Company Profiles
        15.3.1    Teva Pharmaceuticals USA, Inc.
            15.3.1.1    Company Overview
            15.3.1.2    Product Portfolio
            15.3.1.3    Demographic Reach and Achievements
            15.3.1.4    Financial Summary
            15.3.1.5    Certifications
    15.3.2    Sandoz Inc.
            15.3.2.1    Company Overview
            15.3.2.2    Product Portfolio
            15.3.2.3    Demographic Reach and Achievements
            15.3.2.4    Financial Summary
            15.3.2.5    Certifications
    15.3.3    Sun Pharmaceutical Industries Ltd.
            15.3.3.1    Company Overview
            15.3.3.2    Product Portfolio
            15.3.3.3    Demographic Reach and Achievements
            15.3.3.4    Financial Summary
            15.3.3.5    Certifications
    15.3.4    Lupin Pharmaceuticals, Inc.
            15.3.4.1    Company Overview
            15.3.4.2    Product Portfolio
            15.3.4.3    Demographic Reach and Achievements
            15.3.4.4    Financial Summary
            15.3.4.5    Certifications
    15.3.5    Par Pharmaceutical
            15.3.5.1    Company Overview
            15.3.5.2    Product Portfolio
            15.3.5.3    Demographic Reach and Achievements
            15.3.5.4    Financial Summary
            15.3.5.5    Certifications
    15.3.6    Endo Pharmaceuticals
            15.3.6.1    Company Overview
            15.3.6.2    Product Portfolio
            15.3.6.3    Demographic Reach and Achievements
            15.3.6.4    Financial Summary
            15.3.6.5    Certifications
    15.3.7    Others
16    Industry Events and Developments


List of Figures and Tables

1.    Global Generic Drug Market: Key Industry Highlights, 2015 and 2025
2.    United States Pharmaceutical Market: Key Industry Highlights, 2015 and 2025
3.    United States Generic Drug Market: Key Industry Highlights, 2015 and 2025
4.    United States Generic Drug Historical Market: Breakup by Segment (USD Billion), 2015-2019
5.    United States Generic Drug Market Forecast: Breakup by Segment (USD Billion), 2020-2025
6.    United States Generic Drug Historical Market: Breakup by Therapy Area (USD Billion), 2015-2019
7.    United States Generic Drug Market Forecast: Breakup by Therapy Area (USD Billion), 2020-2025
8.    United States Generic Drug Historical Market: Breakup by Drug Delivery (USD Billion), 2015-2019
9.    United States Generic Drug Market Forecast: Breakup by Drug Delivery (USD Billion), 2020-2025
10.    United States Generic Drug Historical Market: Breakup by Distribution Channel (USD Billion), 2015-2019
11.    United States Generic Drug Market Forecast: Breakup by Distribution Channel (USD Billion), 2020-2025
12.    United States Generic Drug Market Structure

Key Questions Answered in the Report

In 2019, the United States generic drug market attained a value of nearly USD 116.5 billion. 

The market is projected to grow at a CAGR of 12% between 2020 and 2025.

The market is estimated to witness a healthy growth in the forecast period of 2020-2025 to reach about USD 230 billion by 2025. 

The major drivers of the industry, such as the rising disposable incomes, increasing population, increasing hygiene awareness, increasing incidences of chronic diseases, and growing technological advancements, are expected to aid the market growth.

The key trend guiding the growth of the United States market includes the launch of several programs to promote generic substitution in the country.

The major segments of the product in the industry are unbranded and branded generic.

The major therapy areas of the product in the industry are CNS, cardiovascular, dermatology, genitourinary/hormonal, respiratory, rheumatology, diabetes, and oncology, among others.

The leading drug delivery segment of United States generic drug is oral drugs.

The distribution channel segment is led by hospital pharmacies. 

The major players in the industry are Teva Pharmaceuticals USA, Inc., Sandoz Inc., Sun Pharmaceutical Industries Ltd., Lupin Pharmaceuticals, Inc., Par Pharmaceutical, and Endo Pharmaceuticals, among others.

Analyst Review

The United States generic drug market attained a value of USD 116.5 billion in 2019 driven by rise in the incidences of chronic diseases. Aided by technological advancements, the market is expected to witness a further growth in the forecast period of 2020-2025, growing at a CAGR of 12%. The United States generic drug market is projected to reach USD 230 billion by 2025. 

EMR's meticulous research methodology delves deep into the market, covering the macro and micro aspects of the industry. Based on its segments, the United States market can be categorised into unbranded and branded generic. On the basis of therapy areas, the industry is divided into CNS, cardiovascular, dermatology, genitourinary/hormonal, respiratory, rheumatology, diabetes, oncology, and others. On the basis of drug delivery, oral drugs are leading the market. On the basis of distribution channels, the hospital pharmacies sector accounts for the leading share in the industry. The key players in the above market include Teva Pharmaceuticals USA, Inc., Sandoz Inc., Sun Pharmaceutical Industries Ltd., Lupin Pharmaceuticals, Inc., Par Pharmaceutical, Endo Pharmaceuticals, and others.

EMR's research methodology uses a combination of cutting-edge analytical tools and the expertise of their highly accomplished team, thus, providing their customers with market insights that are accurate, actionable, and help them remain ahead of their competition. 

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