Reports
United States Generic Drug Market: By Type: Unbranded, Branded; By Therapy Area; By Drug Delivery; By Distribution Channel: Retail Pharmacies, Hospital Pharmacies; Regional Analysis; Historical Market and Forecast (2018-2028); 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 146.14 billion in 2022. The market is further expected to grow at a CAGR of 12% in the forecast period of 2023-2028 to reach a value of approximately USD 288.51 billion by 2028.
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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.
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By type, the generic drug market in the US is divided into::
- 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.
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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 market based on the Porter's five forces model along with giving a SWOT analysis.
| REPORT FEATURES | DETAILS |
|---|---|
| Base Year | 2022 |
| Historical Period | 2018-2022 |
| Forecast Period | 2023-2028 |
| Scope of the Report | Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment- Type, Therapy Area, Drug Delivery, Distribution Channel |
| Breakup by Type | Unbranded, Branded |
| Breakup by Therapy Area | CNS, Cardiovascular, Dermatology, Genitourinary/Hormonal, Respiratory, Rheumatology, Diabetes, Oncology, Others |
| Breakup by Drug Delivery | Oral, Injectables, Dermal/Topical, Inhalers, Others |
| Breakup by Distribution Channel | Retail Pharmacies, Hospital Pharmacies |
| Market Dynamics | SWOT, Porter's Five Forces, Key Indicators for Price and Demand |
| Competitive Landscape | Market Structure, Company Profiles- Company Overview, Product Portfolio, Demographic Reach and Achievements, Certifications |
| Companies Covered | Teva Pharmaceuticals USA, Inc., Sandoz Inc., Sun Pharmaceutical Industries Ltd., Lupin Pharmaceuticals, Inc., Par Pharmaceutical, Endo Pharmaceuticals, Others |
| Report Price and Purchase Option | Explore our purchase options that are best suited to your resources and industry needs. |
| Delivery Format | Delivered as an attached PDF and Excel through email, with an option of receiving an editable PPT, according to the purchase option. |
*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
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
7 Opportunities and Challenges in the Market
8 Global Generic Drug Market Overview
8.1 Key Industry Highlights
8.2 Global Generic Drug Historical Market (2018-2022)
8.3 Global Generic Drug Market Forecast (2023-2028)
8.4 Global Generic Drug Market by Region
8.4.1 North America
8.4.2 Europe
8.4.3 Asia Pacific
8.4.4 Latin America
8.4.5 Latin America
9 United States Pharmaceuticals Market Overview
9.1 Key Industry Highlights
9.2 United States Generic Drug Historical Market (2018-2022)
9.3 United States Generic Drug Market Forecast (2023-2028)
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 (2018-2022)
10.3 United States Generic Drug Market Forecast (2023-2028)
10.4 United States Generic Drug Market by Type
10.4.1 Unbranded
10.4.1.1 Historical Trend (2018-2022)
10.4.1.2 Forecast Trend (2023-2028)
10.4.2 Branded
10.4.2.1 Historical Trend (2018-2022)
10.4.2.2 Forecast Trend (2023-2028)
10.5 United States Generic Drug Market by Therapy Area
10.5.1 CNS
10.5.1.1 Historical Trend (2018-2022)
10.5.1.2 Forecast Trend (2023-2028)
10.5.2 Cardiovascular
10.5.2.1 Historical Trend (2018-2022)
10.5.2.2 Forecast Trend (2023-2028)
10.5.3 Dermatology
10.5.3.1 Historical Trend (2018-2022)
10.5.3.2 Forecast Trend (2023-2028)
10.5.4 Genitourinary/Hormonal
10.5.4.1 Historical Trend (2018-2022)
10.5.4.2 Forecast Trend (2023-2028)
10.5.5 Respiratory
10.5.5.1 Historical Trend (2018-2022)
10.5.5.2 Forecast Trend (2023-2028)
10.5.6 Rheumatology
10.5.6.1 Historical Trend (2018-2022)
10.5.6.2 Forecast Trend (2023-2028)
10.5.7 Diabetes
10.5.7.1 Historical Trend (2018-2022)
10.5.7.2 Forecast Trend (2023-2028)
10.5.8 Oncology
10.5.8.1 Historical Trend (2018-2022)
10.5.8.2 Forecast Trend (2023-2028)
10.5.9 Others
10.6 United States Generic Drug Market by Drug Delivery
10.6.1 Oral
10.6.1.1 Historical Trend (2018-2022)
10.6.1.2 Forecast Trend (2023-2028)
10.6.2 Injectables
10.6.2.1 Historical Trend (2018-2022)
10.6.2.2 Forecast Trend (2023-2028)
10.6.3 Dermal/Topical
10.6.3.1 Historical Trend (2018-2022)
10.6.3.2 Forecast Trend (2023-2028)
10.6.4 Inhalers
10.6.4.1 Historical Trend (2018-2022)
10.6.4.2 Forecast Trend (2023-2028)
10.6.5 Others
10.7 United States Generic Drug Market by Distribution Channel
10.7.1 Retail Pharmacies
10.7.1.1 Historical Trend (2018-2022)
10.7.1.2 Forecast Trend (2023-2028)
10.7.2 Hospital Pharmacies
10.7.2.1 Historical Trend (2018-2022)
10.7.2.2 Forecast Trend (2023-2028)
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 Key Indicators for Demand
11.4 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 Company Profiles
15.2.1 Teva Pharmaceuticals USA, Inc.
15.2.1.1 Company Overview
15.2.1.2 Product Portfolio
15.2.1.3 Demographic Reach and Achievements
15.2.1.4 Financial Summary
15.2.1.5 Certifications
15.2.2 Sandoz Inc.
15.2.2.1 Company Overview
15.2.2.2 Product Portfolio
15.2.2.3 Demographic Reach and Achievements
15.2.2.4 Financial Summary
15.2.2.5 Certifications
15.2.3 Sun Pharmaceutical Industries Ltd.
15.2.3.1 Company Overview
15.2.3.2 Product Portfolio
15.2.3.3 Demographic Reach and Achievements
15.2.3.4 Financial Summary
15.2.3.5 Certifications
15.2.4 Lupin Pharmaceuticals, Inc.
15.2.4.1 Company Overview
15.2.4.2 Product Portfolio
15.2.4.3 Demographic Reach and Achievements
15.2.4.4 Financial Summary
15.2.4.5 Certifications
15.2.5 Par Pharmaceutical
15.2.5.1 Company Overview
15.2.5.2 Product Portfolio
15.2.5.3 Demographic Reach and Achievements
15.2.5.4 Financial Summary
15.2.5.5 Certifications
15.2.6 Endo Pharmaceuticals
15.2.6.1 Company Overview
15.2.6.2 Product Portfolio
15.2.6.3 Demographic Reach and Achievements
15.2.6.4 Financial Summary
15.2.6.5 Certifications
15.2.7 Others
16 Key Trends and Developments in the Market
List of Key Figures and Tables
1. Global Generic Drug Market: Key Industry Highlights, 2018 and 2028
2. United States Pharmaceutical Market: Key Industry Highlights, 2018 and 2028
3. United States Generic Drug Market: Key Industry Highlights, 2018 and 2028
4. United States Generic Drug Historical Market: Breakup by Type (USD Billion), 2018-2022
5. United States Generic Drug Market Forecast: Breakup by Type (USD Billion), 2023-2028
6. United States Generic Drug Historical Market: Breakup by Therapy Area (USD Billion), 2018-2022
7. United States Generic Drug Market Forecast: Breakup by Therapy Area (USD Billion), 2023-2028
8. United States Generic Drug Historical Market: Breakup by Drug Delivery (USD Billion), 2018-2022
9. United States Generic Drug Market Forecast: Breakup by Drug Delivery (USD Billion), 2023-2028
10. United States Generic Drug Historical Market: Breakup by Distribution Channel (USD Billion), 2018-2022
11. United States Generic Drug Market Forecast: Breakup by Distribution Channel (USD Billion), 2023-2028
12. United States Generic Drug Market Structure
Key Questions Answered in the Report
In 2022, the United States generic drug market attained a value of nearly USD 146.14 billion.
The market is projected to grow at a CAGR of 12% between 2023 and 2028.
The market is estimated to witness a healthy growth in the forecast period of 2023-2028 to reach about USD 288.51 billion by 2028.
The major drivers of the market are rising disposable incomes, increasing population, rising incidences of chronic diseases, and growing technological advancements.
The key trends guiding the growth of the market include the launch of several programs to promote generic substitution in the country and increasing hygiene awareness.
The major types in the market include unbranded and branded generic drugs.
The major therapy areas in the market include CNS, cardiovascular, dermatology, genitourinary/hormonal, respiratory, rheumatology, diabetes, and oncology, among others.
The different modes of drug delivery are injectables, dermal/topical, inhalers, and oral drugs, among others.
The major distribution channels in the market are hospital pharmacies and retail pharmacies.
The major players in the United States generic drug market 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 146.14 billion in 2022 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 2023-2028, growing at a CAGR of 12%. The United States generic drug market is projected to reach USD 288.51 billion by 2028.
EMR's meticulous research methodology delves deep into the market, covering the macro and micro aspects of the industry. Based on its type, the United States market can be categorised into unbranded and branded generic drugs. 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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