US Generic Drug Market: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028

US Generic Drug Market: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2023-2028

The US generic drug market size reached US$ 86.9 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 110.7 Billion by 2028, exhibiting a growth rate (CAGR) of 4% during 2023-2028.

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.

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.

Key Market Segmentation:
IMARC Group provides an analysis of the key trends in each sub-segment of the US generic drug market report, along with forecasts at the global level and for the United States from 2023-2028. Our report has categorized the market based on segment, therapy area, drug delivery and distribution channel.

Breakup by Segment:


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:


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:


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.

Breakup by Distribution Channel:

Hospital Pharmacies
Retail Pharmacies

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

Competitive Landscape:
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:

Actavis (Teva)
Sandoz (Novartis)
Sun Pharma
Par Pharmaceuticals (Endo Pharmaceuticals)
Lupin Pharmaceuticals
Dr Reddy’s
Hospira (Pfizer)

Key Questions Answered in This Report

1. What was the size of the US generic drug in 2022?
2. What is the expected growth rate of the US generic drug during 2023-2028?
3. What are the key factors driving the US generic drug market?
4. What has been the impact of COVID-19 on the US generic drug market?
5. What is the breakup of the US generic drug market based on the segment?
6. What is the breakup of the US generic drug market based on the therapy area?
7. What is the breakup of the US generic drug market based on the drug delivery?
8. What is the breakup of the US generic drug market based on the distribution channel?
9. Who are the key companies/players 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 Impact of COVID-19
7.2.4 Market Breakup by Segment
7.2.5 Market Breakup by Therapy Area
7.2.6 Market Breakup by Drug Delivery
7.2.7 Market Breakup by Distribution Channel
7.2.8 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
16.3 US Generic Drug Market - Most Prescribed Generic Drugs
16.4 US Generic Drug Market - Market Breakup by Distribution
16.5 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 (Teva)
21.4 Sandoz (Novartis)
21.5 Sun Pharma
21.6 Par Pharmaceuticals (Endo Pharmaceuticals)
21.7 Lupin Pharmaceuticals
21.8 Dr Reddy’s
21.9 Hospira (Pfizer)

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