In recent years, the United States has witnessed a surge in generic drug approvals, attributed to the FDA's Drug Competition Action Plan aimed at eliminating barriers for generic drug manufacturers. According to the Food and Drug Administration, 956 generic drugs were approved or tentatively approved in the United States in 2023. Additionally, the USFDA authorised the Generic Drug User Fee Amendments (GDUFA) in 2017 to enhance the production and approval processes. GDUFA II allows manufacturers to pay user fees, providing the FDA with additional resources for generic drug reviews. Government initiatives further encourage physicians and pharmacists to promote generic substitution. Furthermore, the upcoming expiration of patents for several brand-name medicines is expected to positively impact the United States generic drug market.
The United States leads the global market for generic drugs due to rigorous evaluations by regulatory bodies ensuring high-quality manufacturing processes. Generic medicines are increasingly produced in the US for their cost-effectiveness and streamlined development without extensive research. They contribute to healthcare system improvement by enhancing patient care and generating savings for various stakeholders. The market is growing rapidly driven by increasing chronic diseases not just in the United States but globally, including diabetes, cardiovascular diseases, respiratory, dermatology and Parkinson's. In 2021, over 32.22 million people in the USA had diabetes and the number is expected to reach 36.29 million by 2045.
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Market Breakup by Type, Therapy Area, Drug Delivery, and Distribution Channel:
- The market is bifurcated into unbranded and branded based on type.
- Based on the therapy area, the market can be divided into CNS, cardiovascular, dermatology, genitourinary/hormonal, respiratory, rheumatology, diabetes, and oncology, among others.
- Based on drug delivery, the market is divided into oral, injectables, dermal/topical, and inhalers, among others.
- By distribution channel, the market is segmented into retail pharmacies and hospital pharmacies.
Key Findings of the Report:
- The United States has experienced a notable increase in generic drug approvals, largely due to initiatives such as the FDA's Drug Competition Action Plan and the Generic Drug User Fee Amendments (GDUFA). In 2023 alone, 956 generic drugs were approved or tentatively approved.
- Efforts to promote generic substitution by physicians and pharmacists contribute to the expansion of the generic drug market.
- Generic drugs are valued for their affordability and streamlined development processes, as they do not require extensive research like brand-name medications. They play a vital role in improving patient care and generating savings for healthcare stakeholders, contributing to the overall healthcare system improvement.
- The increasing prevalence of chronic diseases globally, including cardiovascular diseases, Alzheimer's, diabetes, and Parkinson's, is driving the growth of the generic drug market. With conditions like diabetes projected to affect millions more in the coming years, there is a growing need for accessible and cost-effective medications.
Key Offerings of the Report:
- The EMR report gives an overview of the United States generic drug market for the periods (2017-2023) and (2024-2032).
- The report also offers historical (2017-2023) and forecast (2024-2032) market information for the type, therapy area, drug delivery, and distribution channel of the generic drug market.
- The report analyses the market dynamics, covering the key demand and price indicators in the market, along with providing an assessment of the SWOT and Porter’s Five Forces models.
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. The comprehensive report by EMR looks into the market share, capacity, and latest developments like mergers and acquisitions, plant turnarounds, and capacity expansions of the major players.
Key Highlights of the Report
| REPORT FEATURES |
DETAILS |
| Base Year |
2023 |
| Historical Period |
2017-2023 |
| Forecast Period |
2024-2032 |
| 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 |
|
| 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 Analysis
- Porter's Five Forces Analysis
- Key Indicators for Demand
- Key Indicators for Price
|
| 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
|
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