US Generic Drug Market

Market Overview:

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:

• 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
• Others

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.

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:

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

Report Coverage: