The US generic drug market reached a value of US$ 115.2 Billion in 2019, at a CAGR of 11.7% during 2014-2019. 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.
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. According to IMARC Group, the US generic drug market is expected to reach US$ 208.6 Billion by 2025, at a projected CAGR of 10.46% during 2020-2025.
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. Oral drug delivery method is followed by injectables, dermal/topical and inhalers.
Breakup by Distribution Channel:
On the basis of distribution channels, the market is dominated by hospital pharmacies which account for the majority of the generic drug sales in the region.
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:
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