Rising number of chronic illnesses, rise in ANDA applications and approvals, channel consolidation and significant price pressure, portfolio reduction by MNCs, patent expiry of important pharmaceuticals, and entry of Indian competitors are some of the main drivers driving the US branded generics market growth. However, greater costs relative to unbranded generics are one of the key factors influencing market growth.
Branded generics are generic medications with a proprietary market name. It can be manufactured by either a generic pharmaceutical company or the original manufacturer and commercialized after the original drug’s patent expires. They are offered using a brand name rather than a chemical name. An abbreviated new drug application (ANDA) is filed with the regulatory authority to market branded generics, and it must be therapeutically equivalent to the original drug for which the patent has expired.
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Advantages Offered By Branded Generics Fuels Their Adoption in the US Branded Generics Market
Due to the multiple advantages offered by branded generics, their adoption is expected to rise in the United States. Following are the advantages:-
- They are sold as alternatives to brand-name drugs and are relatively less expensive
- For combination drugs it is difficult to remember their generic names. Branded generics can be easily remembered.
- Attract several consumers who prefer branded drugs only.
- They provide quality assurance from well-established companies.
“Branded generics comprise only a small percentage of total generic prescriptions in the U.S. but they are more profitable than unbranded generics..…”– Tier I Branded Generic Manufacturer, USA
Foray of India Players Adds a Competitive Intensity to the US Branded Generics Market
The share of Indian players in the US branded generics market is expected to further increase in the next five years primarily due to the following:
- High R&D Spend: Large Indian players continue to invest significantly in R&D. Leading Indian players have increased their R&D budgets over the last few years, indicating a good launch pipeline of these players
- Entry of New Indian players: The U.S. market continues to see the entry of new players every year, and these companies are expected to further drive the share of Indian players in overall ANDA approvals
- CDMO Entry: Few Indian CDMOs are also planning to enter the U.S. market
- Focus of Indian players is on specialty/complex generics where competition is relatively lower and launching products early.
Unmet Patient Needs Across Indications Fuels the Growth of the US Branded Generics Market
The unmet patient needs in cardiovascular, gastroenterology, diabetology, oncology, pain management, and dermatology therapeutic areas drives the US branded generics market. Other application areas that are also witnessing increased demand are women’s health, neurology, ophthalmology, respiratory, hormonal, anti-psychotic, and infectious diseases.
Organic and Inorganic Growth Strategies Adopted by Leading Players to Establish Their Foothold in US Branded Generics Market
The leading players operating in the US branded generics market have adopted both organic and inorganic growth strategies such as acquisitions, and partnerships to garner a larger market share.
For instance,
- In November 2021, ANI Pharmaceuticals completed the acquisition of Novitium Pharma, significantly enhancing its R&D capabilities and scale of generics and CDMO businesses.
Competitive Landscape Analysis: US Branded Generics Market
The US branded generics market is marked by the presence of the prominent market players such as follows:-
- Teva,
- Mylan
- Sandoz
- Sun Pharma
- Hikma, among others
The forecast for the US branded generics industry appears positive due to the patent expiration of important pharmaceuticals, the rising significance of Indian businesses, higher profitability than unbranded generics, and unmet patient demands across several therapeutic categories.
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