Delays To Market In Generic Drug Manufacture Can Be Costly

The manufacturing of generic drugs faces significant challenges that can lead to substantial financial losses, especially for companies aiming to leverage first-mover advantages. Being the first to market with a generic drug can result in capturing as much as 90% of the market share for the initial three years, making it imperative for manufacturers to address risks early in the drug development process.

However, several factors can contribute to delays in launching generic drugs. These include limited access to samples of brand-name drugs, patent extensions granted to innovator companies, and an increase in quality-related issues.

The regulatory landscape is also evolving, with stricter requirements being imposed. A notable percentage of product recalls are attributed to failures in quality assurance, underscoring the importance of maintaining high standards in drug manufacturing.

Despite the competitive nature of the generic drug landscape, there remains significant potential for growth, particularly in the injectable generic market. 

Explore the untapped potential for injectable generic drug growth and three priorities for maximizing speed to market.