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API industry snapshot


Molly Bowman
Editorial Director, Generic and Investigational Drugs
Clarivate Analytics


Over the past decade, pharmaceutical pipelines have increasingly focused on specialty products, biologics, and high potency products.  API manufacturers have shifted their focus to these types of products as well. However, most companies have limited resources and capabilities, so they have to be selective about what to pursue and when. The majority of APIs coming off patent post 2017 are in specialist driven oncology and orphan drug categories. These niche segments give manufacturers who have invested in innovative manufacturing capabilities a unique advantage with facilities that are adapted to small batch products. As pipelines continue to focus on specialty products, it is likely that many API manufacturers will continue to invest in process improvements and niche product manufacturing.

Companies purchasing API are increasingly valuing quality and reliability and will continue to be selective in their purchasing decisions. Factors influencing these decisions include direct costs such as the price of materials and services as well as the speed at which a source can deliver.  It is also important for companies to c ...

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