The Ever-Changing Landscape of Biopharmaceutical API Outsourcing
Manufacturing biopharmaceutical APIs present a range of technical and commercial challenges. The contract manufacturing segment of the biopharmaceutical industry has changed dramatically over the brief history of the biopharmaceutical industry and is still a dynamic, growing segment of the industry. Twenty years ago, it was accepted that firms developing biopharmaceuticals would need to build their own development and API manufacturing capacity to commercialize their products. Today, virtually every aspect of development, manufacturing and testing of biopharmaceutical APIs can be outsourced to experienced and reliable firms. During this period, contract manufacturing has grown from a niche segment to a truly significant industry with revenues in excess of $1.5B per year. Industry’s attitudes and perceptions related to outsourcing have also changed significantly during this period and continue to change. This presentation will review the key aspects and challenges of biopharmaceutical API outsourcing in this dynamic industry environment. A brief analysis of the current supply of biopharmaceutical manufacturing capacity will also be presented.