CPHI Milan 2024: Growth and Challenges in the Sterile Injectables Market

As CPHI Milan begins, Pharmaceutical Technology^® Europe sat down with James Hamilton, president of Sharp Sterile, formerly Berkshire Sterile Manufacturing, which was acquired by Sharp in October 2023. Hamilton gave an overview of the sterile injectables market, the drivers for its growth, relevant hurdles that companies are facing, and how outsourcing service providers such as Sharp help those companies.

“On the product side, we're seeing tremendous innovation in biologics and complex molecules, and we all see this,” Hamilton said in the interview. “And the first place that those types of products tend to go are sterile injectables. So, I think the innovation in product discovery and clinical development is driving substantial uptake in sterile manufacturing. So that's kind of the big picture.”

Hamilton then went on to describe two distinct trends on either end of the industry spectrum.

“The first is that orphan drugs—personalized medicine, very small-batch manufacturing—[continue] to grow year on year. In fact, I think approaching 50% of drugs recognized by the FDA are in the orphan category. So there continues to be a significant growth in small-batch manufacturing. Conversely, we all hear about the GLP [good laboratory practice] ones and the explosion in this blockbuster category. So, you have sort of this dual set of circumstances driving small-batch manufacturing and sterile fill/finish at the same time that there's absolute growth and demand for high-capacity manufacturing. So, that's creating a very interesting dynamic in the industry.”

Click the above video to watch the full interview.

Visit Sharp at stand 7B74. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.