HPAPIs: Significant Challenges, A Wealth Of Opportunities

By Dave Backer, Life Science Leader magazine

Over the past decade, the manufacture of highly potent active pharmaceutical ingredients (HPAPIs) has become increasingly attractive to life sciences companies due to significant advances in clinical pharmacology and oncology research. Factor into the equation tough economic conditions, fewer drug approvals, over-capacity, and competition from Asian manufacturers — all contributors to a general reduction in margins and profitability — and it’s not difficult to understand why CMOs are looking to expand from traditional APIs into the lucrative HPAPI market.

This rapidly growing segment already accounts for around 12% of the total pharmaceutical market and has an annual double digit growth rate. A further key driver steering pharmaceutical companies down the high potency route is cost reduction, as companies look to reduce the amount of APIs needed in a drug by increasing its potency. Typically, drugs that contain HPAPIs are much more powerful and are effective at doses of under 10 mg, compared with the typical painkiller dose of 200 mg or more, with lower doses also promising fewer side effects.