Highly Potent Active Pharmaceutical Ingredients (HPAPIs) are rapidly gaining traction in the pharmaceutical sector, particularly in the development of targeted therapies for chronic diseases such as cancer. A recent report by Grand View Research estimates that the global high-potency API contract manufacturing market will reach a valuation of $8.05 billion by 2024, with a compound annual growth rate (CAGR) of 10.98% expected from 2025 to 2030. This growth is largely fueled by a projected 77% increase in global cancer cases from 2022 to 2050, with approximately 75% of new cancer drugs in development classified as high-potency.
While HPAPIs have traditionally been linked to oncology, their application is expanding into various therapeutic areas, including inflammatory and antimicrobial treatments. This shift underscores the necessity for specialized contract manufacturing organizations (CMOs) equipped to handle these complex compounds safely. As demand escalates, regulatory bodies are tightening guidelines regarding occupational exposure limits (OELs) and containment technologies, thereby consolidating the market and compelling sponsor companies to seek partnerships with CDMOs that have advanced containment capabilities. The evolving landscape necessitates that industry players invest in expertise and technology to remain competitive.
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