Known for their low-dose therapeutic efficacy and high target affinity, HPAPIs are in high demand by biopharma companies, which often outsource their production. Approximately 41% of innovator and biosimilar high-potency active pharmaceutical ingredients (HPAPIs) come from contract development and manufacturing organisations (CDMOs), usually when in-house facilities lack specialised capabilities or capacity. With strategic acquisitions and expansions of HPAPI facilities reshaping the HPAPI outsourcing market, GlobalData’s Drugs By Manufacturer Database reveals four CDMOs, namely Lonza; Siegfried; Aspen; and Veranova, are competing for leadership, with two of them, Lonza and Siegfried, pulling out in front.
HPAPIs are typically categorised as cytotoxic, high-potency non-cytotoxic, or others requiring containment (including sex hormones and controlled drugs), and need to be manufactured in specialised, regulated facilities to ensure safety for the environment and operators. Within this sector, Siegfried leads with 28 HPAPI drugs, followed by Lonza with 23, with Aspen and Veranova tied at 15. Lonza was previously ahead but has since been overtaken by Sigfried following its acquisition of Noramco, which included two US HPAPI sites in Wilmington, Delaware; and Athens, Georgia. The deal, finalized in May 2026, added 13 controlled drugs to Siegfried’s contract manufacturing portfolio and expanded its presence in the US, where the majority of outsourced HPAPI manufacturing takes place. Included in this announcement was the acquisition of Extractas Bioscience’s Westbury site on the Australian island of Tasmania, further globalising Siegfried’s supply chain.
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Meanwhile, South Africa-based Aspen manufactures all of the innovator and biosimilar HPAPIs outsourced to it at its Dutch facilities. As the sole contract manufacturer of HPAPIs in the Netherlands, according to GlobalData’s Drugs By Manufacturer Database, Aspen’s portfolio places the country in the global top five for innovator and biosimilar HPAPI contract manufacturing. Lonza and Siegfried, both Switzerland-based companies, manufacture a large portion of their HPAPIs in facilities within their home country but, unlike Aspen, their production sites have a wider geographic distribution. This includes the US, Europe, and, in Lonza’s case, Singapore, reflecting the broader trend toward supply chain globalisation.
For its part, Lonza has a diverse portfolio of small molecule and biologic HPAPI contracts, though it mainly focuses on the immunosuppressant and cytotoxic products that play a key role in oncology. By contrast, 86% of Sigfried’s HPAPI contracts involve controlled-drug manufacturing, primarily marketed for central nervous system indications. Aspen and Veranova also appear to be adopting a specialisation strategy, with Aspen focusing on sex hormones and Veranova on controlled drugs. Specialisation appears to be a successful approach for three out of the leading four CDMOs, offering one rationale for Siegfried’s acquisition.
On the other hand, Lonza has announced new strategies that may enable it to challenge Siegfried’s lead. On June 30, 2026, the CDMO announced plans to expand its HPAPI capacity at its Visp site in Switzerland, focusing on antibody-drug conjugate (ADC) payload-linker capabilities to support the growing ADC market. With Lonza leading in contract manufacturing of biologic and cytotoxic HPAPIs, the company seems well placed as the biopharma industry looks to those two growth areas.
