High-potency active pharmaceutical ingredients (HPAPIs) are in high demand from biopharmaceutical companies, and four contract development and manufacturing organizations (CDMOs) have risen to the top of the outsourcing race, according to GlobalData’s Drugs By Manufacturer Database.

Swiss CDMOs Siegfried and Lonza lead the four-way innovator and biosimilar HPAPI contract manufacturing race, followed by South Africa-based Aspen and Massachusetts-headquartered Veranova, as strategic acquisitions and facility expansions are reshaping the outsourcing market.

“Siegfried leads with 28 HPAPI drugs, followed by Lonza with 23, with Aspen and Veranova tied at 15,” GlobalData said in an analyst comment. “Lonza was previously ahead but has since been overtaken by Siegfried following its acquisition of Noramco, which included two U.S. HPAPI sites in Wilmington, Delaware and Athens, Georgia.”

GlobalData noted that the Noramco acquisition, finalized in May 2026, added 13 controlled drugs to Siegfried’s contract manufacturing portfolio and expanded its presence in the U.S. “where the majority of outsourced HPAPI manufacturing takes place.”

However, the analysis also pointed to Lonza’s “new strategies” that may enable it to challenge Siegfried’s lead in the HPAPI outsourcing market.

“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,” GlobalData said. “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.”

Lonza’s Visp site continues to make progress in ramping up and commencing commercial operations at its HPAPI plant and the CDMO’s new large-scale mammalian drug substance facility. Lonza is looking to Visp to meet growing demand in these markets, as well as advanced expansion projects for bioconjugates.

Specialization vs. diverse approach

GlobalData estimates that approximately 41% of innovator and biosimilar HPAPIs come from CDMOs — usually when in-house facilities lack specialized capabilities or capacity.

“HPAPIs are typically categorized as cytotoxic, high-potency non-cytotoxic, or others requiring containment (including sex hormones and controlled drugs), and need to be manufactured in specialized, regulated facilities to ensure safety for the environment and operators,” according to the firm.

GlobalData described Lonza as having a “diverse portfolio” of small molecule and biologic HPAPI contracts, with the CDMO mainly focused on immunosuppressant and cytotoxic products that are critical in oncology. The firm said 86% of Siegfried’s HPAPI contracts involve controlled-drug manufacturing, primarily marketed for central nervous system indications.

“Aspen and Veranova also appear to be adopting a specialization strategy, with Aspen focusing on sex hormones and Veranova on controlled drugs,” GlobalData said. “Specialization appears to be a successful approach for three out of the leading four CDMOs, offering one rationale for Siegfried’s [Noramco] acquisition.” 

GlobalData noted that South Africa-headquartered Aspen manufactures all the innovator and biosimilar HPAPIs outsourced to it at its Dutch facilities. As the sole contract manufacturer of HPAPIs in the Netherlands, the firm said 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,” according to GlobalData. “This includes the U.S., Europe, and, in Lonza’s case, Singapore, reflecting the broader trend toward supply chain globalization.”

Last year, Veranova announced a strategic investment of more than $50 million to establish cGMP bioconjugation development and manufacturing capabilities at its Devens, Massachusetts facility. The CDMO is adding 9,000 square feet to the Devens site including two cGMP HPAPI suites, which will support handling up to Occupational Exposure Band 6 (OEB6).