The global high potency active pharmaceutical ingredients market size is expected to reach USD 38.84 billion by 2028, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 8.4% from 2021 to 2028. The market is driven by an increased focus on targeted therapies and a surge in demand for cancer therapies.

Key players are leveraging various strategies to increase their production capabilities and promote the outreach of their product offerings.

Aenova has laid the foundation for the new building for highly potent active ingredients at its Regensburg site. Highly potent drugs, especially against cancer, are produced in the new manufacturing facilities. With an investment of around 10 million euros, Aenova will thus be able to significantly increase production capacity to meet increased market demand.

Cytotoxics and cytostatics continue to experience increased demand in the global pharmaceutical market. To meet this growing demand, Aenova, global leading development service provider and contract manufacturer for the pharmaceutical and healthcare industries, is building a new facility at its Regensburg site. The investment of around €10 million will enable the company to significantly expand the production in the field of highly potent active ingredients and, in particular, cancer drugs. The foundation slab for the new building was poured in March 2022.

The Aenova site in Regensburg has been developing and producing tablets and capsules with highly potent active ingredients such as methotrexate, hydroxycarbamide, azathioprine, imatinib on the former von Heyden site since the 1950s. The new four-story building with a total building area of over 4,000 m² will include not only bulk production and packaging of highly potent drugs, but also the associated laboratories, development, warehouses and social rooms. This not only means a significant expansion of the production area and the so-called white areas of development and laboratory to over 300 m² at the Regensburg site. After the planned start of operations at the beginning of 2023, the manufacturing capacities can thus be increased in volume by significantly more than 1 billion tablets and capsules. An entire floor is also reserved for flexible customer requests for "on demand" production, so that existing as well as new customers can be individually supported in line with their requests.

"With this expansion, we are achieving our goal of strengthening the Regensburg site as the "Competence Center HPAPI & Oncology Products" within the Aenova Group," explains Oliver Schmied, Managing Director at the Aenova site in Regensburg. "After all, this will not only enable us to better serve market needs and customer requests, but above all to reliably provide essential medicines for patients suffering from cancer worldwide."

The new building is scheduled for completion in summer 2022 and occupation in fall 2022. This will be followed by the installation of the laboratories and the new "on-demand" GMP area. Additional customer orders can be produced from 2023.

With this major investment program, Aenova is positioning itself as a future-oriented service partner for its customers across all 15 manufacturing sites. Through the three Business Units Solids, Semisolids & Liquids and Softgel Capsules, Aenova is placing itself as a one-stop store from development to scalable high-volume production and packaging services. A special customized offering is the "plant in plant" approach, where Aenova provides its customers with agile solution developments already in the first preliminary phase of a project. Specialized knowledge, such as on demanding release profiles or increased bioavailability, rounds out the offering profile.

With around 4,300 employees at 16 locations in Europe and the USA, Aenova generates annual sales of around €740 million.