GERMANY – Aenova has announced it is investing EUR 10 million (US$$11 million) for a new building for the production of highly potent active pharmaceutical ingredients (HPAPIs) at its site in Regensburg, Germany.
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.
Following the planned start of operations at the beginning of 2023, the manufacturing capacities can be increased in volume by significantly more than one billion tablets and capsules.
According to new research, over 25% of all drugs in the world contain highly potent compounds, including cytotoxic active pharmaceutical ingredients (APIs).
According to Roots Analysis, 25% of product candidates in the development pipeline are also highly potent APIs (HPAPIs), indicating that this trend will continue.
According to the study’s findings, HPAPIs are the basis for 60% of all approved anti-cancer drugs worldwide.
Furthermore, annual revenues from highly potent compound drugs are expected to reach US$35 billion by 2025.
Aenova’s expansion comes at a time when the demand for HPAPIs and cytotoxic drugs is on an upward trend, particularly in anti-cancer therapy development
According to The IQVIA Institute’s report on Global Oncology Trends 2018, the global market for oncology therapy is expected to reach US$200 billion by 2022, with a 10-13% growth rate over the next five years.
Oncology therapies receive accelerated approvals due to the debilitating nature of cancer and the rapid progression from disease onset.
Because of its unique needs and rapid program progression, collaboration with external contract development and manufacturing organizations (CDMOs) is the preferred route for oncology drug development.
Accordingly, drug developers and contract manufacturing organizations (CMOs) have put their bets to invest in expertise in this domain.
Over the past decade, the pharmaceutical industry has witnessed rapid growth in outsourcing services, driven by various factors including the growth of small molecules, increasing API complexities and the need to optimize costs.
Pharma companies have focused on modernizing their manufacturing methods to improve overall product quality.
This also means automation in process development, something that was previously done manually. Installing equipment with large capacities in terms of volume also enables greater production yield.
The HPAPI market is an appealing investment opportunity for many CDMOs/contract manufacturing organizations (CMOs) due to rising demand and rapid growth.