PHARMACEUTICALS
The Budapest site is the main source of EuroAPI ’ s prostaglandin manufacture
The COVID-19 pandemic in 2020 was in some ways a wake-up call , triggering tensions over critical APIs and knocking some companies off balance . It became apparent that building reliable and secure supply chains for key medicines should be one of the industry ’ s top priorities . Close collaboration with drug substance companies capable of ensuring a robust supply at every stage of the API lifecycle emerged as a critical factor in de-risking .
2024 may have been another tipping point where the pharmaceutical industry ’ s over-reliance on APIs and intermediates from China turned into a major issue in building stable supply lines . Last year also saw the awakening of a strong political will , with a slightly different focus on the two sides of the Atlantic .
The EU has tackled the problem with the main objective of preventing shortages of commercial critical medicines . Meanwhile , mounting geopolitical tensions between the USA and China are triggering a dramatic shift on how NCE supply chains will be designed .
This is exemplified by how the Biosecure Act targeted the Chinese CDMOs Wuxi AppTec and Wuxi Biologics . This passed through the US House of Representatives on 16 December 2024 , but has yet to make it through the Senate . If passed , the law would prevent US companies from outsourcing to certain Chinese providers .
Depending on China
Whether it becomes law or not in 2025 , this text is already an effective call to relocate significant parts of the western new API supply chains . Indeed , as per a New York Times article on 31 December 2024 , any such war would mean that “ Washington would also have to work with allies on a crash reshoring of critical products from China on which America has become heavily dependent , including APIs and drones ”. 2
Even so , 80 % of global medicines by volume depend upon China , directly for the API or indirectly through key chemical intermediates or raw materials . This figure is 90 % in some
( possibly exaggerated ) reports . The reshoring pressure applied on the development and production of NCEs is now triggering effective actions to rebalance drug substance supply , the game is still very different further away in the API lifecycle .
Generic medicines comprise around 80 % of each major therapy area by volume and , except in oncology , their share has been slowly increasing over recent years . Right now , generics are dealing with extreme economic pressure . Laboratories have to deal with the contradictory forces of regionalising the supply base and the need to reduce costs by all means for short-term financial results .
So , doing the maths , roughly 60- 80 % of established medicines out now depend on Chinese supply . 3 The Critical Medicines Alliance for Europe is seeking “ to identify the best measures to address and avoid shortages [ and ] to come forward with a strategic plan which the Alliance will consider and endorse ”, as per its first meeting in April 2024.4 However , implementation will take time and
MAR / APR 2025 SPECCHEMONLINE . COM
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