and sustainability have to remain
the key drivers for the European API business
with no compromise on quality
Clients are demanding more quality and more reliability from their API sources to avoid public health risks.
The trend towards outsourcing by big pharmaceutical multinationals is expected to continue growing, which will result in an increased demand for quality APIs;
Companies are increasing their size to face global competition. Mergers and acquisitions are taking place in order to pursue global projects;
There is a growing investment in R&D for API production processes, as well in quality, environment and safety, resulting in better, safer and cleaner technologies and substantial increase of pharmaceutical technology know-how and intellectual property;;
Sustainability and compliance have to remain the key drivers for the APIs business with no compromise on quality;;
API manufacturers ask for global harmonized regulations with an increasingly strong relationship between the EU and the USA.
Defining a robust supply chain
Define a robust supply chain, including the analysis of the key criteria to achieve it taking into account the need for agility, flexibility and resilience. When challenges to achieving robustness are identified, they should be explored to determine whether they are shared or whether solutions have already been found.
Supply chain dependencies
There is a need to reflect on the causes of vulnerabilities, taking into account at what stage of the supply chain they occur and whether they differ for different types of medicines. The discussion should include considering the most frequently observed outage challenges, which pose the greatest threat to supply, to identify the drivers of these vulnerabilities, including dependencies. It is also important to assess the financial impact associated with solving the challenges and drivers.
Consider available methodologies and criteria and identify medicines that are considered critical to public health and discuss methodology for tracking EU manufacturing capacity for those critical products.
Identify modernization needs, including the identification of priority R&D areas, to ensure that supply chains are adequately robust and resilient to meet the EU’s public health needs. This includes the innovation needed to address the challenges in deploying new measures and maintaining competitive production capacity in the EU. This reflection should integrate considerations on green and digital transition requirements, as well as the modernization of manufacturing processes.