This report presents a roadmap for the adoption of PAT and digital twin technologies, which has been produced as part of the ETERNAL Horizon Europe project under the framework of the Work Package 2, which focuses on Digitalization for competitive and scalable methods of production. The report has in particular been produced as part of a task centred on ‘opportunities and barriers for Digitalization of the European pharmaceutical industry’.

Prepared by IRIS Technology Solutions, the leading European company in the manufacture of photonic and artificial intelligence solutions for real time control of industrial and production processes, the report covers the state of the art and digitalization of pharmaceuticals industries, with an emphasis on green pharmaceuticals - trends driving pharmaceutical industry digitalization, pharmaceutical industry applications of PAT and data capturing methods, and Artificial Intelligence applications - before going on to provide the results of a SWOT analysis performed by the project’s digital team.

Pharmaceutical businesses are anticipated to spend more than $4.5 billion on digital transformation by 2030. The application of digital technologies to the pharmaceutical industries has the potential to significantly increase the agility, efficiency and flexibility, the sustainability of the drug manufacturing processes, and the quality of the medicines produced. Digitalization can be implemented in many areas of the pharmaceutical industry, including clinical trials, drug development, manufacturing, and supply chain management. It can help improve the efficiency and accuracy of trials, accelerate the discovery and development of new drugs, optimize the design and operation of pharmaceutical manufacturing facilities to improve efficiency and reduce waste, and in the supply chain track the movement of drugs and ensure their authenticity. Despite all this, the pharmaceutical industry has been more hesitant to adopt digital technologies than other industries due to the complexities and expertise required in its development and manufacturing processes. However, with the growing demand for traditional and new drugs, there is a clear need for digitalization in the sector.

The report’s conclusions and recommendations for regulatory and business decision makers include:

• Fostering collaboration between pharmaceutical companies, technology providers, and research institutions

• Establishing a common framework for the implementation of digital technologies in the sector

• Working closely with regulators to ensure compliance with relevant regulations around data privacy and security

• Encouraging innovation through funding for start-ups and small and medium-sized enterprises working on digital technologies, and

• Focusing on sustainability in the adoption of digital technologies to help reduce waste, optimize resource utilization, and minimize the environmental impact of pharmaceutical manufacturing processes.

Download the Digital Roadmap report