A Siemens commissioned study has identified the UK and Irish biopharmaceutical sector’s key areas for priority investment in digitalisation, with the challenges of time to market and making sense of large amounts of data running as a constant thread.

The independent research engaged 31 key players in the UK and Irish biopharmaceutical sector to discover key areas for business improvement. The study was conducted between late 2019 and early 2022, covering the period affected by the global pandemic.

The key findings indicate that digital transformation in biopharmaceuticals is expected to pick up speed across the rest of the decade, with an increasing gulf likely to open up between leaders and laggards. Translating digitalisation into value for Pharma and Life Sciences manufacturing remains a key focus for many but the challenges of speed and efficiency need to be addressed with urgency.

The respondents also agreed that ‘Big Data’ and data analytics are crucial for driving quality and efficiency, but it is vital to convert infinite data into valuable insight through solutions like BioMAC from Siemens and the National Institute of Bioprocessing Research and Training (NIBRT) is helping organisations to translate data into meaningful and actionable information.

The findings also reveal that with much of pharmaceutical manufacturing still employing heavy use of paper-based records, the adoption of electronic batch records can help streamline process operations, improve regulatory compliance and reduce operational costs.

Andrew Matthews, Head of Pharmaceuticals, Siemens, says: “The concept of a Digital Twin for pharma and life sciences is regrettably not widespread. At a recent ISPE event, it surprised me that only about a fifth of the audience had heard of a Digital Twin, which means many have likely never heard of Industry 4.0 or Pharma 4.0! This short research underlines areas for consideration as identified from the wider industry and is designed to spark further discussion.”

Adrian Abbotts, Business Development Manager for Cell and Gene Therapies, Siemens, adds: “Working with our customers to understand their challenges, we have mapped out the sector’s business demands and aligned our solutions to mitigate them. Patients, products, pace of change and performance are areas of focus for our clients as they try to comprehend global influences such as changing demographics, new manufacturing techniques, tech transfer, supply chain complexity and outsourcing.”

The majority of interviewees highlighted the critical importance of compressing the drug discovery process; in particular, using Industry 4.0 technology to accelerate the speed of new molecule development, such as through computational chemistry and data-driven discovery.

Connecting data ‘silos’ and enabling meaningful data flows is driving moves towards greater standardisation in the industry. One bio-manufacturing technology company noted, “By introducing a new automation platform and further standardising our products, we are making it easy for our customers to integrate their systems into higher-level automation solutions.”

Visibility of digital data flows in all aspects of biopharma – “from concept to clinic” – is also contributing to regulatory supervision, reducing the burden on biopharma companies, and at the same time increasing hard-pressed regulators’ and notified bodies’ ability to scrutinise the industry. “It’s only a matter of time before we see remote inspections by the regulators becoming the norm,” said one respondent.

The UK market, specifically, is estimated to surpass £12bn in 2022, with worldwide markets expecting an average growth rate of around 10% per year. The UK and Ireland remain the number one destination for life sciences inward investment in Europe, ranks number two globally behind the US, and has also grown a thriving domestic industry with more than 5,600 companies producing some of the strongest research and development capability in Europe.