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NIBRT’s Killian O’Driscoll takes an overarching view of the opportunities and challenges facing Ireland’s biopharma sector.
The success of the Irish biopharma industry is well documented, with biopharma firmly established as a key pillar of the Irish economy.
There are 84,000 highly skilled people directly and indirectly employed in the sector and the expectation is that this will increase by up to 10,000 jobs over the next five years.
The biopharma and chemical sector had an export value of €106bn in 2020 – the first time a sector has exceeded the €100bn mark in a single year.
More than 85 pharmaceutical companies operate in Ireland with exemplary regulatory track records. There are more than 50 FDA-approved pharma and biopharma plants including 19 of the world’s top 20 biopharma companies.
The sector has continued to be hugely successful in attracting international capital investments in the last decade, with approximately €15bn of new-build biopharma facilities announced since 2010.
Continued growth but increased competition
According to a 2022 report from Acumen Research and Consulting, the global biopharmaceutical market accounted for $328bn in 2021 and is estimated to garner a market size of $853bn by 2030.
However, the level of international competition for biopharma manufacturing investments has increased considerably. This has been driven by a number of factors including post-pandemic supply chain concerns, as evidenced for example with US president Joe Biden’s executive order on biomanufacturing.
While Ireland remains well positioned to continue to attract biopharma investments, there is a requirement for a continued focus on our core manufacturing value proposition, including addressing cross-sector capacity constraints and competitiveness challenges.
More diverse and complex product pipelines
Monoclonal antibodies (mAbs) are predicted to remain the dominant modality in biopharma by some margin.
However, there is a fast-emerging, unprecedented diversity in therapeutic pipelines including antibody drug conjugates, multi-specific mAbs, multiple-cell therapy modalities, gene therapies, RNA-based therapeutics and vaccines, gene editing such as CRISPR/CAS9, exosome-based therapies etc.
The relationship between manufacturing and discovery/development is increasingly important. The manufacturing processes for advanced therapies are typically complex, costly and difficult to scale.
There is a considerable opportunity for Ireland-based organisations to lead global efforts to create standardised manufacturing platforms for advanced therapies. It is highly likely that future manufacturing investments for advanced therapies will increasingly be dependent on strong association with R&D operations.
Advanced manufacturing agility and resilience
The diversity in clinical assets in manufacturing pipelines is driving fundamental changes in facility design, operations and supply chain with a focus on flexible and agile facilities with the ability to manufacture multiple products.
Digitalisation has potential to be a key enabler of a manufacturing competitive advantage, though significant barriers remain – in particular, access to end-to-end, high-quality data management from research to manufacturing operations.
To remain competitive there is continued demand for new efficiencies, standardisation, improved quality and cost reductions in manufacturing processes.
Key trends, many of which rely on collaborative innovation with third parties, include:
- Supply chain agility with more flexible, modular multi-product facilities and increased resilience in manufacturing networks
- Further adoption of single-use systems at clinical scales and commercial scales
- Steady increase in expression titres and purification yields, with incremental improvements in host cell lines, culture media, expression systems, vectors, promoters etc.
- Process intensification and continuous processing, including upstream perfusion and downstream chromatography
- Implementation of industry 4.0/digitalisation technologies with a particular focus on automation, paperless and data analytics
- Evolving regulatory landscape
Sustainability as a strategic imperative
Latest estimates indicate that the healthcare sector is responsible for between 4pc and 5pc of global emissions, more than 70pc of which are driven by supply chains. Biopharma manufacturing typically has a comparatively high use of energy, water and plastics, and carbon emissions associated with a complex global supply chain.
Most sites in Ireland have policies in place to address issues such as net-zero commitments, sustainable sourcing, circular lifecycles, product packaging, energy-efficient fixtures and equipment, waste minimisation, reduction of carbon emissions, incorporating green chemistry manufacturing techniques, reduction of plastic waste from single-use technology, water efficiency and local environmental impact.
However, it is inevitable that governance, regulatory, employee and consumer imperatives will continue to exert positive pressure on manufacturing and supply chain operations to implement step changes in their sustainability strategy.
The war for talent
As always, access to a diverse talent pool with a broad range of multi-disciplinary skills will be a key determinant of future success. In 2021, the Financial Times, working with Cytiva, published the inaugural Global Biopharma Resilience Index.
Based on data from a survey of 1,165 biopharma executives from 20 countries, access to talent was identified as the primary weakness in the resilience of the global biopharma industry.
Employee-focused policies on topics such as hybrid working, organisational culture, environmental, social and governance (ESG), and equality, diversity and inclusion (EDI) are becoming increasingly important to hire and retain the best talent.
While the success of the Irish biopharma industry is well established, there is little room for complacency as the complexities, risks and level of competition have increased significantly year-on-year. The strong base of the sector in Ireland also provides significant opportunities for diversification and future growth.
Killian O’Driscoll is the chief commercial officer of NIBRT, the National Institute for Bioprocessing Research and Training.
NIBRT is hosting the Biopharma Focus on the Future conference online on Thursday 20 April. The event is free but registration is required in advance.
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