Ireland’s biopharmaceutical industry stands as a global powerhouse, distinguished as the world’s third-largest exporter of pharmaceuticals, writes Niall Cunneen, Associate Partner, Advisory, Sia
Historically built on a foundation of world-class manufacturing and a favourable investment climate, Ireland’s biopharma sector has driven remarkable economic growth. However, amid rapid global evolution—marked by emerging technologies, shifting regulatory landscapes, and intensifying geopolitical and economic pressures—the industry now faces a critical inflection point.
This executive summary outlines recent global market trends, innovative breakthroughs, global comparisons, emerging challenges, and strategic recommendations to ensure Ireland not only maintains but enhances its leadership in the biopharma arena.
Ireland’s competitive strength lies in its robust manufacturing base. Over 85 multinational sites operate within the country, forming a critical link in global pharmaceutical supply chains and contributing significantly to the nation’s trade surplus. Yet, this manufacturing-centric model has come with a trade-off: only a small fraction of these facilities (approximately 5%) are dedicated exclusively to R&D. Consequently, Ireland has not yet cultivated a comparable indigenous innovation ecosystem, which is essential to drive sustainable long-term growth and competitiveness in an era of advanced therapeutics.
In contrast, global leaders such as the US and China have built vibrant ecosystems that combine R&D, venture capital, and cutting-edge technology. For example, innovation hubs like Boston/Cambridge in the U.S. thrive on strong academic-industry partnerships, a deep pool of scientific talent, and robust venture funding. Meanwhile, China’s biopharma landscape is rapidly evolving through aggressive government investments, expansive talent development, and accelerated regulatory pathways, positioning it as a formidable competitor in drug discovery and manufacturing. In Europe, Switzerland and Germany further illustrate the benefits of a balanced ecosystem that marries manufacturing excellence with intensive R&D efforts—an approach that Ireland can emulate.
Emerging technologies are fundamentally reshaping the industry. Advances in artificial intelligence (AI) are now enabling the rapid design of novel drug molecules, significantly shortening discovery timelines and enhancing the precision of personalized medicine. AI-driven platforms not only expedite clinical trial processes by identifying patient subpopulations but also increase the “hit rate” of drug candidates, driving down development costs. Novel biomanufacturing techniques like continuous processing, single-use disposable bioreactors, and advanced automation are transforming production, yielding substantial improvements in efficiency, quality control, and sustainability. Innovations in gene and cell therapies and mRNA-based treatments, are expanding availability of new drugs, with nearly 2,000 active clinical trials globally in advanced therapeutics alone.
Amid these advancements, several challenges are emerging. Global economic headwinds—rising interest rates, inflation, and the looming “patent cliff” have heightened investment uncertainty.
The potential of ‘Trump tariffs’ will mean biopharma companies will have to recover costs elsewhere through lower prices, seeking efficiencies to retain margins or consider relocation. A dual sourcing model could be adopted by some organizations, with a gradual increase in US sourcing resulting in a managed exit of the Irish market. Ireland’s exposure to such a protectionist pivot by the world’s largest economy is significant with the State exporting an estimated €72bn to the US in 2024, a high proportion of which are pharmaceutical products, the overwhelming majority which are produced by US multinationals.
These factors underscore the critical need for supply chain resilience through diversification, dual sourcing strategies, and strategic risk management. Moreover, while Ireland produces a significant number of STEM graduates, there is a growing shortage of specialized talent in advanced areas such as bioprocess engineering, data analytics, and clinical development. Addressing these skills gaps is essential for transitioning from a manufacturing hub to an innovation leader.
Ireland’s biopharmaceutical sector stands at an inflection point. To maintain our hard-won global competitiveness amid these trends and challenges, a concerted strategy is required. Below are actionable, data-backed recommendations for Irish stakeholders (government, industry, academia) to secure the sector’s future growth:
- Government needs to prepare and publish a Life Sciences Strategy as recommended by BPCI in their industry strategy of 2023- Make Ireland the Global Leader in Sustainable Biopharmaceutical and Chemical Manufacturing.
- The recommendations of the EGFSN need to be implemented in full to ensure the talent and skills requirements of the sector are met.
- The industry has grown a robust and thriving manufacturing base, it is vital that this installed base is fit for purpose and needs to deploy the lates digital technologies such as machine learning and Artificial Intelligence. Each site needs to be assessed against the principles of Industry 5.0 and where changes are identified they need to be implemented.
- Government needs to provide supports for the further growth of an indigenous biopharma industry – this could include financial support and support for the commercialisation of R&D.
- The industry needs to establish meaningful links with other Life Sciences clusters in the EU and also the UK. EU examples include Belgium and Denmark.
- Government needs to include the establishment of a viable clinical research sector as part of its Life Sciences Strategy.
- Government needs to prioritise investment in Advanced Therapeutics including Cell and Gene Therapies
- Best practice in sustainable management must be deployed within each and every site to ensure that commitments such as net zero are achieved in a timely manner.
Next Steps
This summary is an excerpt from a White Paper and its primary aim is to prompt dialogue and discussion between all relevant stakeholders. I will be sharing this document with Government, the industry, the research community and those that support the development of this sector inviting them to respond and provide their input at this critical time for the industry.