New Approach Methodologies: a strategic opportunity for Ireland’s life sciences sector
For decades, animal testing has been embedded in drug discovery. It has shaped research processes, regulatory expectations, infrastructure investment and development timelines across the pharmaceutical industry. That model is now beginning to change.
Across Europe, regulatory policy is moving steadily towards the replacement, reduction and refinement of animal use and the greater incorporation of New Approach Methodologies (NAMs) into regulatory science. The European Commission’s roadmap towards phasing out animal testing for chemical safety assessments signals the direction of travel for companies operating in EU markets, including Ireland.
Ireland’s regulatory framework is closely connected to EU legislation and to agencies such as the European Medicines Agency, ECHA and EFSA. As a result, Irish companies and Irish subsidiaries of multinational groups will need to monitor how European expectations around non-animal evidence evolve.
Although Ireland has not introduced a standalone national NAMs strategy, its regulatory and research environment is increasingly aligned with the reduced use of animal testing and the adoption of more human-relevant technologies. For Irish companies, this is not simply a compliance development. It is a regulatory-readiness, innovation and evidence-generation opportunity within Ireland’s wider life sciences ecosystem.
The Health Products Regulatory Authority, Ireland’s medicines regulator, already supports the use of non-animal methods and requires researchers to justify why alternatives cannot be used before animal studies are conducted.
The rise of NAMs therefore offers more than a scientific alternative to established testing models. It has the potential to reorganise parts of the drug discovery business model and to influence where value is created across the life sciences value chain.
Why NAMs matter beyond the science
Much of the debate around NAMs has focused on ethics and science. Advances such as organoids, organ-on-chip systems and AI-enabled predictive modelling are creating viable alternatives to animal studies that may better reflect human biology. However, treating these developments as scientific breakthroughs alone risks missing their wider significance: the transition away from animal testing is also changing how pharmaceutical companies allocate capital, generate evidence, bring medicines to market and create value.
The opportunity and challenge for companies operating in Ireland
For pharmaceutical and biotechnology companies operating in Ireland, NAMs represent both an opportunity and a significant operational challenge. The historic drug discovery process has relied on substantial investment in animal facilities, specialised infrastructure and lengthy pre-clinical testing programmes. This asset-heavy model remains deeply embedded across the industry.
NAMs offer a different path. Rather than relying solely on animal-based research infrastructure, companies can use more agile technologies such as digital platforms, computational biology, advanced in vitro systems and human-derived data. This shifts value creation away from the ownership of large-scale testing facilities and towards integrated technology platforms capable of generating predictive insights earlier in the development process.
Potential to improve development outcomes
The commercial implications could be significant. One of the persistent challenges in drug development is the high rate of clinical failure. Many candidate drugs appear promising in animal studies but fail when tested in humans, contributing materially to the industry’s research and development costs.
Human-relevant technologies have the potential to improve predictive accuracy, enabling researchers to identify weaker candidates earlier and avoid avoidable costs. By focusing resources on the most promising candidates, NAMs could shorten development timelines, reduce late-stage attrition and improve R&D productivity. In an industry where bringing a new medicine to market can take more than a decade and cost billions, even incremental efficiency gains can have meaningful financial implications.
A changing evidential framework
The move towards NAMs also challenges how evidence is generated and assessed. Animal testing has historically been treated as a critical element in regulatory submissions. As NAMs mature, the definition of acceptable evidence is changing, with regulators increasingly considering how data generated through non-animal methods can support decision-making. This is creating a gradual but important transformation in the evidential framework that supports drug development.
For Irish companies, the change requires not only a rethink of research strategy, but also greater investment in regulatory capability. Future success will increasingly depend on integrating multiple evidence sources, including computational models, human-cell data, real-world evidence and advanced analytics, into coherent regulatory submissions.
Tax, IP and value creation considerations
Economic and policy incentives strengthen the Irish market opportunity. Ireland’s focus on research, development and innovation, combined with its established life sciences investment environment, could support greater adoption of NAMs as companies seek more efficient and human-relevant development pathways. Companies developing NAMs-related platforms, AI models, organ-on-chip systems, advanced in vitro tools or data-driven toxicology capabilities should consider whether their activities may qualify for Ireland’s R&D corporation tax credit. Where NAMs activity generates qualifying intellectual property, the Knowledge Development Box may also be relevant, subject to the detailed conditions of the regime.
For Irish subsidiaries of multinational pharmaceutical, biotechnology and medtech groups, NAMs may also influence transfer pricing, funding models and the location of value creation. If Irish teams develop proprietary testing platforms, datasets, regulatory know-how or AI-enabled models, groups will need to consider how those functions, assets and risks are documented and rewarded. This is particularly relevant as Ireland continues to position itself not only as a manufacturing and quality hub, but also as a location for higher-value R&D, digital science and regulatory innovation activities.
Talent and infrastructure will be central to that opportunity. Ireland’s established pharma, biopharma and medtech base provides a strong platform for NAMs adoption, but successful implementation will require investment in computational biology, bioinformatics, data governance, validation science, regulatory affairs and quality systems. The challenge for Irish companies will be translating proof-of-concept technologies into validated, auditable and regulator-accepted processes that can operate within GxP environments.
NAMs also have a responsible business dimension. Investors, patients and the wider public increasingly expect pharmaceutical companies to demonstrate responsible and sustainable innovation. Reduced dependence on animal testing can align with those expectations. For Irish companies and Irish subsidiaries within larger EU groups, NAMs may form part of a broader corporate narrative around scientific innovation, animal welfare, sustainability, data ethics and patient relevance. However, the strongest case for NAMs is not reputational alone. It is operational, regulatory and commercial: companies are adopting NAMs because they can support better science, greater efficiency and more effective resource allocation.
What Irish companies should consider now
The emergence of NAMs should be seen in the context of wider change across the pharmaceutical and life sciences industry, including biologics, personalised medicine, AI-driven drug discovery and advanced analytics. It is not simply the replacement of one research tool with another. It is part of a broader redefinition of how medicines are discovered, how evidence is generated and how value is created.
For the Irish market, NAMs should not be regarded as a narrow compliance exercise. They represent a strategic shift in the way pharmaceutical, biotechnology and medtech companies may operate, invest and respond to changing evidential expectations. As regulatory support strengthens and technological capabilities mature, companies that engage early will be better placed to shape their operating models, evidence strategies and investment priorities.
Irish boards, finance teams and R&D leaders should consider taking a structured approach: mapping current animal-testing dependencies, identifying candidate NAMs use cases, assessing Irish and EU innovation supports, engaging early with regulators, protecting and documenting intellectual property, and building governance around validation, data quality and model accountability. Approached in this way, NAMs can be positioned not only as a scientific transition, but as a strategic investment decision linked to Ireland’s long-term competitiveness in life sciences.
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