Ireland’s pharma sector is not confined to the global behemoths we host; our knowledge economy has also helped birth many groundbreaking and innovative pharmaceutical start-ups and spin-offs.
Examples include Nuritas, a biotechnology company innovating in discovering bioactive peptides in nature; Galactica Biotech, which uses AI to identify new applications for molecules; OmniSpirant Therapeutics, which is developing a disruptive RNA delivery platform technology to develop first-in-class regenerative gene therapies for cancer and respiratory diseases; and Priothera, which is developing the investigational drug mocravimod, currently under clinical development for its use as a post-remission therapy for acute myeloid leukaemia patients.
Bringing new drugs and devices to market is a notoriously difficult and expensive process – even for the big boys. Industry experts say that in order to cultivate an environment where pharma start-ups can truly flourish, it is essential to address a number of Ireland’s policy objectives in this space, including access to funding, incentives and talent.
“Ireland has achieved considerable success in attracting foreign direct investment in the biopharmaceutical and chemical manufacturing sectors. However, historically we have encountered challenges in fostering a robust indigenous biopharma industry,” says Sinead Keogh, director of BioPharmaChem Ireland (BPCI).
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Keogh says a critical area for further investment is research centres within the State’s higher-education institutions, pivotal for generating high-potential spin-outs. “In our recent manifesto, BioPharmaChem Ireland urged the Government to allocate funding to benchmark Ireland against peer countries such as Belgium and France, both of which have developed strong manufacturing bases alongside vibrant start-up ecosystems.”
However, the needle is beginning to turn. In recent years, Keogh says, it has been encouraging to witness the emergence of more biopharma start-ups. “Initiatives such as the Enterprise Ireland-backed DigiBio fellowship programme – a comprehensive, 10-month postgraduate course focused on hands-on training in needs-led innovation – holds promise for the development of new start-ups in areas like digital therapeutics and personalised medicine.”
Steve Kerrigan is professor of precision therapeutics at the RCSI University of Medicine and Health Sciences and co-founder of Inthelia Therapeutics, which is establishing itself as a leader in innovative treatments for sepsis, a condition that causes more than 11 million deaths annually. He believes Ireland’s highly innovative start-up pharmaceutical sector is driven by a combination of strategic factors, including a strong ecosystem, government support, and a focus on emerging trends.
“Partnerships between academia and industry foster innovation, especially in niche areas like therapeutics, biologics, gene therapy, and rare diseases,” Kerrigan says. “Ireland’s investment in research through Research Ireland has led to the development of key academic research programmes that have led to target discovery and drug development.”
He also points out that Ireland’s advanced supply chain and established infrastructure further reduce barriers for new entrants, while our well-educated workforce, with expertise in life sciences, chemistry and engineering, is invaluable.
Novel third and fourth-level courses such as the RCSI University of Medicine and Health Sciences BSc in advanced therapeutic technologies are providing cutting-edge research and training tailored to pharma and biotech, ensuring a steady stream of talent and innovation. Kerrigan also notes that supports from Enterprise Ireland through its commercialisation fund and through its support of technology transfer offices has facilitated the patent protection and commercialisation of these assets through spin-out company formation.
Yet he admits that starting and scaling a start-up company comes with significant barriers, particularly when transitioning from initial basic research to clinical application.
“Beyond technical and financial challenges, securing partnerships, market access and trust from healthcare providers and patients can sometimes be difficult,” he says. “However, this depends on clinical unmet need.” One big challenge, he says, is the high cost of R&D, with the development of a drug often requiring hundreds of millions of euro and years of investment.
“Securing funding during early stages, especially for clinical trials, is difficult, particularly for new start-ups without a track record,” says Kerrigan. “Regulatory hurdles also pose a significant barrier.”
Of course, simple scientific uncertainty is another obstacle, as promising lab results can often fail to translate into effective or safe treatments in human trials. And Kerrigan points out that start-ups face intense competition from established large pharma companies with more resources, as well as from other emerging innovative start-ups.
Inthelia Therapeutics is successfully navigating this complex landscape, however, leveraging support from globally recognised programmes such as Johnson & Johnson’s BlueKnight initiative. Since its establishment in 2021, Inthelia has raised €1.1 million in funding and is seeking further investment to advance its planned human clinical trials.
“Inthelia is on track to transform sepsis care and address one of the most pressing unmet needs in healthcare,” Kerrigan says. “Successfully making the leap from bench to bedside requires not only ground-breaking science but also a strong team that can ensure strategic planning, forward-thinking funding and a clear understanding of the regulatory and commercial landscape.”
