Ireland has moved up the pharma value chain in a competitive climate

Ireland’s pharma industry has come a long way; much of it has been up the value chain. It’s a journey that has seen it evolve from the chemical synthesis of active pharmaceutical ingredients (APIs), through final dosage forms and biotech manufacture, up to and including the new world of advanced therapeutics.

“Ireland has a global biopharmachem manufacturing cluster with a proven track record in operational excellence, compliance and supply security, in addition to a green image,” says Susan Costello, director of the BioPharmaChem Skillnet network.

The past five years have seen a steady rise in approvals worldwide of advanced therapeutics and vaccines, a category of innovative medicines that includes cell-based and gene-based therapies (CGT). These are predicted to drive the next wave of biopharma growth, with analysts estimating that CGT revenues will reach anywhere between $10 billion (€9.13 billion) and $60 billion globally by 2026.

Additional opportunities for the sector here include a move up the value chain toward drug discovery and development, and leveraging Ireland’s significant research capabilities in biotechnologies, microbiome science, advanced materials, drug delivery, data analytics and modelling.

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We will also see the development of sustainable manufacturing processes and of all-island research clusters, Costello predicts.

Science Foundation Ireland will help grow the pipeline of high-skills researchers needed to do it, with a goal that 65 per cent of researchers will move to positions outside of academia by 2025.

Irish-based global business services (GBS) operations have already earned a reputation for managing complexity and uncertainty through their high knowledge base, Costello points out.

“A strong compliance focus has led to a solid reputation for managing risk activities. Ireland is seen as a safe pair of hands. We need to ensure that Ireland is the location of choice for pharma GBS against other very competitive locations through our talent pool and raising the sector’s profile in the labour market,” she says.

The key to this is moving transactional activities to lower-cost locations and for Irish GBS transition to managing knowledge-based activities.

“GBS can diversify into other areas such as cell and gene therapy, clinical trials and supply chain. Ireland is ideally placed to host CGT ‘control towers’ and leverage co-location with manufacturing,” adds Costello.

The contract development and manufacturing organisation (CDMO) sector is expanding and evolving too.

“There is further potential to expand the CDMO sector, building on Ireland’s excellent reputation for quality and strong regulatory compliance,” says Costello. “Irish sites have proven to have a consistently high standard globally, particularly in relation to products with higher levels of complexity.”

BioPharmaChem Skillnet works with industry partners to develop training to support the sector, including virtual training programmes on such topics as aseptic techniques for biomanufacturing; powder handling for active pharmaceutical ingredients; and health and safety.

“Ireland plays a pivotal role in the manufacturing and export of much of the world’s pharmaceuticals and advanced therapy medicinal products‚” says Mark Chalmers, EY Ireland’s partner in life sciences. “And it is well positioned to benefit from the next wave of pharma advances, with a highly skilled workforce and talent pool, combined with a well-integrated, end-to-end pharma and biotech value chain, encompassing research and development, manufacturing, commercial and finance functions.”

We are seeing a tidal wave of scientific pharmaceutical innovation and the volume of health data, and the sources that generate these data are growing exponentially

—  Mark Chalmers

Chalmers believes work is now needed to prepare the healthcare ecosystem for these next generation advanced therapeutics to ensure patients in Ireland benefit from them.

“Cell and gene therapies present unique pricing and market access hurdles that need to be overcome to realise their true value and potential for patients,” he says.

“Healthcare systems like Ireland can often face affordability challenges for the most cutting-edge medications and advanced therapeutics, which often treat a small number of patients, resulting in a high one-time budget impact, compared to traditional chronic therapies administered over an extended time period.”

Innovative science requires equally innovative, customised patient access solutions, Chalmers points out.

“Recent cell and gene therapy health technology and value assessments highlight clinical, economic and system implementation uncertainties as key areas of concern often resulting in delayed patient access,” he adds.

Although Ireland is a world leader in biopharma, greater manufacturer and healthcare system collaboration, as well as joint working and ecosystem partnerships, will further strengthen the sector and ensure its continued success here, Chalmers says.

“We are seeing a tidal wave of scientific pharmaceutical innovation and at the same time the volume of health data, and the sources that generate these data are also growing exponentially,” he adds. “Ireland can successfully utilise this wealth of health data to fuel the pharmaceutical science engine and, in turn, ensure patient insights and treatments are personalised.

“In this way we can measure clinical and non-clinical patient outcomes to better define the value of the holistic patient experience. If we can then link demonstrated health outcomes to the funding of innovation we have the potential to realise the vision of value-based healthcare and ensure patients receive access to and benefit from these next-generation transformative therapies.”

While this has been a very positive story overall, with benefits for patients and lots of good jobs, it’s about keeping the reasons these companies come here in the first place

—  Colin Kavanagh

The industry is indeed going from strength to strength, says Colin Kavanagh, partner in law firm Arthur Cox’s corporate and mergers and acquisitions group, and head of life sciences.

“We have seen it move up the value chain from the original API market, which has now in many cases gone to lower-cost jurisdictions such as eastern Europe or been taken over by contract manufacturers, while the large companies have invested in the manufacturing of high-tech drugs,” says Kavanagh.

He points to the sites of pharma companies such as BMS and MSD, “really high tech, gold standard facilities”, by way of example. He too believes that Ireland benefits from good oversight and regulatory control, thanks to regulatory body the HPRA, which gives confidence to patients and investors alike.

But in addition to the sectoral challenges outlined above, pharma also faces challenges common to all industries in Ireland right now, including inflation, the cost and long timelines of building, and issues around schools and housing, Kavanagh points out.

“Ireland has plenty of space for sites and plenty of people for work – because we are part of the EU, people can more here from abroad,” says Kavanagh.

“But there are lots of jurisdictions competing for these sites which produce these good, high-paying jobs. While this has been a very positive story overall, with benefits for patients and lots of good jobs, it’s about keeping the reasons these companies come here in the first place.”