SECTOR OVERVIEW

Matt Moran, Director, BioPharmaChem Ireland, charts the current performance of Ireland’s biopharma sector and examines the challenges we need to meet if our success is going to continue into the coming years.

A roadmap to a bright future

We are half-way through 2022 and the biopharma sector continues to perform strongly, with capital investment remaining robust. The first half of 2022 was peppered with a number of very positive announcements for the sector, some of which can be seen in Table 1 below.

Taken in addition to ongoing significant investment programmes at MSD and Pfizer across most of their sites, this does indeed paint a very positive picture for the sector in Ireland, with foreign direct investment continuing to drive significant growth within the sector.

Added to this is a decision by Spear Street Capital to invest in a bio incubator at Cherrywood, South Dublin. The 30,000 square feet facility will be run by We Are Pioneer Group (WAPG, formerly Biocity), a UK-based operator in incubating and accelerating life sciences businesses. The WAPG team will help potential start-ups in life sciences by coaching them and advising them of potential sources of finance to help them achieve critical mass. It is hoped that initiatives such as this will help to grow out a strong indigenous life sciences sector that can complement the already strong FDI sector.

The recent opening of the cell therapy production unit by Takeda at Grange Castle represents another important milestone for the sector. This will be Ireland’s first stem cell therapy production facility and heralds a further step in the journey of innovation that the sector has been on since its establishment back in the 1960s. This journey has seen the sector evolve from the chemical synthesis of Active Pharmaceutical Ingredients (APIs), through final dosage forms, biotech manufacture right into the exiting new world of Advanced Therapeutics. The product being made at Grange Castle is designed to treat a side effect of irritable bowel syndrome and is an example of a family of products known as Cell and Gene Therapies – referenced in my last article.

Company Investment Potential Employment Location

Eli Lilly €400m 300 Limerick Merck €440m 370 Cork Takeda €36m 100 Dublin Janssen €150m 180 Cork Amgen €100m Dublin Ipsen €27m Dublin Eirgen €12m Waterford

The evolution of Ireland’s biopharmachem sector from the 1960s to today.

Above: Matt Moran, Director of BioPharmaChem Ireland, addresses the BPCI Annual Dinner in UCC. Below: Matt Moran, Director, BPCI; John O’Halloran, President of UCC; and Brian Killen, MSD, Vice Chair, BPCI, pictured at the BPCI Annual Dinner in UCC.

The National Institute for Bioprocess Training and Research (NIBRT) has just commenced expansion of its Dublin campus to include a wing that will be dedicated to supporting training and research in the CGT field. This will add greatly to Ireland’s ability to compete for investment in this emerging area of therapeutic effect. As well as presenting an opportunity for new inwards investment, it is hoped that there will be opportunities for indigenous companies too. Maynooth-based company Avectas have demonstrated well that these can be converted into real commercial possibilities.

The right kind of talent

Naturally, as the sector continues to invest and expand its operations in Ireland, the demand for the right kind of talent becomes even more acute. BPCI is very happy that Government recognises this and has tasked the Expert Group on Future Skills Needs (EGFSN) with the job of preparing a report on the current skills scenario within the sector in the country. Even more importantly, the task force will seek to identify future trends and to make recommendations of where investment should be made to ensure that Ireland has the correct skills base in place to meet these future investment challenges. BPCI and its members will participate in the important work of the task force and look forward to working with Government to ensure that its recommendations are implemented.

In my last piece, I spoke about the work that BPCI is conducting to prepare a fifth industry strategy for launch in October of this year. An important focus of this work will be to ensure that the sector stays both competitive and sustainable. BPCI hope to realise these twin goals through the work of its Pharma 5.0 Lighthouse Partnership, led by Johnson and Johnson’s Bryan O’Donnell. BPCI also see an opportunity for Ireland to take the lead within the European Union to ensure that pharmaceutical manufacturing is prioritised right the way across the Union. To this end, they have produced a White Paper in partnership with Innopharma. The White Paper has been presented to the European Commission and to Irish MEPs of the European Parliament in Brussels. BPCI feels that this project can aid a transition towards a climate-neutral society, while retaining industrial competitiveness. Industry 5.0 can help to drive this twin transition and involves the interpretation of Industry 4.0 technologies through a human-centric lens. This supports the European commission’s own Industry 5.0 policy brief, which emphasises the powerful role that industry can play in achieving societal goals through green and sustainable production.

Collaboration with Higher Education

ongoing development of the sector here. They achieve this through ensuring a high calibre of graduate students who go on to work in the sector. Of particular importance are graduates in Science Technology, Engineering and Maths – so called STEM subjects. Without these graduates, the industry will find it hard to continue to meet the many challenges that it will undoubtedly face in the coming years. The Higher Education sector also plays a crucial role in supporting R&D in the sector. I read recently that 90% of the roles we will create in the next 20 years do not exist yet. This only emphasises the need for strong collaboration between higher education and industry, also highlighting the need for Government investment in higher education.

To this end, BPCI were particularly delighted that University College Cork allowed us the host our first Annual Dinner in three years at the wonderful Aula Max on their beautiful campus. The industry heard an inspiring address from University President John O’Halloran and we look forward to continuing a very productive collaboration with UCC and all the higher education sector. BPCI and Innopharma produced a White Paper on Implementation of Industry 5.0 Practices in a Pan-European Setting.

White Paper

Implementation of Industry 5.0 Practices in a Pan-European Setting

- leveraging a proof of concept initiative within the Irish ecosystem

The BPCI Annual Dinner in the Aula Max at UCC proved an inspiring event.

A culture of collaboration and innovation

Dr Sinead Keogh, Head of Sectors, Director, Medtech & Engineering, Ibec, pictured at the launch of the Irish Medtech Association strategy, ‘The Global Medtech Hub 2025: Dedication to the expected, the unexpected and everything in between’.

Dr Sinead Keogh, Head of Sectors, Director, Medtech & Engineering, Ibec, reports on the staggering level of innovation that sees Ireland cement its place as a global centre of excellence in the medtech sector.

The global medtech sector is evolving rapidly, and Ireland’s established medtech ecosystem continues to lead as a centre of excellence for advanced manufacturing, product development, and digital innovation.

Ireland’s incomparable global medtech hub

Quite simply, Ireland’s unique ecosystem supports collaboration, connectivity and convergence in leveraging the necessary capabilities to develop and deliver new innovations today and ensures the required resilience to adapt to whatever happens tomorrow.

Ireland’s medtech hub is over 100 years in the making and over time, we’ve developed a proven track record for next level product development, our resilient supply chains, our connections to strategic markets, and our ambitions for the future. Ireland’s ‘can do’ attitude and ability to collaborate helps create solutions and solve problems.

Continued investment will ensure Ireland continues to be positioned to compete. Our unique mix of strategic stakeholders, from academia to large MNCs, supports convergence between life sciences, medtech and technology, enabling next generation innovation through collaboration. Such alchemy of skills and capability will prove a key differentiator.

Innovation with impact

The last five years have seen Irish medtech experience tremendous growth and develop even greater ambition. Ireland is already recognised as a global medtech hub, with 450 companies employing 42,000 people to deliver €12.6 billion in medtech exports, making an impact across the world. In fact, Ireland is the largest employer of medtech professionals in Europe per capita.

Globally, the medtech sector is defined by its strong history of research and innovation, with the average medtech worldwide R&I investment rate estimated to be approximately 8% in the sector. The sector is arguably the most innovative in Europe, with more than 14,200 patent applications filed with the EPO in 2020, representing a 2.6% growth compared with the previous year.

The Irish medtech community has been a driver of this innovation, with patents granted to Irish companies almost doubling from 2017 to 2020, making it stand out as fifth in the world for medtech patents per capita.

Investment surging on foot of strong track record

17 of the top 20 global medtech companies are based here, many with centres of excellence in innovation, including Stryker, Medtronic, Bausch + Lomb, Alcon, Abbott and Johnson & Johnson, to name but a few. In fact 75% of the FDI community are engaged and are continuing to invest in R&D right across the value chain. Boston Scientific recently unveiled a new €100 million expansion and 300 jobs at their operations in Galway. The expansion includes over 40,000 square feet of medical device research and manufacturing space that will be powered by renewable energy. 3M launched a new digital innovation centre in Dublin focusing on AI and computer assisted coding to measure the quality of healthcare delivery to improve clinical outcomes.

Whether it’s acquisitions, IPO’s or scaling globally, the indigenous sector is grabbing international attention in its own right. SilverCloud Health, one of the world’s leading digital mental health companies, was acquired by the US telehealth giant Amwell. The digital therapeutics company, Health Beacon, recently went public, raising a total of €25 million. Athome diagnostics company, LetsGetChecked, gained ‘unicorn’ status with its USD$1 billion valuation, and acute care aerosol drug delivery company, Aerogen, the Medtech Company of the Year 2021 winner, are treating patients in over 75 countries.

The Enterprise Ireland-backed BioInnovate programme continues to churn out investorready companies at pace, with Versono Medical, Symphysis Medical, Tympany Medical and One Projects recently raising capital.

Enabling technologies to stand out

There are a number of enabling technologies driving innovation in healthcare. Artificial intelligence is being advanced by companies as a revolutionary tool which can inform early diagnosis, as well as support more sophisticated advanced manufacturing. Such is the importance of the area that the Irish Government has appointed an AI Ambassador who will champion the National AI strategy. Also, nanotechnology offers the potential to support better drug delivery, as well as reduce the quantity of drug needed, and has the potential to play a role in advancement of wearable technologies.

Robotics has already transformed manufacturing and this sector is also making great strides in advanced surgery. The most recent Disruptive Innovation Fund will mobilise €500 million specifically to support collaborative research in advanced manufacturing, with the Government also establishing an Enterprise Digital Advisory Forum, which Ibec are represented on.

The 3D printed medical device sector is expected to reach $4.9 billion by 2026, not only delivering bespoke implants, but surgeons are also cutting operating times for patients who had their surgery planned with a 3D model. Stryker have invested over €200 million in their 3D innovation centre in Cork, delivering next generation products and services across their medical, surgical, orthopaedics, neurotechnology and spinal offerings.

Personalised medical care and digital therapeutics are also on the rise, with greater adoption of digital health solutions, segments which have also garnered huge attention from investors. Data has the potential to improve healthcare radically, but there are challenges to tapping into this valuable resource; namely, data integration with technical and regulatory barriers, consumer attitude, and company cultures.

The last five years have seen Irish medtech experience tremendous growth and develop even greater ambition.

Partnerships for success

What really sets Ireland apart from its competitors is the richness of its ecosystem, with 50% in the partnership space. Companies like BlueBridge Technologies and S3 Connected Health partner with global multinationals to enable connected devices and disease management solutions.

There has been a clear trend towards greater use of contract manufacturers by medtech companies, with nearly 80% looking to improve collaboration, according to pre Covid-19 research. In parallel with increased 9

technological innovation and more complex business models, the Covid-19 pandemic has accelerated the demand for collaboration underscored by specialisation.

Our globally respected research centres include the Insight Research Centre known for data analytics, while Tyndall National Institute is helping leading companies develop intelligent medical devices and systems. Additionally, the Regenerative Medicine Institute is leading our national stem cell manufacturing facility, with CÚRAM focusing on engineering smart medtech.

Convergence at the cutting edge

As well as being home to nine of the world’s top 10 medtech companies, Ireland is home to all 10 of the world’s top 10 biopharma and technology companies. With sales of €15.7 billion forecast in digital health alone by 2024 and strong growth projections year on year, it’s an attractive area to drive competitive advantage for Ireland.

As part of our Where Digital Health Thrives campaign, to raise awareness of the Ireland as a location of choice for Digital Health, we have already mapped out approximately 200 companies engaging in digital health, with particular strength across the indigenous sector, covering everything from connected medical devices to digital therapeutics.

Calls for a national strategy

The value of adopting a more holistic approach Ireland is home to nine of the world’s top 10 medtech companies, as well as more than 200 indigenous companies engaging in digital health.

to healthcare is accepted, with rising spending pressures and greater demand for international collaboration between both governments and businesses to provide access to vital care. To help Ireland achieve its potential, the Irish Medtech Association, along with Technology Ireland and BioPharmaChem Ireland, are advocating for the Government to develop a national healthtech strategy, led by the Department of Enterprise Trade and Employment. It needs an appropriate appointee put in place in the department to oversee and implement this strategy, which would operate in a similar fashion to Ireland’s Industry 4.0 Strategy 2020-2025. A new vision to maintain our leadership position

This year, we in the Irish Medtech Association launched our strategy, ‘The Global Medtech Hub 2025: Dedication to the expected, the unexpected and everything in between’. The report charts our strengths as a global medtech hub, and how we can use these to achieve our potential to transform healthcare across the world, while growing in Ireland.

We have developed a new vision for the industry in Ireland to be strongly positioned as a global leader in innovative patient-centred medical technology solutions, helping to set the future global healthcare agenda, with a proven ecosystem that is a major contributor to the economy.

To ensure sustainable progress, not only do we need the right policies, but Ireland also needs world class talent that can stay ahead of both the latest technology and business trends. That is why the Connected Health Skillnet has led the development of a firstof-its-kind ‘Future Skills Needs Analysis of the Digital Health Sector in Ireland to 2025’, which will be launched later this year.

We also partnered with the Irish Medtech Skillnet on the development of a ‘Realising your R&D Ambition Strategy’ to help build the level and sophistication of R&D taking place here amongst the FDI community and to support companies take full ownership of product portfolios. This programme will be rolled out again in 2022.

Success founded on innovation

Ireland’s indigenous life sciences sector is built on innovation and scaling globally, writes Garrett Murray, Head of Life Sciences, Enterprise Ireland.

From exciting research projects in our Higher Education Institutions, through to highpotential start-ups (HPSUs) and established Enterprise Ireland clients, Irish researchers and companies are competing and excelling in terms of innovation and product and service development. Agile and ambitious by nature, the Irish life sciences sector responded to the Covid-19 pandemic, with companies supported by Enterprise Ireland at the forefront of meeting the challenges it posed through the application of their research and delivery of innovative solutions.

Overall, according to our most recently published results, the Enterprise Ireland supported life sciences sector accounted for €2.4 billion in annual sales, with exports accounting for €1.9 billion in 2020. The figures for 2021 are forecast to be significantly higher. Most domestic sales go to multinational customers in Ireland and the interconnectivity of this eco-system is a key strength of the Irish economy. R&D investment as a percentage of sales is very high in this sector. The sector is long recognised on the global stage for its immense innovative capacity. It is important to note one in four graduates in Ireland is STEM, the highest per capita in Europe.

These numbers and the internationally competitive nature of our research and innovation community are incredibly strong foundations on which to build future growth.

Recognising the importance of life sciences

The importance of the life sciences sector, in terms of the positive impact it has on the citizens of the world, and the importance of collaboration and co-ordination in meeting the challenges humanity faces has never been more widely recognised.

For instance, in June of this year, over 110 delegates from healthcare systems around the world came to Ireland for the Enterprise Ireland Global Healthcare Forum to engage with Irish companies and the Irish innovation system. Increased investment has followed this recognition.

Last year, The European Commission published a communication, ‘Drawing the Early Lessons from the Covid-19 Pandemic’ (EUR-Lex - 52021DC0380 - EN - EUR-Lex - europa.eu). It highlights the importance of pandemic preparedness but also notes: • The capacity to cope in a pandemic depends on continuous and increased investment in health systems; • The need to set up a Health Important

Project of Common European Interest as soon as possible to enable breakthrough innovation in the health and pharmaceutical sector, making it more resilient; • The requirement to establish a large-scale

EU platform for multi-centre clinical trials; • The reinforced importance of publicprivate partnerships and that stronger supply chains are needed for critical equipment and medicines.

The European Commission also published a Pharmaceutical Strategy for Europe to underpin the need for, “well-functioning international supply chains and a well performing single market for pharmaceuticals, through an approach that covers the entire lifecycle of pharmaceutical products, from production to distribution, consumption and disposal” (A pharmaceutical strategy for Europe: europa.eu). These policy documents will underpin just some of the changes and create opportunities for companies operating in the sector on a European level.

Enterprise Ireland three-year strategy

As we move into a new economic cycle, where global businesses are operating in an ever increasingly complex and changing world, it is a time to reflect and plan.

Earlier this year, Enterprise Ireland launched our three-year strategy, Leading in a Changing World (2022-2024). The key areas of focus for our strategy include: • Seeing Irish companies continue to deliver sustainable employment and economic growth at national and regional level. In

The Disruptive Technology Innovation Fund, administered by Enterprise Ireland, provides a great opportunity for Irish companies to compete for funding and collaborate with other Irish enterprises and researchers.

this context, we are planning to assist with the creation of 45,000 new jobs over the period of the strategy. • Targeting a significant increase in the level of exports from Irish companies of all sizes and across all sectors to €30 billion, as well as increasing the overall number of

Irish companies exporting. • Fostering further entrepreneurship, leading to increased start-up activity across the country. We will also put specific focus on scaling of companies, enabling Irish firms to grow faster and further in global markets.

We’re targeting support to 450 early-stage companies over the next three years, growing our high potential start-up

cohort by 20%. • Supporting our clients to achieve increased productivity through higher levels of operational focus, more innovation and further digital adoption. We are targeting an R&D spend of €1.4 billion by Irish companies to support this activity.

The life sciences sector will be critical in achieving these employment targets, building on the more than 10,000 people already employed by companies across all regions of Ireland. We want to support clients at all stages in their scaling journey to innovate ahead of their competitors and contribute to achieving our ambitious R&D target. To achieve this aim, we will continue to support companies through in-company and collaborative supports at all stages of their research and innovation journey. We do this because we know innovative companies are more productive, create more jobs and scale faster.

Indigenous success stories

Ireland has so many global players in this sector that are exemplars for those commercialising their research or looking to scale their companies.

ICON plc, a global provider of drug and device development and commercialisation services to pharmaceutical, biotechnology, medical device, and government

Ireland’s life sciences sector accounted for €2.4 billion in annual sales, with exports accounting for €1.9 billion, in 2020. development and process intelligence technology using data analytics.

Enterprise Ireland Commercialisation Fund

organisations, have been recognised with a number of prestigious business and industry awards, including Company of the Year at the 2021 Business & Finance Irish Business Awards. In September 2021, it was announced that the company has been awarded €4 million in R&D support administered by Enterprise Ireland to further enhance their data solutions and decentralised clinical trial technology.

At the same awards ceremony, APC Ltd received the Elevation Award, sponsored by Enterprise Ireland. This award recognises Irish companies that are fast-growing and with significant potential to continue to scale globally, focused on Irish companies achieving up to €350 million in revenue. The company focuses on bringing new drugs to market at speed by designing, developing and implementing engineering platform technologies.

In 2020, APC Ltd, through the combination of IP and customers, spun out VLE Therapeutics to drive scientific and digital-led manufacture of vaccines and Advanced Therapeutics. In April of this year, VLE Therapeutics opened their first GMP factory-of-the-future for the manufacture of advanced therapeutic medicines and vaccines in Cherrywood, Dublin, where a life sciences cluster is emerging. Enterprise Ireland has partnered with both companies to support their growth.

Innopharma Education are another success story focused on the sector, providing educational and technology solutions to the pharmaceutical industry. The technology business is focused on the development of Process Analytical Technology (PAT) instrumentation and accelerated process investment include AI-enhanced molecular modelling such as with BioSimulytics based in NovaUCD. This start-up focus is key to our strategy out to 2024 and beyond.

Increasing the number of researchers that take the exciting and rewarding road of commercialisation and leveraging the State’s investment in research and innovation is key to our strategy. The Enterprise Ireland Commercialisation Fund provides an avenue for Ireland’s brightest researchers to commercialise their work and bring their ideas to the market.

Two projects previously awarded

funding include: Adjuvenate: a platform solution for improved subunit vaccines, led by Principal Investigator, Associate Professor Aisling Dunne, Trinity College Dublin; and Development of gene therapies for common retinal disorders, led by Principal Investigator, Professor Jane Farrar, Trinity College Dublin.

Enterprise Ireland continues to prioritise supporting innovative start-ups with a particular focus on increasing the total number of HPSUs that spin-out of the research system. These have included drug development and gene therapy companies such as ATXA Therapeutics and Branca Bunús. Other interesting areas which have recently seen The importance of collaboration

As the pandemic reaffirmed for many of us, little in life can be achieved without collaboration. The challenge-based Disruptive Technology Innovation Fund (DTIF), administered by Enterprise Ireland, provides a great opportunity for Irish companies to compete for funding and collaborate with other Irish enterprises and researchers.

To gain competitive advantage, Irish researchers and enterprises must also continue to look to Europe where there are a myriad of opportunities to seek mono beneficiary and collaborative funding. Irish companies, including Sirius XT and RemedyBio, to name just two, punched way above their weight in winning competitive funding under Horizon 2020. The current European Programme, Horizon Europe provides an even greater allocation of funding to healthcare across several pillars of the Programme, including the European Innovation Council, the Health Cluster and the Innovative Health Initiative (IHI). More information can be found at www.horizoneurope.ie.

In April of this year, the Government published, ‘Impact 2030, Ireland’s Research and Innovation Strategy’. At its core is the objective of supporting Irish enterprises to innovate and scale. The importance of maximising the contribution to sustaining and furthering the health and wellbeing of the people of Ireland is also a key objective outlined in the strategy. I have no doubt that Irish researchers and companies will not only meet this challenge but that they will also increasingly bring their research and innovation to the global stage to improve patient outcomes and help humanity meet the challenges of today and beyond.

The importance of the life sciences sector, in terms of the positive impact it has on the citizens of the world, has never been more widely recognised.

Mallinckrodt is building on our 155-year history of providing medicines that address patient needs. We have operated in Ireland - the home of our global corporate headquarters - for more than 25 years. Since 2016, we have opened new offices, a manufacturing facility and a Global Device Engineering laboratory at the College Business and Technology Park, in Blanchardstown, Dublin15.