By Vishal Dakhole, Vice President Life Sciences, IDA Ireland
In the rapidly evolving biopharmaceutical landscape, Contract Development and Manufacturing Organisations (CDMOs) have become indispensable partners for both emerging biopharmaceutical firms and established pharmaceutical giants.
CDMOs offer a comprehensive range of services, from early-stage drug development to commercial-scale manufacturing, including essential regulatory support, enabling companies to bring their complex therapies to market more efficiently.
Their role is increasingly crucial as the industry shifts toward advanced therapies and novel modalities.
Meeting the Demands of Advanced Therapies
Advanced Therapy Medicinal Products (ATMPs), including gene and cell therapies, are at the forefront of biopharmaceutical innovation.
The complexity of these therapies, combined with the specialised technology required for production, makes it more feasible for small and midsized biotech companies to partner with the right CDMO partner rather than invest in their own manufacturing facilities.
Even large pharmaceutical companies that lack expertise in these cutting-edge modalities are increasingly turning to CDMOs to handle the significant time, cost, and skill demands.
The end-to-end capability support that CDMOs offer is particularly valuable for handling ATMPs, which involve complex manufacturing processes and stringent regulatory requirements.
Expanding Expertise and Capacity
The growth of the biopharmaceutical market has prompted CDMOs to increase capital spending on getting access to cutting-edge technologies, improving operational efficiencies, and significantly expanding their production capabilities.
Recent strategic moves underscore this trend. For example, Agilent Technologies is acquiring the Canadian CDMO Biovectra to enhance its expertise in oligonucleotide and gene-editing technologies.
Belgian CDMO Ardena is acquiring Catalent’s New Jersey facility to expand its operations in the US, offering late-stage clinical oral dosage services. German CDMO Vetter is also expanding with new sites in the US and Germany to meet the growing demand for aseptic fill-finish services.
Additionally, West Pharmaceutical, a globally leading CDMO in innovative solutions for injectable drug administration, is expanding with a new facility in Dublin, Ireland, to meet the increased demand for manufacturing solutions and drug delivery services in the therapy area of metabolic and chronic diseases such as diabetes and obesity.
In general, CDMOs based in the U.S. and EU are expected to gain an increased share of the western markets as companies prefer to reshore manufacturing with local production to make business easier and improve the security of the supply chain.
Role of MedTech CDMO
8 out of the 10 global top-selling drugs are either biologics or vaccines.
The global biologics industry is witnessing steady growth as new drug modalities now account for a significant one-third portion of new drug approvals.
Given the complex nature of ATMPs, the drug delivery device (such as an autoinjector, a prefilled syringe, or a connected drug delivery device) plays a crucial role in ease of administration and compliance.
Earlier this year, Gerresheimer, a German Medtech CDMO, announced an expansion of its production capacities in the US for new innovative drug delivery systems such as inhalers and autoinjectors to support its long-term Biopharma customer.
Vishal Dakhole
The rise of Medtech CDMO, particularly in the design and development of new drug delivery devices, has brought together digital, pharmaceutical, and device convergence, improving clinical outcomes and medication adherence rates while also bolstering the biopharmaceutical sector.
MedTech CDMOs are partnering with global biopharmaceutical companies to create custom device solutions that address their unique needs and play a role in the success of novel biopharmaceuticals that create value for patients.
Medtech CDMO Integer, one of the largest CDMOs in the world, recently announced a US$30 million investment towards a new facility in Galway, Ireland, to support its increasing demand from customers for research into innovative drug delivery systems and manufacturing.
Freudenberg Medical, a leading German Medtech CDMO in design, development, and manufacturing, is also expanding its existing operations in Ireland to support strong demand for innovative solutions and medical systems.
Market Growth and Investment
The global CDMO market for biologics is projected to grow at a compound annual growth rate (CAGR) of 16 per cent, reaching approximately $68 billion by 2027.
This growth is driven by rising demand for biologics, mRNA vaccines, and new advanced therapeutic modalities.
The manufacturing process for these products is complex, requiring specialised skills and significant capital investment.
CDMOs play a crucial role in this landscape, offering end-to-end services for companies that lack the necessary infrastructure.
When selecting locations for new manufacturing investments, CDMOs are considering factors such as established ecosystem, geopolitical stability, supply chain agility aimed at ensuring rapid delivery of treatments to patients in multiple regions, and the availability of skilled talent.
Local supplier ecosystems on the ground are essential to the success of CDMOs because they eventually build a network that can provide a wide range of goods, materials, and services, is adaptable enough to add capacity, and can react quickly to operational disruptions with flexible forecasting and contingency planning.
Countries with established biotech clusters, such as Germany, Denmark, and Ireland, are becoming increasingly attractive for these investments due to their supportive ecosystems and emphasis on STEM education and R&D.
As the third-largest exporter of pharmaceutical products worldwide, Ireland’s robust Life Sciences ecosystem, skilled workforce, and established infrastructure make it an ideal location for CDMO expansion.
By providing advanced training and research solutions in all facets of biopharma manufacturing, Ireland’s National Institute for Bioprocessing Research and Training (NIBRT) is also making a contribution to close the skill talent gap.
Digital transformation is another area of focus for CDMOs, allowing them to make real-time decisions to maximise production, adjust operations, and predict demand, sharing end-to-end transparency and up-to-the-minute visibility into inventory with their contracting biopharmaceutical partners.
Digital Manufacturing Ireland (DMI) is helping manufacturers of all sizes and digital maturity to adopt digital technology into their manufacturing operations to scale, become more agile, and transform their value chains.
The availability of employable operational experience that genuinely comprehends the digital manufacturing environment will soon have an impact on new CDMO locations.
Future Outlook
The future of the biopharmaceutical industry is closely tied to the evolving role of CDMOs, as these organisations continue to meet the growing demand for advanced therapies and biologics.
As innovations in cell and gene therapies, mRNA technology, and personalised medicine become more prominent, the need for specialised manufacturing expertise will only intensify.
CDMOs are uniquely positioned to address this demand, offering tailored solutions that help biotech companies navigate the complexities of these novel modalities.
Furthermore, the global CDMO market is expected to see robust growth, driven by increased investment in new facilities, technologies, and capabilities.
Factors such as supply chain agility, talent availability, and geopolitical stability will play critical roles in shaping where these investments are made.
Countries with strong biotech ecosystems, such as Ireland, Germany, and Denmark, will likely attract further CDMO expansion due to their supportive infrastructure and focus on research and development.
In addition, as biopharma companies continue to weigh the benefits of outsourcing versus building internal manufacturing capabilities, CDMOs will increasingly serve as essential partners in delivering complex therapies to market faster and more efficiently.
Their ability to offer end-to-end services, from early-stage development to commercial-scale production, will be crucial in keeping pace with the industry’s rapid innovation.
Looking ahead, CDMOs will not only drive growth but will also help ensure global access to cutting-edge treatments, making them indispensable to the future of healthcare.
