Dublin-based Uniphar has announced the launch of its 10th cell and gene therapy (CGT) project, reinforcing its position as a global leader in facilitating access to advanced pharmaceutical treatments. The milestone builds upon the company's established expertise in therapeutic areas including neuromuscular diseases and oncology, with a significant focus on pediatric populations.
To date, Uniphar has developed comprehensive go-to-market and clinical development strategies for innovative cell and gene treatments across more than 50 countries, directly benefiting over 600 patients who might otherwise lack access to these cutting-edge therapies.
"The promise of cell and gene therapies continues to grow, as does the expectations of the patient communities who may benefit," said Tom Smith, Strategic Director of Cell and Gene Therapies at Uniphar. "Bringing these complex therapies into new markets presents a unique set of challenges, from regulatory hurdles to complex supply chain logistics."
Smith emphasized the company's approach to overcoming these barriers: "By continuously refining our approach and building tailored and scalable infrastructure, we can ensure these breakthrough therapies reach patients worldwide as quickly and efficiently as possible, particularly in areas with a high unmet need."
Global Expansion and Market Access
With a strong European foundation and ongoing expansion into the U.S. market, Uniphar has focused on enabling cell and gene therapy access in traditionally underserved regions. This effort involves close collaboration with regulatory authorities, healthcare providers, and logistics partners to streamline the delivery of these complex treatments.
Despite these advances, the company acknowledges that equitable access to cell and gene therapies remains a significant challenge globally, with regulatory frameworks, healthcare infrastructure, and economic factors creating barriers in many regions.
Expanded Access Programs Drive Revenue and Insights
Uniphar's expanded access programs (EAPs) have become a cornerstone of its business model, enabling pharmaceutical companies to navigate the complexities of early patient access. These programs allow therapies to reach patients before full commercial availability, addressing critical unmet medical needs while generating valuable real-world data.
Through these initiatives, Uniphar has generated approximately half a billion dollars in revenue for cell and gene pharmaceutical partners, demonstrating the financial sustainability of early access models. Beyond revenue generation, these programs provide crucial insights that inform regulatory discussions, pricing negotiations, and commercial launch strategies.
Market Growth and Future Outlook
The announcement comes amid rapid growth in the global CGT sector. Industry research indicates that spending on cell and gene therapies reached $5.9 billion globally in 2023—representing a 38% increase from the previous year. The overall market was estimated at $21.28 billion in 2024 and is projected to grow to approximately $117.46 billion by 2034.
In the United States alone, the market exceeded $10.59 billion in 2024, highlighting the significant commercial potential of these advanced therapies despite their complex development and delivery requirements.
Strategic Partnerships and Financial Performance
Partnering with over 200 organizations worldwide, Uniphar provides comprehensive support throughout the pharmaceutical development lifecycle—from early-stage medical strategy to patient access solutions. The company leverages its extensive expertise in pharmaceutical access and distribution to create pathways for innovative treatments.
The CGT milestone announcement follows Uniphar's strong financial performance for the year ending December 31, 2024. The company reported that its pharmaceutical and medical technology divisions delivered organic growth of 17.6% and 9.1% respectively, while its supply chain and retail operations saw a 5.5% increase in gross profit.
As Uniphar looks toward the future, the company plans to enhance its CGT platforms in alignment with its broader business offering as a global leader in pharmaceutical and medical technology solutions. With new expanded access programs set to launch, Uniphar continues to focus on innovation in early access models, working to ensure that more patients worldwide can benefit from breakthrough treatments in the rapidly evolving field of cell and gene therapy.
