BERWYN, PA — AscellaHealth has released its Q2 2025 Specialty & Rare Pipeline Digest™, offering stakeholders a detailed look at the rapidly evolving landscape of specialty and rare disease therapies. The quarterly digital publication, provided as a complimentary resource, delivers crucial updates on new and pending drug approvals, biosimilars, and the expanding field of cell and gene therapies (CGTs).
The second quarter of 2025 saw a notable rise in branded specialty medication approvals, underscoring the FDA’s ongoing efforts to accelerate patient access to treatments for complex and rare diseases. CGTs, in particular, continue to gain momentum, with several new therapies receiving approval and others moving through regulatory review. These advancements reflect the growing promise of CGTs in providing transformative options for patients with limited treatment choices.
Andy Szczotka, PharmD, chief pharmacy officer at AscellaHealth, emphasized the need for reliable, centralized intelligence amid this surge in innovation. “The continued acceleration of specialty and rare drug development — with over a dozen new approvals in Q2 alone — highlights the critical need for a comprehensive resource that helps industry stakeholders stay ahead of evolving market dynamics,” he said. He added that AscellaHealth’s team of clinical researchers and analysts meticulously curates the digest to provide actionable insights that enable manufacturers, payers, and providers to make informed strategic decisions and improve patient outcomes.
Looking forward, the specialty drug market is expected to maintain steady growth through 2026, driven by the increasing development of orphan drugs and CGTs. Projections indicate that specialty medications will account for more than half of total drug spending during this period, reflecting their central role in treating complex conditions. Currently, 71% of new drug submissions fall into the specialty category, and 34% have orphan drug designations — figures that highlight the industry’s commitment to addressing unmet medical needs.
AscellaHealth’s digest serves as a vital tool for stakeholders navigating this dynamic environment, providing timely data that supports proactive planning and enhances the ability to manage emerging therapies effectively.
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