BERWYN, Pa., April 02, 2025 (GLOBE NEWSWIRE) -- AscellaHealth, a global partner delivering customizable solutions to support the specialty pharmaceutical industry, today unveiled its latest Specialty & Rare Pipeline Digest™, the industry’s most comprehensive digital resource for information on new, pending and upcoming specialty and rare disease drug launches and approvals, biosimilars and cell and gene therapies (CGTs). As the intricate specialty pharmaceutical landscape evolves with emerging therapies, this complimentary quarterly publication equips stakeholders with vital, timely updates into specialty product pipelines.
"The steady pace of FDA approvals for novel therapies and shifts in treatment approaches, especially in the specialty and orphan drug areas, highlight the demand for these timely, actionable insights to advance treatment options for complex and rare conditions,” says Andy Szczotka, PharmD, chief pharmacy officer, AscellaHealth. “Developed by our talented and dedicated team of clinical researchers and analytics experts, this robust publication empowers manufacturers, payers and providers with the knowledge to strategically navigate this dynamic landscape, supporting our commitment to enhancing patient access to treatment and product affordability."
A Look Back: 2024
In 2024, the FDA approved 50 novel drugs, slightly fewer than the 55 approved in 2023, but still above the 10-year average of 47 approvals annually. Over half of these new drugs target rare or orphan diseases. Furthermore, 66% of the approvals were fast-tracked through at least one of the FDA's expedited programs designed to address serious health conditions, with 16% receiving accelerated approval, reflecting a continued drive for innovation in patient care and the potential to enhance public health.
Projected Trends: 2025-2026
Projections for 2025–2026 indicate that trends will remain similar to those of 2024–2025, despite the introduction of several high-cost treatments for rare diseases. Specialty drugs are expected to continue growing as a significant portion of overall drug spending, with these medications accounting for more than half of total drug expenditures in 2025-2026 and beyond.
Growth in Specialty and Orphan Drug Approvals:
The FDA’s focus on specialty medications and orphan drugs continues to expand, with 71% of recent submissions being for specialty medications and 34% for orphan drugs. This trend reflects a growing commitment to addressing complex and rare conditions through innovative treatments.
Read more findings in the latest Specialty & Rare Pipeline Digest™ here.
About AscellaHealth LLC
AscellaHealth is a global partner that delivers proven end-to-end solutions to both life sciences and healthcare companies to enhance the quality of life for patients with complex, chronic conditions. A dedicated team gets critical healthcare products from manufacturers to patients while ensuring an efficient flow of funds between payers and pharma. Visit www.AscellaHealth.com.
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