The specialty drug pipeline is projected to grow by 8% each year through 2025.
To kick off the first business session of Asembia 2023, Ray Tancredi, divisional vice president at Walgreens, noted 6 major trends in the 2023 specialty therapy pipeline:
Tancredi noted that specialty pharmacies grew by 315% between 2015 and 2021, with hospital or health system-owned specialty pharmacies accounting for about a third of this total growth—and that the specialty drug pipeline is projected to grow by another 8% each year through 2025.
“Specialty pharmacy continues to carry the FDA pipeline year over year,” Tancredi said. “What I saw was about 39 more drugs that could potentially be approved by the end of 2023, and of those 39, I think 28 of them could be considered specialty.”
He first listed 8 major recent specialty drug approvals that “have the potential to change the standard of care in a given disease and/or have a large economic impact to payer.” These were:
Looking to the rest of 2023, there are several more specialty drugs anticipated to receive FDA approval. Here is a wrapped-up version of these anticipated approvals.
Rare and Orphan Disease
Tancredi focused on 23 drugs in the pipeline to treat a large variety of rare and orphan diseases. There are more than 7000 rare diseases, which affect fewer than 200,000 individuals per condition and 30 million Americans overall. Since the Orphan Drug Act was signed into law in 1983, the FDA has approved hundreds of treatments for rare diseases, though most rare diseases still do not have FDA-approved treatments.
This list included 11 oral drugs and 12 drugs delivered via injection. All drugs are in phase 2 or 3 of research and development, or filed for FDA approval.
The orally administrated drugs on this list include:
The drugs delivered via injection on this list include:
Specialty Drugs
Tancredi focused on 19 traditional specialty drugs in the pipeline for FDA approval, including 10 oral drugs, 8 drugs delivered via injection, and 1 delivered via inhalation.
The orally-administrated drugs on this list include:
The drugs delivered via injection on this list include:
Additionally, treprostinil sodium was the only drug on this list delivered via inhalation.
Oncology
Tancredi noted that about 13 oncology drugs are approved each year. In 2023, there are 16 oral drugs and 6 drugs delivered via injection in the pipeline, with 6 drugs in the pipeline for breast cancer and 3 for non-small cell lung cancer (NSCLC).
The orally-administrated drugs on this list include:
The drugs delivered via injection on this list include:
Gene and Cell Therapies
There are 13 injectable gene and cell therapies in the pipeline, with 1 drug delivered topically.
The gene and cell therapies delivered via injection on this list include:
Beremagene geperpavec is also in the pipeline for topical treatment of dystrophic epidermolysis bullosa.
Pharmacy practice is always changing. Stay ahead of the curve with the Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips.
IRA Drug Price Negotiations to Have Far-Reaching Consequences on Health Care System | Asembia 2025
May 1st 2025The Inflation Reduction Act's drug price negotiations could lead to reimbursement complexities, potential pharmacy closures, and reduced patient access to medications, particularly specialty drugs.