Analysts have identifed treatments that may deliver annual sales topping $1 billion over the next 5 years.
A version of this story originally appeared in Formulary Watch®, a sister publication of Drug Topics®.
In their annual Drugs to Watch report,1,2 analysts at market research firm Clarivate identified 15 late-stage experimental treatments that are each forecast to deliver annual sales of more than $1 billion within 5 years. These promising advancements include a broad spectrum of therapeutic developments for rare diseases and toughto-treat conditions including HIV, Parkinson disease, Crohn disease, alopecia, multiple myeloma, and breast cancer.
“Despite the many urgent challenges life sciences companies will face in 2023—from patent cliffs to capital investment—the industry is on the cusp of unlocking revolutionary technologies that could greatly advance human health,” Clarivate said in a news release.2 To be included, candidate drugs were required to be at the preregistration or registration phase, or already launched, in early 2022; drugs launched before 2022 were excluded. After identifying eligible therapies, analysts filtered the data set for drugs that had total forecast sales of $1 billion or more. Read on to learn more about these potential blockbuster medications.
Lecanemab (Leqembi) and donanemab
Both lecanemab and donanemab target early-stage Alzheimer disease; only lecanemab has been approved by the FDA. On January 19, 2023, the FDA issued a complete response letter to the accelerated approval application for donanemab, due to a lack of participants who received continuous treatment for at least 12 months. However, a phase 3 clinical trial is ongoing.
Although lecanemab’s approval “represents a major commercial and clinical milestone in [the Alzheimer disease] market, we assume limited uptake until the FDA grants or refutes full/traditional (expected in the second half of 2023) approval based on its phase 3 data,” Meher Baba Kumar Nakka, senior health care research and data analyst at Clarivate, told Formulary Watch®.
It also remains to be seen whether the Centers for Medicare & Medicaid Services grants full Medicare coverage for the drug, “which we assume will be crucial for the drug’s commercial success (ie, not restricted coverage under coverage with evidence development with prospective registry-based comparative studies),” Baba Kumar Nakka said.
This is the frst dual IL-17 A/F inhibitor to treat moderate to severe plaque psoriasis. “Phase 3 trial results showed superior skin clearance outcomes [compared with] existing treatments. Its less-frequent dosing schedule and good safety profle will likely be attractive to clinicians and patients,” Clarivate noted.
For patients with breast cancer, capivasertib is a novel, highly potent, selective adenosine-5’- triphosphate–competitive pan-Akt kinase inhibitor. “Positive data have emerged from early-phase trials, with clinical beneft to patients irrespective of their PIK3CA/AKT1/PTEN mutational status, and several phase 3 trials are now underway,” according to Clarivate. It is expected to launch in 2023.
This drug belongs to a novel class of oral treatments for chronic kidney disease (CKD)-related anemia. It is a hypoxia-inducible factorprolyl hydroxylase inhibitor developed to treat anemia associated with CKD, which has a high incidence rate and few efective, safe treatment options, according to Clarivate. “Already available for CKD–related anemia in Japan, its uptake has been impressive,” the research frm said. The Prescription Drug User Fee Act (PDUFA) date is February 1, 2023.
As a frst-in-class oral, targeted agent that selectively inhibits tyrosine kinase 2 and a Janus kinase family member that mediates cytokine-driven immune and infammatory signals, deucravacitinib “has the potential to fill a gap in the treatment armamentarium for plaque psoriasis,” Clarivate said. The drug received approval in September 2022.
This novel reformulation of the goldstandard Parkinson disease treatment (carbidopa/levodopa) is delivered via a subcutaneous pump for the treatment of motor fuctuations in advanced Parkinson disease. “In addition to serving a niche group of patients with high unmet need, it offers better efficacy than orally administered carbidopa-levodopa, dosing flexibility and a more convenient pump than existing and upcoming competitors,” Clarivate said. It is expected to launch in 2023.
Lenacapavir is a first-in-class, long-acting HIV-1 capsid inhibitor approved to treat multidrug-resistant HIV in individuals who have been heavily treated—a patient population with unmet medical need. Lenacapavir was approved by the FDA on December 22, 2022.
This drug is a monoclonal antibody (mAb) that will likely be first-in-class treatment for ulcerative colitis and third-in-class treatment approved for Crohn disease. “Part of a set of emerging therapies with novel mechanisms of action, it will contribute to the growing market share held by these therapies,” Clarivate said. Mirikizumab is expected to be launched f rst for ulcerative colitis in 2023; the Crohn disease launch is expected in 2025.
Pegcetacoplan treats paroxysmal nocturnal hemoglobinuria, a rare hematological disease. The drug has already launched in the United States and Europe and is expected to be the f rst drug to launch for geographic atrophy or dry age-related macular degeneration, which has no approved pharmacotherapy, according to Clarivate. The PDUFA date for geographic atrophy is February 2023.
Intended to stimulate hair growth in alopecia, ritlecitinib will “likely benefit from its first-in-class status, rapid onset of action, and expected label for both adults and adolescents,” Clarivate said. The launch of this drug is expected in 2023.
This first-in-class, orally active, single molecule functions as a high-affinity, dual-acting antagonist of both endothelin type A and angiotensin II subtype 1 receptors, associated with progression of kidney disease. “Its development...promises to halt progression for many patients and f lls a gap in the treatment armamentarium,” Clarivate said. The PDUFA date is February 17, 2023.
Teclistamab is a first-in-class, bispecific antibody targeted to B-cell maturation antigen to treat multiple myeloma. Ongoing phase 3 trials are expected to provide confirmation of clinical benefit in the drug’s approved setting and lead to label expansions in other multiple myeloma patient populations—including in combination with other approved agents, Clarivate said. Teclistamab was granted accelerated approval in October 2022.
Teplizumab (Tzield) is the first immunotherapy to launch for type 1 diabetes (T1D). It is a “landmark drug given its potential ability to preserve beta cell function and delay the need for insulin treatment in those with T1D,” Clarivate said. Teplizumab was approved in November 2022.
Valoctocogene roxaparvovec (Roctavian)
Valoctocogene roxaparvovec is poised to be the first gene therapy to launch in the United States for severe hemophilia A. “Treatment benefit is expected to last for years, reduce the number of bleeding events, minimize the need for replacement factor VIII and negate the use of otherwise burdensome prophylaxis treatment,” Clarivate said. The PDUFA date is March 31, 2023
1. Ward M, Patel K, Beers K, et al. Drugs to watch 2023. Clarivate. Accessed January 11, 2023. https://clarivate.com/wp-content/uploads/dlm_uploads/2022/12/J0541_Drugs-to-Watch_Report_2023_V8.2.pdf
2. Clarivate identifies fifteen potential blockbuster drugs in annual Drugs to Watch report. News release. Clarivate. January 10, 2023. Accessed January 11, 2023. https://ir.clarivate.com/news-events/press-releases/news-details/2023/Clarivate-Identifies-Fifteen-Potential-Blockbuster-Drugs-in-Annual-Drugs-to-Watch-Report/default.aspx