Market Spotlight: Cutaneous T-Cell Lymphoma (CTCL)

This Market Spotlight report covers the Cutaneous T-Cell Lymphoma (CTCL) market, comprising key pipeline and marketed drugs, clinical trials, upcoming events, patent information, a 10-year disease incidence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

• Datamonitor Healthcare estimates that in 2016, there were approximately 13,600 incident cases of cutaneous T-cell lymphoma (CTCL) worldwide, and forecasts that number to increase to 16,100 incident cases by 2025.
• It is estimated that the majority of diagnosed cases were in males in 2016. Approved drugs in the CTCL space target antibody-drug conjugate, cluster of differentiation 30, TNFRSF8, microtubules, histone deacetylase, retinoid receptors, retinoid X receptors, DNA synthesis, interleukin-2, and protein synthesis. These drugs are administered via the intravenous, topical, and oral routes.
• The majority of industry-sponsored drugs in active clinical development for CTCL are in Phase II, with only one drug in NDA/BLA phase.
• Therapies in mid-to-late-stage development for CTCL focus on a wide variety of targets, with the majority being administered via the intravenous route.
• High-impact upcoming events include topline Phase II trial results for resminostat. There were 13 licensing and asset acquisition activities involving CTCL drugs during 2013–18. The exclusive acquisition agreement signed in 2016 between Medivir AB and Tetralogic Pharmaceuticals for $238m, for the acquisition of two clinicalstage oncology programs (remetinostat and birinapant), was the largest deal during the period.
• Istodax’s US parent patents (polymorph, process, and composition) are set to expire in August 2021, which will open the door to generic entries.
• The clinical trials distribution across Phase I–IV indicates that the majority of trials for CTCL have been in the early and midphases of development, with 86% of trials in Phase I–II, and only 14% in Phase III–IV.
• The US has a substantial lead in the number of CTCL clinical trials globally. Germany leads the major EU markets, while Japan has the top spot in Asia.
• Clinical trial activity in the CTCL space is dominated by completed trials. Merck & Co, Ligand, and Takeda have the highest number of completed clinical trials for CTCL, with five trials each. Meanwhile, Celgene has six ongoing trials.
• Celgene leads industry sponsors with the highest number of clinical trials for CTCL, followed by Merck & Co and Seattle Genetics.