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

Key Takeaways

• Datamonitor Healthcare estimates that in 2017, there were approximately 15,200 incident cases of cutaneous T-cell lymphoma (CTCL) worldwide, and forecasts that number to increase to 18,060 incident cases by 2026.
• In 2017, there were approximately 5,930 incident cases in the US and five major EU markets (France, Germany, Italy, Spain and the UK), which is forecast to increase to 6,160 by 2026.
• Datamonitor Healthcare estimates that there were approximately 41,900 10-year prevalent cases of CTCL in the US and five major EU markets in 2017, which is expected to increase to 45,030 by 2026.
• Approved drugs in the CTCL space target antibody-drug conjugate, cluster of differentiation 30, tumor necrosis factor receptor superfamily member 8, microtubules, histone deacetylase, interleukin-2, protein synthesis, chemokine receptor 4, retinoid X receptors, retinoid receptors, and DNA 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 Phase III. Therapies in mid-to-late-stage development for CTCL focus on a wide variety of targets. The majority of pipeline drugs in mid-tolate stage development are administered intravenously, with the remainder being tested in oral, topical, intratumoral, and subcutaneous formulations.
• High-impact upcoming events for drugs in the CTCL space comprise topline Phase III trial results for SGX301, and topline Phase II trial results for resminostat.
• The overall likelihood of approval of a Phase I hematologic asset is 10.7%, and the average probability a drug advances from Phase III is 57.6%. Drugs, on average, take 8.7 years from Phase I to approval, compared to 9.2 years in the overall oncology space.
• There have been 14 licensing and asset acquisition deals involving CTCL drugs during 2013–18. The $238m acquisition agreement signed in 2016 between Medivir and TetraLogic Pharmaceuticals for the acquisition of two clinical-stage oncology programs (remetinostat and birinapant) was the largest deal during the period.
• The clinical trials distribution across Phase I–IV indicates that the vast majority of trials for CTCL have been in the early and midphases of development, with 87% of trials in Phase I–II, and only 13% 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.
• Celgene leads the industry sponsors with the highest number of clinical trials for CTCL, followed by Merck & Co.