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 13,900 incident cases of cutaneous T-cell lymphoma (CTCL) worldwide, and forecasts that number to increase to 16,520 incident cases by 2026.
• In 2017, there were approximately 4,790 incident cases of CTCL in the US and five major EU markets (France, Germany, Italy, Spain and the UK), which is forecasted to increase to 5,020 incident cases by 2026.
• Datamonitor Healthcare estimates that there were approximately 34,850 10-year prevalent cases of CTCL in the US and five major EU markets in 2017, which is expected to increase to 36,570 cases 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. Therapies in mid-to-late-stage development for CTCL focus on a wide variety of targets, with the intravenous route being the most common method of delivery.
• High-impact upcoming events comprise topline Phase III trial results for SGX301, topline Phase II trial results for resminostat, and an expected CHMP opinion for Poteligeo.
• The overall likelihood of approval of a Phase I hematologic asset is 10.9%, 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 exclusive acquisition agreement signed in 2016 between Medivir and TetraLogic Pharmaceuticals for $238m for the acquisition of two clinical-stage oncology programs (remetinostat and birinapant) was the largest deal during the period.
• The distribution of clinical trials across Phase I–IV indicates that the vast majority of trials for CTCL have been in the early and mid-phases 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.
• Merck & Co, Ligand, and Takeda have the highest number of completed clinical trials for CTCL, with five trials each.
• Celgene leads industry sponsors with the highest number of clinical trials for CTCL, followed by Merck & Co and Seattle Genetics