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 of CTCL in the US and five major EU markets (France, Germany, Italy, Spain and the UK), which is forecast to increase to 6,160 incident cases 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 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, with only one drug in Phase III. Therapies in development for CTCL focus on a wide variety of targets. The greatest proportion of pipeline drugs in 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, AFM13, and cobomarsen.
• The overall likelihood of approval of a Phase I hematologic asset is 9.6%, and the average probability a drug advances from Phase III is 58.3%. Drugs, on average, take 8.8 years from Phase I to approval, compared to 9.3 years in the overall oncology space.
• There have been 13 licensing and asset acquisition deals involving CTCL drugs during 2014–19. The $298.8m definitive agreement signed in 2019 between Spectrum Pharmaceuticals and Acrotech Biopharma for the sale of seven FDA-approved hematology/oncology products was the largest deal.
• 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 88% of trials in Phase I–II, and only 12% 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. Celgene, 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 overall number of clinical trials for CTCL, followed by Merck & Co