This Market Spotlight report covers the Cutaneous T-Cell Lymphoma (CTCL) market, comprising key marketed and pipeline drugs, clinical trials, upcoming events, regulatory events, recent events and analyst opinion, probability of success, 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 2021, there were approximately 16,410 incident cases of cutaneous T-cell lymphoma (CTCL) worldwide, and forecasts that number to increase to 18,060 incident cases by 2026.
• In 2021, there were approximately 6,040 incident cases of CTCL in the US and five major European 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 44,040 10-year prevalent cases of CTCL in the US and five major European markets in 2021, 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 (CD30), tumor necrosis factor receptor superfamily member 8, microtubules (tubulin), histone deacetylase, interleukin-2 (IL-2), protein synthesis, chemokine receptor 4, the immune system, retinoid X receptors, retinoid receptors, DNA, 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, and intratumoral formulations.
• The only high-impact upcoming event for drugs in the CTCL space is topline Phase II trial results for resminostat. The overall likelihood of approval of a Phase I hematologic asset is 7.7%, and the average probability a drug advances from Phase III is 55.7%. Drugs, on average, take 9.7 years from Phase I to approval, compared to 9.9 years in the overall oncology space.
• 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 91% of trials in Phase I–II, and only 9% in Phase III–IV.
• The US has a substantial lead in the number of CTCL clinical trials globally. France leads the major European markets, while China has the top spot in Asia.
• Clinical trial activity in the CTCL space is dominated by completed trials. Bristol Myers Squibb has the highest number of completed clinical trials for CTCL, with 20 trials.
• Bristol Myers Squibb leads industry sponsors with the highest overall number of clinical trials for CTCL, followed by Merck & Co