Market Spotlight: Cutaneous T-Cell Lymphoma (CTCL)
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.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
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.
- 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.
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
10 Skin-directed therapy
10 Systemic therapy
14 Incidence methodology for the US and five major EU markets
16 Prevalence methodology for the US and five major EU markets
19 MARKETED DRUGS
22 Approvals by country
25 PIPELINE DRUGS
32 RECENT EVENTS AND ANALYST OPINION
32 Poteligeo for CTCL (December 11, 2017)
33 Poteligeo for CTCL (April 07, 2017)
36 KEY UPCOMING EVENTS
37 KEY REGULATORY EVENTS
37 Poteligeo Changes
37 Kyowa Kirin’s Poteligeo Joins Growing CTCL Market
37 Kyowa Hakko Kirin’s Mogamulizumab for CTCL
38 PROBABILITY OF SUCCESS
39 LICENSING AND ASSET ACQUISITION DEALS
39 Helsinn Adds To Cancer Care Portfolio With Actelion’s Valchlor
40 PARENT PATENTS
41 REVENUE OPPORTUNITY
42 CLINICAL TRIALS
43 Sponsors by status
44 Sponsors by phase
45 Recent events
46 Prescription information
LIST OF FIGURES
14 Figure 1: Global trends in incident cases of CTCL, 2017–26
16 Figure 2: Trends in incident cases of CTCL, US and 5EU, 2017–26
25 Figure 3: Overview of pipeline drugs for CTCL in the US
26 Figure 4: Pipeline drugs for CTCL, by company
26 Figure 5: Pipeline drugs for CTCL, by drug type
27 Figure 6: Pipeline drugs for CTCL, by classification
33 Figure 7: Poteligeo for CTCL (December 11, 2017): Phase III – MAVORIC (vs. Vorinostat)
35 Figure 8: Poteligeo for CTCL (April 07, 2017): Phase III – MAVORIC (vs. Vorinostat)
36 Figure 9: Key upcoming events in CTCL
38 Figure 10: Probability of success in the CTCL pipeline
39 Figure 11: Licensing and asset acquisition deals in CTCL, 2013–18
40 Figure 12: Parent patents in CTCL
42 Figure 13: Clinical trials in CTCL
42 Figure 14: Top 10 drugs for clinical trials in CTCL
43 Figure 15: Top 10 companies for clinical trials in CTCL
43 Figure 16: Trial locations in CTCL
44 Figure 17: CTCL trials status
45 Figure 18: CTCL trials sponsors, by phase
LIST OF TABLES
13 Table 1: Global incident cases of CTCL, 2017–26
15 Table 2: Incident cases of CTCL, US and 5EU, 2017–26
17 Table 3: 10-year prevalent cases of CTCL, US and 5EU, 2017–26
18 Table 4: Five-year prevalent cases of CTCL, US and 5EU, 2017–26
20 Table 5: Marketed drugs for CTCL
23 Table 6: Approvals by country for CTCL
28 Table 7: Pipeline drugs for CTCL in the US
32 Table 8: Poteligeo for CTCL (December 11, 2017)
34 Table 9: Poteligeo for CTCL (April 07, 2017)
41 Table 10: Historical global sales, by drug ($m), 2013–17
41 Table 11: Forecasted global sales, by drug ($m), 2018–22
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