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 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
7 KEY TAKEAWAYS
8 DISEASE BACKGROUND
10 Skin-directed therapy
10 Systemic therapy
14 US and 5EU incidence methodology
17 US and 5EU prevalence methodology
20 MARKETED DRUGS
23 Approvals by country
26 PIPELINE DRUGS
33 RECENT EVENTS AND ANALYST OPINION
33 Poteligeo for CTCL (December 11, 2017)
34 Poteligeo for CTCL (April 07, 2017)
37 KEY UPCOMING EVENTS
38 KEY REGULATORY EVENTS
38 Kyowa Hakko Kirin’s Mogamulizumab for CTCL
39 PROBABILITY OF SUCCESS
40 LICENSING AND ASSET ACQUISITION DEALS
40 Helsinn Adds To Cancer Care Portfolio With Actelion’s Valchlor
41 PARENT PATENTS
42 REVENUE OPPORTUNITY
43 CLINICAL TRIALS
44 Sponsors by status
45 Sponsors by phase
46 Recent events
47 Prescription information
LIST OF FIGURES
14 Figure 1: Global trends in incident cases of CTCL, 2017–26
17 Figure 2: Global trends in incident cases of CTCL, US and 5EU, 2017–26
26 Figure 3: Overview of pipeline drugs for CTCL in the US
27 Figure 4: Pipeline drugs for CTCL, by company
27 Figure 5: Pipeline drugs for CTCL, by drug type
28 Figure 6: Pipeline drugs for CTCL, by classifications
34 Figure 7: Poteligeo for CTCL (December 11, 2017): Phase III – MAVORIC (vs. Vorinostat)
36 Figure 8: Poteligeo for CTCL (April 07, 2017): Phase III – MAVORIC (vs. Vorinostat)
37 Figure 9: Key upcoming events in CTCL
39 Figure 10: Probability of success in the CTCL pipeline
40 Figure 11: Licensing and asset acquisition deals in CTCL, 2013–18
41 Figure 12: Parent patents in CTCL
43 Figure 13: Clinical trials in CTCL
43 Figure 14: Top 10 drugs for clinical trials in CTCL
44 Figure 15: Top 10 companies for clinical trials in CTCL
44 Figure 16: Trial locations in CTCL
45 Figure 17: CTCL trials status
46 Figure 18: CTCL trials sponsors, by phase
LIST OF TABLES
13 Table 1: Global incident cases of CTCL, 2017–26
16 Table 2: Incident cases of CTCL, US and 5EU, 2017–26
18 Table 3: Five-year prevalent cases of CTCL, US and 5EU, 2017–26
19 Table 4: 10-year prevalent cases of CTCL, US and 5EU, 2017–26
21 Table 5: Marketed drugs for CTCL
24 Table 6: Approvals by country for CTCL
29 Table 7: Pipeline drugs for CTCL in the US
33 Table 8: Poteligeo for CTCL (December 11, 2017)
35 Table 9: Poteligeo for CTCL (April 07, 2017)
42 Table 10: Historical global sales, by drug ($m), 2013–17
42 Table 11: Forecasted global sales, by drug ($m), 2018–22
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