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 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
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 PIPELINE DRUGS
30 RECENT EVENTS AND ANALYST OPINION
30 Copiktra for CTCL (July 25, 2019)
31 Copiktra for CTCL (March 6, 2019)
31 Multiple Drugs for CTCL (January 17, 2019)
32 Copiktra for CTCL (December 3, 2018)
35 KEY UPCOMING EVENTS
36 KEY REGULATORY EVENTS
36 Anticancers, Orphans & The First CAR-Ts: New EU Drug Approvals In 2018
37 PROBABILITY OF SUCCESS
38 LICENSING AND ASSET ACQUISITION DEALS
38 Mallinckrodt, Transimmune Collaborate On Photopheresis
40 PARENT PATENTS
41 REVENUE OPPORTUNITY
42 CLINICAL TRIAL LANDSCAPE
43 Sponsors by status
44 Sponsors by phase
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
22 Figure 3: Overview of pipeline drugs for CTCL in the US
23 Figure 4: Pipeline drugs for CTCL, by company
23 Figure 5: Pipeline drugs for CTCL, by drug type
23 Figure 6: Pipeline drugs for CTCL, by classification
34 Figure 7: Copiktra for CTCL (December 3, 2018): Phase I – w/Romidepsin or Bortezomib (TCLs) (MSKCC)
35 Figure 8: Key upcoming events in CTCL
37 Figure 9: Probability of success in the CTCL pipeline
38 Figure 10: Licensing and asset acquisition deals in CTCL, 2014–19
40 Figure 11: Parent patents in CTCL
42 Figure 12: Clinical trials in CTCL
42 Figure 13: Top 10 drugs for clinical trials in CTCL
43 Figure 14: Top 10 companies for clinical trials in CTCL
43 Figure 15: Trial locations in CTCL
44 Figure 16: CTCL trials status
45 Figure 17: 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
25 Table 6: Pipeline drugs for CTCL in the US
30 Table 7: Copiktra for CTCL (July 25, 2019)
31 Table 8: Copiktra for CTCL (March 6, 2019)
32 Table 9: Multiple Drugs for CTCL (January 17, 2019)
33 Table 10: Copiktra for CTCL (December 3, 2018)
41 Table 11: Historical global sales, by drug ($m), 2014–18
41 Table 12: Forecasted global sales, by drug ($m), 2019–23
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