Cutaneous T-cell Lymphoma Market Size was USD 399 Million in 2021

The emerging drugs shall significantly impact the cutaneous T-cell lymphoma (CTCL) market size, considering the robust pipeline with a large variety of therapeutic classes in the periphery. Presently, many biologics and drugs are under investigation for CTCL treatment.

Cutaneous T-cell Lymphoma market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Cutaneous T-cell Lymphoma market size from 2019 to 2032. The report also covers current Cutaneous T-cell Lymphoma treatment practice/algorithm, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Key takeaways from the Cutaneous T-cell Lymphoma Market Research Report

• As per DelveInsight analysis, the cutaneous T-cell lymphoma market size in the 7MM was valued at approximately USD 399 million in 2021.

• As per the estimates, the total cutaneous T-cell lymphoma incident population in the 7MM was around 7,485 in 2021.

• The leading cutaneous T-cell lymphoma companies such as Pfizer, Eisai, Citius Pharmaceuticals, Bristol Myers Squibb, Merck, Kyowa Kirin, Medivir, Seagen, Soligenix, 4SC AG, Galderma, Equillium, Innate Pharma, BeiGene, Codiak BioSciences, Astex Pharmaceuticals, and others are developing novel cutaneous T-cell lymphoma drugs that can be available in the cutaneous T-cell lymphoma market in the upcoming years.

• Promising cutaneous T-cell lymphoma therapies include SGX301, Pembrolizumab, Resminostat, CD11301, EQ101, Tolinapant (ASTX660), exoIL-12, Lacutamab, Remetinostat, Resminostat, Tislelizumab (BGB-A317) and others.

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Cutaneous T-cell Lymphoma Overview

Cutaneous T-cell lymphoma (CTCL) is a group of disorders characterized by abnormal accumulation of malignant T-cells in the skin potentially resulting in the development of rashes, plaques, and tumors. Furthermore, more than three out of every four skin lymphomas diagnosed are CTCLs and often appear as eczema-like skin rashes and can affect widespread parts of the body. Most CTCLs typically fall into the category of indolent (i.e. chronic) lymphomas - treatable, but not curable and usually not life-threatening.

Cutaneous T-cell lymphoma Epidemiology Segmentation in the 7MM

• Cutaneous T-cell Lymphoma Incident Population
• Cutaneous T-cell Lymphoma Type-specific Cases
• Cutaneous T-cell Lymphoma Sub-type specific incidence
• Cutaneous T-cell Lymphoma Gender-specific cases
• Cutaneous T-cell Lymphoma Stage-specific cases
• Cutaneous T-cell Lymphoma Treatment-eligible incident population in early-and advanced-stage

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Cutaneous T-cell Lymphoma Marketed Drugs

• Uvadex (Methoxsalen): Mallinckrodt Pharmaceuticals
Uvadex (methoxsalen) is approved for the treatment of CTCL. Methoxsalen is a naturally occurring photoactive substance found in the seeds of the Ammi majus (Umbelliferae) plant. It belongs to a group of compounds known as psoralens or furocoumarins. In February 1999, FDA approved Uvadex for the palliative treatment of the skin manifestations of CTCL that is unresponsive to other forms of treatment. In December 2021, Mallinckrodt announced the results of a retrospective, observational medical chart review study assessing real-world treatment outcomes among CTCL patients who initiated therapy with extracorporeal photopheresis.

• Targretin (Bexarotene): Valeant Pharmaceuticals/ Bausch Health
Targretin (bexarotene) is approved for the treatment of CTCL. It is a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). In December 1999, FDA granted marketing approval for Targretin (bexarotene) capsules for the treatment of cutaneous manifestations of CTCL in patients who are refractory to at least one prior systemic therapy. In March 2001, Targretin received a marketing authorization valid throughout the EU. In January 2016, Minophagen Pharmaceutical announced that Targretin Capsules (bexarotene) 75 mg have been approved in Japan by the Ministry of Health, Labour and Welfare for the treatment of CTCL.

• Potelegio (Mogamulizumab-kpkc): Kyowa Hakko Kirin
Poteligeo is used to treat adult patients with relapsed or refractory MF or SS after at least one prior systemic therapy. It is marketed in Japan for the treatment of relapsed or refractory CTCL. Mogamulizumab is a recombinant humanized monoclonal antibody composed of complementarity-determining regions derived from mouse anti-human CC chemokine receptor 4 monoclonal antibody and framework regions and constant regions derived from human IgG1. In August 2018, the FDA approved mogamulizumab-kpkc (Poteligeo) for treating patients with CTCL who have received at least 1 prior systemic therapy. The approval is specifically for patients with MF or SS, two subtypes of CTCL. The FDA based its decision on results from the Phase III MAVORIC study. In November 2018, European Commission decided granting a marketing authorisation to Poteligo.

• Valchlor/Ledaga (Mechlorethamine): Helsinn Therapeutics
Valchlor is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides‐type CTCL in patients who have received prior skin‐directed therapy. Mechlorethamine HCl is a white to off-white solid that is very soluble in water and methanol, partially soluble in acetone, and generally not soluble in organic solvents. Mechlorethamine, also known as nitrogen mustard, is an alkylating agent which inhibits rapidly proliferating cells. In August 2013, FDA approved Valchlor for the treatment of stage IA/IB mycosis fungoides-type CTCL. In March 2017, the European Commission granted marketing authorization to use the drug under the brand name Ledaga (chlormethine gel) for the treatment of mycosis fungoides-type cutaneous T-cell lymphoma.

• Adcetris (Brentuximab Vedotin): Seagen
Adcetris (Brentuximab vedotin) targets CD30 using our proprietary antibody-drug conjugate (ADC) technology. CD30 is found on the surface of most classical Hodgkin lymphoma (HL) cells and in several types of non-Hodgkin lymphoma, but not commonly found on healthy cells. In November 2017, FDA approved Adcetris (brentuximab vedotin) to treat adult patients with pcALCL and CD30-expressing MF who have received prior systemic therapy. In January 2018, Takeda Pharmaceutical announced that the European Commission extended the current conditional marketing authorization of Adcetris (brentuximab vedotin) and approved Adcetris for the treatment of adult patients with CD30-positive CTCL after at least one prior systemic therapy.

Cutaneous T-cell Lymphoma Emerging Drugs

• I/ONTAK (E7777): Citius Pharmaceuticals
Citius Pharmaceuticals', I/ONTAK (E7777) is a purified reformulation of denileukin diftitox (ONTAK), a previously FDA-approved cancer immunotherapy for the treatment of persistent or recurrent CTCL. Improvements to the original formulation resulted in a therapy that maintains the same amino acid sequence but features greater purity and bioactivity. E7777 is a fusion protein that combines the interleukin-2 (IL-2) receptor-binding domain with diphtheria toxin fragments. ONTAK was marketed in the US from 1999 to 2014, when it was voluntarily withdrawn from the market. Manufacturing improvements resulted in a new formulation, which maintains the same amino acid sequence but features improved purity and bioactivity. The new formulation received regulatory approval in Japan for the treatment of CTCL and PTCL in 2021. The company anticipates filing a biologics license application (BLA) with FDA in the second half of 2022 and commercially launching the product in 2023, subject to FDA approval. In July 2022, Citius Pharmaceuticals held a Type B pre-BLA meeting with the US FDA to discuss I/ONTAK (denileukin diftitox) for the treatment of patients with persistent or recurrent CTCL. In 2011 and 2013, the FDA granted Orphan Drug Designation to E7777 for the treatment of PTCL and CTCL, respectively. The drug has completed Phase III trial for patients with persistent or recurrent CTCL.

• HyBryte (SGX301): Soligenix
Soligenix is developing HyBryte (a proposed proprietary name of SGX301 or synthetic hypericin) for the treatment of CTCL. It is a novel, first-in-class photodynamic therapy utilizing safe, visible light for activation. It contains synthetic hypericin as an active ingredient which is a potent photosensitizer applied topically to skin lesions and activated by visible fluorescent light. In April 2021, Soligenix, announced that the US FDA has conditionally accepted HyBryte as the proposed brand name for SGX301. The company announced that it anticipates submitting a new drug application (NDA) to FDA for marketing authorization of HyBryte (SGX301 or synthetic hypericin) in the treatment of CTCL in the second half of 2022 with the corresponding potential FDA approval in the second half of 2023. The company also anticipates filing MAA submission to the EU for CTCL in first half 2023. The drug has completed Phase III trial.

• Resminostat: 4SC AG
Resminostat being developed by 4SC AG, is a potent inhibitor of class I, IIb and IV HDACs, including a pronounced activity against HDAC6. Resminostat was also investigated by 4SC and its Japanese partner Yakult Honsha in several other cancer indications. The company anticipates unbinding the pivotal Phase II (RESMAIN) study in the first quarter of 2023 and presenting topline data in second quarter of 2023. The company also plans to file for Orphan Drug Designation for CTCL, and seek FDA advice on registration strategy in the US in second half of 2023.

• Lacutamab (IPH4102): Innate Pharma
Lacutamab (IPH4102) is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody being developed for the treatment of CTCL. KIR3DL2 is an inhibitory receptor of the KIR family. It has a restricted expression on normal tissues. The drug is currently in Phase II of a clinical study for Sezary syndrome and Mycosis fungoides. In May 2022, Innate Pharma announced the Phase II (TELLOMAK) study in Sézary syndrome and mycosis fungoides continues to progress and the company expects to report preliminary data from both cohorts in the second half of 2022. In 2019, lacutamab was granted Orphan Drug status in the European Union and in the United States for the treatment of CTCL. In January 2019, the US FDA granted Innate Pharma Fast Track designation for lacutamab for treating adult patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies. In 2020, the company received PRIME designation from the European Medicines Agency for lacutamab to treat Sézary syndrome.

• exoIL-12: Codiak
exoIL-12 is an exosome therapeutic candidate engineered using the engEx platform to display IL-12 in a fully active form on the surface via Codiak's proprietary scaffold protein, PTGRFN. The company initiated a Phase I clinical trial for exoIL-12 in healthy volunteers and patients with early-stage CTCL and plans to expand into other IL-12 responsive solid tumors in the future. In December 2020, the company reported positive results from Part A of Phase I clinical trial of exoIL-12 in healthy human volunteers. On June 30, 2022, Codiak BioSciences, issued a press release announcing platform-validating clinical data from the Phase I trial of exoIL-12 and plans to advance it into Phase II trial. Codiak anticipates initiating a Phase II trial during the first quarter of 2023 in patients with cutaneous malignancies responsive to rIL-12 in studies historically, including CTCL, Kaposi's sarcoma, Merkel cell carcinoma, and squamous cell carcinoma.

Cutaneous T-cell Lymphoma Market Outlook
Cutaneous T-cell lymphomas (CTCL) are the most common types of skin lymphoma. More than three out of every four skin lymphomas diagnosed are CTCLs and often appear as eczema-like skin rashes and can affect widespread parts of the body. There are different subtypes of CTCL. CTCLs are characterized by the recruitment of malignant T-cell clones into the skin. Mycosis fungoides (MF) represent the most common type of CTCL and account for ~50% of all primary cutaneous lymphomas, followed by Sézary syndrome. The most common type is mycosis fungoides. In some cases, CTCL can affect more than just the skin and cause tumors, exfoliation, and ulceration accompanied by infections and itching.

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Scope of the Cutaneous T-cell Lymphoma Market Report
• Study Period: 2019-2032
• Coverage: 7MM
• Cutaneous T-cell Lymphoma Companies: Pfizer, Eisai, Citius Pharmaceuticals, Bristol Myers Squibb, Merck, Kyowa Kirin, Medivir, Wellness Pharma, Seagen, Soligenix, 4SC AG, Galderma, Equillium, and others
• Cutaneous T-cell Lymphoma Therapies: SGX301, Pembrolizumab, Resminostat, CD11301, EQ101, and others
• Cutaneous T-cell Lymphoma Market Dynamics: Cutaneous T-cell Lymphoma Market Drivers and Barriers
• Cutaneous T-cell Lymphoma Market Access and Reimbursement, Unmet Needs

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Table of Content
1. Key Insights
2. Report Introduction
3. Executive Summary
4. Key Events
5. SWOT Analysis
6. Epidemiology and Market Methodology
7. Cutaneous T-cell Lymphoma Market Overview at a Glance
8. Disease Background and Overview
9. Cutaneous T-cell Lymphoma Treatment and Management
10. Treatment Guidelines
11. Epidemiology and Patient Population of Cutaneous T-cell Lymphoma in the 7MM
12. Patient Journey
13. Key Endpoints in Cutaneous T-cell Lymphoma
14. Cutaneous T-cell Lymphoma Marketed Drugs
15. Cutaneous T-cell Lymphoma Emerging Drugs
16. CTCL: 7MM Market Analysis
17. Cutaneous T-cell Lymphoma Unmet Needs
18. Cutaneous T-cell Lymphoma Market Access and Reimbursement
19. Appendix
20. DelveInsight Capabilities
21. Disclaimer
22. About DelveInsight

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