|
市場調査レポート
商品コード
1129027
皮膚T細胞リンパ腫市場 - 市場の洞察、疫学、市場予測:2032年Cutaneous T-Cell Lymphoma - Market Insight, Epidemiology And Market Forecast - 2032 |
||||||
● お客様のご希望に応じて、既存データの加工や未掲載情報(例:国別セグメント)の追加などの対応が可能です。 詳細はお問い合わせください。 |
皮膚T細胞リンパ腫市場 - 市場の洞察、疫学、市場予測:2032年 |
出版日: 2022年09月01日
発行: DelveInsight
ページ情報: 英文 247 Pages
納期: 1~3営業日
|
主要7ヶ国における皮膚T細胞リンパ腫の市場規模は、2021年に3億9,900万米ドルとなりました。同市場は、予測期間(2022年~2032年)にかけてさらに拡大すると予測されています。
当レポートでは、主要7ヶ国における皮膚T細胞リンパ腫市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2032年までの市場規模予測、および医療のアンメットニーズなどを提供しています。
DelveInsight's " Cutaneous T-cell Lymphoma - Market Insights, Epidemiology and Market Forecast- 2032" report delivers an in-depth understanding of the CTCL, historical and forecasted epidemiology as well as the CTCL market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
CTCL market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM CTCL market size from 2019 to 2032. The report also covers current CTCL treatment practice/algorithm, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Study Period: 2019-2032
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.
Several types of cutaneous T-cell lymphoma exist. The most common type is mycosis fungoides. Sezary syndrome is a less common type that causes skin redness over the entire body. Some types of cutaneous T-cell lymphoma, such as mycosis fungoides, progress slowly and others are more aggressive.
Signs and symptoms of CTCL include formation of patches and lumps on skin, enlarged lymph nodes, hair loss, thickening of the skin on the palms of the hands and soles of the feet and rash-like skin redness over the entire body that is intensely itchy.
Different staging systems have been proposed for CTCLs. The most accepted and widely used system is the tumor-node-metastasis (TNM) system. It includes the following stages:
Cutaneous T-cell Lymphoma Diagnosis
The diagnosis of cutaneous T-cell lymphomas is based upon a thorough clinical evaluation, detection of certain symptoms and physical findings, a detailed patient history, and a variety of specialized tests. Such testing is necessary to confirm the specific type (and subtype) of CTCL, to assess the nature and extent of the disease, and to determine the most appropriate treatments.
For those with suspected lymphoma as suggested by thorough patient history and clinical examination, various diagnostic tests may be recommended. These may include biopsies, blood tests, specialized imaging tests, and/or additional tests.
Cutaneous T-cell Lymphoma Treatment
A wide variety of treatment options exist for individuals with CTCL including topical chemotherapy, radiation therapy, photo chemotherapy, vitamin A derivatives (retinoids), and chemotherapy. These treatments may be used alone or in varied combination.
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by total incident population of CTCL, type-specific population of CTCL, subtype-specific population of CTCL, gender-specific population of CTCL, stage-specific population of CTCL, treatment eligible incident population in early and advanced stage in the 7MM market covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2019 to 2032.
Key Findings
This section provides glimpse of the CTCL epidemiology in the 7MM
Drug chapter segment of the CTCL report encloses the detailed analysis of CTCL marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the CTCL clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
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.
Note: Detailed Current therapies assessment will be provided in the full report of CTCL
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 Sezary 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 Sezary 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 Sezary 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.
Note: Detailed emerging therapies assessment will be provided in the final report.
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 Sezary 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.
The overall management of CTCL across stages is complex; there is no unified standard of care or a universal algorithm. Consequently, different stages require different types of care, and following multidisciplinary management is essential. For example, all patients with the advanced-stage disease also have skin lesions remaining from the early stage, and dermatologists should be involved in treating these lesions while administering other therapeutic agents simultaneously.
The treatment of CTCL (Mycosis fungoides and Sezary Syndrome) depends on the disease stage. Early-stage topical therapies include corticosteroids, retinoids, imiquimod (Aldara), ultraviolet-An irradiation (PUVA), and total skin electron beam therapy. Systemic therapies are introduced in the advanced stages where the disease is widespread and/or resistant to topical treatment. Therapies include interferon-alpha injections, stem cell transplants, alemtuzumab (MabCampath), and other chemotherapy regimens. The duration of response to treatment is temporary for most therapies, including Zolinza; the drug has been considered in our report as per NCCN guidelines.
Since CTCL is a cancer indication, incident cases have been considered while estimating the market. Now, although the survival rate of early-stage CTCL patients is relatively higher compared to late-stage cases, no study has been performed to estimate either the prevalence of early-stage cases or the progression of the early-stage population to the later stages of the disease. Hence just like the market size estimation that has been carried out for late-stage CTCL cases, the market size for early-stage cases is based on the incidence of the disease.
The US FDA-approved drugs which are currently available include Istodax (romidepsin), Valchlor (mechlorethamine), Uvadex (methoxsalen), Targretin (bexarotene), Adcetris (brentuximab vedotin), Poteligo (mogamulizumab) and Zolinza (vorinostat).
The CTCL pipeline posseses multiple potential drugs in late- and mid-stage developments to be launched shortly. Key players involved in robust research and development include SGX301 (Soligenix), I/ONTAK (E7777) (Citius Pharma), Remetinostat (Medivir AB), Pembrolizumab (Merck Sharp & Dohme), BNZ-1 (Bioniz Therapeutics), Tislelizumab (BeiGene), exoIL-12 (Codiak BioSciences), Bifikafusp alfa + onfekafusp alfa (Philogen), and ASTX660 (Astex Pharmaceuticals), are some of the major players that are going to alter the market dynamics in the coming years.
Key Findings
This section includes a glimpse of the Low-grade glioma7MM market.
The total market size of CTCL in the United States is expected to increase with a CAGR of 3.7% during the study period (2019-2032).
The total market size of CTCL in EU5 is expected to increase with a CAGR of 3.3% during the study period (2019-2032).
The total market size of CTCL in Japan is expected to increase with a CAGR of 0.3% during the study period (2019-2032).
Analyst Commentary
This section focusses on the rate of uptake of the potential drugs expected to get launched in the market during the study period 2019-2032. The analysis covers CTCL market uptake by drugs; patient uptake by therapies; and sales of each drug. For example- I/ONTAK (E7777), is a purified reformulation of denileukin diftitox (ONTAK). E7777 is a fusion protein that combines the interleukin-2 (IL-2) receptor-binding domain with diphtheria toxin fragments. Currently the drug has completed Phase III trial. The company anticipates filing a biologics license application (BLA) with FDA in the second half of 2022 and commercially launching the product in 2023. As per our analysis, I/ONTAK drug uptake in the US for second-line (Early Stage) is expected to be medium- fast with peak share of 9%, years to peak would be 7 years.
CTCL Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase II, Phase III and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for CTCL emerging therapies.
KOL- Views
To keep up with current market trends, we take KOLs and SME's opinion working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders are professor of dermatology, the University of Pennsylvania, Head of the Dermatology Department, Saint Louis Hospital, Paris, Chief Medical Officer, Citius. Their opinion helps to understand and validate current and emerging therapies treatment patterns or CTCL market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.
Competitive Intelligence Analysis
We perform competitive and market Intelligence analysis of the CTCL market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Key Questions
Market Insights:
Epidemiology Insights:
Current Treatment Scenario, Marketed Drugs and Emerging Therapies: