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Peripheral T-Cell Lymphoma Market Insight, Epidemiology And Market Forecast - 2032

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    Report

  • 235 Pages
  • September 2022
  • Region: Global
  • DelveInsight
  • ID: 4330871
UP TO OFF until Dec 31st 2024
This Peripheral T-cell Lymphoma - Market Insights, Epidemiology and Market Forecast- 2032” report delivers an in-depth understanding of the PTCL, historical and forecasted epidemiology as well as the PTCL market trends in the United States, the EU-5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

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

Geography Covered

  • The United States
  • The EU-5 (Germany, France, Italy, Spain, and the United Kingdom)
  • Japan
Study Period: 2019-2032

Peripheral T-cell Lymphoma Disease Understanding and Treatment Algorithm

Peripheral T-cell Lymphoma Overview

Peripheral T-cell lymphomas (PTCLs) are an uncommon and heterogeneous group of clinically aggressive types of non-Hodgkin lymphoma (NHL) that develop in mature white blood cells called “T cells” and “natural killer (NK) cells.” It is PTCL's origin in the lymphatic system that gave it the name peripheral T-cell lymphoma. In the case of PTCL, the term “peripheral” does not refer to the extremities, but identifies PTCL as cancer that arises in the lymphoid tissues outside of the bone marrow such as lymph nodes, spleen, gastrointestinal tract, and skin.

Signs and symptoms of PTCL include asymptomatic lymphadenopathy, Fever, night sweats, poor appetite, and weight loss include fatigue, painless swelling in the neck, armpit or groin (due to an enlarged lymph node). Different staging systems have been proposed for PTCLs.

Peripheral T-cell Lymphoma Diagnosis

The cells in many subtypes of PTCLs look alike; therefore, making an accurate diagnosis may require the use of additional diagnostic tests, including blood tests, CT (computerized axial tomography), PET (positron emission tomography) scans, MRI (magnetic resonance imaging), and bone marrow biopsy.

Peripheral T-cell Lymphoma Treatment

Currently, newly diagnosed PTCL patients are usually treated with anthracycline-based chemotherapy regimens. For most subtypes of PTCL, the initial treatment is typically a combination chemotherapy regimen, such as CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), CHOEP (cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone), or other multidrug regimens. Patients with relapsed disease are usually treated with combination chemotherapy such as ICE (ifosfamide, carboplatin, and etoposide) or other combination regimens, followed by stem cell transplantation. Treatment for PTCL aims to cure and includes the use of combination chemotherapy regimens - typically CHOP based chemotherapy or EPOCH, localized radiotherapy, stem cell transplants and steroid therapy. Other drugs now approved for relapsed T-cell lymphoma include BELEODAQ (belinostat), ADCETRIS (brentuximab vedotin), POTELIGEO (mogamulizumab), Mundesine (Forodesine Hydrochloride), HIYASTA, DARVIAS, and Others.

Peripheral T-cell Lymphoma Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by total incident population of PTCL, stage-specific Incident Cases of PTCL, and subtype-specific Incident cases of PTCL in the 7MM market covering the United States, EU-5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2019 to 2032.

Key Findings

This section provides glimpse of the PTCL epidemiology in the 7MM

Country Wise- Peripheral T-cell Lymphoma Epidemiology

  • The epidemiology segment also provides the PTCL epidemiology data and findings across the United States, the EU-5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
  • The total incident population of PTCL in the 7MM comprised of 18,027 cases in 2021 and are projected to increase during the forecast period.
  • The total incident population of PTCL in the United States is 6,366 in 2021.
  • The Japan contributed to the largest incident population of PTCL, accounting for ~ 37% of the 7MM in 2021.
  • Among the EU-5 countries, Germany accounted for the highest number of PTCL cases, followed by France, whereas Spain accounted for the lowest cases in 2021.
  • In Japan, the total incident population of PTCL was 6,637 in 2021 and is anticipated to rise during the forecast period.
  • The major types of PTCL include Peripheral T-cell lymphoma (NOS), Anaplastic Large-Cell Lymphoma (ALCL), Angioimmunoblastic T-Cell Lymphoma (AITL) and others. In 2021, the incident population of NOS, ALCL, and AITL in the United States were, 1,998, 1,643, and 1,438, cases.

Drug Chapters

Drug chapter segment of the PTCL report encloses the detailed analysis of PTCL marketed drugs and late stage (Phase-II and Phase III) pipeline drugs. It also helps to understand the PTCL 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

XALKORI (crizotinib): Pfizer

XALKORI is an inhibitor of receptor tyrosine kinases, including ALK, hepatocyte growth factor receptor (HGFR, c-Met), ROS1 (c-ros), and Recepteur d'Origine Nantais (RON). It is indicated for treating patients with metastatic NSCLC whose tumors are ALK- or ROS1-positive as detected by an FDA-approved test. XALKORI is indicated for treating pediatric patients 1 year and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (sALCL) that is ALK-positive. In January 2021, the FDA approved XALKORI for pediatric patients 1 year and older and young adults with relapsed or refractory, systemic ALK-positive ALCL. The EMA has agreed to a Pediatrics Investigational Plan (PIP) for XALKORI, including the treatment of pediatric patients with relapsed or refractory systemic ALK-positive ALCL.

HIYASTA (tucidinostat): HUYA Bioscience International (HUYABIO)
HIYASTA, also known as HBI-8000, is an epigenetic immunomodulator with several approved indications, including monotherapy for two subtypes of T-cell non-Hodgkin's lymphoma, i.e., relapsed or refractory adult T-cell leukemia-lymphoma (ATLL) and relapsed or refractory PTCL in Japan. In June 2021, HUYABIO announced the regulatory approval for HBI-8000 monotherapy of relapsed or refractory (R/R) ATL by the Japanese Pharmaceuticals and Medical Devices Agency.

DARVIAS (darinaparsin): Solasia Pharma

Darinaparsin (SP-02), an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for treating various hematologic and solid tumors. In June 2020, darinaparsin achieved the primary endpoint (antitumor effect) in the Asian multinational Phase II clinical study in patients with relapsed or refractory PTCL in Japan, South Korea, Taiwan, and Hong Kong. In June 2022, Solasia has been approved an NDA for darinaparsin as a treatment for relapsed or refractory PTCL by the MHLW in Japan. The company has completed a Phase IIa study in the US. It plans to conduct a Phase II/III trial in Europe on PTCL patients. In August, 2022, Solasia Pharma announced that DARVIAS Injection launched in Japan for use in relapsed or refractory PTCL.

BELEODAQ (belinostat): Acrotech Biopharma

BELEODAQ, an HDAC inhibitor, has been assessed in several clinical trials as a sole treatment (monotherapy) or combined with other anti-cancer treatments for hematological cancers and solid tumors. Its anti-cancer activity is associated with the inhibition of cell proliferation, the induction of apoptosis (programmed cell death), the inhibition of angiogenesis, and the induction of cellular differentiation. In July 2014, the FDA granted accelerated approval for BELEODAQ to treat patients with relapsed or refractory PTCL.

ADCETRIS (brentuximab vedotin): Seagen/Takeda

ADCETRIS (brentuximab vedotin) is a CD30-directed antibody-drug conjugate (ADC) consisting of three components: the chimeric IgG1 antibody cAC10, specific for human CD30, the microtubule disrupting agent MMAE, and a protease-cleavable linker that covalently attaches MMAE to cAC10. In May 2022, Takeda received approval from the MHLW Japan for a partial change in approved items of the manufacturing and marketing approval of ADCETRIS as a first-line treatment for CD30-positive Hodgkin lymphoma in pediatric patients. In June 2022, the Company announced results from a Phase III Children's Oncology Group trial evaluating ADCETRIS in children and young adults with high-risk, previously untreated classical Hodgkin lymphoma. ADCETRIS, in combination with chemotherapy, showed a clinically meaningful and statistically significant 59% reduction in the risk of disease progression. Based on these data, Seagen submitted sBLA to the FDA for review. The sBLA was granted priority review with a target action date of November 16, 2022

Note: Detailed Current therapies assessment will be provided in the full report of PTCL

Emerging Drugs

Nanatinostat in Combination with Valganciclovir: Viracta Therapeutics

Nanatinostat, an orally available histone deacetylase (HDAC) inhibitor, is being developed by Viracta. It is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. The company has multiple ongoing clinical studies evaluating nanatinostat and valganciclovir in combination to assess its efficacy in patients with relapsed/refractory EBV + malignancies. The Ongoing trials include a pivotal, global, multicenter, open-label Phase II basket trial in multiple subtypes of relapsed/refractory EBV+ lymphoma (NAVAL-1) and a multinational Phase Ib/II trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors. In November 2019, the company announced that the FDA granted FTD for nanatinostat in combination with valganciclovir to treat relapsed/refractory EBV+ lymphoid malignancies. As per the company NAVAL-1 could potentially support multiple NDA filings across various EBV+ lymphoma subtypes. An update on the initial cohorts that may advance into Stage 2 of the trial is anticipated in the fourth quarter of 2022.

Golidocitinib (DZD4205): Dizal Pharmaceuticals

Golidocitinib is a selective JAK1 inhibitor, with an IC50 of 73 nM, weakly inhibits JAK2 and shows inhibition on JAK3 (IC50, >14.7, >30 μM, respectively). Golidocitinib inhibits STAT3 phosphorylation in NCI-H 1975 cells with an IC50 of 161 nM. In May 2022, company presented Phase I/II data in European Hematology Association 2022 for golidocitnib, a selective JAK1 inhibitor, in refractory or relapsed peripheral T cell lymphoma. The company also announced new data from the Phase I/II study of golidocitinib in refractory or relapsed peripheral T-cell lymphoma selected for oral presentation at the 2022 EHA Annual Meeting. In February 2022, the FDA has granted FTD, to golidocitinib (DZD4205), for treating patients with relapsed or refractory PTCL.

Valemetostat Tosylate(DS-3201): Daiichi Sankyo

Valemetostat, a potentially selective first-in-class dual inhibitor of EZH1 and EZH2, is currently in clinical development in the alpha portfolio of Daiichi Sankyo. Valemetostat is designed to counter epigenetic dysregulation by targeting EZH1 and EZH2 enzymes. In December 2021, valemetostat received ODD from the US FDA for PTCL treatment. It also received ODD from the Japan MHLW for treating relapsed/refractory ATL in November 2021. In April 2019, valemetostat received SAKIGAKE Designation from the Japan MHLW to treat adult patients with relapsed/refractory PTCLIn 2021, the company announced the NDA submission in Japan to treat adult T-cell leukemia/lymphoma (ATL) patients. The Japan NDA submission of valemetostat is based on pivotal Phase II study results in Japanese patients with three aggressive subtypes of relapsed/refractory ATL. The company also anticipates the approval of valemetostat (DS-3201) in the first half of 2022.

AFM 13: Affimed

AFM13 is a first-in-class tetravalent, bispecific innate cell engager that specifically binds to CD30 on tumor cells and CD16A on NK cells and macrophages. AFM13 is being developed in PTCL and other CD30-positive lymphomas. The drug has shown a favorable safety profile and signs of therapeutic efficacy as a monotherapy in CD30-positive non-Hodgkin lymphoma with cutaneous manifestation. In 2022, company announced to present topline data of the registration-directed REDIRECT trial in the fourth quarter of 2022. The company has completed enrollment of its REDIRECT study (AFM13-202) and reported updated data of AFM13 combination with NK at a scientific conference in the fourth quarter of 2022. The company expects an FDA meeting in 2022.

COPIKTRA (duvelisib): Secura Bio

COPIKTRA (Duvelisib) is a targeted oral inhibitor of phosphoinositide 3-kinase. The phosphoinositide 3-kinase (PI3K) signaling pathway is a key regulator of cancer proliferation (rapid increase or spread) and metastasis (development of secondary growths away from a primary site of cancer). In October 2019, duvelisib (COPIKTRA) received ODD from FDA for use in the treatment of T-cell lymphoma (Verastem, 2019) and In 2017, FTD was granted to duvelisib for treating people with PTCL who have received at least one prior treatment. It is the first approved dual inhibitor of PI3K-δ and PI3K-γ and received approval as monotherapy from FDA in September 2018 to treat patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. In 2022, Secura Bio announced that it had completed enrollment in the PRIMO study. PRIMO is evaluating COPIKTRA for treating adult patients with relapsed or refractory (r/r) PTCL and has enrolled 157 patients.

Tolinapant (ASTX660): Otsuka Pharmaceutical/Astex Pharmaceuticals

Tolinapant is a synthetic, small molecule, a dual antagonist of cellular inhibitor of apoptosis protein (cIAP) 1 and X-linked inhibitor of apoptosis protein (XIAP) that has been shown to have potent proapoptotic and tumor growth inhibitory activity in nonclinical models. Tolinapant is currently being evaluated in patients with PTCL and CTCL as part of the Phase II portion of Phase I/II study in patients with advanced solid tumors and lymphomas to determine safety, pharmacokinetics, and preliminary activity. In August 2020, Astex Pharmaceuticals announced that the FDA granted ODD to Tolinapant (formerly ASTX660) for treating T-cell lymphoma.

Note: Detailed emerging therapies assessment will be provided in the final report.

PTCL Market Outlook


United States

The therapeutic challenge for PTCL remains as these are aggressive and rare cancers which are extremely diverse. To make matters worse, it remains a disease with poor prognosis and limited treatment options, especially in comparison to its B cell counterparts. The existing treatment options for PTCL include CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone), which emerged as the standard of care in the treatment of aggressive non-Hodgkin lymphomas in the 1990s when the distinction between peripheral T-cell lymphoma and aggressive B-cell-derived non-Hodgkin lymphoma became apparent. The treatment options for PTCL include combination chemotherapy regimens typically CHOP based chemotherapy or EPOCH (cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone), localized radiotherapy, stem cell transplants, and steroid therapy.

The EU-5

The EU-5 has limited approved treatment options for PTCL, which include chemotherapy, steroids, stem cell transplantation, radiotherapy, and targeted therapies.

CHOP is the most common combination chemotherapy used for the treatment of PTCL. Some physicians also include etoposide to CHOP (CHEOP). The European Society for Medical Oncology (ESMO) guidelines for the treatment of PTCL recommends the use of CHOP or CHEOP for the treatment of various types of PTCL as the first line of therapy.

Japan

In Japan, the primary treatment of PTCL is CHOP that has a response rate of 50−65%, however, patients who are resistant to this therapy have an extremely poor prognosis. Other treatment options include radiotherapy, targeted drugs and stem cell transplantation for relapsed and refractory disease.

The FDA-approved drugs which are currently available include XALKORI (crizotinib), HIYASTA (tucidinostat), DARVIAS (darinaparsin), ADCETRIS (brentuximab vedotin), FOLOTYN/DIFOLTA (pralatrexate), ISTODAX (romidepsin), BELEODAQ (belinostat), POTELIGEO (mogamulizumab), and MUNDESINE (forodesine hydrochloride).

The PTCL pipeline possessed multiple potential drugs in late- and mid-stage developments to be launched shortly. Key players involved in robust research and development include Nanatinostat in Combination with Valganciclovir (Viracta Therapeutics), Golidocitinib (Dizal Pharmaceuticals), Valemetostat Tosylate (Daiichi Sankyo), AFM 13(Affimed), COPIKTRA (Secura Bio), Tolinapant (ASTX660) (Otsuka Pharmaceutical/Astex Pharmaceuticals), Tislelizumab (BeiGene), Zarnestra (Tipifarnib) (Kura Oncology) 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 PTCL 7MM market.
  • The total market size of PTCL in the 7MM is USD 564 million in 2021 and is projected to grow during the forecast period (2022-2032).
  • According to the estimates, the highest market size of PTCL is from the United States, in 2021 and is anticipated to grow at a CAGR of 4.9%.
  • Among the EU5 countries, Germany has the maximum revenue share in 2021 while Spain has the lowest market share.
  • The market size of PTCL in Japan is USD 193 million in 2021 which is expected to rise during the forecast period (2022-2032).

The United States Market Outlook

The total market size of PTCL in the United States is expected to increase with a CAGR of 4.9% during the study period (2019-2032).

EU-5 Market Outlook

The total market size of PTCL in EU-5 is expected to increase with a CAGR of 4.2% during the study period (2019-2032).

Japan Market Outlook

The total market size of PTCL in Japan is expected to increase with a CAGR of 2.4% during the study period (2019-2032).

Analyst Commentary

  • PTCL has an active pipeline as many pharmaceutical companies are working towards developing an effective and affordable therapy.
  • In coming pipeline there are a number of emerging therapies which are focusing on novel MOAs such as dual inhibitor of EZH1 and EZH2 (valemetostat tosylate), antagonist of the cellular and X-linked inhibitors of apoptosis proteins (cIAP1/2 and XIAP) (Tolinapant), and others. The recent launch of therapies like HIYASTA, DRAVIAS, and REMITORO in Japan increase the market size of PTCL and covers the unmet need for patient in Japan.
  • The absence of curative treatment presents a good opportunity for companies working toward therapy development.
  • The disease tends to show resistance to medications creating a need for a more efficacious drug; there are many competitors in the drug development space working on different classes of therapeutics. Therefore, therapy should stand out in terms of cost, efficacy, and other relevant parameters to create an impact on the market.
  • Many newly developing drugs, including Tenalisib, COPIKTRA, ZARNESTRA, Tolinapant, and Golidocitinib, are targeting the oral route and focusing on patient compliance.

PTCL Drugs Uptake

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 PTCL market uptake by drugs; patient uptake by therapies; and sales of each drug. For example- COPIKTRA (Duvelisib), is a targeted oral inhibitor of phosphoinositide 3-kinase. In 2017, Fast track designation was granted to duvelisib for the treatment of people with PTCL who have received at least one prior treatment. This drug also has Orphan Drug designation. As per our analysis COPIKTRA, drug uptake in the US for second-line is expected to be medium with peak share of 5%, years to peak would be 6 years.

PTCL Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase II, and Phase III 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 PTCL 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 like MD, Global Head of R&D, Daiichi Sankyo, MD, Chief Medical Officer at Secura Bio, and others. Their opinion helps to understand and validate current and emerging therapies treatment patterns or PTCL 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

The publisher performs competitive and market Intelligence analysis of the PTCL 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.

Scope of the Report

  • The report covers the descriptive overview of PTCL, explaining its causes, signs and symptoms, pathogenesis and currently available therapies.
  • Comprehensive insight has been provided into the PTCL epidemiology and treatment.
  • Additionally, an all-inclusive account of both the current and emerging therapies for PTCL are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
  • A detailed review of PTCL market; historical and forecasted is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM PTCL market.

Report Highlights

  • In the coming years, PTCL market is set to change due emerging therapies in the pipeline, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
  • The companies and academics are working to assess challenges and seek opportunities that could influence PTCL R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
  • As per the analysis the major types of PTCL include Peripheral T-cell lymphoma-NOS, Anaplastic Large-Cell Lymphoma (ALCL), Angioimmunoblastic T-Cell Lymphoma (AITL), Nasal NK/T-cell lymphoma, Enteropathy-type intestinal TCL, Hepatosplenic TCL and others.
  • The report also encompasses other major segments, i.e., total incident population of PTCL, PTCL cases by stage, PTCL cases by types, Genetics and Molecular Aberrancies in PTCL, PTCL line-wise treated patients.
  • Expected Launch of potential therapies, Nanatinostat in Combination with Valganciclovir (Viracta Therapeutics), Golidocitinib (Dizal Pharmaceuticals), Valemetostat Tosylate (Daiichi Sankyo), AFM 13(Affimed), COPIKTRA (Secura Bio), Tolinapant (ASTX660) (Otsuka Pharmaceutical/Astex Pharmaceuticals), and others might change the landscape in treatment of PTCL.
  • The US FDA-approved drugs which are currently available include XALKORI (crizotinib), HIYASTA (tucidinostat), DARVIAS (darinaparsin), ADCETRIS (brentuximab vedotin), FOLOTYN /DIFOLTA (pralatrexate), ISTODAX (romidepsin), BELEODAQ (belinostat), POTELIGEO (mogamulizumab), and others.

PTCL Report Insights

PTCL Report Insights

  • Patient Population
  • Therapeutic Approaches
  • PTCL Pipeline Analysis
  • PTCL Market Size and Trends
  • Market Opportunities
  • Impact of upcoming Therapies

PTCL Report Key Strengths

  • Eleven Years Forecast
  • 7MM Coverage
  • PTCL Epidemiology Segmentation
  • Key Cross Competition
  • Highly Analyzed Market
  • Drugs Uptake

PTCL Report Assessment

  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • SWOT
  • Attribute Analysis

Key Questions Answered

Market Insights:

  • What was the PTCL market share (%) distribution in 2019 and how it would look like in 2032?
  • What would be the PTCL total market size as well as market size by therapies across the 7MM during the study period (2019-2032)?
  • What are the key findings pertaining to the market across the 7MM and which country will have the largest PTCL market size during the study period (2019-2032)?
  • At what CAGR, the PTCL market is expected to grow at the 7MM level during the study period (2019-2032)?
  • What would be the PTCL market outlook across the 7MM during the study period (2019-2032)?
  • What would be the PTCL market growth till 2032 and what will be the resultant market size in the year 2032?
  • How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

  • What is the disease risk, burden and unmet needs of PTCL?
  • What is the historical PTCL patient pool in the United States, the EU-5 (Germany, France, Italy, Spain, and the UK) and Japan?
  • What would be the forecasted patient pool of PTCL at the 7MM level?
  • What will be the growth opportunities across the 7MM with respect to the patient population pertaining to PTCL?
  • Out of the above-mentioned countries, which country would have the highest incident population of PTCL during the study period (2019-2032)?
  • At what CAGR the population is expected to grow across the 7MM during the study period (2019-2032)?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

  • What are the current options for the treatment of PTCL? What are the current treatment guidelines for the treatment of PTCL in the US and Europe?
  • What are the PTCL marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
  • How many companies are developing therapies for the treatment of PTCL?
  • How many emerging therapies are in the mid-stage and late stage of development for the treatment of PTCL?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the PTCL therapies?
  • What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for PTCL and their status?
  • What are the key designations that have been granted for the emerging therapies for PTCL?
  • What are the 7MM historical and forecasted market of PTCL?

Reasons to Buy

  • The report will help in developing business strategies by understanding trends shaping and driving the PTCL.
  • To understand the future market competition in the PTCL market and Insightful review of the SWOT analysis of PTCL.
  • Organize sales and marketing efforts by identifying the best opportunities for PTCL in the US, EU-5 (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
  • Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
  • Organize sales and marketing efforts by identifying the best opportunities for PTCL market.
  • To understand the future market competition in the PTCL market.

Table of Contents

1. Key Insights2. Report Introduction3. Executive Summary4. Key Events5. SWOT Analysis6. Epidemiology and Market Forecast Methodology
7. Peripheral T-cell Lymphoma (PTCL) Market Overview at a Glance in the 7MM
7.1. Market Share (%) Distribution by Therapies in 2019
7.2. Market Share (%) Distribution by Therapies in 2032
8. Disease Background and Overview
8.1. Introduction
8.2. Classification of PTCL
8.2.1. WHO Classification System
8.3. Subtypes of PTCL
8.3.1. Peripheral T-Cell Lymphoma, Not Otherwise Specified (PTCL-NOS)
8.3.2. Anaplastic Large Cell Lymphoma (ALCL)
8.3.3. Angioimmunoblastic T-Cell Lymphoma (AITL)
8.4. Signs and Symptoms
8.5. Cause of PTCL
8.6. Pathophysiology
8.7. Other conditions that can mimic PTCL
8.8. Staging
8.9. Diagnosis
8.9.1. Blood tests
8.9.2. Diagnostic Scans
9. Treatment and Management of PTCL
9.1. Treatment Goals
9.1.1. Treatment for Newly Diagnosed Patients
9.1.2. Treatment for Patients with Relapsed or Refractory PTCL
9.2. Treatment Options
9.2.1. Therapeutic Approaches
9.3. Prospective Treatments
9.3.1. PI3 kinase pathway
9.3.2. Epigenetic therapies
9.3.3. Antibody-based therapies
9.3.4. Immune checkpoint inhibitors
9.4. Personalized Treatment and Biomarkers
9.5. Conclusion
10. Treatment Guidelines
10.1. Leukemia and Lymphoma society guidelines: Peripheral T-cell Lymphoma
10.1.1. Treatment for Newly Diagnosed Patients
10.1.2. Treatment for Patients with Relapsed or Refractory PTCL
10.2. NCCN Guidelines
10.2.1. Peripheral T-Cell Lymphoma
10.2.2. ALCL, ALK-POSITIVE: INTERIM RESTAGING AND ADDITIONAL THERAPY
10.2.3. Second Line Therapy
10.3. ESMO Guidelines
10.3.1. Nodal Peripheral T-cell Lymphoma
10.3.2. Extranodal Peripheral T-cell Lymphoma
10.3.3. Enteropathy-associated T-cell lymphoma (EATL)
10.3.4. Extranodal natural killer/T-cell lymphoma (ENKTCL)
10.3.5. Integrated Management Algorithm for PTCL
10.3.6. Primary Cutaneous Lymphomas
10.4. British Society for Haematology Guideline
10.4.1. Peripheral T-cell lymphoma: not otherwise specified (PTCL-NOS) and angioimmunoblastic T-cell lymphoma (AITL)
10.4.2. Anaplastic large cell lymphoma (ALCL)
10.4.3. Extra-nodal NK/T-cell lymphoma (ENKTL)
10.4.4. Enteropathy-associated T-cell lymphoma (EATL)
10.4.5. Hepatosplenic T-cell lymphoma (HSTL)
10.4.6. Adult T-cell leukemia/lymphoma (ATLL)
11. Epidemiology and Patient Population of 7MM
11.1. Key Findings
11.2. Assumptions and Rationale
11.2.1. United States
11.2.2. EU-5
11.2.3. Japan
11.3. Total Incident Cases of PTCL in the 7MM
11.4. United States
11.4.1. Total Incident Cases of PTCL in the United States
11.4.2. Stage-specific Incident Cases of PTCL in the United States
11.4.3. Subtype-specific Incident cases of PTCL in the United States
11.5. EU-5
11.5.1. Total Incident Cases of PTCL in the EU-5
11.5.2. Stage-specific Incident Cases of PTCL in the EU-5
11.5.3. Subtype-specific Incident Cases of PTCL in the EU-5
11.6. Japan
11.6.1. Total Incident Cases of PTCL in Japan
11.6.2. Stage-specific Incident Cases of PTCL in Japan
11.6.3. Subtype-specific Diagnosed Incident Cases of PTCL in Japan
12. Patient Journey13. Key Endpoints in PTCL
14. Marketed Drugs
14.1. Key Competitors
14.2. XALKORI (crizotinib): Pfizer
14.2.1. Product description
14.2.2. Regulatory milestones
14.2.3. Other developmental activities
14.2.4. Safety and efficacy
14.3. HIYASTA (tucidinostat): HUYA Bioscience International (HUYABIO)
14.3.1. Product Description
14.3.2. Regulatory milestones
14.3.3. Other developmental activities
14.3.4. Safety and efficacy
14.4. DARVIAS (darinaparsin): Solasia Pharma
14.4.1. Product description
14.4.2. Regulatory milestones
14.4.3. Other developmental activities
14.4.4. Safety and efficacy
14.5. REMITORO (denileukin diftitox [genetical recombination]): Eisai
14.5.1. Product description
14.5.2. Regulatory milestones
14.5.3. Other developmental activities
14.5.4. Safety and efficacy
14.6. ADCETRIS (brentuximab vedotin): Seagen/Takeda
14.6.1. Product description
14.6.2. Regulatory milestones
14.6.3. Other developmental activities
14.6.4. Current pipeline activity
14.6.5. Safety and efficacy
14.7. FOLOTYN/DIFOLTA (pralatrexate): Acrotech Biopharma
14.7.1. Product description
14.7.2. Regulatory milestones
14.7.3. Other developmental activities
14.7.4. Safety and efficacy
14.8. ISTODAX (romidepsin): Bristol Myers Squibb
14.8.1. Product description
14.8.2. Regulatory milestones
14.8.3. Other developmental activities
14.8.4. Safety and efficacy
14.9. BELEODAQ (belinostat): Acrotech Biopharma
14.9.1. Product description
14.9.2. Regulatory milestones
14.9.3. Other developmental activities
14.9.4. Safety and efficacy
14.10. POTELIGEO (mogamulizumab): Kyowa Hakko Kirin
14.10.1. Product description
14.10.2. Regulatory milestones
14.10.3. Other developmental activities
14.10.4. Safety and efficacy
14.11. MUNDESINE (forodesine hydrochloride): Mundipharma
14.11.1. Product description
14.11.2. Regulatory milestones
14.11.3. Other developmental activities
14.11.4. Safety and efficacy
15. Emerging Drugs
15.1. Key Competitors
15.2. Nanatinostat in Combination with Valganciclovir: Viracta Therapeutics
15.2.1. Product description
15.2.2. Other developmental activity
15.2.3. Clinical development
15.2.4. Safety and efficacy
15.3. Golidocitinib (DZD4205): Dizal Pharmaceuticals
15.3.1. Product description
15.3.2. Other developmental activity
15.3.3. Clinical development
15.3.4. Safety and efficacy
15.4. Valemetostat Tosylate(DS-3201): Daiichi Sankyo
15.4.1. Product description
15.4.2. Other developmental activity
15.4.3. Clinical development
15.4.4. Safety and efficacy
15.5. CS1001 (sugemalimab): CStone Pharmaceuticals
15.5.1. Product description
15.5.2. Other developmental activity
15.5.3. Clinical development
15.5.4. Safety and efficacy
15.6. Tenalisib (RP6530): Rhizen Pharmaceuticals
15.6.1. Product description
15.6.2. Other developmental activity
15.6.3. Clinical development
15.6.4. Safety and efficacy
15.7. AZD4573: AstraZeneca
15.7.1. Product description
15.7.2. Clinical development
15.8. COPIKTRA (duvelisib): Secura Bio
15.8.1. Product Description
15.8.2. Other developmental activities
15.8.3. Clinical Development
15.8.4. Safety and Efficacy
15.9. Zarnestra (Tipifarnib): Kura Oncology
15.9.1. Product description
15.9.2. Other developmental activities
15.9.3. Clinical development
15.9.4. Safety and efficacy
15.10. Tislelizumab: BeiGene
15.10.1. Product description
15.10.2. Other developmental activities
15.10.3. Clinical development
15.10.4. Safety and efficacy
15.11. ONUREG: Celgene Corporation/BMS
15.11.1. Product description
15.11.2. Other developmental activities
15.11.3. Clinical development
15.11.4. Safety and efficacy
15.12. AFM13: Affimed
15.12.1. Product description
15.12.2. Other developmental activities
15.12.3. Clinical development
15.12.4. Safety and efficacy
15.13. Lacutamab/IPH4102: Innate Pharma
15.13.1. Product description
15.13.2. Other developmental activities
15.13.3. Clinical development
15.14. Tolinapant (ASTX660): Otsuka Pharmaceutical/Astex Pharmaceuticals
15.14.1. Product description
15.14.2. Other developmental activities
15.14.3. Clinical development
15.14.4. Safety and efficacy
15.15. KEYTRUDA (pembrolizumab): Merck Sharp & Dohme Corp.
15.15.1. Product description
15.15.2. Clinical development
15.15.3. Safety and efficacy
15.16. OPDIVO (nivolumab) + Cabiralizumab: Bristol Myers Squibb
15.16.1. Product description
15.16.2. Other developmental activities
15.16.3. Clinical development
16. Peripheral T-cell Lymphoma: 7MM Market Analysis
16.1. Key Findings
16.2. Total Market Size of PTCL in the 7MM
16.3. Market Outlook
16.4. Attribute Analysis
16.5. Key Market Forecast Assumptions
16.6. United States
16.6.1. Total Market Size of PTCL in the United States
16.6.2. Market Size of PTCL by Therapies in the United States
16.7. EU-5
16.7.1. Total Market size of PTCL in the EU-5
16.7.2. Market Size of PTCL by Therapies in the EU-5
16.8. Japan
16.8.1. Total Market size of PTCL in Japan
16.8.2. Market Size of PTCL by Therapies in Japan
17. Unmet Needs18. Market Access and Reimbursement
19. Appendix
19.1. Bibliography
19.2. Report Methodology
20. Publisher Capabilities21. Disclaimer22. About the Publisher
List of Tables
Table 1: Summary of PTCL Market, and Epidemiology (2019-2032)
Table 2: Key Events
Table 3: Old and New WHO classifications of PTCLs
Table 4: Subtypes of PTCL
Table 5: Treatment for Patients with Relapsed or Refractory PTCL
Table 6: Total Incident Cases of PTCL in the 7MM (2019-2032)
Table 7: Total Incident Cases of PTCL in the US (2019-2032)
Table 8: Stage-specific Incident Cases of PTCL in the US (2019-2032)
Table 9: Subtype-specific Incident cases of PTCL in the US (2019-2032)
Table 10: Total Incident Cases of PTCL in the EU-5 (2019-2032)
Table 11: Stage-specific Incident Cases of PTCL in the EU-5 (2019-2032)
Table 12: Subtype-specific Incident Cases of Peripheral T-cell Lymphoma in the EU-5 (2019-2032)
Table 13: Total Incident Cases of PTCL in Japan (2019-2032)
Table 14: Stage-specific Incident Cases of PTCL in Japan (2019-2032)
Table 15: Subtype-specific Incident cases of PTCL in Japan (2019-2032)
Table 16: Comparison of marketed drugs for PTCL
Table 17: ADCETRIS, Clinical Trial Description, 2022
Table 18: Comparison Of Emerging Drugs For PTCL
Table 19: Nanatinostat in Combination With Valganciclovir, Clinical Trial Description, 2022
Table 20: Golidocitinib (DZD4205), Clinical Trial Description, 2022
Table 21: Valemetostat Tosylate, Clinical Trial Description, 2022
Table 22: Sugemalimab (CS1001), Clinical Trial Description, 2022
Table 23: Tenalisib, Clinical Trial Description, 2022
Table 24: AZD4573, Clinical Trial Description, 2022
Table 25: Duvelisib, Clinical Trial Description, 2022
Table 26:Tipifarnib, Clinical Trial Description, 2022
Table 27: Tislelizumab (BGB-A317) , Clinical Trial Description, 2022
Table 28: ONUREG (Azacitidine), Clinical Trial Description, 2022
Table 29: AFM13, Clinical Trial Description, 2022
Table 30: Lacutamab/IPH4102, Clinical Trial Description, 2022
Table 31: Tolinapant (ASTX660), Clinical Trial Description, 2022
Table 32: KEYTRUDA (Pembrolizumab), Clinical Trial Description, 2022
Table 33: OPDIVO (nivolumab) + Cabiralizumab, Clinical Trial Description, 2022
Table 34: Market Size of PTCL in the 7MM, USD million (2019-2032)
Table 35: Key Market Forecast Assumptions for Golidocitinib
Table 36: Key Market Forecast Assumptions for ADCETRIS
Table 37: Key Market Forecast Assumptions for Valemetostat
Table 38: Key Market Forecast Assumptions for Sugemalimab
Table 39: Key Market Forecast Assumptions for Tolinapant
Table 40: Key Market Forecast Assumptions for Nanatinostat + Valganciclovir
Table 41: Key Market Forecast Assumptions for Tenalisib
Table 42: Key Market Forecast Assumptions for COPIKTRA
Table 43: Key Market Forecast Assumptions for Lacutamab
Table 44: Key Market Forecast Assumptions for Zarnestra
Table 45: Key Market Forecast Assumptions for AZD4573
Table 46: Key Market Forecast Assumptions for Tislelizumab
Table 47: Key Market Forecast Assumptions for AFM13
Table 48: Key Market Forecast Assumptions for DARVIAS
Table 49: Key Market Forecast Assumptions for HIYASTA
Table 50: Key Market Forecast Assumptions for REMITORO
Table 51: Key Market Forecast Assumptions for XALKORI
Table 52: Market Size of PTCL in the US, USD million (2019-2032)
Table 53: Market Size of PTCL by Therapies in the US, USD million (2019-2032)
Table 54: Market Size of PTCL in the EU-5, in USD million (2019-2032)
Table 55: Market Size of PTCL by Therapies in Germany, USD million (2019-2032)
Table 56: Market Size of PTCL by Therapies in France, USD million (2019-2032)
Table 57: Market Size of PTCL by Therapies in the Italy, USD million (2019-2032)
Table 58: Market Size of PTCL by Therapies in Spain, USD million (2019-2032)
Table 59: Market Size of PTCL by Therapies in the UK, USD million (2019-2032)
Table 60: Market Size of PTCL by Therapies in the EU-5, USD million (2019-2032)
Table 61: Market Size of PTCL in Japan, USD million (2019-2032)
Table 62: Market Size of PTCL by Therapies in Japan, USD million (2019-2032)
List of Figures
Figure 1: Classification of PTCL
Figure 2: T-cell neoplasms: organ of origin or involvement and associated chromosomal and genetic alterations.
Figure 3: Representative pathology and PET images
Figure 4: Bone marrow biopsy
Figure 5: Total Incident Cases of PTCL in the 7MM (2019-2032)
Figure 6: Total Incident Cases of PTCL in the US (2019-2032)
Figure 7: Stage-specific Incident Cases of PTCL in the US (2019-2032)
Figure 8: Subtype-specific Incident cases of PTCL in the US (2019-2032)
Figure 9: Total Incident Cases of PTCL in the EU-5 (2019-2032)
Figure 10: Stage-specific Incident Cases of PTCL in the EU-5 (2019-2032)
Figure 11: Subtype-specific Incident Cases of PTCL in the EU-5 (2019-2032)
Figure 12: Total Incident Cases of PTCL in Japan (2019-2032)
Figure 13: Stage-specific Incident Cases of PTCL in Japan (2019-2032)
Figure 14: Subtype-specific Incident cases of PTCL in Japan (2019-2032)
Figure 15: Market Size of PTCL in the 7MM, USD million (2019-2032)
Figure 16: Market Size of PTCL in the US, USD million (2019-2032)
Figure 17: Market Size of PTCL by Therapies in the US, USD million (2019-2032)
Figure 18: Market Size of PTCL in the EU-5, in USD million (2019-2032)
Figure 19: Market Size of PTCL by Therapies in EU-5, USD million (2019-2032)
Figure 20: Market Size of PTCL in Japan, USD million (2019-2032)
Figure 21: Market Size of PTCL by Therapies in Japan, USD million (2019-2032)

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Viracta Therapeutics
  • Dizal Pharmaceuticals
  • Daiichi Sankyo
  • CStone Pharmaceuticals
  • Rhizen Pharmaceuticals
  • Kura Oncology
  • BeiGene
  • Celgene Corporation
  • Innate Pharma
  • Otsuka Pharmaceutical
  • Astex Pharmaceuticals
  • Merck Sharp & Dohme Corp.
  • Bristol Myers Squibb
  • Affimed
  • AstraZeneca