Peripheral T-Cell Lymphoma (PTCL) Market and Epidemiology Forecast, 2030 - ResearchAndMarkets.com

The "Peripheral T-Cell Lymphoma (PTCL) - Market Insights, Epidemiology and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.

This report delivers an in-depth understanding of the PTCL, historical and forecasted epidemiology as well as the PTCL market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The PTCL market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM PTCL market size from 2017 to 2030. The report also covers current PTCL treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of PTCL, Stage-specific Incident Cases of PTCL, and Subtype-specific Cases of PTCL, a scenario of PTCL in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2017 to 2030.

Key Findings

• The total incident population of PTCL in the seven major markets was 16,298 in 2017, which is expected to increase in the forecast period.
• The United States accounted for the maximum incident population among the 7MM in 2017.
• In EU5 countries, Germany accounted for the highest cases of PTCL while Spain had the lowest incident population in 2017.
• The estimates suggest higher incidence of PTCL in the United States with 6,110 cases in 2017
• The epidemiological model of estimates a higher proportion of PTCL cases was found in stage IV as compared to other stages in the United States. In 2017, stage I, stage II, stage III, and stage IV PTCL incident cases were 876, 727, 1,434, and 3,074 respectively.
• PTCL-NOS accounts for 31% of all incident cases of PTCL followed by Anaplastic Large-Cell Lymphoma (ALCL) with 26% in the United States in year 2017. Other major subtypes include AITL Nasal NK/T-cell lymphoma, Enteropathy-type intestinal TCL, Hepatosplenic TCL and Others.
• In 2017, the incident cases of PTCL-NOS, ALCL, AITL, nasal NK/T-cell lymphoma, enteropathy-type intestinal TCL, hepatosplenic TCL, and others in the United States were 1,917, 1,577, 1,380, 412, 179, 90, and 555 respectively.

Drug Chapters

This segment of the PTCL report encloses the detailed analysis of the mid- and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.

Emerging Drugs

Denileukin diftitox: Eisai

Denileukin diftitox (DD) is a recombinant cytotoxic fusion protein which is being developed by Eisai. The drug is administered intravenously, that binds the enzymatically active portion of the diphtheria toxin to the receptor-binding domain of the interleukin-2 molecule, thereby targeting cells producing the IL-2 receptor. Denileukin diftitox is already approved with name, Ontak for Cutaneous T-cell Lymphoma. The drug candidate is in Phase II stage of development for Peripheral T-cell lymphoma (PTCL) in Japan.

Azacitidine (CC-486): Celgene Corporation

Azacitidine (CC-486) is being developed by Celgene Corporation. Azacitidine (CC-486) is an oral hypomethylating agent that incorporates into DNA and RNA, allowing sustained epigenetic regulation due to prolonged exposure. The main mechanism of action is thought to be hypomethylation of DNA, as well as direct cytotoxicity to abnormal hematopoietic cells in the bone marrow. Currently, the company is investigating the molecule in two phase III clinical trial for Relapsed or Refractory AITL, and phase II clinical trial for Previously Untreated PTCL.

HBI-8000: HUYA Bioscience International/Quintiles

HBI-8000 (Chidamide/CS055), is a member of the benzamide class of histone deacetylase inhibitors (HDACIs), and HUYA Bioscience International is developing this molecule, as the first approved, oral class I selective HDACI. It works by controlling how tightly DNA is wound around histone proteins, which regulate gene expression. HHBI-8000 became the first benzamide HDAC inhibitor approved worldwide when the drug was approved for the treatment of PTCL in China, where it is now marketed under the trade name Epidaza. Currently, the company is investigating the molecule in phase II clinical trial in Japan, in patients with relapsed or refractory PTCL.

Copiktra (Duvelisib): Verastem

Copiktra (Duvelisib), is a targeted oral inhibitor of phosphoinositide 3-kinase developed by Verastem. 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). Currently, the company is investigating the molecule in phase II PRIMO Study in patients with relapsed or refractory PTCL. The company is planning to build upon their existing Fast Track Designation and Orphan Drug Designation and submit a regulatory package to the US FDA to broaden the use of COPIKTRA and to include treatment of PTCL.

Tislelizumab: BeiGene

Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti-PD-1 monoclonal antibody, administered intravenously that is specifically designed to minimize binding to FcR on macrophages. Currently, the molecule is under investigation in phase II clinical study, relapsed or refractory mature T- and NK- Neoplasms (nasal or non-nasal type, peripheral T-cell lymphoma - not otherwise specified, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, mycosis fungoides, or Sezary syndrome).

Keytruda: Merck Sharp & Dohme Corp

Keytruda is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype against PD-1, designed to block its interaction with PD-L1 and PD-L2 directly which is developed by Merck. Moreover, pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the antitumor immune response.

SP-02 (Darinaparsin, ZIO-101): Solasia Pharma

A novel mitochondrial-targeted agent (organic arsenic) SP-02 is being developed by Solasia Pharma for the treatment of various hematologic and solid cancers. It is being developed to administer intravenously for the treatment of PTCL. The exact mechanism of darinaparsin is not known, but it appears to generate volatile cytotoxic arsenic compounds when glutathione (GSH) concentrations are low.

Ruxolitinib: Incyte/Novartis

Ruxolitinib is an orally administered selective kinase inhibitor that inhibits Janus Associated Kinases (JAKs) JAK1 and JAK2. Incyte and Novartis together are developing Ruxolitinib, which is in phase II stage development for PTCL in collaboration with the University of Nebraska. Ruxolitinib is marketed under the brand name Jakafi for the treatment of Myelofibrosis, including Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis and post-essential Thrombocythemia Myelofibrosis.

Market Outlook

Treatment for PTCL aims to cure and includes the use of combination chemotherapy regimens, localized radiotherapy, stem cell transplants and steroid therapy, etc. It is most often treated with a combination of chemotherapies which includes CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) and CHOEP or EPOCH (etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone). In some cases, stem cell or bone marrow transplant is recommended at the end of combination chemotherapy.

There are only five FDA approved products for PTCL treatment, including Beleodaq (Belinostat, Acrotech Biopharma); Istodax (Romidepsin, Celgene), Folotyn (Pralatrexate, Acrotech Biopharma), Arranon (Nelarabine, GlaxoSmithKline), and Adcetris (Brentuximab vedotin, Seattle Genetics).

In the past years, with no current standard of care for patients with PTCL, there were no approved therapies for the first-line treatment. But recent approval of Adcetris (Brentuximab vedotin) in November 2018 from the US FDA has changed the market landscape. It is now the only FDA-approved regimen in first-line therapy used in combination with chemotherapy for adults with previously untreated systemic ALCL or other CD30-expressing PTCL.

Apart from the available approved therapies, there are some off-label therapies and other emerging therapies that are available for PTCL treatment. Some of the off-label therapies which have been listed in the NCCN guidelines for Relapsed PTCL are MabThera (Rituxan), Bortezomib, Bendamustine, Lenalidomide, and Alemtuzumab.

A study conducted by Abramson et al. (2014), determined the impact of PTCL therapies. The study included a retrospective analysis of 341 newly diagnosed PTCL patients from nine US academic centers diagnosed from January 2000 to December 2010. The outcome was compared with a matched cohort of diffuse large B-cell lymphoma (DLBCL) patients, and prognostic factors were assessed using unilabiate and multivariate analyses.

The study shows that 7% of the patients received only palliative care whereas 318 received chemotherapy: CHOP-like regimens (70%), hyperCVAD/MA (hyperfractionated cyclophosphamide, vincristine, adriamycin, dexamethasone/methotrexate, cytarabine) (6%), or other (18%). The termed other' was given to EPOCH, CMED (cyclophosphamide, methotrexate, etoposide, and dexamethasone), gemcitabine-based, ifosfamide-based, and other therapies. Ten percent of patients underwent stem-cell transplantation (SCT) in the first remission. The overall response rate was 73% (61% complete), and 24% had the primary refractory disease (Abramson et al., 2014).

In Japan, the primary treatment of PTCL is CHOP that has a response rate of 5065% (Kitazume et al., 2019). However, patients who are resistant to this therapy have an extremely poor prognosis. Standard line therapy for R/R PTCL is not established; however, pralatrexate, combination chemotherapy, brentuximab, and romidepsin are used.

The approved therapies for the treatment of PTCL in Japan includes Istodax (romidepsin), Folotyn (pralatrexate), Poteligeo (mogamulizumab), Adcetris (brentuximab vedotin), Mundesine (forodesine hydrochloride), and Arranon (nelarabine).

Key Findings

• The market size of PTCL the seven major markets was found to be USD 815.38 Million in 2017.
• According to estimates, the United States accounts for the largest market size of PTCL, in comparison to Japan and EU5 (Germany, France, Italy, Spain, and United Kingdom).
• Among the EU5 countries, Germany had the highest market size in 2017.
• Among 7MM, Japan accounts for the second-highest market size during the forecast period 2017-2030.

Drugs Uptake

This section focusses on the rate of uptake of the potential drugs that are expected to get launched in the market during the study period 2017-2030. The analysis covers PTCL market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

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 Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for PTCL emerging therapies.

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 is 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

• The seven major PTCL market is anticipated to increase with a CAGR of 8.43% for the study period 2017-2030.
• The United States accounted for 53.58% of the market share in the 7MM.
• Adcetris and Istodax (Romidepsin) for the first line treatment of PTCL is projected to lead the market with the highest market share in 2030.
• In the coming years, PTCL market is set to change due to the rising awareness of the disease, 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.
• Major players are involved in developing therapies for PTCL. Launch of emerging therapies will significantly impact the PTCL market.
• In-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key competitors, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Companies Mentioned

• Eisai
• Celgene Corporation
• HUYA Bioscience International/Quintiles
• Verastem
• BeiGene
• Merck Sharp & Dohme Corp.
• Solasia Pharma
• Incyte/Novartis

For more information about this drug pipelines report visit https://www.researchandmarkets.com/r/hyb449

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