Peripheral T-Cell Lymphoma Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• In 2023, the US accounted for the highest share of the total market in the 7MM (USD 500 million), followed by Japan.
• 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.
• The total incident cases of PTCL in the United States were approximately 12,600 cases in 2023; these cases are estimated to increase by 2034.
• Cyclophosphamide, doxorubicin, prednisone, and brentuximab vedotin (CHP-BV) is a new treatment paradigm in ALCL.
• The launch of therapies such as HIYASTA for ATLL and PTCL, DARVIAS, and REMITORO for R/R ATLL and R/R PTCL in Japan provides more treatment options for patients with PTCL.
• The emerging field of CAR-T and NK (natural killer cells) treatment is also entering the field of T-cell lymphoma. So far, CAR-T/NK studies are still in the preclinical phase, but larger clinical studies are recruiting or underway.
• In addition, new biologics are targeting programmed cell death protein 1/programmed cell death ligand 1; NK-cell engagers are targeting CD30/16a; the ‘Do Not Eat Me’ signals inhibited by the anti-CD47 monoclonal antibody; antibodies such as mogamulizumab targeting CCR4; and a host of others offer new opportunities to build highly disease-specific platforms.

This report delivers an in-depth understanding of top oncogenic drivers/biomarkers in Peripheral T-cell Lymphoma, historical and forecasted epidemiology as well as the Peripheral T-cell Lymphoma Market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Peripheral T-cell Lymphoma market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM Peripheral T-cell Lymphoma Market size from 2020 to 2034. The report also covers current Peripheral T-cell Lymphoma treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Peripheral T-cell Lymphoma Understanding and Treatment Algorithm

Peripheral T-cell Lymphoma Overview

PTCL is 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.” There are three types of lymphocytes, namely B lymphocytes (B cells), T lymphocytes (T cells), and natural killer cells (NK cells). NHL may arise in B cells or T cells, wherein the former is more common than the latter. NHLs may be indolent (slow-growing) or aggressive (fast-growing).

Peripheral T-cell Lymphoma Diagnosis

Most PTCLs are diagnosed by taking a small sample (a “biopsy”) of an enlarged lymph node and then examining the cells under a microscope. 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. HIV testing is important since HIV is a risk factor for lymphoma and acute HIV infection can present with many of the same symptoms as PTCL, including fever, weight loss, and lymphadenopathy.

Peripheral T-cells Lymphoma Treatment

Treatment options and recommendations depend on several factors, including the Subtypes of PTCL, possible side effects, and the patient’s preferences and overall health. The most common treatments for Peripheral T-cell lymphoma are radiotherapy, chemotherapy, steroid therapy, bone marrow transplantation or stem cell transplantation, ADCETRIS, BELEODAQ, FOLOTYN, ISTODAX, XALKORI, and others.

Peripheral T-cells Lymphoma Epidemiology

The Peripheral T-cells Lymphoma epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of Peripheral T-cells Lymphoma, total incident cases of Peripheral T-cells Lymphoma by Subtypes, total cases of Peripheral T-cells Lymphoma by stages, CD30 Expression in of Peripheral T-cells Lymphoma in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• PTCL-NOS is more prevalent in the United States and Europe, and ATLL and NKTCL are more prevalent in Asia. ATLL was frequent in Japan but was not found in other Asian countries, whereas NKTCL made up 44% of the cases in Asia, excluding Japan. ALCL, ALK-positive, was most common in North America, whereas enteropathy-type PTCL was most common in Europe.
• Among EU4 and the UK, Germany accounted for the highest number of PTCL cases, followed by the UK, whereas Spain accounted for the lowest cases in 2023.
• Based on the location of the disease, PTCL is divided into four stages. The epidemiological estimates a higher proportion of PTCL cases was found in stages III-IV as compared to other stages I-II.
• In 2023, approximately 1,150 cases in Japan exhibited CD30 expression in ATLL.

Peripheral T-cells Lymphoma Cancer Drug Chapters

The drug chapter segment of the Peripheral T-cells Lymphoma report encloses a detailed analysis of Peripheral T-cell Lymphoma Marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the Peripheral T-cell lymphoma pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

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. The proposed mechanism of action of the drug involves the disruption of mitochondrial function, increased production of reactive oxygen species, and modulation of intracellular signal transduction pathways. Darinaparsin exerts an anticancer effect by inducing cell cycle arrest and apoptosis. In June 2022, Solasia Pharma announced that DARVIAS had been approved for R/R PTCL by the MHLW later in August 2022, it was launched in Japan. Solasia and Nippon Kayaku announced that DARVIAS was officially listed in the NHI drug price list and will be launched on August 22, 2022 (Solasia Pharma, 2022c).

REMITORO (denileukin diftitox [genetical recombination]): Eisai

REMITORO is a fusion protein consisting of interleukin-2 (IL-2) and a partial sequence of diphtheria toxin and specifically binds to the IL-2 receptor on the surface of tumoral lymphocytes. The antitumor efficacy of denileukin diftitox depends on the intracellular delivery of diphtheria toxin fragment, which inhibits protein synthesis and induces cell death. On March 23, 2021, Eisai obtained manufacturing and marketing approval for REMITORO with the indications of relapsed or refractory PTCL and CTCL in Japan. On May 19, 2021, Eisai launched REMITORO with the indications of relapsed or refractory PTCL and CTCL in Japan. REMITORO was included in Japan’s National Health Insurance Drug Price List on May 19, 2021.

Emerging Drugs

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). The PI3K pathway includes four Class I isoforms: alpha, beta, delta, and gamma (a, ß, d, and ?). The four isoforms play unique roles in the survival of different tumor types, with roles of some isoforms in creating supportive tumor microenvironments (TME). It is the first approved dual inhibitor of PI3K-d and PI3K-? and received approval as monotherapy from the FDA in September 2018 to treat patients with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. In January 2023, Secura Bio announced that the European Commission (EC) issued an ODD for duvelisib for the treatment of patients with PTCL.

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. It has increasing antitumor effects and enhances the antitumor activity of osimertinib compared to treatment with osimertinib alone in mice bearing NCIH1975 cells. In May 2022, the company presented Phase I/II data at the European Hematology Association 2022 for golidocitnib - a selective JAK1 inhibitor, in R/R PTCL. Dizal is conducting Phase II pivotal clinical trials in the US, China, Australia, South Korea, and other countries and regions. According to findings from part B of the Phase II JACKPOT8 study published in Lancet Oncology treatment with golidocitinib elicited favorable benefits among patients with R/T PTCL. Golidocitinib produced an ORR of 44.3% and a complete response rate of 29.5% based on the independent review committee (IRC) assessment.

Drug Class Insights

Treatment for PTCL aims to cure and includes the use of combination chemotherapy regimens, localized radiotherapy, stem cell transplant 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, a stem cell or bone marrow transplant is recommended at the end of combination chemotherapy.

In 2011, the FDA approved Celgene’s ISTODAX (romidepsin injection) for the treatment of PTCL in patients who have received at least one prior 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.

There are several therapeutic approaches also such as standard first-line therapy, monoclonal antibodies, immunoconjugates, HDAC inhibitors, Antifolates, Immunomodulators, and immunosuppressants. Cyclosporine is an immunosuppressive agent that inhibits the nuclear factor of the activated T-cell transcription complex, which activates the genes encoding cytokines and cell surface molecules involved in cell-to-cell communication and death. Nucleoside analogs are chemotherapeutic agents that primarily inhibit DNA replication and repair. Gemcitabine is the most effective pyrimidine nucleoside analog in PTCL.

Peripheral T-cell Lymphoma Market Outlook

As more targetable mutations are discovered, and new targeted drugs are developed, patients and oncologists will have an expanding array of treatment options. Given the rapid pace of drug approvals, it is important to pause and ensure sufficient data supports the use of specific agents in the appropriate treatment settings, including adjuvant, consolidation, first-line, or subsequent therapy.

The therapeutic challenge for PTCL remains as these are aggressive and rare cancers that are extremely diverse. The conventional chemotherapies for PTCL treatment mainly comprise standard first-line therapy, including Anthracycline-based regimens (CHOP, EPOCH) and non-anthracycline-based regimens (platinum, etoposide, gemcitabine, and methylprednisolone). Although, a large majority of patients opted for chemotherapy, however, almost a quarter of them developed the primary refractory disease. A large section of the remaining patient pool - despite attaining a response to induction chemotherapy - relapsed with a median overall survival of only 6 months. Additionally, as per NCCN guidelines, certain types of PTCL are also treated with a combination of six cycles of CHOP-21 or CHOEP and involved site radiation therapy.

The FDA approved products for PTCL treatment, including BELEODAQ (Belinostat, Acrotech Biopharma); ISTODAX (Romidepsin, Celgene), FOLOTYN (Pralatrexate, Acrotech Biopharma), ARRANON (Nelarabine, GlaxoSmithKline), XALKORI (crizotinib, Pfizer), 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. Approval of ADCETRIS 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. The application for ADCETRIS (Brentuximab vedotin) was approved less than 2 weeks after submission under the FDA real-time oncology review pilot program.

Key players, such as Secura Bio, HUYA Bioscience International, Verastem, Solasia Pharma, Seagen, Dizal Pharmaceutical, and others, are evaluating their lead candidates in different stages of clinical development, respectively.

• The total market size in the 7MM for PTCL was estimated to be ~USD 680 million in 2020, which is projected to show positive growth by 2034.
• Approval of ADCETRIS (Brentuximab vedotin) in November 2018, from the US FDA has changed the market landscape. International guidelines recommend ADCETRIS as a preferred choice of second-line therapy for sALCL. NCCN Guidelines recommend ADCETRIS + CHP as a preferred first-line therapy option for ALCL (category 1) or other CD30-positive entities including PTCL-NOS (category 2A). NCCN Guidelines also recommend ADCETRIS as the preferred choice of second-line therapy for relapsed/refractory ALCL and other CD30-positive entities, including PTCL-NOS.
• In October 2023, Innate Pharma announced that the US FDA has placed a partial clinical hold on the lacutamab IND, leading to a pause in new patient enrollment to the company’s ongoing lacutamab trials IPH4102-201 (Phase II TELLOMAK) and 102 (Phase Ib PTCL).
• Emerging therapies such as Viracta therapeutics’ Nanatinostat is the only ones being developed for EBV+ T cell lymphomas in a possible Phase II registrational trial.

Peripheral T-cells Lymphoma Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034, which depends on the competitive landscape, safety, efficacy data, and order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Peripheral T-cell Lymphoma Activities

The report provides insights into therapeutic candidates in Phase III and II. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Non-Small Cell Lung Cancer emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, Medical Oncologists, Pulmonologists and Professors, and Others.

The analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as MD University College London Hospital, Gustave Roussy Institute, Washington University School of Medicine, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Peripheral T-cell Lymphoma Market trends.

Qualitative Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Market Access and Reimbursement

The high costs of therapies affect the affordability and access of these treatment options to patients. The disease advocacy groups working in the area of PTCL help patients with medical billing, insurance coverage, and reimbursement issues. Also, there is financial assistance available from governments as well as pharmaceutical companies to help people who cannot afford their medications. In the US, reimbursement is provided by various health plans such as Medicaid and Medicare. Each state has its own Medicaid health plans, and they also collaborate with private service providers. In the EU, after approval from the EMA, each country has its funding or reimbursement body that determines if a medicine will be funded, reimbursed, or insured based on the assessments. In Japan, the decision is taken by the Central Social Insurance Medical Council (Chuikyo), a separate body designated by the Ministry of Health, Labor, and Welfare (MHLW).

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of Peripheral T-cell Lymphoma, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will impact the current treatment landscape.
• A detailed review of the Peripheral T-cell Lymphoma Market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Peripheral T-cell Lymphoma Market.

Peripheral T-cell Lymphoma Report Insights

• Patient Population
• Therapeutic Approaches
• Peripheral T-cell Lymphoma Pipeline Analysis
• Peripheral T-cell Lymphoma Market Size and Trends
• Existing and future Market Opportunity

Peripheral T-cell Lymphoma Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage
• Peripheral T-cell Lymphoma Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Peripheral T-cell Lymphoma Market Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What is the historical and forecasted Peripheral T-cell Lymphoma patient pool in the United States, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan?
• What was the Peripheral T-cell Lymphoma total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors for this growth?
• How will different PTCL target classes affect the treatment paradigm of the Peripheral T-cell Lymphoma Market?
• What will be the impact of REMITORO’s expected patent expiry?
• How will ROMITORO compete with other therapies in the first- and second lines?
• Which class is going to be the largest contributor in 2034?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
• What are the current and emerging options for treating Peripheral T-cell Lymphoma?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Peripheral T-cell Lymphoma Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.