T-cell Large Granular Lymphocyte Leukemia (T-LGL) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2021 To 2032

T-cell large granular lymphocyte leukemia (T-LGL) Market Outlook and Forecast

T-cell Large Granular Lymphocyte Leukemia (T-LGL) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2021 To 2032

Published Date : 2021-12-16

Updated On : 2022-09-28

Pages : 167

T-cell Large Granular Lymphocyte Leukemia (T-LGL) Market Outlook

Thelansis’s “T-cell Large Granular Lymphocyte Leukemia (T-LGL) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2021 To 2032" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential T-cell Large Granular Lymphocyte Leukemia (T-LGL) treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

T-cell Large Granular Lymphocyte Leukemia (T-LGL) Overview

T-cell large granular lymphocyte leukemia (T-LGL) is a heterogeneous lymphoproliferative disorder of CD3-positive T cells. The median age of T-LGL diagnosis is 60, with an equal male-to-female ratio and an indolent clinical course. A positive rheumatoid factor is found in 60%, polyclonal hypergammaglobulinemia in 10–40%, and a positive Coombs test in 15% of patients. The diagnostic criteria for LGL include a persistent increase in circulating LGLs, confirmatory immunophenotype, and, ideally clonal T cell receptor (TCR) rearrangements. T-LGL leukemia has a mature T cell immunophenotype, with 80% of patients expressing CD3, CD8, and TCRab, but not CD4, and discrepant weak CD5 or CD7 expression. Rare variants may be CD4þ and CD8– or co-expression of CD4 and CD8. Large granular lymphocytes form part of the cellular immune response and produce tumor necrosis factor a and interferon g, leading to cell lysis of damaged cells, such as virally infected cells. Secondary to chronic activation of T cells by viral infection or autoantigen found in rheumatoid arthritis, leading to expansion of an unstable T-LGL population at risk of leukemogenic transformation and uncontrolled cytokine production.

  • The incidence of LGL leukemia ranges from 0.2 to 0.5 cases per one million individuals. The median age at diagnosis is 66.5 years; females are likely to be diagnosed three years earlier compared with males.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2021-2032

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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T-cell Large Granular Lymphocyte Leukemia (T-LGL) Competitive Landscape

S. no Asset Company Stage
1 ABC008 Abcuro, Inc. Phase 1
2 DR-01 Dren Bio Phase 2
3 KT-333 Kymera Therapeutics, Inc. Phase 2
4 Siltuximab EUSA Pharma, Inc. Phase 1
5 anti-CD7 CAR-pNK cells PersonGen BioTherapeutics (Suzhou) Co., Ltd. Phase 1
6 BNZ132-1-40 Bioniz Therapeutics Phase 2
7 MORAb-004 Morphotek Phase 2

 

KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.

COUNTRY No. Of KOLs
USA 17
GERMANY 4
UK 4
SPAIN 3
FRANCE 2
ITALY 3
JAPAN 3
CHINA 4

T-cell Large Granular Lymphocyte Leukemia (T-LGL) Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.

T-cell large granular lymphocyte leukemia (T-LGL) Market Forecast

1.       T-cell Large Granular Lymphocyte Leukemia (T-LGL) – Key Findings Summary

         1.1.    Clinical findings
                     1.1.1. Disease overview
                     1.1.2. Therapeutic practices
                     1.1.3. Future outlook
         1.2.    Commercial findings
                     1.2.1. T-cell Large Granular Lymphocyte Leukemia (T-LGL) market scenario 2021
                     1.2.2. T-cell Large Granular Lymphocyte Leukemia (T-LGL) market scenario 2025
                     1.2.3. T-cell Large Granular Lymphocyte Leukemia (T-LGL) market scenario 2032

2.       T-cell Large Granular Lymphocyte Leukemia (T-LGL) Overview

         2.1.    Disease Introduction
         2.2.    Pathophysiology
         2.3.    Signs and Symptoms
         2.4.    Risk Factors
         2.5.    Etiology
         2.6.    Classification
         2.7.    Pathogenesis
         2.8.    Diagnosis
         2.9.    Complications
         2.10. Treatment Algorithm
                     2.10.1.    Treatment in US (guidelines)
                     2.10.2.    Treatment in EU-5 (guidelines)
                     2.10.3.    Treatment in Japan (guidelines)
                     2.10.4.    Treatment in China (guidelines)
         2.11. Treatment Goals for T-cell Large Granular Lymphocyte Leukemia (T-LGL)
         2.12. Referral Patterns
                     2.12.1.    Referral Scenario in US
                     2.12.2.    Referral Scenario in EU-5
                     2.12.3.    Referral Scenario in Japan
                     2.12.4.    Referral Scenario in China
         2.13. T-cell Large Granular Lymphocyte Leukemia (T-LGL) Prognosis
         2.14. Healthcare burden
                     2.14.1.    Healthcare burden in US
                     2.14.2.    Healthcare burden in EU-5
                     2.14.3.    Healthcare burden in Japan
                     2.14.4.    Healthcare burden in China
         2.15.  Unmet Needs in T-cell Large Granular Lymphocyte Leukemia (T-LGL) management
         2.16.  Market Opportunity for T-cell Large Granular Lymphocyte Leukemia (T-LGL)
         2.17. KOL Comments on current and upcoming/expected treatment practices in T-cell Large Granular Lymphocyte Leukemia (T-LGL)

3.       Epidemiology

         3.1.    Epidemiology Overview
         3.2.    Epidemiology by Geography
                     3.2.1.  T-cell Large Granular Lymphocyte Leukemia (T-LGL) Epidemiology in US (2021-2032)
                             3.2.1.1.              Incidence of T-cell Large Granular Lymphocyte Leukemia (T-LGL)
                             3.2.1.2.              Diagnosed cases
                             3.2.1.3.              Treatable Patient Pool
                             3.2.1.4.              Epidemiology Trends
                     3.2.2.  T-cell Large Granular Lymphocyte Leukemia (T-LGL) Epidemiology in EU-5 (2021-2032)
                             3.2.2.1.              Incidence of T-cell Large Granular Lymphocyte Leukemia (T-LGL)
                             3.2.2.2.              Diagnosed cases
                             3.2.2.3.              Treatable Patient Pool
                             3.2.2.4.              Epidemiology Trends
                     3.2.3.  T-cell Large Granular Lymphocyte Leukemia (T-LGL) Epidemiology in Japan (2021-2032)
                             3.2.3.1.              Incidence of T-cell Large Granular Lymphocyte Leukemia (T-LGL)
                             3.2.3.2.              Diagnosed cases
                             3.2.3.3.              Treatable Patient Pool
                             3.2.3.4.              Epidemiology Trends
                     3.2.4.  T-cell Large Granular Lymphocyte Leukemia (T-LGL) Epidemiology in China (2021-2032)
                             3.2.4.1.              Incidence of T-cell Large Granular Lymphocyte Leukemia (T-LGL)
                             3.2.4.2.              Diagnosed cases
                             3.2.4.3.              Treatable Patient Pool
                             3.2.4.4.              Epidemiology Trends
         3.3.    Epidemiology Trends (World-wide)

4.       Market Outlook

         4.1.    US T-cell Large Granular Lymphocyte Leukemia (T-LGL) Market Forecast 2021-2032
                     4.1.1. Market Progression (Futuristic)
                     4.1.2. Market Trends and Expectations
                             4.1.2.1.              Worst case scenario
                             4.1.2.2.              Base Case Scenario
                             4.1.2.3.              Best Case Scenario
                     4.1.3. Drivers and Barriers
         4.2.    UK T-cell Large Granular Lymphocyte Leukemia (T-LGL) Market Forecast 2021-2032
                     4.2.1. Market Progression (Futuristic)
                     4.2.2. Market Trends and Expectations
                             4.2.2.1.              Worst case scenario
                             4.2.2.2.              Base Case Scenario
                             4.2.2.3.              Best Case Scenario
                     4.2.3. Drivers and Barriers
         4.3.    France T-cell Large Granular Lymphocyte Leukemia (T-LGL) Market Forecast 2021-2032
                     4.3.1. Market Progression (Futuristic)
                     4.3.2. Market Trends and Expectations
                             4.3.2.1.              Worst case scenario
                             4.3.2.2.              Base Case Scenario
                             4.3.2.3.              Best Case Scenario
                     4.3.3. Drivers and Barriers
         4.4.    Germany T-cell Large Granular Lymphocyte Leukemia (T-LGL) Market Forecast 2021-2032
                     4.4.1. Market Progression (Futuristic)
                     4.4.2. Market Trends and Expectations
                             4.4.2.1.              Worst case scenario
                             4.4.2.2.              Base Case Scenario
                             4.4.2.3.              Best Case Scenario
                     4.4.3. Drivers and Barriers
         4.5.    Italy T-cell Large Granular Lymphocyte Leukemia (T-LGL) Market Forecast 2021-2032
                     4.5.1. Market Progression (Futuristic)
                     4.5.2. Market Trends and Expectations
                             4.5.2.1.              Worst case scenario
                             4.5.2.2.              Base Case Scenario
                             4.5.2.3.              Best Case Scenario
                     4.5.3. Drivers and Barriers
         4.6.    Spain T-cell Large Granular Lymphocyte Leukemia (T-LGL) Market Forecast 2021-2032
                     4.6.1. Market Progression (Futuristic)
                     4.6.2. Market Trends and Expectations
                             4.6.2.1.              Worst case scenario
                             4.6.2.2.              Base Case Scenario
                             4.6.2.3.              Best Case Scenario
                     4.6.3. Drivers and Barriers
         4.7.    Japan T-cell Large Granular Lymphocyte Leukemia (T-LGL) Market Forecast 2021-2032
                     4.7.1. Market Progression (Futuristic)
                     4.7.2. Market Trends and Expectations
                             4.7.2.1.              Worst case scenario
                             4.7.2.2.              Base Case Scenario
                             4.7.2.3.              Best Case Scenario
                     4.7.3. Drivers and Barriers
         4.8.    China T-cell Large Granular Lymphocyte Leukemia (T-LGL) Market Forecast 2021-2032
                     4.8.1. Market Progression (Futuristic)
                     4.8.2. Market Trends and Expectations
                             4.8.2.1.              Worst case scenario
                             4.8.2.2.              Base Case Scenario
                             4.8.2.3.              Best Case Scenario
                     4.8.3. Drivers and Barriers
         4.9.    Key Expected Milestones (world-wide) Impacting the Market

5.       Competitive Landscape

         5.1.    Pipeline Therapies Overview
                     5.1.1. Phase III Therapies
                                      5.1.1.1.                     Current Status
                                      5.1.1.2.                     Trial details, results
                                      5.1.1.3.                     Approval Timeline
                                      5.1.1.4.                     Likelihood of approval
                                      5.1.1.5.                     Expected Product Positioning
                             5.1.1.2.              All other Phase III Therapies …..
                             5.1.1.3.              Attribute Analysis of Phase III molecules
                     5.1.2.  Phase II and Phase I/II Therapies
                                      5.1.2.1.                     Current Status
                                      5.1.2.2.                     Trial details, results
                                      5.1.2.3.                     Approval Timelines
                     5.1.3. List of active Pre-clinical Therapies
                                      5.1.3.1.                     Status in T-cell Large Granular Lymphocyte Leukemia (T-LGL)
                                      5.1.3.2.                     Company positioning
                             5.1.3.2.              All other pre-clinical therapies
                     5.1.4. List of Inactive/discontinued assets
                             5.1.4.1.              Business impact of discontinuations on current pipeline
                     5.1.5. Potential winners from T-cell Large Granular Lymphocyte Leukemia (T-LGL) Pipeline
                             5.1.5.1.              Potential Blockbusters across the pipeline

6.       Regulatory/Approval Scenario

         6.1.    Regulatory/Approval Framework in US
                     6.1.1. Policy Framework
                     6.1.2. Payer Expectations
         6.2.    Regulatory/Approval Framework in UK
                     6.2.1. Policy Framework
                     6.2.2. Payer Expectations
         6.3.    Regulatory/Approval Framework in France
                     6.3.1. Policy Framework
                     6.3.2. Payer Expectations
         6.4.    Regulatory/Approval Framework in Germany
                     6.4.1. Policy Framework
                     6.4.2. Payer Expectations
         6.5.    Regulatory/Approval Framework in Italy
                     6.5.1. Policy Framework
                     6.5.2. Payer Expectations
         6.6.    Regulatory/Approval Framework in Spain
                     6.6.1. Policy Framework
                     6.6.2. Payer Expectations
         6.7.       Regulatory/Approval Framework in Japan
                     6.7.1. Policy Framework
                     6.7.2. Payer Expectations
         6.8.       Regulatory/Approval Framework in China
                     6.8.1. Policy Framework
                     6.8.2. Payer Expectations

7.       Clinical Trial Assessment – Current and Future Paradigm

         7.1.    Distribution of Primary Endpoints across trials
         7.2.    Distribution of Secondary Endpoints across trials
         7.3.    Evolution and acceptance of surrogate endpoints
         7.4.    Key Investigator initiated trials
         7.5.    Attrition analysis
                     7.5.1. Suspended/Discontinued Assets
                     7.5.2. Failed Trials, Reasons and Business Impact
                     7.5.3. Terminated Trials, Reasons and Business Impact
                     7.5.4. Withdrawn Trials, Reasons and Business Impact
         7.6.    Trial enrollment scenario and challenges
         7.7.    Clinical Trial Guidance (across geographies)

8.       Thelansis Commentary

         8.1.    Key Unmet needs in T-cell Large Granular Lymphocyte Leukemia (T-LGL)
         8.2.    Possible Best-case Clinical Trial Strategies
         8.3.    Possible Best Case Targeted Product Profile (TPP)
         8.4.    Possible Best-case Market positioning strategies
         8.5.    Possible Best-case Market Access Strategies
         8.6.    Possible Best-case LCM Strategies
         8.7.    Overall View on T-cell Large Granular Lymphocyte Leukemia (T-LGL) Market in Dollar Value

9.       Report Methodology

         9.1.    Secondary research
         9.2.    Primary research
         9.3.    Data collation
         9.4.    Insight Generation

10.   About Thelansis

         10.1.    Our Capabilities
         10.2.    Our Services
         10.3.    Our Contacts
         10.4.    Disclaimer