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Large Granular Lymphocytic Leukemia (LGLL) - Market Insights, Epidemiology, and Market Forecast - 2032

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    Report

  • 141 Pages
  • August 2022
  • Region: Global
  • DelveInsight
  • ID: 5647341
This Large Granular Lymphocytic Leukemia (LGLL)- Market Insights, Epidemiology, and Market Forecast-2032 report delivers an in-depth understanding of the LGLL, historical and forecasted epidemiology as well as the LGLL market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The LGLL market report provides current treatment practices, emerging drugs, LGLL market share of the individual therapies, current and forecasted LGLL market size from 2019 to 2032 segmented by seven major markets. The Report also covers current LGLL treatment practice/algorithm, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered

  • The United States
  • EU5 (Germany, France, Italy, Spain, and the United Kingdom)
  • Japan
Study Period: 2019-2032

LGLL Understanding and Treatment Algorithm

The 's LGLL market report gives a thorough understanding of LGLL by including details such as disease definition, symptoms, causes, pathophysiology, diagnosis, and treatment. Large granular lymphocytic leukemia (LGLL), is a chronic blood disorder with an increased number of large granular lymphocytes (LGLs) in the peripheral blood that accumulate over time. LGLs are characterized by enlarged lymphocytes containing noticeable granules, which can be observed under microscopic examination. In normal conditions, LGLs comprise about 10 to 15 percent of peripheral blood mononuclear cells, but in LGLL, the cases are characterized by extremely high number of LGLs in blood; either by higher number of LGLs than normal, or by a higher percentage compared to other types of white blood cells. Although there are no well-established causes and risk factors of LGLL, it is often times associated with some mutations (like STAT3 and STAT5b), associated comorbidities, age and some common manifestations.

Symptoms of LGLL can range from fatigue and B symptoms (fever, night sweat, and weight loss), changes in blood cell counts like anemia, neutropenia and thrombocytopenia, which can also lead to recurrent infections in certain cases, to splenomegaly, hepatomegaly, and even lymphadenopathy. Although it should be noted that about 30% of the patients are asymptomatic at the time of diagnosis.

Diagnosis

Since the signs and symptoms of LGLL are not very distinctive, with them overlapping with many other diseases and the fact that almost a third of the diagnosed patients are observed to be asymptomatic at the time of diagnosis, making a definite diagnosis for LGLL quite a necessity.

A definite LGLL diagnosis requires evidence of a chronic expanded clonal T- or NK-cell LGL population associated with an appropriate clinical context. It is based on cytology, immunophenotype analysis, and evidence of monoclonality. LGLL can be diagnosed by conducting several tests, including a complete blood count (CBC), usually the first test to show the main sign of LGLL, high white blood cell count and low neutrophil count; flow cytometry with an LGL Panel, which can show the presence of LGLL type; T-cell receptor gene rearrangement (TCR) further tests for types of T-cell clones; bone marrow biopsy; splenectomy and spleen analysis.

Treatment

Presently, immunosuppressive therapy is the backbone for the treatment of LGLL. Even though treatment is not always necessary in patients, due to the disease being indolent, about 60% of the patients still require some form of therapy as soon as the diagnosis is made.

The current treatment that is being offered to the patients is symptomatic and targets associated comorbidities and symptoms instead of the disease itself. For example, current patient care relies on off-label therapies to treat the clinical presentations of LGLL, like neutropenia, anemia, thrombocytopenia, etc., instead of targeted therapies targeting LGLL itself. The distribution pattern of these clinical presentations are also varied across various geographies, with noticeable difference between Japan and the rest of the 7MM (US and EU5).

LGLL Epidemiology

The LGLL epidemiology section provides insights about historical and current LGLL patient pool and forecasted trends for individual seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings

In 2021, the total diagnosed incidence cases of LGLL were about 3840 cases in the 7MM which are expected to grow during the study period, i.e., 2019-2032.

The disease epidemiology covered in the report provides historical as well as forecasted LGLL epidemiology [segmented as Total diagnosed incidence cases, Total type-specific cases of LGLL, Total mutation-specific cases of LGLL, Total age-specific cases of LGLL, Total clinical manifestations-specific cases of LGLL and Total treated cases of LGLL by line of therapies] in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.

Country Wise- LGLL Epidemiology

The epidemiology segment also provides the LGLL epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

LGLL Drug Chapters

The drug chapter segment of the LGLL report encloses the detailed analysis of current drugs being used for LGLL and pipeline drugs as-well. It also helps to understand the LGLL 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.

Treatment

The report provides the details into the emerging therapies under for development for LGLL treatment.

LGLL Market Outlook

The LGLL market outlook of the report helps to build the detailed comprehension of the historic, current, and forecasted LGLL market trends by analyzing the impact of drugs currently in use on the market, unmet needs, and demand of better technology.

This segment gives a thorough detail of LGLL market trend of each drug being used and pipeline therapy, by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria's, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, competition with other therapies, brand value, their impact on the market and view of some key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

Key Findings

The LGLL market size in the 7MM is expected to change during the study period 2019-2032. The total market of LGLL in the seven major markets is expected to increase during the study period (2019-2032). In 2021, the total market size of LGLL was about USD 5.1 million which is expected to rise during the study period (2019-2032).

The United States Market Outlook

The total market size of LGLL in the United States accounted for about USD 3 million in 2021 which is expected to rise during the study period (2019-2032).

EU-5 Countries: Market Outlook

In EU5, the total market size of LGLL was about USD 1.5 million in 2021, which is expected to rise during the study period (2019-2032).

Japan Market Outlook

In Japan, the total market size of LGLL was about USD 653 K in 2021, which is expected to rise during the study period (2019-2032).

LGLL Uptake

This section focuses on the rate of uptake of different drugs in the LGLL market during the study period 2019-2032. The analysis covers LGLL 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 their maximal use, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

LGLL Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase II, and Phase I stages. It also analyses LGLL key players involved in developing targeted therapeutics.

Reimbursement Scenario in LGLL

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

KOL-Views

To keep up with current market trends, we take KOLs and SMEs ' opinions working in the LGLL domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or LGLL market trends. 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 Competitively and Market Intelligence analysis of the LGLL 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 LGLL, explaining its causes, signs and symptoms, pathophysiology, diagnosis, and currently available therapies
  • Comprehensive insight has been provided into the LGLL epidemiology and treatment in the 7MM
  • Additionally, an all-inclusive account of both the current and emerging therapies for LGLL are provided
  • A detailed review of the LGLL market; historical and forecasted is included in the report, covering drug outreach in the 7MM
  • The report provides an edge while developing business strategies, by understanding trends shaping and driving the global LGLL market

Report Highlights

  • In the coming years, the LGLL market may change due to the rising number of old age people in the population of 7MM; 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 LGLL 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 LGLL. The launch of emerging therapies will significantly impact the LGLL market
  • A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for LGLL
  • Our in-depth analysis of the pipeline assets across different stages of development (Phase II and Phase I), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, 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

LGLL Report Insights

  • Patient Population
  • Therapeutic Approaches
  • LGLL Pipeline Analysis
  • LGLL Market Size and Trends
  • Market Opportunities

LGLL Report Key Strengths

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

LGLL Report Assessment

  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness

Key Questions Answered

Market Insights:

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

Epidemiology Insights:

  • What are the disease risk, burden, and regional/ethnic differences of LGLL?
  • What are the key factors driving the epidemiology trend for seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • What has been the historical LGLL diagnosed incidence cases in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • What would be the forecasted incidence of LGLL in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • Where will be the growth opportunities in the 7MM concerning the diagnosed incidence LGLL?
  • Out of all 7MM countries, which country would have the highest incidence of LGLL during the forecast period (2019-2032)?
  • At what CAGR the patient population is expected to grow by 7MM during the forecast period (2019-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

  • What are the current options for the LGLL treatment?
  • What are the current treatment guidelines for the treatment of LGLL in the USA, Europe, and Japan?
  • How many companies are developing therapies for the treatment of LGLL?
  • How many therapies are in-development by each company for LGLL treatment?
  • What are the current stages of development for drugs under development for treatment of LGLL?
  • What are the key collaborations (Industry - Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the LGLL therapies?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for LGLL and its status?
  • What are the current challenges faced in drug development?
  • What are the key designations that have been granted for the emerging therapies for LGLL?
  • What are the global historical and forecasted markets of LGLL?

Reasons to Buy

  • The report will help in developing business strategies by understanding trends shaping and driving the LGLL market
  • Organize sales and marketing efforts by identifying the best opportunities for LGLL in the US, Europe (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 the LGLL market
  • To understand the future market competition in the LGLL market

Table of Contents

1. Key Insights2. Report Introduction
3. LGLL Market Overview at a Glance
3.1. Market Share (%) Distribution of LGLL in 2019
3.2. Market Share (%) Distribution of LGLL in 2032
4. Executive Summary of LGLL5. Epidemiology and Market Methodology
6. Disease overview and background
6.1. Introduction
6.2. Classification of LGLL
6.2.1. T-cell LGL leukemia (T-LGLL)
6.2.2. Chronic lymphoproliferative disorder of natural killer cells (CLPD-NK)
6.2.3. Aggressive natural killer cell leukemia (ANKL)
6.3. Etiology of LGLL
6.4. Clinical Presentation of LGLL
6.5. Manifestations Associated with LGLL
6.5.1. Autoimmune manifestations
6.5.2. Bone marrow failure and other hematologic neoplasms
6.6. Pathogenesis of LGLL
6.7. Genetic Mutations Involved in LGLL
6.7.1. Genetics of T-cell LGLL
6.7.2. Genetics of CLPD-NK
7. Diagnosis of LGL leukemia
7.1. Cytology
7.2. Immunophenotyping
7.3. Clonality
7.4. Molecular findings
7.5. Marrow features
7.6. Diagnostic algorithm
7.7. Differential diagnosis
8. Treatment
8.1. Treatment of Relapsed or Refractory Disease
8.1.1. Treating an aggressive NK-cell LGLL
8.1.2. Treatment algorithm
8.1.3. Treatment Guidelines of LGLL
9. Patient Journey
10. Epidemiology and Patient Population
10.1. Key Findings
10.2. Assumptions and Rationale 7MM
10.3. Epidemiology Scenario in the 7MM
10.3.1. Diagnosed Incidence Cases in the 7MM
10.3.2. Type-specific Cases of LGLL in the 7MM
10.3.3. Mutation-specific Cases of LGLL
10.3.4. Age-specific Cases of LGLL in the 7MM
10.3.5. Clinical manifestations-specific Cases of LGLL
10.3.6. Treated Cases of LGLL by line of therapies
10.4. Epidemiology Scenario in the United States
10.4.1. Diagnosed Incidence Cases in the United States
10.4.2. Type-specific Cases of LGLL in the United States
10.4.3. Mutation-specific Cases of LGLL in the United States
10.4.4. Age-specific Cases of LGLL in the United States
10.4.5. Clinical manifestations-specific cases of LGLL in the United States
10.4.6. Treated Cases of LGLL by line of therapies
10.5. Epidemiology Scenario in EU5
10.5.1. Diagnosed Incidence Cases in EU5
10.5.2. Type-specific Cases of LGLL in EU5
10.5.3. Age-specific Cases of LGLL in EU5
10.5.4. Clinical manifestations-specific cases of LGLL in EU5
10.5.5. Mutation-specific Cases of LGL in the EU5
10.5.6. Treated Cases LGLL by line of therapies
10.6. Epidemiology Scenario in Japan
10.6.1. Diagnosed Incidence Cases in Japan
10.6.2. Type-specific Cases of LGLL in the Japan
10.6.3. Mutation-specific Cases of LGLL
10.6.4. Age-specific Cases of LGLL in the Japan
10.6.5. Clinical manifestations-specific Cases of LGLL
10.6.6. Treated Cases of LGLL by line of therapies
11. Key Endpoints in LGLL Clinical Trials
12. Emerging Drugs
12.1. Key Competitors
12.2. VIDAZA (azacitidine): Bristol Myers Squibb
12.2.1. Product description
12.2.2. Clinical development
12.3. IPH4102 (lacutamab): Innate Pharma
12.3.1. Product description
12.3.2. Clinical development
12.4. KT-333: Kymera Therapeutics
12.4.1. Product description
12.4.2. Clinical development
13. LGLL 7 Major Market Analysis
13.1. Key Findings
13.2. Market Outlook
13.3. 7MM Market Size of LGLL
13.3.1. Total Market Size of LGLL
13.3.2. Market Size by Therapies
13.4. Market Size of LGLL in the United States
13.4.1. Total Market Size of LGLL
13.4.2. Market Size by Therapies
13.5. Market Size of LGLL in EU5
13.5.1. Total Market Size of LGLL
13.5.2. Market Size by Therapies of LGLL
13.6. Market Size of LGLL in Japan
13.6.1. Total Market Size of LGLL
13.6.2. Market Size by Therapies
14. Market Access and Reimbursement15. KOL Views16. SWOT Analysis17. Unmet Needs
18. Appendix
18.1. Acronyms and Abbreviations
18.2. Bibliography
18.3. Report Methodology
19. Publisher Capabilities20. Disclaimer21. About the Publisher
List of Tables
Table 1: Diagnosed Incident Cases of LGLL (2019-2032)
Table 2: Type-specific Cases of LGLL in the 7MM (2019-2032)
Table 3: Mutation-specific Cases of LGLL in the 7MM (2019-2032)
Table 4: Age-specific Cases of LGLL in the 7MM (2019-2032)
Table 5: Clinical manifestations-specific Cases of LGLL in the 7MM (2019-2032)
Table 6: Treated Cases of LGLL by line of therapies (2019-2032)
Table 7: Diagnosed Incidence Cases of LGLL in the United States (2019-2032)
Table 8: Type-specific Cases of LGLL in the United States (2019-2032)
Table 9: Mutation-specific Cases of LGLL in the United States (2019-2032)
Table 10: Age-specific Cases of LGLL in the United States (2019-2032)
Table 11: Clinical manifestations-specific Cases of LGLL in the United States (2019-2032)
Table 12: Treated Cases of LGLL by line of therapies in the United States (2019-2032)
Table 13: Diagnosed Incidence Cases of LGLL in EU5 (2019-2032)
Table 14: Type-specific Cases of LGLL in EU5 (2019-2032)
Table 15: Age-specific Cases of LGLL in EU5 (2019-2032)
Table 16: Stage-specific Cases of LGLL in EU5 (2019-2032)
Table 17: Mutation-specific Cases of LGLL in EU5 (2019-2032)
Table 18: Treated Cases of LGLL by line of therapies in EU5 (2019-2032)
Table 19: Diagnosed Incidence Cases of LGLL in Japan (2019-2032)
Table 20: Type-specific Cases of LGLL in the Japan (2019-2032)
Table 21: Mutation-specific Cases of LGLL in the Japan (2019-2032)
Table 22: Age-specific Cases of LGLL in the Japan (2019-2032)
Table 23: Clinical manifestations-specific Cases of LGLL in the Japan (2019-2032)
Table 24: Treated Cases of LGLL by line of therapies (2019-2032)
Table 25: Comparison of emerging drugs under development
Table 26: VIDAZA (azacitidine); Clinical Trial Description, 2022
Table 27: IPH4102 (lacutamab); Clinical Trial Description, 2022
Table 28: KT-333; Clinical Trial Description, 2022
Table 29: 7MM Market Size of LGLL in USD thousands (2019-2032)
Table 30: Market Size by Therapies in USD thousand (2019-2032)
Table 31: Market Size of LGLL in the United States, in USD thousands (2019-2032)
Table 32: Market Size by Therapies in USD thousand (2019-2032)
Table 33: EU5 Market Size of LGLL in USD thousand (2019-2032)
Table 34: Market Size by in USD thousand (2019-2032)
Table 35: Japan Market Size of LGLL in USD thousand (2019-2032)
Table 36: Market Size by Therapies in USD thousand (2019-2032)
List of Figures
Figure 1: Epidemiology and Market Methodology
Figure 2: Classification of LGLL
Figure 3: Common Etiopathogenesis for LGLL Associated With Autoimmune Disease
Figure 4: Signaling Pathways and Mutations Involved in the Pathogenesis of LGLs.
Figure 5: TAT3 and STAT5b Mutations are Preferentially Found in Phenotypically Distinct LGL Disorders
Figure 6: Diagnostic Algorithm of LGLL
Figure 7: Treatment Algorithm of LGLL
Figure 8: Treatment Algorithm of LGLL
Figure 9: Diagnosed Incidence Cases of LGLL in the 7MM (2019-2032)
Figure 10: Type-specific Cases of LGLL in the 7MM (2019-2032)
Figure 11: Mutation-specific Cases of LGLL in the 7MM (2019-2032)
Figure 12: Age-specific Cases of LGLL in the 7MM (2019-2032)
Figure 13: Clinical manifestations-specific Cases of LGLL in the 7MM (2019-2032)
Figure 14: Treated Cases of LGLL by line of therapies in the 7MM (2019-2032)
Figure 15: Diagnosed Incidence Cases of LGLL in the United States (2019-2032)
Figure 16: Type-specific Cases of LGLL in the United States (2019-2032)
Figure 17: Total Mutation-specific Cases of LGLL in the United States (2019-2032)
Figure 18: Age-specific Cases of LGLL in the United States (2019-2032)
Figure 19: Total clinical manifestations-specific Cases of LGLL in the United States (2019-2032)
Figure 20: Treated Cases of LGLL by line of therapies in the United States (2019-2032)
Figure 21: Diagnosed Incidence Cases of LGLL in the EU5 (2019-2032)
Figure 22: Type-specific Cases of LGLL in EU5 (2019-2032)
Figure 23: Age-specific Cases of LGLL in EU5 (2019-2032)
Figure 24: Clinical manifestations-specific Cases of LGLL in EU-5 (2019-2032)
Figure 25: Mutation-specific Cases of LGLL in EU5 (2019-2032)
Figure 26: Treated Cases of LGLL by line of therapies in EU5 (2019-2032)
Figure 27: Diagnosed Incidence Cases of LGLL in Japan (2019-2032)
Figure 28: Type-specific Cases of LGLL in the Japan (2019-2032)
Figure 29: Mutation-specific Cases of LGLL in the Japan (2019-2032)
Figure 30: Age-specific Cases of LGLL in the Japan (2019-2032)
Figure 31: Clinical manifestations-specific Cases of LGLL in the Japan (2019-2032)
Figure 32: Treated Cases of LGLL by line of therapies in the Japan (2019-2032)
Figure 33: Market Size of LGLL in the 7MM, USD (2019-2032)
Figure 34: Market Size by Therapies in USD (2019-2032)
Figure 35: Market Size of LGLL in the United States, USD (2019-2032)
Figure 36: Market Size by Therapies in USD (2019-2032)
Figure 37: Market Size of LGLL in EU5, USD (2019-2032)
Figure 38: Market Size by Therapies in USD (2019-2032)
Figure 39: Market Size of LGLL in the Japan, USD (2019-2032)
Figure 40: Market Size by Therapies in USD (2019-2032)

Companies Mentioned (Partial List)

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

  • Bristol Myers Squibb
  • Innate Pharma
  • Kymera Therapeutics