Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Market Outlook and Forecast

Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Published Date : 2023-02-11

Updated On : 2023-12-27

Pages : 156

Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Market Outlook

Thelansis’s “Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" 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 Relapsed or refractory chronic lymphocytic leukemia treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Overview

Chronic lymphocytic leukemia (CLL) is a cancer affecting the blood and bone marrow, where blood cells are produced. It is the most common type of adult leukemia and is characterized by a distinct immunophenotype involving CD19+, CD20+, CD5+, CD23+, and surface immunoglobulin (sIg)-positive cells. While the exact cause of CLL in most patients is unknown, approximately 8% to 10% have a first-degree relative with the diagnosis. Initial therapy typically yields complete or partial responses in most patients, but it is not curative, often leading to relapse. Many individuals may need a change in treatment due to intolerance. Relapse is defined as CLL progression after achieving partial or complete remission for at least 6 months, differing from refractoriness, which indicates non-response to treatment, progression during therapy, or progression within 6 months of completing a time-limited treatment. Approximately one-third of patients never require treatment and succumb to unrelated causes. Patients facing relapsed/refractory CLL have various therapeutic options that are both safe and effective. However, those relapsing after multiple therapies, individuals with high-risk diseases, and very young patients may necessitate additional options. Treatment choices are influenced by patient preferences (such as time-limited versus continuous treatment), patient characteristics (including functional status and comorbidities), disease characteristics (standard versus high risk), and costs. CLL is identical to small lymphocytic lymphoma (SLL), a clinically indolent non-Hodgkin lymphoma involving mature (peripheral) B cells.

  • In the US, over 200,000 people live with a CLL diagnosis, with a somewhat higher incidence in males (1.3 to 1 to 1.7 to 1) compared to females.

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: 2023-2033

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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Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Competitive Landscape

S. no Asset Company Stage
1 NX-5948 Nurix Therapeutics Phase 1
2 Duvelisib SecuraBio Phase 3
3 APG-2575 Ascentage Pharma Group Inc. Phase 2
4 MOR00208 MorphoSys AG Phase 2
5 IOV-2001 Iovance Biotherapeutics, Inc. Phase 2
6 LAVA-051 Lava Therapeutics Phase 2
7 MS-553 MingSight Pharmaceuticals, Inc Phase 2
8 Acalabrutinib (ACP-196) Acerta Pharma BV Phase 3
9 DTRM-555 Zhejiang DTRM Biopharma Phase 2
10 GB261 Genor Biopharma Co., Ltd. Phase 2

Continued...

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

Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) 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.

Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Market Forecast

1.  Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) – 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. Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) market scenario 2023
                     1.2.2. Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) market scenario 2028
                     1.2.3. Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) market scenario 2033

2. Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) 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 Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
         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. Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) 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 Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) management
         2.16.  Market Opportunity for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
         2.17. KOL Comments on current and upcoming/expected treatment practices in Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

3.       Epidemiology

         3.1.    Epidemiology Overview
         3.2.    Epidemiology by Geography
                     3.2.1. Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Epidemiology in US (2023-2033)
                             3.2.1.1.              Incidence of Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
                             3.2.1.2.              Diagnosed cases
                             3.2.1.3.              Treatable Patient Pool
                             3.2.1.4.              Epidemiology Trends
                     3.2.2. Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Epidemiology in EU-5 (2023-2033)
                             3.2.2.1.              Incidence of Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
                             3.2.2.2.              Diagnosed cases
                             3.2.2.3.              Treatable Patient Pool
                             3.2.2.4.              Epidemiology Trends
                     3.2.3. Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Epidemiology in Japan (2023-2033)
                             3.2.3.1.              Incidence of Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
                             3.2.3.2.              Diagnosed cases
                             3.2.3.3.              Treatable Patient Pool
                             3.2.3.4.              Epidemiology Trends
                     3.2.4. Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Epidemiology in China (2023-2033)
                             3.2.4.1.              Incidence of Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
                             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 Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Market Forecast 2023-2033
                     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 Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Market Forecast 2023-2033
                     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 Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Market Forecast 2023-2033
                     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 Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Market Forecast 2023-2033
                     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 Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Market Forecast 2023-2033
                     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 Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Market Forecast 2023-2033
                     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 Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Market Forecast 2023-2033
                     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 Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) Market Forecast 2023-2033
                     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 Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
                                      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 Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) 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 Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
         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 Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) 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