Published Date : 2024-07-23
Published Date : 2024-07-23
Updated On : 2025-02-17
Pages : 151
Thelansis’s “Relapsed or Refractory Mycosis Fungoides (MF) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2024 To 2034" 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 Mycosis Fungoides treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Relapsed or refractory mycosis fungoides (MF) represents a persistent or returning form of cutaneous T-cell lymphoma, a rare malignancy arising from atypical T-cells that preferentially localize to the skin. The disease begins subtly, with skin manifestations like flat, scaly patches that mimic benign dermatological conditions but can progress to plaques or tumors that ulcerate and become more invasive. Advanced stages may involve systemic spread, targeting lymph nodes, blood, and internal organs, often resulting in symptoms like fever, weight loss, and significant deterioration in quality of life. Diagnosis requires a comprehensive approach, including clinical evaluation, histopathological analysis, and immunophenotyping, with staging often guided by the TNMB system to assess tumor burden and systemic involvement. Treatment for early-stage MF focuses on localized interventions such as corticosteroids, phototherapy, or topical chemotherapeutic agents, while advanced or refractory cases demand systemic approaches, including retinoids, histone deacetylase inhibitors, monoclonal antibodies like mogamulizumab, or extracorporeal photopheresis. Relapsed cases may benefit from cutting-edge therapies like checkpoint inhibitors or participation in clinical trials evaluating novel agents. The prognosis varies significantly, with early detection offering better outcomes, whereas relapsed or refractory conditions require complex and often experimental strategies, reflecting the challenging nature of this disease.
North America- the United States and Canada
Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Other countries- Japan & China
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.
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
- 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
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.
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.
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.
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.
S. no | Asset | Company | Stage |
1 | AFM13 | Affimed GmbH | Phase 2 |
2 | Pembrolizumab | Merck Sharp & Dohme LLC | Phase 2 |
3 | IPH4102 | Innate Pharma | Phase 3 |
4 | PTX-100 | Prescient Therapeutics, Ltd. | Phase 2 |
5 | BI-1808 | BioInvent International AB | Phase 2 |
6 | BMS-986369 | Bristol-Myers Squibb | Phase 1/2 |
7 | Fenretinide | SciTech Development, Inc. | Phase 1 |
8 | Mogamulizumab | Kyowa Kirin, Inc. | 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 |
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.
1. Relapsed or Refractory Mycosis Fungoides (MF) – 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 Mycosis Fungoides (MF) market scenario 2024 |
1.2.2. Relapsed or Refractory Mycosis Fungoides (MF) market scenario 2029 |
1.2.3. Relapsed or Refractory Mycosis Fungoides (MF) market scenario 2034 |
2. Relapsed or Refractory Mycosis Fungoides (MF) 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 Mycosis Fungoides (MF) |
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 Mycosis Fungoides (MF) 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 Mycosis Fungoides (MF) management |
2.16. Market Opportunity for Relapsed or Refractory Mycosis Fungoides (MF) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Relapsed or Refractory Mycosis Fungoides (MF) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Relapsed or Refractory Mycosis Fungoides (MF) Epidemiology in US (2024-2034) |
3.2.1.1. Incidence of Relapsed or Refractory Mycosis Fungoides (MF) |
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 Mycosis Fungoides (MF) Epidemiology in EU-5 (2024-2034) |
3.2.2.1. Incidence of Relapsed or Refractory Mycosis Fungoides (MF) |
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 Mycosis Fungoides (MF) Epidemiology in Japan (2024-2034) |
3.2.3.1. Incidence of Relapsed or Refractory Mycosis Fungoides (MF) |
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 Mycosis Fungoides (MF) Epidemiology in China (2024-2034) |
3.2.4.1. Incidence of Relapsed or Refractory Mycosis Fungoides (MF) |
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 Mycosis Fungoides (MF) Market Forecast 2024-2034 |
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 Mycosis Fungoides (MF) Market Forecast 2024-2034 |
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 Mycosis Fungoides (MF) Market Forecast 2024-2034 |
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 Mycosis Fungoides (MF) Market Forecast 2024-2034 |
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 Mycosis Fungoides (MF) Market Forecast 2024-2034 |
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 Mycosis Fungoides (MF) Market Forecast 2024-2034 |
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 Mycosis Fungoides (MF) Market Forecast 2024-2034 |
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 Mycosis Fungoides (MF) Market Forecast 2024-2034 |
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 Mycosis Fungoides (MF) |
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 Mycosis Fungoides (MF) 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 Mycosis Fungoides (MF) |
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 Mycosis Fungoides (MF) 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 |