Published Date : 2023-04-09
Published Date : 2023-04-09
Updated On : 2023-12-06
Pages : 163
Thelansis’s “Relapsed or Refractory Peripheral T-Cell Lymphoma (r/r PTCL) 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 Peripheral T-Cell Lymphoma treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Peripheral T-cell lymphoma (PTCL) is a rare group of typically fast-growing Non-Hodgkin's Lymphomas (NHL) that originates from mature T-cells and natural killer (NK) cells, which are mature-stage white blood cells. This subtype of NHL specifically affects T-cells and occurs when these cells develop and proliferate abnormally. Patients diagnosed with PTCL often face a grim prognosis characterized by multiple relapses and resistance to initial treatment. Relapsed or Refractory Peripheral T-cell lymphoma refers to a condition where the disease reappears or grows again after a period of remission (relapsed) or when the lymphoma does not respond to treatment (refractory), meaning that the cancer cells continue to grow, or when the response to treatment does not last very long. Median overall survival for relapsed patients had a longer survival period at 29.1 months compared to refractory patients with only 12.3 months. One-year survival rates are influenced by the response to the initial therapy, with 84% survival among relapsed patients and 52% among refractory patients. Among all relapsed and refractory patients, those achieving a complete response to second-line therapy had a notably extended survival compared to those with a partial response or worse. Recently, the FDA approved four next-generation drugs (pralatrexate, romidepsin, brentuximab vedotin, and belinostat) for treating relapsed and refractory PTCL based on their response rates. However, none of these agents led to improvements in overall survival. The European Medicines Agency (EMA) declined to approve both pralatrexate and romidepsin due to a lack of clear clinical benefits, and belinostat is not licensed in Europe despite being granted orphan designation status by the EMA. Brentuximab vedotin is the only drug approved by the EMA to treat relapsed or refractory systemic ALCL, primarily due to a more favorable benefits-to-risks ratio.
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 | Golidocitinib (AZD4205) | Dizal Pharmaceuticals | Phase 2 |
2 | Belinostat | Spectrum Pharmaceuticals, Inc | Phase 3 |
3 | HBI-8000 | HUYABIO International, LLC. | Phase 2 |
4 | Duvelisib | SecuraBio | Phase 2 |
5 | SHC014748M | Nanjing Sanhome Pharmaceutical, Co., Ltd. | Phase 2 |
6 | SP-02L | Solasia Pharma K.K. | Phase 2 |
7 | Pralatrexate | Acrotech Biopharma Inc. | Phase 2 |
8 | Pralatrexate | Mundipharma (China) Pharmaceutical Co. Ltd | Phase 2 |
9 | Tipifarnib | Kura Oncology, Inc. | Phase 2 |
10 | IMC-001 | ImmuneOncia Therapeutics Inc. | 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 |
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 Peripheral T-Cell Lymphoma (r/r PTCL) – 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 Peripheral T-Cell Lymphoma (r/r PTCL) market scenario 2023 |
1.2.2. Relapsed or Refractory Peripheral T-Cell Lymphoma (r/r PTCL) market scenario 2028 |
1.2.3. Relapsed or Refractory Peripheral T-Cell Lymphoma (r/r PTCL) market scenario 2033 |
2. Relapsed or Refractory Peripheral T-Cell Lymphoma (r/r PTCL) 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 Peripheral T-Cell Lymphoma (r/r PTCL) |
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 Peripheral T-Cell Lymphoma (r/r PTCL) 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 Peripheral T-Cell Lymphoma (r/r PTCL) management |
2.16. Market Opportunity for Relapsed or Refractory Peripheral T-Cell Lymphoma (r/r PTCL) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Relapsed or Refractory Peripheral T-Cell Lymphoma (r/r PTCL) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Relapsed or Refractory Peripheral T-Cell Lymphoma (r/r PTCL) Epidemiology in US (2023-2033) |
3.2.1.1. Incidence of Relapsed or Refractory Peripheral T-Cell Lymphoma (r/r PTCL) |
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 Peripheral T-Cell Lymphoma (r/r PTCL) Epidemiology in EU-5 (2023-2033) |
3.2.2.1. Incidence of Relapsed or Refractory Peripheral T-Cell Lymphoma (r/r PTCL) |
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 Peripheral T-Cell Lymphoma (r/r PTCL) Epidemiology in Japan (2023-2033) |
3.2.3.1. Incidence of Relapsed or Refractory Peripheral T-Cell Lymphoma (r/r PTCL) |
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 Peripheral T-Cell Lymphoma (r/r PTCL) Epidemiology in China (2023-2033) |
3.2.4.1. Incidence of Relapsed or Refractory Peripheral T-Cell Lymphoma (r/r PTCL) |
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 Peripheral T-Cell Lymphoma (r/r PTCL) 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 Peripheral T-Cell Lymphoma (r/r PTCL) 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 Peripheral T-Cell Lymphoma (r/r PTCL) 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 Peripheral T-Cell Lymphoma (r/r PTCL) 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 Peripheral T-Cell Lymphoma (r/r PTCL) 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 Peripheral T-Cell Lymphoma (r/r PTCL) 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 Peripheral T-Cell Lymphoma (r/r PTCL) 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 Peripheral T-Cell Lymphoma (r/r PTCL) 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 Peripheral T-Cell Lymphoma (r/r PTCL) |
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 Peripheral T-Cell Lymphoma (r/r PTCL) 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 Peripheral T-Cell Lymphoma (r/r PTCL) |
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 Peripheral T-Cell Lymphoma (r/r PTCL) 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 |