Published Date : 2023-08-30
Published Date : 2023-08-30
Updated On : 2024-06-04
Pages : 154
Thelansis’s “Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) 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 Steroid-Refractory Acute Graft-Versus-Host Disease treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Steroid-refractory acute graft-versus-host disease (SR-aGVHD) is a life-threatening condition when the first-line treatment for acute graft-versus-host disease (aGVHD), systemic corticosteroids, does not work. aGVHD is a common complication of allogeneic hematopoietic stem cell transplantation (HSCT), occurring in 30-50% of patients. It is caused by the donor's immune cells attacking the recipient's tissues. The incidence and severity of aGVHD are influenced by various risk factors. It tends to occur more frequently and with greater severity in cases of alloHCT from HLA-nonidentical or unrelated donors compared to HLA-matched sibling donors. Additional non-HLA risk factors associated with aGVHD encompass older patient or donor age, the utilization of a female donor for a male recipient, the use of peripheral blood as the source of stem cells, the choice of GVHD prophylaxis, and the recipient's seropositivity for cytomegalovirus. The European Society for Blood and Marrow Transplantation (EBMT) – European Leukemia Net (ELN) consensus working group has generated recommendations on treating aGvHD. In around one-third of cases, the disease is not improved after 4 weeks of treatment. Steroid-resistant or steroid-refractory acute graft-versus-host disease (SR-aGVHD) presents a significant challenge to healthcare providers caring for patients post-allogeneic hematopoietic cell transplantation. Extracorporeal photopheresis (ECP) and anti-thymocyte globulin (ATG) are commonly employed in treating SR-GvHD, with ECP demonstrating particular effectiveness in cases involving the skin, liver, and gut. However, there is no universally accepted standard of care for SR-aGVHD. Patients with steroid-resistant acute graft-versus-host disease (aGVHD) face a grim prognosis, with mortality rates exceeding 90%.
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 | Ryoncil® | Mesoblast, Inc. | Phase 3 |
2 | MC0518 | Medac GmbH | Phase 3 |
3 | ASC930 | ASC Therapeutics | Phase 2 |
4 | Neihulizumab (ALTB-168) | AltruBio Inc. | Phase 2 |
5 | Jaktinib Hydrochloride Tablets | Suzhou Zelgen Biopharmaceuticals Co.,Ltd | Phase 2 |
6 | Ruxolitinib | Incyte Corporation | Phase 2 |
7 | MaaT013 | MaaT Pharma | Phase 2 |
8 | RLS-0071 | ReAlta Life Sciences, Inc. | Phase 2 |
9 | Inolimomab (Leukotac) | ElsaLys Biotech | Phase 3 |
10 | Apraglutide | Ironwood Pharmaceuticals | 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. Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) – 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. Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) market scenario 2023 |
1.2.2. Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) market scenario 2028 |
1.2.3. Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) market scenario 2033 |
2. Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) 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 Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) |
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. Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) 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 Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) management |
2.16. Market Opportunity for Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) Epidemiology in US (2023-2033) |
3.2.1.1. Incidence of Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) Epidemiology in EU-5 (2023-2033) |
3.2.2.1. Incidence of Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) Epidemiology in Japan (2023-2033) |
3.2.3.1. Incidence of Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) Epidemiology in China (2023-2033) |
3.2.4.1. Incidence of Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) |
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 Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) 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 Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) 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 Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) 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 Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) 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 Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) 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 Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) 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 Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) 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 Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) 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 Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) |
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 Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) 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 Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) |
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 Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) 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 |