Published Date : 2024-07-09
Published Date : 2024-07-09
Updated On : 2025-01-13
Pages : 154
Thelansis’s “Warm Autoimmune Hemolytic Anemia (wAIHA) 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 Warm autoimmune hemolytic anemia treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Warm Autoimmune Hemolytic Anemia (wAIHA) encompasses a group of conditions characterized by the destruction of red blood cells (RBCs) due to autoantibodies active at body temperature. These autoantibodies, primarily of the IgG class, lead to hemolysis through extravascular destruction in the spleen and liver. wAIHA may be idiopathic or secondary to conditions such as autoimmune diseases, lymphoproliferative disorders, or infections. Two primary mechanisms contribute to hemolysis: antibody-mediated RBC destruction and complement activation. The pathophysiology involves the binding of autoantibodies to RBCs, resulting in their clearance by splenic macrophages. The direct antiglobulin test (DAT), a cornerstone diagnostic tool, typically detects IgG and complement (C3) on the RBC surface. In wAIHA, anemia manifests as the primary clinical concern, leading to symptoms like fatigue, pallor, and shortness of breath. Additional signs include jaundice and dark-colored urine due to bilirubin elevation. Splenomegaly is common, and severe cases may result in complications like thrombosis. Peripheral blood smear findings often reveal spherocytes and polychromasia, indicative of hemolysis.
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 | Rilzabrutinib | Sanofi | Phase 2 |
2 | IASO-782 injection | Shanghai IASO Biotechnology Co., Ltd | Phase 1 |
3 | Obexelimab | Zenas BioPharma (USA), LLC | Phase 3 |
4 | M281 | Janssen Research & Development, LLC | Phase 2/3 |
5 | Fostamatinib disodium | Rigel Pharmaceuticals | Phase 3 |
6 | Ianalumab | Novartis Pharmaceuticals | Phase 3 |
7 | HMPL-523 | Hutchison Medipharma Limited | Phase 2/3 |
8 | ANX005 | Annexon, Inc. | Phase 2 |
9 | APL-2 | Apellis Pharmaceuticals, Inc. | Phase 2 |
10 | Povetacicept | Alpine Immune Sciences, Inc. | Phase 1/2 |
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. Warm Autoimmune Hemolytic Anemia (wAIHA) – 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. Warm Autoimmune Hemolytic Anemia (wAIHA) market scenario 2024 |
1.2.2. Warm Autoimmune Hemolytic Anemia (wAIHA) market scenario 2029 |
1.2.3. Warm Autoimmune Hemolytic Anemia (wAIHA) market scenario 2034 |
2. Warm Autoimmune Hemolytic Anemia (wAIHA) 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 Warm Autoimmune Hemolytic Anemia (wAIHA) |
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. Warm Autoimmune Hemolytic Anemia (wAIHA) 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 Warm Autoimmune Hemolytic Anemia (wAIHA) management |
2.16. Market Opportunity for Warm Autoimmune Hemolytic Anemia (wAIHA) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Warm Autoimmune Hemolytic Anemia (wAIHA) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Warm Autoimmune Hemolytic Anemia (wAIHA) Epidemiology in US (2024-2034) |
3.2.1.1. Incidence of Warm Autoimmune Hemolytic Anemia (wAIHA) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Warm Autoimmune Hemolytic Anemia (wAIHA) Epidemiology in EU-5 (2024-2034) |
3.2.2.1. Incidence of Warm Autoimmune Hemolytic Anemia (wAIHA) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Warm Autoimmune Hemolytic Anemia (wAIHA) Epidemiology in Japan (2024-2034) |
3.2.3.1. Incidence of Warm Autoimmune Hemolytic Anemia (wAIHA) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Warm Autoimmune Hemolytic Anemia (wAIHA) Epidemiology in China (2024-2034) |
3.2.4.1. Incidence of Warm Autoimmune Hemolytic Anemia (wAIHA) |
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 Warm Autoimmune Hemolytic Anemia (wAIHA) 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 Warm Autoimmune Hemolytic Anemia (wAIHA) 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 Warm Autoimmune Hemolytic Anemia (wAIHA) 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 Warm Autoimmune Hemolytic Anemia (wAIHA) 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 Warm Autoimmune Hemolytic Anemia (wAIHA) 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 Warm Autoimmune Hemolytic Anemia (wAIHA) 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 Warm Autoimmune Hemolytic Anemia (wAIHA) 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 Warm Autoimmune Hemolytic Anemia (wAIHA) 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 Warm Autoimmune Hemolytic Anemia (wAIHA) |
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 Warm Autoimmune Hemolytic Anemia (wAIHA) 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 Warm Autoimmune Hemolytic Anemia (wAIHA) |
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 Warm Autoimmune Hemolytic Anemia (wAIHA) 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 |