Published Date : 2022-09-30
Published Date : 2022-09-30
Updated On : 2023-07-04
Pages : 161
Thelansis’s “Hematopoietic Stem Cell Transplantation (HSCT) Market Outlook, Competitive Landscape, and Market Forecast Report – 2022 To 2032" covers disease overview, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Hematopoietic Stem Cell Transplantation treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Hematopoietic stem cell transplantation (HSCT) involves transplanting stem cells from different sources (such as bone marrow, growth factor-stimulated peripheral blood, and umbilical cord blood) to treat various malignant (e.g., leukemia, lymphoma) and non-malignant (e.g., sickle cell disease) diseases by rebuilding the patient's hematopoietic system. HSCT has become a widely accepted therapy for a range of malignant and non-malignant diseases. It is increasingly used as a treatment option for various disorders. Three main types of HSCT procedures exist:
HSCT is classified based on its purpose, HSC origin, and HSC donor type. Allogeneic transplantation requires matching HLA antigens between the donor and patient, which can be done at different resolution levels. Most HSCT procedures use autologous HSC for various forms of cancer, with multiple myeloma being the most common indication. However, advances in less toxic and equally effective therapies have led to decreased use of autologous HSCT for cancer treatment. Allogeneic transplants are predominantly performed for patients with hematologic malignancies, particularly acute leukemias. Most HSCTs for lymphoid malignancies are autologous, while those for myeloid malignancies are allogeneic. Autologous HSCT is also preferred for patients with autoimmune disorders. The distribution is approximately 64% lymphoid malignancies, 25% myeloid malignancies, 4% solid tumors, and 7% non-malignant disorders. While HSCT can lead to favorable outcomes and significant patient improvement, it is associated with considerable morbidity, mortality, and long-term health issues. Major complications include infections, graft-versus-host disease (GVHD), and graft failure or rejection.
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 | Defibrotide | Jazz Pharmaceuticals | Phase 3 |
2 | Letermovir | Merck Sharp & Dohme LLC | Phase 3 |
3 | Seretide | GlaxoSmithKline | Phase 3 |
4 | Ravulizumab | Alexion | Phase 3 |
5 | Ixazomib | Millennium Pharmaceuticals, Inc. | Phase 1 |
6 | Brentuximab Vedotin (SGN-35) | Seagen Inc. | Phase 2 |
7 | AB-205 | Angiocrine Bioscience | Phase 3 |
8 | Iberdomide | Bristol-Myers Squibb | Phase 2 |
9 | Omidubicel | Gamida Cell ltd | Phase 3 |
10 | BL-8040 | BioLineRx, Ltd. | Phase 3 |
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. Hematopoietic Stem Cell Transplantation (HSCT) – Key Findings Summary |
1.1. Commercial Potential |
1.1.1. Market potential |
1.1.2. Therapeutic practices |
1.1.3. Market outlook |
1.2. Commercial findings |
1.2.1. Hematopoietic Stem Cell Transplantation (HSCT) market scenario 2022 |
1.2.2. Hematopoietic Stem Cell Transplantation (HSCT) market scenario 2027 |
1.2.3. Hematopoietic Stem Cell Transplantation (HSCT) market scenario 2032 |
2. Hematopoietic Stem Cell Transplantation (HSCT) Overview |
2.1. Introduction to Hematopoietic Stem Cell Transplantation (HSCT) |
2.2. Pathogenesis |
2.3. Technology and platform |
2.4. Applications |
2.5. Risk Factors |
2.6. Therapeutic evolutions |
2.7. Clinical practice |
2.8. Hematopoietic Stem Cell Transplantation (HSCT) adoption and clinical practice |
2.8.1. Treatment landscape for Hematopoietic Stem Cell Transplantation (HSCT) in US |
2.8.2. Treatment landscape for Hematopoietic Stem Cell Transplantation (HSCT) in EU-5 |
2.8.3. Treatment landscape for Hematopoietic Stem Cell Transplantation (HSCT) in Japan |
2.8.4. Treatment landscape for Hematopoietic Stem Cell Transplantation (HSCT) in China |
2.9. Treatment Goals for Hematopoietic Stem Cell Transplantation (HSCT) |
2.10. Referral Patterns for Hematopoietic Stem Cell Transplantation (HSCT) |
2.10.1. Referral Scenario in US |
2.10.2. Referral Scenario in EU-5 |
2.10.3. Referral Scenario in Japan |
2.10.4. Referral Scenario in China |
2.11. Hematopoietic Stem Cell Transplantation (HSCT) Healthcare burden |
2.11.1. Hematopoietic Stem Cell Transplantation (HSCT) Healthcare burden in US |
2.11.2. Hematopoietic Stem Cell Transplantation (HSCT) Healthcare burden in EU-5 |
2.11.3. Hematopoietic Stem Cell Transplantation (HSCT) Healthcare burden in Japan |
2.11.4. Hematopoietic Stem Cell Transplantation (HSCT) Healthcare burden in China |
2.12. Current unmet Needs |
2.13. Market Opportunity for Hematopoietic Stem Cell Transplantation (HSCT) |
2.14. Payer’s Expectations from Hematopoietic Stem Cell Transplantation (HSCT) |
2.15. KOL Comments on Hematopoietic Stem Cell Transplantation (HSCT) current and upcoming/expected clinical practices |
3. Market Outlook
|
3.1. US Hematopoietic Stem Cell Transplantation (HSCT) Market Forecast 2022-2032 |
3.1.1. Market Progression (Futuristic) |
3.1.2. Market Trends and Expectations |
3.1.2.1. Worst Case Scenario |
3.1.2.2. Base Case Scenario |
3.1.2.3. Best Case Scenario |
3.1.3. Drivers and Barriers |
3.2. UK Hematopoietic Stem Cell Transplantation (HSCT) Market Forecast 2022-2032 |
3.2.1. Market Progression (Futuristic) |
3.2.2. Market Trends and Expectations |
3.2.2.1. Worst Case Scenario |
3.2.2.2. Base Case Scenario |
3.2.2.3. Best Case Scenario |
3.2.3. Drivers and Barriers |
3.3. France Hematopoietic Stem Cell Transplantation (HSCT) Market Forecast 2022-2032 |
3.3.1. Market Progression (Futuristic) |
3.3.2. Market Trends and Expectations |
3.3.2.1. Worst Case Scenario |
3.3.2.2. Base Case Scenario |
3.3.2.3. Best Case Scenario |
3.3.3. Drivers and Barriers |
3.4. Germany Hematopoietic Stem Cell Transplantation (HSCT) Market Forecast 2022-2032 |
3.4.1. Market Progression (Futuristic) |
3.4.2. Market Trends and Expectations |
3.4.2.1. Worst Case Scenario |
3.4.2.2. Base Case Scenario |
3.4.2.3. Best Case Scenario |
3.4.3. Drivers and Barriers |
3.5. Italy Hematopoietic Stem Cell Transplantation (HSCT) Market Forecast 2022-2032 |
3.5.1. Market Progression (Futuristic) |
3.5.2. Market Trends and Expectations |
3.5.2.1. Worst Case Scenario |
3.5.2.2. Base Case Scenario |
3.5.2.3. Best Case Scenario |
3.5.3. Drivers and Barriers |
3.6. Spain Hematopoietic Stem Cell Transplantation (HSCT) Market Forecast 2022-2032 |
3.6.1. Market Progression (Futuristic) |
3.6.2. Market Trends and Expectations |
3.6.2.1. Worst Case Scenario |
3.6.2.2. Base Case Scenario |
3.6.2.3. Best Case Scenario |
3.6.3. Drivers and Barriers |
3.7. Japan Hematopoietic Stem Cell Transplantation (HSCT) Market Forecast 2022-2032 |
3.7.1. Market Progression (Futuristic) |
3.7.2. Market Trends and Expectations |
3.7.2.1. Worst Case Scenario |
3.7.2.2. Base Case Scenario |
3.7.2.3. Best Case Scenario |
3.7.3. Drivers and Barriers |
3.8. China Hematopoietic Stem Cell Transplantation (HSCT) Market Forecast 2022-2032 |
3.8.1. Market Progression (Futuristic) |
3.8.2. Market Trends and Expectations |
3.8.2.1. Worst Case Scenario |
3.8.2.2. Base Case Scenario |
3.8.2.3. Best Case Scenario |
3.8.3. Drivers and Barriers |
3.9. Key Expected Milestones (world-wide) Impacting the Market |
4. Competitive Landscape
|
4.1. Pipeline Therapies Overview |
4.2. Phase III/ II Profiles |
4.2.1. All Other Company (All Other Product) Profile |
4.2.1.1. Current Status |
4.2.1.2. Trial details, results (Targeted Disease Segments) |
4.2.1.3. Approval Timeline |
4.2.1.4. Likelihood of approval (KOL Comments) |
4.3. Phase I Profiles |
4.3.1. All Other Company (All Other Product) Profile |
4.3.1.1. Current Status |
4.3.1.2. Trial details, results (Targeted Disease Segments) |
4.3.1.3. Approval Timeline |
4.3.1.4. Likelihood of approval (KOL Comments) |
4.4. Preclinical/Phase I ready Therapies |
4.4.1. All Other Product (All Other Company) Profile |
4.4.1.1. Current Status (Targeted Disease Segments) |
4.4.1.2. Competitive Benchmarking |
4.4.1.3. Company Profile |
4.5. Attrition analysis |
4.5.1. Discontinued and Assets with No Development Reported |
4.5.2. Reasons and class-effect of discontinuations |
5. Regulatory/Approval Scenario for Hematopoietic Stem Cell Transplantation (HSCT) |
5.1. Regulatory/Approval Framework in US |
5.1.1. Policy Framework |
5.1.2. Payer Expectations |
5.2. Regulatory/Approval Framework in UK |
5.2.1. Policy Framework |
5.2.2. Payer Expectations |
5.3. Regulatory/Approval Framework in France |
5.3.1. Policy Framework |
5.3.2. Payer Expectations |
5.4. Regulatory/Approval Framework in Germany |
5.4.1. Policy Framework |
5.4.2. Payer Expectations |
5.5. Regulatory/Approval Framework in Italy |
5.5.1. Policy Framework |
5.5.2. Payer Expectations |
5.6. Regulatory/Approval Framework in Spain |
5.6.1. Policy Framework |
5.6.2. Payer Expectations |
5.7. Regulatory/Approval Framework in Japan |
5.7.1. Policy Framework |
5.7.2. Payer Expectations |
5.8. Regulatory/Approval Framework in China |
5.8.1. Policy Framework |
5.8.2. Payer Expectations |
6. Clinical Trial Assessment – Current and Future Paradigm of Hematopoietic Stem Cell Transplantation (HSCT)
|
6.1. Distribution of Primary Endpoints across trials |
6.2. Distribution of Secondary Endpoints across trials |
6.3. Evolution and acceptance of surrogate endpoints |
6.4. Key Investigator initiated trials |
6.5. Attrition analysis |
6.5.1. Suspended/Discontinued Assets |
6.5.2. Failed Trials, Reasons and Business Impact |
6.5.3. Terminated Trials, Reasons and Business Impact |
6.5.4. Withdrawn Trials, Reasons and Business Impact |
6.6. Trial enrollment scenario and challenges |
6.7. Clinical Trial Guidance (across geographies) |
7. Thelansis Commentary
|
7.1. Key Unmet needs in Hematopoietic Stem Cell Transplantation (HSCT) |
7.2. Possible Best-case Clinical Trial Strategies |
7.3. Possible Best Case Targeted Product Profile (TPP) |
7.4. Possible Best-case Market Positioning Strategies |
7.5. Possible Best-case Market Access Strategies |
7.6. Possible Best-case LCM Strategies |
7.7. Overall View on Hematopoietic Stem Cell Transplantation (HSCT) Market in Dollar Value |
8. Report Methodology
|
8.1. Secondary research |
8.2. Primary research |
8.3. Data collation |
8.4. Insight Generation |
9. About Thelansis
|
9.1. Our Capabilities |
9.2. Our Services |
9.3. Our Contacts |
9.4. Disclaimer |