Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) Market Outlook and Forecast

Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033

Published Date : 2023-12-19

Updated On : 2024-10-26

Pages : 155

Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) Market Outlook

Thelansis’s “Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) 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 Allogeneic Hematopoietic Stem Cell Transplantation treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) Overview

Hematopoietic stem cell transplant (HSCT) is a procedure where healthy hematopoietic stem cells are given to patients with dysfunctional or depleted bone marrow. HSCT therapy is used for both malignant (Acute myeloid leukemia, Myelodysplastic syndromes, Chronic myeloid leukemia, Acute lymphoblastic leukemia, Myeloproliferative disorders, Non-Hodgkin’s lymphoma, Multiple myeloma, Chronic lymphocytic leukemia, Hodgkin’s disease, Juvenile chronic myeloid leukemia)and non-malignant (Aplastic anemia, Paroxysmal nocturnal hemoglobinuria, Fanconi’s anemia, Blackfan-Diamond anemia, Thalassemia major, Sickle cell anemia, Severe combined immunodeficiency, Wiskott-Aldrich syndrome and Inborn errors of metabolism) diseases. In allogeneic hematopoietic stem cell transplantation (HSCT), the stem cells are sourced from a donor different from the recipient. Typically, the donor and recipient share a degree of genetic compatibility known as HLA (human leukocyte antigen) matching, determined by the genes found on chromosome 6. Each individual inherits a set of MHC (major histocompatibility complex) alleles, forming HLA pairs. Crucial HLA loci include HLA-A, HLA-B, HLA-C, HLA-DR, and HLA-DQ. The selection of a donor for allogeneic HSCT considers several factors, including the patient's specific disease, disease stage, and the urgency of finding a suitable donor. In cases where allogeneic HSCT is being contemplated, having a fully HLA-matched sibling as the donor is the preferred choice. This preference is due to the lower risk of graft rejection and graft-versus-host disease (GvHD) when using allogeneic stem cells from a fully HLA-matched sibling. Stem cells can be obtained from three sources:

  1. Bone Marrow: This involves a surgical procedure using hollow needles to extract liquid bone marrow from the hip bones. Anticoagulants are added to prevent clumping, and sterile filters remove impurities. Bone marrow can be stored at room temperature, in a refrigerator for a limited time, or cryopreserved for longer storage.
  2. Peripheral Blood Progenitor Cells (PBPCs): PBPCs containing HPCs are collected from peripheral blood using an apheresis device. A growth factor is usually administered before collection. Autologous PBPC donors may receive chemotherapy. PBPCs can be stored at room temperature, in refrigerators, or cryopreserved like bone marrow.
  3. Umbilical Cord Blood (UCB): UCB, once considered waste, is collected safely after childbirth. Further processing removes red blood cells, which are cryopreserved for future use. UCB can be stored privately or publicly for unrelated recipients.

Complications following a bone marrow transplant can be acute or chronic and are influenced by various factors, including age, performance status, stem cell source, and preparative regimen. Acute complications occur within the first 90 days, including myelosuppression, sinusoidal obstruction syndrome, mucositis, graft-versus-host disease, bacterial and viral infections, and fungal infections. Chronic complications encompass chronic GVHD, infections with encapsulated bacteria, and varicella-zoster virus reactivation. The number of allogeneic HCTs performed in the USA increased compared to autologous HCTs. The most common type of allogeneic HCT was from an unrelated donor, followed by transplants from a related donor.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2023-2033

Current Clinical Practice and Treatment Algorithm

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.

KOL Insights:

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

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- 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

NPV/ IRR Calculator-

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.

Competitive Landscape:

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.

Clinical Trial Assessment-

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.

Unmet Medical Needs Overview-

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.

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Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) Competitive Landscape

S. no Asset Company Stage
1 Efprezimod alfa OncoImmune, Inc. Phase 2
2 RGI-2001 Regimmune Corporation Phase 2
3 ASP0113 Astellas Pharma Global Development, Inc. Phase 3
4 SER-155 Seres Therapeutics, Inc. Phase 1
5 Treosulfan medac GmbH Phase 3
6 RC1012 injection Guangdong Ruishun Biotech Co., Ltd Phase 1/2
7 Acalabrutinib AstraZeneca Phase 2
8 Tabelecleucel Atara Biotherapeutics Phase 3
9 mRNA-1647 ModernaTX, Inc. Phase 2
10 Palifermin with Leuprolide Acetate Swedish Orphan Biovitrum 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

Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

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.

Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) Market Forecast

1.  Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) – 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. Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) market scenario 2023
                     1.2.2. Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) market scenario 2028
                     1.2.3. Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) market scenario 2033

2. Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) 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 Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)
         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. Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) 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 Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) management
         2.16.  Market Opportunity for Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)
         2.17. KOL Comments on current and upcoming/expected treatment practices in Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)

3.       Epidemiology

         3.1.    Epidemiology Overview
         3.2.    Epidemiology by Geography
                     3.2.1. Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) Epidemiology in US (2023-2033)
                             3.2.1.1.              Incidence of Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)
                             3.2.1.2.              Diagnosed cases
                             3.2.1.3.              Treatable Patient Pool
                             3.2.1.4.              Epidemiology Trends
                     3.2.2. Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) Epidemiology in EU-5 (2023-2033)
                             3.2.2.1.              Incidence of Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)
                             3.2.2.2.              Diagnosed cases
                             3.2.2.3.              Treatable Patient Pool
                             3.2.2.4.              Epidemiology Trends
                     3.2.3. Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) Epidemiology in Japan (2023-2033)
                             3.2.3.1.              Incidence of Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)
                             3.2.3.2.              Diagnosed cases
                             3.2.3.3.              Treatable Patient Pool
                             3.2.3.4.              Epidemiology Trends
                     3.2.4. Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) Epidemiology in China (2023-2033)
                             3.2.4.1.              Incidence of Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)
                             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 Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) 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 Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) 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 Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) 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 Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) 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 Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) 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 Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) 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 Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) 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 Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) 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 Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)
                                      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 Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) 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 Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)
         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 Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) 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