Published Date : 2021-12-06
Published Date : 2021-12-06
Updated On : 2023-08-27
Pages : 165
Thelansis’s “Diffuse Intrinsic Pontine Glioma (DIPG) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2021 To 2032" 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 Diffuse Intrinsic Pontine Glioma treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Diffuse intrinsic pontine glioma (DIPG) is an aggressive form of childhood cancer primarily found in the brainstem, with a remarkably low occurrence rate that predominantly affects pediatric patients. Approximately 10% of DIPG cases lack specific histological features such as mitotic figures and microvascular proliferation, aligning them with WHO grade II tumors. The prevailing theory regarding DIPG development attributes it to a mutation in the H3 gene, specifically within the N-terminal tail of histone H3. Recent discoveries have revealed these mutations to be prevalent in midline pontine high-grade gliomas, especially in DIPG. The substitution of lysine at position 27 within the H3 encoding gene plays a pivotal role in driving DIPG's oncogenic process. It is suggested that any mutation targeting one of the histone H3 variants (H3.1, H3.2, or H3.3) may contribute to DIPG development. The H3K27 mutation and the loss of H3K27me3 are crucial markers, as they are characteristic of DIPG and likely represent the initial genomic event leading to tumor transformation. To diagnose suspected DIPG, the most effective diagnostic study involves magnetic resonance imaging (MRI) of the brain, both with and without contrast. Typically, over 50% of the enlarged ventral pons will exhibit an elevated signal on the T2 FLAIR MRI sequence. Treatment involves the administration of steroids, specifically dexamethasone, with the aim of stabilizing neurological symptoms until potential neurosurgical biopsy or radiation therapy becomes feasible. However, the prognosis for DIPG remains bleak due to the lack of effective therapies. It stands as the leading cause of death among childhood brain tumors, with most patients diagnosed before the age of seven. Following diagnosis, the median survival period is typically a mere nine months, and only a small minority, approximately 10%, manage to survive beyond two years. When compared to pediatric glioblastoma, DIPG's prognosis is the bleakest, with a significantly lower overall survival rate.
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 | SONALA-001 | SonALAsense, Inc. | Phase 2 |
2 | BXQ-350 | Bexion Pharmaceuticals, Inc. | Phase 1 |
3 | AloCELYVIR | Apices Soluciones S.L. | Phase 2 |
4 | H3.3-K27M | TCRCure Biopharma Ltd. | Phase 1 |
5 | ONC201 | Chimerix | Phase 1 |
6 | PTC596 | PTC Therapeutics | Phase 1 |
7 | DSP-7888 | Sumitomo Pharma Co., Ltd. | Phase 2 |
8 | MTX110 | Midatech Pharma US Inc. | Phase 1 |
9 | DNX-2401 | DNAtrix, Inc. | Phase 1 |
10 | GDC-0084 | Kazia Therapeutics Limited | Phase 1 |
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. Diffuse Intrinsic Pontine Glioma (DIPG) – 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. Diffuse Intrinsic Pontine Glioma (DIPG) market scenario 2021 |
1.2.2. Diffuse Intrinsic Pontine Glioma (DIPG) market scenario 2025 |
1.2.3. Diffuse Intrinsic Pontine Glioma (DIPG) market scenario 2032 |
2. Diffuse Intrinsic Pontine Glioma (DIPG) 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 Diffuse Intrinsic Pontine Glioma (DIPG) |
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. Diffuse Intrinsic Pontine Glioma (DIPG) 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 Diffuse Intrinsic Pontine Glioma (DIPG) management |
2.16. Market Opportunity for Diffuse Intrinsic Pontine Glioma (DIPG) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Diffuse Intrinsic Pontine Glioma (DIPG) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Diffuse Intrinsic Pontine Glioma (DIPG) Epidemiology in US (2021-2032) |
3.2.1.1. Incidence of Diffuse Intrinsic Pontine Glioma (DIPG) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Diffuse Intrinsic Pontine Glioma (DIPG) Epidemiology in EU-5 (2021-2032) |
3.2.2.1. Incidence of Diffuse Intrinsic Pontine Glioma (DIPG) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Diffuse Intrinsic Pontine Glioma (DIPG) Epidemiology in Japan (2021-2032) |
3.2.3.1. Incidence of Diffuse Intrinsic Pontine Glioma (DIPG) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Diffuse Intrinsic Pontine Glioma (DIPG) Epidemiology in China (2021-2032) |
3.2.4.1. Incidence of Diffuse Intrinsic Pontine Glioma (DIPG) |
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 Diffuse Intrinsic Pontine Glioma (DIPG) Market Forecast 2021-2032 |
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 Diffuse Intrinsic Pontine Glioma (DIPG) Market Forecast 2021-2032 |
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 Diffuse Intrinsic Pontine Glioma (DIPG) Market Forecast 2021-2032 |
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 Diffuse Intrinsic Pontine Glioma (DIPG) Market Forecast 2021-2032 |
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 Diffuse Intrinsic Pontine Glioma (DIPG) Market Forecast 2021-2032 |
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 Diffuse Intrinsic Pontine Glioma (DIPG) Market Forecast 2021-2032 |
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 Diffuse Intrinsic Pontine Glioma (DIPG) Market Forecast 2021-2032 |
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 Diffuse Intrinsic Pontine Glioma (DIPG) Market Forecast 2021-2032 |
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 Diffuse Intrinsic Pontine Glioma (DIPG) |
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 Diffuse Intrinsic Pontine Glioma (DIPG) 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 Diffuse Intrinsic Pontine Glioma (DIPG) |
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 Diffuse Intrinsic Pontine Glioma (DIPG) 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 |