Published Date : 2022-03-22
Published Date : 2022-03-22
Updated On : 2022-12-29
Pages : 158
Thelansis’s “Severe Hypertriglyceridemia (sHTG) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 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 Severe Hypertriglyceridemia (sHTG) treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Hypertriglyceridemia is a prevalent metabolic disorder characterized by elevated levels of triglycerides, a type of fat, in the bloodstream. It is a triglyceride concentration greater than 150 mg/dL in the blood. This condition has been linked to various diseases, including atherosclerosis, obesity, and insulin resistance, increasing the risk of cardiovascular disease (CVD). Severe hypertriglyceridemia (sHTG), defined as fasting triglyceride concentrations above 10.0 mmol/L, can be classified into two categories: 1. Polygenic hypertriglyceridemia (also known as type V hyperlipoproteinemia according to the Fredrickson classification) is caused by a combination of genetic, demographic, and clinical factors, including obesity, diabetes mellitus, untreated hypothyroidism, alcohol consumption, and certain medications. 2. Familial chylomicronemia syndrome (also known as type I hyperlipoproteinemia, according to the Fredrickson classification) is a genetic disorder. Both forms are associated with elevated fasting chylomicronemia and very low-density lipoprotein levels. Familial chylomicronemia syndrome tends to be more severe and resistant to treatment. The clinical symptoms of severe hypertriglyceridemia with chylomicrons include abdominal pain and acute pancreatitis. The biochemical thresholds for hypertriglyceridemia are: normal (<1.7 mmol/L), borderline high (1.7 to 2.3 mmol/L), high (2.3 to 5.6 mmol/L), and very high (>5.6 mmol/L). A triglyceride level greater than 10.0 mmol/L is considered severely elevated and increases the risk of pancreatitis. Severe hypertriglyceridemia is usually diagnosed through a routine blood test known as a lipid profile. The risk factors for severe hypertriglyceridemia include genetic disorders, obesity, untreated diabetes, and certain medications. Individuals with extremely high levels of triglycerides may experience symptoms such as abdominal pain, nausea, vomiting, yellow-colored skin bumps (xanthomas), and acute pancreatitis.
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 | Olezarsen | Ionis Pharmaceuticals, Inc. | Phase 3 |
2 | BIO89-100 | 89bio, Inc. | Phase 2 |
3 | ARO-APOC3 | Arrowhead Pharmaceuticals | Phase 3 |
4 | Ethyl Icosapentate | Mochida Pharmaceutical Company, Ltd. | Phase 2 |
5 | Gemcabene | NeuroBo Pharmaceuticals Inc. | Phase 2 |
6 | Evinacumab (Anti-ANGPTL3) | Regeneron Pharmaceuticals | Phase 2 |
7 | K-877 | Kowa Research Institute, Inc. | Phase 3 |
8 | CaPre | Acasti Pharma Inc. | Phase 2 |
9 | Setmelanotide | Rhythm Pharmaceuticals, Inc. | Phase 2 |
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. Severe Hypertriglyceridemia (sHTG) – 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. Severe Hypertriglyceridemia (sHTG) market scenario 2022 |
1.2.2. Severe Hypertriglyceridemia (sHTG) market scenario 2025 |
1.2.3. Severe Hypertriglyceridemia (sHTG) market scenario 2032 |
2. Severe Hypertriglyceridemia (sHTG) 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 Severe Hypertriglyceridemia (sHTG) |
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. Severe Hypertriglyceridemia (sHTG) 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 Severe Hypertriglyceridemia (sHTG) management |
2.16. Market Opportunity for Severe Hypertriglyceridemia (sHTG) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Severe Hypertriglyceridemia (sHTG) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Severe Hypertriglyceridemia (sHTG) Epidemiology in US (2022-2032) |
3.2.1.1. Incidence of Severe Hypertriglyceridemia (sHTG) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Severe Hypertriglyceridemia (sHTG) Epidemiology in EU-5 (2022-2032) |
3.2.2.1. Incidence of Severe Hypertriglyceridemia (sHTG) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Severe Hypertriglyceridemia (sHTG) Epidemiology in Japan (2022-2032) |
3.2.3.1. Incidence of Severe Hypertriglyceridemia (sHTG) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Severe Hypertriglyceridemia (sHTG) Epidemiology in China (2022-2032) |
3.2.4.1. Incidence of Severe Hypertriglyceridemia (sHTG) |
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 Severe Hypertriglyceridemia (sHTG) Market Forecast 2022-2032 |
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 Severe Hypertriglyceridemia (sHTG) Market Forecast 2022-2032 |
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 Severe Hypertriglyceridemia (sHTG) Market Forecast 2022-2032 |
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 Severe Hypertriglyceridemia (sHTG) Market Forecast 2022-2032 |
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 Severe Hypertriglyceridemia (sHTG) Market Forecast 2022-2032 |
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 Severe Hypertriglyceridemia (sHTG) Market Forecast 2022-2032 |
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 Severe Hypertriglyceridemia (sHTG) Market Forecast 2022-2032 |
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 Severe Hypertriglyceridemia (sHTG) Market Forecast 2022-2032 |
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 Severe Hypertriglyceridemia (sHTG) |
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 Severe Hypertriglyceridemia (sHTG) 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 Severe Hypertriglyceridemia (sHTG) |
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 Severe Hypertriglyceridemia (sHTG) 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 |