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DelveInsight's report titled "Severe Hypertriglyceridemia Market Insights, Epidemiology, and Market Forecast - 2034" offers a thorough examination of Severe Hypertriglyceridemia, encompassing its historical and projected epidemiology alongside market dynamics in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
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Main Highlights from the Severe Hypertriglyceridemia Market Report
On December 15, 2025, Arrowhead Pharmaceuticals launched a trial to assess the effectiveness and safety of plozasiran in roughly 288 adult individuals with severe hypertriglyceridemia (SHTG) who have experienced at least two previous episodes of acute pancreatitis (AP) not linked to other causes, with one incident within the past 12 months before screening. Participants will be randomly allocated in a blinded fashion to receive either plozasiran 25 mg via subcutaneous injection every three months or a placebo. All enrolled subjects will be advised to adhere to a prescribed low-fat diet and ongoing medications for the duration of the study.
On December 01, 2025, Ionis Pharmaceuticals Inc. carried out a trial involving about 800 individuals with SHTG transitioning from studies ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326). The first day of this trial could coincide with the Week 53 visit of either ISIS 678354-CS5 or ISIS 678354-CS6, as relevant. Subjects will be administered olezarsen over a 157-week treatment phase. The trial encompasses a 31-day screening period, a 157-week treatment phase, and a 13-week follow-up period.
The overall count of diagnosed prevalent cases of Severe Hypertriglyceridemia across the 7MM reached approximately 3.6 million in 2023, with expectations of growth in the coming years.
In 2023, the United States recorded the highest number of diagnosed prevalent cases of Severe Hypertriglyceridemia in the 7MM, totaling 2.7 million.
Within EU4 and the UK, Germany had the greatest number of SHTG cases, while Spain had the fewest in 2023.
A large proportion of Severe Hypertriglyceridemia patients go undetected. Among those identified, roughly 50% do not undergo treatment, indicating a critical shortfall in both detection and care for the disease.
Regarding type-specific cases, secondary SHTG instances outnumbered primary SHTG cases.
Prominent players in the Severe Hypertriglyceridemia sector include Amarin Corporation, Ionis Pharmaceuticals, Arrowhead Pharmaceuticals, 89bio, NorthSea Therapeutics B.V., MediciNova, and others.
Promising treatments for Severe Hypertriglyceridemia encompass Plozasiran, Olezarsen, DR10624 Injection, ARO-APOC3, Pegozafermin, Omefas, K-877, Fenofibrate, and others.
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Severe Hypertriglyceridemia Epidemiology Breakdown in the 7MM
Overall Diagnosed Prevalent Cases of Severe Hypertriglyceridemia
Type-Specific Diagnosed Prevalent Cases of Severe Hypertriglyceridemia
Treatable Cases of Severe Hypertriglyceridemia
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Severe Hypertriglyceridemia Approved Medications
VASCEPA/VAZKEPA: Amarin Corporation VASCEPA is an ethyl ester form of eicosapentaenoic acid (EPA), prescribed orally alongside dietary changes to lower triglyceride levels in adults with severe (=500 mg/dL) hypertriglyceridemia. It stands as the pioneering and sole FDA-approved drug for mitigating cardiovascular risk beyond standard cholesterol management in high-risk individuals. In July 2012, VASCEPA received FDA approval in the US for triglyceride reduction in patients with levels of =500 mg/dL. In March 2021, marketing approval was extended to icosapent ethyl in the European Union for decreasing cardiovascular event risks in high-risk patients, branded as VAZKEPA. That same year, the company introduced VAZKEPA in Germany.
Severe Hypertriglyceridemia Pipeline Drugs
Olezarsen: Ionis Pharmaceuticals Olezarsen is an investigational RNA-targeted Ligand Conjugated Antisense (LICA) therapy aimed at individuals prone to conditions from high triglyceride levels, such as those with FCS and SHTG. It is currently in Phase III trials for SHTG. As of October 2024, Ionis Pharmaceuticals anticipates Phase III results for olezarsen in 2025, with potential US approval for SHTG treatment projected between 2026 and 2027.
Plozasiran: Arrowhead Pharmaceuticals Plozasiran (previously known as ARO-APOC3) is engineered to decrease ApoC-III protein synthesis via the body's natural RNA interference (RNAi) process. The medication is presently in Phase III development. Arrowhead Pharmaceuticals is preparing to start SHASTA-5, a Phase III trial for SHTG patients at elevated risk of acute pancreatitis. Based on an August 2024 update, Arrowhead Pharmaceuticals forecasts market launch and expansion for plozasiran in SHTG by 2027.
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Severe Hypertriglyceridemia Key Players Amarin Corporation, Ionis Pharmaceuticals, Arrowhead Pharmaceuticals, 89bio, NorthSea Therapeutics B.V., MediciNova, and others.
Severe Hypertriglyceridemia Market Perspective Managing SHTG poses significant difficulties, as conventional therapies often fall short in substantially reducing triglyceride levels or averting acute pancreatitis, its most dangerous outcome. Although dietary adjustments are essential for primary hypertriglyceridemia, they frequently do not bring triglyceride levels under 500 mg/dl, the point for preventing AP. Standard pharmacological approaches—like statins, fibrates, niacin, and omega-3 fatty acids—yield only moderate triglyceride decreases and lack strong proof of AP prevention. These options depend on an intact lipolytic pathway, rendering them ineffective for Familial Chylomicronemia Syndrome (FCS), where this pathway is deficient. This points to a substantial gap in the Severe Hypertriglyceridemia Therapeutics Market for superior treatments that address both triglyceride lowering and AP risk reduction.
Severe Hypertriglyceridemia Therapeutic Landscape Current management of Severe Hypertriglyceridemia relies on various drug categories for SHTG care, including statins, fibrates, omega-3 fatty acids, and niacin. Statins currently dominate the SHTG market, trailed by fibrates, niacin, and omega-3 fatty acids. Even with options such as statins, fibrates, and omega-3 fatty acids, SHTG still markedly affects patients' well-being, revealing a notable deficiency in existing treatments.
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Coverage of the Severe Hypertriglyceridemia Market Report
Regions: 7MM
Time Frame: 2020-2034
Key Companies: Amarin Corporation, Ionis Pharmaceuticals, Arrowhead Pharmaceuticals, 89bio, NorthSea Therapeutics B.V., MediciNova, and others.
Therapies:
Competitive Analysis: SWOT evaluation and entry tactics
Unmet Needs, Expert Opinions, Analyst Perspectives, Market Access, and Reimbursement
Table of Contents
1: Core Insights
2: Introduction to the Severe Hypertriglyceridemia Market Report
3: Overview of the Severe Hypertriglyceridemia Market at a Glance
4: Methodology for Severe Hypertriglyceridemia Epidemiology and Market Analysis
5: Executive Summary of Severe Hypertriglyceridemia
6: Major Developments
7: Background and Overview of Severe Hypertriglyceridemia
8: Epidemiology and Patient Demographics of Severe Hypertriglyceridemia
9: Patient Experience in Severe Hypertriglyceridemia
10: Approved Drugs for Severe Hypertriglyceridemia
11: Emerging Therapies for Severe Hypertriglyceridemia
12. Competitive Landscape
13: Unaddressed Needs in Severe Hypertriglyceridemia
14: SWOT Analysis of Severe Hypertriglyceridemia
15: Insights from Key Opinion Leaders
16: Reimbursement and Access Considerations
17: Appendix
18: DelveInsight's Expertise
19: Disclaimer
20: About DelveInsight
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