Severe Hypertriglyceridemia (SHTG) - Market Insight, Epidemiology and Market Forecast - 2032

This ‘Severe Hypertriglyceridemia-Market Insights, Epidemiology, and Market Forecast-2032' report deliver an in-depth understanding of the Severe Hypertriglyceridemia, historical and forecasted epidemiology as well as the Severe Hypertriglyceridemia market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

The Severe Hypertriglyceridemia market report provides current treatment practices, emerging drugs, market share of the individual therapies, current and forecasted 7MM Severe Hypertriglyceridemia market size from 2019 to 2032. The Report also covers current Severe Hypertriglyceridemia treatment practice, market drivers, market barriers, SWOT analysis, reimbursement, market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2019-2032

Severe Hypertriglyceridemia Disease Understanding and Treatment Algorithm

Severe Hypertriglyceridemia Overview

Triglycerides are fats synthesized by the liver or, in the case of those derived from dietary sources, are ingested by the liver; the triglycerides are subsequently transported throughout the circulation by triglyceride-rich lipoproteins. Most of the elevations of triglycerides are mild to moderate in nature, and the pathophysiology involves hepatic overproduction of very-low-density lipoproteins (VLDLs).

In developed countries, the average plasma triglyceride level doubles from early adulthood to mid-adult life. According to the American Heart Association/American College of Cardiology, serum triglyceride concentration less than 150 mg/dL is considered a healthy level. But serum triglyceride concentration of more than 150 mg/dL can lead to a serious level of hypertriglyceridemia.

Hypertriglyceridemia is a common clinical condition most often identified in individuals who have had a lipid profile as part of cardiovascular risk assessment. It is often caused or exacerbated by uncontrolled diabetes mellitus, obesity, and sedentary habits, all of which are more prevalent in industrialized societies than in developing nations. Based on the Serum triglyceride concentration, hypertriglyceridemia can be categorized into mild, moderate, and severe.

Individuals with severe hypertriglyceridemia have triglyceride levels more than three times the normal triglycerides level. SHTG is well known to be associated with severe diseases such as acute pancreatitis and cardiovascular disease.

SHTG occur from VLDL overproduction and defective triglyceride clearance due to either saturation or dysfunction of the enzyme lipoprotein lipase (LPL), resulting in the accumulation of chylomicrons and VLDLs

Severe Hypertriglyceridemia Diagnosis

Severe Hypertriglyceridemia is typically diagnosed after a routine blood test called a lipid profile. The National Cholesterol Education Program recommends that everyone have a lipid profile done every five years, beginning at 20. However, for people with or at risk for coronary heart disease, it is recommended to have a lipid profile done yearly.

A triglycerides test is usually part of a lipid profile. A triglycerides test is a blood test. During the test, a health care professional will take a blood sample from a vein in the arm using a small needle. After the needle is inserted, a small amount of blood will be collected into a test tube or vial. Patients may feel a little sting when the needle goes in or out. This usually takes less than five minutes.

Different guidelines and expert committees have designated different cut-off values for classification of the severity of hypertriglyceridemia.

Severe Hypertriglyceridemia Treatment

Hypertriglyceridemia is causally linked to cardiovascular disease and pancreatitis. Lifestyle modifications play a paramount role in its treatment. It is associated with overweight, metabolic syndrome, and diabetes mellitus, and is often discovered prevalently. Clinically, there are two distinct aspects to triglyceride reduction: modifying lipid levels to decrease ASCVD (Atherosclerotic Cardiovascular Disease) risk; and reducing triglyceride to decrease the risk for acute pancreatitis.

Treatments may include fibrates that are the first-line treatment in patients with severe hypertriglyceridemia. For ASCVD risk reduction, statins are advised as the cornerstone, with emerging evidence on omega-3 fatty acid therapy. Fibrates have shown benefits as monotherapy but not when added to statin therapy, eicosapentaenoic acid (EPA), niacin, statins, and others. Pharmacological management in severe hypertriglyceridemia is centered on fenofibrate and omega-3 fatty acid therapy to prevent pancreatitis.

Severe Hypertriglyceridemia Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases of hypertriglyceridemia, diagnosed prevalent cases of hypertriglyceridemia, severity-specific diagnosed prevalent cases of hypertriglyceridemia, and etiology-specific diagnosed prevalent cases of severe hypertriglyceridemia scenario of Severe Hypertriglyceridemia in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2019 to 2032.

Key Findings

• Total prevalent cases of hypertriglyceridemia in the 7MM were found to be approximately 154,013,879 in 2021. These cases are expected to increase by 2032 at a CAGR of 0.4% during the study period (2019-2032).
• Among 7MM, the United States has the highest prevalent cases of hypertriglyceridemia with 67,562,886 cases in 2021.
• Assessments as per the analysts show that total diagnosed prevalent cases of hypertriglyceridemia in the 7MM were approximately 69,306,246 in 2021.
• The total diagnosed prevalent cases of severe hypertriglyceridemia in the 7MM were observed to be 3,465,312 in 2021. These cases are expected to increase during the forecasted period (2022-2032).
• The highest diagnosed prevalent cases of severe hypertriglyceridemia were observed in the US as compared to EU-5 and Japan in the year 2021 and these cases are expected to increase in the forecast period.
• Among the European countries, Germany had the highest diagnosed prevalent population of severe hypertriglyceridemia with 365,335 cases, followed by the UK with 277,161 cases in 2021. On the other hand, Spain had the lowest diagnosed prevalent population.
• In Japan, 563,272 diagnosed prevalent cases of were recorded in the year 2021, accounting for 16.25% in 7MM.
• As per the publisher's assessment, for severe hypertriglyceridemia, the etiology-specific distribution of the disease suggests secondary type predominance in the US.

Severe Hypertriglyceridemia Epidemiology

The epidemiology segment also provides the Severe Hypertriglyceridemia epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

Severe Hypertriglyceridemia Drug Chapters

The drug chapter segment of the Severe Hypertriglyceridemia report encloses the detailed analysis of Severe Hypertriglyceridemia marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the Severe Hypertriglyceridemia clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug, and the latest news and press releases.

Severe Hypertriglyceridemia Marketed Drugs

Epanova (Omega-3-carboxylic acid): AstraZeneca

Epanova (omega-3-carboxylic acids) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Epanova is the first FDA-approved prescription omega-3 in free fatty acid form. The dosage of Epanova is 2 g (two capsules) or 4 g (four capsules), making it the first prescription omega-3 to have a dosing option as few as two capsules once a Day 1. It can be taken with or without food.

Vascepa/Vazkepa: Amarin Corporation

Vascepa is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an orally administered adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Vascepa is the first and only FDA-approved medication for reducing cardiovascular risk beyond cholesterol-lowering therapy in high-risk patients approved for treatment. It is also indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adults with elevated TG levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus.

List of products to be continued in the report…

Severe Hypertriglyceridemia Emerging Drugs

Olezarsen: Ionis Pharmaceuticals

Olezarsen, formerly known as IONIS-APOCIII-LRx and AKCEA-APOCIII-LRx, is a ligand-conjugated (LICA) investigational antisense medicine designed to inhibit the production of Apoc-III in the liver. Previously it was being investigated for familial chylomicronemia syndrome (FCS), but in late 2021, Ionis Pharmaceuticals has also started an investigational study dedicated to Severe Hypertriglyceridemia patients.

Pegozafermin (BIO89-100): 89bio

Pegozafermin (BIO89-100) is engineered using a proprietary glycoPEGylation technology to prolong the biological activity of FGF21 while maintaining the efficacy of native FGF21 - an endogenous metabolic hormone that regulates energy expenditure and glucose and lipid metabolism. It is currently being developed for the treatment of nonalcoholic steatohepatitis (“NASH”) and the treatment of Severe Hypertriglyceridemia.

List of products to be continued in the report…

Severe Hypertriglyceridemia Market Outlook

Despite ongoing treatment with fibrates and prescription omega-3 fatty acids, Severe Hypertriglyceridemia results in a substantial reduction in the quality of life for patients; these patients continue to suffer. Therefore, there is a significant unmet medical need to develop a novel effective, and safe treatment to lower triglycerides in patients with this disorder.

Guideline recommended therapies - that includes lifestyle and dietary measures (e.g., fibrates and omega-3 fatty acids), statins, and nicotinic acid - do not offer effective treatment for patients with SHTG. Even the drugs of the first choice, such as fibrates, do not offer fast onset of action, while immediately acting drugs like omega-3-fatty acid and medium-chain triglycerides are not powerful enough to lower excessively elevated triglycerides levels rapidly.

Currently, GlaxoSmithKline's Lovaza/Omacor, Amarin's Vascepa/ Vazkepa, and AstraZeneca's Epanova are omega-3 fatty acids approved by regulatory authorities in the 7MM. Generics for the first two are already available Epanova is not yet launched.

Companies across the globe are diligently working toward the development of novel treatment therapies with a considerable amount of success over the years. Key players, such as Ionis Pharmaceuticals, 89bio, Arrowhead Pharmaceuticals, and others are developing drugs for the treatment of Severe Hypertriglyceridemia.

The market of Severe Hypertriglyceridemia is quite robust yet possesses some unmet needs. With the approval of emerging therapies, the overall market is expected to witness a boost.

Key Findings

• The market size of Severe Hypertriglyceridemia in seven major markets was USD 3,060 million in 2021, which is further expected to increase by 2032 at a Compound Annual Growth Rate (CAGR) of 8.1% for the study period (2019-2032)
• The expected Launch of potential therapies may increase market size in the coming years, assisted by an increase in the diagnosed prevalent population of Severe Hypertriglyceridemia.
• Upcoming therapies such as Olezarsen (ApoC-III), ARO-APOC3, Pegozafermin (BIO89-100), Epeleuton (DS102), and others have the potential to create a significant positive shift in the Severe Hypertriglyceridemia market size.
• The United States accounts for the largest market size of Severe Hypertriglyceridemia, in comparison to EU5 (Germany, Italy, France, Spain, and the United Kingdom) and Japan.
• Among the EU5 countries, Germany had the highest market size with USD 244 million in 2021.

The United States Market Outlook

This section provides the total Severe Hypertriglyceridemia market size and market size by therapies in the United States.

EU-5 Market Outlook

The total Severe Hypertriglyceridemia market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total Severe Hypertriglyceridemia market size and market size by therapies in Japan are provided.

Severe Hypertriglyceridemia Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Severe Hypertriglyceridemia market or expected to get launched in the market during the study period 2019-2032. The analysis covers the Severe Hypertriglyceridemia market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allows, the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Severe Hypertriglyceridemia Development Activities

The report provides insights into different therapeutic candidates in phase II, and phase III stages also analyze key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Severe Hypertriglyceridemia emerging therapies.

Reimbursement Scenario in Severe Hypertriglyceridemia

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

The publisher performs competitively and market Intelligence analysis of the Severe Hypertriglyceridemia market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of Severe Hypertriglyceridemia, explaining its etiology, signs and symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the Severe Hypertriglyceridemia epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Severe Hypertriglyceridemia is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Severe Hypertriglyceridemia market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Severe Hypertriglyceridemia market.

Report Highlights

• The robust pipeline with novel MOA and oral ROA and increasing diagnosed prevalence will positively drive the Severe Hypertriglyceridemia market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Severe Hypertriglyceridemia R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for Severe Hypertriglyceridemia. The launch of emerging therapies will significantly impact the Severe Hypertriglyceridemia market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Severe Hypertriglyceridemia Report Insights

• Patient Population
• Therapeutic Approaches
• Severe Hypertriglyceridemia Pipeline Analysis
• Severe Hypertriglyceridemia Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Severe Hypertriglyceridemia Report Key Strengths

• 11-Years Forecast
• The 7MM Coverage
• Severe Hypertriglyceridemia Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Severe Hypertriglyceridemia Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT analysis

Key Questions Answered

Market Insights:

• What was the Severe Hypertriglyceridemia market share (%) distribution in 2019 and how it would look like in 2032?
• What would be the Severe Hypertriglyceridemia total market size as well as market size by therapies across the 7MM during the forecast period (2022-2032)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Severe Hypertriglyceridemia market size during the forecast period (2022-2032)?
• At what CAGR, the Severe Hypertriglyceridemia market is expected to grow at the 7MM level during the forecast period (2022-2032)?
• What would be the Severe Hypertriglyceridemia market outlook across the 7MM during the forecast period (2022-2032)?
• What would be the Severe Hypertriglyceridemia market growth till 2032 and what will be the resultant market size in the year 2032?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What is the disease risk, burden, and unmet needs of Severe Hypertriglyceridemia?
• What is the historical Severe Hypertriglyceridemia patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient pool of Severe Hypertriglyceridemia at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Severe Hypertriglyceridemia?
• Out of the above-mentioned countries, which country would have the highest population of Severe Hypertriglyceridemia during the forecast period (2022-2032)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2022-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Severe Hypertriglyceridemia along with the approved therapy?
• What are the current treatment guidelines for the treatment of Severe Hypertriglyceridemia in the US and Europe?
• What are the Severe Hypertriglyceridemia marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of Severe Hypertriglyceridemia?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Severe Hypertriglyceridemia?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Severe Hypertriglyceridemia therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Severe Hypertriglyceridemia and their status?
• What are the key designations that have been granted for the emerging therapies for Severe Hypertriglyceridemia?
• What are the 7MM historical and forecasted market of Severe Hypertriglyceridemia?

Reasons to Buy

• The report will help in developing business strategies by understanding trends shaping and driving Severe Hypertriglyceridemia.
• To understand the future market competition in the Severe Hypertriglyceridemia market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Severe Hypertriglyceridemia in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Severe Hypertriglyceridemia market.
• To understand the future market competition in the Severe Hypertriglyceridemia market.