Severe Hypertriglyceridemia Market

Key Highlights

• In 2022, the total prevalent cases of Hypertriglyceridemia (HTG) were around 154 million in the 7MM, of which US accounting for highest number of cases.
• The majority of Severe Hypertriglyceridemia (SHTG) patients were estimated in the US followed by EU4 and the UK and Japan.
• In 2022, the market size of SHTG was highest in the US among the 7MM accounting for approximately USD 1,400 million and lowest in Spain with nearly USD 100 million that is further expected to increase by 2032.
• The current treatment market of SHTG aims to lower the levels of triglyceride with the help Statins, Fibrates, Niacin, and Omega-3 fatty acids. The larger market is covered by Statins, making up the total market of around USD 840 million in 2022, in the US.
• The total market size of the SHTG treatment market is anticipated to experience growth during the forecast period due to expected entry of emerging therapies that includes Olezarsen (ApoC-III), ARO-APOC3, and Pegozafermin (BIO89-100).
• Diagnosed prevalent cases of secondary SHTG comprised of higher share of SHTG (0.8 million cases) in 2022 in the US.

Request for unlocking the CAGR of the Severe Hypertriglyceridemia Market

DelveInsight's “Severe Hypertriglyceridemia- Market Insights, Epidemiology and Market Forecast– 2032” report delivers an in-depth understanding of the Severe Hypertriglyceridemia, historical and forecasted epidemiology as well as the Severe Hypertriglyceridemia market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Severe Hypertriglyceridemia market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Severe Hypertriglyceridemia market size from 2019 to 2032. The report also covers current Severe Hypertriglyceridemia treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2019-2032

Severe Hypertriglyceridemia Market Disease: Understanding and Treatment Algorithm

Severe Hypertriglyceridemia Overview

High triglycerides are the characteristic condition for the disease called hypertriglyceridemia. Patients with severe hypertriglyceridemia (SHTG) have triglyceride levels more than three times the normal level. It leads to multiple serious conditions, including cardiovascular disease (CVD) and acute pancreatitis.

High triglycerides may contribute to the hardening of the arteries or the thickening of the artery walls (arteriosclerosis) — which increases the risk of stroke, heart attack, and heart disease. SHTG does not have noticeable symptoms; however, individuals with extremely high levels of triglycerides (greater than 2,000 mg/dL) can experience recurrent abdominal pain, nausea, vomiting, xanthomas (yellow-colored bumps on the skin), and acute pancreatitis.

Severe Hypertriglyceridemia Diagnosis

Hypertriglyceridemia is diagnosed by doing blood tests to check very-low-density lipoprotein (VLDL) and triglyceride levels. Blood tests show a mild to moderate increase in triglycerides (about 200–500 mg/dL). 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.

The patient journey is categorized into genetically based disorders (primary disorders) and secondary disorders due to other diseases. Lipoprotein lipase (LPL) deficiency and Apolipoprotein (Apo) C-II deficiency are two well genetically characterized kinds of SHTG that usually present in infancy as chylomicronemia syndromes causing SHTG at a very early childhood age. Nausea, vomiting, etc affect the patient. The patient then is diagnosed by triglyceride test, where doctors are able to find the levels of triglycerides and confirm if the patient have SHTG.

There are various clinical practice guidelines for the management of hypertriglyceridemia and the role of prescription omega-3 fatty acids in preventing pancreatitis and CV disease in individuals with high and very high TG levels.

Further details related to country-based variations are provided in the report

Severe Hypertriglyceridemia Treatment

The treatment for SHTG includes dietary restrictions and lipid-lowering drug treatment such as the use of medium-chain triglycerides (MCT), fibrates, omega-3-fatty acids (omega-3-FA), and nicotinic acid. Drugs like fenofibrate, Lovaza, VASCEPA, etc. are approved for SHTG.

Patients with very high triglyceride levels (i.e., 500 mg per dL or higher) usually require drug therapy in addition to therapeutic lifestyle changes. Fibrates or niacin is a practical first-line choice for these patients.

Severe Hypertriglyceridemia Epidemiology

As the market is derived using the patient-based model, the Severe Hypertriglyceridemia epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by, Prevalent Cases of Hypertriglyceridemia (HTG), Diagnosed Prevalent Cases of HTG, Severity-specific Diagnosed Prevalent Cases of HTG, and Etiology-specific Diagnosed Prevalent Cases of SHTG in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032. The total diagnosed prevalent cases of Severe Hypertriglyceridemia (SHTG) in the 7MM comprised approximately 3.4 million cases in 2022 and are projected to increase during the forecasted period

• In 2022, the total diagnosed prevalent cases of Hypertriglyceridemia (HTG) were 69 million and for Severe Hypertriglyceridemia (SHTG) were 3 million cases in the 7MM, which is expected to rise by 2032.
• The United States showed the highest diagnosed prevalent population of HTG compared to other 7MM countries. As per DelveInsight’s estimates, the country alone accounts for nearly 44% of total diagnosed prevalent cases, for HTG, in the 7MM countries.
• The severity-specific diagnosed prevalent cases of HTG segmented based on their triglyceride levels into mild, moderate and severe cases. These cases were observed to be highest for moderate cases followed by mild and severe cases.
• In 2022, among the 7MM, the etiology-specific distribution of severe hypertriglyceridemia was done, and the number of diagnosed prevalent cases of primary and secondary SHTG were found to be 1.5 and 2 million, respectively.
• EU4 and the UK countries accounted for nearly 1.4 million diagnosed prevalent cases of Severe Hypertriglyceridemia in 2022. Of these cases, 0.36 million cases were estimated in Germany accounting for the highest number of diagnosed prevalent cases of SHTG in Europe.
• Japan accounted for 16% of the total diagnosed prevalent cases of Severe Hypertriglyceridemia i.e. in the 7MM in 2022, with approximately 0.5 million cases.

Severe Hypertriglyceridemia Drug Chapters

The drug chapter segment of the Severe Hypertriglyceridemia report encloses a detailed analysis of Severe Hypertriglyceridemia marketed drugs and late-stage (Phase-III and Phase-II) severe hypertriglyceridemia pipeline drugs. It also helps to understand the Severe Hypertriglyceridemia clinical trials details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Severe Hypertriglyceridemia Marketed Drugs

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. The approval of other emerging drugs are supposed to have a tough competition to this approved drug.

Note: Detailed current therapies assessment will be provided in the full report of Severe Hypertriglyceridemia

Emerging Severe Hypertriglyceridemia Drugs

Olezarsen: Ionis Pharmaceuticals

Olezarsen, formerly known as IONIS-APOCIII-LRx and AKCEA-APOCIII-LRx, is a ligand-conjugated (LICA) investigational antisense medicine to inhibit the production of Apoc-III in the liver.

Along with olezarsen, the company was developing Vupanorsen (with Pfizer) to lower the elevated TG level in cardiovascular disease (CVD). But due to unsatisfactory results, Vupanorsen got dropped. Olezarsen is presently being developed in Phase III as an antisense medicine to target apoC-III and is expected to enter the treatment market soon.

ARO-APOC3: Arrowhead Pharmaceuticals, Inc

ARO-APOC3 is designed to reduce the production of apolipoprotein C-III (apoc-III), a component of triglyceride-rich lipoproteins (TRLs), including VLDL and chylomicrons. It is a key regulator of triglyceride metabolism and has been granted with Orphan Drug Designation (ODD) for treating familial chylomicronemia syndrome (FCS).

ARO-APOC3 is in Phase II for SHTG, while olezarsenan another emerging drug is already in Phase III for SHTG, and is expected to get approval earlier than ARO-APOC3 and will be in the market as a competitor of ARO-APOC3.

Note: Detailed emerging therapies assessment will be provided in the final report.

Drug Class Insights

The existing Severe Hypertriglyceridemia treatment mainly include different classes of drug for treating SHTG. These classes statins, fibrates, omega-3 fatty acids, and niacin; however, these recommendations are largely based on observational studies.

Severe Hypertriglyceridemia Market Outlook

To treat SHTG, most guidelines recommend treatment with statins, fibrates, omega-3 fatty acids, or niacin; however, these recommendations are largely based on observational studies. Drug treatment aims to reduce triglyceride and the risk of pancreatitis and cardiovascular disease in patients with SHTG.

When observed classwise, the total market in this disease area has been dominated by statins, followed by fibrates, omega 3-fatty acids, and niacin. Currently, the market is filled with generics of non-omega-3 products, and if more potent therapy makes it to the market, it may enjoy good revenue.

The launch of emerging therapies, such as Olezarsen (Ionis Pharmaceuticals), ARO-APOC3 (Arrowhead Pharmaceuticals, Inc.), and Pegozafermin (89bio, Inc.) are expected to create a positive impact on the market.

• The total market size of Severe Hypertriglyceridemia in the 7MM was around USD 2.4 billion in 2022. This is estimated to increase by 2032 at a constant CAGR.
• Among the 7MM, the US consistently captured the highest market of about USD 1.4 billion in 2022, which is anticipated to grow during the forecast period.
• In 2022, EU4 and the UK captured an estimated USD 687 million, and Japan covered market of about USD 325 million.
• Among the forecasted emerging therapies, ARO-APOC3 is expected to capture highest market in the 7MM by 2032.

Severe Hypertriglyceridemia Drugs Uptake

This section focuses on the rate of uptake of the potential severe hypertriglyceridemia drugs expected to get launched in the market during the study period 2019-2032. For example, for ARO-APOC3, we expect the drug uptake to be medium with a probability-adjusted peak share of around 10%, and years to the peak is expected to be 7 years from the year of launch.

Further detailed analysis of emerging therapies drug uptake in the report…

Severe Hypertriglyceridemia Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes severe hypertriglyceridemia companies involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for Severe Hypertriglyceridemia emerging therapies.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on Severe Hypertriglyceridemia (SHTG) evolving treatment landscape, patient reliance on conventional therapies, patient’s therapy switching acceptability, and drug uptake along with challenges related to accessibility, include KOL from Southern California Permanente Medical Group, Centro de Salud Universitario Pinto, University of Glasgow, and others.

Delveinsight’s analysts connected with 50+ KOLs to gather insights, however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or Severe Hypertriglyceridemia market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis, and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis is done to analyze multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

To increase the availability of drugs and lower the pocket burden on patients, the US insurance program covers HTG drugs. Due to its cost-effectiveness, VASCEPA is covered by several large commercial and Medicare Part D payers. The company, Amarin is also working with payers to enhance its strong managed care position and remove barriers to VASCEPA prescriptions to ensure patients need therapy.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Severe Hypertriglyceridemia Market Report Scope

• The report covers a segment of key events, an executive summary, descriptive overview of Severe Hypertriglyceridemia (SHTG), explaining its causes, signs and symptoms, pathogenesis, and currently available therapies
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression along with treatment guidelines
• Additionally, an all-inclusive account of both the current and emerging therapies along with the elaborative profiles of late-stage and prominent therapies will have an impact on the current treatment landscape
• A detailed review of the Severe Hypertriglyceridemia (SHTG) market; historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach
• The Patient-based Severe Hypertriglyceridemia Market Forecasting report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preference that help in shaping and driving the 7MM Severe Hypertriglyceridemia market

Severe Hypertriglyceridemia Market Report Insights

• Patient-based Severe Hypertriglyceridemia Market Forecasting
• Therapeutic Approaches
• Severe Hypertriglyceridemia Pipeline Analysis
• Severe Hypertriglyceridemia Market Size and Trends
• Existing and future Market Opportunity

Severe Hypertriglyceridemia Report Key Strengths

• 10 Years Forecast
• 7MM Coverage
• Severe Hypertriglyceridemia Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

Severe Hypertriglyceridemia Report Assessment

• Current Treatment Practices
• Severe Hypertriglyceridemia Unmet Needs
• Severe Hypertriglyceridemia Pipeline Product Profiles
• Severe Hypertriglyceridemia Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions

Market Insights:

• What was the Severe Hypertriglyceridemia (SHTG) total market size, the market size by therapies, and market share (%) distribution in 2019, and how it would all look in 2032? What are the contributing factors for this growth?
• What are the unmet needs associated with the current treatment market of Severe Hypertriglyceridemia (SHTG)?
• What will be the impact of VASCEPA patent expiry?
• How is Olezarsen going to compete with the existing therapies for Severe Hypertriglyceridemia (SHTG) after approval?
• Which drug is going to be the largest contributor in 2032?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What are the disease risk, burden, and unmet needs of Severe Hypertriglyceridemia (SHTG)? What will be the growth opportunities across the 7MM concerning the patient population of Severe Hypertriglyceridemia (SHTG)?
• What is the historical and forecasted Severe Hypertriglyceridemia (SHTG) patient pool in the United States, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan?
• Why do only limited patients appear for diagnosis?
• Which severity stage is more prevalent and why?
• What factors are affecting the diagnosis of the indication?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Severe Hypertriglyceridemia (SHTG)? What are the current treatment guidelines for the treatment of Severe Hypertriglyceridemia (SHTG) in the US and Europe?
• How many companies are developing therapies for the treatment of Severe Hypertriglyceridemia (SHTG)?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of Severe Hypertriglyceridemia (SHTG)?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the key designations that have been granted for the emerging therapies for Severe Hypertriglyceridemia (SHTG)?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
• What are the 7MM historical and forecasted market of Severe Hypertriglyceridemia?

Reasons to buy

• The Patient-based Severe Hypertriglyceridemia Market Forecasting report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Severe Hypertriglyceridemia (SHTG) Market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), 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.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the Conjoint analysis section to provide visibility around leading classes
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs
• To understand the perspective of Key Opinion Leaders’ around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in future
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy