- Dyslipidemia Market is anticipated to grow during the forecast period (2023–2032) owing the several companies such as Ionis Pharmaceuticals, Arrowhead Pharmaceuticals, Innovent Biologics, JW Pharmaceutical, and others investigating their assets in the late and mid-late stage of development. With the expected approval of these therapies during the forecast period (2023–2032]), the overall therapeutic Dyslipidemia market is likely to rise at a significant CAGR.
- DelveInsight’s analyst estimates that the prevalence of Dyslipidemia continues to be high, with most US adults affected by some form of lipid abnormality. Efforts toward screening, risk stratification, and initiating appropriate treatment should be maximized.
- The Dyslipidemia market has been significant and is expected to continue growing due to the high prevalence of Dyslipidemia in the 7MM and the increasing awareness of its association with cardiovascular diseases. Factors such as sedentary lifestyles, unhealthy diets, and the rising incidence of obesity and diabetes contribute to the growing burden of Dyslipidemia.
- Statins are typically administered to lower LDL-C levels effectively in Dyslipidemia patients; as a result, the class contributes to the maximum share in the current market.
DelveInsight’s report titled “Dyslipidemia – Market Insights, Epidemiology, and Market Forecast –2032” comprehensively analyzes Dyslipidemia. The report includes a detailed examination of the historical and projected epidemiology data that includes prevalent and diagnosed prevalent cases of Dyslipidemia segmented by type, gender, and age. The Dyslipidemia market report offers an in-depth understanding of the various aspects related to the patient population, including diagnosis, prescriptions patterns, physician perspectives, market access, treatment, and future market developments for the seven major markets, including the United States, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan from 2019 to 2032.
In order to gauge the market’s overall potential and identify business opportunities, the report discusses current Dyslipidemia treatment practices and algorithms as well as unmet medical needs.
Dyslipidemia is the term for unbalanced or unhealthy lipids such as cholesterol, low-density lipoprotein cholesterol (LDL-C), triglycerides, and high-density lipoprotein (HDL). It is a significant risk factor for cardiovascular disease, including heart attacks and strokes. Various factors, including genetics, diet, physical inactivity, obesity, diabetes, certain medical conditions, and medications, can cause Dyslipidemia. Treatment for Dyslipidemia typically involves lifestyle modifications such as adopting a healthy diet, engaging in regular physical activity, maintaining a healthy weight, and avoiding tobacco smoking. Additionally, medication may be prescribed to help manage lipid levels, such as statins, fibrates, niacin, or cholesterol absorption inhibitors. Regular monitoring of lipid levels is crucial for effectively managing Dyslipidemia and reducing the risk of cardiovascular complications.
Dyslipidemia Diagnosis and Treatment Algorithm
Diagnosing and treating Dyslipidemia typically involves several steps, including the identification of risk factors, laboratory testing, lifestyle modifications, and, if necessary, medication interventions.
The cornerstone of dyslipidemia diagnosis is a lipid profile blood test. This test typically requires 9–12 h fasting before collecting the blood sample. The lipid profile measures the levels of various lipids in the blood, including total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides.
The treatment generally aims to reduce the risk of cardiovascular disease by achieving specific target levels for LDL-C and non-HDL-C (which includes LDL-C and other atherogenic lipoproteins). The most commonly prescribed medications for Dyslipidemia are statins, which work by reducing LDL-C levels. Other medications, such as ezetimibe, bile acid sequestrants, fibrates, and PCSK9 inhibitors, may be considered based on the individual’s specific needs.
The Dyslipidemia epidemiology section provides insights into the historical and current dyslipidemia patient pool and forecasted trends for seven individual major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool, its trends, and assumptions undertaken.
The epidemiology section on the dyslipidemia market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.
- According to The National Health and Nutrition Examination Survey 2003–2006, an estimated 53% (105.3 million) of US adults have lipid abnormalities: 27% (53.5 million) have high LDL-C, 23% (46.4 million) have low HDL-C, and 30% (58.9 million) have high TG. Among patients with serum TG levels ≥200 mg/dL, approximately 13% (25.7 million) of adults have non-HDL-C levels ≥130 mg/dL. Also, 21% (42.0 million) of US adults have mixed Dyslipidemia (high LDL-C with either low HDL-C and/or high TG), with nearly 6% (11.6 million) having all three lipid abnormalities.
- As per Pappan et al. (2022), in 2005–2008, an estimated 33.5% of the US adults older than 20 years of age had high LDL-C levels. Of these individuals with elevated LDL-C levels, only 48.1% received treatment, and 33.2% had their LDL-C controlled.
- According to Nave et el. (2013), the overall diagnosed prevalence of Dyslipidemia in Germany (total cholesterol ≥190 mg/dL or medical diagnosis of Dyslipidemia) is 64.5% for men and 65.7% for women. More than half of these men and women have previously undiagnosed Dyslipidemia.
- As per Akiyama et al. (2015), the prevalence of hyper LDL-C, hyper TG, and hypo HDL-C were 29.3, 24.2, and 10.2%, respectively, and the overall prevalence of Dyslipidemia was 56.5% in Japan.
Get detailed insights into the historical as well as forecasted epidemiology trends in the 7MM, at: Dyslipidemia Epidemiology Forecast
Dyslipidemia Market Outlook
The treatment and management of Dyslipidemia involve a combination of lifestyle modifications and the use of medications. A healthy diet, physical activity, smoking cessation, and other healthy choices can improve overall cardiovascular health. The choice of medication depends on individual factors, such as lipid profile, overall health, and risk of cardiovascular disease. Current treatment guidelines for managing Dyslipidemia focus on low-density lipoprotein cholesterol (LDL-C) reduction.
Statins are among the most widely used medications, with atorvastatin being one of the best-selling pharmaceuticals. Statins inhibit HMG-CoA reductase, the rate-limiting enzyme in cholesterol biosynthesis. The subsequent reduction in intracellular cholesterol leads to an upregulation of LDL receptors on the surface of hepatocytes, which augments their LDL-clearing capacity. The FDA-approved statins include atorvastatin, rosuvastatin, simvastatin, pravastatin, fluvastatin, lovastatin, and pitavastatin.
In August 2009, Kowa Pharmaceuticals’ LIVALO (pitavastatin), a potent HMG-CoA reductase inhibitor, was approved by the FDA (statin) for the primary treatment of hypercholesterolemia and combined Dyslipidemia.
PCSK9 is a serine protease found in many tissues but mainly expressed in the liver that targets LDL-R. It leads the receptors to lysosome-mediated degradation, thus diminishing their recycling and decreasing the removal rate of circulating LDL-C with a subsequent increase in LDL-C concentration in the blood. Therefore, in 2015, the US FDA approved two monoclonal antibodies, alirocumab, and evolocumab, as a therapeutic option in addition to diet and a maximally tolerated dose of statins for patients with familial hypercholesterolemia and in cases of statin intolerance.
The use of small interfering RNA (siRNA) represents another strategy to reduce PCSK9 secretion. In December 2021, the US FDA approved LEQVIO (inclisiran), the first and only small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholesterol (also known as bad cholesterol or LDL-C) with two doses a year, after an initial dose and one at 3 months. Moreover, inclisiran is also approved by the European Medicines Agency (EMA) to treat adults with primary hypercholesterolemia or mixed Dyslipidemia.
Further, in 2020, the FDA approved bempedoic acid (NEXLETOL) for treating adults with HeFH or established ASCVD who require additional lowering of LDL-C. Bempedoic acid has been demonstrated to lower LDL-C levels. The FDA-approved dose combination with maximally tolerated statin therapy is 180 mg, administered orally once daily. Following the approval of bempedoic acid in just a few days was the combination product of bempedoic acid and ezetimibe (NEXLIZET) as a single tablet. The FDA approved the combination product for the same indication as bempedoic acid.
Volanesorsen is a second-generation 2′-O-methoxyethyl (2′-MOE) chimeric antisense therapeutic oligonucleotide (ASO) that can decrease plasma apolipoprotein C3 and triglycerides (TG) levels through LPL-independent pathways. It received conditional approval from the EMA in 2019 to treat familial chylomicronaemia syndrome (FCS), a genetic condition that gives rise to high levels of fats called triglycerides in the blood. On the contrary, the US FDA refused to approve the drug due to its safety issues of thrombocytopenia and bleeding risks.
Further, lomitapide is a microsomal triglyceride transfer protein (MTP) inhibitor, approved in several countries in addition to a low-fat diet and other lipid-lowering drugs or LDL-apheresis to treat patients with HoFH. The US FDA and EMA both approved the drug in 2012 and 2013, respectively.
Although several drugs have been approved, there are several challenges in treatment. For instance, statins may cause side effects in certain individuals. These can include muscle pain, liver abnormalities, gastrointestinal issues, and, rarely, more serious side effects like rhabdomyolysis. Further, Dyslipidemia requires long-term management and adherence to medication regimens can be challenging for some patients.
According to DelveInsight, the Dyslipidemia market in the 7MM is expected to change significantly during the study period 2019–2032.
Dyslipidemia Drug Chapters
Dyslipidemia Marketed Drugs
LEQVIO (inclisiran): Novartis
Inclisiran is a first-in-class siRNA to lower cholesterol and keep it low with two doses a year. It was approved by EMA and US FDA in December 2020 and December 2021, respectively. LEQVIO reduces the amount of LDL-C in the bloodstream by improving the liver’s natural ability to prevent the production of a protein that keeps circulating cholesterol levels high. It is an SC injection given by a healthcare provider with an initial dose, then again at 3 months, and then every 6 months. This approach may help those who have trouble sticking to self-administered medicines and have a greater dosing frequency. In July 2023, the US FDA approved an expanded indication for LEQVIO (inclisiran) to include treatment of adults with high LDL-C and who are at increased risk of heart disease.
NILEMDO (bempedoic acid): Esperion
NILEMDO, an oral, once-daily, non-statin LDL-cholesterol (LDL-C) lowering medicine, was approved in the US and Europe in February and April 2020, respectively. It is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by inhibiting cholesterol synthesis in the liver. The patent claimed for Bempedoic acid in the US is scheduled to expire in December 2025; however, the claim methods of using bempedoic acid are set to expire in December 2023.
Dyslipidemia Emerging Drugs
The currently available treatments for dyslipidemia aim to mitigate the complications associated with the condition. The Dyslipidemia market dynamics are expected to change, primarily due to increased healthcare spending worldwide. Dyslipidemia Market players such as Ionis Pharmaceuticals, NewAmsterdam Pharma, Menarini Group, Arrowhead Pharmaceuticals, and others actively develop Dyslipidemia treatments.
Obicetrapib: NewAmsterdam Pharma/Menarini Group
Obicetrapib is a novel, selective CETP inhibitor that potently decreases low-density lipoprotein-cholesterol (LDL-C) as well as increases high-density lipoprotein-cholesterol (HDL-C) and the number of ApoA1-containing lipoproteins. In July 2021, the company reported positive results from a Phase II study of oral obicetrapib demonstrating over 50% LDL-lowering as an adjunct to high-intensity statins. In June 2022, NewAmsterdam signed a licensing deal with the Menarini Group to commercialize obicetrapib in Europe. It is currently being investigated under three Phase III trials: BROADWAY, BROOKLYN, and PREVAIL as a lipid-modifying therapy.
ARO-APOC3: Arrowhead Pharmaceuticals
ARO-APOC3 is an investigational subcutaneously administered RNAi therapeutic targeting apolipoprotein C-III (APOC3). In March 2023, the US FDA granted fast-track designation (FTD) to ARO-APOC3 for reducing triglycerides in adult patients with familial chylomicronemia syndrome. Further, the drug has also been granted orphan drug designation (ODD) by the FDA and the European Union. It is currently undergoing Phase II and III trials as a treatment for patients with severe hypertriglyceridemia (SHTG), mixed Dyslipidemia (MD), and familial chylomicronemia syndrome (FCS).
Olezarsen: IONIS Pharmaceuticals
Olezarsen, formerly known as IONIS-APOCIII-LRx and AKCEA-APOCIII-LRx, is an investigational ligand-conjugated antisense (LICA) medicine designed to inhibit the production of apoC-III for patients who are at risk of disease due to elevated triglyceride levels. In January 2013, the US FDA granted FTD to olezarsen for familial chylomicronemia syndrome. It is currently being investigated in a Phase III trial for severe hypertriglyceridemia patients and familial chylomicronemia syndrome.
Explore more about the emerging therapies and key companies actively working in the market: Dyslipidemia Pipeline Insights
Dyslipidemia Market Segmentation
DelveInsight’s ‘Dyslipidemia Market Insights, Epidemiology, and Market Forecast – 2032’ report provides a detailed outlook of the current and future Dyslipidemia market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.
Dyslipidemia Market Size by Countries
The total Dyslipidemia market size is analyzed for individual countries (the United States Market, EU4 (Germany, France, Italy, and Spain) and the UK market, and Japan). The United States accounted for a larger portion of the 7MM market for Dyslipidemia in 2022 due to the high prevalence of the condition and the higher cost of treatments. With the potential early entry of new products, this dominance is predicted to continue.
Dyslipidemia Market Size by Therapies
To depict each nation’s distinct historical and projected market shares, the Dyslipidemia market is separated by therapies and medication classes. Ongoing research focuses on a novel mode of action, including apolipoprotein C-III (apoC-III) inhibition, selective peroxisome proliferation, inhibition of PCSK9 expression, and others to improve the quality of life for individuals with Dyslipidemia.
However, educating patients about the importance of lipid management, the significance of lifestyle modifications, and improving patient adherence are some major challenges hindering the Dyslipidemia market growth.
Note: Detailed market segment assessment will be provided in the final report.
Dyslipidemia Drugs Uptake
This section focuses on the sales uptake of potential Dyslipidemia drugs that have recently launched or are anticipated to be launched in the Dyslipidemia market between 2019 and 2032. It estimates the market penetration of Dyslipidemia drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the Dyslipidemia market.
The emerging Dyslipidemia therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry, and other market dynamics, as well as the unmet need they fulfill in the Dyslipidemia market.
Note: Detailed assessment of drug uptake and attribute analysis will be provided in the full report on Dyslipidemia.
Dyslipidemia Market Access and Reimbursement
DelveInsight’s ‘Dyslipidemia – Market Insights, Epidemiology, and Market Forecast – 2032’ report provides a descriptive overview of the market access and reimbursement scenario of Dyslipidemia.
This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.
To keep up with current Dyslipidemia market trends and fulfill gaps in secondary findings, we interview KOLs and SMEs’ working in the Dyslipidemia domain. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or Dyslipidemia market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the Dyslipidemia unmet needs.
Dyslipidemia: KOL Insights
DelveInsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as Nantes Université in France, the Department of Neurological Surgery at Duke University Medical Center, and Durham in the US.
“Around 20–30% of patients cannot achieve the desired LDL-C goal through statin therapy alone. This challenge in reaching LDL-C goals with statins highlights the need for innovative drugs in cardiovascular medicine.”
“Lifestyle modifications, including adopting a heart-healthy diet, engaging in regular physical activity, achieving and maintaining a healthy weight, and avoiding tobacco use, are essential for managing dyslipidemia.”
Note: Detailed assessment of KOL Views will be provided in the full report of Dyslipidemia.
Competitive Intelligence Analysis
We perform Competitive and Market Intelligence analysis of the Dyslipidemia Market using various Competitive Intelligence tools, including SWOT analysis, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Dyslipidemia Pipeline Development Activities
The report provides insights into therapeutic candidates in Phase II and III stages. It also analyses Dyslipidemia Companies involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging Dyslipidemia therapies.
Dyslipidemia Report Insights
- Dyslipidemia Patient Population
- Therapeutic Approaches
- Dyslipidemia Pipeline Analysis
- Dyslipidemia Market Size and Trends
- Dyslipidemia Market Opportunities
- Impact of Upcoming Therapies
Dyslipidemia Report Key Strengths
- 10 Years Forecast
- The 7MM Coverage
- Dyslipidemia Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Dyslipidemia Market
- Dyslipidemia Drugs Uptake
Dyslipidemia Report Assessment
- Dyslipidemia Current Treatment Practices
- Unmet Needs
- Dyslipidemia Pipeline Product Profiles
- Dyslipidemia Market Attractiveness
- What are the key findings of the market across 7MM, and what country will have the largest Dyslipidemia market size during the forecast period (2023–2032)?
- What are the major causes of Dyslipidemia, and how is it diagnosed?
- What are the marketed drugs for Dyslipidemia in the 7MM?
- At what CAGR is the Dyslipidemia market, and is epidemiology expected to grow in the 7MM during the forecast period (2023–2032)?
- In what ways would the unmet needs impact the Dyslipidemia market dynamics and subsequently influence the analysis of related trends?
- What would be the forecasted patient pool of Dyslipidemia in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
- What are the current treatment guidelines and options for Dyslipidemia in the US, Europe, and Japan?
- What are the latest advancements in novel therapies, targets, mechanisms of action, and technologies being developed to address the limitations of existing therapies for Dyslipidemia?
- How many companies are currently engaged in the development of therapies for the treatment of Dyslipidemia?