Global Dyslipidemia Market - 2024-2031

Overview

The global dyslipidemia market reached US$ 17.58 billion in 2023 and is expected to reach US$ 55.95 billion by 2031, growing at a CAGR of 15.70% during the forecast period 2024-2031.

Dyslipidemia is a medical condition characterized by abnormal levels of lipids (fats) in the blood, which include cholesterol and triglycerides. Dyslipidemia is an umbrella term that encompasses various disorders related to lipid levels, including high levels of low-density lipoprotein (LDL) cholesterol ("bad" cholesterol), low levels of high-density lipoprotein (HDL) cholesterol ("good" cholesterol) and elevated triglycerides. These lipid imbalances can increase the risk of cardiovascular diseases, such as coronary artery disease, stroke and peripheral artery disease.

The dyslipidemia market growth is driven by the high prevalence of lipid disorders and rising cardiovascular disease rates worldwide, especially in aging populations and regions with lifestyle risk factors like poor diet and sedentary behavior. For instance, the National Institute of Health (NIH), stated that according to the World Health Organization (WHO), 39% of the world's adult population has been affected by elevated blood cholesterol, with a relatively higher prevalence among women (40%) than among men (37%). Raised blood cholesterol can have several consequences that increase the burden of the disease.

Market Dynamics: Drivers & Restraints

Rising product development activities and regulatory approvals

The market for dyslipidemia is experiencing significant growth due to rising product development activities and subsequent regulatory approvals for commercial use. Due to the rising burden of dyslipidemia conditions, several manufacturers are focusing on developing novel therapies and advancing the existing ones.

For instance, in June 2024, Daewoong Bio launched a new product that combines the hyperlipidemia drug rosuvastatin with the dietary supplement Omega-3. It offers improvements in lipids and instability and tolerability compared to rosuvastatin alone.

Rising regulatory approvals especially FDA approvals are significantly driving growth in the dyslipidemia market by introducing innovative and effective treatment options for lipid management, particularly for patients who do not respond well to traditional therapies like statins. This regulatory support accelerates the availability of novel drugs for dyslipidemia treatment, expanding the dyslipidemia market by addressing diverse patient needs and improving cardiovascular outcomes.

For instance, in March 2024, the U.S. Food and Drug Administration (FDA) approved NEXLETOL (bempedoic acid) tablets and NEXLIZET (bempedoic acid and ezetimibe) tablets developed by Esperion Therapeutics, Inc. These drugs are used alone or in combination with statins for primary hyperlipidemia.

Additionally, in March 2024, the U.S. Food and Drug Administration (FDA) approved Praluent (alirocumab) developed by Regeneron Pharmaceuticals Inc. for extended application to pediatric patients aged 8 and older with heterozygous familial hypercholesterolemia (HeFH). This drug can be used in adjunct with diet and other lipid-lowering drugs.

High cost associated with the dyslipidemia treatment

The high cost of advanced dyslipidemia treatments, particularly newer therapies like PCSK9 inhibitors and RNA-based drugs, is a barrier to the dyslipidemia market growth. For instance, according to the NIH, PCSK9 inhibitors were initially priced at around $14,000 per year, making them less accessible despite their effectiveness in lowering LDL cholesterol in high-risk patients. Although prices have since been reduced to around $5,850 annually in some markets, they still remain costly compared to generic statins, which can be as low as $10 per month.

This price disparity limits access, especially among uninsured patients or those in low- and middle-income countries and contributes to lower patient adherence for dyslipidemia. Additionally, high costs put pressure on healthcare systems and insurance providers, often resulting in restrictive reimbursement policies. Consequently, fewer prescriptions for these advanced drugs are written, slowing market adoption and hampering growth despite rising demand for innovative treatments for dyslipidemia.

Segment Analysis

The global dyslipidemia market is segmented based on treatment type, route of administration, distribution channel and region.

Treatment Type:

The statins segment is expected to dominate the global dyslipidemia market share

Statins are the recommended first-line agents for the treatment of dyslipidemia. These drugs inhibit HMG-CoA reductase, an enzyme that plays a crucial role in the cholesterol biosynthesis pathway. By doing so, statins reduce the levels of cholesterol in the body and reduce the risk of cardiovascular events. Several regional health agencies and global health bodies recommend statins as a first-line treatment option for lowering LDL-C. For instance, according to the American Heart Association, statins are recommended for most dyslipidemia patients as they are more effective in risk reduction for heart attack and stroke.

Among the statins group for dyslipidemia, high-intensity statins such as Atorvastatin and Rosuvastatin are widely used. According to the 2023 European Society of Cardiology (ESC) guidelines, these drugs are indicated in patients with diabetes and at high risk for cardiovascular events, as they lower the LDL-c by 40% to 63%. Usage of these drugs also reduces the incidence of major cerebral and coronary complications.

Moreover, these drugs for dyslipidemia are among the top-selling lipid-lowering drugs worldwide. For instance, Atorvastatin sold under the brand name Lipitor, manufactured by Viatris Inc. has generated approximately US$ 1.5 billion in 2023. In addition, Rosuvastatin sold under the brand name Crestor, manufactured by AstraZeneca generated approximately US$ 1.1 billion in the same year.

The bile acid sequestrants segment is the fastest-growing segment in the dyslipidemia market

The bile acid sequestrants segment is expected to be the fastest-growing segment in the dyslipidemia market over the forecast period due to its role as an effective, non-systemic treatment option that lowers LDL cholesterol with fewer systemic side effects. Unlike statins, which are associated with muscle-related side effects, bile acid sequestrants work locally in the gastrointestinal tract to prevent bile acid reabsorption, thereby lowering cholesterol with minimal impact on the bloodstream. This makes them particularly valuable for statin-intolerant patients and those seeking combination therapies to manage their lipid levels.

Recent studies underscore the growing demand for bile acid sequestrants. For instance, the NIH study showed that combining bile acid sequestrants with statins can reduce LDL cholesterol by an additional 18%, a significant advantage for patients needing more aggressive lipid management. Additionally, as bile acid sequestrants are typically less expensive and have a long-standing safety profile, they appeal to both patients and healthcare providers looking for cost-effective alternatives. These factors, along with increased usage for both combination treatments, are driving the growth of bile acid sequestrants within the dyslipidemia treatment.

North America is expected to hold a significant position in the global dyslipidemia market

The North America region is expected to hold the largest share in the dyslipidemia market over the forecast period, owing to the higher prevalence of dyslipidemia, overall higher expenditure on healthcare and the strong presence of market leaders generating higher revenues in the region.

For instance, in March 2024, an epidemiology study published in the Journal of the American Heart Association stated that 25% of the adolescent population in the U.S. have dyslipidemia, and the prevalence cases are approximately 30% of the total population in the age group 18 to 39. The study suggested that early interventions and preventative measures among this population could prevent cardiovascular disease risks in the future.

Moreover, in the U.S., the risk of CVD is also higher. According to the American Heart Association, in the next 30 years 6 in 10 U.S. which is approximately 184 million people are expected to have one or the other type of CVD.

This alarming rise in dyslipidemia prevalence and the availability of advanced therapies contribute to the region's dominance in the global market. Several global leaders are operating actively in the region by investing in R&D activities, focusing on innovative product launches, etc. Moreover, these companies generate a major portion of revenue for their product from the North America region.

For instance, Novartis AG has launched LEQVIO (Inclisiran) a novel siRNA therapy for dyslipidemia, first in the U.S. market post its approval from the FDA. The product has bagged a sales value of US$ 355 million in 2023, and a major portion of it is generated from the U.S. market.

Asia Pacific is growing at the fastest pace in the dyslipidemia market

The Asia Pacific region is experiencing the fastest growth in the dyslipidemia market due to the rising prevalence of lipid disorders and increasing healthcare investments. Countries like China, India and Japan are witnessing significant lifestyle shifts, including increased consumption of high-fat diets and sedentary behaviors, contributing to an escalating burden of dyslipidemia and associated cardiovascular diseases.

For instance, according to the National Institute of Health, 2024, metabolic non-communicable disease health report of India: the ICMR-INDIAB nationwide cross-sectional epidemiological study (ICMR-INDIAB-17)12 on 113043 individuals (79506 from rural and 33537 from urban areas) showed the overall prevalence of dyslipidemia to be 81.2%. Low HDL cholesterol accounted for most with a prevalence of 66.9%.

Governments in the Asia-Pacific region are increasing healthcare spending, with an emphasis on preventive care and managing chronic diseases. For instance, Japan's "Healthy Life Expectancy" initiative includes aggressive screening programs for cardiovascular risk factors, fostering early detection and treatment of dyslipidemia. Moreover, multinational pharmaceutical companies are increasingly entering the Asia-Pacific market, forming partnerships with local firms to expand drug access and support new product launches.

Competitive Landscape

The major global players in the dyslipidemia market include Viatris Inc., AstraZeneca, Organon group of companies, Regeneron Pharmaceuticals, Inc., Amgen Inc., Novartis AG, Esperion Therapeutics, Inc., Pfizer Inc., Teva Pharmaceuticals USA, Inc., Lupin Pharmaceuticals, Inc. and among others.

Emerging Players

The emerging players in the dyslipidemia market include Arrowhead Pharmaceuticals, Inc., Alnylam Pharmaceuticals, Inc., Kowa Pharmaceuticals America, Inc., Gemphire Therapeutics Inc. and Ionis Pharmaceuticals, Inc. among others.

FDA Approvals

• In March 2024, Esperion cleared that the United States Food and Drug Administration (FDA) has approved broad new label expansions for NEXLETOL (bempedoic acid) Tablets and NEXLIZET (bempedoic acid and ezetimibe) Tablets based on positive CLEAR Outcomes data that include indications for cardiovascular risk reduction and expanded LDL-C lowering in both primary and secondary prevention patients. In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
• In July 2023, the U.S. Food and Drug Administration (FDA) approved Leqvio (inclisiran) developed by Novartis AG, for extended application to earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy.

Why Purchase the Report?

• To visualize the global dyslipidemia market segmentation based on treatment type, route of administration, distribution channel and region and understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of the dyslipidemia market with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping is available in excel consisting of key products of all the major players.

The global dyslipidemia market report would provide approximately 62 tables, 57 figures and 195 pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies