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January 2025
The global hyperlipidemia drugs market size is calculated at USD 23.8 billion in 2024, grew to USD 24.47 billion in 2025, and is projected to reach around USD 31.49 billion by 2034. The market is expanding at a CAGR of 2.84% between 2025 and 2034. The rising prevalence of hyperlipidemia, growing research and development activities, and favorable regulatory frameworks drive the market.
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Hyperlipidemia is a condition in which excess fats or lipids are present in the blood and can increase the risk of heart attack or stroke. Hyperlipidemia or antihyperlipidemic drugs lower blood cholesterol levels and decrease heart attack risk. The cholesterol-lowering drugs include statins, PCSK9 inhibitors, fibric acid derivatives, bile acid sequestrants, nicotinic acid, cholesterol absorption inhibitors, omega-3 fatty acids, and ACL inhibitors. These drugs generally stop the body from making cholesterol, slow down or reduce cholesterol production, help the liver break down cholesterol, or help the body maintain good cholesterol. The different types of cholesterol include low-density lipoprotein (LDL), triglycerides, and high-density lipoprotein (HDL).
The rising prevalence of cholesterol and cardiovascular diseases necessitates prescribing hyperlipidemia drugs, augmenting market growth. The growing research and development activities lead to the development of novel antihyperlipidemic drugs and drug delivery systems. Technological advancements streamline research and development activities, boosting the market. Favorable regulatory frameworks by several regulatory agencies also promote the market.
Artificial intelligence (AI) and machine learning (ML) algorithms can play a vital role in various aspects, from diagnosis to treatment. AI can be used to enhance the diagnostic accuracy of hyperlipidemia, helping physicians to make timely clinical decisions. AI and ML can assist researchers in developing novel hyperlipidemia drugs or drug delivery systems to increase efficacy and decrease side effects. Drugs developed through AI can provide more targeted action and faster onset of action. AI and ML can predict the pharmacokinetic and pharmacodynamic properties of the newly developed drugs. Additionally, AI and ML can help healthcare professionals design personalized treatment regimens for cholesterol patients by analyzing their medical history. This enhances treatment efficiency and leads to better patient outcomes.
Growing Awareness
The major growth factor of the hyperlipidemia drugs market is the growing awareness of the need to prevent heart attacks. Hyperlipidemia drugs may help prevent the risk of heart attacks or cardiovascular disorders. Several government and private organizations launch initiatives and impose guidelines to increase awareness about preventing heart attack risk, owing to the rising prevalence of cholesterol and cardiovascular disorders. It has been reported that in 2023, 75% of people are over the target of LDL cholesterol, and hypercholesterolemia is the most common and worst-monitored cardiovascular risk factor. Hyperlipidemia drugs, especially statins, along with a healthy lifestyle and a balanced diet, are used to lower the risk of heart disease and heart events in patients with high risk. According to the Johns Hopkins Medicine report, approximately 200 million people take statin drugs globally.
Medication Adherence
The major challenge of the market is the lack of medication adherence for these drugs. Several patients either avoid taking hyperlipidemia drugs regularly due to side effects such as muscle pain or might forget to take these medications. In addition, patients have a lack of awareness about the importance of taking such medications or have concerns about their long-term use, restricting the hyperlipidemia drugs market growth.
Growing Research and Development
The growing research and development activities present future hyperlipidemia drug market opportunities. Several researchers are developing novel drugs and targets involved in hyperlipidemia. Some common examples of novel drugs under development include lomitapide, inclisiran, bempedoic acid, and pemafibrate. Apart from small molecules, novel biologicals such as oligonucleotides and recombinant proteins have also been developed and evaluated for antihyperlipidemic action. The growing research is also supported by various regulatory agencies. Several novel pharmaceutical therapies with innovative mechanisms of action have been approved by the Food and Drug Administration and European Medicine Agency. These novel therapeutics can transform the treatment of hyperlipidemia. The growing research and development leads to an increasing number of clinical trials to assess the safety, efficacy, and toxicity of novel drugs. As of January 2025, 2,244 clinical trials related to hyperlipidemia are registered on the clinicaltrials.gov website.
By drug class, the statins segment held a dominant presence in the hyperlipidemia drugs market in 2024. Statins are the first-line class of drugs used to treat patients with mixed hyperlipidemia and improve their lipid profile. The FDA-approved statins include atorvastatin, rosuvastatin, simvastatin, pravastatin, fluvastatin, lovastatin, and pitavastatin. They have also been proven to lower heart disease and stroke risk. Thus, the rising prevalence of cardiovascular diseases and cholesterol, as well as growing awareness for preventing heart disease risk, promote the segment’s growth. The extended applications of statins other than lowering cholesterol have the potential to drive the segment’s growth.
By drug class, the PCSK9 inhibitors segment is expected to grow at the fastest rate in the market during the forecast period. PCSK9 inhibitors are a novel class of hyperlipidemia drugs that are estimated to revolutionize the management of atherosclerotic risk. The FDA-approved PCSK9 inhibitors include alirocumab and evolocumab. The demand for PCSK9 inhibitors is set to increase in the coming years due to their ability to decrease LDL cholesterol by 50-70%, alone or in combination with statins.
By route of administration, the oral segment held the largest share in the hyperlipidemia drugs market in 2024. Oral hyperlipidemia drugs are easy to administer, eliminating the need for trained professionals. They are relatively cheaper, resulting in increased medication adherence. Additionally, oral hyperlipidemia drugs eliminate the risk of injection site infection risk and lead to high patient compliance. Oral drugs are taken by people of all age groups, including the geriatric population. The geriatric population is more prone to developing hypercholesterolemia. Hence, the rising geriatric population fuels the segment’s growth.
By route of administration, the parenteral segment is anticipated to grow with the highest CAGR in the hyperlipidemia drugs market during the studied years. Parenteral hyperlipidemia drugs are given through intravenous or intramuscular routes. Parenteral drugs bypass the first-pass metabolism and are delivered and absorbed directly into body fluids. They have a faster onset of action, resulting in a stronger effect than oral medications. The parenteral route is preferred as it can deliver precise dosage rapidly. They are mostly used when the digestive system is not functioning correctly or the individual needs to give their digestive system a rest.
By distribution channel, the retail pharmacies segment led the global hyperlipidemia drugs market in 2024. The segmental growth is attributed to special discounts, availability of generic alternatives, and same-day home delivery facilities. Retail pharmacies have skilled professionals who can guide patients in taking hyperlipidemia drugs. Pharmacists at retail stores play a crucial role in increasing patient medication adherence. The rising accessibility to retail stores also augments the segment’s growth. It is reported that 90% of U.S. citizens live within 5 miles of a retail pharmacy.
By distribution channel, the online pharmacies segment is projected to expand rapidly in the market in the coming years. Online pharmacies allow customers to order medications in the comfort of their homes. The rising geriatric population and superior facilities such as special discounts and offers and free home delivery propel the segment’s growth. Online pharmacies also provide facilities to automatically refill their prescription drugs monthly, as cholesterol drugs are taken for a lifetime, eliminating the need to order medicines every month.
North America dominated the global hyperlipidemia drugs market in 2024. The rising geriatric population, technological advancements, and the presence of key players drive the market. Key players such as AstraZeneca, Pfizer, and Eli Lilly & Company hold the major share of the market. Around 10% of Americans are estimated to suffer from cholesterol and require hyperlipidemia drugs. The favorable regulatory policies also contribute to market growth. The Food and Drug Administration and Health Canada regulate the approval of hyperlipidemia drugs in the U.S. and Canada, respectively. The increasing healthcare expenditure and advanced healthcare infrastructure promote the market. The state-of-the-art research and development facilities and rising investments potentiate the market in North America. Canada’s Minister of Health announced an investment of $26.6 million from the Canadian Institutes of Health Research (CIHR) to improve the health of people in Canada through integrated care policies and practices.
Asia-Pacific is anticipated to grow at the fastest rate in the hyperlipidemia drugs market during the forecast period. The increasing prevalence of hyperlipidemia, sedentary lifestyles, and rising disposable income drive the market. According to the Korean Society of Lipids and Atherosclerosis, 2 out of 5 adults in Korea suffer from hyperlipidemia. It is estimated that cardiovascular events will increase by 9.2 million in China between 2010 and 2030. The growing research and development activities and the increasing number of clinical trials augment market growth in Asia-Pacific. The growing demand for generic alternatives potentiates the development of generic hyperlipidemia drugs. India is the world’s largest producer and exporter of generic drugs. Around 40% of India’s generic drugs are exported globally. The presence of suitable manufacturing infrastructure allows foreign companies to set up their manufacturing facilities in Asia-Pacific countries.
Koh Jae-ho, Product Manager at Daewoong Bio, commented on the launch of CRA-TG, a combination of rosuvastatin and unsaturated fatty acid omega-3, that there is a high demand for omega-3-statin combination drugs in Korea due to high triglyceride levels of Koreans. Hence, the company developed CRA-TG to improve compliance among hyperlipidemia patients.
By Drug Class
By Route of Administration
By Distribution Channel
By Region
January 2025
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