Hyperlipidemia Drugs Market Analysis Report by Drug Class (Statins, PCSK9 Inhibitors, Bile Acid Sequestrants, Cholesterol Absorption Inhibitors, Fibric Acid Derivatives, Combination), and Segment Forecasts, 2016 - 2022

Industry Insights

The global hyperlipidemia drugs market size was valued at USD 19.3 billion in 2016. It is estimated to progress at a CAGR of 2.3% over the forecast period. Introduction of new guidelines that redefined at-risk patient groups and the emergence of novel drug classes promising better efficacy and safety levels are among the key factors stoking market growth. Hyperlipidemia is caused by an elevation in blood lipid levels and can be classified into two types - primary and secondary. Primary or familial hyperlipidemia is caused by genetic factors, whereas secondary hyperlipidemia is caused by environmental factors. Statins are the first line of therapy for this disorder.

A total cholesterol level of 170mg/dl or less is acceptable, 170 to 199mg/dl is borderline, and 200mg/dl or more is high. According to the American Heart Association, cholesterol levels steadily increase after 20 years of age. They normally decline after the age of 70 in women and 60 in men. Additionally, women of all ages tend to have about 10mg/dl higher mean HDL-C levels as compared to men of all ages. The market is anticipated to grow modestly during the forecast period. Some of the factors anticipated augmenting the market are the emergence of new drug classes for the benefit of nonstatin users, an increase in the number of statin users, and guidelines recommending the use of antihyperlipidemics to lower the risk of cardiovascular diseases (CVD).

Hyperlipidemia guidelines in the U.S. are playing an imperative role in the growth of the market as they address the dosage regimen of statins, which include patients aged 21 years and above suffering from the risk of developing Atherosclerotic Cardiovascular Disease (ASCVD). As a result, the target population for statins is expanding to other comorbidities of high cholesterol and triglyceride levels. Most antihyperlipidemic drugs have minor adverse effects. However, some drugs are likely to cause serious adverse effects such as liver damage or type 2 diabetes. Drug classes such as CETP inhibitors have been withdrawn or discontinued even in the later stages of trials due to adverse effects or failure to achieve satisfactory results. Risks associated with antihyperlipidemics pose a major challenge to their entry into the market.

High cholesterol in the blood increases the risk of myocardial infarction and stroke. Thus, hypercholesterolemia increases susceptibility to CVD. Hyperlipidemia is associated with other major comorbidities such as diabetes type II and chronic kidney disease. According to the World Health Organization (WHO), hypercholesterolemia is estimated to result in more than 2.6 million deaths each year. Almost 37.0% of adults in the U.S. have high LDL-C levels. Yet, lesser than 50.0% of patients receive any form of treatment and approximately 33.0% of patients undergoing treatment are unable to achieve normal lipid levels.

Drug Class Insights

On the basis of drug class, the market has been segmented into statins, bile acid sequestrants, cholesterol absorption inhibitors, fabric acid derivatives, PCSK9 inhibitors, combination, and miscellaneous antihyperlipidemic agents. Miscellaneous antihyperlipidemic drug class includes omega-3 fatty acids, nicotinic acids, lomitapide, mipomersen, and bempedoic acid.

In 2016, statins led the hyperlipidemia drugs market with a share of approximately 30.0%. However, the market for statins is projected to decline at a CAGR of more than 7.5% during the forecast period due to the arrival of more effective therapies such as PCSK9 inhibitors and bempedoic acid. These new drug classes are poised to target statin-resistant as well as statin-intolerant population. High adverse effects associated with the use of upcoming drugs is expected to negatively impact the sales of statins

Miscellaneous antihyperlipidemic agents include niacin, omega-3 fatty acids, MTP-inhibitors, apoB-100 inhibitors, and more recent agents such as ACL-inhibitors. This drug class is estimated to witness healthy growth over the forecast period due to improved safety and efficacy profiles of pipeline drugs and an increase in adoption among end users. The higher efficacy of this drug class compared to statins and its ability to reduce the risk of CVD during ongoing clinical trials are among factors anticipated to boost its adoption among nonstatin users.

Regional Insights

Europe was the leading revenue contributor in the global arena in 2016, representing more than half of the overall market. The region is likely to maintain its dominance until 2022. This can be attributed to the high prevalence of hypercholesterolemia in this region. It was followed by North America with about 35.50% revenue share.

Japan’s hyperlipidemia market has fewer growth opportunities owing to the non-availability of key revenue-generating products, such as bempedoic acid. Thus, its market share is projected to decline by more than 1.5% by 2022.

Hyperlipidemia Drugs Market Share Insights

Some of the key players operating in the market are AstraZeneca; Merck & Co., Inc.; Pfizer, Inc.; DAIICHI SANKYO COMPANY, LIMITED; Amgen, Inc.; and Sanofi. Several companies, such as Esperion Therapeutics and CJ Healthcare, have promising drugs in the pipeline. Various companies, such as AstraZeneca; Merck & Co., Inc.; and Daiichi Sankyo, are poised to lose significant share due to patent expiration of drugs offered by them, which include Crestor, Zetia, Vytorin, and Welchol. Amgen and Sanofi are expected to witness healthy growth due to an increase in the usage of PCSK9 inhibitors such as Repatha and Praluent.

Recent Developments

• In January 2023, AstraZeneca entered into an agreement to acquire CinCor Pharma, Inc., a US-based clinical-stage biopharmaceutical company, centered on creating novel medicines for safe and uncontrolled hypertension as well as incessant kidney disease.

• In November 2021, Pfizer announced topline results from Phase 2b Trial of Vupanorsen in Statin-treated participants with Dyslipidemia.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global & country levels and provides an analysis of industry trends in each of the sub-segments from 2016 to 2022. This report provides an analysis of the market trends in each sub-category as well as forecasts revenue growth from 2016 to 2022. For the purpose of this study, Grand View Research has segmented the global hyperlipidemia drugs market report based on drug class and region:

• Drug Class Outlook (Revenue, USD Million, 2016 - 2022)

  • Statins

  • Bile Acid Sequestrants

  • Cholesterol Absorption Inhibitors

  • Fibric Acid Derivatives

  • PCSK9 Inhibitors

  • Combination

  • Miscellaneous

• Regional Outlook (Revenue, USD Million, 2016 - 2022)

  • The U.S.

  • The U.K.

  • Germany

  • Spain

  • France

  • Italy

  • Japan