Global Hypercholesterolemia Treatment Market - 2023-2030

Overview

Global Hypercholesterolemia Treatment Market reached US$ 15.1 billion in 2022 and is expected to reach US$ 49.7 billion by 2030, growing with a CAGR of 16.6% during the forecast period 2023-2030.

The global hypercholesterolemia treatment market is experiencing significant growth in recent years with various factors influencing its dynamics such as increasing prevalence, rising aging population, clinical trials, and others. Government investments in better treatment will continue to drive and boost the global market. The global hypercholesterolemia treatment industry is placing increasing emphasis on advancements in drug developments to reduce its impact.

Moreover, hypercholesterolemia is characterized by high blood cholesterol. They are 2 types, genetic and acquired hypercholesterolemia. The treatment is based on the type of disease. Statins, pcsk9 inhibitors, ezetimibe, bile acid sequestrants, niacin, bempedoic acid, and others are used for the treatment of hypercholesterolemia. The statins segment is expected to hold the largest market share over the forecast period and in some situations. Similarly, North America dominates the market, capturing the largest market share owing to the region's advanced healthcare infrastructure, and presence of major players.

Owing to the increasing prevalence of hypercholesterolemia, growing awareness, rising aging population, increasing clinical trials and regulatory approvals, increasing demand for novel therapeutics, increasing demand for generic medicines, and advancements in treatment options are the major factors expected to drive the global hypercholesterolemia treatment market over the forecast period. However, the availability of alternative treatment options and side effects associated with the drugs are expected to hamper the market share.

Dynamics

Increasing Demand for Novel Therapeutics is Expected to Drive the Growth of the Market

There is an increasing demand for novel therapeutics, which is expected to drive the global market over the forecast period. Novel therapeutics aim to address the unmet needs associated with hypercholesterolemia treatment by providing alternative or complementary treatment options. As patients become more informed about hypercholesterolemia and its treatment options, there is a growing demand for therapies that are not only effective but also have fewer side effects, are easier to administer, and fit into modern lifestyles.

For instance, on May 18, 2022, Sun Pharma said that it is planning to launch a medication to reduce low-density lipoprotein (LDL) cholesterol. The Mumbai-based drug major said one of its wholly-owned subsidiaries plans to launch a first-in-class oral drug, Bempedoic Acid, in India for reducing LDL cholesterol. The company will launch the drug under the brand name Brillo.

Moreover, many advancements also developing for the early diagnosis of the condition. Ongoing research in the field of hypercholesterolemia has led to the development of novel therapeutic approaches. This includes new drugs, combination therapies, technologically advanced devices, and targeted treatments that address specific genetic or metabolic factors contributing to high cholesterol levels.

For instance, on September 01, 2022, Digital therapeutic company Hello Heart announced that it has released a new feature on its app that allows users to follow and understand their cholesterol levels. Hello Heart's app, available on Google Play and the Apple App Store, focuses solely on heart health and helps people track blood pressure, pulse, medications, weight, activity, and now cholesterol.

Rising Regulatory Approvals and Clinical Trials Also Drive the Growth of the Market

There are continuous ongoing clinical trials and regulatory approvals, which are expected to drive the market share over the forecast period, by building trust in patients about the safety and efficacy of the therapeutics. The positive results from clinical trials can boost investor confidence and patient trust in the usage of medicines for hypercholesterolemia treatment. This increased confidence can attract funding for further research and development and conduct more clinical trials, allowing companies to invest in more innovative therapeutics and driving the market.

For instance, on July 12, 2022, Verve Therapeutics, a biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, announced that the first patient has been dosed with VERVE-101, in its heart-1 clinical trial. VERVE-101 is a novel, investigational gene editing medicine developed by Verve and designed to be a single-course treatment that permanently turns off the PCSK9 gene in the liver to reduce disease-driving low-density lipoprotein cholesterol (LDL-C). heart-1 is a global Phase 1b clinical trial that will evaluate VERVE-101 as a treatment for patients with heterozygous familial hypercholesterolemia, a prevalent and potentially life-threatening subtype of atherosclerotic cardiovascular disease.

The increasing regulatory approvals for new hypercholesterolemia treatments, such as drugs, or procedures, this improves the range of therapeutic options available to patients and healthcare providers. This treatment expansion choice can increase the market growth as it meets the needs of individuals who not have responded well to existing therapeutics. The regulatory approvals such as FDA approvals also increase the patient's trust in the usage of the therapeutics.

For instance, on March 22, 2023, Regeneron Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has extended the approval of Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 with homozygous familial hypercholesterolemia. Evkeeza is the first angiopoietin-like 3 (ANGPTL3) inhibitor treatment indicated for children as young as 5 years old to control dangerously high levels of low-density lipoprotein cholesterol.

Increasing Aging Population and Awareness of Treatment Options Expected to Drive the Growth of the Market

The increasing aging population and increasing awareness of treatment options are expected to drive the market over the forecast period. As the global population continues to age, the prevalence of hypercholesterolemia and related cardiovascular diseases tends to rise. For instance, according to the Cleveland Clinic Organization, hypercholesterolemia is very common and about 1 out of every 20 people has hypercholesterolemia. Nearly 1/3 of American adults have high LDL-C. The increasing prevalence is mainly based on the rising aging population, it is most common in people after 40 years of age.

The increasing awareness about hypercholesterolemia and its associated treatment options is expected to drive the growth of the market over the forecast period. Public awareness about hypercholesterolemia is continuously raising due to several factors. Many organizations and many companies are focussing on the condition and developing awareness programs to address and reduce the severe conditions associated with hypercholesterolemia.

For instance, on March 21, 2023, More than 2 million veterans are living with atherosclerotic cardiovascular disease (ASCVD) and require management of their high cholesterol, according to the Department of Veterans Affairs (VA). Left unaddressed, high cholesterol increases the chance of experiencing heart attack and stroke. To control high cholesterol among veterans, the American Heart Association, the world's leading nonprofit organization focused on heart and brain health for all, in collaboration with the VA, has launched a new VA Medical Center program to help former service members with ASCVD who are at high risk of cardiovascular events.

Availability of Alternative Treatment Options is Expected to Hamper the Market's Growth

The availability of alternative treatment options is expected to hamper the market growth over the forecast period. Many individuals with hypercholesterolemia can manage their condition effectively through lifestyle modifications, such as adopting a heart-healthy diet, increasing physical activity, quitting smoking, and limiting alcohol consumption. These lifestyle changes may be preferred by some patients over pharmaceutical interventions.

Moreover, These dietary plans may be preferred by individuals looking for natural ways to address their condition. Some people turn to dietary supplements like plant sterols, red yeast rice, and omega-3 fatty acids as alternatives or complements to traditional medications for lowering cholesterol levels. Registered dietitians and nutritionists can provide tailored dietary guidance to help individuals manage their cholesterol levels without medication.

Side Effects Associated with Drugs is Also Expected to Hamper the Market Growth

The side effects associated with hypercholesterolemia drugs are expected to hamper the market growth over the forecast period. Statins are the most commonly used drugs for the treatment of hypercholesterolemia and are known to have potential side effects. The common side effects can include muscle pain, weakness (myalgia), liver enzyme abnormalities, and in rare cases, severe muscle problems like rhabdomyolysis.

These side effects may discourage some patients from taking statins or lead to treatment discontinuation. This treatment discontinuation is due to patients unsatisfaction. In response to side effects, some patients and healthcare providers may explore alternative cholesterol-lowering medications or treatment strategies that have different side effect profiles.

Segment Analysis

The global hypercholesterolemia treatment market is segmented based on disease type, treatment type, distribution channel, and region.

The Statins Segment Accounted for Approximately 39.7% of the hypercholesterolemia Treatment Market Share

The statins segment is expected to hold the largest market share over the forecast period. Statins are microorganism-derived drugs that greatly impair the cell synthesis of cholesterol by competitively inhibiting the activity of the enzyme HMG-CoA reductase. Statins, also lower the blood level of cholesterol chiefly by increasing the number of high-affinity receptors that recognize plasma LDL and by diminishing the VLDL synthesis rate in the liver. Many adjuncts are still evolving to statins for the better and more effective treatment of hypercholesterolemia.

For instance, on July 10, 2023, Novartis announced that the US Food and Drug Administration (FDA) has approved a label update for Leqvio (inclisiran) to enable earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy. This patient population includes those who have comorbidities such as hypertension and diabetes and have not yet had a first cardiovascular event2.

Moreover, Statins are drugs that can lower cholesterol. The statins mainly work by blocking a substance that the body needs to make cholesterol. Lowering cholesterol isn't the only benefit associated with statins. These medications have also been linked to a lower risk of heart disease and stroke. These drugs may help stabilize the plaques on blood vessel walls and reduce the risk of certain blood clots.

Geographical Penetration

North America Accounted for Approximately 38.9% of the Market Share in 2022, Owing to the Strong Presence of Major Players and Advanced Healthcare Infrastructure

North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and advanced healthcare infrastructure. North America especially the United States and Canada is home to many pharmaceutical and medical device companies, this strong presence of key players can actively perform in clinical trials and research activities, results in regulatory approvals such as FDA approvals for novel therapeutics are seen in the region.

For instance, on August 29, 2022, Amgen Inc. presented new study data from the Phase 3 FOURIER open-label extension (OLE) studies of Repatha (evolocumab) in adults with atherosclerotic cardiovascular disease (ASCVD) These data were simultaneously published in Circulation. Repatha is the first and only proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) to date to show long-term clinical outcomes in patients with ASCVD for up to 8.4 years. Repatha is indicated in adults with primary hypercholesterolemia or mixed dyslipidemia, as an adjunct to diet.

Furthermore, North America is known for its well-established and advanced healthcare infrastructure including hospitals, specialty clinics, research and academic institutes, and others. This advanced healthcare infrastructure is at the forefront of better treatment for hypercholesterolemia patients. This advanced healthcare infrastructure also offers favorable reimbursement policies to patients for effective treatment. The improved insurance coverage offers the better treatment for many patients at affordable costs, leading to market dominance in the region.

Competitive Landscape

The major global players in the hypercholesterolemia treatment market include: Amgen Inc., Amryt Pharma plc, AstraZeneca Plc., Regeneron Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Teva Pharmaceutical Industries Ltd., Cipher Pharmaceuticals Inc., Pfizer Inc., Merck & Co., Inc., and Sun Pharmaceutical Industries Limited among others.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for pharmaceutical industries worldwide, including the global hypercholesterolemia treatment market. During the pandemic, many clinical trials, research activities, and regulatory approvals have been temporarily postponed due to the redirected focus on the COVID-19 pandemic and its related restrictions.

The onset of the pandemic in early 2020 led to widespread lockdowns and restrictions, impacting regular cardiovascular check-ups, appointments, and consultations including hypercholesterolemia worldwide, this leads to the increasing disease severity. Many hospitals are focused on COVID-19 cases, this reduced the hypercholesterolemia treatment.

Moreover, the COVID-19 pandemic severely disrupted global supply chains, impacting the transportation of raw materials of cholesterol-related therapeutics and medical devices. Movement restrictions and border closures delayed shipments and caused drug transportation delays. Additionally, some countries faced shortages of drugs for treatment due to disruptions in their supply chain networks.

Russia-Ukraine Conflict Analysis

The Russia-Ukraine conflict is estimated to have a moderate impact on the global hypercholesterolemia treatment market. Many clinical trials and research activities are temporarily disrupted. The conflict has less impact mainly due to the low prevalence and absence of key market players in this region.

By Disease Type

• Genetic Hypercholesterolemia (Familial Hypercholesterolemia)
  • Heterozygous Familial Hypercholesterolemia
  • Homozygous Familial Hypercholesterolemia

• Acquired Hypercholesterolemia

By Treatment Type

• Statins
• PCSK9 Inhibitors
• Ezetimibe
• Bile Acid Sequestrants
• Niacin
• Bempedoic Acid
• Others

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region

• North America
  • U.S.
  • Canada
  • Mexico

• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe

• South America
  • Brazil
  • Argentina
  • Rest of South America

• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific

• Middle East and Africa

Key Developments

• On June 16, 2023, Cholesgen Co. Ltd., a biotech/biomedical research company, entered into a collaboration with AstraZeneca, to advance research and development in hypercholesterolemia and related metabolic diseases. The three-year collaboration aims to validate genetic drug targets and progress therapeutic molecules into clinical development. The joint research effort will leverage complementary strengths and focus on selected targets from Cholesgen's early-stage portfolios. Cholesgen will be entitled to receive an initial payment, as well as a pre-defined license package for each qualified drug candidate nominated by AstraZeneca to progress into clinical development.
• On June 01, 2023, Esperion announced that it has submitted Supplemental New Drug Applications (sNDA) to the U.S. Food and Drug Administration (FDA) for the Company's oral non-statin products NEXLETOL and NEXLIZET. In its sNDAs, Esperion seeks to add the use of both NEXLETOL and NEXLIZET for cardiovascular risk reduction and also seeks to remove the statin limitation in the LDL-C indication. NEXLETOL and NEXLIZET are indicated as adjuncts to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
• On January 5, 2023, Amryt, a global, commercial-stage biopharmaceutical company dedicated to acquiring, developing, and commercializing novel treatments for rare diseases, is pleased to announce positive results from its APH-19 Phase 3 trial of lomitapide for the treatment of Homozygous Familial Hypercholesterolemia (HoFH) in children aged 5-17 years.

DataM Intelligence Opinion:

According to the DataM Intelligence, the hypercholesterolemia treatment market experiencing the rapid growth in recent years and is expected to grow rapidly in the coming years due to its increasing prevalence and novel therapeutic innovations for better patient outcomes. Many innovative treatment options are going to develop in the coming years by reducing the adverse effects and for effective treatment.

Moreover, lifestyle changes, natural remedies to reduce high bad cholesterol, rising aging population are the factors mainly driving the market. Many clinical trials and research activities are still going on for novel therapeutics, which is expected to growth in the global hypercholesterolemia treatment market in the upcoming years.

Why Purchase the Report?

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

The global hypercholesterolemia treatment market report would provide approximately 61 tables, 58 figures, and 186 Pages.

Target Audience 2023

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