Global Hypercholesterolemia Market Research Report: Forecast (2023-2028)

Market Definition

Hypercholesterolemia is a condition in the human body where levels of cholesterol spike abnormally, resulting in higher blood pressure, strokes or heart attacks. Usually stemming from underrated thyroid levels and unhealthy eating habits resulting in chronic diseases such as heart disease, diabetes, and others, it may pose serious life threats. The primary cause, however, may be genetic.

Market Insights & Analysis: Global Hypercholesterolemia Market (2023-28)

The Global Hypercholesterolemia Market is projected to grow at a CAGR of around 3.2% during the forecast period, i.e., 2023-28. The market is driven by the alarming rise in the prevalence of cardiovascular diseases and chronic disorders such as diabetes, obesity, and others worldwide. Elevated levels of non-HDL cholesterol and LDL in the blood may result in life-threatening conditions, including heart disease and stroke. According to WHO, raised total cholesterol is a major cause of disease burden in both the developed and developing world as a risk factor for ischemic heart disease and stroke. Globally, a third of ischaemic heart disease is due to high cholesterol. Overall, raised cholesterol is estimated to cause 2.6 million deaths (4.5% of total) and 29.7 million DALYS, or 2% of total DALYS.

There was a negative association between SDI and high LDL-C-related age-standardized death and DALY rates when SDI surpassed 0.71 and 0.71, respectively. As such, rigorous research, clinical studies, and trials for treatment leading to effective drugs are observed to be a solid booster to the Global Hypercholesterolemia Market landscape. For instance,

In July 2022, NewAmsterdam Pharma, a clinical-stage business, introduced BROOKLYN, a phase 3 trial designed to evaluate the efficacy of obicetrapib on LDL-C levels in patients with heterozygous familial hypercholesterolemia as an adjunct to maximally tolerated lipid-lowering therapy.

In fact, the number of homozygous familial hypercholesterolemia clinical studies done worldwide grew by 93% between 2016 to 2020, as per clinicaltrials.gov. These aspects are expected to stimulate the market revenue growth during the forecast period.

Global Hypercholesterolemia Market Driver:

Surging R&D Activities and Clinical Studies Drive Market Growth - Rising Research and development (R&D) activities associated with hypercholesterolemia and fueling clinical trials of the treatment drugs produced by major pharmaceutical manufacturers , drive market growth around the globe. Due to increasing changes in lifestyle and unhealthy diets, individuals have high bad cholesterol in their bloodstreams. The disease risk has increased with obesity, unhealthy lifestyle, intake of unhealthy food, and most importantly diabetes. 

Moreover, according to the International Diabetes Federation (IDF), 1 in 10 individuals are suffering from hypercholesterolemia. Although 537 million adults are living with diabetes, 643 million adults are estimated to have diabetes by 2030. This reflects the high prevalence of hypercholesterolemia as diabetes increases the risk of hypercholesterolemia. Thus, anticipated to increase the CAGR value of Hypercholesterolemia Market around globe during the projected period. 

In addition, North America accounted for a considerable share of Market in recent years due to increasing R&D activities and an increasing clinical studies number over the region. For instance,

In 2022, Ionic Pharmaceutical collaborated with AstraZeneca to release an antisense drug to lower blood cholesterol levels in hypercholesterolemia patients by targeting a protein, that is a proprotein convertase subtilisin/kexin type 9.

Global Hypercholesterolemia Market Possible Restraint:

Adverse effects of low-cholesterol drugs and hinder the Market growth - Drugs used for the treatment for hypercholesterolemia contain some side effects such as aches, muscle and joint pain, vomiting, diarrhea, nausea, gas, or constipation. Impediments with muscles and the risk of diabetes enhanced by use of these statins are the major side effects. Most adverse effects of the hypercholesterolemia drugs are associated with liver damage and type 2 diabetes. For instance, CETP inhibitors, a drug class used for hypercholesterolemia have been withdrawn in the later stages of the clinical trial due to adverse effects. Due to these side effects, the Hypercholesterolemia Drug Market would be negatively affected.

Global Hypercholesterolemia Market Growth Opportunity:

Constant Advances in Genetic Therapies for FH To Bring Lucrative Prospects - The paradigm shifts in the treatment methods, paired with the rapid advancement in gene therapy technology in recent years, have revolutionized the way FH patients were treated earlier. Genetic therapies are being constantly developed for Familial Hypercholesterolemia and may bring absolute LDL-C dipping. Unlike existing lipid-lowering therapies, exhibiting difficulty in achieving lipid target levels in FH patients, Gene Therapy has shown excellent therapeutic potential. With further optimization of delivery efficiency, immunogenicity, and the precision of gene therapy, the market players may maximize their revenue in the coming years.

Global Hypercholesterolemia Market (2023-28): Segmentation Analysis

The Global Hypercholesterolemia Market study of MarkNtel Advisors evaluates & highlights the major trends & influencing factors in each segment & includes predictions for the period 2023–2028 at the global, regional, and national levels. Based on the analysis, the market has been further classified as:

Based on Disease Type,

• Genetic
• Acquired

Between the two, the Genetic segment acquired the largest market share in the historical period with Familial Hypercholesterolemia (FH) as a common genetic disorder, remained prominent. According to the Centers for Disease Control and Prevention, more than one million people in the U.S. have familial hypercholesterolemia, but unfortunately, only about 30% know about it. Being an inherited disorder, FH makes it crucial to get family members tested in order to find more such cases. Since FH involves gene mutation of those involved in the catabolism of Low-Density Lipoprotein Cholesterol (LDL-C), autosomal dominant inheritance is the common pattern for familial hypercholesterolemia induced by mutations in LDLR, APOB, or PCSK9 genes.

As such, cascade testing that involves a diagnosis of FH through genetic testing, a blood cholesterol test, or both, has turned up in recent years, thereby fetching the attention of market players. Moreover, the expanding screening programs for familial hypercholesterolemia and their affordability coupled with the clinical advances of new therapeutics for this disorder have bolstered the market growth in the past few years. Moreover, the steady adoption of diagnostic methods such as the Simon Broome Register (SBR), Dutch Lipid Clinic Network (DCLN), or Make Early Diagnosis to Prevent Early Death (MEDPED) has again led to the industry's ascension in the historical period.

Global Hypercholesterolemia Market Regional Projection

Geographically, the Global Hypercholesterolemia Market expands across:

• North America
• South America
• Europe
• Middle East & Africa
• Asia-Pacific

On the geographical front, North America grabbed the maximum market share in 2022 and is anticipated to prevail in the same trend. The dominance of the region is primarily attributed to the growing awareness accompanied by the substantial healthcare expenditure by the respective governments. With more than one million people suffering from Familial Hypercholesterolemia in the US alone, the situation across the region continues to be life-threatening. Besides, recent instances of type-2 diabetes in adults and underrated thyroid levels, when paired with a lack of a wholesome diet, have brought the attention of researchers, & healthcare service providers and compelled them to come up with more effective solutions for the condition and, derived disorders in the past few years. For instance,

• In July 2022, VERVE-101, a novel, investigational gene editing medicine by Verve Therapeutics, got its first patient. The aim was to design a single-course treatment that permanently turns off the PCSK9 gene in the liver, thereby reducing disease-driving low-density lipoprotein cholesterol (LDL-C). Being a clinical-stage biotechnology company, based in the U.S., the brand is highly focused on promoting heart wellness.

Regulatory Landscape in the Global Hypercholesterolemia Market

• In December 2021, the FDA authorized Leqvio injection with active ingredient inclisiran to treat heterozygous familial hypercholesterolemia.
• In Feb 2021, The Food & Drug Administration (FDA), approved evinacumab to lower LDL cholesterol for patients with homozygous familial hypercholesterolemia aged above 12 years.

Global Hypercholesterolemia Industry Recent Developments 

• In April 2022, Ionis Pharmaceuticals, Inc., a biotechnology company based in Carlsbad, California, found that its AstraZeneca-partnered cholesterol med pulls down levels of the troublesome substance in patients during a Phase -2 trial. Earlier, Ionis designed the antisense therapy ION449 to downsize plasma levels of PCSK9 and, by extension, lower low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia

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