Hypercholesterolemia Market - Size, Share, Industry Trends, and Forecasts (2024 - 2031)

By Type:

Based on type, the market is bifurcated into genetic and acquired.

Trends in the Type:

• Gene therapies that target LDL cholesterol levels have shown promise, indicating a shift towards more effective and targeted treatments.
• The acquired hypercholesterolemia segment is largely influenced by lifestyle factors such as diet, obesity, and sedentary habits. The increasing prevalence of these conditions globally is expected to sustain the demand for cholesterol management solutions.

In 2023, the genetic segment accounted for the largest market revenue in the hypercholesterolemia market, and it is also expected to grow at the fastest rate over the forecast period.

• Genetically acquired hypercholesterolemia is the term used to describe conditions in which genetic factors, rather than lifestyle choices, are the primary cause of elevated cholesterol levels.
• Familial hypercholesterolemia is a common form that is usually inherited in an autosomal dominant pattern.
• Mutations in genes that control LDL receptor function cause impaired blood clearance of LDL cholesterol.
• To lower cholesterol and lower the risk of cardiovascular disease, treatment often consists of a combination of pharmacological interventions such as PCSK9 inhibitors or statins and lifestyle modifications.
• Sun Pharma, in May 2022, launched its first-in-class lipid-lowering drug known as Brillo. It is advised for people with inherited genetic disorder that causes high cholesterol levels or established heart disease where cholesterol levels remain high, despite lifestyle changes and the use of a maximum tolerated dose of statins.
• Thus, the above factors are boosting the hypercholesterolemia market trends.

By Treatment Type:

The treatment type is categorized into statins, bile acid resins, fibric acid derivatives, PCSK 9 inhibitors, niacin, and others.

Trends in the Treatment Type:

• Increasing focus on tailoring treatments based on genetic profiles and individuals are potential trends influencing the segment.
• The growing trend towards combining therapies helps to achieve better cholesterol levels.

The statins segment accounted for the largest revenue share of the total 23.89% in the year 2023.

• Statins are a class of drugs that are used to treat hypercholesterolemia, a condition caused by elevated blood cholesterol.
• Statins lower the amount of cholesterol produced in the liver by blocking the HMG-CoA reductase, and it lowers the production of cholesterol in the liver by blocking the enzymes.
• Lower LDL levels are significant risk factors for cardiovascular diseases.
• Furthermore, as per the analysis, statins may slightly lower triglycerides and raise HDL cholesterol.
• Statins are generally prescribed and consumed orally. The statins available to use generally include atorvastatin, fluvastatin, and lovastatin. Atorvastatin is the most prescribed statin.
• Many companies launched a new and more effective version of atorvastatin.
• According to a paper published in NLM in February 2024, it was found that Statins, approved by the FDA, inhibit the HMG-CoA reductase enzyme, lowering LDL and cholesterol levels. High-risk patients need higher-intensity statins, with a focus on dosing, interactions, and monitoring strategies for optimal management.
• Thus, the use of statins maintains the LDL levels, thus boosting the hypercholesterolemia market demand.

PCSK 9 inhibitor segment is anticipated to register the fastest CAGR during the forecast period.

• A class of drugs known as PSCK-9 (Kexin type 9) is used to lower blood cholesterol levels.
• They function by blocking the PSCK9 protein, which typically lessens the liver's capacity to eliminate low-density lipoprotein (LDL) cholesterol from the blood.
• Because of these, the chance of cardiovascular conditions such as strokes is decreased.
• PCSK9 inhibitors include drugs alirocumab and evolocumab.
• Evolocumab binds to a protein called PCSK9, which normally degrades LDL receptors in the liver. By blocking PCSK9, evolocumab increases the number of LDL receptors, leading to a more efficient removal of LDL cholesterol from the bloodstream.
• As mentioned in a paper published in NLM in February 2024, PCSK9 inhibitors, like Evolocumab and Alirocumab, lower LDL cholesterol by 50%-60% by preventing LDL receptor destruction. These drugs offer alternative treatments for patients intolerant to statins or with severe hypercholesterolemia, complementing statin therapy for cardiovascular disease risk management.
• This reduction in LDL cholesterol levels can help decrease the risk of heart attack, stroke, and other cardiovascular events, thus driving the demand for the segment.

By Route of Administration:

The route of administration segment is categorized into oral and injectable.

Trends in the Route of Administration:

• There is a growing trend for the use of injectable biologics, as they are administered subcutaneously and are effective in lowering LDL levels.

The oral segment accounted for the largest revenue of the total hypercholesterolemia market share in 2023.

• The oral route is the most common route for the administration of drugs to treat this condition.
• Cholesterol-lowering drugs mainly statin, fibrates, bile acid resins, and other drugs are administered orally in the form of tablets or capsules.
• These drugs function by moving toward different parts of the metabolism of cholesterol, such as stopping the liver's production of cholesterol, decreasing the intestine's absorption of cholesterol, or speeding up the removal of cholesterol from the blood system.
• For the administration of medications, the oral route has various benefits such as patient compliance, convenience, and ease of use. Oral medications are simple and self-administered at home without a doctor's supervision, making it possible for patients to successfully follow treatment plans.
• Various drugs are being introduced for the treatment of this condition that are administrated orally.
• In 2023, Lupin received FDA approval for pitavastatin tablets to reduce (LDL-C). These tablets are administrated orally for the treatment.
• Thus, due to its various benefits, the oral route of administration is boosting the market trends.

The injectable segment is anticipated to register the fastest CAGR during the forecast period.

• Certain medication that lowers cholesterol is injected, most commonly by intravenous infusion, to reduce the cholesterol level in patients as it achieve adequate control of medications.
• One such class of drug is known as PCSK9 inhibitors, which are monoclonal antibodies that work by targeting the PCSK9 protein to lower LDL cholesterol levels.
• According to Cleaveland Clinic, PCSK9 inhibitors, like Evolocumab and Alirocumab, are injectable medications that lower LDL cholesterol by preventing LDL receptor destruction. They are used for patients with high cholesterol unresponsive to statins.
• Therefore, due to their quick action on controlling cholesterol, they have lately been holding a high revenue share.

By Distribution Channel:

The distribution channels segment is categorized into online and offline. The offline segment is further categorized into hospital pharmacies, retail pharmacies, and others.

Trends in the Distribution Channel:

• Pharmaceutical companies are increasingly selling medications for cholesterol through online pharmacies and telehealth services.

The offline segment accounted for the largest market revenue of the overall hypercholesterolemia market share in 2023.

• Offline stores are easy to access, offer competitive prices on drugs, and provide patients with information and support on how to use medicines and drugs safely and effectively.
• In addition, they are often the first point of contact for patients after being diagnosed with this condition.
• The high benefits and easy availability of drugs across offline stores are creating lucrative hypercholesterolemia market trends.
• Therefore, owing to the comfort they provide to patients, often on an immediate basis, offline segments have been making the largest revenue.

The online segment is expected to hold the highest CAGR over the forecast period.

• The increasing sale of pharmaceutical products through e-commerce platforms is expected to provide lucrative trends for online pharmacies over the forecast period.
• According to the report by the National Investment Promotion and Facilitation Agency in June 2021, the Indian e-pharmacy sales in 2019 accounted for USD 0.5 billion which is expected to reach USD USD 4.5 billion compounded rate of 44%.
• Thus, the growing e-pharmacy sales are providing lucrative opportunities for segment growth over the forecast period.

Regional Analysis:

The regional segment includes North America, Europe, Asia Pacific, the Middle East and Africa, and Latin America.

In 2023, North America accounted for the highest market share at 39.17% and was valued at USD 6,602.73 Million, and is expected to reach USD 19,258.97 Million in 2031. In North America, the U.S. accounted for the highest market share of 67.12% during the base year of 2023. Based on the hypercholesterolemia market analysis, North America has a well-established healthcare infrastructure, with a high number of hospitals, clinics, and pharmacies. This makes it easy for people with this condition to access drugs and treatment for this condition. Moreover, the high prevalence of this condition across the region is driving the demand for treatment across the region.

• In May 2023, according to the Centers for Disease Control and Prevention, 86 million U.S. adults have total cholesterol levels above 200 mg/dL, which is higher than the normal range.

Asia Pacific is expected to witness the fastest CAGR over the forecast period of 17.1% during 2024-2031. There is a growing awareness of hypercholesterolemia management in the Asia Pacific region. Governments in the Asia Pacific region are increasing their support for hypercholesterolemia management. This is leading to increased access to drugs and other essential supplies, which is expected to create lucrative growth prospects for the hypercholesterolemia market across the region over the forecast period. All these above-mentioned factors are collectively boosting the market across the Asia Pacific region and creating lucrative growth prospects for the hypercholesterolemia market demand in the Asia Pacific region.

In Latin America, the hypercholesterolemia market is witnessing a rise due to increased awareness of cardiovascular diseases and growing access to healthcare services. The adoption of various treatment options, including statins and PCSK9 inhibitors, is expected to grow as patients seek effective management strategies. The region's focus on public health initiatives is also driving market trends.

In Europe, the hypercholesterolemia market is growing, driven by rising obesity rates and increased cardiovascular disease awareness. Statins remain the primary treatment, but newer therapies like PCSK9 inhibitors are gaining traction. Efforts to enhance screening and preventive care are also shaping market dynamics, fostering a shift toward personalized medicine.

In the Middle East and Africa, the hypercholesterolemia market is influenced by increasing awareness of cardiovascular health, rising obesity rates, and genetic predispositions. Statin therapies dominate, but newer treatments like PCSK9 inhibitors are gaining traction. Additionally, lifestyle changes and healthcare access improvements are vital for managing cholesterol levels effectively.