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

By Type:

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

Trends in the type:

• New biomarkers for acquired lipid disorders are being identified, enabling earlier detection and more tailored treatment approaches for individuals at risk due to lifestyle factors.

The genetic segment accounted for the largest revenue share in 2023 and is anticipated to register the fastest CAGR during the forecast period.

• The genetic segment includes conditions such as Familial Hypercholesterolemia (FH), which involves inherited mutations affecting cholesterol metabolism, leading to significantly elevated cholesterol levels from birth.
• It significantly increases the risk of cardiovascular diseases, driving demand for early diagnosis and specialized treatments.
• Growing awareness of this condition has led to increased screening efforts, propelling advancements in genetic testing and therapies. The development of targeted therapies offers a more personalized approach, enhancing treatment efficacy and patient outcomes.
• In November 2023, a single infusion of the CRISPR-based gene-editing therapy VERVE-101 demonstrated significant efficacy in lowering LDL cholesterol for individuals with inherited high LDL cholesterol. Presented at the American Heart Association's Scientific Sessions, this novel treatment effectively reduced LDL cholesterol by up to 55% and PCSK9 protein levels by up to 84% in early human trials. Although the study revealed some mild adverse events, it suggests VERVE-101 could offer a durable and effective treatment for FH. Further trials with larger cohorts are underway to validate these findings and assess long-term safety.
• In conclusion, the genetic segment's prominence is bolstered by ongoing advancements in genetic research and early diagnostic capabilities, driving the hypercholesterolemia market trends.

By Treatment Type :

Based on treatment type, the market is segmented into statins, bile acid resins, fibric acid derivatives, PCSK 9 inhibitors, Niacin, and others.

Trends in the treatment Type:

• New bile acid sequestrants are being formulated with enhanced binding capacities, improving their efficacy in lowering LDL cholesterol levels while minimizing gastrointestinal side effects.
• Combination therapies that pair fibric acid derivatives or niacin with other lipid-lowering agents are being developed to offer a synergistic effect, providing better lipid control with fewer side effects.

The statins accounted for the largest revenue share of 51.44% of the total hypercholesterolemia market share in 2023.

• Statins remain the cornerstone of cholesterol management, widely prescribed to lower LDL cholesterol levels and reduce cardiovascular risk.
• They have also been shown to provide additional cardiovascular benefits beyond cholesterol reduction, such as stabilizing atherosclerotic plaques and reducing inflammation, which further reinforces their clinical value.
• They are widely used not only for managing this condition but also for primary and secondary prevention of cardiovascular events such as heart attacks and strokes.
• They work by inhibiting HMG-CoA reductase, an enzyme crucial for cholesterol production in the liver. The broad applicability and established efficacy of statins have maintained their dominance in the market.
• In conclusion, statins' established effectiveness, broad acceptance, and the opportunity they present ensure their position as the largest segment by treatment type in the hypercholesterolemia market.

The PCSK9 inhibitors are anticipated to register the fastest CAGR during the forecast period.

• PCSK9 inhibitors, such as alirocumab and evolocumab, represent a novel class of drugs that significantly reduce LDL cholesterol levels by inhibiting the PCSK9 protein.
• Their advanced mechanism of action provides an effective treatment option for patients with statin intolerance or those who require additional LDL reduction.
• The broadening of indications for PCSK9 inhibitors, including approvals for pediatric and high-risk populations, further solidifies their role in comprehensive cholesterol management.
• In 2021, the FDA approved Repatha® (evolocumab) for pediatric patients aged 10 and older with heterozygous familial FH (HeFH). It was also approved for treating homozygous FH (HoFH) in patients aged 10 and older. Repatha® is a human monoclonal antibody that inhibits PCSK9, enhancing LDL-C removal from the bloodstream.
• In conclusion, the innovative approach, significant LDL reduction capabilities, and growing demand for PCSK9 inhibitors position them as the fastest-growing segment in the hypercholesterolemia market.

By Route of Administration:

Based on the route of administration, the market is segmented into oral and injectable routes of administration.

Trends in the route of administration:

• Microneedle patches are being developed for the transdermal delivery of cholesterol-lowering drugs, offering a pain-free and convenient alternative to injections.
• Sublingual tablets are under research for cholesterol management, providing rapid absorption and improved patient adherence for those who struggle with swallowing pills.

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

• Oral medications, including statins and bile acid resins, are preferred for their ease of use and patient compliance.
• They provide a convenient method for long-term cholesterol management, essential for chronic conditions like hypercholesterolemia, reducing the need for frequent healthcare visits.
• Advances in formulation technology have improved the efficacy and tolerability of oral cholesterol-lowering drugs, making them more appealing to both patients and healthcare providers.
• In March 2024, the FDA approved new labels for NEXLETOL® and NEXLIZET® to reduce LDL-C and cardiovascular risk. These oral medications, containing bempedoic acid and, in the case of NEXLIZET®, also ezetimibe, are indicated for both primary and secondary prevention of cardiovascular events. This approval makes them the first non-statin LDL-C lowering drugs available for primary prevention. NEXLETOL and NEXLIZET offer an alternative for patients unable to tolerate statins, expanding their use to over 70 million patients in the U.S.
• In conclusion, the trends favoring the convenience and wide adoption of oral medications contribute to making this segment the largest in the market.

The injectable route of administration is anticipated to register the fastest CAGR during the forecast period.

• Injectable treatments, such as PCSK9 inhibitors, offer a novel approach to managing this disease, providing advanced efficacy for patients with high cardiovascular risk.
• These treatments are particularly valuable for patients who do not achieve adequate control with oral medications or have genetic conditions like HoFH, requiring more aggressive intervention.
• As per the market analysis, the advancement in injectable treatments is fueled by their effectiveness in lowering LDL cholesterol levels in patients, especially those who are statin-intolerant or have contraindications to other therapies.
• In 2021, the FDA approved Praluent (alirocumab) injection for adult patients with HoFH, a rare genetic condition causing severely high cholesterol. Praluent intended as an add-on to other treatments, works by inhibiting the PCSK9 protein, which controls LDL receptor levels and facilitates LDL cholesterol removal.
• In conclusion, the innovative nature, improved delivery, and the trend toward injectable treatments are driving hypercholesterolemia market opportunities.

By Distribution Channel:

Based on distribution channels, the market is segmented into online and offline, whereas offline distribution channel is further segmented into hospital pharmacies, retail pharmacies, and others.

Trends in the distribution channel:

• Blockchain technology is being integrated into offline distribution channels to ensure the authenticity of cholesterol-lowering drugs, preventing counterfeit medications from reaching patients.
• AI-driven inventory management systems in offline pharmacies are enhancing the efficiency of drug stocking and ensuring the availability of treatments when needed.

The offline distribution channels accounted for the largest revenue share in 2023.

• Offline distribution channels, including hospital and retail pharmacies, play a crucial role in managing and dispensing treatments for elevated cholesterol levels.
• These channels offer vital services such as patient counseling, medication management, and monitoring, enhancing overall patient care.
• As per the market analysis, the extensive network of offline pharmacies enables comprehensive patient education, immediate access to medications, and personalized support, which are crucial for managing chronic conditions.
• Their ability to facilitate emergency access to medications and address complex patient needs further underscores their importance in the market.
• In conclusion, the extensive services, personalized care, and immediate access provided by offline pharmacies make them the most significant distribution channel for treatments, driving the hypercholesterolemia market trend.

The online distribution channel is anticipated to register the fastest CAGR during the forecast period.

• This growth is driven by the increasing hypercholesterolemia market demand for convenience and advancements in digital healthcare platforms, enabling remote management of cholesterol-lowering treatments.
• Online pharmacies utilize advanced digital infrastructure and patient support services, offering streamlined access to treatments. They provide enhanced accessibility, flexible delivery options, and integration with telemedicine services.
• Innovations such as personalized online care plans and virtual consultations are becoming essential for managing chronic conditions effectively.
• The adoption of health tech innovations, combined with the convenience of home delivery and remote consultations, is positioning online pharmacies as a pivotal component of the market.
• In conclusion, the rapid of online distribution channels is driven by the evolving digital landscape and patient preference for remote healthcare solutions, making online pharmacies a key driver of market growth.

Regional Analysis:

The regions covered are North America, Europe, Asia Pacific, the Middle East and Africa, and Latin America.

Asia Pacific region was valued at USD 3.97 Billion in 2023. Moreover, it is projected to grow by USD 4.49 Billion in 2024 and reach over USD 12.22 Billion by 2031. Out of this, China accounted for the maximum revenue share of 31.6%.

The hypercholesterolemia market analysis underscores that this growth is driven by the region's increasing focus on personalized medicine and genomic testing, particularly in Japan, South Korea, and China. Personalized medicine tailors treatments based on individual genetic profiles, crucial for managing this condition, where genetic factors significantly influence the condition. Genomic testing identifies mutations in genes like LDLR, APOB, and PCSK9, enabling customized treatment plans with targeted therapies.

• For instance, in January 2023, researchers Zhiyong Du and colleagues published a study in China that involved the analysis of a cost-effective metabolomic approach for screening HoFH in patients with severe FH. The study identified a unique serum metabolome profile that differentiated HoFH from severe HeFH with a 91.3% accuracy rate. This approach offers a more economical alternative to genetic testing, aiding clinicians in preselecting patients for further genetic confirmation and familial cascade screening.

North America is estimated to reach over USD 18.84 Billion by 2031 from a value of USD 6.44 Billion in 2023 and is projected to grow by USD 7.25 Billion in 2024. This advancement in the market is primarily driven by the increasing prevalence of lifestyle-related diseases, such as obesity and cardiovascular disorders, which are major contributors to high cholesterol levels. The region's advanced healthcare infrastructure and a strong focus on early diagnosis and treatment of cholesterol-related conditions also play a significant role in the global hypercholesterolemia market expansion.

• For example, In August 2023, the FDA approved Evkeeza (evinacumab-dgnb) as an add-on therapy for patients aged 12 years and older with HoFH. Evkeeza, which targets and inhibits the ANGPTL3 protein to enhance lipid breakdown, demonstrated a 47% reduction in LDL-C levels in clinical trials, compared to a 2% increase with a placebo. This approval underscores North America's commitment to advancing treatment options for rare, life-threatening genetic disorders.

Europe's market is driven by the region's aging population and the high prevalence of genetic disorders like FH. The strong presence of key pharmaceutical players in countries like Germany and the UK, coupled with extensive research and development activities, further accelerates hypercholesterolemia market expansion.

The Middle East and Africa region is witnessing advancement in the market due to the increasing adoption of digital health technologies and mobile health applications that assist in managing cholesterol levels. Countries like the UAE and Israel are at the forefront of integrating these technologies into their healthcare systems, allowing for better patient engagement and adherence to cholesterol-lowering therapies.

Latin America's market growth is driven by the rising focus on herbal and plant-based cholesterol-lowering supplements. The region's rich biodiversity and traditional knowledge of medicinal plants have led to increased research and commercialization of natural remedies for the condition, especially in countries like Brazil and Peru.