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市場調查報告書
商品編碼
1801261
高血脂藥物市場規模、佔有率、趨勢及預測(按藥物類型、最終用戶和地區),2025 年至 2033 年Hyperlipidemia Drugs Market Size, Share, Trends and Forecast by Drug Type, End User, and Region, 2025-2033 |
2024年,全球高血脂藥物市場規模達230.8億美元。展望未來, IMARC Group預測,到2033年,該市場規模將達到271.8億美元,2025-2033年期間的複合年成長率為1.69%。歐洲目前佔據市場主導地位,2024年其市佔率將超過39.0%。新型降血脂療法的日益普及、政府利好政策和監管部門的批准、醫療支出的不斷成長以及民眾心血管風險管理意識的不斷增強,都是對高脂血症藥物市場佔有率產生積極影響的因素。
全球市場主要受到久坐不動的生活方式、不良的飲食習慣和肥胖導致的高脂血症盛行率不斷上升的影響。此外,降血脂療法的不斷進步也擴大了治療選擇。此外,新興經濟體醫療基礎設施的不斷擴大和醫療服務可近性的提高也提高了藥物的吸收率,從而促進了市場擴張。支持藥品核准的優惠監管政策以及針對他汀類藥物和聯合療法的報銷政策的實施,也促進了高脂血症藥物市場的成長。此外,製藥公司在新藥開發和生命週期管理方面的策略性舉措正在提升市場滲透率。例如,2024年4月29日,赫爾辛基大學宣布成立Moncyte Oy,這是一家專注於個人化高膽固醇治療的衍生公司。 Moncyte開發了一項專利技術,可以分析影響降膽固醇藥物療效的細胞機制,從而為患者提供個人化治療方案。這項創新旨在加快達到目標膽固醇水平,從而降低心血管疾病的風險。
美國是市場中一個重要的地區,主要得益於醫療保健支出的成長以及降血脂藥物的良好保險覆蓋。包括苯海拉明酸和基因沉默療法在內的下一代調脂療法的臨床研究不斷擴大,使得可用的治療方案更加多樣化。同時,對預防心臟病學的日益重視以及醫療機構中有利措施的實施,也為市場提供了支撐。為了在2027年預防100萬例心臟病發作和中風,美國醫療保險和醫療補助服務中心(Medicare & Medicaid Services)和美國疾病管制與預防中心(CDC)於2024年9月16日再次宣布致力於「百萬心臟」計畫。除了鼓勵心血管健康的ABCS(基本原則)並提高心臟復健的參與度外,該計畫還高度重視降低空氣污染、菸草使用和缺乏運動。 「百萬心臟2027」計畫納入了旨在解決健康的社會決定因素和改善全國健康狀況的策略,同時承認心臟病患病率的差異。
基於RNA的LDL降低療法的出現
對基於RNA的療法,尤其是小干擾RNA (siRNA)和反義寡核苷酸(ASO)的投入增加,正在支持高血脂藥物市場的需求。這些療法針對參與脂質代謝的肝臟通路,以較低的給藥頻率持續降低LDL-C。各大製藥公司正在擴展產品線,推出針對載脂蛋白B (ApoB)和血管生成素樣蛋白3 (ANGPTL3)的新型RNA候選藥物,旨在實現除降低LDL-C之外更廣泛的脂質管理。鑑於這些方法在降低心血管風險方面的有效性,監管機構擴大批准它們。長期安全性和成本效益仍然是關鍵考慮因素,它們決定著市場的採用率,並推動創新降血脂療法之間的競爭。 2024年5月29日,西奈山的研究人員宣布,一種名為zodasiran的在研小干擾RNA (siRNA)療法可有效降低混合型高血脂症患者的各種膽固醇和三酸甘油酯水平。 2b期全球試驗表明,與安慰劑相比,佐達西蘭顯著降低了三酸甘油酯(54-74%)、低密度脂蛋白膽固醇(高達20%)、非高密度脂蛋白膽固醇(高達36%)和殘留膽固醇(73-82%)。這些結果表明,佐達西蘭或可為持續性血脂升高患者提供一種有前景的常規療法替代方案。
轉向固定劑量聯合療法
市場正轉向聯合療法,即將多種降脂藥物整合到單一製劑中,增強了高血脂藥物的市場前景。 2024年3月22日,依折麥布、貝培多酸及其固定劑量複方片劑獲得歐洲藥品管理局人用藥品委員會 (CHMP) 批准。 3期CLEAR Outcomes試驗的分析顯示,心血管事件和低密度脂蛋白膽固醇 (LDL-C) 顯著下降,這為這些建議的製定奠定了基礎。這一市場趨勢源於用藥依從性的提高、治療負擔的減輕以及治療強度的最佳化,這些因素共同推動了脂質含量最低的聯合用藥:他汀類藥物/依折麥布和PCSK9抑製劑。製藥公司正致力於開發新型固定劑量複方製劑 (FDC),將基於RNA或貝培多酸的療法應用於他汀類藥物不耐受或單藥治療療效不佳的高風險患者。
擴大新興經濟體的市場滲透率
高血脂藥物市場的一個重要趨勢是人們對心血管風險因素的認知不斷提高,這推動了診斷率的提高。在新興經濟體中,隨著健康問題、肥胖和心血管疾病的增多,高血脂藥物在新興經濟體中正經歷巨大的成長。根據世界衛生組織的數據,膽固醇導致2,970萬個殘疾調整生命年(DALYS),佔所有DALYS的2%,並造成260萬例死亡,佔所有死亡的4.5%。老化人口更容易罹患心血管疾病和高膽固醇,這也是推動市場成長的因素。政府在預防保健方面的政策訂定推動了對降血脂治療的需求。 PCSK9抑制劑和苯甲酸酯正透過分級定價策略和本地合作夥伴關係逐步上市。目前,大型製藥公司正將重點轉向區域合作,以克服監管的複雜性並擴大可及性。在醫療保健資源有限的地區,數位健康計劃和遠距醫療透過提高患者的參與度和依從性,進一步促進了血脂管理。
The global hyperlipidemia drugs market size was valued at USD 23.08 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 27.18 Billion by 2033, exhibiting a CAGR of 1.69% during 2025-2033. Europe currently dominates the market, holding a significant market share of over 39.0% in 2024. The growing adoption of novel lipid-lowering therapies, favorable government policies and regulatory approvals, rising medical expenditure, and increasing awareness regarding cardiovascular risk management among the masses are some of the factors positively impacting the hyperlipidemia drugs market share.
The global market is majorly influenced by the increasing prevalence of hyperlipidemia due to sedentary lifestyles, poor dietary habits, and obesity. Additionally, continual advancements in lipid-lowering therapies are expanding treatment options. Also, expanding healthcare infrastructure and greater access to medical services in emerging economies are improving drug uptake, which is facilitating market expansion. The implementation of favorable regulatory policies supporting drug approvals and reimbursement policies for statins and combination therapies are also enhancing hyperlipidemia drug market growth. Moreover, pharmaceutical companies' strategic initiatives for novel drug development and lifecycle management are increasing market penetration. For example, on April 29, 2024, the University of Helsinki announced the establishment of Moncyte Oy, a spinout company focused on personalizing high cholesterol treatments. Moncyte has developed a patented technology that analyzes cellular mechanisms affecting the efficacy of cholesterol-lowering drugs, enabling tailored therapies for patients. This innovation aims to expedite the achievement of target cholesterol levels, thereby reducing the risk of cardiovascular diseases.
The United States is a significant region in the market, primarily driven by increased healthcare spending coupled with favorable insurance coverage for lipid-lowering agents. Expanding clinical research on next-generation lipid-modifying therapies, including bempedoic acid and gene-silencing treatments, is diversifying available treatment options. In line with this, the growing emphasis on preventive cardiology and the implementation of favorable initiatives across healthcare settings is supporting the market. On September 16, 2024, in order to prevent one Million heart attacks and strokes by 2027, the Centers for Medicare & Medicaid Services and the CDC renewed their dedication to the Million Hearts project. In addition to encouraging the ABCS of cardiovascular health and raising involvement in cardiac rehabilitation, the program places a high priority on lowering air pollution, tobacco use, and physical inactivity. Million Hearts 2027 incorporates strategies to address social determinants of health and enhance health outcomes across the country, acknowledging differences in the prevalence of heart disease.
Emergence of RNA-Based Therapies for LDL Reduction
The increased investment in RNA-based therapies, particularly small interfering RNA (siRNA) and antisense oligonucleotides (ASOs) is supporting the hyperlipidemia drugs market demand. These therapies target hepatic pathways involved in lipid metabolism, offering sustained LDL-C reduction with less frequent dosing. Major pharmaceutical companies are expanding pipelines with novel RNA-based candidates targeting apolipoprotein B (ApoB) and angiopoietin-like protein 3 (ANGPTL3), aiming for broader lipid management beyond LDL-C reduction. Regulatory agencies are increasingly approving these approaches, given their efficacy in reducing cardiovascular risk. Long-term safety and cost-effectiveness remain key considerations, shaping market adoption and driving competition among innovative lipid-lowering therapies. On May 29, 2024, Mount Sinai researchers announced that an investigational small interfering RNA (siRNA) therapy, zodasiran, effectively reduced various cholesterol and triglyceride levels in individuals with mixed hyperlipidemia. The phase 2b global trial demonstrated significant reductions in triglycerides (54-74%), LDL cholesterol (up to 20%), non-HDL cholesterol (up to 36%), and remnant cholesterol (73-82%) compared to placebo. These findings suggest that zodasiran could offer a promising alternative to conventional therapies for patients with persistent lipid elevations.
Shift Toward Fixed-Dose Combination Therapies
The market is shifting towards combination therapies with the integration of multiple lipid-lowering agents in a single formulation, which is enhancing the hyperlipidemia drugs market outlook. On March 22, 2024, Ezetimibe, bempedoic acid, and the fixed-dose combination tablet of the two were approved by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). Analysis from the Phase 3 CLEAR Outcomes trial, which showed notable decreases in cardiovascular events and low-density lipoprotein cholesterol (LDL-C), served as the basis for these recommendations. This market trend is due to the increased medication adherence, decreased treatment burden, and optimized treatment intensity account for the overall push for the administration of the lipid-lowest combination: statins/ezetimibe and PCSK9 inhibitors. Pharmaceutical companies are focusing on developing novel FDCs that incorporate RNA-based or bempedoic acid-based therapies in high-risk patients with statin intolerance or an insufficient response to monotherapy.
Expanding Market Penetration in Emerging Economies
One of the significant hyperlipidemia drugs market trends is the increasing awareness of cardiovascular risk factors, which is driving diagnosis rates. In the emerging economies. The drugs for hyperlipidemia are witnessing tremendous growth in emerging economies with the increase in health issues, obesity, and cardiovascular diseases. As per WHO, cholesterol contributes to 29.7 Million DALYS, or 2% of all DALYS, and 2.6 Million fatalities, or 4.5% of all deaths. The aging population, which is more prone to cardiovascular diseases and high cholesterol, is also driving the market. The adoption of government policies in preventive care is driving demand for lipid-lowering treatments. PCSK9 inhibitors and bempedoic acid are gradually being launched through tiered pricing strategies and local partnerships. Major pharmaceutical companies are now shifting focus towards regional collaborations to overcome the complexity of regulation and increase access. Digital health initiatives and telemedicine further enable the management of lipids by increasing patient involvement and adherence in regions where there is limited access to healthcare.
Statins lead the market with around 45.9% of market share in 2024 due to their well-established efficacy in reducing levels of low-density lipoprotein (LDL) cholesterol. As first-line therapy, they are widely prescribed for managing hyperlipidemia, particularly in patients with high cholesterol and those at risk of atherosclerotic cardiovascular disease. It has been characterized extensively through the inhibition of HMG-CoA reductase, which builds confidence in it among physicians and enhances its wide clinical uptake. This remains the most cost-effective therapy given how high prescription rates are worldwide despite the competition that PCSK9 inhibitors and other new lipid-lowering therapies bring. Statins, atorvastatin, rosuvastatin, and simvastatin will maintain their market share largely due to generic availability, affordability, and widespread real-world data supporting long-term safety and efficacy.
Hospitals lead the market with around 37.6% of market share in 2024 as are they are critical to the management of high-risk patients with severe lipid disorders and cardiovascular conditions. They serve as primary treatment centers for acute cardiovascular events, where lipid-lowering therapies, including statins and adjunctive drugs, are prescribed for both immediate intervention and long-term management. Hospitals also conduct lipid profile screenings, ensuring early diagnosis and treatment initiation. With access to specialized cardiologists and lipidologists, hospitals drive adherence to guideline-based therapies, including combination treatments for patients unresponsive to statins alone. They also promote newer lipid-lowering drugs like PCSK9 inhibitors and bempedoic acid, especially for high-risk or statin-intolerant patients.
In 2024, Europe accounted for the largest market share of over 39.0% due to the presence of an aging population, high prevalence of cardiovascular diseases, and well-established healthcare infrastructure. The area also has a rising need for high-end lipid-lowering treatments, such as PCSK9 inhibitors and bempedoic acid, especially in high-risk patients with a certain intolerance to statin treatment. Strict regulatory standards and cost-containment measures influence drug pricing and market access, shaping competition among branded and generic products. The government-initiated preventive healthcare measures and cholesterol screening programs ensure early diagnosis and consequent treatment initiation. The increasing burden of obesity and sedentary lifestyles further accelerates demand for hyperlipidemia management. With continuous innovation and research in cardiovascular therapeutics, Europe remains a key market for lipid-lowering drugs, influencing global treatment trends and pharmaceutical investments.
United States Hyperlipidemia Drugs Market Analysis
The United States holds a substantial share of the North American hyperlipidemia drugs market at 82.00%. The rising levels of obesity lead to the increased demand for advanced treatments, which is driving the adoption of hyperlipidemia drugs. According to the Institute for Health Metrics and Evaluation, by 2050, it is anticipated that there will be 43.1 Million overweight and obese children and adolescents in the US (up 6.74 Million from 2021) and 213 Million adults (up 41.4 Million). The increased cholesterol levels are linked to changed dietary habits and sedentary lifestyles. Therefore, it is essential to control lipid-related disorders through timely medical interventions. Medical institutions have intensified the effort to sensitize people to the control of cholesterol, urging for earlier diagnosis and treatment. Advances in pharmacy present an innovative formulation targeting the effective treatment of obesity-related lipid imbalances. Furthermore, strong emphasis by healthcare providers on preventive care and treatment of individuals before the complication stage supports the market growth. Also, the widespread availability through well-established channels ensures the utilization of these drugs. In addition, increased interest in reducing obesity's long-term implications for public health creates opportunities for collaborations between research institutes and clinicians to enhance drug safety and efficacy, thereby increasing its uptake.
Asia Pacific Hyperlipidemia Drugs Market Analysis
Diabetes prevalence has emerged as a major concern, leading to a surge in the adoption of hyperlipidemia drugs across the region. The World Health Organization (WHO) estimates that 77 Million adults in India over the age of 18 have type 2 diabetes, and almost 25 Million are prediabetics, which denotes that they have a higher chance of getting the disease in the near future. Since diabetes often accompanies abnormal cholesterol levels, the demand for proper lipid management is on the rise. Healthcare systems in the region mainly focus on comprehensive strategies to prevent complications related to diabetes and incorporate cholesterol management into regular care. Increasing awareness among people regarding the relationship between diabetes and cardiovascular risks significantly promotes early intervention. In recent years, diagnostic efforts have increased in an attempt to identify lipid abnormalities so that timely treatment can be initiated. The increasing affordability of formulations for a wide range of populations has increased their availability further. In addition, campaigns aimed at disease management encourage regular medication use and, therefore, greater compliance. The establishment of modern healthcare infrastructure helps the widespread distribution of these treatments to ensure that they are available across all sections of society.
Europe Hyperlipidemia Drugs Market Analysis
The rising incidence of cardiovascular conditions has significantly impacted the adoption of hyperlipidemia drugs, as these conditions often stem from elevated cholesterol levels. According to WHO, cardiovascular diseases (CVDs) constitute the primary cause of mortality and disability. More than two out of five (42.5%) of all deaths in Europe in 2019 were attributed to CVDs, accounting for an estimated 4.2 Million deaths. Lifestyle shifts increase the prevalence of unhealthy lipid profiles, necessitating effective pharmaceutical solutions. The focus on reducing cardiovascular risks further drives healthcare providers to incorporate advanced lipid-lowering therapies into treatment protocols. Enhanced awareness campaigns underscore the role of cholesterol management in preventing heart-related complications, encouraging individuals to seek timely medical interventions. With better diagnostics, the medical setting has diagnosed cases of hyperlipidemia much earlier and implemented more directed treatment plans. Increasing cooperation between clinical research organizations and pharmaceutical companies also enables therapies with better safety profiles to enter the market. Healthcare professionals continue to emphasize personalized treatment regimens, ensuring that patients receive optimized care tailored to their specific risk factors and medical histories.
Latin America Hyperlipidemia Drugs Market Analysis
The expansion of private healthcare services has significantly boosted the utilization of hyperlipidemia drugs. According to the International Trade Administration, Brazil is the largest healthcare market in Latin America, with 7,191 hospitals, 62% are private. Enhanced accessibility of quality health results in patients having a better opportunity for diagnosis earlier and better management of lipid-related disorders. Private facilities progressively integrate specialized treatments, which leads to an increased uptake of advanced pharmaceutical products. Additionally, preventive care measures have also been strengthened through enlightening campaigns by healthcare providers, encouraging patients to correct cholesterol imbalances earlier. With state-of-the-art medical technology now introduced into private systems, proper and efficient diagnosis is possible, which in turn enhances the adoption of drugs. Investment in healthcare infrastructure further facilitates the accessibility and affordability of such treatments to a wider population, thereby providing an impetus to the market.
Middle East and Africa Hyperlipidemia Drugs Market Analysis
The rising number of healthcare facilities has accelerated the adoption of hyperlipidemia drugs by improving access to necessary treatments. There were 4,482 private medical facilities and 55,208 licensed professionals in Dubai's healthcare sector, which is expected to grow by another 3-6% in facilities and 10-15% in professionals in 2023, according to research by the Dubai Healthcare City Authority. Enhanced diagnostic services have enabled earlier identification of lipid-related conditions, promoting proactive management. New healthcare centers are increasingly incorporating specialized therapies into their services, offering tailored solutions for lipid abnormalities. Awareness campaigns spearheaded by medical professionals have encouraged individuals to seek timely interventions, further driving the use of advanced drug formulations. Improvements in healthcare delivery systems have ensured that more patients can benefit from comprehensive lipid management, reducing the overall burden of cholesterol-related complications.
The market is dynamic and highly competitive, with innovation in pharmaceuticals, patent expirations, and strategic collaborations. The main players expand their product portfolios by developing novel lipid-lowering therapies, such as PCSK9 inhibitors, bempedoic acid, and combination treatments. Generic drug manufacturers intensify competition by offering low-cost statins and fibrates, making these products more accessible in price-sensitive markets. New therapies, biosimilars, and reformulated drugs approved by the regulatory authority's impact market dynamics and pricing strategies. Advancements are further enhanced through mergers and acquisitions and research partnerships with other institutions. With increasing demand for personalized medicine and combination therapies, competition remains strong as firms seek to differentiate products based on safety, efficacy, and long-term cardiovascular benefits.