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市場調査レポート
商品コード
1801261
高脂血症治療薬の世界市場 - 市場規模、シェア、動向、予測:薬剤タイプ別、エンドユーザー別、地域別、2025年~2033年Hyperlipidemia Drugs Market Size, Share, Trends and Forecast by Drug Type, End User, and Region, 2025-2033 |
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高脂血症治療薬の世界市場 - 市場規模、シェア、動向、予測:薬剤タイプ別、エンドユーザー別、地域別、2025年~2033年 |
出版日: 2025年08月01日
発行: IMARC
ページ情報: 英文 116 Pages
納期: 2~3営業日
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高脂血症治療薬の世界市場規模は、2024年に230億8,000万米ドルとなりました。今後、IMARC Groupは、2033年には271億8,000万米ドルに達し、2025年から2033年にかけて1.69%のCAGRを示すと予測しています。現在、欧州が市場を独占しており、2024年には39.0%を超える大きな市場シェアを占めています。新規脂質低下療法の採用拡大、有利な政府政策と規制当局の承認、医療費の増加、心血管リスク管理に関する大衆の意識の高まりなどが、高脂血症治療薬市場シェアにプラスの影響を与えています。
世界市場は、座りがちなライフスタイル、食生活の乱れ、肥満による高脂血症の有病率増加の影響を大きく受けています。また、脂質低下療法の継続的な進歩により、治療の選択肢が拡大しています。また、新興国における医療インフラの拡大や医療サービスへのアクセスの向上により、薬剤の服用率が向上し、市場の拡大が促進されています。スタチンや併用療法に対する医薬品承認や償還政策を支援する有利な規制政策の実施も、高脂血症治療薬市場の成長を促進しています。さらに、新薬開発やライフサイクルマネジメントに対する製薬企業の戦略的取り組みが、市場浸透を高めています。例えば、2024年4月29日、ヘルシンキ大学は、高コレステロール治療の個別化に特化したスピンアウト企業Moncyte Oyの設立を発表しました。Moncyte社は、コレステロール低下薬の効果に影響する細胞メカニズムを分析し、患者に合わせた治療を可能にする特許技術を開発しました。この技術革新は、目標コレステロール値の達成を早めることで、心血管疾患のリスクを低減することを目的としています。
米国は同市場において重要な地域であり、主に医療支出の増加と脂質低下薬に対する有利な保険適用がその要因となっています。ベンペド酸や遺伝子サイレンシング治療を含む次世代脂質改善療法の臨床研究が拡大し、利用可能な治療選択肢が多様化しています。これに伴い、予防循環器学が重視されるようになり、医療の現場で好ましい取り組みが実施されるようになったことが、市場を支えています。2024年9月16日、2027年までに100万人の心臓発作と脳卒中を予防するため、Centers for Medicare & Medicaid ServicesとCDCは、Million Heartsプロジェクトへの献身を新たにしました。このプログラムでは、心臓血管の健康のABCSを奨励し、心臓リハビリテーションへの関与を高めることに加え、大気汚染、タバコの使用、運動不足を改善することを最優先しています。ミリMillion Hearts 2027は、心臓病の有病率の違いを認識しながら、健康の社会的決定要因に対処し、国全体の健康アウトカムを向上させる戦略を取り入れています。
LDL減少のためのRNAベースの治療法の出現
RNAベースの治療薬、特にsmall interfering RNA(siRNA)やアンチセンス・オリゴヌクレオチド(ASO)への投資の増加が高脂血症治療薬市場の需要を支えています。これらの治療薬は脂質代謝に関与する肝経路を標的とし、少ない投与回数で持続的なLDL-Cの低下をもたらします。大手製薬企業は、アポリポ蛋白B(ApoB)やアンジオポエチン様蛋白質3(ANGPTL3)を標的とする新規RNAベースの候補薬でパイプラインを拡充しており、LDL-Cの低下だけでなく、より広範な脂質管理を目指しています。心血管系リスクの低減に有効であることから、規制当局がこれらのアプローチを承認するケースが増えています。長期的な安全性と費用対効果は依然として重要な検討事項であり、市場導入を形成し、革新的な脂質低下療法間の競争を促進しています。2024年5月29日、マウントサイナイの研究者らは、研究中のsiRNA(small interfering RNA)療法であるzodasiranが、混合型高脂血症の患者において様々なコレステロール値とトリグリセリド値を効果的に低下させたと発表しました。第2b相国際共同試験では、プラセボと比較して、トリグリセリド(54~74%)、LDLコレステロール(最大20%)、非HDLコレステロール(最大36%)、残存コレステロール(73~82%)の有意な減少が示されました。これらの所見は、ゾダシランが脂質上昇が持続する患者に対して、従来の治療法に代わる有望な選択肢を提供する可能性を示唆しています。
合剤へのシフト
市場は複数の脂質低下剤を1剤に配合した配合剤へとシフトしており、高脂血症治療薬市場の見通しを高めています。2024年3月22日、エゼチミブ、ベンペド酸、および両剤の合剤錠が欧州医薬品庁の医薬品委員会(CHMP)で承認されました。心血管イベントと低比重リポ蛋白コレステロール(LDL-C)の顕著な減少を示した第3相CLEAR Outcomes試験の分析結果が、今回の勧告の根拠となりました。このような市場動向は、服薬アドヒアランスの向上、治療負担の軽減、治療強度の最適化が、スタチン/エゼチミブとPCSK9阻害薬という脂質最少の組み合わせの投与を全体的に後押ししていることに起因しています。製薬会社は、スタチン不耐性や単剤治療で十分な効果が得られない高リスク患者を対象に、RNAベースまたはベンペド酸ベースの治療薬を組み込んだ新規FDCの開発に注力しています。
新興国における市場浸透の拡大
重要な高脂血症治療薬市場動向の一つは、心血管リスク因子に対する意識の高まりであり、これが診断率を押し上げています。新興国では高脂血症治療薬は、健康問題、肥満、心血管疾患の増加に伴い、新興経済国で著しい成長を遂げています。WHOによると、コレステロールは全死亡者数の2%に相当する2,970万人の死亡に寄与し、全死亡者数の4.5%に相当する260万人が死亡しています。心血管疾患や高コレステロール血症になりやすい高齢化も市場を牽引しています。予防医療における政府政策の採用が、脂質低下治療の需要を促進しています。PCSK9阻害剤とベムペド酸は、段階的な価格戦略や地域提携を通じて徐々に上市されつつあります。大手製薬会社は現在、規制の複雑さを克服し、アクセスを拡大するため、地域提携に重点を移しています。デジタルヘルスイニシアチブと遠隔医療は、ヘルスケアへのアクセスが限られている地域における患者の関与とアドヒアランスを高めることにより、脂質管理をさらに可能にします。
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.