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市場調査レポート
商品コード
1345452
高コレステロール血症治療の世界市場-2023年~2030年Global Hypercholesterolemia Treatment Market - 2023-2030 |
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カスタマイズ可能
適宜更新あり
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高コレステロール血症治療の世界市場-2023年~2030年 |
出版日: 2023年09月06日
発行: DataM Intelligence
ページ情報: 英文 186 Pages
納期: 即日から翌営業日
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概要
世界の高コレステロール血症治療市場は、2022年に151億米ドルに達し、2023~2030年の予測期間中にCAGR 16.6%で成長し、2030年には497億米ドルに達すると予測されています。
世界の高コレステロール血症治療市場は、有病率の増加、高齢化人口の増加、臨床試験など、そのダイナミクスに影響を与える様々な要因によって、近年著しい成長を遂げています。より良い治療に対する政府の投資は、世界市場を引き続き牽引し、押し上げるでしょう。世界の高コレステロール血症治療業界は、その影響を軽減するために薬剤開発の進歩にますます重点を置くようになっています。
さらに、高コレステロール血症は血中コレステロールの高さを特徴とし、遺伝性高コレステロール血症と後天性高コレステロール血症の2種類があります。治療は病気のタイプに基づいて行われます。高コレステロール血症の治療には、スタチン、PCSK9阻害剤、エゼチミブ、胆汁酸分泌抑制剤、ナイアシン、ベンペド酸などが使用されます。スタチン系薬剤セグメントは、予測期間中および状況によっては最大の市場シェアを占めると予想されます。同様に北米も市場を独占しており、同地域の高度な医療インフラと大手企業の存在によって最大の市場シェアを獲得しています。
高コレステロール血症の有病率の増加、認知度の向上、高齢化人口の増加、臨床試験および規制当局による承認の増加、新規治療薬に対する需要の増加、ジェネリック医薬品に対する需要の増加、治療オプションの進歩が、予測期間にわたって世界の高コレステロール血症治療市場を牽引すると予想される主な要因です。しかし、代替治療オプションの利用可能性や薬剤に伴う副作用が市場シェアの妨げになると予想されます。
ダイナミクス
新規治療薬の需要増加が市場成長を牽引すると予測
新規治療薬に対する需要の高まりが、予測期間中の世界市場を牽引すると予想されます。新規治療薬は、代替または補完的な治療選択肢を提供することで、高コレステロール血症治療に関連するアンメットニーズに対処することを目的としています。患者が高コレステロール血症やその治療法について知識を深めるにつれて、有効性だけでなく副作用が少なく、投与が容易で、現代のライフスタイルに適合した治療法に対する需要が高まっています。
例えば、2022年5月18日、サン・ファーマは低比重リポ蛋白(LDL)コレステロールを低下させる薬の発売を計画していると発表しました。ムンバイに本社を置く医薬品大手サン・ファーマは、完全子会社がインドで、LDLコレステロールを低下させるファースト・イン・クラスの経口薬剤、ベンペド酸を発売する予定であると発表しました。同社はこの医薬品を「Brillo」というブランド名で発売する予定です。
さらに、高コレステロール血症の早期診断のための開発も進んでいます。高コレステロール血症分野の継続的研究により、新しい治療アプローチが開発されています。これには、新薬、併用療法、技術的に進歩した機器、高コレステロール値の原因となる特定の遺伝的・代謝的要因に対処する標的治療などが含まれます。
例えば、2022年9月1日、デジタル治療会社のハローハートは、ユーザーが自分のコレステロール値を追跡し、理解できるようにするアプリの新機能をリリースしたと発表しました。Google PlayとApple App Storeで入手可能なHello Heartのアプリは、心臓の健康だけに焦点を当て、血圧、脈拍、投薬、体重、活動、そして今回のコレステロールの追跡を支援します。
規制当局の承認と臨床試験の増加が市場の成長を促進
継続的に実施されている臨床試験と規制当局の承認は、治療薬の安全性と有効性に関する患者の信頼を築くことで、予測期間中の市場シェアを押し上げると予想されます。臨床試験の良好な結果は、高コレステロール血症治療薬の使用に対する投資家の信頼と患者の信用を高めることができます。このような信頼の高まりは、さらなる研究開発や臨床試験の実施に必要な資金を引き寄せ、企業がより革新的な治療薬に投資することを可能にし、市場を牽引します。
例えば、2022年7月12日、単一コースの遺伝子編集医薬品による心血管疾患治療への新たなアプローチを開拓するバイオテクノロジー企業であるヴァーブ・セラピューティクスは、heart-1臨床試験において、最初の患者にVERVE-101が投与されたと発表しました。VERVE-101は、ヴァーヴ社が開発した新規の治験用遺伝子編集医薬品であり、肝臓のPCSK9遺伝子を恒久的にオフにし、疾病を促進する低比重リポ蛋白コレステロール(LDL-C)を減少させる単回投与治療薬として設計されています。heart-1は、アテローム性動脈硬化性心血管病の有病かつ生命を脅かす可能性のあるサブタイプであるヘテロ接合性家族性高コレステロール血症患者に対する治療薬としてVERVE-101を評価する国際共同第1b相臨床試験です。
高コレステロール血症治療に対する薬物や手技などの新たな規制当局の承認が増加することにより、患者やヘルスケアプロバイダーが利用できる治療選択肢の幅が広がります。このような治療法の選択肢の拡大は、既存の治療法では十分な効果が得られない患者のニーズを満たすため、市場の成長を高める可能性があります。FDA承認などの規制承認も、治療薬の使用に対する患者の信頼を高めます。
例えば、2023年3月22日、Regeneron Pharmaceuticals, Inc.は、米国食品医薬品局(FDA)が、ホモ接合性家族性高コレステロール血症の5歳から11歳の小児を治療するために、他の脂質低下療法の補助薬としてEvkeeza(evinacumab-dgnb)の承認を拡大したと発表しました。Evkeezaは、危険なほど高値の低比重リポ蛋白コレステロールをコントロールするために、5歳の小児に適応がある初めてのアンジオポエチン様3(ANGPTL3)阻害剤治療薬です。
高齢化人口の増加と治療選択肢の認知度が市場成長を牽引する見通し
高齢化の進展と治療選択肢の認知度の向上が、予測期間を通じて市場を牽引するとみられます。世界人口の高齢化が進むにつれ、高コレステロール血症および関連する心血管疾患の有病率は上昇する傾向にあります。例えば、クリーブランド・クリニック機構によると、高コレステロール血症は非常に一般的で、約20人に1人が高コレステロール血症です。アメリカの成人の1/3近くはLDL-Cが高いです。高コレステロール血症の増加は、主に高齢化社会の進行に基づくもので、40歳以降の人に最も多くみられます。
高コレステロール血症とそれに関連する治療オプションに関する認知度の向上が、予測期間中の市場の成長を促進すると予想されます。高コレステロール血症に関する人々の意識は、いくつかの要因によって継続的に高まっています。多くの組織や多くの企業が、高コレステロール血症に関連する深刻な状態に対処し、それを軽減するために、この状態に注目し、啓発プログラムを開発しています。
例えば、2023年3月21日、退役軍人省(VA)によると、200万人以上の退役軍人がアテローム性動脈硬化性心血管疾患(ASCVD)を抱え、高コレステロールの管理を必要としています。高コレステロールを放置しておくと、心臓発作や脳卒中を起こす可能性が高くなります。退役軍人の高コレステロールを管理するために、すべての人の心臓と脳の健康に焦点を当てた世界有数の非営利団体である米国心臓協会は、VAと協力して、心血管イベントのリスクが高いASCVDの元軍人を支援する新しいVA医療センタープログラムを開始しました。
代替治療オプションの利用が市場成長の妨げになる見込み
代替治療オプションの利用可能性は、予測期間における市場成長の妨げになると予想されます。高コレステロール血症の患者の多くは、心臓によい食事の摂取、運動量の増加、禁煙、飲酒の制限などの生活習慣の改善を通じて、病状を効果的に管理することができます。このようなライフスタイルの変化は、患者によっては薬剤による介入よりも好まれることがあります。
さらに、これらの食事療法は、自分の症状に対処する自然な方法を探している人に好まれるかもしれません。コレステロール値を下げるために、植物ステロール、紅麹、オメガ3脂肪酸などの栄養補助食品を、従来の薬物療法の代替または補完として利用する人もいます。登録栄養士や管理栄養士は、薬に頼らずにコレステロール値を管理できるよう、個人に合った食事指導を行うことができます。
薬剤に伴う副作用も市場成長の妨げになると予想される
高コレステロール血症治療薬に伴う副作用は、予測期間中の市場成長の妨げになると予想されます。スタチン系薬剤は、高コレステロール血症の治療に最も一般的に使用される薬剤であり、潜在的な副作用があることが知られています。一般的な副作用には、筋肉痛、脱力感(筋肉痛)、肝酵素異常、まれに横紋筋融解症のような重篤な筋肉障害などがあります。
これらの副作用により、スタチンの服用をためらったり、治療中止に至る患者もいます。この治療中止は患者の不満足によるものです。副作用に対して、患者やヘルスケアプロバイダーによっては、別のコレステロール低下薬や副作用プロファイルの異なる治療戦略を模索することがあります。
Global Hypercholesterolemia Treatment Market reached US$ 15.1 billion in 2022 and is expected to reach US$ 49.7 billion by 2030, growing with a CAGR of 16.6% during the forecast period 2023-2030.
The global hypercholesterolemia treatment market is experiencing significant growth in recent years with various factors influencing its dynamics such as increasing prevalence, rising aging population, clinical trials, and others. Government investments in better treatment will continue to drive and boost the global market. The global hypercholesterolemia treatment industry is placing increasing emphasis on advancements in drug developments to reduce its impact.
Moreover, hypercholesterolemia is characterized by high blood cholesterol. They are 2 types, genetic and acquired hypercholesterolemia. The treatment is based on the type of disease. Statins, pcsk9 inhibitors, ezetimibe, bile acid sequestrants, niacin, bempedoic acid, and others are used for the treatment of hypercholesterolemia. The statins segment is expected to hold the largest market share over the forecast period and in some situations. Similarly, North America dominates the market, capturing the largest market share owing to the region's advanced healthcare infrastructure, and presence of major players.
Owing to the increasing prevalence of hypercholesterolemia, growing awareness, rising aging population, increasing clinical trials and regulatory approvals, increasing demand for novel therapeutics, increasing demand for generic medicines, and advancements in treatment options are the major factors expected to drive the global hypercholesterolemia treatment market over the forecast period. However, the availability of alternative treatment options and side effects associated with the drugs are expected to hamper the market share.
There is an increasing demand for novel therapeutics, which is expected to drive the global market over the forecast period. Novel therapeutics aim to address the unmet needs associated with hypercholesterolemia treatment by providing alternative or complementary treatment options. As patients become more informed about hypercholesterolemia and its treatment options, there is a growing demand for therapies that are not only effective but also have fewer side effects, are easier to administer, and fit into modern lifestyles.
For instance, on May 18, 2022, Sun Pharma said that it is planning to launch a medication to reduce low-density lipoprotein (LDL) cholesterol. The Mumbai-based drug major said one of its wholly-owned subsidiaries plans to launch a first-in-class oral drug, Bempedoic Acid, in India for reducing LDL cholesterol. The company will launch the drug under the brand name Brillo.
Moreover, many advancements also developing for the early diagnosis of the condition. Ongoing research in the field of hypercholesterolemia has led to the development of novel therapeutic approaches. This includes new drugs, combination therapies, technologically advanced devices, and targeted treatments that address specific genetic or metabolic factors contributing to high cholesterol levels.
For instance, on September 01, 2022, Digital therapeutic company Hello Heart announced that it has released a new feature on its app that allows users to follow and understand their cholesterol levels. Hello Heart's app, available on Google Play and the Apple App Store, focuses solely on heart health and helps people track blood pressure, pulse, medications, weight, activity, and now cholesterol.
There are continuous ongoing clinical trials and regulatory approvals, which are expected to drive the market share over the forecast period, by building trust in patients about the safety and efficacy of the therapeutics. The positive results from clinical trials can boost investor confidence and patient trust in the usage of medicines for hypercholesterolemia treatment. This increased confidence can attract funding for further research and development and conduct more clinical trials, allowing companies to invest in more innovative therapeutics and driving the market.
For instance, on July 12, 2022, Verve Therapeutics, a biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, announced that the first patient has been dosed with VERVE-101, in its heart-1 clinical trial. VERVE-101 is a novel, investigational gene editing medicine developed by Verve and designed to be a single-course treatment that permanently turns off the PCSK9 gene in the liver to reduce disease-driving low-density lipoprotein cholesterol (LDL-C). heart-1 is a global Phase 1b clinical trial that will evaluate VERVE-101 as a treatment for patients with heterozygous familial hypercholesterolemia, a prevalent and potentially life-threatening subtype of atherosclerotic cardiovascular disease.
The increasing regulatory approvals for new hypercholesterolemia treatments, such as drugs, or procedures, this improves the range of therapeutic options available to patients and healthcare providers. This treatment expansion choice can increase the market growth as it meets the needs of individuals who not have responded well to existing therapeutics. The regulatory approvals such as FDA approvals also increase the patient's trust in the usage of the therapeutics.
For instance, on March 22, 2023, Regeneron Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has extended the approval of Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 with homozygous familial hypercholesterolemia. Evkeeza is the first angiopoietin-like 3 (ANGPTL3) inhibitor treatment indicated for children as young as 5 years old to control dangerously high levels of low-density lipoprotein cholesterol.
The increasing aging population and increasing awareness of treatment options are expected to drive the market over the forecast period. As the global population continues to age, the prevalence of hypercholesterolemia and related cardiovascular diseases tends to rise. For instance, according to the Cleveland Clinic Organization, hypercholesterolemia is very common and about 1 out of every 20 people has hypercholesterolemia. Nearly 1/3 of American adults have high LDL-C. The increasing prevalence is mainly based on the rising aging population, it is most common in people after 40 years of age.
The increasing awareness about hypercholesterolemia and its associated treatment options is expected to drive the growth of the market over the forecast period. Public awareness about hypercholesterolemia is continuously raising due to several factors. Many organizations and many companies are focussing on the condition and developing awareness programs to address and reduce the severe conditions associated with hypercholesterolemia.
For instance, on March 21, 2023, More than 2 million veterans are living with atherosclerotic cardiovascular disease (ASCVD) and require management of their high cholesterol, according to the Department of Veterans Affairs (VA). Left unaddressed, high cholesterol increases the chance of experiencing heart attack and stroke. To control high cholesterol among veterans, the American Heart Association, the world's leading nonprofit organization focused on heart and brain health for all, in collaboration with the VA, has launched a new VA Medical Center program to help former service members with ASCVD who are at high risk of cardiovascular events.
The availability of alternative treatment options is expected to hamper the market growth over the forecast period. Many individuals with hypercholesterolemia can manage their condition effectively through lifestyle modifications, such as adopting a heart-healthy diet, increasing physical activity, quitting smoking, and limiting alcohol consumption. These lifestyle changes may be preferred by some patients over pharmaceutical interventions.
Moreover, These dietary plans may be preferred by individuals looking for natural ways to address their condition. Some people turn to dietary supplements like plant sterols, red yeast rice, and omega-3 fatty acids as alternatives or complements to traditional medications for lowering cholesterol levels. Registered dietitians and nutritionists can provide tailored dietary guidance to help individuals manage their cholesterol levels without medication.
The side effects associated with hypercholesterolemia drugs are expected to hamper the market growth over the forecast period. Statins are the most commonly used drugs for the treatment of hypercholesterolemia and are known to have potential side effects. The common side effects can include muscle pain, weakness (myalgia), liver enzyme abnormalities, and in rare cases, severe muscle problems like rhabdomyolysis.
These side effects may discourage some patients from taking statins or lead to treatment discontinuation. This treatment discontinuation is due to patients unsatisfaction. In response to side effects, some patients and healthcare providers may explore alternative cholesterol-lowering medications or treatment strategies that have different side effect profiles.
The global hypercholesterolemia treatment market is segmented based on disease type, treatment type, distribution channel, and region.
The statins segment is expected to hold the largest market share over the forecast period. Statins are microorganism-derived drugs that greatly impair the cell synthesis of cholesterol by competitively inhibiting the activity of the enzyme HMG-CoA reductase. Statins, also lower the blood level of cholesterol chiefly by increasing the number of high-affinity receptors that recognize plasma LDL and by diminishing the VLDL synthesis rate in the liver. Many adjuncts are still evolving to statins for the better and more effective treatment of hypercholesterolemia.
For instance, on July 10, 2023, Novartis announced that the US Food and Drug Administration (FDA) has approved a label update for Leqvio (inclisiran) to enable earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy. This patient population includes those who have comorbidities such as hypertension and diabetes and have not yet had a first cardiovascular event2.
Moreover, Statins are drugs that can lower cholesterol. The statins mainly work by blocking a substance that the body needs to make cholesterol. Lowering cholesterol isn't the only benefit associated with statins. These medications have also been linked to a lower risk of heart disease and stroke. These drugs may help stabilize the plaques on blood vessel walls and reduce the risk of certain blood clots.
North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and advanced healthcare infrastructure. North America especially the United States and Canada is home to many pharmaceutical and medical device companies, this strong presence of key players can actively perform in clinical trials and research activities, results in regulatory approvals such as FDA approvals for novel therapeutics are seen in the region.
For instance, on August 29, 2022, Amgen Inc. presented new study data from the Phase 3 FOURIER open-label extension (OLE) studies of Repatha (evolocumab) in adults with atherosclerotic cardiovascular disease (ASCVD) These data were simultaneously published in Circulation. Repatha is the first and only proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) to date to show long-term clinical outcomes in patients with ASCVD for up to 8.4 years. Repatha is indicated in adults with primary hypercholesterolemia or mixed dyslipidemia, as an adjunct to diet.
Furthermore, North America is known for its well-established and advanced healthcare infrastructure including hospitals, specialty clinics, research and academic institutes, and others. This advanced healthcare infrastructure is at the forefront of better treatment for hypercholesterolemia patients. This advanced healthcare infrastructure also offers favorable reimbursement policies to patients for effective treatment. The improved insurance coverage offers the better treatment for many patients at affordable costs, leading to market dominance in the region.
The major global players in the hypercholesterolemia treatment market include: Amgen Inc., Amryt Pharma plc, AstraZeneca Plc., Regeneron Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Teva Pharmaceutical Industries Ltd., Cipher Pharmaceuticals Inc., Pfizer Inc., Merck & Co., Inc., and Sun Pharmaceutical Industries Limited among others.
The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for pharmaceutical industries worldwide, including the global hypercholesterolemia treatment market. During the pandemic, many clinical trials, research activities, and regulatory approvals have been temporarily postponed due to the redirected focus on the COVID-19 pandemic and its related restrictions.
The onset of the pandemic in early 2020 led to widespread lockdowns and restrictions, impacting regular cardiovascular check-ups, appointments, and consultations including hypercholesterolemia worldwide, this leads to the increasing disease severity. Many hospitals are focused on COVID-19 cases, this reduced the hypercholesterolemia treatment.
Moreover, the COVID-19 pandemic severely disrupted global supply chains, impacting the transportation of raw materials of cholesterol-related therapeutics and medical devices. Movement restrictions and border closures delayed shipments and caused drug transportation delays. Additionally, some countries faced shortages of drugs for treatment due to disruptions in their supply chain networks.
The Russia-Ukraine conflict is estimated to have a moderate impact on the global hypercholesterolemia treatment market. Many clinical trials and research activities are temporarily disrupted. The conflict has less impact mainly due to the low prevalence and absence of key market players in this region.
According to the DataM Intelligence, the hypercholesterolemia treatment market experiencing the rapid growth in recent years and is expected to grow rapidly in the coming years due to its increasing prevalence and novel therapeutic innovations for better patient outcomes. Many innovative treatment options are going to develop in the coming years by reducing the adverse effects and for effective treatment.
Moreover, lifestyle changes, natural remedies to reduce high bad cholesterol, rising aging population are the factors mainly driving the market. Many clinical trials and research activities are still going on for novel therapeutics, which is expected to growth in the global hypercholesterolemia treatment market in the upcoming years.
The global hypercholesterolemia treatment market report would provide approximately 61 tables, 58 figures, and 186 Pages.
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