![]() |
市場調査レポート
商品コード
1345420
ホモ接合性家族性高コレステロール血症の世界市場-2023年~2030年Global Homozygous Familial Hypercholesterolemia Market - 2023-2030 |
||||||
カスタマイズ可能
適宜更新あり
|
ホモ接合性家族性高コレステロール血症の世界市場-2023年~2030年 |
出版日: 2023年09月06日
発行: DataM Intelligence
ページ情報: 英文 195 Pages
納期: 即日から翌営業日
|
概要
世界のホモ接合性家族性高コレステロール血症市場は、2022年に8,370万米ドルに達し、2023-2030年の予測期間中にCAGR 2.5%で成長し、2030年には1億180万米ドルに達すると予測されます。HoFHの原因となる遺伝子変異を正確に特定し、早期診断を容易にする遺伝子診断の進歩へのシフトといった動向が、世界のホモ接合性家族性高コレステロール血症市場を独占すると予想されます。
世界のホモ接合性家族性高コレステロール血症市場は近年著しく成長しており、今後も上昇傾向が続くと予測されています。同市場は、CRISPR-Cas9やRNA干渉(RNAi)のような新規技術の開拓など、いくつかの重要な動向の影響を受け、変革期を迎えています。
さらに、心血管障害の有病率の上昇、モノクローナル抗体のような潜在的な新興治療薬の発売、疾患に対する意識の高まり、臨床試験の増加などが、ホモ接合性家族性高コレステロール血症市場規模を押し上げています。
ホモ接合性家族性高コレステロール血症のアプローチを用いた疾患治療のための研究活動の増加、確立されたバイオ医薬品および製薬会社の存在は、北米地域の需要促進要因の一部です。アストラゼネカ、ヴィアトリス、アコードヘルスケア、その他の競合企業も積極的に市場に参入しています。
ダイナミクス
心血管疾患の有病率の増加が、ホモ接合性家族性高コレステロール血症市場の成長を牽引
心血管疾患(CVDs)の有病率の上昇は、ホモ接合性家族性高コレステロール血症(HoFH)市場の主要な促進要因です。HoFHは高濃度のLDL-Cと心臓発作や脳卒中などのCVDリスクの上昇を特徴とするため、この疾患に対する意識の高まりが早期発見と介入を促し、ひいては効率的なHoFH治療に対する需要を促進しています。
例えば、米国疾病予防管理センター(Centers for Disease Control and Prevention 2023)の報告書によると、心臓病は米国における主要な死因の一つであり、米国では40秒に1人の割合で心臓発作に苦しんでいます。米国では毎年、約805,000人が心臓発作を起こしています。さらに冠動脈性心疾患は最も一般的な心臓病であり、2021年には375,476人が死亡します。CVDと冠動脈性心疾患の負担は増加の一途をたどっており、HoFH市場は予測期間中に成長すると予想されます。
遺伝子治療の進歩がホモ接合性家族性高コレステロール血症市場の成長を促進する
CRISPR-Cas9、低分子干渉RNA(SiRNA)、エクソソーム介在療法など、ホモ接合性家族性高コレステロール血症における技術進歩の高まりが、市場の需要を牽引すると予想されます。CRISPR/Cas9システムは、ZFNとTALENに次ぐ革命的な第3世代の遺伝子編集ツールであり、現在選択されているゲノム編集ツールです。
例えば、National Library of Medicine 2022年の記事によると、CRISPR/Cas9遺伝子編集システム(AAV-CRISPR/Cas9)を含むアデノ随伴ウイルス(AAV)は、LDL受容体機能が低下したLDLR変異マウスを標的とする最近のin vivo動物実験で使用された(AAV-CRISPR/Cas9)。研究者らは、AAV-CRISPR/Cas9遺伝子編集を用いて、肝細胞の変異を部分的に固定し、LDL受容体タンパク質の発現を回復させることができることを発見しました。
その結果、血清総コレステロール値、トリグリセリド値、LDLコレステロール値が大幅に低下しました。その結果、大動脈におけるアテローム性動脈硬化プラーク形成は著しく減少し、CRISPR/Cas9がヘテロ接合性およびホモ接合性家族性高コレステロール血症の治療に有望であることが示されました。このように、遺伝子治療技術の進歩は、予測期間にわたって市場の需要を促進するでしょう。
ホモ接合性家族性高コレステロール血症治療に伴う高コストが市場の成長を妨げる
ホモ接合性家族性高コレステロール血症の治療費が高いことは、同市場にとって大きな障壁です。これらの治療薬は高額であるため、患者にとっては購入が困難であり、多くの人々がこれらの重要な治療法を受けることができません。このような経済的負担は、低所得者層により多くの影響を及ぼす可能性があり、HoFH患者の生命を救うことができる治療を受けられる人々に格差を生じさせます。
例えば、低比重リポ蛋白(LDL)アフェレーシスを減少させるロミタピド製剤は、米国ではJuxtapidというブランドで販売されています。この経口5mgカプセルは28カプセル供給で約53,471米ドルです。さらに、ジェネリック医薬品が入手できないため、発展途上国や低所得諸国では購入が困難となる可能性があります。したがって、上記の要因により、市場は当面抑制要因に直面すると予想されます。
Global Homozygous Familial Hypercholesterolemia Market reached US$ 83.7 million in 2022 and is expected to reach US$ 101.8 million by 2030 growing with a CAGR of 2.5% during the forecast period 2023-2030. The trend such as the shift towards advancements in genetic diagnostics due to its precise potential in identification of genetic mutations responsible for HoFH, facilitating early diagnosis is expected to dominate the global homozygous familial hypercholesterolemia market.
The global homozygous familial hypercholesterolemia market has grown significantly in recent years and is projected to continue on its upward trend. The market is undergoing a transformational period, influenced by several significant trends such development of novel technologies like CRISPR-Cas9 and RNA interference (RNAi).
Furthermore, the rising prevalence of cardiovascular disorders, launch of potential emerging therapies such as monoclonal antibodies, rising awareness of the disease, increasing number of clinical trials are driving up the homozygous familial hypercholesterolemia market size.
The growing research activities for treating disease using homozygous familial hypercholesterolemia approach and presence of establish biopharmaceutical and pharmaceutical companies are some of the factors in demand from North American regions. With significant competitors like AstraZeneca, Viatris Inc., Accord Healthcare, and others actively operating in the market.
The rising prevalence of cardiovascular diseases (CVDs) is a major driver for the homozygous familial hypercholesterolemia (HoFH) market. As HoFH is characterized by high levels of LDL-C and increased risk of CVDs like heart attacks and strokes, growing awareness of this disease fuels early detection and interventions that in turn drive demand for efficient HoFH treatments.
For instance, according to Centers for Disease Control and Prevention 2023 report, heart disease disease is one of the leading cause of death in U.S. Every 40 seconds some or other person in U.S. suffer from heart attack. In U.S. every year, approximately 805,000 people have heart attack. Moreover coronary heart disease is the most common type of heart disease, killing 375,476 people in 2021. As the CVD and coronary heart disease burden continues to increase, the HoFH market is expected to grow during the forecast period.
The growing technological advancement in homozygous familial hypercholesterolemia such as CRISPR-Cas9, small interfering RNA (SiRNA), exosome-mediated therapy and others is expected to drive the demand for the market. The CRISPR/Cas9 system is revolutionary third generation gene editing tool after ZFNs and TALENs and currently the genome editing tool of choice.
For instance, according to National Library of Medicine 2022 article state that, the adeno-associated virus (AAV) containing the CRISPR/Cas9 gene editing system (AAV-CRISPR/Cas9) was used in a recent in vivo animal study to target LDLR mutant mice with impaired LDL receptor function (AAV-CRISPR/Cas9). The researchers discovered that using AAV-CRISPR/Cas9 gene editing, they were able to partially fix the mutation in hepatocytes, restoring LDL receptor protein expression.
This resulted in major decreases in serum total cholesterol, triglyceride, and LDL cholesterol levels. As a result, atherosclerotic plaque formation in the aorta reduced significantly, indicating CRISPR/Cas9's potential promise for treating heterozygous and homozygous familial hypercholesterolemia. Thus, advancements in technologies for gene therapies will drive the demand for the market over the forecast period.
The high cost of treatment for homozygous familial hypercholesterolemia is a significant barrier for this market. The high costs of these medications may make them difficult to afford for patients, preventing many people from obtaining these vital therapies. This financial burden can affect more persons in low-income areas, causing gaps in who can receive therapies that can save lives for patients with HoFH.
For instance, Lomitapide drug, sold under the brand of Juxtapid in U.S for reducing the low-density lipoprotein (LDL) apheresis cost around cost around. This oral 5 mg capsule cost around $53,471 for a supply of 28 capsules. Moreover, unavailability of generic version may find it difficult to afford for the pateint in developing and low income countries. Thus, owing to the above factors the market is expected to face a restraint over the foreseeable future.
The global homozygous familial hypercholesterolemia market is segmented based on drug class, route of administration, technology, distribution channel, and region.
The statins segment is poised to dominate the homozygous familial hypercholesterolemia market due to effectiveness in reducing LDL cholesterol levels and managing cardiovascular risk. Statins are the mainstay treatment for treating the homozygous familial hypercholesterolemia due to its ability to reduce the LDL-C by diminishing hepatic cholesterol synthesis acting on the 3-hydroxy-3-methylglutaryl coenzyme-A (HMG-CoA)-reductase.
Also, the rising prevalence of atherosclerosis is major factors where treatment such as statins are very effective. For instance, according to Family Heart Foundation studies, it has shown that statins can reduce LDL-cholesterol by 35 to 55% and can reduce the risk of cardiovascular disease by 22% for each 40 mg/dL reduction in LDL-cholesterol.
Currently, rosuvastatin has the most potent lipid-lowering capability of any presently available statin and is suggested for people with primary hyperlipidemia and mixed dyslipidemia, homozygous FH, primary dysbetalipoproteinemia, and hypertriglyceridemia. Also, statins are ery effective in children and are proven to be safe with children suffering from lipid disorders.
Moreover, statins are more effective when given in combination with other adjuncts treatment such as evinacumab, PCSK9 inhibitors, and other. Many new treatment are that are use as adjuncts to statins are expected to get FDA approval. Thus, due to statins better effectiveness the segment is expected to dominate over the forecast period.
North America, particularly the U.S., dominates the global homozygous familial hypercholesterolemia market due to presence of huge number of key players settled in the region, growing prevalence of atherosclerotic cardiovascular disease (ASCVD), and high research activities along with developments of technologies by major organization in the region.
For instance, according to National Librabry of Medicine 2022 article, approximately the prevalence of ASCVD in the US was about 24 million in 2019, approximately 10% of the total US population are above 21 years old. It was found heavy comorbidity burden among ASCVD patients and 31.2% were at very high risk for recurrent events. Thus, owing to above factors the region is expected to grow over the forecast period.
The major global players in the homozygous familial hypercholesterolemia market include: AstraZeneca, Viatris Inc., Teva Pharmaceutical Industries Ltd., Accord Healthcare, Changzhou Pharmaceutical Factory, Regeneron Pharmaceuticals, Inc., Amryt Pharma plc, Amgen Inc., Organon, Global Inc., CMP Pharma, and among others.
The COVID-19 pandemic has had a significant impact on the lifestyle and management of people with FH, especially homozygous FH (HoFH). Fear of COVID-19 has caused many to avoid getting medical attention. Furthermore, because FH patients were designated high-risk groups due to their greater vulnerability to COVID-19 infection, FH patients' access to cardiovascular therapy and prevention during the pandemic was limited.
For intance, according to the National Librabry of Medicine 2022 article, this population-based study found that FH patients with COVID-19 have a considerably increased risk of acute myocardial infarction. Overall, the COVID-19 pandemic has established hurdles to cardiovascular therapy for patients with FH, particularly HoFH. Thereby creating a major impact on the homozygous familial hypercholesterolemia market.
The Global Homozygous Familial Hypercholesterolemia (HoFH) Market is expected to rise rapidly, because of advances in genetic diagnostics, gene treatments such as CRISPR-Cas9, and growing awareness of the condition. The link between HoFH and cardiovascular disorders creates demand for effective treatments, but addressing treatment affordability and accessibility is essential. While gene editing technologies have immense possibilities, but don't come without problems and safety issues.
The market is segmented based on several characteristics, with North America dominant due to research capability and disease incidence. New treatments such as Evkeeza and Praluent demonstrate continued innovation, whereas COVID-19 highlights the importance of robust healthcare systems and equal access to therapy. Balancing developments with ethical issues remain crucial in navigating this landscape.
The global homozygous familial hypercholesterolemia market report would provide approximately 53 tables, 54 figures and 195 Pages.
LIST NOT EXHAUSTIVE