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市場調査レポート
商品コード
1606536
脳脊髄液シャントシステムの世界市場-2024~2031年Global Cerebral Spinal Fluid (CSF) Shunt Systems Market - 2024-2031 |
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カスタマイズ可能
適宜更新あり
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脳脊髄液シャントシステムの世界市場-2024~2031年 |
出版日: 2024年12月04日
発行: DataM Intelligence
ページ情報: 英文 176 Pages
納期: 即日から翌営業日
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概要
世界の脳脊髄液シャントシステム市場は、2023年に8億9,420万米ドルに達し、2031年には13億9,830万米ドルに達すると予測され、予測期間中にはCAGR 5.8%で成長する見込みです。
脳脊髄液(CSF)シャントシステムは、過剰な脳脊髄液(CSF)を脳や脊髄の一部から身体の別の部位に迂回させるように設計された医療機器であり、通常、水頭症として知られるCSFの異常貯留がある場合に使用されます。髄液シャントシステムは主に、脳内に髄液が貯留して頭蓋内圧が上昇し、脳組織を損傷する可能性のある水頭症やその他の疾患の治療に使用されます。脳脊髄液シャントシステムは、脳脊髄液の異常貯留に関連する状態を管理する上で重要な役割を果たし、正常な脳機能を維持し、長期的な神経学的損傷を防ぐのに役立っています。
脳脊髄液シャントシステムの世界の需要は、いくつかの要因によって拡大しています。特に成人と小児人口の間で、水頭症、外傷性脳損傷、頭蓋内圧亢進症などの神経疾患の有病率が増加していることが主要要因です。例えばWHOによると、2021年には世界で30億人以上が神経疾患を抱えて生活しています。より効果的なシャントシステムや侵襲の少ない手技など、医療技術の進歩が市場の成長を支えています。
例えば、UCLA保健機構によると、米国では出生1,000人に2人の割合で水頭症が発生しています。出生後に発症する人の数は不明です。約12万5,000人が脳脊髄液(CSF)シャントシステムを使用して生活しており、米国では年間3万3,000個のシャントが設置されています。
促進要因と抑制要因
水頭症の有病率の上昇
水頭症の有病率の上昇が髄液シャントシステム市場の成長を大きく牽引しており、予測期間中も牽引していくと予想されます。水頭症は、脳内の脳脊髄液の異常な蓄積を特徴とする疾患で、頭蓋内圧の上昇につながり、未治療の場合、脳障害を引き起こす可能性があります。
例えば、Medscapeによると、水頭症の世界の有病率は10万人当たり約85例と推定され、年齢層によって顕著な差があり、小児では10万人当たり88例、成人では10万人当たり11例です。また、Neurology Indiaによると、水頭症の発生率は、低・中所得国(LMIC)では出生10万人あたり123人であるのに対し、高所得国では79人です。先天性水頭症(出生時から存在)と後天性水頭症(外傷、感染症、腫瘍による)の有病率はともに増加しており、髄液シャントシステムの需要に直接寄与しています。
高齢者に多い正常圧水頭症も大きな要因です。世界人口の高齢化、特に先進国では、正常圧水頭症の診断が増加しており、多くの場合、シャントによる治療が必要です。例えば、アルツハイマー病協会によると、正常圧水頭症は主に60~70歳代に発症します。水頭症協会は、70万人近くの成人が正常圧水頭症であると推定しています。
着床後合併症の高いリスク
植え込み後の合併症のリスクが高いことが、脳脊髄液シャントシステム市場の妨げになると予想されます。これらの合併症は患者の転帰に影響を及ぼすだけでなく、追加の医療コスト、治療時間の増加、シャント技術に対する患者や医療従事者の信頼の低下にもつながります。感染症は、髄液シャント植え込み後の最も一般的な合併症の1つです。
例えば、ScienceDirectによると、シャント感染率は約5%~15%で、ほとんどの感染症は創部の汚染に起因します。感染症のほぼ70%は、皮膚細菌叢ブドウ球菌によるものです。髄液シャント感染症は通常、留置後2ヵ月以内に発症します。
感染症は髄膜炎や敗血症などの重篤な合併症につながる可能性があり、シャントを交換し、抗生物質や再手術などの集中治療を受ける必要があります。再手術の必要性は全体的な医療費を増加させ、シャントシステムの長期的な存続に影響を与えるため、市場の受け入れが制限されます。
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Overview
The global cerebral spinal fluid shunt systems market reached US$ 894.2 million in 2023 and is expected to reach US$ 1398.3 million by 2031, growing at a CAGR of 5.8% during the forecast period 2024-2031.
Cerebrospinal Fluid (CSF) shunt systems are medical devices designed to divert excess cerebrospinal fluid (CSF) from one part of the brain or spinal cord to another area of the body, typically when there is an abnormal accumulation of CSF, a condition known as hydrocephalus. These systems are primarily used to treat hydrocephalus and other conditions that cause fluid buildup in the brain, which can lead to increased intracranial pressure, potentially damaging brain tissue. CSF shunt systems play a crucial role in managing conditions related to abnormal CSF buildup, helping to maintain normal brain function and prevent long-term neurological damage.
The global demand for cerebral spinal fluid shunt systems is growing due to several factors. A key driver is the increasing prevalence of neurological disorders such as hydrocephalus, traumatic brain injuries and intracranial hypertension, particularly among both the adult and pediatric populations. For instance, according to the WHO, in 2021, more than 3 billion people worldwide were living with a neurological condition. Advances in medical technologies, including more effective shunting systems and less invasive procedures, support market growth.
For instance, according to the UCLA Health Organization, hydrocephalus occurs in two out of every 1,000 births in the United States. It is not known how many people develop it after birth. Approximately 125,000 persons are living with cerebrospinal fluid (CSF) shunt systems and 33,000 shunts are placed annually in the United States.
Market Dynamics: Drivers & Restraints
Rising prevalence of hydrocephalus
The rising prevalence of hydrocephalus is significantly driving the growth of the spinal fluid shunt systems market and is expected to drive over the forecast period. Hydrocephalus, a condition characterized by the abnormal accumulation of cerebrospinal fluid in the brain, leads to increased intracranial pressure, potentially causing brain damage if untreated.
For instance, according to Medscape, the global prevalence of hydrocephalus is estimated at approximately 85 cases per 100,000 individuals, with notable variation across age groups, 88 per 100,000 in the pediatric population and 11 per 100,000 in adults. Additionally, according to Neurology India, the incidence of hydrocephalus is 123 per 100,000 births in low- and middle-income countries (LMICs) compared to 79 per 100,000 births in high-income countries. The prevalence of both congenital hydrocephalus (present from birth) and acquired hydrocephalus (due to trauma, infections, or tumors) is increasing, contributing directly to the demand for CSF shunt systems.
Normal pressure hydrocephalus, common among the elderly, is another major factor. The aging global population, particularly in developed countries, is leading to more diagnoses of normal pressure hydrocephalus, which often requires shunt intervention. For instance, according to the Alzheimer's Association, normal pressure hydrocephalus primarily affects people in their 60s and 70s. The Hydrocephalus Association estimates that nearly 700,000 adults have normal-pressure hydrocephalus
High risk of post-implantation complications
The high risk of post-implantation complications is expected to hamper the cerebral spinal fluid shunt systems market. These complications not only affect patient outcomes but also lead to additional healthcare costs, increased treatment time and a decrease in patient and provider confidence in shunt technologies. Infections are one of the most common complications after CSF shunt implantation.
For instance, according to ScienceDirect, shunt infection rates range from about 5% to 15%, with most infections resulting from wound contamination. Almost 70% of infections are caused by skin flora staphylococcal organisms. CSF shunt infections usually occur within 2 months after implantation.
Infections can lead to serious complications such as meningitis or sepsis, requiring the shunt to be replaced and the patient to undergo intensive treatment, including antibiotics or even re-surgery. The need for repeated surgeries increases the overall healthcare costs and impacts the long-term viability of shunt systems, limiting their market acceptance.
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The global cerebral spinal fluid shunt systems market is segmented based on product type, material, valve type, indication, age group, end-user and region.
The ventriculoperitoneal shunts segment is expected to dominate the global cerebral spinal fluid shunt systems market share
The ventriculoperitoneal shunts segment holds a major portion of the cerebral spinal fluid shunt systems market share and is expected to continue to hold a significant portion of the market share over the forecast period due to their widespread use, effectiveness and cost-efficiency in treating hydrocephalus, particularly in pediatric patients. These shunts are preferred for their ability to effectively redirect excess cerebrospinal fluid from the brain's ventricles to the peritoneal cavity (abdomen), where the fluid can be absorbed into the bloodstream.
Thus, due to the wide advantages offered by ventriculoperitoneal shunts, many major and emerging market players are focussing on these stunts. For instance, in May 2024, CereVasc, Inc. approval from the US Food and Drug Administration (FDA) to initiate its "Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc eShunt System in the Treatment of Normal Pressure Hydrocephalus" (STRIDE trial). The STRIDE pivotal study compares the safety and efficacy of its novel eShunt System for the treatment of patients with Normal Pressure Hydrocephalus to treatment with the current standard of care, the ventriculoperitoneal (VP) shunt.
Ventriculoperitoneal shunts are considered the gold standard in treating hydrocephalus, especially in congenital cases. This widespread use in both pediatric and adult populations significantly contributes to their market dominance. Ventriculoperitoneal shunts are highly effective in the long-term management of hydrocephalus, with studies showing that they are successful in reducing symptoms and improving patient outcomes, especially when timely intervention is applied.
North America is expected to hold a significant position in the global cerebral spinal fluid shunt systems market
North America region is expected to hold the largest market share over the forecast period. North America, especially the United States has a high prevalence of hydrocephalus, a major condition treated by CSF shunt systems. According to the Hydrocephalus Association, around 1 in 500 to 1,000 live births are affected by congenital hydrocephalus in the United States, leading to a significant demand for shunt devices.
For instance, according to the UCLA Health Organization, hydrocephalus occurs in two out of every 1,000 births in the United States. It is not known how many people develop it after birth. Approximately 125,000 persons are living with cerebrospinal fluid (CSF) shunt systems and 33,000 shunts are placed annually in the United States.
North America is home to the most advanced shunt technologies. Companies in the region have pioneered the development of programmable shunts and anti-siphon devices, which offer better control over cerebrospinal fluid flow and minimize the risk of complications such as infection or over-drainage. These innovations enhance patient outcomes and make CSF shunt systems more effective, leading to greater adoption and market share.
For instance, in August 2024, Aesculap, Inc. (Aesculap), in partnership with Christoph Miethke GmbH & Co. KG (MIETHKE), cleared that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the M.scio System. This unique, non-invasive, telemetric pressure measurement system is designed to provide continuous access to long-term, intracranial pressure (ICP) monitoring of cerebrospinal fluid (CSF) for the management of hydrocephalus via a permanent, fully implantable sensor.
Asia Pacific is growing at the fastest pace in the cerebral spinal fluid shunt systems market
The Asia Pacific region is experiencing the fastest growth in the cerebral spinal fluid shunt systems market. The prevalence of hydrocephalus and other neurological disorders is rising in the Asia Pacific region. The incidence of congenital hydrocephalus in countries like India and China is on the rise, partly due to better survival rates among preterm infants and improvements in neonatal care. For example, India has seen an increase in congenital hydrocephalus diagnoses, with studies indicating a prevalence of about 0.6-1.2 per 1,000 live births.
Medical tourism is also contributing to the growth of the CSF shunt market in Asia Pacific. Countries like India, Thailand and Singapore are popular destinations for medical tourists seeking affordable and high-quality hydrocephalus treatment. For instance, according to the Ministry of Tourism, India has been ranked 10th in the Medical Tourism Index (MTI) for 2020-21 out of 46 destinations in the world by the Medical Tourism Association. The increase in medical tourism is partly due to the availability of skilled healthcare professionals and modern surgical facilities at relatively lower costs compared to Western countries.
The major global players in the cerebral spinal fluid shunt systems market include Medtronic plc, Aesculap, Inc., Sophysa, Integra LifeSciences Corporation, Christoph Miethke GmbH & Co. KG, Delta Surgical, Anuncia Inc., Spiegelberg GmbH & Co. KG, HpBio, BIcakcIlar and among others.
The global cerebral spinal fluid shunt systems market report delivers a detailed analysis with 86 key tables, more than 85 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.