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全球脑脊髓液 (CSF) 分流系统市场 - 2024-2031

Global Cerebral Spinal Fluid (CSF) Shunt Systems Market - 2024-2031

出版日期: 2024年12月04日 | 出版商:

DataM Intelligence | 英文 176 Pages | 商品交期: 最快1-2个工作天内

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简介目录

概述

2023年，全球脑脊髓液分流系统市场达到8.942亿美元，预计2031年将达到13.983亿美元，2024-2031年预测期间复合年增长率为5.8%。

脑脊髓液(CSF) 分流系统是一种医疗设备，旨在将多余的脑脊髓液(CSF) 从大脑或脊髓的一个部分转移到身体的另一个区域，通常是在脑脊髓液异常积聚（一种称为脑积水的病症）时进行。这些系统主要用于治疗脑积水和其他导致大脑积液的疾病，这可能导致颅内压升高，可能损害脑组织。脑脊髓液分流系统在管理与脑脊髓液异常积聚相关的疾病方面发挥着至关重要的作用，有助于维持正常的大脑功能并防止长期神经损伤。

由于多种因素，全球对脑脊髓液分流系统的需求不断增长。一个关键的驱动因素是脑积水、创伤性脑损伤和颅内高压等神经系统疾病的盛行率不断增加，特别是在成人和儿童群体中。例如，根据世界卫生组织的数据，到 2021 年，全球有超过 30 亿人患有神经系统疾病。医疗技术的进步，包括更有效的分流系统和微创手术，支持了市场的成长。

例如，根据加州大学洛杉矶分校卫生组织的数据，在美国，每 1,000 名新生儿中就有两人患有脑积水。目前尚不清楚有多少人在出生后患有这种疾病。美国约有 125,000 人使用脑脊髓液 (CSF) 分流系统，每年安装 33,000 例分流器。

市场动态：

驱动程式和限制

脑积水盛行率上升

脑积水盛行率的上升极大地推动了脊髓液分流系统市场的成长，预计在预测期内将继续增长。脑积水是一种以脑脊髓液异常积聚为特征的疾病，会导致颅内压升高，如果不及时治疗，可能会导致脑损伤。

例如，根据Medscape 报告，全球脑积水盛行率估计约为每10 万人中85 例，不同年龄组之间存在显着差异，儿科人群中脑积水盛行率为每10 万人中88例，成人每10 万人中11 例。此外，根据印度神经病学中心的数据，在低收入和中等收入国家(LMIC)，脑积水的发生率为每100,000 名新生儿中123 例，而高收入国家每100,000 名新生儿中脑积水的发生率为79 例。先天性脑积水（从出生起）和后天性脑积水（由于创伤、感染或肿瘤）的盛行率都在增加，直接增加了对脑脊髓液分流系统的需求。

正常压力脑积水在老年人中常见，是另一个主要因素。全球人口老化，特别是在已开发国家，导致更多人诊断出正常压力脑积水，这通常需要分流干预。例如，根据阿兹海默症协会的说法，正常压力脑积水主要影响 60 多岁和 70 多岁的人。脑积水协会估计，近 70 万名成年人患有正常压力脑积水

植入后併发症的高风险

植入后併发症的高风险预计将阻碍脑脊髓液分流系统市场。这些併发症不仅影响患者的治疗结果，还会导致额外的医疗费用、增加治疗时间以及患者和医疗服务提供者对分流技术的信心下降。感染是脑脊髓液分流器植入后最常见的併发症之一。

例如，根据 ScienceDirect，分流器感染率约为 5% 至 15%，其中大多数感染是由伤口污染引起的。几乎 70% 的感染是由皮肤菌丛葡萄球菌引起的。脑脊髓液分流感染通常发生在植入后 2 个月内。

感染可能导致严重的併发症，如脑膜炎或败血症，需要更换分流管，患者需要接受强化治疗，包括抗生素甚至再次手术。重复手术的需要增加了整体医疗成本，并影响分流系统的长期可行性，限制了其市场接受度。

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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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Segment Analysis

The global cerebral spinal fluid shunt systems market is segmented based on product type, material, valve type, indication, age group, end-user and region.

Indication:

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.

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.

Competitive Landscape

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.

Why Purchase the Report?

Pipeline & Innovations: Insights into clinical trials, product pipelines, and upcoming advancements.
Market Positioning: Analysis of product performance and growth potential for optimized strategies.
Real-World Evidence: Integration of patient feedback for enhanced product outcomes.
Physician Preferences: Insights into healthcare provider behaviors and adoption strategies.
Regulatory & Market Updates: Coverage of recent regulations, policies, and emerging technologies.
Competitive Insights: Analysis of market share, competitor strategies, and new entrants.
Pricing & Market Access: Review of pricing models, reimbursement trends, and access strategies.
Market Expansion: Strategies for entering new markets and forming partnerships.
Regional Opportunities: Identification of high-growth regions and investment prospects.
Supply Chain Optimization: Assessment of risks and distribution strategies.
Sustainability & Regulation: Focus on eco-friendly practices and regulatory changes.
Post-Market Surveillance: Enhanced safety and access through post-market data.
Value-Based Pricing: Insights into pharmacoeconomics and data-driven R&D decisions.

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.

Target Audience 2023

Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
Supply Chain: Distribution and Supply Chain Managers.
Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
Academic & Research: Academic Institutions.

1. Methodology and Scope

1.1. Research Methodology
1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

3.1. Snippet by Product Type
3.2. Snippet by Material
3.3. Snippet by Valve Type
3.4. Snippet by Indication
3.5. Snippet by Age-Group
3.6. Snippet by End-User
3.7. Snippet by Region

4. Dynamics

4.1. Impacting Factors
- 4.1.1. Drivers
  - 4.1.1.1. Rising Prevalence of Hydrocephalus
  - 4.1.1.2. Technological Advancements in Stunt Systems
- 4.1.2. Restraints
  - 4.1.2.1. High Risk of Post-Implantation Complications
- 4.1.3. Opportunity
- 4.1.4. Impact Analysis

5. Industry Analysis

5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Patent Analysis
5.5. Regulatory Analysis
5.6. SWOT Analysis
5.7. Unmet Needs

6. By Product Type

6.1. Introduction
- 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 6.1.2. Market Attractiveness Index, By Product Type
6.2. Ventriculoperitoneal Shunts*
- 6.2.1. Introduction
- 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
6.3. Ventriculoatrial Shunts
6.4. Lumboperitoneal Shunts
6.5. Ventriculopleural Shunts
6.6. Others

7. By Material

7.1. Introduction
- 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
- 7.1.2. Market Attractiveness Index, By Material
7.2. Silicone-based Shunts*
- 7.2.1. Introduction
- 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.3. Polymer-based Shunts
7.4. Metal-based Shunts

8. By Valve Type

8.1. Introduction
- 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Valve Type
- 8.1.2. Market Attractiveness Index, By Valve Type
8.2. Fixed Pressure Valves*
- 8.2.1. Introduction
- 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Adjustable Pressure Valves

9. By Indication

9.1. Introduction
- 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 9.1.2. Market Attractiveness Index, By Indication
9.2. Congenital Hydrocephalus*
- 9.2.1. Introduction
- 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Acquired Hydrocephalus
9.4. Post-Surgical Hydrocephalus
9.5. Others

10. By Age Group

10.1. Introduction
- 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Age Group
- 10.1.2. Market Attractiveness Index, By Age Group
10.2. Pediatrics*
- 10.2.1. Introduction
- 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
10.3. Adults
10.4. Geriatrics

11. By End-User

11.1. Introduction
- 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 11.1.2. Market Attractiveness Index, By End-User
11.2. Hospitals*
- 11.2.1. Introduction
- 11.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
11.3. Specialty Clinics
11.4. Ambulatory Surgical Centers
11.5. Others

12. By Region

12.1. Introduction
- 12.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
- 12.1.2. Market Attractiveness Index, By Region
12.2. North America
- 12.2.1. Introduction
- 12.2.2. Key Region-Specific Dynamics
- 12.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 12.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
- 12.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Valve Type
- 12.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 12.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Age Group
- 12.2.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 12.2.9. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 12.2.9.1. U.S.
  - 12.2.9.2. Canada
  - 12.2.9.3. Mexico
12.3. Europe
- 12.3.1. Introduction
- 12.3.2. Key Region-Specific Dynamics
- 12.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 12.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
- 12.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Valve Type
- 12.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 12.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Age Group
- 12.3.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 12.3.9. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 12.3.9.1. Germany
  - 12.3.9.2. U.K.
  - 12.3.9.3. France
  - 12.3.9.4. Spain
  - 12.3.9.5. Italy
  - 12.3.9.6. Rest of Europe
12.4. South America
- 12.4.1. Introduction
- 12.4.2. Key Region-Specific Dynamics
- 12.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 12.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
- 12.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Valve Type
- 12.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 12.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Age Group
- 12.4.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 12.4.9. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 12.4.9.1. Brazil
  - 12.4.9.2. Argentina
  - 12.4.9.3. Rest of South America
12.5. Asia-Pacific
- 12.5.1. Introduction
- 12.5.2. Key Region-Specific Dynamics
- 12.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 12.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
- 12.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Valve Type
- 12.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 12.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Age Group
- 12.5.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
- 12.5.9. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
  - 12.5.9.1. China
  - 12.5.9.2. India
  - 12.5.9.3. Japan
  - 12.5.9.4. South Korea
  - 12.5.9.5. Rest of Asia-Pacific
12.6. Middle East and Africa
- 12.6.1. Introduction
- 12.6.2. Key Region-Specific Dynamics
- 12.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
- 12.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
- 12.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Valve Type
- 12.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
- 12.6.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Age Group
- 12.6.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

13. Competitive Landscape

13.1. Competitive Scenario
13.2. Market Positioning/Share Analysis
13.3. Mergers and Acquisitions Analysis

14. Company Profiles

14.1. Medtronic plc*
- 14.1.1. Company Overview
- 14.1.2. Product Portfolio and Description
- 14.1.3. Financial Overview
- 14.1.4. Key Developments
14.2. Aesculap, Inc.
14.3. Sophysa
14.4. Integra LifeSciences Corporation
14.5. Christoph Miethke GmbH & Co. KG
14.6. Delta Surgical
14.7. Anuncia Inc.
14.8. Spiegelberg GmbH & Co. KG
14.9. HpBio
14.10. BIcakcIlar (LIST NOT EXHAUSTIVE)