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市场调查报告书
商品编码
1861115
全球内超音波超音波引导针市场:市场规模、份额和趋势分析(2026-2032 年)EUS Needle Market Size and Shares and Trend Analysis | Global | 2026-2032 | Includes: Fine Needle Aspiration and Fine Needle Biopsy |
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2025年全球内超音波超音波(EUS)引导针市场价值约3.74亿美元。预计到2032年,该市场将超过4.9亿美元,年复合成长率为3.9%。
本报告涵盖超音波超音波穿刺针,依器械类型分为细针穿刺抽吸针和细针切片针。报告量化了销售量、平均售价、市场价值、成长率和企业市场占有率。此外,报告还分析了市场趋势和驱动因素、近期併购活动以及技术发展。历史资料截至2022年,预测资料截至2032年。
研究报告反映了随着影像和影像的进步,医院和内视镜中心如何评估 EUS 引导下的组织取样,并揭示了价格趋势、培训机会和监管要求正在影响各个地区的采用情况。
市场概览
超音波换能器用于在超音波内视镜引导下对胃肠道及其邻近器官进行组织取样。可对胰臟、胆道系统、黏膜下肿块和淋巴结等病变进行细胞学和组织学取样。随着超音波影像品质的提高和临床医生操作技能的增强,超音波内视镜引导下取样在疾病诊断和分期中发挥重要作用。
近年来,抛弃式内视镜穿刺针的价格呈下降趋势,支撑了手术数量的稳定成长。预计在预测期内,价格环境将趋于稳定,并继续以较为温和的速度下降。价格优势扩大了医院和门诊内视镜中心的准入范围,增加了用户数量,并在利润率较低的情况下支撑了总收入的成长。预计销售量的持续成长将支撑市场的持续成长。
细针穿刺和细针活检的市场模式持续演变。超音波内视镜引导下细针穿刺(EUS-FNA)在细胞学领域有着悠久的应用历史。而超音波内视镜引导下细针穿刺活检(EUS-FNB)则随着用于获取组织核心样本进行组织学评估的设备而扩展。随着病理需求转向辅助检测,以及临床指南强调准确的亚型分类,越来越多的中心开始采用细针穿刺活检。这种市场格局的演变影响着平均售价和手术的经济效益,因为细针穿刺活检设备通常比细针穿刺设备更昂贵。
总体而言,EUS 针的应用反映了诊断准确性、工作流程效率和成本控制的融合,这得益于成像技术的改进、组织产量的一致性提高以及临床医生对 EUS 引导手术的信心增强。
市场驱动因素
改进的诊断能力
包括超音波超音波在内的新型诊断方法正在提高胃肠道异常和疾病的检出率。影像处理和视觉化技术的进步,例如高清超音波和增强型内视镜光学系统,提高了靶向精度和取样可靠性。随着诊断准确性的提高,预计切片检查数量将会增加,从而推动对超音波内视镜穿刺针的需求,并促进市场扩张。
成像和引导技术的进步
影像品质的提升和符合人体工学的内视镜操作技术的进步,提高了病灶定位和穿刺路径规划的准确性。更清晰的视野有助于对难以取样的目标进行采样,并减少获取诊断材料所需的穿刺次数。这些改进将提高首次穿刺成功率,缩短手术时间,从而促进超音波内视镜引导下组织取样的广泛应用。
消化系统疾病增加
由于人口老化和检测技术的进步,需要组织学确诊的疾病,例如胰臟肿块、囊肿、胆道狭窄和黏膜下病变等,在全球范围内的发病率持续上升。随着患者数量的增加,细针穿刺活检(FNA)和细针穿刺活检(FNB)的使用量也相应增加。这种需求的成长,加上提供超音波内视镜(EUS)服务的机构数量不断增加,将推动相关设备在预测期内持续成长。
价格实惠且随处可得
多年来抛弃式针头价格的持续下降,使得超音波内视镜针头更容易被各种临床机构所接受。製造商面临利润率压缩,但不断增长的基本客群抵消了这一影响。预计价格将保持稳定,仅会出现小幅下降,因此,推动市场价值成长的主要因素可能仍将是销售成长。
市场限制
技术挑战和培训需求
对微小或难以触及的病灶进行取样极具挑战性。标靶定位需要精确的角度控制、稳定的内视镜位置以及一致的吸引和导丝操作技巧。有效应用超音波内视镜通常依赖专门的培训,这可能会限制内视镜医师资源有限的中心采用该技术。在某些地区,培训机会和技术人员的可用性仍然是重要的限制。
组织采集方法之间的竞争
细针穿刺活检 (FNA) 和细针穿刺活检 (FNB) 的偏好可能因病理需求、设备成本和临床医生熟练程度而异。此外,除超音波内视镜 (EUS) 外的其他切片检查技术也可能导致某些病例转向其他适应症。这些因素将影响产品组合,并对平均售价构成压力,即使手术总量增加,也会导致整体市场价值成长放缓。
监管和合规要求
严格的设备设计、製造和临床应用标准会延长研发週期并增加营运成本。监管合规虽然必要,但可能会阻碍市场准入,并减缓产品迭代速度。在成本敏感型市场,冗长的核准流程和采购规则会延迟产品升级,并限制平均售价的成长。
目标市场和数据范围
定量范围
市场规模、市占率、市场预测、成长率、销售量、平均售价
定性数据
影响超音波内视镜需求成长的趋势、限制因素、竞争对手分析及SWOT分析、併购、公司简介及产品系列、FDA召回事件、颠覆性技术、疾病概述
时期
基准年为2025年,预测期间为2026-2032年,历史资料为2022-2024年。
数据来源
对产业领导者的初步访谈、政府医师资料、监管资料、私人医院资料、进出口资料、iData Research 内部资料库。
方法
收入模型为单位乘以平均售价,透过程序和利用率输入检验,并与 FNA 和 FNB 的采用和替代假设相符。
医疗环境
医院、专科诊所、门诊内视镜中心
目标市场及区隔
EUS针头市场
竞争分析
波士顿科学公司在2025年EUS穿刺针市场占有领先地位。该公司凭藉其Acquire细针活检装置和Expect细针抽吸装置产品线,在市场上占据了强大的地位,这两大产品线合计占据了相当大的市场份额。庞大的装机量、完善的分销网络以及丰富的产品组合,巩固了该公司在众多地区的领先地位。
库克医疗是第二大竞争对手。该公司凭藉其EchoTip Ultra超音波针保持着强大的市场地位,并且在可重复使用器械领域也十分活跃,这使其业务遍及各种采购模式和地区。
美敦力凭藉其可重复使用的产品以及 SharkCore 细针活检和 Beacon 细针抽吸系统,占据了相当大的市场份额,这些产品极大地促进了公司 EUS 针的销售,并涵盖了细胞学和组织学应用案例。
EUS 针头市场集中度适中,全球领导者拥有广泛的产品组合,而区域分销商则迎合区域价格分布和采购方式。
科技与临床趋势
在重视组织学和辅助检查的地区,EUS-FNB 的应用日益增多,与 FNA 相比,这可以提高 ASP,并改善某些病变的诊断工作流程。
EUS-FNA 广泛用于各种标靶的细胞学检查,并且不断优化尖端设计、斜面形状和针芯选择。
高清超音波和改进的关节镜成像技术可以更好地进行定位,并减少诊断所需的穿刺次数。
随着感染预防和简化工作流程减少对再处理基础设施的依赖,人们对一次性设备的偏好持续增长。
透过程序清单和培训模组对组织采集进行标准化,有助于提高产量比率一致性并减少实验室间的差异。
我们的筹资策略在价格稳定性和供应的可靠性和连续性之间取得平衡,优先选择能够满足多种设备尺寸需求并能快速补货的供应商。
地区
该报告涵盖全球各区域,包括北美、欧洲、亚太地区、拉丁美洲以及中东和非洲。
图表清单
图表列表
调查方法
全球关税的影响
超音波超音波针市场
The global endoscopic ultrasound needle market was valued at nearly $374 million in 2025. The market is expected to grow at a compound annual growth rate of 3.9 percent to reach over $490 million by 2032.
This report covers endoscopic ultrasound needles segmented by device type into fine-needle aspiration and fine-needle biopsy. It quantifies unit sales, average selling prices, market values, growth rates, and company shares, and it analyzes market drivers and limiters, recent mergers and acquisitions, and technology trends. It provides historical data to 2022 and forecasts to 2032.
The scope reflects how hospitals and endoscopy centers evaluate EUS-guided tissue acquisition as imaging and visualization improve, while pricing trends, training access, and regulatory requirements shape adoption across regions.
Market Overview
Endoscopic ultrasound needles are used for EUS-guided tissue acquisition across the gastrointestinal tract and adjacent organs. They enable cytology and histology sampling of lesions in the pancreas, biliary system, subepithelial masses, and lymph nodes. As ultrasound image quality improves and clinician familiarity grows, EUS-guided sampling plays a larger role in diagnosis and staging.
In recent years, disposable EUS needle prices have trended downward, which supported a steady rise in procedure volumes. The pricing environment is anticipated to stabilize, with modest additional declines over the forecast horizon. Affordability expands access for hospitals and ambulatory endoscopy centers, which increases the installed user base and supports higher total revenues despite tighter margins. Sustained gains in unit sales are expected to underpin continued market growth.
The market mix between fine-needle aspiration and fine-needle biopsy continues to evolve. EUS-FNA has a long record for cytology. EUS-FNB has expanded due to devices designed to obtain core tissue for histologic assessment. As pathology needs shift toward ancillary testing and as clinical guidelines emphasize accurate subtyping, FNB adoption is increasing in many centers. This mix affects average selling prices and procedure economics, since FNB devices typically command a premium over FNA.
Overall, EUS needle adoption reflects a convergence of diagnostic accuracy, workflow efficiency, and cost control, supported by improved imaging, more consistent tissue yields, and growing clinician comfort with EUS-guided techniques.
Market Drivers
Increased diagnostic capabilities
New diagnostic approaches that include ultrasound endoscopy are strengthening detection of gastrointestinal abnormalities and disease. Improvements in imaging and visualization, including high-definition ultrasound and enhanced endoscope optics, have increased targeting precision and sampling confidence. As diagnostic accuracy improves, biopsy volumes are expected to rise, which drives greater demand for EUS needles and supports market expansion.
Advancements in imaging and guidance
Incremental advances in image quality and ergonomic scope control are improving lesion localization and needle trajectory planning. Better visualization facilitates sampling of difficult targets and reduces the number of passes needed to obtain diagnostic material. These gains support higher first-pass success and shorter procedure time, which encourages broader use of EUS-guided tissue acquisition.
Rising incidence of gastrointestinal disorders
Global prevalence of conditions that require tissue confirmation, including pancreatic masses, cysts, biliary strictures, and subepithelial lesions, continues to rise with aging populations and improved detection. As patient volumes increase, utilization of FNA and FNB grows accordingly. This demand increase, combined with more centers offering EUS services, supports sustained unit growth through the forecast period.
Price accessibility and broader adoption
A multiyear decline in disposable needle prices made EUS needles more accessible across a wider range of care settings. While manufacturers faced margin compression, expanding customer bases helped offset the impact. With pricing expected to stabilize and only modest reductions projected, unit growth will remain the main driver of market value.
Market Limiters
Technical challenges and training needs
Sampling small or hard-to-reach lesions can be difficult. Certain targets require precise angulation, stable scope position, and consistent suction and stylet techniques. Effective use of EUS often depends on specialized training, which can limit adoption in centers with fewer advanced endosonographers. Training access and proctoring availability remain important constraints in some regions.
Competition among tissue-acquisition techniques
Preference patterns between FNA and FNB can shift based on pathology requirements, device cost, and clinician familiarity. In addition, alternative biopsy modalities outside EUS in select indications can divert cases. These factors influence product mix and apply pressure on average selling prices, which moderates overall market value growth even as total procedures rise.
Regulatory and compliance requirements
Strict standards for device design, manufacturing, and clinical use can lengthen development timelines and raise operating costs. Regulatory compliance is necessary but can act as a barrier to market entry and slow the pace of product iteration. In cost-sensitive markets, longer approval cycles and procurement rules can delay upgrades and restrain ASP expansion.
Market Coverage and Data Scope
Quantitative coverage
Market size, market shares, market forecasts, growth rates, units sold, and average selling prices.
Qualitative coverage
Growth trends, limiters, competitive analysis and SWOT for top competitors, mergers and acquisitions, company profiles and product portfolios, FDA recalls, disruptive technologies, and disease overviews that shape demand for EUS needles.
Time frame
Base year 2025, forecasts 2026 to 2032, historical data 2022 to 2024.
Data sources
Primary interviews with industry leaders, government physician data, regulatory data, hospital private data, import and export data, and the iData Research internal database.
Method note
Revenue is modeled from units multiplied by ASP, validated with procedure and utilization inputs, and cross-checked against adoption and replacement assumptions for FNA and FNB.
Care settings
Hospitals, specialty clinics, and ambulatory endoscopy centers.
Markets Covered and Segmentation
EUS Needle Market
Competitive Analysis
Boston Scientific held the leading position in the EUS needle market in 2025. The company has a strong presence through its Acquire fine-needle biopsy devices and Expect fine-needle aspiration product line, which together secure a significant share. The installed base, distribution reach, and portfolio depth support its leadership across many regions.
Cook Medical ranked as the second-largest competitor. The company maintains a strong position with its EchoTip Ultra Endoscopic Ultrasound Needle and participates in the reusable segment, which broadens its presence across different purchasing models and regions.
Medtronic has a notable share supported by its reusable offering and its SharkCore fine-needle biopsy system and Beacon fine-needle aspiration system. These lines contribute meaningfully to the company's EUS needle sales and provide coverage across cytology and histology use cases.
The market remains moderately concentrated across global leaders with broad portfolios and regional distributors that address local price points and procurement practices.
Technology and Practice Trends
EUS-FNB adoption is increasing where histology and ancillary testing are prioritized, which can raise ASPs relative to FNA and improve diagnostic workflow for certain lesions.
EUS-FNA remains widely used for cytology in a broad range of targets, with continued optimization of tip designs, bevel geometry, and stylet options.
Imaging improvements in high-definition ultrasound and scope articulation support better targeting and reduce the number of passes needed for diagnosis.
Single-use device preference continues to expand as infection prevention and streamlined workflow reduce reliance on reprocessing infrastructure.
Tissue acquisition standardization through procedural checklists and training modules helps improve yield consistency and reduces variability between centers.
Procurement strategies balance price stabilization with reliability and supply continuity, favoring vendors that can support multiple device sizes and quick replenishment.
Geography
This edition provides global coverage, including North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
Where is the largest and fastest growing opportunity within EUS needles and how will the mix between FNA and FNB evolve through the forecast period.
How do pricing trends and procedure volumes interact to drive market value, and what is the outlook for price stabilization versus further reductions.
Which technology and practice trends will shape adoption, including imaging improvements, needle design updates, and single-use preference.
How do leading competitors position their portfolios across regions, and what is the likely impact of procurement and regulatory environments on share and pricing.
What training, workflow, and pathology requirements affect device selection, including yield targets and the need for core tissue to support diagnostic confidence.
How should commercial teams plan for growth in hospitals and ambulatory centers, and where are the key risks to value, including technical challenges, regulatory timelines, and mix shifts between FNA and FNB.
The Global Endoscopic Ultrasound Needle Market Report from iData Research answers these questions with procedure-aware models, company share analysis, and price benchmarking. Use it to quantify demand by device type, plan portfolio strategy, set pricing and contracting targets, and prioritize training and support programs that improve diagnostic yield.
Table Of Contents
List Of Figures
List Of Charts
Research Methodology
Impact Of Global Tariffs
Eus Needle Market