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市場調查報告書

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1861115

全球內超音波內視鏡引導針市場：市場規模、佔有率和趨勢分析（2026-2032 年）

EUS Needle Market Size and Shares and Trend Analysis | Global | 2026-2032 | Includes: Fine Needle Aspiration and Fine Needle Biopsy

出版日期: 2025年10月03日 | 出版商:

iData Research Inc. | 英文 64 Pages | 商品交期: 最快1-2個工作天內

價格

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簡介目錄圖表

2025年全球內超音波內視鏡（EUS）引導針市場價值約3.74億美元。預計到2032年，該市場將超過4.9億美元，年複合成長率為3.9%。

本報告涵蓋超音波內視鏡穿刺針，依器械類型分為細針穿刺抽吸針和細針切片針。報告量化了銷售量、平均售價、市場價值、成長率和企業市場占有率。此外，報告還分析了市場趨勢和促進因素、近期併購活動以及技術發展。歷史資料截至2022年，預測資料截至2032年。

研究報告反映了隨著影像和影像的進步，醫院和內視鏡中心如何評估 EUS 引導下的組織取樣，並揭示了價格趨勢、培訓機會和監管要求正在影響各個地區的採用情況。

市場概覽

超音波換能器用於在超音波內視鏡引導下對胃腸道及其鄰近器官進行組織取樣。可對胰臟、膽道系統、黏膜下腫塊和淋巴結等病變進行細胞學和組織學取樣。隨著超音波影像品質的提高和臨床醫生操作技能的增強，超音波內視鏡引導下取樣在疾病診斷和分期中發揮重要作用。

近年來，拋棄式內視鏡穿刺針的價格呈下降趨勢，支撐了手術數量的穩定成長。預計在預測期內，價格環境將趨於穩定，並繼續以較為溫和的速度下降。價格優勢擴大了醫院和門診內視鏡中心的准入範圍，增加了用戶數量，並在利潤率較低的情況下支撐了總收入的成長。預計銷售量的持續成長將支撐市場的持續成長。

細針穿刺和細針活體組織切片的市場模式持續演變。超音波內視鏡引導下細針穿刺（EUS-FNA）在細胞學領域有著悠久的應用歷史。而超音波內視鏡引導下細針穿刺活體組織切片（EUS-FNB）則隨著用於獲取組織核心樣本進行組織學評估的設備而擴展。隨著病理需求轉向輔助檢測，以及臨床指南強調準確的亞型分類，越來越多的中心開始採用細針穿刺活體組織切片。這種市場格局的演變影響著平均售價和手術的經濟效益，因為細針穿刺活體組織切片設備通常比細針穿刺設備更昂貴。

總體而言，EUS 針的應用反映了診斷準確性、工作流程效率和成本控制的融合，這得益於成像技術的改進、組織產量的一致性提高以及臨床醫生對 EUS 引導手術的信心增強。

市場促進因素

改進的診斷能力

包括超音波內視鏡在內的新型診斷方法正在提高胃腸道異常和疾病的檢出率。影像處理和視覺化技術的進步，例如高清超音波和增強型內視鏡光學系統，提高了靶向精度和取樣可靠性。隨著診斷準確性的提高，預計切片檢查數量將會增加，從而推動對超音波內視鏡穿刺針的需求，並促進市場擴張。

成像和引導技術的進步

影像品質的提升和符合人體工學的內視鏡操作技術的進步，提高了病灶定位和穿刺路徑規劃的準確性。更清晰的視野有助於對難以取樣的目標進行採樣，並減少獲取診斷材料所需的穿刺次數。這些改進將提高首次穿刺成功率，縮短手術時間，從而促進超音波內視鏡引導下組織取樣的廣泛應用。

消化系統疾病增加

由於人口老化和檢測技術的進步，需要組織學確診的疾病，例如胰臟腫塊、囊腫、膽道狹窄和黏膜下病變等，在全球範圍內的發病率持續上升。隨著患者數量的增加，細針穿刺活體組織切片（FNA）和細針穿刺活體組織切片（FNB）的使用量也相應增加。這種需求的成長，加上提供超音波內視鏡（EUS）服務的機構數量不斷增加，將推動相關設備在預測期內持續成長。

價格實惠且隨處可得

多年來拋棄式針頭價格的持續下降，使得超音波內視鏡針頭更容易被各種臨床機構所接受。製造商面臨利潤率壓縮，但不斷成長的基本客群抵消了這一影響。預計價格將保持穩定，僅會出現小幅下降，因此，推動市場價值成長的主要因素可能仍將是銷售成長。

市場限制

技術課題和培訓需求

對微小或難以觸及的病灶進行取樣極具課題性。標靶定位需要精確的角度控制、穩定的內視鏡位置以及一致的吸引和導絲操作技巧。有效應用超音波內視鏡通常依賴專門的培訓，這可能會限制內視鏡醫師資源有限的中心採用該技術。在某些地區，培訓機會和技術人員的可用性仍然是重要的限制。

組織採集方法之間的競爭

細針穿刺活體組織切片 (FNA) 和細針穿刺活體組織切片 (FNB) 的偏好可能因病理需求、設備成本和臨床醫生熟練程度而異。此外，除超音波內視鏡 (EUS) 外的其他切片檢查技術也可能導致某些病例轉向其他適應症。這些因素將影響產品組合，並對平均售價構成壓力，即使手術總量增加，也會導致整體市場價值成長放緩。

監管和合規要求

嚴格的設備設計、製造和臨床應用標準會延長研發週期並增加營運成本。監管合規雖然必要，但可能會阻礙市場准入，並減緩產品迭代速度。在成本敏感型市場，冗長的核准流程和採購規則會延遲產品升級，並限制平均售價的成長。

目標市場和數據範圍

定量範圍

市場規模、市佔率、市場預測、成長率、銷售量、平均售價

定性數據

影響超音波內視鏡需求成長的趨勢、限制因素、競爭對手分析及SWOT分析、併購、公司簡介及產品系列、FDA召回事件、顛覆性技術、疾病概述

時期

基準年為2025年，預測期間為2026-2032年，歷史資料為2022-2024年。

數據來源

對產業領導者的初步訪談、政府醫師資料、監管資料、私人醫院資料、進出口資料、iData Research 內部資料庫。

方法

收入模型為單位乘以平均售價，透過程序和利用率輸入檢驗，並與 FNA 和 FNB 的採用和替代假設相符。

醫療環境

醫院、專科診所、門診內視鏡中心

目標市場及區隔

EUS針頭市場

依器械類型：細針穿刺、細針切片

競爭分析

波士頓科學公司在2025年EUS穿刺針市場佔有領先地位。該公司憑藉其Acquire細針活體組織切片裝置和Expect細針抽吸裝置產品線，在市場上佔了強大的地位，這兩大產品線合計佔了相當大的市場佔有率。龐大的裝機量、完善的分銷網路以及豐富的產品組合，鞏固了該公司在眾多地區的領先地位。

庫克醫療是第二大競爭對手。該公司憑藉其EchoTip Ultra超音波針保持著強大的市場地位，並且在可重複使用器械領域也十分活躍，這使其業務遍及各種採購模式和地區。

美敦力憑藉其可重複使用的產品以及 SharkCore 細針活體組織切片和 Beacon 細針抽吸系統，佔了相當大的市場佔有率，這些產品極大地促進了公司 EUS 針的銷售，並涵蓋了細胞學和組織學應用案例。

EUS 針頭市場集中度適中，全球領導者擁有廣泛的產品組合，而區域分銷商則迎合區域價格分佈和採購方式。

科技與臨床趨勢

在重視組織學和輔助檢查的地區，EUS-FNB 的應用日益增多，與 FNA 相比，這可以提高 ASP，並改善某些病變的診斷工作流程。

EUS-FNA 廣泛用於各種標靶的細胞學檢查，並且不斷最佳化尖端設計、斜面形狀和針芯選擇。

高清超音波和改進的關節鏡成像技術可以更好地進行定位，並減少診斷所需的穿刺次數。

隨著感染預防和簡化工作流程減少對再處理基礎設施的依賴，人們對一次性設備的偏好持續成長。

透過程序清單和培訓模組對組織採集進行標準化，有助於提高產量比率一致性並減少實驗室間的差異。

我們的籌資策略在價格穩定性和供應的可靠性和連續性之間取得平衡，優先選擇能夠滿足多種設備尺寸需求並能快速補貨的供應商。

地區

該報告涵蓋全球各區域，包括北美、歐洲、亞太地區、拉丁美洲以及中東和非洲。

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

By device type: fine-needle aspiration, fine-needle biopsy.

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.

Why This Report

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 CONTENT

Table Of Contents

List Of Figures

List Of Charts

Research Methodology

Step 1: Project Initiation & Team Selection
Step 2: Prepare Data Systems And Perform Secondary Research
Step 3: Preparation For Interviews & Questionnaire Design
Step 4: Performing Primary Research
Step 5: Research Analysis: Establishing Baseline Estimates
Step 6: Market Forecast And Analysis
Step 7: Identify Strategic Opportunities
Step 8: Final Review And Market Release
Step 9: Customer Feedback And Market Monitoring

Impact Of Global Tariffs

Eus Needle Market

9.1 Executive Summary
- 9.1.1 Global Eus Needle Market Overview
- 9.1.2 Competitive Analysis
- 9.1.3 Procedure Segmentation
- 9.1.4 Market Segmentation
- 9.1.5 Regions Included
9.2 Introduction
9.3 Procedure Numbers
9.4 Market Overview
- 9.4.1 By Segment
- 9.4.2 By Region
9.5 Market Analysis And Forecast
- 9.5.1 Fine Needle Aspiration Market
- 9.5.2 Fine Needle Biopsy Market
9.6 Drivers And Limiters
- 9.6.1 Market Drivers
- 9.6.2 Market Limiters
9.7 Competitive Market Share Analysis

Abbreviations

簡介目錄圖表

LIST OF CHARTS

Chart 9-1: EUS Needle Market, Global, 2025 & 2032
Chart 9-2: EUS Needle Procedures, Global, 2025
Chart 9-3: EUS Needles Procedures by Region, Global, 2022 - 2032
Chart 9-4: Biopsy Forceps & Polypectomy Snares Market by Segment, Global, 2022 - 2032
Chart 9-5: EUS Needle Market by Segment by Region, Global, 2022 - 2032
Chart 9-6: Leading Competitors, EUS Needle Market, Global, 2025

LIST OF FIGURES

Figure 9-1: EUS Needle Procedure Segmentation
Figure 9-2: EUS Needle Market Segmentation
Figure 9-3: EUS Needle Regions Covered, Global (1 of 2)
Figure 9-4: EUS Needle Regions Covered, Global (2 of 2)
Figure 9-5: EUS Needles Procedures by Region, Global, 2022 - 2032
Figure 9-6: EUS Needles Procedures by Country, North America, 2022 - 2032
Figure 9-7: EUS Needles Procedures by Country, Latin America, 2022 - 2032 (1 of 2)
Figure 9-8: EUS Needles Procedures by Country, Latin America, 2022 - 2032 (2 of 2)
Figure 9-9: EUS Needles Procedures by Country, Western Europe, 2022 - 2032
Figure 9-10: EUS Needles Procedures by Country, Central & Eastern Europe, 2022 - 2032 (1 of 2)
Figure 9-11: EUS Needles Procedures by Country, Central & Eastern Europe, 2022- 2032 (2 of 2)
Figure 9-12: EUS Needles Procedures by Country, Middle East, 2022 - 2032
Figure 9-13: EUS Needles Procedures by Country, Asia-Pacific, 2022 - 2032 (1 of 3)
Figure 9-14: EUS Needles Procedures by Country, Asia-Pacific, 2022 - 2032 (2 of 3)
Figure 9-15: EUS Needles Procedures by Country, Asia-Pacific, 2022 - 2032 (3 of 3)
Figure 9-16: EUS Needles Procedures by Country, Africa, 2022 - 2032
Figure 9-17: EUS Needle Market by Segment, Global, 2022 - 2032 (US$M)
Figure 9-18: EUS Needle Market by Segment by Region, Global, 2022 - 2032 (US$M)
Figure 9-19: Total EUS Needle Market, Global, 2022 - 2032
Figure 9-20: Units Sold by Region, EUS Needle Market, Global, 2022 - 2032
Figure 9-21: Average Selling Price by Region, EUS Needle Market, Global, 2022 - 2032 (US$)
Figure 9-22: Market Value by Region, EUS Needle Market, Global, 2012 - 2032 (US$M)
Figure 9-23: Fine Needle Aspiration Market, Global., 2022 - 2032
Figure 9-24: Units Sold by Region, Fine Needle Aspiration Market, Global, 2022 - 2032
Figure 9-25: Average Selling Price by Region, Fine Needle Aspiration Market, Global, 2022 - 2032 (US$)
Figure 9-26: Market Value by Region, Fine Needle Aspiration Market, Global, 2022 - 2032 (US$M)
Figure 9-27: Fine Needle Biopsy Market, Global., 2022 - 2032
Figure 9-28: Units Sold by Region, Fine Needle Biopsy Market, Global, 2022 - 2032
Figure 9-29: Average Selling Price by Region, Fine Needle Biopsy Market, Global, 2022 - 2032 (US$)
Figure 9-30: Market Value by Region, Fine Needle Biopsy Market, Global, 2022 - 2032 (US$M)
Figure 9-31: Leading Competitors, EUS Needle Market, Global, 2025