Endoscopic Ultrasound Needles Market Size and Share

Endoscopic Ultrasound Needles Market (2025 - 2030)
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Endoscopic Ultrasound Needles Market Analysis by Mordor Intelligence

The endoscopic ultrasound needles market size stands at USD 162.08 million in 2025 and is projected to reach USD 223 million by 2030, reflecting a 6.59% CAGR. The growing demand for precision diagnostics, the rapid convergence of artificial intelligence with needle design, and the shift away from surgical biopsies underpin the steady expansion of the endoscopic ultrasound needles market. Hospitals continue to anchor global volumes, yet ambulatory surgical centers are winning share as outpatient biopsies gain traction. Fork-tip geometries, 25G gauges, and Nitinol construction collectively redefine sampling efficiency, while North America sustains its leadership through comprehensive reimbursement policies. Competitive intensity is shaped by proprietary tip designs, AI-enabled targeting technology, and strict FDA Class II requirements that raise entry barriers.

Key Report Takeaways

  • By product type, biopsy needles captured 58.32% revenue share in 2024 and are projected to grow at 8.54% CAGR through 2030.
  • By needle gauge, 22 G held 28.54% of the endoscopic ultrasound needles market share in 2024, while 25 G is projected to advance at a 7.66% CAGR to 2030.
  • By tip design, Franseen needles led with a 30.34% share in 2024, and fork-tip designs are expanding at a 7.32% CAGR.
  • By application, pancreatic lesions accounted for a 28.78% share in 2024, while bronchial or mediastinal lesions are projected to rise at an 8.97% CAGR.
  • By end user, hospitals retained 43.54% share in 2024 and ambulatory surgical centers are growing at 9.11% CAGR.
  • By geography, North America held 42.32% share in 2024 and Asia-Pacific is registering the fastest 7.54% CAGR.

Segment Analysis

By Product Type – Biopsy Needles Drive Market Evolution

Biopsy needles held a 58.32% market share of the endoscopic ultrasound needles market in 2024, reflecting oncologists’ demand for intact core tissue that enables comprehensive molecular profiling. Their 8.54% CAGR through 2030 outpaces aspiration tools as personalized medicine protocols standardize across cancer centers. The endoscopic ultrasound needles market benefits from this structural shift, with biopsy instruments commanding premium pricing against stable year-on-year volume growth.

Aspiration needles retain their value for rapid on-site cytology, particularly in community settings without access to molecular labs. Yet the widening tissue requirements of pancreatic, biliary, and bronchial oncology place a growing ceiling on cytology-only devices. Established vendors leverage FDA 510(k) pathways to deploy iterative enhancements that maintain regulatory compliance while boosting diagnostic yield.

Endoscopic Ultrasound Needles Market: Market Share by Product Type
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By Needle Gauge – Ultra-Fine Precision Gains Momentum

The 22 G gauge provided the largest contribution at 28.54% in 2024, balancing core volume with manageable bleeding risk. However the 25 G category shows a 7.66% CAGR through 2030, winning adoption for delicate pancreatic and pediatric cases where minimal trauma is paramount. Endoscopic Ultrasound Needles market size for 25 G solutions is projected to expand steadily as nitinol alloys allow thinner walls yet maintain lumen integrity.

Larger 19 G products support demanding genomic studies at academic centers, although slower growth keeps them niche. Gauge selection remains tightly linked to FDA validation protocols that test each diameter for tensile strength and biocompatibility.

By Tip Design – Fork-Tip Innovation Reshapes Sampling Efficiency

Franseen tips controlled 30.34% share in 2024, but Fork-Tip designs post the highest 7.32% CAGR to 2030. Comparative trials demonstrate higher intact-core rates and fewer passes per case, which aligns with payer pressure to shorten procedure time. The endoscopic ultrasound needles market therefore responds with rapid product cycles emphasizing proprietary cutting surfaces.

Lancet and side-beveled tools remain relevant for hyper-vascular lesions where controlled entry reduces hemorrhage risk. Collaborative R&D between STARmed and Olympus illustrates the strategic value of pairing surface metallurgy with ergonomics to protect share in this competitive arena.

By Application – Bronchial Sampling Emerges as Growth Driver

Pancreatic lesions accounted for 28.78% of global procedures in 2024, confirming the organ’s ongoing diagnostic challenge. Yet bronchial and mediastinal indications are clocking an 8.97% CAGR as pulmonologists adopt EUS-bronchoscope hybrids for lung cancer staging. Endoscopic Ultrasound Needles market size in thoracic oncology thus expands beyond classical gastroenterology.

Biliary strictures and gastrointestinal wall masses add diversified volume, supported by 2024 American College of Gastroenterology guidelines that endorse EUS biopsy for indeterminate biliary narrowing.

By Material – Nitinol Innovation Challenges Steel Dominance

Stainless steel held 60.32% share in 2024 due to cost advantages and well-understood mechanical behavior. Nitinol grows at 7.67% CAGR by offering flexibility and shape memory that preserve tip sharpness through multiple passes. Endoscopic ultrasound needles market share for nitinol climbs fastest in centers that tackle tortuous anatomy such as pancreatic tail lesions.

ISO 13485 quality frameworks guide alloy consistency, corrosion resistance, and manufacturing traceability, building clinician trust in these premium devices.

Endoscopic Ultrasound Needles Market: Market Share by Material
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By End User – Ambulatory Centers Capture Market Momentum

Hospitals retained a 43.54% share in 2024, but ambulatory surgical centers posted a robust 9.11% CAGR through 2030. Medicare reimbursement parity and consumer preference for outpatient care boost procedure migration. The endoscopic ultrasound needles market size within ambulatory centers is expected to expand as compact cart-based EUS platforms become more prevalent in suburban clinics.

Specialty cancer clinics leverage high throughput to negotiate bulk prices, sustaining demand for single-use needles that avoid reprocessing overhead. Device makers now tailor packaging and accessory kits for same-day discharge workflows, strengthening their positioning with facility administrators.

Geography Analysis

North America generated 42.32% of global revenue in 2024, buoyed by CPT codes 43238 and 43242 that secure reimbursement in both hospital and ambulatory settings. Academic networks funnel constant clinical trials, which accelerates early adoption of AI-guided targeting and nitinol needles. Canadian centers follow U.S. protocols, while Mexican medical tourism funnels additional volumes from uninsured U.S. patients seeking lower procedure costs.

Asia-Pacific records the fastest 7.54% CAGR, driven by government oncology initiatives, growing specialist training pipelines, and urban hospital expansion. China’s cancer screening plan funds EUS suites in provincial centers, while Japan’s aging demographics propel demand for gentler diagnostics. Private hospitals in India add premium EUS services for overseas patients, broadening the endoscopic ultrasound needles market footprint. Diverse regulatory regimes require tailored submissions, but recent alignment of China’s National Medical Products Administration with ISO standards eases entry for global brands.

Europe exhibits steady growth anchored in evidence-based guidelines and well-funded universal healthcare. Germany, the United Kingdom, and France lead installations, often pairing high-end needles with AI-assisted imaging upgrades. Southern Europe trails slightly yet benefits from EU Medical Device Regulation harmonization, which streamlines purchasing decisions. Real-world evidence programs across university hospitals further validate performance claims, reinforcing clinician confidence in new designs.

Endoscopic Ultrasound Needles Market CAGR (%), Growth Rate by Region
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Competitive Landscape

The endoscopic ultrasound needles industry shows moderate fragmentation. No single vendor exceeds a one-third share, and the top five together control under 50%, creating space for mid-sized specialists. Boston Scientific and Olympus leverage integrated scope-to-needle ecosystems that encourage bundled procurement contracts. Cook Medical focuses on core-biopsy geometry, while Fujifilm and Pentax rely on channel partnerships to expand regional reach.

Differentiation centers on proprietary tip designs, alloy composition, and AI-enabled positioning software. Vendors file continuous 510(k) submissions to sustain product cadence, knowing minor performance gains can sway hospital value analyses. Strategic collaborations, such as the 2024 STARmed-Olympus alliance, combine materials engineering with distribution muscle to accelerate market penetration.

New entrants emphasize ultra-fine pediatric gauges, reusable handle systems with disposable sheaths, and software modules that overlay lesion maps on live ultrasound feeds. These niche offerings seek to exploit unmet needs rather than confront incumbents head-on. Over the planning horizon, consolidation remains plausible if dominant imaging vendors pursue bolt-on acquisitions to close technology gaps.

Endoscopic Ultrasound Needles Industry Leaders

  1. Medtronic PLC

  2. CONMED Corporation

  3. Olympus Corporation

  4. Boston Scientific Corporation

  5. Cook Group Incorporated

  6. *Disclaimer: Major Players sorted in no particular order
Endoscopic Ultrasound Needles Market
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Recent Industry Developments

  • October 2025: Olympus launched the SecureFlex needle system with enhanced flexibility for difficult anatomy, maintaining tip sharpness throughout prolonged cases
  • February 2025: Limaca Medical commenced U.S. sales of its Precision-GI™ platform targeted at high-volume ambulatory settings
  • May 2024: Cook Medical launched EchoTip AcuCore needles to capture larger core specimens for genomic profiling.

Table of Contents for Endoscopic Ultrasound Needles Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope Of The Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Growing Burden of Gastrointestinal and Pancreatic Cancers
    • 4.2.2 Rising Preference for Minimally Invasive Diagnostic Procedures
    • 4.2.3 Increasing Geriatric Population with Comorbidities
    • 4.2.4 Favorable Reimbursement Policies for Endoscopic Ultrasound Procedures
    • 4.2.5 Rapid Adoption of Franseen and Fork-Tip Fine Needle Biopsy Technology
    • 4.2.6 Integration of AI-Guided Targeting Systems in EUS Platforms
  • 4.3 Market Restraints
    • 4.3.1 Shortage of Skilled Endoscopic Ultrasound Operators
    • 4.3.2 High Cost of Premium Biopsy Needles and Reusable Accessories
    • 4.3.3 Stringent Infection-Control Protocols Increasing Procedure Turnaround Time
    • 4.3.4 Competition from Emerging Non-Invasive Liquid Biopsy Technologies
  • 4.4 Value / Supply-Chain Analysis
  • 4.5 Regulatory Landscape
  • 4.6 Technological Outlook
  • 4.7 Porter's Five Forces
    • 4.7.1 Threat Of New Entrants
    • 4.7.2 Bargaining Power Of Buyers
    • 4.7.3 Bargaining Power Of Suppliers
    • 4.7.4 Threat Of Substitutes
    • 4.7.5 Intensity Of Competitive Rivalry

5. Market Size & Growth Forecasts (Value, USD)

  • 5.1 By Product Type
    • 5.1.1 Aspiration Needles
    • 5.1.2 Biopsy Needles
  • 5.2 By Needle Gauge
    • 5.2.1 19G
    • 5.2.2 22G
    • 5.2.3 25G
  • 5.3 By Tip Design
    • 5.3.1 Lancet
    • 5.3.2 Franseen
    • 5.3.3 Fork-Tip
    • 5.3.4 Side-Beveled
  • 5.4 By Application
    • 5.4.1 Pancreatic Lesions
    • 5.4.2 Gastrointestinal Wall Lesions
    • 5.4.3 Bronchial / Mediastinal Lesions
    • 5.4.4 Biliary Lesions
  • 5.5 By Material
    • 5.5.1 Stainless-Steel
    • 5.5.2 Nitinol
  • 5.6 By End-User
    • 5.6.1 Hospitals
    • 5.6.2 Ambulatory Surgical Centers
    • 5.6.3 Specialty Clinics
  • 5.7 Geography
    • 5.7.1 North America
    • 5.7.1.1 United States
    • 5.7.1.2 Canada
    • 5.7.1.3 Mexico
    • 5.7.2 Europe
    • 5.7.2.1 Germany
    • 5.7.2.2 United Kingdom
    • 5.7.2.3 France
    • 5.7.2.4 Italy
    • 5.7.2.5 Spain
    • 5.7.2.6 Rest of Europe
    • 5.7.3 Asia-Pacific
    • 5.7.3.1 China
    • 5.7.3.2 Japan
    • 5.7.3.3 India
    • 5.7.3.4 Australia
    • 5.7.3.5 South Korea
    • 5.7.3.6 Rest of Asia-Pacific
    • 5.7.4 Middle East & Africa
    • 5.7.4.1 GCC
    • 5.7.4.2 South Africa
    • 5.7.4.3 Rest of Middle East & Africa
    • 5.7.5 South America
    • 5.7.5.1 Brazil
    • 5.7.5.2 Argentina
    • 5.7.5.3 Rest of South America

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Market Share Analysis
  • 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
    • 6.3.1 ACE Medical Devices Pvt. Ltd
    • 6.3.2 Boston Scientific Corporation
    • 6.3.3 CONMED Corporation
    • 6.3.4 Cook Medical (Cook Group)
    • 6.3.5 ENDO-FLEX GmbH
    • 6.3.6 Fujifilm Holdings Corporation
    • 6.3.7 GI Supply
    • 6.3.8 Hakko Co. Ltd
    • 6.3.9 Laborie Medical Technologies
    • 6.3.10 Lishen Scientific
    • 6.3.11 Medi-Globe GmbH
    • 6.3.12 Medtronic Plc
    • 6.3.13 Micro-Tech Endoscopy
    • 6.3.14 Olympus Corporation
    • 6.3.15 Pentax Medical (HOYA)
    • 6.3.16 Sono Scape Medical
    • 6.3.17 South-Pioneer Technology
    • 6.3.18 Steris Endoscopy
    • 6.3.19 Taewoong Medical Co.
    • 6.3.20 US Endoscopy

7. Market Opportunities & Future Outlook

  • 7.1 White-Space & Unmet-Need Assessment
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Global Endoscopic Ultrasound Needles Market Report Scope

As per the scope of the report, endoscopic ultrasound (EUS) needles are specialized biopsy tools used during endoscopic ultrasound procedures to obtain tissue samples from organs and lesions within or adjacent to the gastrointestinal tract. They enable minimally invasive fine-needle aspiration (FNA) or fine-needle biopsy (FNB), providing high diagnostic accuracy for conditions like pancreatic, biliary, and mediastinal lesions. 

The endoscopic ultrasound needles market is segmented by Product (Aspiration Needles and Biopsy Needles), Needle Gauge (19G, 22G, 25G), Tip Design (Lancet, Franseen, Fork-Tip, Side-Beveled), Application (Pancreatic Lesions, Gastrointestinal Wall Lesions, Bronchial/Mediastinal Lesions, Biliary Lesions), Material (Stainless-Steel, Nitinol), End-User (Hospitals, Ambulatory Surgical Centers, Specialty Clinics), and geography (North America, Europe, Asia Pacific, the Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD million) for the above segments.

By Product Type
Aspiration Needles
Biopsy Needles
By Needle Gauge
19G
22G
25G
By Tip Design
Lancet
Franseen
Fork-Tip
Side-Beveled
By Application
Pancreatic Lesions
Gastrointestinal Wall Lesions
Bronchial / Mediastinal Lesions
Biliary Lesions
By Material
Stainless-Steel
Nitinol
By End-User
Hospitals
Ambulatory Surgical Centers
Specialty Clinics
Geography
North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & Africa GCC
South Africa
Rest of Middle East & Africa
South America Brazil
Argentina
Rest of South America
By Product Type Aspiration Needles
Biopsy Needles
By Needle Gauge 19G
22G
25G
By Tip Design Lancet
Franseen
Fork-Tip
Side-Beveled
By Application Pancreatic Lesions
Gastrointestinal Wall Lesions
Bronchial / Mediastinal Lesions
Biliary Lesions
By Material Stainless-Steel
Nitinol
By End-User Hospitals
Ambulatory Surgical Centers
Specialty Clinics
Geography North America United States
Canada
Mexico
Europe Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East & Africa GCC
South Africa
Rest of Middle East & Africa
South America Brazil
Argentina
Rest of South America
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Key Questions Answered in the Report

How big is the Global Endoscopic Ultrasound Needles Market?

The Global Endoscopic Ultrasound Needles Market size is expected to reach USD 162.08 million in 2025 and grow at a CAGR of 6.59% to reach USD 223.00 million by 2030.

What is the current Global Endoscopic Ultrasound Needles Market size?

In 2025, the Global Endoscopic Ultrasound Needles Market size is expected to reach USD 162.08 million.

Who are the key players in Global Endoscopic Ultrasound Needles Market?

Medtronic PLC, CONMED Corporation, Olympus Corporation, Boston Scientific Corporation and Cook Group Incorporated are the major companies operating in the Global Endoscopic Ultrasound Needles Market.

Which is the fastest growing region in Global Endoscopic Ultrasound Needles Market?

Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).

Which region has the biggest share in Global Endoscopic Ultrasound Needles Market?

In 2025, the North America accounts for the largest market share in Global Endoscopic Ultrasound Needles Market.

What years does this Global Endoscopic Ultrasound Needles Market cover, and what was the market size in 2024?

In 2024, the Global Endoscopic Ultrasound Needles Market size was estimated at USD 151.40 million. The report covers the Global Endoscopic Ultrasound Needles Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Global Endoscopic Ultrasound Needles Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.

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