수술용 스테이플러 : 시장 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The surgical stapler market size is valued at USD 6.24 billion in 2025 and is forecast to reach USD 8.73 billion by 2030 at a 6.95% CAGR.

Growth pivots on rapid robotic-surgery integration, hospital sustainability mandates encouraging reloadable cartridges, and the aging population that pushes higher-acuity orthopedic and bariatric procedures. Large hospital chains are standardizing powered staplers to trim OR time, while ambulatory surgery centers adopt cost-efficient manual variants to keep capital budgets lean. Adoption also benefits from regulatory clarity on ISO 13485-aligned quality systems, which lowers compliance uncertainty for device upgrades. Together, these factors reposition staplers as data-rich surgical tools rather than commodity closure devices, an evolution that broadens addressable procedure volumes worldwide.

Global Surgical Stapler Market Trends and Insights

Integration with Robotic-Assisted Surgery Platforms

Robotic platforms now ship with staplers engineered for wristed articulation and predictive firing algorithms that interpret tissue feedback in milliseconds, enabling precise staple lines through single-port or multi-port access. The installed base of 8,606 da Vinci systems generates stable pull-through demand for proprietary reloads, a revenue model reinforced by Q1 2024 robotic revenue of USD 1.89 billion. APAC hospitals are leapfrogging straight to robotic theatres, fostering platform-agnostic stapler designs that support mixed fleets and reduce vendor lock-in. Innovative three-actuator circular staplers showcased in peer-reviewed prototypes promise 75-degree cartridge flexion, directly addressing esophageal anastomosis challenges. As processors inside next-generation systems scale 10,000-fold, staplers will incorporate real-time analytics that adjust firing parameters to individual tissue thickness, pushing device intelligence to the surgical field edge.

Rising Preference for Minimally-Invasive Procedures

Surgeries performed through ports under 10 mm rose 17% in 2024, reaching 2.63 million global cases. Complex foregut and thoracic procedures now rely on highly articulated staplers that maneuver within restrictive cavities, trimming conversion-to-open rates. Ambulatory centers seek staplers that cut setup time; powered reloadables satisfy this by delivering consistent compression without repeated handle squeezes. FDA clearance of the SP SureForm 45 in April 2025 underscores how staplers follow procedural migration patterns rather than dictating them. Embedded SmartFire sensors close the tactile-feedback gap inherent to MIS approaches, allowing surgeons to trust digital compression readouts instead of manual feel.

Post-Operative Infection & Leakage Incidents

Case reports cite staple-line leakage leading to small-bowel obstruction years after surgery, fueling surgeon caution toward indiscriminate staple use. Incidence of vascular injuries during VATS has triggered unplanned thoracotomies, sparking guideline revisions that urge advanced imaging of staple paths. Orthopedic literature shows higher infection odds for metal staples compared with sutures, particularly where devices remain until bone healing. Pediatric appendectomies illustrate age-specific risks when staples are retained. These events push some surgeons to suture or use barbed threads in anatomies prone to adhesion, tempering volume growth in the short term.

Other drivers and restraints analyzed in the detailed report include:

1. Rapid Adoption of Powered & Reloadable Staplers
2. Surge in Bariatric & Metabolic Surgeries Globally
3. Stringent Regulatory Safety Requirements & Recalls

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Linear devices held 40.74% of the surgical stapler market size in 2024, anchored on the back of gastrointestinal and thoracic workloads where transection and anastomosis are routine. Long cartridges streamline sleeve gastrectomy and lung resection by spanning wide tissue diameters in single passes, cutting OR time and anesthetic exposure. Three-row circular staplers, though niche, cut anastomotic leakage from 6.1% to 2.1% in colorectal surgery, illustrating targeted clinical gains that preserve premium pricing. Cutter combinations remain confined to specialty trauma scenarios, yet drive reload sales because blade wear necessitates fresh cartridges.

Stapler reloads, projected to rise 8.02% annually, give procurement officers a quick payback path toward ESG goals without altering surgeon workflow. Procurement data show reloads costing 30-40% less than full disposables over a two-year life cycle once sterilization uptime is optimized. Hospitals negotiating bulk contracts secure further unit discounts, a lever unavailable on single-use devices. Consequently, reloads increasingly command capital-budget line items previously reserved for endoscopes, expanding their footprint inside strategic sourcing agendas.

Abdominal procedures delivered 36.91% of the surgical stapler market share in 2024 as bariatric, colorectal, and hepatobiliary cases rely on stapling for speed and hemostasis. Standardized firing sequences reduce variability across surgical teams, helping hospitals comply with value-based purchasing benchmarks. Robotic systems broaden adoption by offering 360-degree articulation for deep-pelvic colorectal anastomoses, widening clinical acceptance.

Orthopedic demand grows at an 8.76% CAGR on the back of knee and hip replacements for an aging population. Rapid skin closure slices OR turnover time by up to 12 minutes per case, translating to one extra daily slot in high-volume arthroplasty suites. Spine fusions and sports-medicine portals also turn to absorbable staplers that eliminate removal clinic visits, driving incremental volume. Cardiac and thoracic indications lean toward vascular reloads that seal friable pulmonary arteries in lobectomies, while OB/GYN procedures such as hysterectomies benefit from reduced blood loss via precise staple placement.

The Surgical Stapler Market Report is Segmented by Product (Linear Surgical Stapler, Circular Surgical Stapler, and More), Application (Abdominal Surgery, Obstetrics & Gynecological Surgeries, and More), by Mechanism (Manual and Powered), by Usability (Disposable and Reusable), End-User (Hospitals and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America remained the largest shareholder, with 34.57% of the surgical stapler market size in 2024, and is set to advance at a 6.27% CAGR to 2030. Installed robotic fleets create steady consumable pull-through, while ESG programs promote reloadables that cut waste. Medicare's bundled-payment models reward lower readmissions, so hospitals increasingly monitor staple-line leaks to preserve financial margins. However, reliance on titanium imports exposes manufacturers to geopolitical tariffs, prompting some to explore cobalt-chromium or biopolymer alternatives.

Europe grows at a 6.63% CAGR, supported by EU MDR rules that elevate quality thresholds and encourage advanced material research. Germany and the United Kingdom jointly account for more than half of regional robotic cases, boosting demand for highly articulated staplers. Many university hospitals measure procurement carbon footprints; as a result, reusable handles gain faster traction here than in North America. Local supply chains insulate the region from Asia-Pacific metal volatility, giving European OEMs continuity advantages during raw-material shocks.

Asia-Pacific posts the leading 8.34% CAGR through 2030. China, adding 12% yearly robotic capacity, is cultivating domestic stapler brands that undercut imports while chasing FDA clearance for export ambitions. India's USD 11 billion medical-device sector eyes double-digit growth on favorable tax holidays, backing capacity-expansion for powered staplers geared to tier-2 city hospitals. CE-cleared APAC innovators plan global rollout by 2035, intensifying competitive dynamics worldwide. The Middle East & Africa and South America track 7.82% and 7.29% CAGRs respectively, buoyed by medical-tourism corridors and hospital-infrastructure investments linked to national health-vision programs.

1. B. Braun
2. Beckton Dickinson
3. Conmed
4. EziSurg Medical
5. Frankenman International Ltd.
6. Grena Limited
7. Intuitive Surgical
8. Johnson & Johnson
9. Lexington Medical, Inc.
10. Medtronic
11. Meril Life Science
12. Purple Surgical
13. Reach Surgical Inc.
14. Smiths Group
15. Solventum Corporation
16. Standard Bariatrics
17. Stryker
18. Surgnova Healthcare Technologies
19. Teleflex
20. Zimmer Biomet

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

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 Integration with robotic-assisted surgery platforms
  • 4.2.2 Rising preference for minimally-invasive procedures
  • 4.2.3 Rapid adoption of powered & reloadable staplers
  • 4.2.4 Growing geriatric orthopedic procedures demanding fast skin-closure solutions
  • 4.2.5 Surge in bariatric & metabolic surgeries globally
  • 4.2.6 Hospital ESG mandates favoring reusable cartridge systems
• 4.3 Market Restraints
  • 4.3.1 Next-generation bioadhesive sealants reducing dependence on mechanical stapling
  • 4.3.2 Post-operative infection & leakage incidents
  • 4.3.3 Concentrated titanium supply disrupting staple raw material pricing
  • 4.3.4 Stringent regulatory safety requirements & recalls
• 4.4 Supply Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power of Buyers
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitute Products
  • 4.7.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value)

• 5.1 By Product
  • 5.1.1 Linear Surgical Stapler
  • 5.1.2 Circular Surgical Stapler
  • 5.1.3 Cutter Stapler
  • 5.1.4 Skin Stapler
  • 5.1.5 Stapler Reloads
• 5.2 By Application
  • 5.2.1 Abdominal Surgery
  • 5.2.2 Obstetrics & Gynecological Surgeries
  • 5.2.3 Cardiac & Thoracic Surgeries
  • 5.2.4 Orthopedic Surgery
  • 5.2.5 Other Surgical Applications
• 5.3 By Mechanism
  • 5.3.1 Manual
  • 5.3.2 Powered
• 5.4 By Usability
  • 5.4.1 Disposable
  • 5.4.2 Reusable
• 5.5 By End-User
  • 5.5.1 Hospitals
  • 5.5.2 Ambulatory Surgical Centers
  • 5.5.3 Specialty Clinics
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 India
    • 5.6.3.3 Japan
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East and Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Competitive Benchmarking
• 6.3 Market Share Analysis
• 6.4 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.4.1 B. Braun Melsungen AG
  • 6.4.2 Becton, Dickinson and Company
  • 6.4.3 ConMed Corporation
  • 6.4.4 EziSurg Medical
  • 6.4.5 Frankenman International Ltd.
  • 6.4.6 Grena Limited
  • 6.4.7 Intuitive Surgical Inc.
  • 6.4.8 Johnson & Johnson Services, Inc.
  • 6.4.9 Lexington Medical, Inc.
  • 6.4.10 Medtronic plc
  • 6.4.11 Meril Life Sciences Pvt. Ltd.
  • 6.4.12 Purple Surgical
  • 6.4.13 Reach Surgical Inc.
  • 6.4.14 Smith & Nephew plc
  • 6.4.15 Solventum Corporation
  • 6.4.16 Standard Bariatrics
  • 6.4.17 Stryker Corporation
  • 6.4.18 Surgnova Healthcare Technologies
  • 6.4.19 Teleflex Incorporated
  • 6.4.20 Zimmer Biomet Holdings Inc.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment