全球訂書釘緊固裝置市場：市場規模、佔有率和趨勢分析（2025-2031 年）

2024年全球訂書釘緊固裝置市場規模為4.7億美元。預計到2031年，該市場規模將達到約7.3億美元，年複合成長率為6.5%。

本報告涵蓋用於創傷、四肢和重組固定手術的形狀記憶釘和機械加壓釘。報告量化了銷售量、平均售價 (ASP)、市場規模、成長率和企業市場占有率，並分析了市場促進因素和限制因素、併購、技術趨勢和監管動態。歷史資料截至 2021 年，預測資料截至 2031 年。

市場概覽

在創傷和重組手術中，骨釘固定系統用於固定骨碎片並促進癒合。這些裝置因其操作簡便、所需器械少以及能夠在截骨和骨癒合部位提供可靠的加壓而廣受歡迎。在全球創傷市場中，骨釘固定系統是成長最快的固定方式之一，這得益於其臨床適應症的不斷擴大、人口老化以及材料設計的持續改進。

市場擴張反映了踝/腳、手部和小關節手術中微創固定方式的穩定普及。骨科醫生經常使用縫合釘進行截骨術、關節融合術和小骨重組。與鋼板螺絲固定相比，該裝置的優勢在於其低輪廓設計、高效的植入技術和更短的手術時間。

• 在全球範圍內，需求受到三大相互關聯的趨勢所驅動：

與老化和肥胖相關的骨折發生率增加，推動了對固定裝置的需求。

特種合金和形狀記憶材料的創新

在發展中地區擴大創傷護理

鎳鈦合金形狀記憶釘的問世具有革命性意義。鎳鈦合金的溫度敏感性使其具有可控的伸長特性，能夠在骨癒合或截骨部位提供可控的壓力，促進骨癒合，同時最大限度地減少器械突出。隨著競爭對手的湧入和技術的日益成熟，釘狀固定裝置已從一種小眾解決方案發展成為某些解剖區域的主流固定選擇。

市場促進因素

人口統計因素

人口結構變化仍然是骨釘固定裝置市場最強勁的成長動力之一。隨著人口老化，骨質疏鬆症和肥胖症的盛行率持續上升。這兩種疾病都會增加骨折風險並降低骨骼質量，擴大需要進行骨釘固定的患者群體。

全球約有10%的25歲以上成年人患有糖尿病，糖尿病會削弱骨骼結構並延緩癒合，增加骨折風險。隨著人們壽命延長和慢性病盛行率上升，預期骨折發生率，尤其是髖部、踝部和足部骨折的發生率將會增加。

骨質疏鬆性骨折仍是老年人長期喪失行動能力的主要原因之一。這類骨折常發生於某些解剖部位，而微型固定裝置（例如縫合釘）則能夠在這些部位兼顧強度和微創性。隨著醫療保健系統努力高效地滿足老齡化人口的需求，縫合釘因其能夠縮短手術時間並簡化術後護理，可能會變得更加普及。

新興技術

特種合金的快速發展正在改變釘合固定裝置市場，製造商們推出了兼具彈性、形狀記憶特性和耐腐蝕性的合金，從而提高了抗壓強度和臨床性能。

最突出的例子是鎳鈦合金（Nitinol），它具有在體溫作用下恢復原狀的特性。鎳鈦合金釘能夠提供持續的壓縮力，促進骨骼癒合，並最大限度地降低骨不連的風險。其簡便性和可靠性使其在整形外科創傷、足部手術和脊椎融合手術中廣泛使用。

同時，機械加壓縫合釘也在不斷改進，其符合人體工學的設計以及預緊力設計都更加簡化了操作。許多系統提供不同長度的釘腿和釘桿配置，以適應不同的解剖部位。設計的多樣性和新材料的出現，正推動著眾多新創企業湧入這個高成長市場，試圖分得一杯羹。

降低手術複雜性

與鋼板螺絲固定相比，縫合釘可降低手術的複雜性並縮短手術時間。它們所需的輔助器具更少，植入速度更快，且無需精確的硬體對準。這些特性使其特別適用於希望提高手術室效率和病患接收能力的醫療機構。

這些工作流程優勢促使外科醫生擴大將縫合釘視為小骨和低應力區域的可行選擇。縫合釘操作簡便，也使其在門診手術中心（ASC）中備受歡迎，因為這些中心注重使用小型器械和縮短手術時間，以提高效率並控制成本。

市場限制

與鋼板和螺絲的競爭

儘管釘合式固定裝置的應用日益廣泛，但它仍然面臨著來自傳統鋼板和螺絲的競爭，而鋼板和螺絲是整形外科創傷領域的主要固定方法，它有著悠久的臨床成功歷史，並且深深植根於外科培訓和醫院供應鏈中。

這些結構提供了廣泛的配置靈活性，使外科醫生能夠使用單一系統處理多種類型的骨折。大量臨床證據支持鋼板螺絲治療的療效，這不斷增強了外科醫生的信心，並減緩了某些適應症中採用縫合釘的轉換速度。

平均售價下降

與其他整形外科植入物一樣，釘合固定裝置也面臨價格壓力。面對不斷上漲的成本，醫院和醫療系統越來越依賴集團採購組織 (GPO) 和政府採購來整合採購力量。這些籌資策略導致價格下降和採購標準化，壓縮了供應商的利潤空間。

自2021年中國推行價值導向型採購政策以來，平均售價（ASP）顯著下降。西歐和北美也面臨類似的壓力，即使技術不斷進步，供應商漲價的空間也受到限制。隨著時間的推移，銷售量將穩定成長，但市場價值擴張速度將會放緩。

醫療設備法規

新版歐洲醫療設備法規 (MDR) 的實施為製造商帶來了巨大的合規成本。這些法規日益趨同於美國FDA 標準，並要求提供大量的臨床證據才能獲得產品核可和續約。這些成本可能會成為中小企業的一大障礙，而這些企業歷來在設計旗艦新產品方面最具創新力。

監管負擔的加重可能會在未來幾年減緩創新和產品上市的步伐。對於現有製造商而言，合規成本的增加可能會提高維修成本，並限制其推出改進產品的靈活性，從而可能在某些地區市場扼殺競爭。

競爭分析

史賽克

截至2024年，史賽克（Stryker）是全球縫合釘固定器材市場的領導者。該公司提供種類豐富的縫合釘產品，其可靠性和性能享譽全球。史賽克的成功歸功於其廣泛的全球分銷網路、強大的臨床支持體係以及將縫合釘產品整合到龐大的整形外科和創傷產品組合中的能力。預計該公司強大的品牌實力和與外科醫生建立的長期合作關係將繼續鞏固其在預測期內的主導地位。

德普合成公司

DePuy Synthes在全球市場佔據第二大佔有率，這主要得益於主導地位。該公司專有的鎳鈦合金技術使其釘子可在常溫下使用，從而在置入過程中提供更佳的操作性和更穩定的壓迫力。這些專有專利在形狀記憶系統日益普及的市場中賦予了DePuy Synthes強大的競爭優勢。隨著產品不斷改進並整合到其創傷護理產品組合中，DePuy Synthes有望繼續保持其在全球釘固定裝置市場的佔有率。

Arthrex

Arthrex在全球市佔率排名第三，在機械加壓縫合釘和形狀記憶縫合釘領域均佔有重要地位。進軍國際市場，尤其是西歐市場，進一步鞏固了公司的市場地位。公司的優勢在於其在創傷和運動醫學領域與外科醫生建立的牢固關係、廣泛的教育推廣以及卓越的創新聲譽。預計持續的地域擴張和產品線拓展將推動公司在2031年之前實現永續成長。

其他競爭對手，例如 Zimmer Biomet、CONMED 和 Acumed，則服務於特定市場，擁有專注於特定解剖區域或手術類型的利基產品系列。儘管這些公司在全球市場佔有率較小，但它們透過專業的設備設計和區域性專業知識為創新做出了貢獻。

市場區隔摘要

• 訂書釘緊固裝置市場進一步細分為以下幾個部分：

形狀記憶訂書釘

機械加壓釘

• 量化指標：市場規模、市佔率、預測、成長率、銷售量、平均售價。
• 定性內容：市場成長趨勢、市場限制、主要競爭對手的競爭和 SWOT 分析、併購、公司簡介、產品系列、顛覆性技術、疾病概況。
• 資料來源：對行業領導者的直接訪談、監管和醫院資料、私人採購資料、進出口記錄以及 iData Research 的內部資料庫。

技術與實務的趨勢

由於鎳鈦諾基形狀記憶合金具有優異的彈性和溫度相關的壓縮性能，因此在產品創新方面處於主導。

預載機械壓縮系統簡化了植入過程，並標準化了壓縮力。

符合人體解剖學形狀的縫合釘可改善骨骼接觸並最大限度地減少刺激。

無菌一次性試劑盒可簡化工作流程並降低污染風險。

微創設備可以幫助在門診手術機構實施手術，加速術後恢復。

數位化模板和影像相容性提高了術前規劃和手術精度。

目標市場和數據範圍

• 週期：基準年 2024 年，預測期間 2025-2031 年，歷史資料 2021-2023 年。
• 醫療機構：醫院、整形外科創傷中心和門診手術中心（ASC）。
• 調查方法：市場收入透過單位銷售乘以平均售價 (ASP) 計算得出，並透過程式建模、醫院採購數據和製造商報告的銷售額進行檢驗。

地區

本期內容涵蓋北美、歐洲、亞太地區、拉丁美洲以及中東和非洲等全球範圍。

附錄簡稱調查方法。

目錄

圖表清單

圖表列表

調查方法

全球關稅的影響

訂書針固定裝置市場

• 執行摘要
  • 全球訂書釘緊固裝置市場概覽
  • 競爭分析
  • 流程分段
  • 市場區隔
  • 目標區域
• 介紹
• 手術次數
  • 釘合固定裝置技術
• 市場概覽
  • 按細分市場
  • 按地區
• 市場分析與預測
  • 訂書針固定裝置總市場
  • 形狀記憶訂書機市場
  • 機械式壓縮縫合裝置市場
• 駕駛員和約束裝置
• 競爭市佔率分析

簡稱

The global staple fixation market was valued at $470 million in 2024. The market is expected to grow at a compound annual growth rate (CAGR) of 6.5 percent, reaching nearly $730 million by 2031.

This report covers shape memory and mechanical compression staples used in trauma, extremity, and reconstructive fixation procedures. It quantifies unit sales, average selling prices (ASPs), market values, growth rates, and company shares, while analyzing market drivers and limiters, mergers and acquisitions, technology trends, and regulatory developments. Historical data extend to 2021, and forecasts run through 2031.

Market Overview

Staple fixation systems are used in trauma and reconstructive surgery to secure bone fragments and accelerate healing. These devices have gained attention due to their simplicity, minimal instrumentation, and ability to provide reliable compression across osteotomy or fusion sites. In the global trauma market, staples represent one of the fastest-growing fixation options, supported by expanding clinical indications, a growing elderly population, and ongoing improvements in material design.

The market's rise reflects steady adoption in foot and ankle, hand, and small joint surgeries, where minimally invasive fixation is preferred. Orthopedic surgeons often use staples for osteotomies, arthrodesis, and small bone reconstruction. The devices are attractive for their low profile, efficient insertion technique, and reduced surgical time compared to plate-and-screw constructs.

• Globally, demand is being driven by three intersecting trends:

Aging and obesity-related fracture incidence, which increases the need for fixation devices;

Technological innovation in specialty alloys and shape memory materials; and

Broader access to trauma care in developing regions.

The introduction of nitinol-based shape memory staples has been particularly transformative. Nitinol's temperature-sensitive expansion provides controlled compression at the fusion or osteotomy site, enhancing bone healing and minimizing hardware prominence. As more competitors enter the market and technology matures, staple fixation is evolving from a niche solution to a mainstream fixation option in select anatomical regions.

Market Drivers

Demographic Factors

Demographic shifts remain one of the strongest growth engines for the staple fixation market. Populations are aging, and the prevalence of osteoporosis and obesity continues to climb. Both conditions increase fracture risk and reduce bone quality, expanding the pool of patients who require fixation.

Globally, nearly 10 percent of adults over age 25 are affected by diabetes, which compounds fracture risk by weakening bone structure and delaying healing. As individuals live longer and chronic disease prevalence rises, the incidence of fractures-particularly hip, ankle, and foot fractures-is expected to increase.

In older adults, osteoporotic fractures remain the leading cause of long-term mobility loss. These fractures frequently occur in anatomical regions where smaller fixation devices, such as staples, can offer a balance of strength and minimal invasiveness. As healthcare systems adapt to treat aging populations efficiently, staples are expected to gain further traction for their ability to reduce operative time and simplify postoperative care.

Emerging Technology

The rapid evolution of specialty alloys is reshaping the staple fixation market. Manufacturers are introducing alloys that combine elasticity, memory properties, and corrosion resistance, which improve compressive strength and clinical performance.

The most notable example is nitinol, a nickel-titanium alloy that returns to its original shape when exposed to body temperature. Nitinol staples deliver continuous compression over time, aiding fusion and minimizing nonunion risk. Their simplicity and reliability have led to growing adoption in orthopedic trauma, podiatric, and spinal fusion applications.

In parallel, mechanical compression staples have improved through better ergonomics and preloaded designs that simplify handling. Many systems now offer variable leg lengths and bar configurations to address different anatomical sites. The combination of design versatility and new materials has led to an influx of new entrants seeking to capture share in this high-growth segment.

Reduced Surgical Complexity

Staples reduce the complexity and duration of surgical procedures compared to plate and screw constructs. They require fewer accessory instruments, have shorter insertion times, and eliminate the need for extensive hardware alignment. This makes them particularly suitable for facilities aiming to improve operating room efficiency and patient throughput.

Because of these workflow advantages, surgeons often view staples as an effective option for smaller bones or less demanding load-bearing regions. The procedural simplicity also makes staple fixation attractive in ambulatory surgical centers (ASCs), where compact instrumentation and shorter procedures are valued for efficiency and cost control.

Market Limiters

Competition from Plates and Screws

Despite growing adoption, staple fixation devices still face competition from traditional plates and screws, which remain the dominant fixation method in orthopedic trauma. Plates and screws have a long-established clinical track record and are deeply integrated into surgical training and hospital supply chains.

These constructs offer broad configurational flexibility, allowing surgeons to address diverse fracture types with a single system. The depth of clinical evidence supporting plate-and-screw outcomes continues to reinforce surgeon confidence, slowing the rate of staple conversion in certain indications.

ASP Decreases

Like other orthopedic implant categories, staple fixation is affected by pricing pressure. Hospitals and healthcare systems face rising costs and increasingly rely on group purchasing organizations (GPOs) and government tenders to consolidate buying power. These procurement strategies favor lower pricing and standardized purchasing, which compresses margins across suppliers.

Regions such as China, following the introduction of value-based procurement policies in 2021, have seen significant ASP reductions. Similar pressures in Western Europe and North America limit the ability of suppliers to raise prices even as technology advances. Over time, this will moderate market value expansion despite steady growth in unit sales.

Medical Device Regulation

The introduction of new medical device regulation (MDR) in Europe has added significant compliance costs for manufacturers. These rules align more closely with U.S. FDA standards and require extensive clinical evidence for product approval and renewal. Smaller companies, which have historically been the most innovative in developing new staple designs, may find these costs prohibitive.

This increased regulatory burden could slow the pace of innovation and product launches in the coming years. For established manufacturers, compliance raises the cost of maintaining CE certification and limits flexibility in launching incremental product variations, potentially dampening competition in some regional markets.

Competitive Analysis

Stryker

Stryker was the leading competitor in the global staple fixation market in 2024. The company offers a comprehensive range of staples recognized worldwide for reliability and performance. Stryker's success stems from its broad global distribution network, extensive clinical support programs, and ability to bundle staple products within larger orthopedic and trauma portfolios. The company's brand strength and long-standing surgeon relationships are expected to sustain its leading position over the forecast period.

DePuy Synthes

DePuy Synthes held the second-largest share of the global market, driven primarily by leadership in shape memory staples. The company's proprietary nitinol technology enables staples to be used at room temperature, offering improved ease of use and consistent compression upon implantation. These unique patents provide a strong competitive edge in markets where shape memory systems are gaining popularity. With continued product refinement and integration into broader trauma portfolios, DePuy Synthes is expected to maintain its share in the global staple fixation market.

Arthrex

Arthrex ranked third globally, with significant presence in both mechanical compression and shape memory staple segments. The company's expansion into international markets, particularly in Western Europe, has strengthened its position. Arthrex benefits from strong surgeon engagement, educational outreach, and a reputation for innovation across trauma and sports medicine segments. Its continued geographic expansion and broadening of product lines are expected to support sustained growth through 2031.

Other competitors, including Zimmer Biomet, CONMED, and Acumed, participate in select markets with niche portfolios focused on specific anatomical regions or procedural types. While these companies hold smaller global shares, they contribute to innovation through specialized device designs and regional expertise.

Market Segmentation Summary

• Staple Fixation Market - Further Segmented Into:

Shape Memory Staples

Mechanical Compression Staples

• Quantitative Coverage: Market size, market shares, forecasts, growth rates, units sold, and average selling prices.
• Qualitative Coverage: Market growth trends, market limiters, competitive analysis and SWOT for top competitors, mergers and acquisitions, company profiles, product portfolios, disruptive technologies, and disease overviews.
• Data Sources: Primary interviews with industry leaders, regulatory and hospital data, private purchasing data, import/export records, and iData Research's internal database.

Technology and Practice Trends

Nitinol-based shape memory alloys dominate product innovation due to superior elastic properties and temperature-dependent compression.

Preloaded mechanical compression systems simplify implantation and standardize compression force.

Anatomically contoured staples improve bone contact and minimize irritation.

Sterile single-use kits improve workflow efficiency and reduce contamination risk.

Minimally invasive instrumentation supports ASC adoption and faster postoperative recovery.

Digital templating and imaging compatibility improve preoperative planning and procedural precision.

Market Coverage and Data Scope

• Time Frame: Base year 2024, forecasts 2025-2031, historical data 2021-2023.
• Care Settings: Hospitals, orthopedic trauma centers, and ambulatory surgical centers (ASCs).
• Methodology: Market revenues calculated as units multiplied by ASP, validated through procedure modeling, hospital procurement data, and manufacturer-reported sales.

Geography

This edition provides global coverage across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa.

Methodology Appendix and Acronym Glossary included.

Why This Report

Identify which staple types-shape memory or mechanical compression-are growing fastest and where.

Understand how demographics, chronic diseases, and new alloys will shape the next phase of market expansion.

Benchmark top competitors and assess how product patents and portfolios affect global share.

Quantify how procurement pressures and regulatory changes will influence ASPs and profitability.

Explore where staples outperform plates and screws and in which indications they are gaining share.

Track regional adoption trends across North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa.

The Global Staple Fixation Market Report from iData Research delivers comprehensive, device-level analysis with company share tracking, pricing benchmarks, and technology outlooks.

It helps suppliers, investors, and strategists quantify demand, evaluate competition, and plan for long-term growth in this expanding orthopedic fixation market.

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

Staple Fixation Market

• 10.1 Executive Summary
  • 10.1.1 Global Staple Fixation Market Overview
  • 10.1.2 Competitive Analysis
  • 10.1.3 Procedure Segmentation
  • 10.1.4 Market Segmentation
  • 10.1.5 Regions Included
• 10.2 Introduction
• 10.3 Procedure Numbers
  • 10.3.1 Total Staple Fixation Procedures
• 10.4 Market Overview
  • 10.4.1 By Segment
  • 10.4.2 By Region
• 10.5 Market Analysis And Forecast
  • 10.5.1 Total Staple Fixation Market
  • 10.5.2 Shape Memory Staple Fixation Market
  • 10.5.3 Mechanical Compression Staple Fixation Market
• 10.6 Drivers And Limiters
  • 10.6.1 Market Drivers
  • 10.6.2 Market Limiters
• 10.7 Competitive Market Share Analysis

Abbreviations

LIST OF CHARTS

• Chart 10-1: Staple Fixation Market, Global, 2024 & 2031
• Chart 10-2: Staple Fixation Procedures, Global, 2024
• Chart 10-3: Staple Fixation Procedures by Region, Global, 2021 - 2031
• Chart 10-4: Staple Fixation Market by Segment, Global, 2021 - 2031
• Chart 10-5: Staple Fixation Market by Region, Global, 2021 - 2031
• Chart 10-6: Leading Competitors, Staple Fixation Market, Global, 2024

LIST OF FIGURES

• Figure 10-1: Staple Fixation Procedure Segmentation
• Figure 10-2: Staple Fixation Market Segmentation
• Figure 10-3: Staple Fixation Regions Covered, Global (1 of 2)
• Figure 10-4: Staple Fixation Regions Covered, Global (2 of 2)
• Figure 10-5: Staple Fixation Procedures by Region, Global, 2021 - 2031
• Figure 10-6: Staple Fixation Procedures by Country, North America, 2021 - 2031
• Figure 10-7: Staple Fixation Procedures by Country, Latin America, 2021 - 2031 (1 of 2)
• Figure 10-8: Staple Fixation Procedures by Country, Latin America, 2021 - 2031 (2 of 2)
• Figure 10-9: Staple Fixation Procedures by Country, Western Europe, 2021 - 2031
• Figure 10-10: Staple Fixation Procedures by Country, Central & Eastern Europe, 2021 - 2031 (1 of 2)
• Figure 10-11: Staple Fixation Procedures by Country, Central & Eastern Europe, 2021 - 2031 (2 of 2)
• Figure 10-12: Staple Fixation Procedures by Country, Middle East, 2021 - 2031
• Figure 10-13: Staple Fixation Procedures by Country, Asia-Pacific, 2021 - 2031 (1 of 3)
• Figure 10-14: Staple Fixation Procedures by Country, Asia-Pacific, 2021 - 2031 (2 of 3)
• Figure 10-15: Staple Fixation Procedures by Country, Asia-Pacific, 2021 - 2031 (3 of 3)
• Figure 10-16: Staple Fixation Procedures by Country, Africa, 2021 - 2031
• Figure 10-17: Staple Fixation Market by Segment, Global, 2021 - 2031 (US$M)
• Figure 10-18: Staple Fixation Market by Region, Global, 2021 - 2031 (US$M)
• Figure 10-19: Staple Fixation Market, Global, 2021 - 2031
• Figure 10-20: Units Sold by Region, Staple Fixation Market, Global, 2021 - 2031
• Figure 10-21: Average Selling Price by Region, Staple Fixation Market, Global, 2021 - 2031 (US$)
• Figure 10-22: Market Value by Region, Staple Fixation Market, Global, 2021 - 2031 (US$M)
• Figure 10-23: Shape Memory Staple Fixation Market, Global, 2021 - 2031
• Figure 10-24: Units Sold by Region, Shape Memory Staple Fixation Market, Global, 2021 - 2031
• Figure 10-25: Average Selling Price by Region, Shape Memory Staple Fixation Market, Global, 2021 - 2031 (US$)
• Figure 10-26: Market Value by Region, Shape Memory Staple Fixation Market, Global, 2021 - 2031 (US$M)
• Figure 10-27: Mechanical Compression Staple Fixation Market, Global, 2021 - 2031
• Figure 10-28: Units Sold by Region, Mechanical Compression Staple Fixation Market, Global, 2021 - 2031
• Figure 10-29: Average Selling Price by Region, Mechanical Compression Staple Fixation Market, Global, 2021 - 2031 (US$)
• Figure 10-30: Market Value by Region, Mechanical Compression Staple Fixation Market, Global, 2021 - 2031 (US$M)
• Figure 10-31: Leading Competitors, Staple Fixation Market, Global, 2024