全球订书钉紧固装置市场：市场规模、份额和趋势分析（2025-2031 年）

2024年全球订书钉紧固装置市场规模为4.7亿美元。预计到2031年，该市场规模将达到约7.3亿美元，年复合成长率为6.5%。

本报告涵盖用于创伤、四肢和重组固定手术的形状记忆钉和机械加压钉。报告量化了销售量、平均售价 (ASP)、市场规模、成长率和企业市场占有率，并分析了市场驱动因素和限制因素、併购、技术趋势和监管动态。历史资料截至 2021 年，预测资料截至 2031 年。

市场概览

在创伤和重组手术中，骨钉固定係统用于固定骨碎片并促进癒合。这些装置因其操作简便、所需器械少以及能够在截骨和骨癒合部位提供可靠的加压而广受欢迎。在全球创伤市场中，骨钉固定係统是成长最快的固定方式之一，这得益于其临床适应症的不断扩大、人口老化以及材料设计的持续改进。

市场扩张反映了踝/脚、手部和小关节手术中微创固定方式的稳定普及。骨科医生经常使用缝合钉进行截骨术、关节融合术和小骨重组。与钢板螺丝固定相比，该装置的优势在于其低轮廓设计、高效的植入技术和更短的手术时间。

• 在全球范围内，需求受到三大相互关联的趋势所驱动：

与老化和肥胖相关的骨折发生率增加，推动了对固定装置的需求。

特种合金和形状记忆材料的创新

在发展中地区扩大创伤护理

镍钛合金形状记忆钉的问世具有革命性意义。镍钛合金的温度敏感性使其具有可控的伸长特性，能够在骨癒合或截骨部位提供可控的压力，促进骨癒合，同时最大限度地减少器械突出。随着竞争对手的涌入和技术的日益成熟，钉状固定装置已从一种小众解决方案发展成为某些解剖区域的主流固定选择。

市场驱动因素

人口统计因素

人口结构变化仍然是骨钉固定装置市场最强劲的成长动力之一。随着人口老化，骨质疏鬆症和肥胖症的盛行率持续上升。这两种疾病都会增加骨折风险并降低骨骼质量，扩大需要进行骨钉固定的患者群体。

全球约有10%的25岁以上成年人患有糖尿病，糖尿病会削弱骨骼结构并延缓癒合，增加骨折风险。随着人们寿命延长和慢性病盛行率上升，预期骨折发生率，尤其是髋部、踝部和足部骨折的发生率将会增加。

骨质疏鬆性骨折仍是老年人长期丧失行动能力的主要原因之一。这类骨折常发生于某些解剖部位，而微型固定装置（例如缝合钉）则能够在这些部位兼顾强度和微创性。随着医疗保健系统努力高效地满足老龄化人口的需求，缝合钉因其能够缩短手术时间并简化术后护理，可能会变得更加普及。

新兴技术

特种合金的快速发展正在改变钉合固定装置市场，製造商们推出了兼具弹性、形状记忆特性和耐腐蚀性的合金，从而提高了抗压强度和临床性能。

最突出的例子是镍钛合金（Nitinol），它具有在体温作用下恢復原状的特性。镍钛合金钉能够提供持续的压缩力，促进骨骼癒合，并最大限度地降低骨不连的风险。其简便性和可靠性使其在整形外科创伤、足部手术和脊椎融合手术中广泛使用。

同时，机械加压缝合钉也在不断改进，其符合人体工学的设计以及预紧力设计都更加简化了操作。许多系统提供不同长度的钉腿和钉桿配置，以适应不同的解剖部位。设计的多样性和新材料的出现，正推动着众多新创企业涌入这个高成长市场，试图分得一杯羹。

降低手术复杂性

与钢板螺丝固定相比，缝合钉可降低手术的复杂性并缩短手术时间。它们所需的辅助器具更少，植入速度更快，且无需精确的硬体对准。这些特性使其特别适用于希望提高手术室效率和病患接收能力的医疗机构。

这些工作流程优势促使外科医生越来越多地将缝合钉视为小骨和低应力区域的可行选择。缝合钉操作简便，也使其在门诊手术中心（ASC）中备受欢迎，因为这些中心注重使用小型器械和缩短手术时间，以提高效率并控製成本。

市场限制

与钢板和螺丝的竞争

儘管钉合式固定装置的应用日益广泛，但它仍然面临着来自传统钢板和螺丝的竞争，而钢板和螺丝是整形外科创伤领域的主要固定方法，它有着悠久的临床成功历史，并且深深植根于外科培训和医院供应链中。

这些结构提供了广泛的配置灵活性，使外科医生能够使用单一系统处理多种类型的骨折。大量临床证据支持钢板螺丝治疗的疗效，这不断增强了外科医生的信心，并减缓了某些适应症中采用缝合钉的转换速度。

平均售价下降

与其他整形外科植入物一样，钉合固定装置也面临价格压力。面对不断上涨的成本，医院和医疗系统越来越依赖集团采购组织 (GPO) 和政府采购来整合采购力量。这些筹资策略导致价格下降和采购标准化，压缩了供应商的利润空间。

自2021年中国推行价值导向型采购政策以来，平均售价（ASP）显着下降。西欧和北美也面临类似的压力，即使技术不断进步，供应商涨价的空间也受到限制。随着时间的推移，销售量将稳定成长，但市场价值扩张速度将会放缓。

医疗设备法规

新版欧洲医疗设备法规 (MDR) 的实施为製造商带来了巨大的合规成本。这些法规日益趋同于美国FDA 标准，并要求提供大量的临床证据才能获得产品核可和续约。这些成本可能会成为中小企业的一大障碍，而这些企业历来在设计旗舰新产品方面最具创新力。

监管负担的加重可能会在未来几年减缓创新和产品上市的步伐。对于现有製造商而言，合规成本的增加可能会提高维修成本，并限制其推出改进产品的灵活性，从而可能在某些地区市场扼杀竞争。

竞争分析

史赛克

截至2024年，史赛克（Stryker）是全球缝合钉固定器材市场的领导者。该公司提供种类丰富的缝合钉产品，其可靠性和性能享誉全球。史赛克的成功归功于其广泛的全球分销网络、强大的临床支持体係以及将缝合钉产品整合到庞大的整形外科和创伤产品组合中的能力。预计该公司强大的品牌实力和与外科医生建立的长期合作关係将继续巩固其在预测期内的主导地位。

德普合成公司

DePuy Synthes在全球市场占据第二大份额，这主要得益于主导地位。该公司专有的镍钛合金技术使其钉子可在常温下使用，从而在置入过程中提供更佳的操作性和更稳定的压迫力。这些专有专利在形状记忆系统日益普及的市场中赋予了DePuy Synthes强大的竞争优势。随着产品不断改进并整合到其创伤护理产品组合中，DePuy Synthes有望继续保持其在全球钉固定装置市场的份额。

Arthrex

Arthrex在全球市占率排名第三，在机械加压缝合钉和形状记忆缝合钉领域均占有重要地位。进军国际市场，尤其是西欧市场，进一步巩固了公司的市场地位。公司的优势在于其在创伤和运动医学领域与外科医生建立的牢固关係、广泛的教育推广以及卓越的创新声誉。预计持续的地域扩张和产品线拓展将推动公司在2031年之前实现永续成长。

其他竞争对手，例如 Zimmer Biomet、CONMED 和 Acumed，则服务于特定市场，拥有专注于特定解剖区域或手术类型的利基产品系列。儘管这些公司在全球市场份额较小，但它们透过专业的设备设计和区域性专业知识为创新做出了贡献。

市场区隔摘要

• 订书钉紧固装置市场进一步细分为以下几个部分：

形状记忆订书钉

机械加压钉

• 量化指标：市场规模、市占率、预测、成长率、销售量、平均售价。
• 定性内容：市场成长趋势、市场限制、主要竞争对手的竞争和 SWOT 分析、併购、公司简介、产品系列、颠覆性技术、疾病概况。
• 资料来源：对行业领导者的直接访谈、监管和医院资料、私人采购资料、进出口记录以及 iData Research 的内部资料库。

技术与实务的趋势

由于镍钛诺基形状记忆合金具有优异的弹性和温度相关的压缩性能，因此在产品创新方面处于主导。

预载机械压缩系统简化了植入过程，并标准化了压缩力。

符合人体解剖学形状的缝合钉可改善骨骼接触并最大限度地减少刺激。

无菌一次性试剂盒可简化工作流程并降低污染风险。

微创设备可以帮助在门诊手术机构实施手术，加速术后恢復。

数位化模板和影像相容性提高了术前规划和手术精度。

目标市场和数据范围

• 週期：基准年 2024 年，预测期间 2025-2031 年，历史资料 2021-2023 年。
• 医疗机构：医院、整形外科创伤中心和门诊手术中心（ASC）。
• 调查方法：市场收入透过单位销售乘以平均售价 (ASP) 计算得出，并透过程式建模、医院采购数据和製造商报告的销售额进行检验。

地区

本期内容涵盖北美、欧洲、亚太地区、拉丁美洲以及中东和非洲等全球范围。

附录简称调查方法。

目录

图表清单

图表列表

调查方法

全球关税的影响

订书针固定装置市场

• 执行摘要
  • 全球订书钉紧固装置市场概览
  • 竞争分析
  • 流程分段
  • 市场区隔
  • 目标区域
• 介绍
• 手术次数
  • 钉合固定装置技术
• 市场概览
  • 按细分市场
  • 按地区
• 市场分析与预测
  • 订书针固定装置总市场
  • 形状记忆订书机市场
  • 机械式压缩缝合装置市场
• 驾驶员和约束装置
• 竞争市占率分析

简称

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