全球外固定装置市场：市场规模、份额和趋势分析（2025-2031 年）

预计到 2024 年，全球外固定装置市场规模将达到 8.4 亿美元，到 2031 年将达到约 10 亿美元，年复合成长率为 2.8%。

本报告涵盖创伤和重组手术中使用的单侧和环状外固定装置。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。此外，报告还分析了手术趋势、市场驱动因素和限制因素、技术进步、近期併购以及竞争策略。历史资料截至 2021 年，预测持续至 2031 年。

市场概览

外固定是整形外科创伤治疗的基石，当内固定不适用或有禁忌症时，外固定可用于稳定骨折部位。这些系统由钢针、钢棒、夹具和连接框架组成，透过经皮固定来固定骨碎片，从而在癒合过程中进行逐步调整和稳定。

在全球范围内，外固定仍是治疗多发性创伤、开放性骨折、肢体畸形矫正和复杂骨不连的关键手段。虽然内固定在某些市场持续扩大市场份额，但外固定仍在严重创伤、小儿整形外科和重组手术中发挥不可替代的作用。

市场稳定成长主要得益于手术量的增加、涂层技术的进步以及固定材料和设计的持续创新。例如，用于促进骨整合的羟基磷灰石层和用于预防感染的抑菌涂层等钉涂层技术的进步，有助于减少术后併发症并提升产品价值。

此外，外固定市场也间接受益于内固定的扩张：使用外固定装置进行临时固定通常领先使用钢板或螺丝进行最终固定，这意味着骨折治疗的发展总体上支持了外固定的需求。

在新兴地区，由于创伤护理的可及性提高以及医院对经济实惠、可重复使用的器械套装的需求，其使用量持续扩大；而在已开发市场，由于手术复杂性增加以及对结合了半固定和环形固定元素的混合固定係统的偏好，高风险患者的平均售价 (ASP) 略有上涨。

市场驱动因素

暂时固定的适应症

外固定广泛用于复杂骨折（包括严重粉碎性骨折和开放性骨折）的临时固定。外科医师使用这些系统来对齐和固定骨碎片，待病患病情稳定或软组织状况允许后，再进行内固定。这种「过渡到最终固定」的模式确保了外固定装置的重要性，即使内固定手术的数量不断增加。因此，外固定市场与创伤手术的总数同步成长。

微创手术

虽然内固定是许多择期手术的主流方法，但在开放手术风险较高的情况下，外固定仍然至关重要。这些系统透过较小的切口和较少的出血提供微创稳定性。其优点包括手术时间更短、组织损伤更小以及更早恢復活动，尤其适用于多重伤害或健康状况不佳的患者。

使用抑菌涂层（例如硝酸银）和促进骨骼生长的涂层（例如羟基磷灰石）进一步提高了安全性，并降低了感染率。这些因素，加上人体工学的改进和模组化程度的提高，促使外固定技术在内固定技术日益普及的同时，仍被广泛应用。

使用骨移植替代物

在创伤和重组外科手术中，骨移植替代材料和骨糊剂的整合应用，外固定装置的使用提供了支持。这些材料能够促进骨再生，并逐渐被人体吸收，因此必须在整个癒合期间保持指定。外固定装置可在移植材料整合过程中提供稳定的定位，并促进骨移植替代材料与固定装置之间的平行生长。

涂料与材料创新

钉涂层技术的进步是市场稳定的关键因素。羟基磷灰石涂层可促进骨骼长入并减少微动，而抑菌涂层则可最大限度地减少细菌定植。这些进步降低了感染风险，改善了长期疗效，增强了外科医师对外部固定作为一种安全持久的治疗方案的信心。

市场限制

竞标竞争

公共采购（竞标）是外部固定市场定价的主要驱动因素。政府和医院系统越来越多地透过竞争性竞标进行批量采购，供应商主要以价格作为竞标。竞标的主导地位，尤其是在欧洲、亚太和中东地区，正持续对平均售价（ASP）构成下行压力。

大型製造商在参与竞标处于有利地位，而小型企业则难以保持盈利，这加强了大型跨国供应商的主导地位，即使整体市场价值增长仍然温和。

设备再利用

根据当地法规和政策，外固定装置，特别是框架和夹具，在消毒后通常可以重复使用。虽然出于感染控制的考虑，官方并不建议这样做，但在某些地区，为了降低成本，部分重复使用的做法仍然存在。这种做法限制了更换量，减缓了设备的成长速度，尤其是在预算紧张的市场。

灭菌和再处理会产生一定的成本，部分抵消了节省的费用，但对市场成长的整体影响仍然是负面的。随着医院持续关注成本控制，再利用仍将是限制总收入成长的重要因素。

国内固定市场的成长

内固定装置（如钢板、螺丝和髓内钉）的成功在一定程度上是以牺牲外固定係统为代价的。钛植入和解剖型钢板的日益普及扩大了内固定可治疗的骨折类型范围。特别是，髓内钉在股骨和髋骨等长骨骨折的治疗中越来越广泛使用。

儘管外固定仍用于复杂创伤和畸形矫正，但由于内固定恢復时间更短且美容效果更佳，需要外固定的适应症数量正在减少。随着内固定係统的进步，成熟经济外固定外固定的单位成长率呈现下降趋势。

竞争分析

德普合成公司

2024年，DePuy Synthes持续保持在全球外固定器材市场的领先地位。该公司拥有丰富且成熟的产品线，包括模组化单侧固定係统、混合框架和儿科专用器械。 DePuy Synthes的销售网络和卓越的品质口碑持续增强了外科医生的忠诚度和医院的青睐。预计其强劲的市场地位将在整个预测期内保持下去。

史赛克

史赛克在全球市占率排名第二，其霍夫曼™外固定係统广为人知，该系统广泛应用于急性创伤和重组手术。史赛克在许多发展中地区占据领先地位，并在北美和西欧保持着强劲的市场份额。史赛克专注于设计效率、模组化调节和可互换器械，将易用性与手术流程的一致性相结合，从而推动了其稳定成长。

史密斯和内夫

史密斯医疗在全球市场份额排名第三，这主要得益于其专业的环形系统，尤其是泰勒空间框架®（Taylor Spatial Frame®），该产品在复杂畸形矫正和肢体延长方面赢得了良好的声誉。公司在全球范围内，尤其是在北美和西欧的业务布局，巩固了其在先进外科手术应用领域的地位。持续投资于技术和外科医生培训项目，并有望帮助公司保持其竞争优势。

其他参与企业包括 Zimmer Biomet、Orthofix 以及几家提供价格具有竞争力的单侧系统的地区性製造商。虽然这些公司总合市场份额较小，但它们正在加剧竞标竞争，并在价格敏感的市场中扩大市场准入。

市场范围和细分

• 外固定装置市场进一步细分为以下几个部分：

单侧外固定装置

环形外固定装置

• 量化指标：市场规模、市场占有率、市场预测、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：对产业领导者的直接访谈、政府和监管机构资料、医院采购资料、进出口记录、iData Research 内部资料库。

技术与实务的趋势

混合型外固定装置正被越来越多地使用，它结合了单侧固定的简单性和环形系统的多功能性。

在销钉和钢丝上涂上羟基磷灰石和抑菌剂，可以持续降低感染率并提高固定稳定性。

轻质合金和碳纤维桿增强了框架强度，同时最大限度地减少了患者的不适感。

与数位成像技术的兼容性使得精准定位和术后调整成为可能。

可重复使用零件管理和灭菌追踪系统可提高成本控制和合规性。

畸形矫正手术的培训和模拟工具使外科医生能够熟练先进的框架结构。

市场和数据覆盖范围

• 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：全球的医院、创伤中心和专业整形外科机构。
• 调查方法：市场收入采用单位乘法模型检验，以平均售价 (ASP) 为基础，并结合手术量、竞标数据和医院采购资讯进行三角验证。

附件包括补充调查方法文件和简称词彙表。

目录

图表清单

图表列表

调查方法

全球关税的影响

外固定装置市场

• 执行摘要
  • 全球外固定装置市场概览
  • 竞争分析
  • 流程分段
  • 市场区隔
  • 目标区域
• 介绍
• 手术次数
  • 全外固定
• 市场概览
  • 按细分市场
  • 按地区
• 市场分析与预测
  • 整体外固定装置市场
  • 圆形外固定装置市场
  • 单侧外固定市场
  • 基于解剖单元分析的外固定
• 驾驶员和约束装置
• 竞争市占率分析

简称

The global external fixation market was valued at $840 million in 2024 and is projected to increase at a compound annual growth rate (CAGR) of 2.8 percent, reaching approximately $1 billion by 2031.

This report covers unilateral and circular external fixation devices used for trauma and reconstructive procedures. It quantifies unit sales, average selling prices (ASPs), market values, growth rates, and company shares, and analyzes procedure trends, market drivers and limiters, technology advancements, recent mergers and acquisitions, and competitive strategies. Historical data extend to 2021 and forecasts continue through 2031.

Market Overview

External fixation is a cornerstone in orthopedic trauma management, providing stabilization for fractures where internal fixation is not immediately suitable or contraindicated. These systems consist of pins, rods, clamps, and connecting frames that secure bone fragments through percutaneous attachment, allowing for gradual adjustment and stabilization during healing.

Globally, external fixation remains vital in the treatment of polytrauma, open fractures, limb deformity correction, and complex nonunions. While internal fixation continues to expand its share in some markets, external fixation holds an irreplaceable role in severe trauma, pediatric orthopedics, and reconstructive surgery.

The market's steady growth is driven by increasing surgical volumes, advances in coating technology, and ongoing innovation in fixation materials and design. Pin-coating advancements-such as hydroxyapatite layers that encourage osteointegration and bacteriostatic coatings that resist infection-are helping to reduce postoperative complications and extend product value.

Moreover, the external fixation market benefits indirectly from the expansion of internal fixation. Temporary fixation using external devices often precedes definitive plate or nail fixation, meaning growth in overall fracture care also sustains external fixation demand.

Emerging regions continue to expand usage as access to trauma care improves and as hospitals seek cost-effective, reusable instrumentation sets. Meanwhile, in developed markets, procedural complexity and preference for hybrid fixation systems-blending unilateral and circular components-are driving moderate ASP increases within high-acuity segments.

Market Drivers

Temporary Fixation Applications

External fixation is widely used for temporary stabilization in complex fractures, including highly comminuted and open fractures. Surgeons use these systems to align and maintain bone fragments prior to internal fixation once the patient is stable or soft tissue conditions allow. This bridge-to-definitive-fixation model ensures continued relevance of external devices alongside rising internal fixation volumes. As a result, the external fixation market grows in parallel with overall trauma treatment volumes.

Minimally Invasive Surgery

While internal fixation dominates in many elective procedures, external fixation remains essential for cases where open surgery poses risk. These systems offer minimally invasive stabilization with smaller incisions and reduced blood loss. Benefits include shorter operating times, lower tissue disruption, and faster return to motion, especially in patients with multiple injuries or compromised health.

The use of bacteriostatic coatings, such as silver nitrate, and bone growth coatings, such as hydroxyapatite, has further improved safety outcomes by lowering infection rates. Combined with improved ergonomics and modularity, these factors help sustain adoption even as internal fixation expands.

Use of Bone Graft Substitutes

The integration of bone graft substitutes and bone putties in trauma and reconstructive procedures supports external fixation use. These materials, which aid bone regeneration and are gradually resorbed by the body, must be held in place during healing. External fixation provides stable positioning throughout graft integration, driving parallel growth between bone graft substitutes and fixation hardware.

Innovation in Coatings and Materials

Technological improvements in pin coatings represent a major contributor to market stability. Hydroxyapatite coatings encourage bone growth and reduce micro-motion, while bacteriostatic coatings minimize the formation of bacterial colonies. These advances have decreased infection risk and improved long-term outcomes, expanding surgeon confidence in external fixation as a safe and durable option.

Market Limiters

Tender Competition

Public procurement, or tendering, is a key factor affecting pricing in the external fixation market. Government and hospital systems increasingly consolidate purchasing through competitive contracts where vendors bid primarily on price. The prevalence of tenders, particularly in Europe, Asia-Pacific, and the Middle East, results in constant downward pressure on ASPs.

While large manufacturers are equipped to manage tender participation, smaller companies face difficulty maintaining profitability. Over time, this dynamic reinforces the dominance of major multinational suppliers, even as total market value growth remains moderate.

Equipment Reuse

External fixation devices, especially frames and clamps, can often be reused after sterilization, depending on local regulations and hospital policies. Although not officially promoted due to infection control concerns, partial reuse continues in some regions to reduce costs. This practice suppresses replacement volumes and slows unit growth, especially in markets with constrained budgets.

While sterilization and reprocessing incur costs that offset some savings, the overall impact remains negative for market expansion. As hospitals continue to focus on cost containment, reuse will remain an important limiter to overall revenue growth.

Growth of Internal Fixation Markets

The success of internal fixation devices, such as plates, screws, and intramedullary nails, has come partly at the expense of external fixation systems. Increasing use of titanium implants and anatomic plating has expanded the range of fractures treatable with internal fixation. Intramedullary nails, in particular, continue to gain traction for long-bone fractures, especially in the hip and femur.

While external fixation maintains a role in complex trauma and deformity correction, internal fixation's faster recovery times and smaller external profile reduce the number of indications requiring external stabilization. As these internal systems advance, the external fixation market faces slower unit growth in mature economies.

Competitive Analysis

DePuy Synthes

DePuy Synthes held the leading global share of the external fixation market in 2024. The company benefits from a broad and established catalog that includes modular unilateral systems, hybrid frames, and specialized pediatric constructs. DePuy Synthes' distribution scale and reputation for quality continue to reinforce surgeon loyalty and hospital preference. Its strong position is expected to persist through the forecast period.

Stryker

Stryker ranked second globally and is recognized for its Hoffman(TM) external fixation system, which has widespread use across both acute and reconstructive trauma. The company holds the top position in many developing regions and strong secondary shares in North America and Western Europe. Its focus on design efficiency, modular adjustability, and compatible instrumentation supports both usability and procedural consistency, helping Stryker maintain steady growth.

Smith & Nephew

Smith & Nephew held the third-largest global share, supported by its specialized circular systems, notably the Taylor Spatial Frame(R), which remains highly regarded for complex deformity correction and limb lengthening. The company's global presence, particularly in North America and Western Europe, strengthens its position in advanced surgical applications. Continued investment in technology and surgeon training programs is expected to sustain its competitive role.

Additional participants include Zimmer Biomet, Orthofix, and several regional manufacturers supplying cost-competitive unilateral systems. While their aggregate market share is smaller, their presence increases tender competition and broadens access in price-sensitive markets.

Market Coverage and Segmentation

• External Fixation Market - Further Segmented Into:

Unilateral External Fixation Devices

Circular External Fixation Devices

• Quantitative coverage: Market size, market shares, market 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, government and regulatory data, hospital procurement data, import/export records, and iData Research's internal database.

Technology and Practice Trends

Hybrid external fixators are increasingly used, combining the simplicity of unilateral constructs with the versatility of circular systems.

Pin and wire coatings using hydroxyapatite and bacteriostatic agents continue to lower infection rates and improve fixation stability.

Lightweight alloys and carbon fiber rods enhance frame strength while minimizing patient discomfort.

Digital imaging compatibility supports precise placement and postoperative adjustments.

Reusable component management and sterilization tracking systems improve cost control and compliance.

Training and simulation tools for deformity correction procedures increase surgeon familiarity with advanced frame configurations.

Market Coverage and Data Scope

• Time frame: Base year 2024, forecasts 2025-2031, historical data 2021-2023.
• Care settings: Hospitals, trauma centers, and specialized orthopedic institutes worldwide.
• Methodology: Market revenues are modeled as units multiplied by ASP, validated through triangulation with procedure volumes, tender data, and hospital procurement inputs.

Methodology Appendix and Acronym Glossary included.

Why This Report

Identify which device types-unilateral or circular-are growing fastest and where regional demand is strongest.

Understand how temporary fixation and internal fixation interplay influence unit sales and pricing trends.

Benchmark leading competitors and analyze their technology, pricing strategies, and global reach.

Track the impact of public tenders, pricing pressure, and equipment reuse on market value.

Examine the latest coating and material innovations improving clinical outcomes.

Assess how emerging regions are driving demand through access expansion and trauma care investment.

The Global External Fixation Market Report from iData Research provides a complete view of global market structure, with data-driven forecasts, company share analysis, and technology coverage to support strategic planning, pricing decisions, and growth initiatives in the orthopedic trauma sector.

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

External Fixation Market

• 12.1 Executive Summary
  • 12.1.1 Global External Fixation Market Overview
  • 12.1.2 Competitive Analysis
  • 12.1.3 Procedure Segmentation
  • 12.1.4 Market Segmentation
  • 12.1.5 Regions Included
• 12.2 Introduction
• 12.3 Procedure Numbers
  • 12.3.1 Total External Fixation Procedures
• 12.4 Market Overview
  • 12.4.1 By Segment
  • 12.4.2 By Region
• 12.5 Market Analysis And Forecast
  • 12.5.1 Total External Fixation Market
  • 12.5.2 Circular External Fixation Market
  • 12.5.3 Unilateral External Fixation Market
  • 12.5.4 External Fixation By Anatomy Unit Analysis
    • 12.5.4.1 Shoulder Girdle External Fixation Units
    • 12.5.4.2 Upper Arm External Fixation Units
    • 12.5.4.3 Forearm External Fixation Units
    • 12.5.4.4 Hand And Wrist External Fixation Units
    • 12.5.4.5 Hip External Fixation Units
    • 12.5.4.6 Upper Leg External Fixation Units
    • 12.5.4.7 Knee External Fixation Units
    • 12.5.4.8 Lower Leg External Fixation Units
    • 12.5.4.9 Ankle External Fixation Units
    • 12.5.4.10 Foot And Toe External Fixation Units
• 12.6 Drivers And Limiters
  • 12.6.1 Market Drivers
  • 12.6.2 Market Limiters
• 12.7 Competitive Market Share Analysis

Abbreviations

LIST OF CHARTS

• Chart 12-1: External Fixation Market, Global, 2024 & 2031
• Chart 12-2: External Fixation Procedures, Global, 2024
• Chart 12-3: External Fixation Procedures by Region, Global, 2021 - 2031
• Chart 12-4: External Fixation Market by Segment, Global, 2021 - 2031
• Chart 12-5: External Fixation Market by Region, Global, 2021 - 2031
• Chart 12-6: Leading Competitors, External Fixation Market, Global, 2024

LIST OF FIGURES

• Figure 12-1: External Fixation Procedure Segmentation
• Figure 12-2: External Fixation Market Segmentation
• Figure 12-3: External Fixation Regions Covered, Global (1 of 2)
• Figure 12-4: External Fixation Regions Covered, Global (2 of 2)
• Figure 12-5: External Fixation Procedures by Region, Global, 2021 - 2031
• Figure 12-6: External Fixation Procedures by Country, North America, 2021 - 2031
• Figure 12-7: External Fixation Procedures by Country, Latin America, 2021 - 2031 (1 of 2)
• Figure 12-8: External Fixation Procedures by Country, Latin America, 2021 - 2031 (2 of 2)
• Figure 12-9: External Fixation Procedures by Country, Western Europe, 2021 - 2031
• Figure 12-10: External Fixation Procedures by Country, Central & Eastern Europe, 2021 - 2031 (1 of 2)
• Figure 12-11: External Fixation Procedures by Country, Central & Eastern Europe, 2021 - 2031 (2 of 2)
• Figure 12-12: External Fixation Procedures by Country, Middle East, 2021 - 2031
• Figure 12-13: External Fixation Procedures by Country, Asia-Pacific, 2021 - 2031 (1 of 3)
• Figure 12-14: External Fixation Procedures by Country, Asia-Pacific, 2021 - 2031 (2 of 3)
• Figure 12-15: External Fixation Procedures by Country, Asia-Pacific, 2021 - 2031 (3 of 3)
• Figure 12-16: External Fixation Procedures by Country, Africa, 2021 - 2031
• Figure 12-17: External Fixation Market by Segment, Global, 2021 - 2031 (US$M)
• Figure 12-18: External Fixation Market by Region, Global, 2021 - 2031 (US$M)
• Figure 12-19: External Fixation Market, Global, 2021 - 2031
• Figure 12-20: Units Sold by Region, External Fixation Market, Global, 2021 - 2031
• Figure 12-21: Average Selling Price by Region, External Fixation Market, Global, 2021 - 2031 (US$)
• Figure 12-22: Market Value by Region, External Fixation Market, Global, 2021 - 2031 (US$M)
• Figure 12-23: Circular External Fixation Market, Global, 2021 - 2031
• Figure 12-24: Units Sold by Region, Circular External Fixation Market, Global, 2021 - 2031
• Figure 12-25: Average Selling Price by Region, Circular External Fixation Market, Global, 2021 - 2031 (US$)
• Figure 12-26: Market Value by Region, Circular External Fixation Market, Global, 2021 - 2031 (US$M)
• Figure 12-27: Unilateral External Fixation Market, Global, 2021 - 2031
• Figure 12-28: Units Sold by Region, Unilateral External Fixation Market, Global, 2021 - 2031
• Figure 12-29: Average Selling Price by Region, Unilateral External Fixation Market, Global, 2021 - 2031 (US$)
• Figure 12-30: Market Value by Region, Unilateral External Fixation Market, Global, 2021 - 2031 (US$M)
• Figure 12-31: External Fixation Units Sold by Anatomy, Global, 2021 - 2031 (1 of 2)
• Figure 12-32: External Fixation Units Sold by Anatomy, Global, 2021 - 2031 (2 of 2)
• Figure 12-33: Shoulder Girdle External Fixation Units by Region, Global, 2021 - 2031
• Figure 12-34: Upper Arm External Fixation Units by Region, Global, 2021 - 2031
• Figure 12-35: Forearm External Fixation Units by Region, Global, 2021 - 2031
• Figure 12-36: Hand and Wrist External Fixation Units by Region, Global, 2021 - 2031
• Figure 12-37: Hip External Fixation Units by Region, Global, 2021 - 2031
• Figure 12-38: Upper Leg External Fixation Units by Region, Global, 2021 - 2031
• Figure 12-39: Knee External Fixation Units by Region, Global, 2021 - 2031
• Figure 12-40: Lower Leg External Fixation Units by Region, Global, 2021 - 2031
• Figure 12-41: Ankle External Fixation Units by Region, Global, 2021 - 2031
• Figure 12-42: Foot and Toe External Fixation Units by Region, Global, 2021 - 2031
• Figure 12-43: Leading Competitors, External Fixation Market, Global, 2024