全球外固定裝置市場：市場規模、佔有率和趨勢分析（2025-2031 年）

預計到 2024 年，全球外固定裝置市場規模將達到 8.4 億美元，到 2031 年將達到約 10 億美元，年複合成長率為 2.8%。

本報告涵蓋創傷和重組手術中使用的單側和環狀外固定裝置。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。此外，報告還分析了手術趨勢、市場促進因素和限制因素、技術進步、近期併購以及競爭策略。歷史資料截至 2021 年，預測持續至 2031 年。

市場概覽

外固定是整形外科創傷治療的基石，當內固定不適用或有禁忌症時，外固定可用於穩定骨折部位。這些系統由鋼針、鋼棒、夾具和連接框架組成，透過經皮固定來固定骨碎片，從而在癒合過程中進行逐步調整和穩定。

在全球範圍內，外固定仍是治療多發性創傷、開放性骨折、肢體畸形矯正和複雜骨不連的關鍵手段。雖然內固定在某些市場持續擴大市場佔有率，但外固定仍在嚴重創傷、小兒整形外科和重組手術中發揮不可替代的作用。

市場穩定成長主要得益於手術量的增加、塗層技術的進步以及固定材料和設計的持續創新。例如，用於促進骨整合的羥基磷灰石層和用於預防感染的抑菌塗層等釘塗層技術的進步，有助於減少術後併發症並提升產品價值。

此外，外固定市場也間接受益於內固定的擴張：使用外固定裝置進行臨時固定通常領先使用鋼板或螺絲進行最終固定，這意味著骨折治療的發展總體上支持了外固定的需求。

在新興地區，由於創傷護理的可及性提高以及醫院對經濟實惠、可重複使用的器械套裝的需求，其使用量持續擴大；而在已開發市場，由於手術複雜性增加以及對結合了半固定和環形固定元素的混合固定系統的偏好，高風險患者的平均售價 (ASP) 略有上漲。

市場促進因素

暫時固定的適應症

外固定廣泛用於複雜骨折（包括嚴重粉碎性骨折和開放性骨折）的臨時固定。外科醫師使用這些系統來對齊和固定骨碎片，待病患病情穩定或軟組織狀況允許後，再進行內固定。這種「過渡到最終固定」的模式確保了外固定裝置的重要性，即使內固定手術的數量不斷增加。因此，外固定市場與創傷手術的總數同步成長。

微創手術

雖然內固定是許多擇期手術的主流方法，但在開放手術風險較高的情況下，外固定仍然至關重要。這些系統透過較小的切口和較少的出血提供微創穩定性。其優點包括手術時間更短、組織損傷更小以及更早恢復活動，尤其適用於多重傷害或健康狀況不佳的患者。

使用抑菌塗層（例如硝酸銀）和促進骨骼生長的塗層（例如羥基磷灰石）進一步提高了安全性，並降低了感染率。這些因素，加上人體工學的改進和模組化程度的提高，促使外固定技術在內固定技術日益普及的同時，仍被廣泛應用。

使用骨移植替代物

在創傷和重組外科手術中，骨移植替代材料和骨糊劑的整合應用，外固定裝置的使用提供了支持。這些材料能夠促進骨再生，並逐漸被人體吸收，因此必須在整個癒合期間保持指定。外固定裝置可在移植材料整合過程中提供穩定的定位，並促進骨移植替代材料與固定裝置之間的平行生長。

塗料與材料創新

釘塗層技術的進步是市場穩定的關鍵因素。羥基磷灰石塗層可促進骨骼長入並減少微動，而抑菌塗層則可最大限度地減少細菌定植。這些進步降低了感染風險，改善了長期療效，增強了外科醫師對外部固定作為一種安全持久的治療方案的信心。

市場限制

競標競爭

公共採購（競標）是外部固定市場定價的主要促進因素。政府和醫院系統擴大透過競爭性競標進行批量採購，供應商主要以價格作為競標。競標的主導地位，尤其是在歐洲、亞太和中東地區，正持續對平均售價（ASP）構成下行壓力。

大型製造商在參與競標處於有利地位，而小型企業則難以保持盈利，這加強了大型跨國供應商的主導地位，即使整體市場價值成長仍然溫和。

設備再利用

根據當地法規和政策，外固定裝置，特別是框架和夾具，在消毒後通常可以重複使用。雖然出於感染控制的考慮，官方並不建議這樣做，但在某些地區，為了降低成本，部分重複使用的做法仍然存在。這種做法限制了更換量，減緩了設備的成長速度，尤其是在預算緊張的市場。

滅菌和再處理會產生一定的成本，部分抵消了節省的費用，但對市場成長的整體影響仍然是負面的。隨著醫院持續關注成本控制，再利用仍將是限制總收入成長的重要因素。

國內固定市場的成長

內固定裝置（如鋼板、螺絲和髓內釘）的成功在一定程度上是以犧牲外固定系統為代價的。鈦植入和解剖型鋼板的日益普及擴大了內固定可治療的骨折類型範圍。特別是，髓內釘在股骨和髖骨等長骨骨折的治療中越來越廣泛使用。

儘管外固定仍用於複雜創傷和畸形矯正，但由於內固定恢復時間更短且美容效果更佳，需要外固定的適應症數量正在減少。隨著內固定系統的進步，成熟經濟外固定外固定的單位成長率呈現下降趨勢。

競爭分析

德普合成公司

2024年，DePuy Synthes持續保持在全球外固定器材市場的領先地位。該公司擁有豐富且成熟的產品線，包括模組化單側固定系統、混合框架和兒科專用器械。 DePuy Synthes的銷售網路和卓越的品質口碑持續增強了外科醫生的忠誠度和醫院的青睞。預計其強勁的市場地位將在整個預測期內保持下去。

史賽克

史賽克在全球市佔率排名第二，其霍夫曼™外固定系統廣為人知，該系統廣泛應用於急性創傷和重組手術。史賽克在許多發展中地區佔據領先地位，並在北美和西歐保持著強勁的市場佔有率。史賽克專注於設計效率、模組化調節和可互換器械，將易用性與手術流程的一致性相結合，從而推動了其穩定成長。

史密斯和內夫

史密斯醫療在全球市場佔有率排名第三，這主要得益於其專業的環形系統，尤其是泰勒空間框架®（Taylor Spatial Frame®），該產品在複雜畸形矯正和肢體延長方面贏得了良好的聲譽。公司在全球範圍內，尤其是在北美和西歐的業務佈局，鞏固了其在先進外科手術應用領域的地位。持續投資於技術和外科醫生培訓項目，並有望幫助公司保持其競爭優勢。

其他參與企業包括 Zimmer Biomet、Orthofix 以及幾家提供價格具有競爭力的單側系統的地區性製造商。雖然這些公司總合市場佔有率較小，但它們正在加劇競標競爭，並在價格敏感的市場中擴大市場准入。

市場範圍和細分

• 外固定裝置市場進一步細分為以下幾個部分：

單側外固定裝置

環形外固定裝置

• 量化指標：市場規模、市場佔有率、市場預測、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：對產業領導者的直接訪談、政府和監管機構資料、醫院採購資料、進出口記錄、iData Research 內部資料庫。

技術與實務的趨勢

混合型外固定裝置正被擴大使用，它結合了單側固定的簡單性和環形系統的多功能性。

在銷釘和鋼絲上塗上羥基磷灰石和抑菌劑，可以持續降低感染率並提高固定穩定性。

輕質合金和碳纖維桿增強了框架強度，同時最大限度地減少了患者的不適感。

與數位成像技術的兼容性使得精準定位和術後調整成為可能。

可重複使用零件管理和滅菌追蹤系統可提高成本控制和合規性。

畸形矯正手術的培訓和模擬工具使外科醫生能夠熟練先進的框架結構。

市場和數據覆蓋範圍

• 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：全球的醫院、創傷中心和專業整形外科機構。
• 調查方法：市場收入採用單位乘法模型檢驗，以平均售價 (ASP) 為基礎，並結合手術量、競標數據和醫院採購資訊進行三角驗證。

附件包括補充調查方法文件和簡稱詞彙表。

目錄

圖表清單

圖表列表

調查方法

全球關稅的影響

外固定裝置市場

• 執行摘要
  • 全球外固定裝置市場概覽
  • 競爭分析
  • 流程分段
  • 市場區隔
  • 目標區域
• 介紹
• 手術次數
  • 全外固定
• 市場概覽
  • 按細分市場
  • 按地區
• 市場分析與預測
  • 整體外固定裝置市場
  • 圓形外固定裝置市場
  • 單側外固定市場
  • 基於解剖單元分析的外固定
• 駕駛員和約束裝置
• 競爭市佔率分析

簡稱

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