全球生物可吸收創傷固定裝置市場：市場規模、佔有率和趨勢分析（2025-2031 年）

2024年全球生物可吸收固定裝置市場規模為4,720萬美元。預計到2031年，該市場將達到4,380萬美元，年複合成長率為-1.0%。

本報告涵蓋生物可吸收固定領域的整個產品組合，包括由聚乳酸 (PLA) 和Polyglycolic乙醇酸 (PGA) 聚合物製成的銷釘、螺絲和固定裝置，這些裝置旨在穩定骨折、截骨術、骨移植、骨合成術以及韌帶、肌腱、半月軟骨和其他軟組織結構的重新連接。

該分析涵蓋了銷售量、平均售價 (ASP)、市場規模、成長率和企業市場占有率等詳細資訊，以及市場促進因素和限制因素、手術量、近期併購、競爭分析和技術趨勢。歷史資料截至 2021 年，預測資料截至 2031 年。

市場概覽

生物可吸收固定裝置旨在為骨骼和軟組織的癒合過程提供臨時穩定性和機械支撐。與金屬植入不同，它們會逐漸分解並被人體吸收，無需植入。儘管在大骨頭中的應用有限，且面臨來自成熟金屬系統的競爭，但這一獨特優勢仍持續吸引研究和臨床領域的關注。

目前，生物可吸收固定裝置最廣泛應用於小骨創傷、顱顏重組和軟組織修復手術，這些手術承受的動態負荷適中。整體市場價值的輕微下降可歸因於新產品上市速度放緩以及與金屬替代品相比，其機械強度持續存在局限性。然而，具有更高生物相容性、機械耐久性和可控分解特性的新一代生物可吸收材料的推出，預計將部分抵消這一下滑趨勢，並在預測期內維持市場穩定。

本產業持續研發將PLA、PGA和鈣基填料結合的聚合物共混物和複合材料，以平衡強度、柔韌性和吸收時間。這些材料創新有望拓寬適應症範圍，並增強傳統上更傾向於使用金屬內固定系統的外科醫生的信心。

儘管與鈦和不銹鋼固定裝置相比，生物可吸收技術仍然是一個小眾市場，但它具有明顯的程序優勢：淘汰金屬取出手術、降低感染風險，並能更好地與生物癒合相結合，使其成為未來整形外科手術創新的關鍵支柱。

隨著研究的進展和中小企業推出最佳化的聚合物配方，生物可吸收固定裝置的全球市場可能會在運動醫學、四肢手術和兒科整形外科找到新的機會。

市場促進因素

拓展產品線

生物可吸收固定市場的主要驅動力是器材類型和材料成分的不斷擴展。目前的技術主要支援小直徑器械，例如用於小關節和軟組織修復的鋼釘和螺絲。雖然這些器械非常適合低負荷適應症，但人們正在努力提高其強度和剛度，以用於更大的骨骼和更複雜的解剖部位。

聚合物加工技術和共聚物化學的進步正在克服一些傳統上與生物可吸收材料相關的軟組織反應問題。隨著這些挑戰的緩解，製造商能夠設計出尺寸更大的植入，用於承受更大負荷的應用。這些進步不僅拓展了生物可固定裝置的臨床應用範圍，也增加了適用患者的數量，從而促進了此類裝置在整體市場規模有限的情況下仍能穩步應用於外科手術。

更大的靈活性和臨床效用

生物可吸收固定裝置為外科醫生提供了極大的靈活性，可用於永久性和臨時性固定。例如，生物可吸收釘可用於復位骨碎片，而無需後續取出。在跟骨（足跟骨）骨折等病例中，可將釘子齊骨切斷並留在原位，以便外科醫生在必要時使用金屬板進行二次固定。

生物可吸收釘和螺絲會隨著時間推移完全被人體吸收，外科醫生無需擔心術後清除殘留金屬碎片的問題。這項特性簡化了手術流程，縮短了手術時間，並最大限度地減少了術後併發症。隨著醫療保健系統不斷提高效率和縮短恢復時間，這些優勢使得生物可吸收固定方法在某些適應症中更具吸引力。

減少手術需求

生物可吸收固定裝置最顯著的優點之一是無需二次手術取出植入。對患者而言，這意味著手術風險降低、治療費用減少、滿意度提高。從臨床角度來看，避免取出金屬零件可以降低二次創傷、感染和疤痕組織相關併發症的風險。

病人和醫護人員通常認為生物可吸收裝置的暫時性是一種心理優勢。植入不會永久留在體內這一事實有助於提高接受度，尤其是在年輕且更活躍的人群中。隨著醫療保健系統越來越重視以患者為中心的治療效果和整體生活品質，這一因素持續推動著該領域的發展。

材料科學進展

近年來，共聚物配方和生物複合材料的研究取得了顯著進展，開發了具有更高拉伸強度、可預測的吸收曲線和生物完整性的生物可吸收植入。透過添加磷酸鈣和羥基磷灰石等元素，研發人員旨在創造能夠模擬天然骨骼行為並在癒合過程中促進骨傳導的材料。

這些創新技術延長了產品在負荷下的使用壽命，同時確保在臨床上可接受的時限內完全吸收。最終產品兼具雙重優勢：在癒合過程中保持機械穩定性，並逐漸被天然骨組織取代，從而減少長期併發症。預計這些進步將重新激發人們對特定細分市場的興趣，並帶來價值成長。

市場限制

產品強度不足

生物可吸收固定裝置的主要限制在於其機械強度低於金屬植入。雖然吸收過程的優點在於避免了手術取出，但也降低了植入的長期承重能力。因此，生物可吸收裝置通常僅限於低應力應用，例如小骨骨折和軟組織固定，而非股骨等長骨骨折。

在嚴重創傷病例中，使用生物可吸收固定材料可能導致穩定性不足，增加骨不連和延遲癒合的風險。關鍵骨折治療領域的市場滲透率有限，也反映了這個臨床限制。為了應對這項挑戰，一些製造商正在開發生物複合材料裝置，將可吸收聚合物與陶瓷填料結合，以犧牲吸收速度和脆性為補償，提高強度。

外科醫生技能不足

外科醫生技能和培訓的不足仍然是生物可吸收裝置廣泛應用的一大障礙。大多數骨科醫生在金屬內固定系統方面經驗豐富，熟練植入放置和後續取出技術。而生物可吸收裝置則通常需要不同的器械、植入技術和操作特性。

與成熟的金屬植入系統相比，新型植入物的學習曲線較長，且缺乏長期數據，這使得許多外科醫生持謹慎態度。此外，植入取出手術被認為是標準治療的一部分，並且由保險覆蓋，因此，醫生缺乏經濟獎勵去轉向那些無需後續手術的替代方案。

高成本

雖然生物可吸收固定裝置具有許多臨床和以患者為中心的優勢，但成本仍是一大障礙。生物可吸收植入通常比金屬植入物更昂貴，即便它們的適應症相似或更窄。受成本限制的醫院和手術中心可能不願意儲備這些產品，除非能夠明確證明其對病人或手術的益處。

此外，金屬螺絲和鋼板的可靠性和低成本限制了外科醫生採用價格更高的生物可吸收替代品的動力，尤其是在預期療效改善甚微的情況下。這種成本差異持續限制生物可吸收替代品的普及，尤其是在對成本敏感的醫療保健市場，例如拉丁美洲、亞太地區和歐洲部分地區。

監管和生產方面的挑戰

生物可吸收醫療器材的生產涉及複雜的聚合物合成、滅菌和成型工藝，這些工藝對溫度和濕度非常敏感。要實現穩定的品質、可預測的分解速率和機械強度，需要嚴格的製程控制和先進的生產基礎設施。監管途徑，尤其是在歐洲醫療設備法規 (MDR) 等新框架下，需要進行大量的臨床前和臨床檢驗，這增加了研發成本和上市時間。

規模較小的製造商往往難以滿足這些要求，這限制了創新，也限制了競爭多樣性，導致市場仍集中在少數幾家擁有成熟研發和監管能力的大公司手中。

市場覆蓋範圍和數據範圍

• 目標時期：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、整形外科和創傷中心以及進行骨骼和軟組織修復手術的門診手術機構。
• 調查方法：收入以「銷售量×平均售價」計算，並透過一手調查、醫院採購資料以及全球進出口記錄進行檢驗。

競爭分析

2024年，Arthrex在全球生物可吸收固定材料市場佔據主導地位。公司領先地位主要歸功於其在小關節修復和運動醫學的強大實力，而這兩個領域正是生物可吸收固定材料應用最廣泛的領域。 Arthrex的主要產品包括TRIM-IT™系列螺絲和釘子、BioComposite™螺絲以及Bio-Compression系列螺絲和釘子。公司持續的材料研發舉措和豐富的臨床產品組合確保其始終處於該領域的創新前沿。

憑藉其 LactoSorb® 可吸收固定系統，Zimmer Biomet 已成為第二大競爭對手。該產品的機械可靠性和生物相容性增強了 Zimmer Biomet 在包括顱顏和聽骨應用在內的各種固定手術領域的地位。 LactoSorb® 的持續應用以及該公司在聚合物技術方面的投入預計將使其保持競爭優勢。

康美公司是市場上的第三大競爭對手。其SmartNail和SmartPin系統因其高效的骨折固定效果和易用性而備受認可。儘管康美公司已將業務拓展至生物可吸收固定材料以外的領域，但其在可吸收植入技術領域的長期專業經驗仍為其在特定地區的市場認可度和現有銷售額做出貢獻。

地區

本版提供了涵蓋北美、歐洲、亞太地區、拉丁美洲以及中東和非洲的全球調查結果。

該報告包含 35 頁詳細數據和分析。

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

生物可吸收固定裝置市場

• 執行摘要
  • 全球生物可吸收固定裝置市場概覽
  • 競爭分析
  • 目標區域
• 介紹
• 市場分析與預測
• 駕駛員和約束裝置
• 競爭市佔率分析

簡稱

The global bioabsorbable fixation market was valued at $47.2 million in 2024. The market is projected to decrease at a compound annual growth rate (CAGR) of -1.0%, reaching $43.8 million by 2031.

This report covers the complete suite of products within the bioabsorbable fixation segment, including pins, screws, and fixation devices composed of polylactic acid (PLA) and polyglycolic acid (PGA) polymers. These devices are designed for the stabilization of fractures, osteotomies, bone grafts, and fusions, as well as for the reattachment of ligaments, tendons, meniscal tears, and other soft tissue structures.

The analysis includes unit sales, average selling prices (ASPs), market values, growth rates, and company shares, along with detailed coverage of market drivers and limiters, procedure volumes, recent mergers and acquisitions, competitive analysis, and technology trends. Historical data is provided to 2021, with forecasts through 2031.

Market Overview

Bioabsorbable fixation devices are engineered to provide temporary stabilization and mechanical support during the healing process of bone and soft tissue. Unlike metal implants, they gradually degrade and are absorbed by the body, eliminating the need for implant removal. This unique advantage continues to attract research and clinical interest despite limited large-bone applications and competitive pressure from established metallic systems.

Currently, bioabsorbable fixation is most widely used in small-bone trauma, craniofacial reconstruction, and soft-tissue repair procedures, where the biomechanical demands are moderate. The market's modest decline in overall value reflects slower product adoption and persistent limitations in mechanical strength relative to metallic alternatives. However, the introduction of next-generation bioabsorbable materials with improved biocompatibility, mechanical durability, and controlled degradation profiles is expected to offset part of the decline and maintain market stability through the forecast period.

The industry continues to explore polymer blends and composite materials, combining PLA, PGA, and calcium-based fillers to balance strength, flexibility, and resorption time. These material innovations are expected to broaden indications and enhance confidence among surgeons who have historically favored metal fixation systems.

Although the market remains niche compared with titanium and stainless-steel fixation, bioabsorbable technology offers clear procedural advantages. Its elimination of hardware removal surgeries, reduction in infection risks, and better integration with biological healing position it as an important segment of future orthopedic innovation.

As research progresses and smaller companies introduce optimized polymer formulations, the global market for bioabsorbable fixation devices is likely to find new opportunities in sports medicine, extremity surgery, and pediatric orthopedics.

Market Drivers

Product Range Expansion

A key driver for the bioabsorbable fixation market is the ongoing expansion of device types and material compositions. Current technology primarily supports small-diameter devices, such as pins and screws, used in small-joint and soft-tissue repair. These devices are ideal for low-load indications, but efforts are underway to improve strength and stiffness for use in larger bones and more demanding anatomical sites.

Developments in polymer processing and copolymer chemistry have helped overcome some of the soft-tissue reaction issues historically associated with bioabsorbable materials. As these challenges are mitigated, manufacturers can design larger implants capable of supporting greater load-bearing applications. These advancements not only broaden the clinical scope of bioabsorbable fixation but also increase the potential number of eligible patients, driving steady procedural adoption even as overall market value remains constrained.

Greater Flexibility and Clinical Utility

Bioabsorbable fixation devices offer surgeons greater flexibility in both definitive and temporary fixation procedures. For example, bioabsorbable pins can be used for bone fragment reduction without the need for subsequent removal. In cases such as calcaneal (heel bone) fractures, pins can be cut flush with the bone surface and left in place, allowing surgeons to proceed with secondary fixation using metallic plates if needed.

Because the bioabsorbable pins and screws are fully resorbed over time, surgeons are not concerned about residual hardware fragments that might otherwise require surgical removal. This feature simplifies procedures, reduces operative time, and minimizes post-surgical complications. As healthcare systems continue to value efficiency and shorter recovery times, these benefits enhance the appeal of bioabsorbable fixation in select indications.

Reduction in Required Surgery

One of the most recognized advantages of bioabsorbable fixation is its ability to eliminate the need for a second surgery for implant removal. For patients, this translates to reduced procedural risk, lower treatment costs, and improved satisfaction. From a clinical perspective, avoiding hardware removal reduces the chance of secondary trauma, infection, or complications related to scar tissue.

Patients and clinicians often perceive the temporary nature of bioabsorbable devices as a psychological benefit. The knowledge that the implant will not remain in the body indefinitely contributes to higher acceptance rates, particularly in younger and more active populations. As healthcare systems place growing emphasis on patient-centered outcomes and overall quality of life, this factor continues to support the segment's resilience.

Advancements in Material Science

Recent research into copolymer formulations and bio-composite materials has produced bioabsorbable implants with improved tensile strength, predictable resorption profiles, and biological integration. By incorporating elements such as calcium phosphate and hydroxyapatite, developers aim to create materials that mimic natural bone behavior and promote osteoconduction during healing.

These innovations extend product lifespan under load while ensuring complete resorption within a clinically acceptable timeframe. The resulting devices provide the dual benefits of mechanical stability during healing and gradual replacement by natural bone, reducing long-term complications. Such advancements are anticipated to drive renewed interest and incremental value growth in select subsegments.

Market Limiters

Inadequate Product Strength

A primary limitation of bioabsorbable fixation devices remains their lower mechanical strength compared to metal implants. The resorption process, while beneficial in avoiding removal surgery, simultaneously reduces the long-term load-bearing capacity of the implant. For this reason, bioabsorbable devices are generally restricted to low-stress applications, such as small bone fractures or soft-tissue fixation, rather than large long-bone fractures.

In severe trauma cases, the use of bioabsorbable fixation can lead to insufficient stabilization, increasing the risk of malunion or delayed healing. The market's limited penetration in major fracture care reflects this clinical constraint. To address the issue, some manufacturers are developing biocomposite devices that combine resorbable polymers with ceramic fillers, offering enhanced strength at the cost of slower absorption and higher brittleness.

Limited Surgeon Familiarity

Surgeon familiarity and training continue to act as barriers to broader adoption. The majority of orthopedic surgeons have extensive experience with metallic fixation systems and are proficient in both implant placement and subsequent hardware removal. In contrast, bioabsorbable devices often require different instrumentation, insertion techniques, and handling characteristics.

Many surgeons remain cautious due to the learning curve and the lack of long-term data compared to established metal systems. Additionally, since implant removal procedures are a known and reimbursable part of standard care, there is less financial incentive for practitioners to switch to alternatives that eliminate these follow-up interventions.

High Costs

While bioabsorbable fixation offers clinical and patient-centric benefits, cost remains a significant barrier. Bioabsorbable implants are typically more expensive than their metal counterparts, despite serving similar or smaller indications. Hospitals and surgical centers operating under cost constraints may be reluctant to stock these products unless specific patient or procedural advantages can be clearly demonstrated.

Furthermore, given the reliability and lower cost of metal screws and plates, surgeons have limited motivation to adopt higher-priced bioabsorbable alternatives, especially when the perceived improvement in outcomes is marginal. This cost differential continues to limit penetration, particularly in cost-sensitive healthcare markets across Latin America, Asia-Pacific, and parts of Europe.

Regulatory and Manufacturing Challenges

The production of bioabsorbable devices involves complex polymer synthesis, sterilization, and molding processes that are sensitive to heat and humidity. Achieving consistent quality, predictable degradation rates, and mechanical strength requires stringent process control and advanced manufacturing infrastructure. Regulatory pathways, especially under newer frameworks such as Europe's MDR, demand extensive preclinical and clinical validation, raising both development costs and time to market.

Smaller manufacturers often face challenges meeting these requirements, which constrains innovation and limits competitive diversity. As a result, the market remains concentrated among a few large companies with established research and regulatory capabilities.

Market Coverage and Data Scope

• Time Frame: Base year 2024, forecasts 2025-2031, and historical data 2021-2023.
• Care Settings: Hospitals, orthopedic and trauma centers, and ambulatory surgical facilities performing bone and soft-tissue repair procedures.
• Methodology: Revenues are calculated as units X ASP, validated through primary interviews, hospital procurement data, and global import/export records.

Competitive Analysis

Arthrex held the leading position in the global bioabsorbable fixation market in 2024. The company's leadership stems from its strong presence in small-joint repair and sports medicine, where bioabsorbable fixation products are most commonly used. Arthrex's key offerings include the TRIM-IT(TM) line of pins and screws, BioComposite(TM) screws, and Bio-Compression pins and screws. The company's ongoing material development initiatives and wide procedural portfolio ensure it remains at the forefront of innovation in this category.

Zimmer Biomet ranked as the second-leading competitor, supported by its LactoSorb(R) Resorbable Fixation System. The product's mechanical reliability and biocompatibility have reinforced Zimmer Biomet's position across various fixation procedures, particularly in craniofacial and small-bone applications. Continued adoption of LactoSorb(R) and the company's investment in polymer technology are expected to sustain its competitive presence.

CONMED was the third-leading competitor in the market. Its SmartNail(R) and SmartPin(R) systems are recognized for efficient fracture stabilization and ease of use. Although CONMED has diversified its product focus beyond bioabsorbable fixation, its long-standing expertise in resorbable implant technology continues to contribute to market recognition and legacy sales in select regions.

Geography

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

35 pages of detailed data and analysis.

Methodology Appendix and Acronym Glossary included.

Why This Report

What is driving adoption of next-generation bioabsorbable materials and in which surgical specialties they are gaining traction.

How will material innovation and improved mechanical performance influence future clinical applications.

Which factors are slowing penetration compared to metallic fixation systems, and where pricing pressures are most acute.

What company strategies are shaping the competitive landscape for small-joint and soft-tissue fixation.

How regulatory frameworks and manufacturing costs impact new product introductions and market entry.

The Global Bioabsorbable Fixation Market Report from iData Research provides a complete analysis of market size, competitive share, pricing trends, and procedural adoption across regions.

The study combines quantitative forecasting with qualitative insights to help manufacturers, investors, and distributors understand where opportunities and constraints exist within this niche but strategically important orthopedic segment.

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

Bioabsorbable Fixation Market

• 5.1 Executive Summary
  • 5.1.1 Global Bioabsorbable Fixation Market Overview
  • 5.1.2 Competitive Analysis
  • 5.1.3 Regions Included
• 5.2 Introduction
• 5.3 Market Analysis And Forecast
• 5.4 Drivers And Limiters
  • 5.4.1 Market Drivers
  • 5.4.2 Market Limiters
• 5.5 Competitive Market Share Analysis

Abbreviations

LIST OF CHARTS

• Chart 5-1: Bioabsorbable Fixation Market, Global, 2024 & 2031
• Chart 5-2: Bioabsorbable Fixation Units Sold, Global, 2024
• Chart 5-3: Bioabsorbable Fixation Market, Global, 2021 - 2031
• Chart 5-4: Leading Competitors, Bioabsorbable Fixation Market, Global, 2024

LIST OF FIGURES

• Figure 5-1: Bioabsorbable Fixation Regions Covered, Global (1 of 2)
• Figure 5-2: Bioabsorbable Fixation Regions Covered, Global (2 of 2)
• Figure 5-3: Bioabsorbable Fixation Market, Global, 2021 - 2031
• Figure 5-4: Units Sold by Region, Bioabsorbable Fixation Market, Global, 2021 - 2031
• Figure 5-5: Average Selling Price by Region, Bioabsorbable Fixation Market, Global, 2021 - 2031 (US$)
• Figure 5-6: Market Value by Region, Bioabsorbable Fixation Market, Global, 2021 - 2031 (US$M)
• Figure 5-7: Leading Competitors, Bioabsorbable Fixation Market, Global, 2024