全球生物可吸收创伤固定装置市场：市场规模、份额和趋势分析（2025-2031 年）

2024年全球生物可吸收固定装置市场规模为4,720万美元。预计到2031年，该市场将达到4,380万美元，年复合成长率为-1.0%。

本报告涵盖生物可吸收固定领域的整个产品组合，包括由聚乳酸 (PLA) 和Polyglycolic乙醇酸 (PGA) 聚合物製成的销钉、螺丝和固定装置，这些装置旨在稳定骨折、截骨术、骨移植、骨合成术以及韧带、肌腱、半月软骨和其他软组织结构的重新连接。

该分析涵盖了销售量、平均售价 (ASP)、市场规模、成长率和企业市场占有率等详细信息，以及市场驱动因素和限制因素、手术量、近期併购、竞争分析和技术趋势。历史资料截至 2021 年，预测资料截至 2031 年。

市场概览

生物可吸收固定装置旨在为骨骼和软组织的癒合过程提供临时稳定性和机械支撑。与金属植入不同，它们会逐渐降解并被人体吸收，无需植入。儘管在大骨头中的应用有限，且面临来自成熟金属系统的竞争，但这一独特优势仍持续吸引研究和临床领域的关注。

目前，生物可吸收固定装置最广泛应用于小骨创伤、颅颜重组和软组织修復手术，这些手术承受的动态负荷适中。整体市场价值的轻微下降可归因于新产品上市速度放缓以及与金属替代品相比，其机械强度持续存在局限性。然而，具有更高生物相容性、机械耐久性和可控降解特性的新一代生物可吸收材料的推出，预计将部分抵消这一下滑趋势，并在预测期内维持市场稳定。

本产业持续研发将PLA、PGA和钙基填料结合的聚合物共混物和复合材料，以平衡强度、柔韧性和吸收时间。这些材料创新有望拓宽适应症范围，并增强传统上更倾向于使用金属内固定係统的外科医生的信心。

儘管与钛和不銹钢固定装置相比，生物可吸收技术仍然是一个小众市场，但它具有明显的程序优势：淘汰金属取出手术、降低感染风险，并能更好地与生物癒合相结合，使其成为未来整形外科手术创新的关键支柱。

随着研究的进展和中小企业推出优化的聚合物配方，生物可吸收固定装置的全球市场可能会在运动医学、四肢手术和儿科整形外科找到新的机会。

市场驱动因素

拓展产品线

生物可吸收固定市场的主要驱动力是器材类型和材料成分的不断扩展。目前的技术主要支援小直径器械，例如用于小关节和软组织修復的钢钉和螺丝。虽然这些器械非常适合低负荷适应症，但人们正在努力提高其强度和刚度，以用于更大的骨骼和更复杂的解剖部位。

聚合物加工技术和共聚物化学的进步正在克服一些传统上与生物可吸收材料相关的软组织反应问题。随着这些挑战的缓解，製造商能够设计出尺寸更大的植入，用于承受更大负荷的应用。这些进步不仅拓展了生物可固定装置的临床应用范围，也增加了适用患者的数量，从而促进了此类装置在整体市场规模有限的情况下仍能稳步应用于外科手术。

更大的灵活性和临床效用

生物可吸收固定装置为外科医生提供了极大的灵活性，可用于永久性和临时性固定。例如，生物可吸收钉可用于復位骨碎片，而无需后续取出。在跟骨（足跟骨）骨折等病例中，可将钉子齐骨切断并留在原位，以便外科医生在必要时使用金属板进行二次固定。

生物可吸收钉和螺丝会随着时间推移完全被人体吸收，外科医生无需担心术后清除残留金属碎片的问题。这项特性简化了手术流程，缩短了手术时间，并最大限度地减少了术后併发症。随着医疗保健系统不断提高效率和缩短恢復时间，这些优势使得生物可吸收固定方法在某些适应症中更具吸引力。

减少手术需求

生物可吸收固定装置最显着的优点之一是无需二次手术取出植入。对患者而言，这意味着手术风险降低、治疗费用减少、满意度提高。从临床角度来看，避免取出金属零件可以降低二次创伤、感染和疤痕组织相关併发症的风险。

病人和医护人员通常认为生物可吸收装置的暂时性是一种心理优势。植入不会永久留在体内这一事实有助于提高接受度，尤其是在年轻且更活跃的人群中。随着医疗保健系统越来越重视以患者为中心的治疗效果和整体生活质量，这一因素持续推动着该领域的发展。

材料科学进展

近年来，共聚物配方和生物复合材料的研究取得了显着进展，开发了具有更高拉伸强度、可预测的吸收曲线和生物完整性的生物可吸收植入。透过添加磷酸钙和羟基磷灰石等元素，研发人员旨在创造能够模拟天然骨骼行为并在癒合过程中促进骨传导的材料。

这些创新技术延长了产品在负荷下的使用寿命，同时确保在临床上可接受的时限内完全吸收。最终产品兼具双重优势：在癒合过程中保持机械稳定性，并逐渐被天然骨组织取代，从而减少长期併发症。预计这些进步将重新激发人们对特定细分市场的兴趣，并带来价值成长。

市场限制

产品强度不足

生物可吸收固定装置的主要限制在于其机械强度低于金属植入。虽然吸收过程的优点在于避免了手术取出，但也降低了植入的长期承重能力。因此，生物可吸收装置通常仅限于低应力应用，例如小骨骨折和软组织固定，而非股骨等长骨骨折。

在严重创伤病例中，使用生物可吸收固定材料可能导致稳定性不足，增加骨不连和延迟癒合的风险。关键骨折治疗领域的市场渗透率有限，也反映了这个临床限制。为了应对这项挑战，一些製造商正在开发生物复合材料装置，将可吸收聚合物与陶瓷填料结合，以牺牲吸收速度和脆性为补偿，提高强度。

外科医生技能不足

外科医生技能和培训的不足仍然是生物可吸收装置广泛应用的一大障碍。大多数骨科医生在金属内固定係统方面经验丰富，熟练植入放置和后续取出技术。而生物可吸收装置则通常需要不同的器械、植入技术和操作特性。

与成熟的金属植入系统相比，新型植入物的学习曲线较长，且缺乏长期数据，这使得许多外科医生持谨慎态度。此外，植入取出手术被认为是标准治疗的一部分，并且由保险覆盖，因此，医生缺乏经济奖励去转向那些无需后续手术的替代方案。

高成本

虽然生物可吸收固定装置具有许多临床和以患者为中心的优势，但成本仍是一大障碍。生物可吸收植入通常比金属植入物更昂贵，即便它们的适应症相似或更窄。受成本限制的医院和手术中心可能不愿意储备这些产品，除非能够明确证明其对病人或手术的益处。

此外，金属螺丝和钢板的可靠性和低成本限制了外科医生采用价格更高的生物可吸收替代品的动力，尤其是在预期疗效改善甚微的情况下。这种成本差异持续限制生物可吸收替代品的普及，尤其是在对成本敏感的医疗保健市场，例如拉丁美洲、亚太地区和欧洲部分地区。

监管和生产方面的挑战

生物可吸收医疗器材的生产涉及复杂的聚合物合成、灭菌和成型工艺，这些工艺对温度和湿度非常敏感。要实现稳定的品质、可预测的降解速率和机械强度，需要严格的製程控制和先进的生产基础设施。监管途径，尤其是在欧洲医疗设备法规 (MDR) 等新框架下，需要进行大量的临床前和临床检验，这增加了研发成本和上市时间。

规模较小的製造商往往难以满足这些要求，这限制了创新，也限制了竞争多样性，导致市场仍集中在少数几家拥有成熟研发和监管能力的大公司手中。

市场覆盖范围和数据范围

• 目标时期：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、整形外科和创伤中心以及进行骨骼和软组织修復手术的门诊手术机构。
• 调查方法：收入以「销售量×平均售价」计算，并透过一手调查、医院采购资料以及全球进出口记录进行检验。

竞争分析

2024年，Arthrex在全球生物可吸收固定材料市场占据主导地位。公司领先地位主要归功于其在小关节修復和运动医学的强大实力，而这两个领域正是生物可吸收固定材料应用最广泛的领域。 Arthrex的主要产品包括TRIM-IT™系列螺丝和钉子、BioComposite™螺丝以及Bio-Compression系列螺丝和钉子。公司持续的材料研发倡议和丰富的临床产品组合确保其始终处于该领域的创新前沿。

凭藉其 LactoSorb® 可吸收固定係统，Zimmer Biomet 已成为第二大竞争对手。该产品的机械可靠性和生物相容性增强了 Zimmer Biomet 在包括颅颜和听骨应用在内的各种固定手术领域的地位。 LactoSorb® 的持续应用以及该公司在聚合物技术方面的投入预计将使其保持竞争优势。

康美公司是市场上的第三大竞争对手。其SmartNail和SmartPin系统因其高效的骨折固定效果和易用性而备受认可。儘管康美公司已将业务拓展至生物可吸收固定材料以外的领域，但其在可吸收植入技术领域的长期专业经验仍为其在特定地区的市场认可度和现有销售额做出贡献。

地区

本版提供了涵盖北美、欧洲、亚太地区、拉丁美洲以及中东和非洲的全球调查结果。

该报告包含 35 页详细数据和分析。

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

生物可吸收固定装置市场

• 执行摘要
  • 全球生物可吸收固定装置市场概览
  • 竞争分析
  • 目标区域
• 介绍
• 市场分析与预测
• 驾驶员和约束装置
• 竞争市占率分析

简称

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