美国整形外科契约製造市场规模、份额和趋势分析报告：按类型、服务和细分市场预测，2025-2033 年

美国整形外科契约製造市场摘要

预计 2024 年美国整形外科契约製造市场规模为 24.8 亿美元，到 2033 年将达到 72.8 亿美元，2025 年至 2033 年的复合年增长率为 13.16%。

市场成长的动力来自于与关节重组、创伤和脊椎手术相关的手术量的增加，以及目标商标产品製造商 (OEM) 为提高效率和缩短上市时间而增加的营运外包。

此外，人口老化和运动伤害的增加也导致整形外科植入和手术器械的需求不断增加。此外，日益增长的成本压力促使原始设备製造商（OEM）更加依赖契约製造製造商进行精密加工、无尘室组装和监管支持，从而促进了整个供应链的长期合作。此外，技术创新对植入设计、器械和灭菌方法产生了显着影响。 3D列印技术发展势头强劲，尤其是在製造患者专用植入和工具方面。 PEEK、钛合金和生物可吸收材料等高性能材料的使用也日益增加。

美国整形外科契约製造市场规模及成长预测（2023-2033）

数位化製造工具、自动化和人工智慧主导的品管系统正越来越多地融入製造流程中。对创新手术器械和物联网托盘的探索也推动了医院库存管理和手术计画的改进。大量的资本投资正在增强先进的製造能力和垂直整合的服务产品。美国的受託製造厂商(CDMO) 正在获得资金，以扩大其 CNC 加工、射出成型、增材製造和无尘室包装能力。私募股权公司和原始设备製造商也在进行策略性收购和合资企业，以增强其实力并在四肢和脊椎等快速成长的领域中获得竞争优势。这些投资与对速度、扩充性和法规遵循日益增长的需求相一致。美国的监管环境复杂但定义明确，要求契约製造製造商遵守 FDA 第 820 部分（品质系统法规）和 ISO 标准。对设计可追溯性、灭菌验证和供应链风险管理的审查日益严格。

目录

第一章调查方法与范围

第二章执行摘要

第 3 章美国整形外科契约製造市场变数、趋势与范围

• 市场体系展望
  • 母市场展望
  • 相关/辅助市场展望
• 市场动态
  • 市场驱动因素分析
  • 市场限制因素分析
  • 市场机会分析
• 技术格局
• 定价分析
• 市场分析工具
  • 波特五力分析
  • PESTEL 与 SWOT 分析
  • COVID-19影响分析

第四章美国整形外科契约製造市场：类型评估与趋势分析

• 细分仪表板
• 美国整形外科契约製造市场：类型变化分析
• 美国整形外科契约製造市场规模与趋势分析（按类型）（2021-2033）
• 植入
• 装置
• 案件
• 托盘

第五章美国整形外科契约製造市场：服务估算与趋势分析

• 细分仪表板
• 美国整形外科契约製造市场：服务差异分析
• 美国整形外科契约製造市场规模与趋势分析（按服务，2021-2033 年）
• 锻造/铸造
• 髋部加工和精加工
• 膝盖加工和精加工
• 脊椎与创伤
• 设备加工及精加工
• 其他的

第六章 竞争态势

• 市场参与企业分类
  • 市场领导者
  • 新兴企业
• 2024年公司市占率/估值分析
• 公司简介
  • Tecomet, Inc
  • Orchid Orthopedic Solutions
  • Cretex companies
  • Viant
  • ARCH Medical Solutions Corp.
  • Avalign Technologies
  • LISI Medical
  • Paragon Medical
  • Norman Noble, Inc.
  • Autocam Medical

U.S. Orthopedic Contract Manufacturing Market Summary

The U.S. orthopedic contract manufacturing market size was estimated at USD 2.48 billion in 2024 and is projected to reach USD 7.28 billion by 2033, growing at a CAGR of 13.16% from 2025 to 2033. The market growth is driven by increased procedural volumes related to joint reconstruction, trauma, and spine surgeries. Besides, growth is further supported by rising original equipment manufacturers (OEMs) outsourcing operations to enhance efficiency and shorten time-to-market.

In addition, the rising aging population and a growing sports injuries have contributed to the increased demand for orthopedic implants and surgical instruments. Moreover, the cost pressures have led OEMs to depend on contract manufacturers for precision machining, cleanroom assembly, and regulatory support, fueling the long-term collaborations throughout the supply chain. Besides, technological innovations have notably impacted implant design, instrumentation, and sterilization methods. 3D printing has gained momentum, particularly for creating patient-specific implants and tools. High-performance materials like PEEK, titanium alloys, and bioresorbables are increasingly being utilized.

U.S. orthopedic contract manufacturing market size and growth forecast (2023-2033)

The integration of digital manufacturing tools, automation, and AI-driven quality control systems into production processes has increased. There has also been exploration into innovative surgical instruments and IoT-enabled trays for better hospital inventory management and procedural planning. Substantial capital investments have enhanced advanced manufacturing capabilities and vertically integrated service offerings. U.S.-based contract development and manufacturing organizations (CDMOs) have received funding to expand their CNC machining, injection molding, additive manufacturing, and cleanroom packaging abilities. Private equity firms and OEMs have also engaged in strategic acquisitions and joint ventures to consolidate their strengths and achieve a competitive advantage in rapidly growing areas such as extremities and spine operations. These investments align with the increasing demand for speed, scalability, and regulatory adherence. The regulatory landscape in the U.S. is complex yet well-defined, with contract manufacturers required to adhere to the FDA's Part 820 (Quality System Regulation) and ISO standards. There has been heightened scrutiny regarding design traceability, sterilization validation, and supply chain risk management.

U.S. Orthopedic Contract Manufacturing Market Report Segmentation

This report forecasts revenue growth at country levels and analyzes the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. orthopedic contract manufacturing market report based on type, and service:

• Type Outlook (Revenue, USD Million, 2021 - 2033)
• Implants
• Instruments
• Cases
• Trays
• Service Outlook (Revenue, USD Million, 2021 - 2033)
• Forging/Casting
• Spine & Trauma
• Knee Machining & Finishing
• Instrument Machining & Finishing
• Hip Machining & Finishing
• Others

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Type
  • 1.2.2. Service
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased Database
  • 1.4.2. GVR's Internal Database
  • 1.4.3. Secondary Sources
  • 1.4.4. Primary Research
• 1.5. Information Or Data Analysis
  • 1.5.1. Data Analysis Models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity Flow Analysis
  • 1.7.2. Value-Chain-Based Sizing & Forecasting
  • 1.7.3. Multivariate Model Analysis
• 1.8. List Of Secondary Sources
• 1.9. List Of Abbreviations
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

Chapter 3. U.S. Orthopedic Contract Manufacturing Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Related/Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
    • 3.2.1.1. Rising Aging Population
    • 3.2.1.2. Emerging Demand For Outsourcing Among OEMs
    • 3.2.1.3. Technological Advancements Across Orthopedic Products
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Strict FDA regulations.
    • 3.2.2.2. Supply chain disruptions and material shortages delay production timelines.
  • 3.2.3. Market Opportunity Analysis
• 3.3. Technology Landscape
• 3.4. Pricing Analysis
• 3.5. Market Analysis Tools
  • 3.5.1. Porter's Five Force Analysis
  • 3.5.2. PESTEL by SWOT Analysis
  • 3.5.3. COVID-19 Impact Analysis

Chapter 4. U.S. Orthopedic Contract Manufacturing Market: Type Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. U.S. Orthopedic Contract Manufacturing Market Type Movement Analysis
• 4.3. U.S. Orthopedic Contract Manufacturing Market Size & Trend Analysis, by Type, 2021 - 2033 (USD Million)
• 4.4. Implants
  • 4.4.1. Implants Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.5. Instruments
  • 4.5.1. Instruments Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.6. Cases
  • 4.6.1. Cases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.7. Trays
  • 4.7.1. Trays Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Orthopedic Contract Manufacturing Market: Service Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. U.S. Orthopedic Contract Manufacturing Market Service Movement Analysis
• 5.3. U.S. Orthopedic Contract Manufacturing Market Size & Trend Analysis, by Service, 2021 - 2033 (USD Million)
• 5.4. Forging/Casting
  • 5.4.1. Forging/Casting Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Hip Machining & Finishing
  • 5.5.1. Hip Machining & Finishing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.6. Knee Machining & Finishing
  • 5.6.1. Knee Machining & Finishing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.7. Spine & Trauma
  • 5.7.1. Spine & Trauma Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.8. Instrument Machining & Finishing
  • 5.8.1. Instrument Machining & Finishing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.9. Others
  • 5.9.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. Competitive Landscape

• 6.1. Market Participant Categorization
  • 6.1.1. Market Leaders
  • 6.1.2. Emerging Players
• 6.2. Company Market Share/Assessment Analysis, 2024
• 6.3. Company Profiles
  • 6.3.1. Tecomet, Inc
    • 6.3.1.1. Company Overview
    • 6.3.1.2. Financial Performance
    • 6.3.1.3. Service Benchmarking
    • 6.3.1.4. Strategic Initiatives
  • 6.3.2. Orchid Orthopedic Solutions
    • 6.3.2.1. Company Overview
    • 6.3.2.2. Financial Performance
    • 6.3.2.3. Service Benchmarking
    • 6.3.2.4. Strategic Initiatives
  • 6.3.3. Cretex companies
    • 6.3.3.1. Company Overview
    • 6.3.3.2. Financial Performance
    • 6.3.3.3. Service Benchmarking
    • 6.3.3.4. Strategic Initiatives
  • 6.3.4. Viant
    • 6.3.4.1. Company Overview
    • 6.3.4.2. Financial Performance
    • 6.3.4.3. Service Benchmarking
    • 6.3.4.4. Strategic Initiatives
  • 6.3.5. ARCH Medical Solutions Corp.
    • 6.3.5.1. Company Overview
    • 6.3.5.2. Financial Performance
    • 6.3.5.3. Service Benchmarking
    • 6.3.5.4. Strategic Initiatives
  • 6.3.6. Avalign Technologies
    • 6.3.6.1. Company Overview
    • 6.3.6.2. Financial Performance
    • 6.3.6.3. Service Benchmarking
    • 6.3.6.4. Strategic Initiatives
  • 6.3.7. LISI Medical
    • 6.3.7.1. Company Overview
    • 6.3.7.2. Financial Performance
    • 6.3.7.3. Service Benchmarking
    • 6.3.7.4. Strategic Initiatives
  • 6.3.8. Paragon Medical
    • 6.3.8.1. Company Overview
    • 6.3.8.2. Financial Performance
    • 6.3.8.3. Service Benchmarking
    • 6.3.8.4. Strategic Initiatives
  • 6.3.9. Norman Noble, Inc.
    • 6.3.9.1. Company Overview
    • 6.3.9.2. Financial Performance
    • 6.3.9.3. Service Benchmarking
    • 6.3.9.4. Strategic Initiatives
  • 6.3.10. Autocam Medical
    • 6.3.10.1. Company Overview
    • 6.3.10.2. Financial Performance
    • 6.3.10.3. Service Benchmarking
    • 6.3.10.4. Strategic Initiatives

List of Tables

• Table 1 List of Secondary Sources
• Table 2 List of Abbreviations
• Table 3 U.S. Orthopedic Contract Manufacturing Market Estimates and Forecasts, by Type, 2021 - 2033 (USD Million)
• Table 4 U.S. Orthopedic Contract Manufacturing Market Estimates and Forecasts, by Service, 2021 - 2033 (USD Million)

List of Figures

• Fig. 1 U.S. Orthopedic Contract Manufacturing Market Segmentation
• Fig. 2 Data Analysis Models
• Fig. 3 Market Formulation and Validation
• Fig. 4 Data Validating & Publishing
• Fig. 5 Market Research Process
• Fig. 6 Information Procurement
• Fig. 7 Primary Research
• Fig. 8 Value-chain-Based Sizing & Forecasting
• Fig. 9 QFD Modelling for Market Share Assessment
• Fig. 10 Market Formulation & Validation
• Fig. 11 Commodity Flow Analysis
• Fig. 12 Market Outlook
• Fig. 13 Segment Snapshot 1
• Fig. 14 Segment Snapshot 2
• Fig. 15 Competitive Landscape Snapshot
• Fig. 16 Market Dynamics
• Fig. 17 Porter's Five Force Analysis
• Fig. 18 PESTEL Analysis
• Fig. 19 U.S. Orthopedic Contract Manufacturing Market: Type outlook key takeaways
• Fig. 20 U.S. Orthopedic Contract Manufacturing Market: Type movement analysis
• Fig. 21 Implants Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• Fig. 22 Instruments Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• Fig. 23 Cases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• Fig. 24 Trays Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• Fig. 25 U.S. Orthopedic Contract Manufacturing Market: Service outlook key takeaways
• Fig. 26 U.S. Orthopedic Contract Manufacturing Market: Service movement analysis
• Fig. 27 Forging/Casting Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• Fig. 28 Hip Machining & Finishing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• Fig. 29 Knee Machining & Finishing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• Fig. 30 Spine & Trauma Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• Fig. 31 Instrument Machining & Finishing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• Fig. 32 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• Fig. 33 Market Participant Categorization
• Fig. 34 U.S. Orthopedic Contract Manufacturing Market Share/Assessment Analysis, 2024
• Fig. 35 Strategic framework