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市場調查報告書
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1813841

美國整形外科契約製造市場規模、佔有率和趨勢分析報告：按類型、服務和細分市場預測，2025-2033 年

U.S. Orthopedic Contract Manufacturing Market Size, Share & Trends Analysis Report By Type (Implants, Instruments, Cases, Trays), By Service (Forging/Casting, Spine & Trauma, Knee Machining & Finishing), And Segment Forecasts, 2025 - 2033
出版日期: | 出版商: Grand View Research | 英文 120 Pages | 商品交期: 2-10個工作天內

價格

美國整形外科契約製造市場摘要

預計 2024 年美國整形外科契約製造市場規模為 24.8 億美元，到 2033 年將達到 72.8 億美元，2025 年至 2033 年的複合年成長率為 13.16%。

市場成長的動力來自於與關節重組、創傷和脊椎手術相關的手術量的增加，以及目標商標產品製造商 (OEM) 為提高效率和縮短上市時間而增加的營運外包。

此外，人口老化和運動傷害的增加也導致整形外科植入和手術器械的需求不斷增加。此外，日益成長的成本壓力促使原始設備製造商（OEM）更加依賴契約製造製造商進行精密加工、無塵室組裝和監管支持，從而促進了整個供應鏈的長期合作。此外，技術創新對植入設計、器械和滅菌方法產生了顯著影響。 3D列印技術發展勢頭強勁，尤其是在製造患者專用植入和工具方面。 PEEK、鈦合金和生物可吸收材料等高性能材料的使用也日益增加。

美國整形外科契約製造市場規模及成長預測（2023-2033）

數位化製造工具、自動化和人工智慧主導的品管系統正擴大融入製造流程中。對創新手術器械和物聯網托盤的探索也推動了醫院庫存管理和手術計畫的改進。大量的資本投資正在增強先進的製造能力和垂直整合的服務產品。美國的受託製造廠商(CDMO) 正在獲得資金，以擴大其 CNC 加工、射出成型、積層製造和無塵室包裝能力。私募股權公司和原始設備製造商也在進行策略性收購和合資企業，以增強其實力並在四肢和脊椎等快速成長的領域中獲得競爭優勢。這些投資與對速度、擴充性和法規遵循日益成長的需求相一致。美國的監管環境複雜但定義明確，要求契約製造製造商遵守 FDA 第 820 部分（品質系統法規）和 ISO 標準。對設計可追溯性、滅菌驗證和供應鏈風險管理的審查日益嚴格。

目錄

第1章調查方法與範圍

第2章執行摘要

第 3 章美國整形外科契約製造市場變數、趨勢與範圍

  • 市場體系展望
    • 母市場展望
    • 相關/輔助市場展望
  • 市場動態
    • 市場促進因素分析
    • 市場限制因素分析
    • 市場機會分析
  • 技術格局
  • 定價分析
  • 市場分析工具
    • 波特五力分析
    • PESTEL 與 SWOT 分析
    • COVID-19影響分析

第4章美國整形外科契約製造市場：類型評估與趨勢分析

  • 細分儀表板
  • 美國整形外科契約製造市場：類型變化分析
  • 美國整形外科契約製造市場規模與趨勢分析（按類型）（2021-2033）
  • 植入
  • 裝置
  • 案件
  • 托盤

第5章美國整形外科契約製造市場：服務估算與趨勢分析

  • 細分儀表板
  • 美國整形外科契約製造市場：服務差異分析
  • 美國整形外科契約製造市場規模與趨勢分析（按服務，2021-2033 年）
  • 鍛造/鑄造
  • 髖部加工和精加工
  • 膝蓋加工和精加工
  • 脊椎與創傷
  • 設備加工及精加工
  • 其他

第6章 競爭態勢

  • 市場參與企業分類
    • 市場領導者
    • 新興企業
  • 2024年公司市佔率/估值分析
  • 公司簡介
    • Tecomet, Inc
    • Orchid Orthopedic Solutions
    • Cretex companies
    • Viant
    • ARCH Medical Solutions Corp.
    • Avalign Technologies
    • LISI Medical
    • Paragon Medical
    • Norman Noble, Inc.
    • Autocam Medical
Product Code: GVR-4-68040-702-8

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