미국의 정형외과 수탁제조 시장 규모, 점유율, 동향 분석 보고서 : 유형별, 서비스별, 부문별 예측(2025-2033년)

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