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US and EU Plastic Injection Molding Machine Market, Opportunity, Growth Drivers, Industry Trend Analysis and Forecast, 2025-2034

Publisher Global Market Insights
Published Jun 27, 2025
Length 319 Pages
SKU # GMI20284309

Description

US & EU Plastic Injection Molding Machine for MedTech Market was valued at USD 1.16 billion in 2024 and is estimated to grow at a CAGR of 11.4% to reach USD 1.67 billion by 2034. The market is witnessing substantial growth driven by the increasing need for precision-engineered components in the medical sector, particularly in diagnostic devices, surgical tools, and sterile packaging. With the rising demand for minimally invasive procedures and stringent regulatory compliance in healthcare manufacturing, injection molding has become a preferred method for producing high-accuracy, high-volume MedTech components.

Plastic injection molding machines enable cost-efficient production while ensuring consistency and complex geometry, critical for medical-grade applications. Innovations in mold designs, material selection, and machine automation are reshaping the MedTech manufacturing landscape across both the US and EU regions. Leading medical device manufacturers are actively investing in sustainable and scalable injection molding infrastructure to support the surge in demand for personalized medicine, wearables, and disposable diagnostic devices.

By Machine Type, Hydraulic Machines led the market in 2024, accounting for USD 471.5 million in revenue. These machines remain popular due to their robust performance, high clamping force, and adaptability in processing a wide range of thermoplastics used in medical components. Despite growing interest in all-electric machines for cleaner operations, hydraulic systems continue to dominate in high-pressure molding for thick-walled products and packaging applications. Continuous technological advancements in energy efficiency and control systems are also making hydraulic machines more sustainable and cost-effective for medical use.

By Technology, Multi-Cavity and Family Mold Designs held a dominant position in the market, generating USD 431.1 million in 2024. These technologies allow manufacturers to produce multiple identical or varied parts in a single injection cycle, significantly enhancing productivity and reducing per-unit costs. With rising demand for mass production of precision medical parts, including syringes, inhalers, and catheter components, the adoption of multi-cavity and family molds has surged. Their ability to minimize material waste and ensure dimensional accuracy makes them ideal for high-throughput MedTech manufacturing environments.

By Application, the Packaging segment emerged as the largest revenue contributor, valued at USD 650.3 million in 2024. Medical packaging requires strict adherence to hygiene and safety standards, prompting manufacturers to adopt advanced molding machines capable of delivering contaminant-free, durable, and tamper-proof packaging solutions. From blister packs and IV bag connectors to surgical trays and tube caps, plastic injection molding enables the production of standardized and customized medical packaging at scale. The increasing use of smart and sustainable packaging materials is further boosting innovation and investment in this segment.

By Region, the Midwest in the US and Germany in the EU stood out as key contributors, collectively generating USD 405 million in 2024. The Midwest, home to several medical manufacturing clusters, benefits from a skilled workforce, robust infrastructure, and government incentives supporting MedTech innovation. Germany, known for its advanced engineering capabilities, continues to lead the European market with strong investments in medical device automation and cleanroom-compatible molding solutions. Both regions are also prioritizing Industry 4.0 integration in plastic molding processes, enhancing real-time monitoring, traceability, and quality assurance.

Key players operating in the US & EU Plastic Injection Molding Machine for MedTech Market include ENGEL Austria GmbH, Arburg GmbH + Co KG, Sumitomo (SHI) Demag, Milacron LLC, and Husky Injection Molding Systems. These companies are focusing on product customization, automation, and energy-efficient machine platforms tailored to MedTech requirements. Strategic collaborations with medical OEMs, expansion of cleanroom-compatible machinery, and R&D in biocompatible materials are shaping the competitive landscape.

As the MedTech sector continues to evolve with trends such as point-of-care diagnostics, telemedicine devices, and 3D-printed medical tools, the role of high-performance injection molding machines in ensuring reliable, scalable, and regulatory-compliant manufacturing will only become more crucial.

Table of Contents

319 Pages
Chapter 1 Methodology and Scope
1.1 Industry coverage
1.2 Market scope and definitions
1.3 Research design
1.4 Market size estimates and calculations
1.4.1 Approach 1: Company revenue share analysis
1.4.2 Approach 2: Data mining approach (investor presentations)
1.5 Key trends for market estimates
1.6 Forecast model
1.7 Primary research & validation
1.7.1 Primary sources
1.7.2 Data mining sources
1.7.2.1 Paid sources 35
1.7.2.2 Public sources
Chapter 2 Executive Summary
2.1 Market Snapshot
2.1.1 U.S. and Plastic Injection Molding Machine Market, 2021-2034
2.1.2 MedTech Segment Overview
2.1.3 MedTech Packaging Applications Overview
2.1.3.1 Packaging 38
2.1.3.1.1 Sterile Packaging Components
2.1.3.1.2 Caps and closures
2.1.3.1.1 Protective Packaging
2.1.3.1.1 Other
2.1.3.2.1 Diagnostic 40
2.1.3.2.1 Surgical
2.1.3.2.2 Others
2.2 Key Trends and Opportunities
2.2.1 Molding Solution Providers
2.2.2 MedTech Companies with In-House Molding
2.2.3 Contract Manufacturers
2.3 Regional Insights
2.3.2 Europe
2.4 Competitive Landscape Snapshot
2.4.1 Molding Solution Providers
2.4.2 MedTech Companies with In-House Molding
2.4.3 Contract Manufacturers
Chapter 3 Industry Insights
3.1 Industry ecosystem
3.2 Value Chain Analysis
3.2.1 Profit Margin Analysis
3.2.2 Raw Material Suppliers
3.3 Manufacturers
3.4 Distributors
3.5 End-users in MedTech Segment
3.6 Trump administration tariff analysis
3.6.1 Impact on trade
3.6.1.1 Trade volume disruptions
3.6.1.2 Retaliatory measures
3.6.2 Impact on the industry
3.6.2.1 Supply-side Impact (Raw Materials)
3.6.2.1.1 Price Volatility in Key Materials
3.6.2.1.2 Supply chain restructuring
3.6.2.1.3 Production cost implications
3.6.2.2 Demand-side Impact (Selling Price)
3.6.2.2.1 Price Transmission to End Markets
3.6.2.2.2 Market share dynamics
3.6.2.2.3 Consumer Response Patterns
3.6.3 Key Companies Impacted
3.6.4 Strategic industry responses
3.6.4.1 Supply Chain Reconfiguration
3.6.4.2 Pricing and Product Strategies
3.6.4.3 Policy Engagement
3.6.5 Outlook and Future Considerations
3.7 Regulatory Framework Analysis
3.7.1 FDA Regulations for Medical Device Manufacturing
3.7.1.1 FDA's Statutory Authority and Historical Context
3.7.1.2 Device Classification Structure
3.7.1.3 Premarket Regulatory Procedures
3.7.1.3.1 510(k) Clearance
3.7.1.3.2.1 Premarket Approval (PMA)
3.7.1.3.3 De Novo Classification
3.7.1.3.4 Additional Submission Pathways
3.7.1.4 Manufacturing Quality and Design Controls
3.7.1.4.1 Quality System Regulation (QSR)
3.7.1.4.2 Device Listing and Registration
3.7.1.4.3 Postmarket Surveillance and Reporting
3.7.1.4.4 Unique Device Identification (UDI) System
3.7.1.4.5 User Fee Programs: MDUFA
3.7.2 ISO 13485 Standards
3.7.2.1 Strategic relevance for plastic injection molders in medtech packaging
3.7.2.2 Scope of ISO 13485:2016 for Injection Molding Operations
3.7.2.3 Integration with FDA and European regulatory expectations
3.7.2.3.1 U.S.(FDA)
3.7.2.3.2 Europe (EU MDR)
3.7.2.4 Key Requirements for Molders
3.7.2.5 Certification and Market Signals
3.7.2.6 Implementation Considerations
3.7.3 EU Medical Device Regulation (MDR)
3.7.3.1 Regulatory Scope
3.7.3.2 Device Classification (Annex VIII)
3.7.3.3 General Safety and Performance Requirements (Annex I)
3.7.3.4 Manufacturing Quality Systems (Article 10, Annex IX & XI)
3.7.3.5 Unique Device Identification (UDI) and Labeling (Articles 27-28)
3.7.3.6 Economic Operators and Responsibilities
3.7.3.7 Post-Market Surveillance (PMS) and Vigilance
3.7.3.8 Technical Documentation (Annex II & III)
3.7.3.9 Transition Deadlines and Market Access
3.7.4 Good Manufacturing Practices (GMP)
3.7.4.1.1 Alignment with Medical Packaging Requirements
3.7.4.1.2 Documentation and Traceability
3.7.4.1.3 Process Validation and Cleanroom Compliance
3.7.4.1.4 Regulatory Integration
3.7.5 Impact on machine specifications and design
3.7.5.1 Cleanroom Compatibility
3.7.5.2 Enhanced Process Monitoring and Control
3.7.5.3 Material Handling & Validation
3.7.5.4 Sterilization-Compatible Molds and Tooling
3.7.5.5 Integration with MES/QMS Platforms
3.7.5.6 Validated Automation Interfaces
3.8 Technological Landscape
3.8.1 Cleanroom-Compatible Injection Molding Machines
3.8.2 Micro-Injection Molding Technology
3.8.3 Multi-Component Injection Molding
3.8.4 IoT and Smart Manufacturing Integration
3.8.5 Automation and Robotics in Medical Injection Molding
3.9 Industry Challenges and Restraints
3.9.1 Regulatory Compliance Challenges
3.9.2 High Initial Investment Costs
3.9.3 Material Compatibility Issues
3.9.4 Validation and Documentation Requirements
3.10 Market Drivers
3.10.1 Rising Demand for Medical Devices
3.10.2 Technological Advancements in Healthcare
3.10.3 Aging Population and Chronic Diseases
3.10.4 Shift Towards Minimally Invasive Procedures
3.10.5 Increased Focus on Single-Use Medical Devices
3.11 Market Opportunities
3.11.1 Emerging Markets for Medical Devices
3.11.2 Customization and Personalization in Medical Products
3.11.3 Sustainable and Biocompatible Materials
3.11.4 Integration of 3D Printing with Injection Molding
3.12 Porter's analysis
3.13 PESTEL analysis
3.13.1 Overview of MedTech Packaging
3.13.1.1 Types of MedTech Packaging
3.13.1.2 Key Applications
3.13.1.3 Material Requirements for MedTech Packaging
3.13.1.4 Regulatory Requirements for MedTech Packaging
3.13.1.5 Technological Innovations in MedTech Packaging
3.13.1.5.1 Smart Packaging Technologies
3.13.1.5.2 Antimicrobial Packaging Materials
3.13.1.5.3 Tamper-Evident and Child-Resistant Designs
3.13.1.5.4 Sustainable and Recyclable Materials
3.13.1.5.5 High-Precision Multi-Cavity Molding
3.13.1.5.6 Integration with Cleanroom Automation
3.13.1.5.7 In-Mold Labeling (IML) and Marking
3.13.1.5.8 Digital Twins and Process Simulation
3.13.1.5.9 Integration with 3D Printing
3.13.1.5.10 Self-Sealing and Aseptic Packaging Designs
3.13.1.6 Market Trends and Growth Opportunities
3.13.1.6.1 Personalized & Patient-Centric Packaging
3.13.1.6.2 Tamper-Evident & Anti-Counterfeiting Solutions
3.13.1.6.3 In-Line Sterilization Integration
3.13.1.6.4 Simulation & Digital Twin Adoption
3.14 B2B End-User Analysis in MedTech Segment
3.14.1 Overview of B2B End-Users
3.14.1.1 MedTech Companies with In-House Injection Molding Operations
3.14.1.2 Pharmaceutical Companies
3.14.1.3 Contract Manufacturing Organizations (CMOs)
3.14.1.4 Research & Development Institutions
3.14.2 End-User Requirement Analysis
3.14.3 End-User Buying Behavior
3.14.4 Material Considerations for Medical Application
3.14.4.1 Polyethylene (PE)
3.14.4.2 Polypropylene (PP)
3.14.4.3 Polycarbonate (PC)
3.14.4.4 Polyetheretherketone (PEEK)
3.14.4.5 Thermoplastic Elastomers (TPEs)
Chapter 4 Competitive Landscape
4.1 Introduction
4.1.1 Market Share by Plastic Machine Type
4.1.2 Market share by Molding Solution Providers
4.1.3 Market Share by Plastic molds addressing the MedTech / Pharma companies
4.2 Competitive Benchmarking
4.2.1 Product Portfolio Analysis
4.2.2 Technology Comparison
4.2.3 Service Offerings Comparison
4.2.4 Market Presence Evaluation
4.3 Strategic Initiatives
4.3.1 New Product Launches
4.3.2 Mergers and Acquisitions
4.3.3 Partnerships and Collaborations
4.4 SWOT Analysis of Key Players
4.5 Competitive positioning matrix
4.5.1 Product Positioning
4.5.2 Price-Performance Positioning
4.5.3 Geographic Presence
4.5.4 Innovation Capabilities
4.6 Competitive positioning matrix
4.7 Strategy dashboard
4.7.1 Competitive benchmarking
4.7.1.1 Manufacturing capabilities
4.7.1.2 Product portfolio strength
4.7.1.3 Distribution network
4.7.1.4 R&D investments
Chapter 5 US&EU Plastic Injection Molding Machine for MedTech Market, By Machine Type
5.1 Hydraulic Machines
5.2 Electric Machines
5.3 Hybrid Machines
5.4 Micro Machines
Chapter 6 US&EU Plastic Injection Molding Machine for MedTech Market, By Technology
6.1 Hot Runner Systems and Cold Runner Systems
6.2 Multi-Cavity and Family Mold Designs
6.3 Stack Mold Technology
6.4 Servo-Actuated Mold Systems
6.5 High-Precision Mold Technologies
Chapter 7 US&EU Plastic Injection Molding Machine for MedTech Market, By Clamping Force
7.1 0-200 Ton Force
7.2 201-500 Ton Force
7.3 Above 500 Ton Force
Chapter 8 US&EU Plastic Injection Molding Machine for MedTech Market, By Application
8.1 Packaging
8.1.1 Sterile Packaging Components
8.1.2 Caps and Closures
8.1.3 Protective Packaging
8.1.4 Others
8.2 Diagnostic
8.3 Surgical
8.4 Others
Chapter 9 US&EU Plastic Injection Molding Machine for MedTech Market, By End- user 137
9.1 B2B MedTech Companies
9.1.1 Large
9.1.2 SMEs
9.2 Pharmaceutical and Combination Product Manufacturers
9.3 Contract Manufacturing Organizations (CMOs)
9.4 Research and Development Organizations
9.4.1 Medical Research Institutions
9.4.2 Medical Incubators and Innovation Centers
Chapter 10 US&EU Plastic Injection Molding Machine for MedTech Market, By U.S & EU
10.1 United States
10.1.1 Machine Type trends
10.1.2 Technology trends
10.1.3 Clamping Force trends
10.1.4 Application trends
10.1.5 End-user trends
10.2 Europe
10.2.1 Machine Type trends
10.2.2 Technology trends
10.2.3 Clamping Force trends
10.2.4 Application trends
10.2.5 End-user trends
10.2.6 Germany
10.2.6.1 Machine Type trends
10.2.6.2 Technology trends
10.2.6.3 Clamping Force trends
10.2.6.4 Application trends
10.2.6.5 End-user trends
10.2.7 UK 171
10.2.7.1 Machine Type trends
10.2.7.2 Technology trends
10.2.7.3 Clamping Force trends
10.2.7.4 Application trends
10.2.7.5 End-user trends
10.2.8 France
10.2.8.1 Machine Type trends
10.2.8.2 Technology trends
10.2.8.3 Clamping Force trends
10.2.8.4 Application trends
10.2.8.5 End-user trends
10.2.9 Italy
10.2.9.1 Machine Type trends
10.2.9.2 Technology trends
10.2.9.3 Clamping Force trends
10.2.9.4 Application trends
10.2.9.5 End-user trends
10.2.10 Spain
10.2.10.1 Machine Type trends
10.2.10.2 Technology trends
10.2.10.3 Clamping Force trends
10.2.10.4 Application trends
10.2.10.5 End-user trends
10.2.11 Rest of EU Countries
10.2.11.1 Machine Type trends
10.2.11.2 Technology trends
10.2.11.3 Clamping Force trends
10.2.11.4 Application trends
10.2.11.5 End-user trends
Chapter 11 Company Profiles
11.1 Molding Solution Providers
11.1.1 MoldFlo solutions
11.1.1.1 Financial data
11.1.1.2 Product landscape
11.1.1.3 Strategic outlook
11.1.1.4 SWOT analysis
11.1.2 Synventive
11.1.2.1 Financial data
11.1.2.1.1 Sales revenue, 2021-2023 (USD Million)
11.1.2.2 Product landscape
11.1.2.3 Strategic outlook
11.1.2.4 SWOT analysis
11.1.3 Moldpro ApS
11.1.3.1 Financial data
11.1.3.2.1 Product landscape
11.1.3.3 Strategic outlook
11.1.3.4 SWOT analysis
11.1.4 Autodesk Moldflow
11.1.4.1 Financial data
11.1.4.1.1 Sales revenue, 2022-2024 (USD Million)
11.1.4.2 Product landscape
11.1.4.3 Strategic outlook
11.1.4.4 SWOT analysis
11.1.5 Moldex3D
11.1.5.1 Financial data
11.1.5.2 Product landscape
11.1.5.3 Strategic outlook
11.1.5.4 SWOT analysis
11.1.6 ARBURG GmbH + Co KG
11.1.6.1 Financial data
11.1.6.2 Product landscape
11.1.6.3 Strategic outlook
11.1.6.4 SWOT analysis
11.1.7 Männer group
11.1.7.1 Financial data
11.1.7.1.1 Sales revenue, 2021-2023 (USD Million)
11.1.7.2 Product landscape
11.1.7.3 Strategic outlook
11.1.7.4 SWOT analysis
11.1.8 SIMCON
11.1.8.1 Financial data
11.1.8.2 Product landscape
11.1.8.3 Strategic outlook
11.1.8.4 SWOT analysis
11.1.9 SIGMASOFT
11.1.9.1 Financial data
11.1.9.2 Product landscape
11.1.9.3 Strategic outlook
11.1.9.4 SWOT analysis
11.1.10 iTAC Software
11.1.10.1 Financial data
11.1.10.1.1 Sales revenue, 2021-2023 (USD Million)
11.1.10.2 Product landscape
11.1.10.3 Strategic outlook
11.1.10.4 SWOT analysis
11.2 MedTech Companies with In-House Molding
11.2.1 Abbott
11.2.1.1 Financial data
11.2.1.1.1 Sales revenue, 2022-2024 (USD Million)
11.2.1.2 Product landscape
11.2.1.3 Strategic outlook
11.2.1.4 SWOT analysis
11.2.2 Baxter
11.2.2.1 Financial data
11.2.2.1.1 Sales revenue, 2021-2024 (USD Million)
11.2.2.2 Product landscape
11.2.2.3 Strategic outlook
11.2.2.4 SWOT analysis
11.2.3 BD 260
11.2.3.1 Financial data
11.2.3.1.1 Sales revenue, 2022-2024 (USD Million)
11.2.3.2 Product landscape
11.2.3.3 Strategic outlook
11.2.3.4 SWOT analysis
11.2.4 Fresenius
11.2.4.1 Financial data
11.2.4.1.1 Sales revenue, 2023-2024 (USD Million)
11.2.4.2 Product landscape
11.2.4.3 Strategic outlook
11.2.4.4 SWOT analysis
11.2.5 Medtronic
11.2.5.1 Financial data
11.2.5.1.1 Sales revenue, 2023-2024 (USD Million)
11.2.5.2 Product landscape
11.2.5.3 Strategic outlook
11.2.5.4 SWOT analysis
11.2.6 Novo Nordisk
11.2.6.1 Financial data
11.2.6.1.1 Sales revenue, 2022-2024 (USD Million)
11.2.6.2 Product landscape
11.2.6.3 Strategic outlook
11.2.6.4 SWOT analysis
11.2.7 Stryker
11.2.7.1 Financial data
11.2.7.1.1 Sales revenue, 2022-2024 (USD Million)
11.2.7.2 Product landscape
11.2.7.3 Strategic outlook
11.2.7.4 SWOT analysis
11.2.8 Ultradent
11.2.8.1 Financial data
11.2.8.2 Product landscape
11.2.8.3 Strategic outlook
11.2.8.4 SWOT analysis
11.2.9 B BRAUN
11.2.9.1 Financial data
11.2.9.1.1 Sales revenue, 2021-2024 (USD Million)
11.2.9.2 Product landscape
11.2.9.3 Strategic outlook
11.2.9.4 SWOT analysis
11.2.10 Sanner Group
11.2.10.1 Financial data
11.2.10.2 Product landscape
11.2.10.3 Strategic outlook
11.2.10.4 SWOT analysis
11.3 Contract Manufacturers
11.3.1 Biomerics
11.3.1.1 Financial data
11.3.1.2 Product landscape
11.3.1.3 Strategic outlook
11.3.1.4 SWOT analysis
11.3.2 C&J Industries
11.3.2.1 Financial data
11.3.2.2 Product landscape
11.3.2.3 Strategic outlook
11.3.2.4 SWOT analysis
11.3.3 Biomerics
11.3.3.1 Financial data
11.3.3.2 Product landscape
11.3.3.3 Strategic outlook
11.3.3.4 SWOT analysis
11.3.4 Flex
11.3.4.1 Financial data
11.3.4.1.1 Sales revenue, 2022-2024 (USD Million)
11.3.4.2 Product landscape
11.3.4.3 Strategic outlook
11.3.4.4 SWOT analysis
11.3.5 HTI Plastics
11.3.5.1 Financial data
11.3.5.2 Product landscape
11.3.5.3 Strategic outlook
11.3.5.4 SWOT analysis
11.3.6 Jabil
11.3.6.1 Financial data
11.3.6.1.1 Sales revenue, 2021-2023 (USD Million)
11.3.6.2 Product landscape
11.3.6.3 Strategic outlook
11.3.6.4 SWOT analysis
11.3.7 Kaysun
11.3.7.1 Financial data
11.3.7.2 Product landscape
11.3.7.3 Strategic outlook
11.3.7.4 SWOT analysis
11.3.8 Phillips-Medisize
11.3.8.1 Financial data
11.3.8.2 Product landscape
11.3.8.3 Strategic outlook
11.3.8.4 SWOT analysis
11.3.9 Röchling
11.3.9.1 Financial data
11.3.9.2 Product landscape
11.3.9.3 Strategic outlook
11.3.9.4 SWOT analysis
11.3.10 Stelray
11.3.10.1 Financial data
11.3.10.2 Product landscape
11.3.10.3 Strategic outlook
11.3.10.4 SWOT analysis

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