Italy 3D Printing Medical Devices Market Analysis

Italy 3D Printing Medical Devices Market Analysis


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Italy's 3D printing medical devices market size was valued at $71 Mn in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 15.8% from 2022 to 2030 and will reach $230 Mn in 2030. The market is segmented by component, application, technology, and end user. The Italy 3D Printing Medical Devices market will grow 3D printing technology has made a significant impact in the medical industry by enabling the production of personalized and complex medical devices. The key market players are Some of the key players in the market include 3D-Side, EGO3D, Mecuris Italia, MT Ortho, REJOINT, Storm Line, WASP MED, and others.

ID: IN10ITMD002 CATEGORY: Medical Devices GEOGRAPHY: Italy AUTHOR: Chandani Patel

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Italy 3D Printing Medical Devices Market Executive Summary

Italy's 3D printing medical devices market size was valued at $71 Mn in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 15.8% from 2022 to 2030 and will reach $230 Mn in 2030. Italy's healthcare expenditure was approximately 8.9% of GDP in 2019, according to data from the Organization for Economic Cooperation and Development (OECD). This is lower than the healthcare expenditure of other developed countries with universal healthcare systems.

3D printing technology has shown great potential in the field of medical devices, offering a range of benefits such as improved customization, precision, and cost-effectiveness. 3D printing technology has revolutionized the production of prosthetic limbs, allowing for the creation of customized prostheses that fit the patient's unique anatomy. 3D-printed prosthetics can also be produced more quickly and at a lower cost than traditional prosthetics. 3D printing technology can be used to produce customized implants that fit a patient's unique anatomy, reducing the risk of complications and improving patient outcomes.

In recent years, Italy has shown a growing interest in 3D printing medical devices as a way to improve patient outcomes and reduce healthcare costs. One example of this is the use of 3D-printed prosthetic devices, which can be customized to fit the specific needs of individual patients and reduce the need for costly surgical procedures.

Several Italian hospitals and research institutions have also been involved in research and development initiatives related to 3D printing medical devices, such as the production of customized implants and surgical instruments. The Italian market for 3D-printed medical devices is a quickly expanding and fiercely competitive sector that is expected to expand much more over the next several years. This market is anticipated to increase in the future due to the emphasis on innovative products, cost-effectiveness, and personalized medical devices.

italy 3D printing medical devices market

Market Dynamics

Market Growth Drivers

Italy is renowned for its engineering prowess and cutting-edge technologies. The ability to produce individualized and sophisticated medical devices thanks to 3D printing technology has had a huge impact on the medical sector. This has fuelled the Italian market for 3D-printed medical devices. Moreover, medical equipment may be made specifically for each patient's needs thanks to 3D printing. The need for 3D-printed medical gadgets has grown in Italy as a result.

Additionally, With the increasing incidence of chronic diseases, the demand for medical devices that can improve the quality of life for patients has increased. 3D printing allows for the production of complex medical devices that can help in the treatment of chronic diseases, thereby driving market growth.

Market Restraints

  1. Lack of Skilled Workforce: The production of 3D-printed medical devices requires specialized skills and expertise. The lack of a skilled workforce can be a major challenge for companies looking to enter the market and scale their operations
  2. High Cost: The cost of 3D printing medical devices is relatively high compared to traditional manufacturing methods. This can be a major restraint in the adoption of 3D printing technology for medical devices
  3. Regulatory Challenges: The regulatory requirements for 3D-printed medical devices are strict in Italy, which can be a significant barrier to entry for new players in the market. This can also lead to delays in the approval process for new 3D-printed medical devices

Competitive Landscape

Key Players

  • 3D-Side: This company specializes in the design and production of patient-specific implants for cranio-maxillofacial surgery using 3D printing technology
  • EGO3D: EGO3D is a 3D printing company that produces customized prosthetic and orthotic devices for patients with disabilities or injuries
  • Mecuris Italia: Mecuris Italia develops and produces personalized prostheses using 3D printing technology, with a focus on improving patient outcomes and quality of life
  • MT Ortho: MT Ortho is a medical device company that produces orthopedic implants and surgical instruments using 3D printing technology
  • REJOINT: REJOINT is a medical device company that produces custom-made knee replacements using 3D printing technology. Their implants are designed to improve patient outcomes and reduce recovery times
  • Storm Line: Storm Line produces medical-grade 3D printing filaments and resin for use in a range of medical applications, including implants and surgical tools
  • WASP MED: WASP MED is a medical division of WASP, an Italian 3D printing company. They produce custom-made prostheses and orthoses using 3D printing technology

Healthcare Policies and Regulatory Landscape

In Italy, medical devices, including those made using 3D printing technology, are regulated by the Italian Ministry of Health. The regulations are in line with European Union regulations, specifically the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

To sell a 3D-printed medical device in Italy, manufacturers must obtain a Conformity Assessment Certificate from a Notified Body. The certificate confirms that the device meets the essential requirements outlined in the MDR and IVDR.

Manufacturers must also comply with the specific regulations for medical devices made using 3D printing technology. These regulations include requirements for the design, materials, production process, and validation of the devices. For example, the design of a 3D-printed medical device must be validated using computer-aided engineering (CAE) simulations, and the device must be produced using validated software and equipment.

Additionally, 3D-printed medical devices must undergo an appropriate testing and clinical evaluation to ensure they are safe and effective for their intended use. Manufacturers must also comply with post-market surveillance requirements, including reporting adverse events and conducting post-market clinical follow-ups.

1. Executive Summary
1.1 Device Overview
1.2 Global Scenario
1.3 Country Overview
1.4 Healthcare Scenario in Country
1.5 Regulatory Landscape for Medical Device
1.6 Health Insurance Coverage in Country
1.7 Type of Medical Device
1.8 Recent Developments in the Country

2. Market Size and Forecasting
2.1 Market Size (With Excel and Methodology)
2.2 Market Segmentation (Check all Segments in Segmentation Section)

3. Market Dynamics
3.1 Market Drivers
3.2 Market Restraints

4. Competitive Landscape
4.1 Major Market Share

4.2 Key Company Profile (Check all Companies in the Summary Section)

4.2.1 Company
4.2.1.1 Overview
4.2.1.2 Product Applications and Services
4.2.1.3 Recent Developments
4.2.1.4 Partnerships Ecosystem
4.2.1.5 Financials (Based on Availability)

5. Reimbursement Scenario
5.1 Reimbursement Regulation
5.2 Reimbursement Process for Diagnosis
5.3 Reimbursement Process for Treatment

6. Methodology and Scope

Italy 3D Printing Medical Devices Market Segmentation

By Component

The Italy market is divided into three categories based on the component: equipment, materials, and software & services. End customers frequently employ software and services for designing and processing control of 3D-printed medical devices, particularly for bespoke items. The cost-effectiveness, utility, uniformity, and precision given by services for medical device 3D printing, together with a rise in demand for personalized 3D printed medical equipment among hospitals and surgical centers, are driving the market demand for software & surgical guides.

  • Equipment
    • 3D Printers
    • 3D Bioprinters
  • Materials
  • Plastics
    • Thermoplastics
    • Photopolymers
  • Metals and Metal Alloys
  • Biomaterials
  • Ceramics
  • Paper
  • Wax
  • Other Materials
  • Services & Software

By Application

The Italy market is divided into surgical guides, surgical tools, tissue-engineered goods, hearing aids, wearable medical devices/implantable medical devices, standard prostheses and implants, custom prosthetics and implants, and other medical devices based on the application. Due to the widespread adoption of 3D printing technology in the production of prosthetics and implants, the increased availability of high-quality biomaterials and ceramics for 3D printing, and ongoing industry investment in the development of novel 3D printers, the custom prosthetics and implants segment is expected to hold a larger share of the market in 2022.

  • Surgical Guides
    • Dental Guides
    • Craniomaxillofacial Guides
    • Orthopedic Guides
    • Spinal Guides
  • Surgical Instruments
  • Surgical Fasteners
  • Scalpels
  • Retractors
  • Standard Prosthetics & Implants
  • Orthopedic Implants
  • Dental Prosthetics & Implants
  • Craniomaxillofacial Implants
  • Bone & Cartilage Scaffolds
  • Ligament & Tendon Scaffolds
  • Custom Prosthetics & Implants
  • Tissue-engineered Products
  • Hearing Aids
  • Wearable Medical Devices
  • Other Applications

By Technology

According to technology, the global market has been divided into three categories: three-dimensional printing (3DP) or adhesion bonding; electron beam melting (EBM); laser beam melting (LBM); photopolymerization; droplet deposition or extrusion-based technologies; and other technologies. The laser beam melting (LBM) segment is anticipated to hold the greatest market share in 2022, in large part due to the growing use of this technology in the dental sector and for the production of implants for minimally invasive surgery.

  • Laser Beam Melting
    • Direct Metal Laser Sintering
    • Selective Laser Sintering
    • Selective Laser Melting
    • LaserCUSING
  • Photopolymerization
  • Digital Light Processing
  • Stereolithography
  • Two-photon Polymerization
  • PolyJet 3D Printing
  • Fused Deposition Modeling
  • Multiphase Jet Solidification
  • Low-temperature Deposition Manufacturing
  • Microextrusion Bioprinting
  • Droplet Deposition/Extrusion-based Technologies
  • Electron Beam Melting
  • Three-dimensional Printing/Adhesion Bonding/Binder Jetting
  • Other Technologies

By End User

The Italy market has been divided into hospitals and surgical facilities, dental and orthopedic clinics, academic institutions and research labs, pharma-biotech and medical device firms, and clinical research organizations based on end users. In 2022, hospitals and surgical centers are anticipated to hold the greatest market share. The high proportion of this market may be due to the ongoing expansion of internal 3D printing capabilities, the expansion of existing 3D printing laboratories, the rising affordability of 3D printing services, and the quick uptake of cutting-edge technology by hospitals in developed markets.

  • Hospitals & Surgical Centers
  • Dental & Orthopedic Clinics
  • Academic Institutions & Research Laboratories
  • Pharma-Biotech & Medical Device Companies
  • Clinical Research Organizations

Insights10 will provide you with the reports within 10 key parameters which are:

  1. Market Overview
  2. Market Growth Drivers & Restraints
  3. Epidemiology of Disease Type
  4. Market Segmentation
  5. Market Share
  6. Competitive Landscape
  7. Key Company Profiles
  8. Healthcare Policies & Regulatory Framework
  9. Reimbursement Scenario
  10. Factors Driving Future Growth

Based on our many years of experience, we believe that these are the parameters that are critical to decision-making for business stakeholders. Our focused approach to developing reports focused on 10 key parameters, enabled us to arrive at the name “Insights10”.

 

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The study on the market covers the analysis of the leading geographies such as Asia-Pacific, Africa, Europe, Middle East, North America, and  Latin America for the period of 2022 to 2030. The qualitative analysis covers the industry landscape and trends, market opportunities, competitive landscape, and policy and regulatory scenario, and the quantitative analysis covers different market estimates and forecasts.

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Stage III: Interpretation and Presentation

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Last updated on: 06 April 2023
Updated by: Vidhi Upadhyay

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