US 3D Printing Medical Devices Market Analysis

US 3D Printing Medical Devices Market Analysis


$ 3999

The US 3D printing medical devices market is projected to grow from $1.2 Bn in 2022 to $3.6 Bn by 2030, registering a CAGR of 14.3% during the forecast period of 2022-30. 3D printing enables medical devices to be customized to the individual patient's needs, which can improve patient outcomes and satisfaction. The US 3D printing medical devices market is highly competitive, with several established players and new entrants vying for market share. Some of the major players in the US 3D printing medical devices market include Stratasys, Stryker Corporation, 3D Systems, and Materialise NV

ID: IN10USMD002 CATEGORY: Medical Devices GEOGRAPHY: US AUTHOR: Shivam Zalke

Buy Now

US 3D Printing Medical Devices Market Executive Summary

The US 3D printing medical devices market is projected to grow from $1.2 Bn in 2022 to $3.6 Bn by 2030, registering a CAGR of 14.3% during the forecast period of 2022-30.

The US 3D printing medical devices market is a rapidly growing segment of the medical device industry. 3D printing, also known as additive manufacturing, is the process of creating three-dimensional objects by layering materials on top of each other. In the medical device industry, 3D printing has been used to create a wide range of devices, including implants, prosthetics, and surgical instruments.

The US 3D printing medical devices market is driven by several factors, including:

  1. Advancements in 3D Printing Technology: The development of new 3D printing materials and technologies has expanded the range of medical devices that can be created using 3D printing
  2. Customization of Medical Devices: 3D printing allows for the customization of medical devices based on individual patient needs, which can improve patient outcomes and reduce healthcare costs
  3. Shorter Manufacturing Times: 3D printing can reduce the time required to manufacture medical devices, which can improve patient access to care and reduce wait times
  4. Cost-effectiveness: 3D printing can reduce the cost of manufacturing medical devices, which can make healthcare more affordable and accessible for patients

Some of the key applications of 3D printing in the medical device industry include:

  1. Orthopedic Implants: 3D printing is used to create customized orthopedic implants, such as hip and knee replacements
  2. Prosthetics: 3D printing is used to create customized prosthetics, which can improve patient comfort and function
  3. Dental Implants: 3D printing is used to create dental implants and other dental devices
  4. Surgical Instruments: 3D printing is used to create surgical instruments, such as bone saws and retractors

The US 3D printing medical devices market is highly competitive, with several established players and new entrants vying for market share. Some major players in the US 3D printing medical devices market include Stratasys, Stryker Corporation, 3D Systems, and Materialise NV.

US 3D printing medical devices market analysis

Market Dynamics

Drivers of the US 3D Printing Medical Devices Market

The US 3D printing medical devices market is driven by several factors, including:

  1. Increased Customization and Personalization: 3D printing enables medical devices to be customized to the individual patient's needs, which can improve patient outcomes and satisfaction.
  2. Reduced Costs: 3D printing allows for the production of medical devices at a lower cost than traditional manufacturing methods, which can lead to cost savings for healthcare providers and patients.
  3. Faster Time to Market: 3D printing allows for rapid prototyping and faster development of medical devices, which can speed up the time it takes for new products to reach the market.
  4. Growing Demand for Implants and Prosthetics: The aging population in the US is driving demand for medical devices such as implants and prosthetics, and 3D printing is well-suited for producing these types of devices.
  5. Technological Advancements: Advances in 3D printing technology, such as the ability to print with a wider range of materials, are expanding the potential uses of 3D printing in the medical field.
  6. Regulatory Support: Regulatory agencies such as the FDA are increasingly supportive of 3D printing in the medical field, which is helping to drive adoption and investment in this area.

Restraints of the US 3D Printing Medical Devices Market

The US 3D printing medical devices market also faces several restraints, including:

  1. Limited Reimbursement Policies: The reimbursement policies for 3D printed medical devices are not yet well-established, which can limit adoption by healthcare providers
  2. Regulatory Challenges: Although regulatory support for 3D printing in the medical field is growing, there are still regulatory challenges that need to be addressed, particularly around quality control and validation
  3. Intellectual Property Issues: The 3D printing of medical devices can raise intellectual property concerns, particularly if a device is patented or trademarked
  4. Limited Availability of Skilled Professionals: The production of 3D-printed medical devices requires specialized skills and expertise, and there may be a shortage of professionals with these skills
  5. Limited Scalability: 3D printing is currently best suited for producing low-volume, high-value medical devices, which may limit scalability and profitability for some companies
  6. Material Limitations: While the range of materials that can be used in 3D printing is expanding, there are still limitations on the types of materials that can be used for medical devices, particularly for implantable devices

Developments in US 3D Printing Medical Devices Market

The US 3D printing medical devices market is rapidly evolving and has seen several notable developments, including:

  1. Increased Adoption: 3D printing is increasingly being adopted for the production of medical devices, with companies developing new 3D printing technologies and medical device manufacturers incorporating 3D printing into their production processes
  2. New Applications: 3D printing is being used for new applications in the medical field, such as the production of personalized prosthetics, orthotics, and surgical tools
  3. Partnership and Collaboration: There has been a growing trend of partnerships and collaborations between 3D printing companies, medical device manufacturers, and healthcare providers to develop new products and improve patient outcomes
  4. Regulatory Advancements: Regulatory agencies such as the FDA are taking steps to support the development and adoption of 3D printed medical devices, including issuing guidance on 3D printing in the medical field and approving the first 3D printed drug
  5. Advancements in Materials: There have been significant advancements in the range of materials that can be used for 3D printing medical devices, including biocompatible and biodegradable materials
  6. Integration with Other Technologies: 3D printing is being integrated with other technologies, such as artificial intelligence and robotics, to improve the accuracy and efficiency of medical device production and surgical procedures

Competitive Landscape

Key Players in US 3D Printing Medical Devices Market

The US 3D printing medical devices market is a highly competitive market with several key players, including:

  • Stratasys Ltd.: Stratasys is a leading 3D printing company that provides solutions for a range of industries, including healthcare. The company's medical solutions include anatomical models, surgical guides, and implantable devices.
  • 3D Systems Corporation: 3D Systems is another major player in the 3D printing market, offering a range of medical solutions, including implants, surgical tools, and prosthetics
  • Materialise NV: Materialise is a Belgian company that specializes in 3D printing software and services. The company provides 3D printing solutions for a range of medical applications, including implants, surgical tools, and anatomical models.
  • EOS GmbH: EOS is a German company that provides industrial 3D printing solutions, including for the medical industry. The company's medical solutions include implants, surgical guides, and anatomical models.
  • SLM Solutions Group AG: SLM Solutions is a German company that specializes in metal 3D printing solutions for a range of industries, including healthcare. The company's medical solutions include implants and prosthetics.
  • EnvisionTEC: EnvisionTEC is a US-based company that provides 3D printing solutions for a range of industries, including healthcare. The company's medical solutions include dental models, hearing aids, and prosthetics.

Other notable players in the US 3D printing medical devices market include Renishaw, Oxford Performance Materials, and Arcam AB.

Healthcare Policies and Regulatory Landscape

The US 3D printing medical devices market is subject to a range of healthcare policies and regulations. The following are some of the key policies and regulatory bodies that impact the market:

  1. The Food and Drug Administration (FDA): The FDA regulates the development and marketing of medical devices in the US, including those produced using 3D printing. The agency has issued guidance on using 3D printing in medical device production and has approved several 3D-printed medical devices.
  2. Medicare and Medicaid: These government-run healthcare programs provide insurance coverage for medical procedures and devices, including those produced using 3D printing. Reimbursement policies for 3D-printed medical devices are not yet well-established, but some devices are eligible for coverage.
  3. The Affordable Care Act (ACA): The ACA includes provisions related to the regulation of medical devices, including those produced using 3D printing. The law requires medical devices to be safe and effective and mandates certain reporting and tracking requirements.
  4. The National Institutes of Health (NIH): The NIH is a federal agency that funds and conducts biomedical research. The agency has invested in research related to 3D printing in the medical field and has provided funding for the development of 3D-printed medical devices.
  5. The International Organization for Standardization (ISO): The ISO is a non-governmental organization that develops international standards for a range of industries, including healthcare. The ISO has developed standards for designing, producing, and testing 3D-printed medical devices.
  6. The Center for Devices and Radiological Health (CDRH): The CDRH is a division of the FDA that is responsible for regulating medical devices. The division reviews applications for new medical devices, including those produced using 3D printing, and assesses their safety and effectiveness.

1. Report Description of the US 3D Printing Medical Devices Market
1.1 Research Scope and Assumption
1.2 Objective of the study
1.3 Research Methodology
1.4 Reason to buy the report

2. US 3D Printing Medical Devices Market Executive Summary
2.1 US 3D Printing Medical Devices Market – Market Overview
2.2 Market Size, Growth Prospects, and Key findings

3. Market Dynamics of the US 3D Printing Medical Devices Market
3.1 Market Growth Drivers Analysis
3.2 Market Restraints Analysis

4. US 3D Printing Medical Devices Market Segmentation

4.1 By Component
4.1.1 Equipment
4.1.1.1 3D Printers
4.1.1.2 3D Bioprinters
4.1.2 Materials
4.1.2.1 Plastics
4.1.2.1.1 Thermoplastics
4.1.2.1.2 Photopolymers
4.1.2.2 Metals and Metal Alloys
4.1.2.3 Biomaterials
4.1.2.4 Ceramics
4.1.2.5 Paper
4.1.2.6 Wax
4.1.2.7 Other Materials
4.1.3 Services & Software

4.2 By Application
4.2.1 Surgical Guides
4.2.1.1 Dental Guides
4.2.1.2 Craniomaxillofacial Guides
4.2.1.3 Orthopedic Guides
4.2.1.4 Spinal Guides

4.2.2 Surgical Instruments
4.2.2.1 Surgical Fasteners
4.2.2.2 Scalpels
4.2.2.3 Retractors

4.2.3 Standard Prosthetics & Implants

4.2.4 Custom Prosthetics & Implants
4.2.4.1 Orthopedic Implants
4.2.4.2 Dental Prosthetics & Implants
4.2.4.3 Craniomaxillofacial Implants

4.2.5 Tissue-engineered Products
4.2.5.1 Bone & Cartilage Scaffolds
4.2.5.2 Ligament & Tendon Scaffolds

4.2.6 Hearing Aids
4.2.7 Wearable Medical Devices
4.2.8 Other Applications

4.3 By Technology

4.3.1 Laser Beam Melting
4.3.1.1 Direct Metal Laser Sintering
4.3.1.2 Selective Laser Sintering
4.3.1.3 Selective Laser Melting
4.3.1.4 LaserCUSING

4.3.2 Photopolymerization
4.3.2.1 Digital Light Processing
4.3.2.2 Stereolithography
4.3.2.3 Two-photon Polymerization
4.3.2.4 PolyJet 3D Printing

4.3.3 Droplet Deposition/Extrusion-based Technologies
4.3.3.1 Fused Deposition Modeling
4.3.3.2 Multiphase Jet Solidification
4.3.3.3 Low-temperature Deposition Manufacturing
4.3.3.4 Microextrusion Bioprinting

4.3.4 Electron Beam Melting
4.3.5 Three-dimensional Printing/Adhesion Bonding/Binder Jetting
4.3.6 Other Technologies

4.4 By End User
4.4.1 Hospitals & Surgical Centers
4.4.2 Dental & Orthopedic Clinics
4.4.3 Academic Institutions & Research Laboratories
4.4.4 Pharma-Biotech & Medical Device Companies
4.4.5 Clinical Research Organizations

5. US 3D Printing Medical Devices Market Share
5.1 Market Analysis, Insights, and Forecast – By Revenue

6. Competitive Landscape
6.1 Major Top Market Players

7. Key Company Profiles

7.1 Company 1
7.1.1 Overview
7.1.2 Financial Performance
7.1.3 Product & Services
7.1.4 Strategic initiatives

7.2 Company 2
7.2.1 Overview
7.2.2 Financial Performance
7.2.3 Product & Services
7.2.4 Strategic initiatives

7.3 Company 3
7.3.1 Overview
7.3.2 Financial Performance
7.3.3 Product & Services
7.3.4 Strategic initiatives

7.4 Company 4
7.4.1 Overview
7.4.2 Financial Performance
7.4.3 Product & Services
7.4.4 Strategic initiatives

7.5 Company 5
7.5.1 Overview
7.5.2 Financial Performance
7.5.3 Product & Services
7.5.4 Strategic initiatives

8. Healthcare Policies and Regulatory Landscape
8.1 Healthcare Policies in the US
8.2 Regulatory Framework in the US
8.3 Pricing & Reimbursement Scenario in US 3D Printing Medical Devices Market

9. Factors Driving Future Growth
9.1 New Trends and Development US 3D Printing Medical Devices Market
9.2 Future Opportunities

10. Strategic Recommendations

3D Printing Medical Devices Market Segmentation

By Component

The Australia 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 process 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 personalised 3D printed medical equipment among hospitals and surgical centres, 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 Australia 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 Australia market has been divided into hospitals and surgical facilities, dental and orthopaedic clinics, academic institutions and research labs, pharma-biotech and medical device firms, and clinical research organisations based on end users. In 2022, hospitals and surgical centres 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”.

 

Stage I: Market Data Collection

Primary Interviews: We have developed a network of experts, freelancers, and researchers across countries through which we engage with local experts to gather key data points and assumptions about each market. We also engage regularly with some of the best market research agencies such as Atheneum, GuidePoint, GLG, etc. to conduct surveys and interviews, and build intelligence. We have language translators as a part of our team, who between them can cover 30+ languages allowing us to extract better local insights.

Secondary Data Collection: We have developed strong expertise and experience in secondary data collection methods for developing unique data sets and research material. We gather data from multiple reliable sources to maintain a high level of accuracy and consistency. The market data is analyzed and forecasted using appropriate statistical and coherent models. The report offers an overall analysis of the market size, growth, and market share as well as a segment-level analysis of the specific market. Our report includes precise, to-the-point information related to the overall market, competition, growth drivers, challenges, regulatory updates, and competition.

Data Sources: We have access to multiple highly reliable free and subscription data sources. We have many years of experience to understand which sources are more dependable for what and which to prefer for the reliable and latest information. The key sources of information include the following, but are not limited to:

 

 

Stage II: Market Data Analysis and Statistical Model

Market Trends: We generally look at macro parameters and micro indicators. The macro parameters include changes in government policies, demand and supply of the market, government intervention programs, and major market share. The micro indicators are GDP growth, market size, market volume, etc. We also understand nuances specific to each country like the US, Canada, India, Germany, etc., and have worked across 60+ countries and hence not only understand global trends but how these differ by country, how payment models, market structure, cultural parameters, etc. differ in each country.

Market Sizing and Analysis: Our expert data analytics team has created various market forecast models by employing the top-down approach i.e. starting with the large overall market and segmenting different areas and the bottom-up approach i.e. starting with population and epidemiology and rolling up based on spend, etc., estimating the size of the market, and distributing among the geographic and/or product segments.

The top-down approach is mainly used for new product forecasting and the bottom-up approach is used for demand estimation of any product for different countries summed up to form the total market. We are able to round off insights and build stronger forecasts because we always do both these methods and triangulate the final numbers.

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.

Data Triangulation & Validation:

Data triangulation of various sources and results of the research are carried out by benchmarking with reliable sources such as industry statistics, statistical databases, and company-level averages, etc.

We make sure to finalize the numbers in alignment with the market research. Firstly, our internal experts ensure thorough validation and checking to ensure accurate and precise analysis and then validation is also done using a multiple-data analysis model. Two-level validation is done and entails the finalization of the report scope and the way of representation pattern.

 

 

Stage III: Interpretation and Presentation

Analysis & Interpretation: The information gathered is then analyzed and synthesized. The second series of interviews are done if necessary to check and validate. The future opportunities are analyzed by understanding product commercialization and many other factors. It also comprises the analysis of data discrepancies observed across various data sources. Information procured from secondary and primary results is then, interpreted by considering the following parameters: (a partial list)

  • Establishing market drivers and trends
  • Analyzing the regulatory landscape to understand future growth
  • Market Segment based analysis to obtain revenue/volume
  • ​Analyzing current needs and determining penetration to estimate the market

Insights: Our reports deliver actionable insights backed with supporting facts and figures to assist you in achieving exemplary growth. Our in-depth analyses are interspersed with relevant insights and statistics to offer an executive-level view of a given market. The description helps in correlating many minor factors affecting the market and their impact on the different segments within the market.

Data curated from the analysis and interpretation are drawn to portray all in one consolidated report.

Presentation & Reporting: The market research report is presented in different forms such as charts by using a scientific approach for easy understanding. Historic, current, and future analysis is provided for each market in terms of both value and volume. The size of the market is interpreted in the US Dollar value and the respective unit, based on the product, for volume consumption.

The foreign exchange rates are calculated on the respective dates and for the respective regions covered in the study.

To request a free sample copy of this report, please complete the form below.


We value your inquiry and offer free customization with every report to fulfil your exact research needs.


This report addresses

  • Intelligent insights to take informed business decisions
  • Qualitative, acute and result oriented market analysis
  • Market size and forecasts from 2022 to 2030
  • Opportunities for expansion and in-depth market analysis
  • Segmentation and regional revenue forecasts
  • Analysis of the market share and competitive landscape
  • Strategic Recommendations to chart future course of action
  • Comprehensive Market Research Report in PDF and PPT formats

Need more?

  • Ask our analyst how this study was put together to learn more
  • Discuss additional requirements as part of the free customisation
  • Add more countries or regions to the scope 
  • Get answers to specific business questions 
  • Develop the business case to launch the product
  • Find out how this report may influence your business revenue
Last updated on: 17 March 2023

Related reports (by category)


Related reports (by geography)


subscribe to our newsletter
up