Market Overview
3D Printed Implants Market is estimated to reach at a CAGR of 7.5% during the forecast period (2024-2031).
Implantable medical devices printed in 3D. Implantable medical devices made from 3D printing are used in numerous sections of the human body. Vascular stents, heart valve prostheses, orthopedic implants, and artificial joint prostheses are examples of common items. The global 3D printed implants market is driven by many factors, such as technological advancement and increased use of 3D printed implants in surgical procedures.
As per DataM Intelligence, 3D Printed Implants Market study analysis offers an in-depth outlook on the market containing quantitative and qualitative data. It gives an outlook and forecast of the global market based on market segmentation. It also provides global 3D Printed Implants Market size, and growth, along with the latest trends, opportunities, and forecast till 2030 for the global market with esteem to major countries such as the United States, Canada, Brazil, Germany, Italy, Spain, United Kingdom, Russia, European countries, United Arab Emirates, Saudi Arabia, South Africa, Japan, China, India, South Korea, Australia, and rest of the countries over the globe.
Among all regions, the North American region is expected to hold the largest share of the global market over the forecast period. 3D Printed Implants Market in the United States and Canada produces the utmost share. Whereas the European 3D Printed Implants Market is projected to continue its presence globally during the period of 2024-2031.
Market Summary
| Metrics | Details |
| Market CAGR | 7.5% |
| Segments Covered | By Implantation Technology, By Application, By End User, and By Region |
| Report Insights Covered | Competitive Landscape Analysis, Company Profile Analysis, Market Size, Share, Growth, Demand, Recent Developments, Mergers and acquisitions, New Product Launches, Growth Strategies, Revenue Analysis, and Other key insights. |
| Fastest Growing Region | Asia Pacific |
| Largest Market Share | North America |
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Market Dynamics
The technological advancement in this market is estimated to drive the global 3D printed implants market
3D printing technology, because of its advantages in high accuracy, complex structure, and high material usage, has become widely used in the field of implantable medical devices in recent decades. Patient-specific anatomical level products with great flexibility and resolution in microstructures are possible with three-dimensional (3D) printing. 3D printing has become a leading Orthopaedic and pharmaceutical manufacturing technology, with cost-effective manufacturing for high productivity. It is apt for a wide range of applications, including tissue engineering models, anatomical models, pharmacological design and validation models, medical apparatus and instruments. Today, 3D printing provides clinically viable medical items and platforms ideal for new research domains such as tissue and organ printing.
For example, on February 17, 2021, the design and print complicated implants for domestic and international markets, the Apollo Hospitals Group has partnered with Anatomiz3D Medtech Pvt Ltd. To begin, 3D-printing facilities for 3D printed implants will be established in several Apollo Hospitals, allowing clinicians to visualise and manufacture implants for difficult patients. In 2021, VESTAKEEP Care M40 3DF, a novel 3D-printable PEEK (polyetheretherketone) biomaterial created by Evonik Industries AG for medical applications requiring up to 30 days of body contact. Extrusion-based 3D printing processes like fused filament fabrication and fused deposition modelling can prepare the high-performance polymer.
The increased use of 3D printed implants in surgical procedures is assumed to drive the global 3D printed implants market
Advances in 3D printing technology, such as a wider selection of filament materials and improved precision, indicate that this manufacturing method will be used more frequently for medical implants. Advances in materials 3D printing, which were made as recently as 2020, have resulted in significant progress in the medical industry. Nitinol may be 3D printed, according to studies conducted by the Australian government's scientific research organisation CSIRO last year, permitting mass manufacture of artery stents for circulation disorders. Because of its shape memory qualities, nitinol, titanium, and nickel alloy are attractive for peripheral artery disease (PAD). Fat deposits in the arteries of the legs or arms create PAD, which reduces blood flow to the limbs.
Stents implanted in these damaged arteries must be able to deform while maintaining their shape while the user movements their limbs. As a result, Nitinol is a good material to use for making these stents. Nitinol stents may now be 3D manufactured, according to a CSIRO study. This represents significant progress in additive manufacturing metallurgy (nitinol is rarely used in 3D printing) and an improvement in the geometry of these stents. The intricate mesh design of these 3D-printed stents allows them to expand and compress more efficiently than regular stents. Prosthetic medicine isn't the only branch of medicine that necessitates a high level of personalization. Patient-specific gadgets (such as hearing aids) and implants (prosthetic joints, cranial plates, and even heart valves) are increasingly turning to 3D printing because of their ease of customization and speed of production.
Traditionally, heart valves and hearing aids required a full week of rigorous, hand-crafted adjustments by expert workers. From casting to fitting, a hearing aid requires nine steps before 3D printing. Hearing aids may now be scanned in 3D and printed in one day. 3D printing can provide complex, porous surfaces for implants like titanium prosthetic joints or cranial plates, making them less likely to be rejected by patients' bodies.
Chinese company Meditool has designed and developed its hardware and software. The programme can read and interpret images straight from magnetic resonance imaging (MRI) and computed tomography scan (CT) devices routinely utilised. The software creates a 3D model that is easily printable and sends it to the printer. Polyetheretherketone, a high-performance polymer supplied by Evonik, is used to 3D print the implants (PEEK). Arterial stents can be made to the user's specifications and manufactured quickly. Rapid production also means that the product is more widely available.
The high-cost and stringent FDA approval’s is estimated to hamper the global 3D printed implants market
3D printed implants improve surgical efficiency, recuperation time, and patient quality of life, but all of this comes at a hefty expense. 3D printing, in comparison to traditional implants, uses a variety of resources and sophisticated machines, making it highly advanced yet pricey technology. There is a lot of pricey 3D modelling software which are utilised in for manufacturing 3D printed implants. Simulations and interactive anatomical representations benefit greatly from the use of 3D modelling tools. They're also a terrific way for doctors and patients to gain a better image of a condition. Mimics, Stratasys Ltdatics, Magic, Quant AM, and NX Siemens are examples of FDA-approved software used by 3D Incredible. Other software options include Within Medical, 3DS Max, Ossa 3D, 3D-Doctor, and others. This software is costly, and it requires FDA approval before it can be used by any Orthopaedic company.
Renishaw AM 400, Sindoh 3DWOX 1, CraftUnique Craftbot PLUS, and other 3D printing machines are quite expensive and need a significant initial commitment. Because most 3D printed implants cannot be mass-produced, machine run time increases, increasing infrastructure operating costs. Apart from that, operating a 3D printer necessitates a high level of maintenance and highly skilled personnel; all these aspects are estimated to hamper the market.
COVID-19 Impact Analysis
COVID-19 has affected the healthcare industry negatively. To stop its spread, government-imposed lockdown. People are fearful they may experience occupational effects and negative health from the COVID-19 pandemic. The supply of the raw materials for the manufacturing of the implants and most of the surgical procedures has halted due to COVID-19. This has affected the global 3D printed implants market as many have stopped manufacturing units.
Market Segmentation Analysis
The electron beam melting technology is estimated to dominate the global 3D printed implants market
As a recognised leader in cost-effective Additive Manufacturing (AM) solutions for orthopaedic implants and aerospace applications, the electron beam melting method has the potential to unleash a new generation of additive innovation. This cutting-edge technology gives design flexibility, superior material qualities, and stacking capabilities. When we combine these benefits with the elimination of heat treatment and wire cutting, EBM technology will help the firm become more productive.
A high-power electron beam is used in the EBM process to generate the energy required for high melting capacity and productivity. The vacuum maintains a clean and controlled atmosphere, while the hot process allows making parts with no residual stress. EBM technique allows for more design freedom because of fewer supports, and higher volume builds due to tightly stacked pieces. A combination that enables the production of intricate and sophisticated orthopaedic implants. Furthermore, a rising number of CE-certified and FDA-cleared implants using Arcam EBM technology are available on the market.
The United Kingdom-based company has launched an electron beam melting variation to the market that addresses this flaw. Although the NeuBeam technique still uses an electron beam as its energy source, precautions taken to avoid charged powder particles have resulted in higher process efficiencies than traditional EBM metal 3D printing.
The orthopedic segment is estimated to dominate the global 3D printed implants market
3D printing technology is rapidly gaining traction in the healthcare field. Orthopedic 3D printing is no exception. When it comes to using 3D printing in orthopaedics, the development of metallic implants and individualised prostheses is ultimately the most important and valuable trend. The materials, equipment, and manufacturing capabilities available for 3D printing decide this. For 3D printing and manufacturing, common metal materials include multiple titanium grades (Grade CP1/2, Ti6Al4V), cobalt-chrome alloys (e.g., ASTM F75), and stainless steel (e.g., 316L).
The inherent geometric freedom of 3D printing in orthopaedic implants is one of the technology's key advantages. This not only enables for more natural anatomical shapes to be created, but it also allows for the creation of porous bone replacement scaffolds that can be easily integrated into the implant design. This allows for normal bone ingrowth, which increases the implant's stability.
On February 22, 2021, the Patient-Specific Talus Spacer, the world's first implant to replace the talus, was authorised by the US Food and Drug Administration (FDA). This is especially beneficial for people who have talus avascular necrosis (AVN). The Patient-Specific Talus Spacer is a cobalt-chromium alloy ankle implant that is custom 3D manufactured.
Market Geographical Analysis
North America region is estimated to dominate the global 3D printed implants market
The increasing prevalence of people suffering from conditions like orthopedic, dental and cardiac diseases is assumed to drive the market in this region. According to the Centers for Disease Control and Prevention (CDC), periodontitis, a more severe form of periodontal disease, affects half of all Americans aged 30 and over. This equates to around 64.7 million people in the United States. Bio-resorbable scaffold for periodontal healing and regeneration, socket preservation, bone and sinus augmentation treatments, guided implant placement, peri-implant maintenance, and implant education are all examples of 3D printing in periodontology. The United States has always been in the forefront of adopting 3D printing technologies. The approval process for 3D printed medical items and implants in the United States is possibly the most difficult. Manufacturing and design, as well as Device Testing, are two areas where it is carried out. In the United States, powder bed fusion is the most common process for 3D printing implants.
In 2019, The US Food and Drug Administration granted 510(k) clearance to 3D Systems' novel biocompatible denture material, Next Dent Denture Denture 3D+ (FDA).
Companies and Competitive Landscape
Major key players in the global 3D printed implants market are 3D Systems Corporations, Stratasys Ltd, Arcam AB, EnvisionTEC, SLM Solutions Group AG, Renishaw, Materialize N. V., BioBots, Andreas Stihl AG & Co. KG, Aspect Biosystems, Formlabs, Medprin, Stratasys, Organovo, Rokit, Cyfuse Biomedical and LimaCorporate S.p.A., (Lima).
The global 3D printed implants market is moderate due to the technological advancements in 3D printing and the increasing demand for customized products.
Lima Corporate
Overview: LimaCorporate is a multinational medical device firm that helps surgeons improve their patients' quality of life by delivering reconstructive and fixation orthopaedic solutions. The company is based in Italy and is dedicated to creating revolutionary products and techniques that allow surgeons to choose the best solutions for each patient. The company’s mission is to provide cutting-edge technologies to help orthopaedic surgeons reclaim their patients' Emotion of Motion.
Product Portfolio: The company comprises orthopaedics, medical devices, orthopaedics and medical supplies. LimaCorporate's product line includes primary and revision implants for major joints and comprehensive extremity treatments with fixation.
Key Development: LimaCorporate S.p.A. (Lima) and Hospital for Special Surgery (HSS) have joined forces to build the first provider-based design and 3D printing facility for custom complex joint replacement solutions. The new, FDA-regulated commercial facility, known as the ProMade PoC (Point of Care) and will provide faster and more accessible care for U.S. patients requiring personalised solutions for their orthopaedic conditions, as well as influence the advancement of these complex orthopaedic solutions globally.
