The global 3D printing medical device software market was valued at USD 940.90 million in 2022. It is projected to reach USD 4,110.09 million by 2031, growing at a CAGR of 17.80% during the forecast period (2023-2031).
Medical devices that are 3D printed are artificial devices that replace a missing body part or biological structure and are manufactured by laying successive layers of material using inputs from a digital 3D model. Three-dimensional medical devices are made using 3D printing by building up layers of basic materials. A digital 3-D file, such as an MRI or a computer-aided design, is used to create medical devices (CAD). As 3D printing is adaptable, designers can modify it without using additional tools. Medical gadgets are manufactured with the anatomy of a patient in mind. The software employed in the 3D printing of medical equipment carries out several operations, including printing, designing, analyzing, visualizing, planning, and simulating.
Implants, surgical instruments, prosthetics, and devices for tissue engineering are the most common 3D-printed medical devices. The 3D-printed implants are medical implants created using 3D printing technology to create intricate geometries. These raw materials include plastics, biomaterial inks, metals, and alloys. Fused deposition modeling, digital light processing, stereolithography, and selective laser melting are the technologies used to create 3D-printed medical devices. These are utilized by hospitals, diagnostic centers, academic institutions, and others for orthopedic, spinal, dental, and hearing aid applications.
The creation of hardware and materials has long been the primary emphasis of the 3D printing sector. The 3D printing of medical equipment has recently seen a significant increase in software development. The 3D printing sector has profited enormously from software compatibility. It has aided in minimizing the procedures, resources, and labor required to create a model for printing. Technical improvements have allowed the development of novel 3D-printed goods to meet the expanding demand for 3D-printed medical equipment in the healthcare sector. Key market participants concentrate on creating unique goods as conventional production procedures are time-consuming.
Strict regulatory requirements must be met before 3D-printed medical devices can be approved. To comply with FDA rules, manufacturers must ensure quality standards. The medical devices created by 3D printing are governed by the FDA's Center for Devices and Radiological Health (CDRH). The influx of new, smaller competitors is increasing the diversity of the 3D printing market. Materials utilized to make medical devices are typically not approved by the FDA. As an illustration, the FDA has approved spinal implants composed of titanium but has yet to provide general approval for using titanium in medical devices. As a result of the demand for more clarity surrounding printing procedures, FDA requests comprehensive information from companies that produce medical devices using 3D printing. Both individually created and mass-produced medical gadgets fall within this uncertainty. As a result, the market expansion is being constrained by uncertainties over FDA compliance.
Parts are built directly from CAD files in a method known as direct digital manufacturing (DDM). This procedure costs less money and takes less time. It is anticipated that DDM technology will significantly expand the production of customized goods because it is cost-effective. A sizeable portion of the DDM market comprises medical devices and technologically cutting-edge DDM processes. The possibility of establishing new items would significantly increase due to the 3D printing sector, including innovative techniques and materials. Additionally, it is anticipated that demand for DDM will dramatically increase during the forecast period due to the growing demand for cost-effective products.
The global printing medical device software market is segmented by type, function, application, and end-user.
The global printing medical device software market is bifurcated based on type into integrated and standalone.
The integrated segment is the highest contributor to the market and is estimated to grow at a CAGR of 17.70% during the forecast period. This refers to integrating software solutions with other CAD applications for a more efficient workflow. Medical gadget customization according to business requirements is simple with integrated software. Such software's design aspects are incorporated, so no tools or time-consuming assembly is needed. As a result, time and money are saved in a big way. GrabCAD 3D printing software, for instance, is provided by Stratasys Ltd. and accelerates the CAD-to-print process.
Solutions for software that are standalone 3D printed medical devices can function without additional hardware. These devices have yet to be implemented. Affordability, promptness, and same-day prototyping are characteristics of standalone 3D printing medical device software solutions. For low-volume production, such software solutions are perfect. They also have simple design processes and cost-effective industrial-grade durability. The segment is expected to develop in the anticipated time frame due to additional advantages, including direct digital production.
Based on function, the global printing medical device software market is bifurcated into Printing, analysis, Planning, Design, Visualization, Navigation, and Others.
The printing segment is the highest contributor to the market and is estimated to grow at a CAGR of 17.90% during the forecast period. To better envision and demonstrate the use of medical devices, doctors and other healthcare professionals print physical representations of the gadgets. One layer is added to another during the printing process to produce objects. The program would add "Support" during printing operations if the model was created using an extruded-based plastic printer and contained areas not resting on the printing bed. These so-called "Supports" are merely detachable printing byproducts that serve as a base for features that might warp while printing.
In the process of developing 3D-printed medical equipment, analysis is crucial. It entails contrasting objects still being worked on with the completed project. The ability to print tiny structures can be assessed by looking at the wall thickness of medical devices. Additionally, color can be added to the printed model using analysis.
For 3D printing to be successfully implemented, planning is essential. Materialize, one of the top businesses provides Materialize Mimics Care Suite, which supports image-based planning and medical 3D printing in hospitals. This integrated solution aids in applying standards to complicated scenarios. Utilizing tools to prepare effectively can help you save time.
Designers and other sectors like marketing and manufacturing use CAD software to envision designs. Simple visualization ensures that all departments employ the same items during communications. One such 3D printing program utilized in 3D viewing and navigation through patient-centric, tailored, and anatomical structures are Vesalius3D 2.9.0.
Based on application, the global printing medical device software market is bifurcated into medical imaging, dental, surgery, research, physical therapy, aesthetic medicine, and others.
The medical imaging segment is the highest contributor to the market and is estimated to grow at a CAGR of 17.75% during the forecast period. Medical imaging is the technique of visualizing internal body regions in preparation for medical intervention. Among other things, it uses X-ray radiography, magnetic resonance imaging, and fluoroscopy. In many aspects, 3D printing is related to medical imaging. It aids in supplying information for the development of 3D medical models. It serves as a radiation phantom in medicine. The need for 3D printing software for medical imaging is anticipated to be driven by these applications. Planmeca Romexis, Imagine, and AIS-ACETON IMAGING SUITE are some medical imaging software examples.
The dental business is one of the most popular markets for 3D printing software. Developing the orthodontic model and producing bridges, caps, crowns, and dentures are just a few examples of the many uses. Additionally, 3D printing aids in the creation of surgical instruments and the restoration of broken teeth. Due to advantages including affordability, efficiency, and speed of service, 3D printing medical device software has become increasingly popular in the dental sector. Additionally, the prevalence of 3D printing software in the dentistry sector is anticipated to increase due to the rising need for affordable dental solutions and the number of dental patients.
More and more surgical departments are utilizing 3D printing software in some capacity. Besides comprehensive virtual surgery planning, 3D printing is a visual assistance for preplanning surgery. Implants, surgical guides, and surgical 3D models make up the majority of 3D-printed surgical components. FDM and SLA are used to print directions and models, while SLM, EBM, and SLS are used to create implants.
Software for 3D-printed medical devices has enormous growth potential. Many studies are being done to determine the possible uses of 3D printing software for medical devices. For instance, 3D printing enables patients to create prosthetics tailored to their needs. Patients can model their prostheses using a technique developed by Body Labs to ensure a more comfortable fit. The goal of Massachusetts Institute of Technology researchers utilizing 3D printing software is to create prosthetic sockets that are more comfortable.
Physical therapy applications now use 3D printing medical device software. One usage for 3D printing is in the rehabilitation of the hands. The creation of finger orthoses and other auxiliary devices is possible with 3D printing. 3D printing software in rehabilitation clinics is fueled by the growing use of technology in physical therapy. Physical therapy software includes ECG NM 700, podiatry software, FOOT SCAN, and Continuum of Care Software, among others.
Based on end-user, the global printing medical device software market is bifurcated into medical devices companies, dental laboratories, hospitals and clinics, research institutes, and others.
The medical devices companies’ segment is the highest contributor to the market and is estimated to grow at a CAGR of 17.60% during the forecast period. Companies that manufacture medical devices held the most significant market share in 2019. Medical device businesses produced powerful 3D printing software for medical devices. The pharmaceutical and biotechnology industries contribute much to 3D-printed medical equipment production. The production of medical devices using 3D printing involves significant participants in the pharmaceutical industry. For instance, DePuy Synthes, a Johnson and Johnson Medical Devices division, announced the release of new titanium, a 3D-printed prosthesis for treating degenerative spine illness, in September 2019. Thus, there is a significant need for 3D printing medical devices software due to important companies' introduction of new 3D printed medical devices.
The creation of custom 3D-printed dental items is a project of the dental laboratory. In the past few years, the 3D printing of medical devices has advanced and gained widespread popularity in dental laboratories. A further factor driving this segment's growth is the involvement of essential companies in creating and introducing new products. The launch of a dental 3D printer and the business unit was announced by Formlabs, a global 3D printer company that has installed bases for small to large dental labs. Additionally, Formlabs unveiled the Form 3BL, a dental and medical 3D printer designed for biocompatible materials, in September 2020. The Form 3L, Formlabs' premier large format printer, will also begin shipping.
Private research institutes and university-based research institutes are examples of research institutions. The research institutions segment is anticipated to rise as more R&D is conducted to create cutting-edge 3D-printed medical products. Additionally, this sector is expanding due to increased funding from the public and private sectors for R&D at academic institutions. Grand Valley State University in Michigan got a USD 0.5 million research grant in February 2019 to investigate 3D printing technology for the production of medical devices. In addition, five research institutes received funding totaling USD 2.6 million from the U.S. Food and Drug Administration (FDA) in October 2018 to investigate and advance biomanufacturing, including 3D bioprinting.
The global printing medical device software market is divided into four regions: North America, Europe, Asia-Pacific, and LAMEA.
North America is the major revenue contributor and is expected to grow at a CAGR of 17.50% during the forecast period. The Americas led the market for 3D printing medical devices software in 2019 and is anticipated to hold this position during the evaluation period. This can be linked to the introduction and quick uptake of cutting-edge technologies and the presence of essential companies here. For instance, the region is home to companies like Materialise and Stratasys. Government and non-government groups also support area researchers' technological advancement by providing numerous subsidies to research organizations.
Europe is expected to grow at a CAGR of 17.10% during the forecast period. Due to technological improvements and a thriving medical sector, Europe held the second-largest share of the 3D printing medical devices software market in 2019. The largest markets for 3D printing medical device software are Germany, the U.K., Italy, and France. The surge in funding from private players and the rising number of companies in the field of 3D printing medical device software are assisting entrepreneurs in developing cutting-edge products. For instance, the German business 3YOURMIND has created automation software to control additive manufacturing.
Asia-Pacific is expected to experience the fastest growth over the projected period. Due to the skill pool in the area, international companies are concentrating on collaboration and setting up new offices there. For instance, Materialise, a well-known U.S. company that develops software for 3D printing medical equipment, recently opened a new office in China to conduct 3D printing software R&D there. Several firms, like think3D and Osteo3D, are developing software for 3D printing medical equipment in China and India. These startups are fueling the expansion of this area by providing services to customers all around the world.
Over the past few years, the Middle East and Africa have seen a steady increase in the market for 3D printing software for medical equipment. The increase in investment from private businesses and governmental organizations is one of the main drivers of this market's expansion. According to the International Trade Administration survey, Saudi Arabia has the most significant healthcare industry in the Near East.
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