3D Printed Medical Device Market

Market Overview

3D printing, commonly known as additive manufacturing, has been used to produce certain medical equipment, such as orthopedic, cranial, dental, surgical, crown, and external prosthetic devices. The crux of this technology is its ability to create complex geometric constructs suited to the needs of patients or physicians. This allows it to cover a broad variety of medical uses, ranging from operational preparation to customized surgical instruments. Recently, 3D printing has under the oversight of the regulatory body for medical care.

Owing to rising incidences of periodontitis, osteoarthritis, diabetes-related gangrene, bone and peripheral vascular disorders, the global demand for imprinted 3D medical devices is forecasted to expand. For example, in April 2018, scientists at Sri Ramachandra University, India, recorded 42% of periodontal diseases in southern India.

The industry is projected to bolster over the forecast period due to improved access to the funding for induction of 3D printing technology in the healthcare industry by government bodies and public sources. This initiative is one of the key drivers for the growth of 3D printing in the field of medical devices. 3D printing technology facilitates innovative custom functionality and accelerated output for medical products and appliances.

Moreover, the rising number of accidents is projected to fuel the development of this sector. For instance, according to a report by crashstats.gov, 10,511 deaths were reported by the National Highways Public Safety Administration in the United States in 2018.

With a volume share of 46.0% North America and the European market, were influential in the global market for 3D printing medical devices in 2019. In particular, the 3D printing industry is led by factors such as technical innovation, expanded public-private spending, convenient production of personalized medical devices, and rising appliances. However, factors such as the stringent regulatory framework and shortage of qualified practitioners can hinder the market’s growth over the coming years.

However, the expiry of key patents in the coming years and the poor conditions of organ donation are foreseen to provide industry leaders with prospects for expansion, such as the reconfiguration of supply chain models for pharmaceutical drugs and a growing range of other supply chain models.

Market Dynamics

Technological Enhancement in 3D Printing

Thanks to the growing need for 3D printing in the health field, many companies are gradually concentrating on the development of innovative 3D printed goods and technologies. Since conventional processing processes require more time and cost, major companies are focusing on creating modern, easier and less time-consuming goods and innovations using 3D printers.

In industries such as aviation, shipping, oil and gas, and consumer goods, composites of low-weight are widely in demand. Compared to traditional production methods, development time and expense can be reduced if the composite material is manufactured using 3D printing.  For instance, metal 3D printing company, Desktop Metal have moved to composite 3D printing with the introduction of Fiber 3D printing.

Besides, rapidly growing startups with promising technologies such as 3D printing company, Spectroplast; Once click metal, developer of low power fusion 3D printer and Evolve Additive Solutions have entered the market with innovative technology or their version of existing technology.

Rigorous Supervisory Procedure for Approval of 3D-Printed Medical Equipment

Powerful regulatory criteria impede the expansion of the demand for 3D printed medical devices (especially in the U.S.). Simple 3D printing technologies are FDA-approved, but sophisticated machines that have to comply with a range of FDA specifications limit the availability of large-scale 3D-printed items. Besides, state regulations and manufacturing laws impede the availability of 3D-based drugs.

Moreover, the individualization of 3D-printed products presents new obstacles in the application of the design management model for acceptance by the FDA for market adoption. The adaptability and unique techniques of 3D printed medical equipment pose unique challenges in complying with regulatory standards for quality assurance in production. The FDA requires to discuss and convey clear powder material properties, optimized printing criteria, such as structure guidance and laser control to ensure quality construction. 3D printed devices, such as cleaning, finishing, or sterilization, are unique for post-printing.

Regional Analysis

Based on region, the market is divided into North America, Europe, Asia-Pacific, and SAMEA. Amongst these regions, Asia-Pacific dominated the market in 2019 based on revenue. The rising development of 3D education, research and training centers combined with growing interest and effort by the key market player to expand their distribution amongst emerging APAC countries is a key factor fueling the market growth.

North America is projected to grow rapidly due to the presence of numerous key 3D printing research companies in this region. Ease in 3D implementation regulation is another primary factor for the growth of this region. For instance, under U.S. FDA, the biological research and evaluation center has regulated 3D for biological application. In 2016, the U.S. FDA recognized device testing and remanufacturing and design consideration as two areas for validation and verification of 3D device approvals.

Segmental Analysis

On the Basis of Components, the 3D Printer Segment Is Expected  to Bolster over the Forecast Period

In 2017, the Software & Services Group comprised the highest proportion of the demand for 3D medical devices. The creation of software tools for the manufacturing and construction of high-quality 3D printed medical devices is projected to leads to the growth of the software and service market.

Until recently, there was a shortage of emphasis on 3D printing technologies in terms of hardware and materials. 3D printing has revealed that designers have to work with a complicated modeling environment that produces an expensive and challenging procedure with a broad variety of manufacturing equipment.

Therefore, simulation approaches need to be built in a way that simulation results can be more accurate. Finally, the methods for additive modeling must now become more intuitive and easier to use.

2020 is considered to be the year in which all of the technical problems have been resolved. Tech advances are targeted, particularly in the field of design, which will open up a quicker and easier 3D printing process.

In the end, it would help to incorporate technology into the manufacturing process to design technological applications that meet with AM specifications. However, as per our analyst 3D printing is projected to be the highest growing sector throughout the forecast period.

By Technology, PhotopolymerizationHeld the Prominent Market Share in 2019

Based on technology, the market is bifurcated into laser beam melting (LBM) technology, electron beam melting (EBM) technology, selective laser melting (SLM), direct metal laser sintering (DMLS), photopolymerization, selective laser sintering (SLS), and others. Out of these photopolymerization held the dominant market share in 2019.

This surge is primarily attributable to the factors such as numerous applications of this technology across various medical devices like porous scaffolds, prosthetics and implants, and dental restorations. Other benefits of this method are that it provides high-resolution physical properties, and enables the designing of multifaceted models with numerous somatic assets.

By Type, Surgical Guides Dominated the Market in 2019

By type, the market is segmented into surgical guides, dental guides, craniomaxillofacial guides, orthopedic guides, surgical instruments, retractors, scalpels, and others. Out of these, surgical guides dominated marketing in 2019. It is a patient-specific device that is 3D printed based on ceramic and DIACOM data. They are used for the precise placement of implants. Rising utilization of digitally compelled procedures.

Besides, they assist in reducing the surgery time as the surgical plan is readily available on the computer ahead of the actual surgery. Moreover, they reduce the rehabilitation time as the operations are done without any access sutures, cutting, pain inflammation, etc.

Impact of covid-19

COVID-19 is a pandemic triggered by extreme acute respiratory coronavirus-2 syndrome (SARS-CoV-2). It has grown to more than 180 countries worldwide, contributing to a range of overcrowded health systems. Due to a large number of patients and competition with the supply chain, there is a lack of medical equipment and personal protective products. To resolve the shortage of facilities, the additive manufacturing corporation has taken steps in this respect.

FDA in collaboration with NIH, VA, and America, promoted non-traditional methods of manufacturing products, including personal safety devices, and PPE using 3D printing. This collaboration provided VA with a clinical study of the 3D-printed COVID-19 reaction samples, and the NIH made them available on the 3D Print Exchange.

The Food and Drug Administration has even entered into this interagency MOU to promote the usage of new processing technologies, such as 3D printers, in reaction to the COVID-19 pandemic.

For the America Made MOU cooperation and non-profit collaborations, the FDA is focusing actively on interactions and standards to verify the open access definitions submitted to the 3DPX NIH. These initiatives bolstered the market throughout the COVID-19 periods. Besides, the lack of availability of manpower during the COVID-19situation strengthened the demand for 3D printed medical devices.

Recent Developments

• On 12 May 2021, Orbotech will Announce Roll-to-Roll Manufacturing Solutions for Flexible Printed Circuits. This initiative will bolster its grasp over the flexible printed circuit board (PCB) market significantly.
• In February 2019, Aurora Labs, an Australian metal-based 3D printer manufacturer, partnered with Royal pert hospital and UWA to develop titanium 3D printed medical implants.