3D Printed Implants Global Market Report 2022

Major players in the 3D printed medical implants market are 3D Systems Corporations, Stratasys Ltd, Arcam AB, EnvisionTEC, SLM Solutions Group AG, Organovo HoldingsInc., Oxford Performance Materials, Materialise, Cyfuse Biomedical K.K., and Bio3D Technologies.

The global 3d printed implants market is expected to grow from $1.89 billion in 2021 to $2.25 billion in 2022 at a compound annual growth rate (CAGR) of 18.8%. The market is expected to grow to $4.5 billion in 2026 at a compound annual growth rate (CAGR) of 18.9%

The 3D printed medical implants market consists of sales of 3D printed medical implants and related services. In 3D printing technology, an artificial three dimensions physical object is created with the help of computer-aided design (CAD) or a magnetic resonance image (MRI), which can replace the missing or defective body parts, to give support or recover damaged biological structure. 3D printed medical implants include 3D dental crowns, 3D dental bridges, 3D acetabular hip implants, and shoulder implants.

The main implantation technologies in 3D printed medical implants are laser beam melting, electronic beam melting, droplet deposition, laminated deposition, and two-photon polymerization.The laser beam melting is a manufacturing process in which 3D components are digitally cut into 2D layers by using a high-performance laser to melt and bond at these points.

The various applications include are dental, orthopedic, and craniomaxillofacial that are used by end-users such as medical and surgical centers, pharmaceutical companies, the biotechnology industry, and medical institutions.

North America was the largest region in the 3D printed medical implants market in 2021.Asia Pacific was the second-largest region in the 3D printed medical implants market.

The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa.

The increasing prevalence of various medical conditions is driving the growth of the 3D printed medical implants market.As the number of people suffering from orthopedic, cardiac, and dental diseases is increasing, the demand for 3D dental crowns, 3D dental bridges, 3D acetabular hip implants, shoulder implants, and various other implants is rising.

According to the World Health Organization (WHO), the US had around 65 million people suffering from periodontitis i.e. Inflammation and infection of the ligaments and bones that support the teeth. This mainly occurred due to the rising prevalence of periodontitis, diabetes-related gangrene, osteoarthritis, and peripheral vascular disease. Similarly, the rise in prevalence of other medical conditions is driving the demand for use of 3D printed medical implants.

The stringent approval process for the selection of a new material to be used in 3D implants is a time-consuming process that acts as a restraint for the 3D Printed Medical Implants market. 3D Printing requires high-quality materials that should adhere to specific criteria set by regulatory bodies such as US FDA. These regulatory bodies provide procedure guidelines, requirements, and monitor material quality control. For example, the US FDA approved spinal implants made from titanium alloy, but it didn’t approve titanium alloy to be used in any other medical device. For each new use of the material, manufacturing companies need to get approval again from regulatory bodies. This causes a lag in the manufacturer’s operational cycle and delays the product launch, thus affecting sales and restraining the growth of the 3D printed medical implants market.

Many companies in this market are collaborating with various hospitals and rehabilitation centers to provide customizable devices for the specific needs of patients.These collaborations are aimed to be mutually beneficial for both, as the companies can use the network of the hospitals to promote their product and the hospitals would get customizable devices at their convenience.

For example, In January 2019, Renishaw, a global manufacturer of 3D implants, collaborated with University Dental Hospital of Wales (UDH), Cardiff, to help overcome challenges associated with surgical implants.This would help Renishaw to work with hospitals and become the major supplier of medical additive manufacturing devices.

Similarly, in January 2019, Hospital for Special Surgery (HSS) collaborated with Lima Corporate to provide a 3D printed facility for orthopedic implants. This collaboration would help HSS to use Lima’s technology to produce new innovative products for orthopedic joint care and to expand its product portfolio.

The US FDA’s Center for Devices and Radiological Health (CDRH) is the regulatory authority for companies that manufacture, repackage, relabel, and/or import medical devices sold in the United States.The medical devices made using 3D printing technology are subject to regulatory requirements before they are marketed (premarket requirements), and also after they are marketed (post-market requirements).

FDA classifies 3D printed medical devices into three classes, i.e., Class I, II, and III, with regulatory controls minimum for class I devices and maximum for class III devices. Most class III devices require premarket approval whereas class I devices are exempted from the approval. The manufacturers of 3D printed medical implants are required to establish and follow quality systems to ensure that their products consistently meet applicable requirements and specifications. The manufacturers also need to comply with FDA’s standards regarding device design, manufacturing, and testing considerations during the development of 3D printed medical devices.

In 2020, Stryker has announced the acquisition of Wright Medical Group N.V., for an undisclosed amount. This acquisition increases Stryker global market position in trauma and extremities, issuing crucial opportunities to advance creativity and reach more patients. Wright Medical Group N.V., is US- based Company is a medical device company focused on extremities and biologics.

The countries covered in the 3D printed medical implants market are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, and USA.