The global market for 3D printing of medical devices should grow from $3.1 billion in 2018 to $6.6 billion by 2023 at a compound annual growth rate (CAGR) of 16.4% for the period of 2018-2023.

Report Scope:

The scope of this report is broad and covers various types of 3D printed orthodontic appliances, 3D printed medical and surgical instruments, 3D printed implants and 3D printed orthopedic and prosthetic devices used for various end-user application industries. The market is broken down by major types, technologies, region and application of 3D printed orthodontic appliances, 3D printed medical and surgical instruments, 3D printed implants and 3D printed orthopedic and prosthetic devices. Revenue forecasts from 2018 through 2023 are given for each of the 3D printed orthodontic appliances, 3D printed medical and surgical instruments, 3D printed implants, 3D printed orthopedic and prosthetic devices segments and regional markets, with estimated values derived from manufacturers’ total revenues. The report will not cover 3D printed biologics.

The report also includes a discussion of the major players across each regional 3D printed orthodontic appliances, 3D printed medical and surgical instruments, 3D printed implants and 3D printed orthopedic and prosthetic devices market. Further, it explains the major drivers and regional dynamics of the global of 3D printed orthodontic appliances, 3D printed medical and surgical instruments, 3D printed implants and 3D printed orthopedic and prosthetic devices market and current trends within the industry.

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The report concludes with a focus on the distribution landscape and includes detailed profiles of the major retailers and wholesalers in the global 3D printed orthodontic appliances, 3D printed medical and surgical instruments, 3D printed implants and 3D printed orthopedic and prosthetic devices market.

Report Includes:

– 65 data tables
– An overview of the global 3D printed medical devices market
– Analyses of global market trends, with data from 2017, 2018, and projections of compound annual growth rates (CAGRs) through 2023
– Characterisation and quantification of orthopedic and cranial implants, surgical instruments and dental restorations based on product types, materials and end-user market
– Explanation of the major drivers and regional dynamics of the global 3D printing of medical device market and current trends within the industry
– Snapshot of new innovations in 3D printing technologies and 3D printing materials
– Profiles of key players in the market including Amedica Corp., BioArchitects, Dentis USA, Esstech Inc., and Handsmith Inc.

Summary

Three-dimensional (3D) printed medical devices are a subsection of the larger medical devices industry. These devices are can be manufactured at end-user facilities with 3D printers and compatible scanners and software but also purchased through an outsourced 3D printing vendor, which uses transmitted patient scans digitally to print the device that is then delivered to the healthcare provider.

There are numerous end-user markets for 3D printed medical devices. Globally, hospitals, physical therapist clinics, outpatient care centers and physicians’ offices use millions of medical devices for implanting joints, surgeries (instruments), joint braces (orthopedics) and prosthetics. 3D printed orthodontic appliances are becoming common at orthodontic clinics and are manufactured in-house at an increasing rate.

Definition

3D printing is a process in which material is joined or solidified under computer control to create a 3D object, with material being added together (such as liquid molecules or powder grains being fused together). The term “3D printing” is used interchangeably with additive manufacturing (AM; we will use both in this report). Unlike material removed from a stock in the conventional machining process (subtractive manufacturing), AM builds a 3D object from a computer-aided design model, usually by successively adding material layer by layer. There are many different 3D printing technologies, the most common by number of users being fused deposition modeling.

The term “3D printing” originally referred to a process that deposits a binder material onto a powder bed with inkjet printer heads layer by layer. More recently, the term is being used in popular vernacular to encompass a wider variety of AM techniques.

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While the industry is seeing dramatic success, there are hurdles to future success. Insiders at recent conferences are recognizing the continued need for global industry standards, both in terminology and production methodologies but also in testing standards and safety standards. Many of these standards are being applied to the industry by government agencies that test devices and give approval to new devices, but industry companies will work together to enhance these standards.

Government regulations are another hurdle for industry companies. The U.S. Food and Drug Administration (FDA) is a powerful agency in the global industry, as it approves devices and sets guidelines that companies much adhere to when submitting new devices to testing. The FDA issued in December 2017 a guidance for 3D printing medical device manufacturers: Technical Considerations for Additive Manufactured Devices. The guidance is intended to share FDA’s “initial thoughts regarding technologies that are likely to be of public health importance early in product development.” As of 2018, the FDA has approved more than 100 medical devices, and one prescription drug, that involve 3D printing.

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