Growing Acceptance of Medical 3D Printing Printing ... · • Global orthopedic implant and medical device manufacturers such as Stryker, Zimmer Biomet, and more • Small specialty

Growing Acceptance of Medical 3D Printing and the Specialty Medical 3D Printing Business Model A SMARTECH WHITE PAPER

PUBLISHED MAY 2016

Entire contents copyright SMARTECH MARKETS PUBLISHING. The information contained in this report is based on the best information available to us, but accuracy and completeness cannot be guaranteed. SmarTech Markets and its author(s) shall not stand liable for possible errors of fact or judgment. The information in this report is for the exclusive use of representative purchasing companies and may be used only by personnel at the purchasing site per sales agreement terms. Reproduction in whole or in any part is prohibited, except with the express written permission of SMARTECH MARKETS PUBLISHING.

© 2016 SmarTech Markets Publishing 1 364 Stone Creek Point #305 Charlottesville, VA 22902 http://www.smartechpublishing.com

Acceptance of 3D Printed Medical Solutions Has Reached Record Levels The medical industry has long been a leader in terms of adoption of 3D printing technology and development of specific solutions that can only be achieved through additive fabrication. Historically, this can be attributed to the origins of 3D printing technologies and the capabilities that early rapid prototyping systems had in transitioning into tools to serve new market opportunities for the manufacture of usable components.

Technologies such as stereolithography and material jetting, originally designed to produce high-quality three dimensional models and prototypes or casting patterns, provided a flexible platform for development of new materials that helped create specialty markets for medical models and training equipment along with software that could translate medical imaging data into a three-dimensional CAD file.

Over time, the capabilities of nearly every prominent three-dimensional printing technology have been adapted for use within the context of healthcare—whether it be for producing medical models, surgical drilling or cutting guides, prosthetic devices, implants, or more classically in prototyping and manufacturing medical equipment and devices.

In 2016, the acceptance of 3D printing technologies for the purposes of medical care are at an all-time high, with use of a number of popular print technologies spanning all manner of treatment. In particular over the last two years, SmarTech has observed extremely promising growth in acceptance of the technology among two key groups:

• Global orthopedic implant and medical device manufacturers such as Stryker, Zimmer Biomet, and more

• Small specialty medical 3D printing solutions companies

Growth in use of 3D printing to produce real-world medical solutions at the largest medical device and orthopedic manufacturers alone is a hugely positive development that has only really taken shape in the last two years. Although a number of licensed products developed and printed by smaller specialty medical companies have been sold by the industry's largest on a license basis for several years, it has only been recently that these same major market drivers have begun to develop and produce their own internal solutions in the areas of 3D printed orthopedic implants and custom surgical devices.


But just as exciting as the largest names in the industry growing their direct involvement is the groundswell of start-up and specialty companies developing businesses specifically around the idea of new 3D printed medical treatments and products. A huge growth in this area has been observed over the last twelve months, encompassing all manner of medical practice areas and 3D print technologies.

To provide context to this growth, SmarTech provides a brief recap of significant 3D printable medical solutions released to the market or in latter stages of development since early 2015 in Exhibit 1 below:

Exhibit 1: Major Growth in 3D Printed Medical Solutions and Products Q1 2015-Q1 2016

Product (Company)

Solution Area Associated Print Technology

Status

Tritanium Posterior Lumbar Cage (Stryker Corp.)

Spinal implant Metal powder bed fusion

Q2’16 Release

Unite3D Bridge Fixation System (Zimmer Biomet)

Ankle fusion implant

Metal powder bed fusion

Received FDA Clearance in Q1’16

iMcustom orthotic insoles (iMcustom)

Custom orthotic foot insole

Material extrusion Entering retail availability in the U.S. at Sam’s Club

BodyCAD OnCall (BodyCAD)

Customized orthopedic implants for complex cases paired with custom surgical instruments

Multiple technologies

Available

Custom cranial implants (BioArchitects

Craniomaxilliofacial implants

Metal powder bed fusion

FDA Clearance received Q1’16


Product (Company)

Solution Area Associated Print Technology

Status

iFit Knee Replacement (ConforMIS)

Custom knee arthroplasty

Polymer and metal powder bed fusion

Available as of Q2’15

NovaCast (Mediprint)

Printed fracture brace

Material extrusion/polymer powder bed fusion

Patented, under development

Source: SmarTech Markets Publishing

These examples of acceptance of 3D printing technology within the medical community, among many others not listed, demonstrate a key trend for 3D printing in the medical market—that commercial applications are rapidly making it to market, having a real impact beyond just research institutions and limited one-off treatment cases. Although special case treatments powered by 3D printed implants or medical devices are fantastic in their own right, SmarTech believes that there is huge market potential for medical 3D printing solutions in large scale applications, many of which remain untapped or have very low penetration today.

Exhibit 2 below further demonstrates the expanding future potential for medical 3D printing activity via presentation of SmarTech’s aggregated medical 3D printing application value presented by several prominent application categories.


Exhibit 2: Total Projected Medical 3D Printing Application Value, by Category, 2014-2024


Finding a Niche for 3D Printing Technologies in the Medical Industry Because of the mountain of unsolved or underserved medical problems that can be found around the world, entrepreneurs and innovators in both the 3D printing and medical industries have begun to come together to apply print technologies in novel ways to create medical solutions or improve medical treatment.

Because of this, use of 3D printing technologies in the medical world has a very high degree of variability, which leads to variations in requirements for printed parts and different value drivers for the use of AM technology. Both existing technologies can be applied—sometimes through the development of special materials for medical use—as well as the development of new

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024

Total $806.2 $973.8 $1,229.2 $1,686.6 $2,528.3 $3,347.1 $4,287.3 $5,703.7 $7,588.3 $8,571.3 $9,639.2

Printed Prosthe<cs $1.6 $5.8 $12.0 $18.0 $24.7 $45.5 $80.5 $126.2 $169.3 $201.1 $241.8

Printed Opthalmic & Ortho<c Devices $1.8 $4.5 $8.3 $15.6 $27.8 $45.0 $55.2 $63.3 $74.2 $84.2 $101.8

Medical Models $10.0 $18.7 $30.3 $48.9 $71.8 $104.1 $151.7 $216.7 $305.5 $448.1 $570.4

Printed Surgical Guides & Tools $281.0 $315.8 $354.9 $387.5 $435.5 $469.5 $493.4 $518.5 $545.0 $574.1 $605.1

Orthopedic and Other Implants $511.8 $629.0 $823.6 $1,216.6 $1,968.5 $2,683.0 $3,506.6 $4,779.0 $6,494.4 $7,263.8 $8,120.2

$806.2 $973.8 $1,229.2

$1,686.6

$2,528.3

$3,347.1

$4,287.3

$5,703.7

$7,588.3

$8,571.3

$9,639.2

$-‐

$1,000.0

$2,000.0

$3,000.0

$4,000.0

$5,000.0

$6,000.0

$7,000.0

$8,000.0

$9,000.0

$10,000.0

Revenu

e ($USM

)


variations of the parent printing processes used today in order to create a specialty medical 3D printing solution.

These differences in applications create a complex marketplace for the use of 3D printing in the medical industry. SmarTech has segmented applications of 3D printing in the context of medical solutions into four groups for which the analysis of current and future potential 3D printing in medical applications is based upon. These categories group the parts produced by 3D printers that serve purpose in medical applications together for easier analysis of a complex market structure. These groups are:

• Direct Patient Use Parts (DPUs)

• Medical Professional Assistance Parts (MPAs)

• Medical Manufacturing Parts

• Biomedical Research Parts

To demonstrate the breadth of varying requirements for applications even within these defined medical 3D printing component subsegments, SmarTech has engaged in an extensive analysis of potential commercial applications in each category and rated the current standard requirements based on a two-spectrum plane to show how there is significant opportunity for certain 3D print technology and material pairings to address unmet needs in end markets. This is presented in Exhibit 3.



In Exhibit 3, note that for the listed 3D Printed Direct Patient Use Components, each is approximated a position on the graph based on each application’s balance between mechanical performance and aesthetic requirements (on the Y axis), as well as the primary benefit it brings to the market balanced between a highly custom solution versus one that is more manufacturable or cost effective through 3D printing versus a competing traditional solution (on the X axis).

Note that these spectrums are relative—the aspects of mechanical performance and aesthetic quality are not necessarily mutually exclusive. Additionally, 3D printed Direct Patient Use Parts can in some cases provide both a customized solution that also provides cost-effectiveness or other benefits related to the manufacturability of the part itself.

For example, acetabular hip cups printed in Ti6Al4V using metal powder bed fusion technology of the electron beam variety can include custom geometric features for patients with structural damage, but also have manufacturability benefits from the porous surfaces that result from the electron beam

3D#Printed#Direct#Pa-ent#Use#Components#Mechanical)Priority)

Aesthe1c)Priority)

Hip)Cups)

Upper)Extremity)Prosthe1cs)

Lower)Extremity)Prosthe1cs)

Op1cal)Frames)

Ortho1c)Insoles)

External)Bracing)

Spinal)Truss/Cage)

Facial)Prosthe1cs)

Knee)&)Other)Orthopedic)Implant)

Manufacturability)

Custom

iza1o

n)

Complex)Case)Implant)

Craniomaxilliofacial)Implant)


sintering of metal powder which enhance osseointegration without secondary manufacturing processes to add surface texturing.

Another example might be in the case of upper extremity prosthetics such as hands—these are both custom solutions and highly feasible through 3D printing, however the weighting of the primary benefit leans more heavily towards manufacturability because 3D printing affords a cost-effective solution that simply does not exist through traditional means.

Using similar frameworks, stakeholders in the medical industry with interest in 3D printing technology (or vice versa) should analyze the current market and potential solutions and carve out a niche in a market rife with untapped potential.

Medical 3D Printing Markets and the Rise of Specialty Solutions and Print Services The theme of the medical 3D printing opportunity today is, therefore, one of vast complexity and unsolved problems waiting to be addressed through the possibilities that additive fabrication has already introduced to the market thus far.

Thanks to early innovators and pioneers in medical prosthetics, implants, and models, medical specialists now understand the potential for 3D printing to be applied to fix problems where a patient-specific solution is the only viable treatment. Additionally, medical professionals—and specifically medical device manufacturers—are beginning to understand how 3D printing can also reinvent existing treatments in an entirely new approach through innovative cost structuring and supply chain flexibility.

While the largest medical device firms are taking a more direct role now, the medical industry appears to be one of the best suited opportunities for disruptive start-ups and specialty print service providers to capitalize on expertise with 3D printing technology and related materials.

Larger medical manufacturers, and even material suppliers are also finding ways to specialize in medical 3D printing by developing new variations of print processes to be able to process new materials relevant to the medical industry. This is evidenced by efforts for silicone 3D printing from both Fripp Design and Wacker Chemie, both of which have developed individual printers to print in variants of silicone. In particular, Fripp Design and its Picsima printer are already pursuing using their technology for the printing of highly realistic facial prosthetics.


Therefore, SmarTech firmly believes that the medical 3D printing market is witnessing a continued revolution towards specialty solutions and services. Broader players involved in numerous medical applications have been established already—Materialise, 3D Systems, etc. However, growth in highly specialized firms providing specific services like medical modeling, patient- specific prosthetics, new surgical planning solutions backed by custom printed implants and associated custom surgical guides for specific procedures, and also new medical devices designed by specialists and manufactured by 3D printing, paints an interesting picture for the future of the medical 3D printing market.

Pursuing a special niche within medical 3D printing can be an effective business model through first-mover advantage, as well as creating strong competitive positions and raising barriers to entry. For areas such as medical models, SmarTech expects an increase in 3D printing service providers specializing in this area as acceptance of medical models grows significantly in the next three years. Although there is potential to eventually bring this activity into primary care environments for even greater efficiency, specialty providers will no doubt choose to focus on models for complex procedures and providing access to high-end printers that are able to provide extreme realism.

Surgical cutting and drilling guides, as well as custom surgical tools, are also an area where a specialty business model lends itself well. With the wealth of different surgical procedures that 3D printed implants are able to serve where traditional solutions do not exist or are insufficient, there are likely a number of opportunities for medical and orthopedic specialists to create specific solutions matched to print technologies, software, and materials.

Even more wide open opportunity areas exist with prosthetics, healthcare products, and surgical and medical devices redesigned around the capabilities of AM to improve procedural success rates. Companies such as Osiris Biomedical, Additive Orthotics and Prosthetics, Medi Print, and many more recent start-ups are looking to blaze new trails in specialized medical 3D printed solutions and services.

Related Reports 3D-Printed Medical Prosthetics Markets

3D-Printed Medical Implant Markets: Orthopedic and Other Applications

Opportunities for Additive Manufacturing in Surgical Planning and Modeling

3D Printing in Medical Markets 2015: An Opportunity Analysis and Ten-Year Forecast


About the Analyst Scott Dunham – Vice President of Research, SmarTech Markets

Scott Dunham is Vice President of Research at SmarTech Markets Publishing, bringing with him years of research experience in the areas of advanced manufacturing and 3D printing. Scott holds a Bachelor's degree in marketing and research from the University of Kentucky's Gatton School of Business & Economics, and has been a featured speaker at 3D printing industry events around the world.

About SmarTech Markets Publishing Why SmarTech?

When a company purchases a report from SmarTech Markets Publishing or engages us for custom consulting, it receives:

• Comprehensive analysis that reflects today’s 3D printing market realities and tomorrow’s profitable possibilities.

• Detailed forecasts that are both believable and provide our clients with an edge over the competition.

• Actionable recommendations identifying where money will be made and where it will be lost.

• Candid market assessments based on today’s best strategic thinking, not just data dumps from the Internet.

SmarTech offerings complement internal product planning and technology roadmapping and provide low-cost knowledge enhancement for firms in the 3D printing industry.


SmarTech’s Coverage Areas

Equipment and Software End-User Markets Materials

3D printers for advanced manufacturing Aerospace Metals

Personal 3D printers Automotive Plastics

3D scanners Education Bio-materials

Additive manufacturing software Hobbyists

Medical and dental

Bio-printing

Low-volume manufacturing

Mass customization

Service bureaus

Industry reports are our core deliverable, but we also carry out custom consulting when clients need more detailed assessments of companies and markets than can be included in an off-the-shelf report. In addition, SmarTech offers due diligence services to the financial community.


About Us

SmarTech Markets Publishing delivers industry analysis and market forecasts for the 3D printing/additive manufacturing industry. Our coverage provides insight for those companies offering 3D printing services, materials and software sectors, as well as those that make the 3D printers themselves.

SmarTech Markets Publishing is the leading provider of market research and industry analysis in the 3D printing/additive manufacturing sector. We have published reports on most of the important revenue opportunities in the 3D printing sector including personal printers, low-volume manufacturing, 3D printing materials, medical/dental markets and other promising 3D market segments. Our client roster includes some of the largest 3D printer firms, materials firms and investors in the world. And you can follow SmarTech on Twitter where we discuss technology trends, company announcements and the industry’s on-going progress.

The SmarTech Team

The team at SmarTech has had decades of experience providing information for high-tech industry sectors and our forecasting and research methodology has been tried and tested over more than 30 years. We realize how easy it is to be lured into unrealistically bullish revenue projections. So we go the extra mile to ensure our forecasts are hype free.

Contact SmarTech:

Website: www.smartechpublishing.com

Email: [email protected]

Phone: 434-872-9008

SmarTech Markets Publishing

364 Stone Creek Point #305

Charlottesville, VA 22902

Documents

Growing Acceptance of Medical 3D Printing Printing ... · • Global orthopedic implant and medical device manufacturers such as Stryker, Zimmer Biomet, and more • Small specialty