For an Executive Summary of this report please contact ben.suntivarakom@visiongainglobal.com (+44 (0)20 7549 9976) or refer to our website: https://www.visiongain.com/Report/1386/3D-Printing-for-Healthcare-R-D-Industry-and-Market-2015-2025

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Contents
1. Report Overview
1.1 Overview of 3D Printing for Healthcare: Industry and Market 2015-2025
1.2 3D Printing for Healthcare, Market Segmentation
1.3 Market Definition
1.4 How This Report Delivers
1.5 Main Questions Answered by This Analytical Report
1.6 Why You Should Read This Report
1.7 Methods of Research and Analysis
1.8 Frequently Asked Questions (FAQ)
1.9 Associated Reports
1.10 About Visiongain
2.1 3D Printing
2.1.1 The Original 3D Printing Process
2.1.2 Selective Laser Sintering (SLS)
2.1.3 Direct Metal Laser Sintering (DMLS)
2.1.4 Electron Beam Melting (EBM)
2.1.5 Stereolithography (SLA)
2.2 Bio-printing: The Printing of Living Cells
2.2.1 How 3D Printing With Living Tissue Works
2.2.2 The Near- and Long-Term Applications for 3D Bio-printing
2.2.3 Current Problems With 3D Bio-printing
1. Report Overview
2. Introduction to 3D Printing for the Healthcare Industry

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Contents
2.3 The 3D Printing of Pharmaceuticals
2.3.1 3D Printing Technology in Drug Discovery
2.4 Classifying Medical Devices
2.4.1 The US Medical Devices Classification System
2.4.2 The EU Medical Devices Classification System
3. The 3D Printing Market for the Healthcare Industry, 2015-2025
3.1 The 3D Printing Market for Healthcare in 2013: Technology vs. Products
3.2 3D Printed Products in the Healthcare Industry: A Breakdown by Application
3.3 The 3D Printing Market for Healthcare: A Global Revenue Forecast 2015-2025
3.4 Driving and Restraining Forces Affecting That Industry
3.5 The 3D Printing Market for Healthcare: Technology vs. Products Revenue Forecast 2015-
2025
3.5.1 Technology: Revenue Forecast 2015-2025
3.5.2 Drivers and Restraints in the 3D Printing Technology Submarket
3.5.3 Products: Revenue Forecast 2015-2025
3.6 The 3D Printing Market for Healthcare: Application Submarket Revenue Forecasts 2015-
2025
3.6.1 Dental Products: Revenue Forecast 2015-2025
3.6.2 Medical Implants: Revenue Forecast 2015-2025
3.6.2.1 Medical Implants: Patient-Specific Orthopaedic and Cranio-maxillofacial Implants
Are Produced Using 3D Printing Technology
3.6.2.2 The Driving and Restraining Factors Surrounding 3D Printed Medical Implants,
2015
3.6.3 Bio-printed Tissue: Revenue Forecast 2015-2025
3.6.4 Bio-printed Tissue: Commercial Launch in Q4 2014
3. The 3D Printing Market for the Healthcare Industry, 2015-2025

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Contents
3.6.5 Other Applications: Revenue Forecast 2015-2025
3.6.6 Other Applications: Medical Modelling, Prototypes and Pharmaceuticals
4. The Leading National Markets for 3D Printing; Healthcare, 2015-
2025
4.1 Leading National Markets – 3D Printing for Healthcare, 2013
4.2 Leading National Markets: Comparison of Revenue and Market Share, 2019 and 2025
4.3 Leading National Markets: 3D Printing for Healthcare, Grouped Revenue Forecasts, 2015-
2025
4.4 The US Will Remain the Largest National Market Throughout the Forecast Period
4.4.1 Pioneering Use of 3D Printed Medical Implants in the US
4.4.2 FDA Regulatory Requirements: Abridged Pathways Encourage Innovation
4.5 The EU5 Account for 30.55% of the Market in 2013, But How Will This Change During the
Forecast Period?
4.5.1 Germany Will Remain the Largest Market of the EU5 Throughout the Forecast Period
4.5.2 France: Strong Growth but a Decreasing Market Share
4.5.3 The UK: A Strong Network for 3D Printed Medical Implants Will Stimulate Sales of
those Products
4.5.4 Italian Orthopaedic Device Manufacturers are Prominent Consumers of Arcam’s AM
Technology
4.5.5 Spain: the Smallest Consumer in the EU5
4.6 Japan: Growth Will be Driven by Domestic and International Innovation
4.7 China: Domestic Innovation is Keeping Pace With the Western World
4.8 Will 3D Printing Penetrate the Russian Healthcare Market?
4.9 Brazil: A Rapidly Growing Dental Market Presents Opportunities for 3D Printing
4.10 The Indian Market is at an Early Stage
4. Leading National Markets for 3D Printing in Healthcare, 2015-
2025

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Contents
4.11 The RoW Market is Fast Growing
5. Market Leading Organisations; 3D Printing for Healthcare
5.1 Industry leaders in 2014
5.2 Organisations in the Medical Implants Sector
5.2.1 Stratasys: Total Revenues Up Over 80% from 2013
5.2.2 3D Systems: 574% Growth in Healthcare Revenues since 2010
5.2.3 Tissue Regeneration Systems: Commercialising 3D Printed Bioresorbable Skeletal
Reconstruction Implants
5.2.4 Oxford Performance Materials: Selling Two FDA Approved Facial Reconstruction
Implants
5.2.5 EOS: A Manufacturer of 3D Printers
5.2.6 Within Technologies: A Manufacturer of Software for 3D Printing
5.2.6.1 Within Medical: A New Initiative Combining Medical Implant Design Software
and a 3D Printing Manufacturing Program
5.2.7 C&A Tool: Manufacturing Parts for the Surgical, Orthopaedic, Implant and Tooling
Fields
5.2.8 Tronrud Engineering: A Provider of DMLS Since November 2011
5.2.9 Alphaform AG: Focussing on its 3D Printing Business
5.2.10 3T RPD Ltd: A UK-Based AM Company
5.2.11 Arcam AB Achieving Rapid Growth Since 2012
5.2.12 Xilloc Medical: Patient-Specific Implants from Design to Production
5.2.13 Renishaw: UK-based 3D Printer Manufacturer
5.2.14 Fripp Design and Research: Developed Picsima Technology for Printing Soft Tissue
Prostheses
5.2.15 Materialise: A Global Software and Printing Services Provider
5. Market Leading Organisations in 3D Printing for Healthcare

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5.2.16 4WEB Medical: Over 3000 Spinal Implants Currently In Use
5.2.17 Replica 3dm: Offering Medical Models for the NHS
5.3 Organisations in the 3D Bio-printing Sector
5.3.1 Organovo: Offering the First 3D Bio-printed Tissue for Sale
5.3.2 RegenHU: Creating 3D Bio-printers and BioInks
5.3.3 Bio 3D Technologies: The World’s First Modular Bio-printer
5.3.4 Osteopore International: Two FDA Approved Products
5.3.5 EnvisionTEC: 3D Printing and Bio-printing Solutions
5.3.6 Rainbow Biosciences: Bio-printing Based on Magnetic Nanoparticles
5.3.7 Wake Forest Institute for Regenerative Medicine: 3D Bio-printing Research
5.3.7.1 Timeline for Commercially Available Therapeutic Applications
5.3.7.2 Commercial Applications: Drug Development
5.4 Organisations in Other Industry Sectors
5.4.1 Aprecia Pharmaceuticals: Oral Drug Delivery System Produced by 3D Printing
Technology
5.4.2 The Cronin Group, University of Glasgow: Working on the 3D Printing of
Pharmaceuticals
6.1 R&D in the Field of Medical Implants
6.1.1 Improving Biocompatibility of 3D Printed Medical Implants with Vitamin B2
6.1.2 3D Printed Intervertebral Discs Could Look Forward to a Share of a $90bn Market
6.1.3 3D Printing of Bionic Organs With Enhanced Functionality
6.1.4 Returning Vision: Printing a Bionic Eye
6.2 R&D in the Field of Bioengineering
6.2.1 3D Printing of Skin Grafts: In Hospitals Within 10 Years?
6. 3D Printing for the Healthcare Industry: The R&D Pipeline, 2014

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6.2.2 The Production of Implantable Cartilage Using 3D Printing
6.2.3 3D Printing Blood Vessels is a Step Towards the Fabrication of Organs
6.2.3.1 Work at the University of Pennsylvania and MIT
6.2.3.2 Work at Fraunhofer
6.2.3.3 Work at Harvard
6.2.3.4 Work at The University of Iowa
6.2.4 3D Printing of Replacement Ears for Reconstructive Surgery
6.2.5 3D Printing to Fabricate Artificial Heart Valves
6.2.6 3D Printing of Nipple Areola Complex Graft for Reconstructive Surgery
6.2.7 3D Printing of Human Embryonic Stem Cells
6.3 R&D in Other Fields
6.3.1 The 3D Printing of Pharmaceuticals: The Potential to Improve Access to
Pharmaceuticals in Remote Corners of the World?
6.3.2 3D Printing Pills: University of Central Lancashire
6.3.3 Bio-robots for Targeted Drug Delivery
7. Qualitative Analysis of the 3D Printing Industry for Healthcare, 2014-
2015 Onwards
7.1 3D Printing Industry for Healthcare 2014: Strengths and Weaknesses
7.1.1 Annual Growth Rate at Highest Levels To Date
7.1.2 Demand for Customised Products is High
7.1.3 3D Printed Products Can Improve Health Outcomes and Reduce Costs
7.1.4 Time and Resources Can be Saved
7.1.5 3D Printing Can Produce Complex Shapes and Parts
7.1.6 3D Printing Technology is Advancing Rapidly
7. Qualitative Analysis of the 3D Printing Industry for Healthcare,
2015 Onwards

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Contents
7.1.7 3D Printing is Expensive
7.1.8 Economies of Scale are not Achieved Using Current Technology
7.1.9 A More Sophisticated Technology Requires Fewer Workers and New Skills
7.1.10 Access to Technology and Expertise Currently Limited
7.2 Opportunities and Threats Facing the Industry, 2015-2025
7.2.1 Governments are Funding 3D Printing R&D Projects
7.2.2 Increasing Demand for Personalised Medicine Represents a Lucrative Opportunity
7.2.3 There is Considerable Media Interest in the Technology
7.2.4 New Applications for 3D Printing Technology are Being Developed
7.2.5 Opportunities Exist in Post-Production Finishing
7.2.6 Regulatory Guidelines Must be Clarified
7.2.7 Long-term Studies of 3D Printed Medical Products Do Not Exist
7.2.8 Legal Questions Have Yet to be Answered
7.2.9 High Volume Manufacturing is More Economical Using Traditional Methods
7.3 A STEP Analysis of the 3D Printing Industry for Healthcare, 2015-2025
7.3.1 Social Influences on Market Trends
7.3.2 Technological Influences on Market Trends
7.3.3 Economic Influences on the Market
7.3.4 Political Influences on the Market
8. Research Interviews
8.1 Interview with Michael Renard, Executive Vice President, Commercial Operations,
Organovo
8.1.1 On the Applications for 3D Bio-printing
8.1.2 On the Commercial Prospects of the Technology
8. Research Interviews

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Contents
8.1.3 On Potential Factors That Could Inhibit Development
8.1.4 On Their Newly Released exVive3D Liver Human Tissue
8.1.5 On the Future of Organovo and the 3D Bio-printing Industry
8.2 Interview with Jim Fitzsimmons, President and CEO, Tissue Regeneration Systems
8.2.1 On the Background of TRS
8.2.2 On TRS’ Product Portfolio
8.2.3 On Their Commercialisation Strategy
8.2.4 On TRS’ Future
8.3 Interview with Matthew Sherry, Managing Director, Replica 3dm
8.3.1 On the History Behind Replica 3dm
8.3.2 On Their Services and R&D Pipeline
8.3.3 On Replica 3dm’s Growth Plans
8.3.4 On the 3D Printing For Healthcare Industry
8.4 Interview with Professor Lee Cronin, Regius Chair of Chemistry, University of Glasgow
8.4.1 On the Cronin Group’s 3D Printed Technology
8.4.2 On Commercialisation Opportunities for Their Technology
8.5 Interview with Peter Leys, Executive Chairman, Materialise N.V.
8.5.1 On the Beginning of Materialise N.V.
8.5.2 On the Medical Products and Services Offered by Materialise N.V.
8.5.3 On Materialise’s Most Lucrative Products and Markets in 2015 and Beyond
8.5.4 On Regulatory Challenges Facing 3D Printing in the Healthcare Industry
8.5.5 On the Prospects of Materialise N.V. Over the Forecast Period
8.6 Interview with Andy Middleton, General Manager, EMEA (Europe, Middle East and
Africa), Stratasys
8.6.1 On Stratasys’ Offerings for the Healthcare Industry

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Contents
8.6.2 On the Demand for 3D Printing in Healthcare
8.6.3 On the Future of 3D Printing in the Healthcare Industry
8.7 Interview with Dr Lothar Koch, Head of Biofabrication Group in the Nanotechnology
Department, Laser Zentrum Hannover
8.7.1 On Laser-Assisted Bio-printing
8.7.2 On the Uses of 3D Printed Tissue
8.7.3 On 3D Printed Tissue vs. Traditional In Vitro Models
8.7.4 On 3D Printed Tissue for Transplantation
8.7.5 On Research in the Field
8.7.6 On the Timeline for Commercial Availability
9. Conclusions from Our Study
9.1 The 3D Printing Market for the Healthcare Industry: Technology vs. End Products, 2015-
2025
9.2 3D Printed Products for the Healthcare Industry by Application: Comparison of Revenue,
2013, 2019 and 2025
9.3 The Leading National Markets for 3D Printing in the Healthcare Industry, 2015-2025
9.4 Trends in the Industry and Market
9.4.1 Governments Want To Be Leaders in the Field
9.4.2 Personalised Medical Products Are Penetrating The Market
9.4.3 3D Printing Technology is Already Established in the Field of Dentistry
9.4.4 Bio-printing Will Take-Off Over The Next 10 years
9.4.5 Submarkets Will Expand – Systems, Software, Raw Materials & Products Visiongain’s
9. Conclusions from Our Study

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3D Printing for Healthcare: R&D, Industry
and Market 2015-2025
Through this partnership, Compass3D offers Stratasys 3D printing solutions in the Brazilian
market, in particular the Objet 3D Printing platform and materials for AM. Brazil has a rapidly
growing dental market as a result of the expanding middle class population. The digital dental
market is also expanding rapidly with new dental practices purchasing the latest technology;
increasing uptake of 3D printing dental solutions will be a main driver of growth during the forecast
period. Between 2013 and 2019, the Brazilian 3D printing market for healthcare will expand at a
CAGR of 31.21%. This high rate of growth is partly a consequence of 3D printing being a novel
manufacturing technique in that country.
Table 4.14 The Brazilian 3D Printing Market for Healthcare: Revenue ($m) and Market
Share (%) Forecast, 2014-2025
Brazil 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Revenue ($m) 10 14 19 25 33 42 53 66 80 95 111 129 148
AGR (%) 36.3 35.0 32.2 30.1 27.7 26.2 23.6 20.8 18.8 17.9 15.5 14.8
Market Share (%) 1.70 1.73 1.75 1.78 1.80 1.83 1.85 1.88 1.90 1.93 1.95 1.98 2.00
CAGR (%) 31.21 18.54
Figure 4.15 The Brazilian 3D Printing Market for Healthcare: Revenue Forecast ($m),
2014-2025
0
20
40
60
80
100
120
140
160
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Revenue($m)
Year
Between 2019 and 2025, revenue growth will slow to a CAGR of 18.54%. Traditional methods of
manufacturing will remain an important feature of the Brazilian orthopaedics market on account of
Source: visiongain 2015; CAGR values for year ranges 2013-2019 and 2019-2025
Source: visiongain 2015

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3D Printing for Healthcare: R&D, Industry
and Market 2015-2025
5.3.7.1 Timeline for Commercially Available Therapeutic Applications
The first achievement by the team at WFIRM was the 3D printing of flat tissues, such as skin.
Following this, tubular organs such as blood vessels were produced. Now, hollow, non-tubular
organs such as the bladder and stomach have been successfully produced by the technology.
These have more complex structures and functions. Building solid organs, such as a kidney or
heart, is still a challenge for the technology. Reportedly, it takes 30 minutes to print a miniature
version of these organs, which measure a few centimetres in size.
The launch of commercial applications for this technology will follow a similar pattern, with simple
flat tissues becoming available first. A large amount of data will be needed for regulatory approval,
and the tissues and structures that were first developed will accrue this first. Visiongain predicts
that 3D printed skin will be available commercially by 2024, in a small number of specific locations.
Hospitals will have the machinery to print skin cells directly onto the patient’s body, including
keratinocytes, hair follicles, oil glands and melanocytes. Following this, tubular structures will
become available, followed by hollow and then non-hollow organs. The printing of more complex
organs are unlikely to be available commercially for two or more decades, owing to the complex
technologies and legal issues involved. However, the printing of skin, cartilage and tissue will have
many promising therapeutic applications in the healthcare industry.
A more realistic goal in this time period is to replace damaged tissue with cell therapy and thereby
restore function of the organ. Tissue transplants created from a patient’s own cells would not be
rejected, overcoming perhaps the most important issue in the field of transplantation. For example,
instead of building a replacement kidney, the focus is on improving renal function. This could also
be achieved by implanting a device into the body to augment kidney function; institute scientists
have grown kidney cells on an artificial renal device with a tubular component, collection system
and a reservoir. When implanted in animals, this functioned as a mini-kidney. This would boost the
limited function of diseased kidneys and increase the life expectancy of patients. It would also
relieve the pressure on the organ transplant waiting list, reducing waiting times.
5.3.7.2 Commercial Applications: Drug Development
As well as therapeutic applications, 3D printed human tissue or organs can be used for drug
testing and development purposes. The 3D printers at the Wake Forest Institute print human cells
in hydrogel-based scaffolds. These engineered organs can then be placed on a 5 cm chip and
linked together with a circulating blood substitute. This blood substitute supplies the cells with
oxygen and nutrients, keeping them alive. This also provides a method of introducing chemical or
biological agents into the system to test their effect on the tissues. Sensors can then measure
temperature, oxygen levels, pH and other factors to feedback how the organs react. This

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3D Printing for Healthcare: R&D, Industry
and Market 2015-2025
Organisations Working in
the Field
Cornell University
Applications of the
Technology
Repairing and replacing IVDs
Stage of Development In vivo animal tests
Potential Market Launch < 10 years
In the US, 30 m people suffer from lower back pain caused by the degeneration of an intervertebral
disc (IVD) and up to 4 m patients await surgery. It is estimated that $90bn is spent every year on
treatment for this condition. However, treatment options are limited. Surgical interventions may
replace the IVD with a mechanical device, which fuse the adjacent vertebrae, reducing mobility and
potentially damaging adjacent discs. Non-biological total disc replacement implants overcome
these shortcomings, but they often fail, become dislodged, or osteolysis occurs. A properly
engineered biological IVD implant would be a valuable tool in this clinical field. The Bonassar
Research Group at Cornell University are working on both IVD repair and replacement using 3D
printing with biomaterials. This technology has been tested in vivo in rats.
IVDs are comprised of two distinct regions: the annulus fibrosus (AF); and the nucleus pulposus
(NP). The NP is gelatinous tissue that provides the compressive properties of the IVD. It is
surrounded by the AF, which is highly organised fibrocartilage providing tensile strength. The
repairing of a punctured disc using 3D printing focuses on the NP region, filling the IVD to its
original height with high-density collagen gel using a 3D printer. Reports also indicate that stem
cells can be used in this process, which are printed directly onto the rats’ spinal disc guided by MRI
and CT images. After surgery, the stem cells form spinal disc tissue, resulting in a fully repaired
IVD. Visiongain believes that this technology will be available in the clinic during our forecast
period, provided further research is successful.
The technology can also be used to create tissue engineered intervertebral discs as a biological
replacement option. Transplantation is a more invasive procedure. Using CT and MRI scans as a
digital template, an IVD can be entirely fabricated using a 3D printer, ovine NP cells suspended in
alginate and AF cells suspended in collagen. The IVDs can be printed to exact native
specifications. When implanted into the caudal spines of rats for the duration of 6 months, these
engineered implants reproduced native shape and composite structure, integrated with
neighbouring vertebrae and produced extracellular matrix with native levels of collagen and
proteoglycans. The engineered tissue was functional, maintained disc height and had similar
mechanical properties to the native IVD. This procedure has been performed on 100 rats and has
resulted in full mobility and low mortality. The team are now focusing on refining the properties of
Source: visiongain 2015