Forecast
Period
|
2026-2030
|
Market Size (2024)
|
USD 2.54 Billion
|
CAGR
(2025-2030)
|
8.91%
|
Fastest
Growing Segment
|
Implants
|
Largest
Market
|
North
America
|
Market
Size (2030)
|
USD 4.19
Billion
|
Market Overview
Global 3D Printing Medical Devices Market was valued at USD 2.54 Billion in 2024 and is expected to reach USD 4.19 Billion by 2030 with a CAGR of 8.91% during the forecast period. The global market for 3D printing in medical devices has experienced substantial growth in recent years and is set for continued expansion. Also known as additive manufacturing, 3D printing is transforming the medical sector by enabling the production of customized, patient-specific devices, lowering production costs, and improving both the accuracy and speed of medical treatments. A primary factor driving this market is the increasing demand for personalized medical devices. 3D printing facilitates the creation of devices such as prosthetics, implants, and orthotic devices tailored to an individual's unique anatomical needs. Traditional medical device manufacturing is often costly and time-consuming, while 3D printing offers cost efficiencies by minimizing waste, optimizing production timelines, and reducing labor expenses.
Ongoing advancements in 3D printing technologies, including the use of biocompatible materials and enhanced printing speeds and precision, are further promoting the adoption of 3D-printed medical devices. Innovations such as 3D-printed surgical instruments, bone implants, and custom prosthetics are gaining momentum. As the technology matures, it is increasingly being approved by regulatory bodies, including the U.S. FDA and the European Medicines Agency (EMA), boosting manufacturer confidence and creating new growth opportunities. North America remains the largest market for 3D printing in medical devices, driven by the presence of leading companies, advanced healthcare infrastructure, and strong regulatory frameworks, with the United States being a key contributor. The Asia-Pacific region is expected to experience the highest growth rates, fueled by increased healthcare spending, rising demand for customized solutions, and technological advancements. While regulatory approvals for 3D-printed medical devices are increasing, the complex and stringent approval processes can still present challenges for new market entrants. Furthermore, the high initial investment required to establish 3D printing facilities and the need for specialized labor may hinder adoption, particularly in resource-constrained environments.
The global 3D printing medical devices market is poised for continued growth as more healthcare providers and manufacturers adopt the technology. The integration of artificial intelligence (AI) and machine learning with 3D printing is expected to further refine the precision and functionality of medical devices. Additionally, advancements in bioprinting, the creation of tissues and organs through 3D printing, present significant opportunities for the future of regenerative medicine.
Key Market Drivers
Increasing
Prevalence of Chronic Diseases
The escalating prevalence of chronic
diseases worldwide stands as a prominent catalyst driving the robust growth of
the Global 3D Printing Medical Devices Market. As chronic conditions such as
cardiovascular diseases, orthopedic ailments, and various forms of cancer
become more pervasive, the demand for innovative and tailored medical solutions
intensifies. Traditional manufacturing methods often struggle to meet the
intricate and personalized requirements posed by these conditions. According to the World Health Organization (WHO), noncommunicable diseases (NCDs) were responsible for at least 43 million deaths globally in 2021, accounting for 75% of all non-pandemic-related deaths. Alarmingly, 18 million of these deaths occurred before the age of 70, with 82% of these premature fatalities occurring in low- and middle-income countries. This increasing burden of chronic diseases creates significant demand for personalized medical solutions, such as customized implants, prosthetics, and other medical devices, all of which can be effectively manufactured using 3D printing technology. However, 3D
printing technology emerges as a transformative force in addressing this
challenge. By allowing the creation of customized implants, prosthetics, and
medical devices, 3D printing offers a solution that is precisely tailored to
the unique anatomical features of individual patients. This level of
personalization not only enhances the efficacy of treatments but also minimizes
the risk of complications, a critical factor in managing chronic diseases.
The increasing incidence of chronic
diseases is notably linked to factors such as sedentary lifestyles, poor
dietary habits, and aging populations. As individuals live longer, the
likelihood of developing chronic conditions rises, necessitating advanced medical
interventions. 3D printing's ability to produce patient-specific implants and
devices plays a pivotal role in providing more effective and targeted
treatments. For instance, in orthopedics, 3D printing allows for the creation
of implants that mimic the patient's bone structure, ensuring a precise fit and
better integration with the existing anatomy. In the realm of cardiovascular
health, patient-specific stents and heart valves can be crafted, reducing the
risk of complications and improving overall treatment outcomes.
Moreover, the customization afforded by
3D printing is not limited to implants alone; it extends to various medical
devices, including prosthetics and surgical tools. For individuals with chronic
conditions such as limb loss, 3D printing enables the production of prosthetics
that are not only functional but also tailored to the unique contours of the
patient's body. This not only enhances comfort but also contributes to improved
mobility and quality of life.
Advancements
in Material Science
Advancements in material science stand
as a driving force behind the unprecedented growth of the Global 3D Printing
Medical Devices Market, revolutionizing the landscape of healthcare
manufacturing. As the field of material science continues to push boundaries,
introducing innovative and biocompatible materials, 3D printing technology
gains the capacity to produce medical devices with enhanced performance,
durability, and patient safety. Traditional manufacturing methods often face
limitations in creating complex structures and incorporating specific material
properties required for medical applications. However, the continuous evolution
of materials compatible with 3D printing allows for the fabrication of
intricate and patient-specific devices, ranging from implants to surgical
instruments.
The ability to utilize a diverse range
of materials, including biodegradable polymers, ceramics, and various metals,
expands the scope of 3D printing applications in the medical field. These
materials can be tailored to mimic the mechanical and chemical properties of
natural tissues, fostering the creation of implants that closely resemble the
patient's own anatomy. For instance, bioresorbable materials enable the
development of temporary implants that gradually dissolve in the body as the
tissue heals, eliminating the need for additional surgeries for implant
removal. This not only streamlines the patient's recovery process but also
reduces the risk of complications. Furthermore, advancements in material
science contribute to the bioprinting sector, a specialized branch of 3D
printing focused on creating living tissues and organs. Bioink formulations,
comprising cells and biomaterials, continue to evolve, enabling the fabrication
of complex tissue structures with improved viability and functionality. While
full-scale organ bioprinting remains a long-term goal, the progress in
materials is already facilitating the creation of tissue models for drug
testing, disease research, and personalized medicine.
The exploration of nanomaterials and
smart materials further elevates the capabilities of 3D printing in the medical
domain. Nanomaterials exhibit unique properties, such as enhanced strength and
surface interactions, making them valuable components in the development of
advanced medical devices. Smart materials, which respond to external stimuli,
open avenues for the creation of devices with dynamic functionalities, such as
drug delivery systems that release therapeutic agents in response to specific physiological
conditions.
Increasing
Research and development
The Global 3D Printing Medical Devices
Market is witnessing a robust upswing, propelled by a surge in research and
development (R&D) activities that are reshaping the landscape of healthcare
manufacturing. The dynamic intersection of technology and medicine is driving
an era of unprecedented innovation, and R&D efforts are at the forefront of
this transformative wave. Researchers and industry players are investing
significantly in exploring the full potential of 3D printing technology for
medical applications, leading to advancements in materials, processes, and
applications.
Researchers are exploring a diverse
range of materials, including biodegradable polymers, ceramics, and metals,
with the aim of creating implants and devices that seamlessly integrate with
the human body. These materials are not only designed to mimic the mechanical
properties of natural tissues but also to promote biocompatibility, reducing
the risk of rejection or adverse reactions. Such advancements are crucial for
the production of patient-specific implants that optimize functionality and
enhance the overall success of medical interventions. In January 2025, Axial3D raised USD 18.2 million in its latest funding round, advancing its mission to establish patient-specific surgery as the standard of care. The funding round saw the participation of both existing investors- Techstart, Innovation Ulster Limited, and Clarendon as well as three new investors: 57 Stars, Whiterock, and Innovate UK. Axial3D is focused on providing tailored 3D solutions to surgeons, radiologists, and engineers. The company has recently expanded its capabilities by opening a new 3D printing center of excellence in Belfast and securing investment from Stratasys, a leader in additive manufacturing. Additionally, in 2023, Axial3D received FDA clearance for its AI-driven medical image segmentation platform. This substantial investment underscores the growing focus on research and development in the medical technology space, particularly as the demand for personalized healthcare solutions continues to rise.
Furthermore, R&D efforts are driving
innovations in the customization of 3D printed medical devices. The ability to
tailor implants, prosthetics, and surgical instruments to the unique anatomical
characteristics of individual patients is a transformative aspect of 3D
printing. Researchers are exploring advanced imaging techniques, such as CT
scans and MRIs, to capture precise patient data that can be translated into
detailed 3D models for printing. This patient-centric approach not only
improves the efficacy of medical treatments but also contributes to faster
recovery times and reduced post-operative complications.
Collaborations between research
institutions, healthcare providers, and industry stakeholders are accelerating
the pace of innovation in 3D printing medical devices. These partnerships
foster interdisciplinary approaches, combining medical expertise with
technological know-how to address complex healthcare challenges. Such
collaborations facilitate the development of cutting-edge solutions, ranging
from bioprinting living tissues to creating intricate surgical guides that
enhance precision in procedures. As regulatory frameworks adapt to the
evolving landscape of 3D printed medical devices, R&D activities play a
crucial role in ensuring compliance with safety and efficacy standards.
Researchers are actively engaged in studying the long-term effects and
performance of 3D printed implants, contributing valuable data to regulatory
agencies and paving the way for wider acceptance and adoption of these
technologies.

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Key Market Challenges
Complex
Regulatory Landscape
The Global 3D Printing Medical Devices
Market faces a formidable challenge in the form of a complex regulatory
landscape that hampers its seamless growth and adoption. The intricate nature
of 3D printing technology, with its ability to produce highly customized and
patient-specific medical devices, adds a layer of complexity to the traditional
regulatory approval processes.
Regulatory bodies worldwide are tasked
with ensuring the safety, efficacy, and consistency of medical devices, and 3D
printed devices are no exception. However, the unique characteristics of 3D
printing, including the variability in materials, printing techniques, and
customization options, present challenges in establishing standardized
evaluation criteria. As a result, regulatory agencies are navigating uncharted
territory, striving to strike a delicate balance between encouraging innovation
and safeguarding patient well-being.
One of the challenges lies in defining
clear and comprehensive guidelines that address the specific considerations of
3D printing. The adaptability of the technology to various medical fields, from
orthopedics to dentistry, adds layers of intricacy that demand a nuanced
regulatory approach. Manufacturers must provide evidence not only of the safety
and effectiveness of their 3D printed medical devices but also of the
reliability and consistency of the 3D printing process itself.
The time-consuming nature of the
regulatory approval process can impede the timely introduction of innovative 3D
printed medical solutions to the market. The need for regulatory bodies to
thoroughly understand and evaluate the novel aspects of 3D printing technology,
coupled with the evolving nature of the technology itself, creates a
challenging environment for both manufacturers and regulatory agencies.
Material
Limitations
Material limitations stand as a
significant impediment to the seamless progression of the Global 3D Printing
Medical Devices Market. While the field of 3D printing has seen remarkable
strides, the selection of suitable materials for medical applications remains a
challenge. Biocompatibility, strength, and durability are crucial factors that
must align to meet the rigorous standards required for medical devices,
particularly those intended for implantation.
In the realm of 3D printing, the range
of available materials has expanded, encompassing biodegradable polymers,
ceramics, and various metals. However, achieving the delicate balance between
these material properties remains a focal point for researchers and manufacturers.
Ensuring biocompatibility, where the material interacts safely with the human
body without causing adverse reactions, is paramount. This is particularly
challenging for long-term implantation, where the material must integrate
seamlessly with natural tissues.
Strength and durability are equally
critical, especially for load-bearing medical devices like orthopedic implants.
Researchers grapple with the task of developing materials that can withstand
the mechanical stresses within the body while maintaining their structural
integrity over time. Balancing these material properties while keeping the
manufacturing process cost-effective adds an additional layer of complexity to
the material selection challenge.
Moreover, the regulatory landscape adds
another dimension to material limitations. Regulatory approval often
necessitates extensive testing and documentation of the materials used in 3D
printed medical devices. This requires manufacturers to demonstrate not only
the performance and efficacy of the devices but also the reliability and safety
of the materials employed.
Key Market Trends
Rise
Of Patient-Specific Implants and Prosthetics
The rise of patient-specific implants
and prosthetics stands as a driving force propelling the Global 3D Printing
Medical Devices Market into new frontiers of innovation. Traditional
manufacturing methods often struggle to meet the unique anatomical variations
among individuals, leading to compromises in the fit and functionality of
implants and prosthetics. However, 3D printing technology has emerged as a
game-changer, enabling the creation of bespoke medical devices precisely
tailored to each patient's specific anatomy. This level of personalization not
only enhances the efficacy of treatments but also contributes to improved
patient outcomes and satisfaction.
Orthopedic implants, in particular, have
witnessed a remarkable transformation with the advent of 3D printing. Surgeons
can now utilize detailed patient scans to design implants that perfectly match
the contours of an individual's bones. This customization minimizes the risk of
complications, accelerates the healing process, and improves overall implant
performance. Similarly, in the field of prosthetics, 3D printing allows for the
fabrication of personalized limbs and components that mirror the exact requirements
of the user. This has a profound impact on amputees, offering them not just
functional prosthetics but devices that align seamlessly with their unique
physiology, enhancing mobility and comfort. In
September 2024, Amnovis reached a significant milestone by producing over
50,000 titanium implants. The company began offering this manufacturing service
in 2021, utilizing a heat treatment-free 3D printing process that is
revolutionizing the production of spinal, orthopedic, and cranio-maxillofacial
(CMF) implants. This innovative technology offers key benefits, including
unmatched production speed, cost efficiency, and reduced time to market, which
are transforming the way patient-specific implants and prosthetics are
manufactured. In addition to its heat treatment-free approach, Amnovis also
provides a comprehensive range of traditional titanium 3D printing services,
such as Ti-6Al-4V grade 23 with classical heat treatments like Hot Isostatic
Pressing (HIP). This flexibility enables original equipment manufacturers
(OEMs) to select the most appropriate manufacturing method to meet their
specific needs, further driving the rise of personalized, patient-specific
medical devices.
The adoption of patient-specific
implants and prosthetics is driven by the growing awareness of the benefits of
personalized medicine and the increasing prevalence of conditions requiring
such interventions. Moreover, advancements in materials science, including
biocompatible and bioresorbable materials, further contribute to the success of
3D-printed medical devices. As this trend gains momentum, the Global 3D
Printing Medical Devices Market is poised for sustained growth, with
implications not only for orthopedics and prosthetics but also for other
medical specialties seeking to harness the power of customization for improved
patient care.
Rise
Of Bioprinting
The rise of bioprinting is a
transformative factor propelling the Global 3D Printing Medical Devices Market
to unprecedented heights. Bioprinting represents a revolutionary intersection
of 3D printing technology and regenerative medicine, allowing for the precise
layer-by-layer deposition of living cells, biomaterials, and growth factors to
create functional tissues and even entire organs. This innovative approach
holds immense promise in addressing the critical shortage of organs for
transplantation and has opened up new avenues for personalized medicine. The
ability to fabricate tissues with intricate vascular networks is a
breakthrough, overcoming one of the major challenges in tissue engineering.
In the medical devices realm,
bioprinting is making significant strides, particularly in the creation of
patient-specific implants and artificial tissues. This includes the development
of 3D-printed skin grafts, cartilage replacements, and even complex organs like
the liver and kidney. The demand for customized solutions in reconstructive
surgery, especially for patients with congenital anomalies or those requiring
complex tissue reconstructions, has fueled the integration of bioprinting
technologies into mainstream healthcare. In June 2024, Tethon 3D introduced the Bison Bio DLP 3D printer, a new desktop-sized system designed specifically for research and development applications in the medical field. Developed in collaboration with 3D printer manufacturer Carima, the Bison Bio is compatible with Tethon 3D’s Tethon LAP photoinitiator and Tethon GelMA hydrogel bioink, which were created in partnership with biomaterials company Cell Bark Innovation. This new printer, priced starting at USD 19,950, is now available for purchase through Tethon 3D’s official website. The system features a 385 nm vat polymerization process and offers three adjustable build sizes—30 x 20 mm, 57 x 32 mm, and 96 x 54 mm—allowing for customization based on specific needs. The Bison Bio is designed to enhance cell viability, a key challenge in light-based bioprinting, by ensuring a high percentage of live cells within 3D bioprinted scaffolds. This makes the printer an appealing choice for medical, pharmaceutical, and scientific laboratories, further contributing to the rise of bioprinting in creating patient-specific tissues and structures.
The implications of bioprinting extend
beyond structural components to drug discovery, where 3D-printed tissue models
can be used for more accurate testing of pharmaceuticals. This not only
enhances the efficiency of the drug development process but also reduces the
reliance on animal testing. As bioprinting technologies mature, the Global 3D
Printing Medical Devices Market is witnessing increased research and
investment, leading to the development of more advanced and clinically viable
solutions. However, challenges such as scalability, standardization, and
ethical considerations continue to be areas of active exploration and
discussion.
Segmental Insights
Application Insights
Based
on application, the Implants emerged as the fastest
growing segment in the global market for 3D Printing Medical Devices during the
forecast period. The rapid growth of the implants segment
can be attributed to the ability of 3D printing to produce highly customized
implants that are specifically designed to meet the unique anatomical needs of
individual patients. Unlike traditional implants, which often require
adjustments or follow a standard, one-size-fits-all approach, 3D printing
offers precision in design and a better fit, leading to improved patient
outcomes and fewer complications.
Advancements
in 3D printing technology have enabled the creation of intricate and complex
implant designs that were once difficult or impossible to achieve using
conventional manufacturing methods. This includes the use of biocompatible
materials like titanium, which are ideal for medical implants. Additionally, 3D
printing helps reduce production costs by eliminating the need for molds and
tooling, while also accelerating the manufacturing process. This results in
faster production and delivery times, and a reduction in material waste,
contributing to overall cost efficiency.The demand for personalized implants is
increasing, particularly in fields like orthopedics, dental, and
cranio-maxillofacial surgery. As the global population ages and more people
require joint replacements, dental implants, or facial reconstructive surgeries,
the need for customized solutions continues to rise. Regulatory bodies such as
the U.S. FDA are progressively approving 3D-printed medical devices, including
implants, as the technology matures and safety standards are established. This
growing regulatory support is fueling further market expansion and encouraging
wider adoption of 3D-printed implants in healthcare settings
Component Insights
Based
on component, the materials emerged as the dominating segment in the global
market for 3D Printing Medical Devices in 2024. The materials used in 3D
printing medical devices are crucial to ensuring safety, performance, and
biocompatibility for human implantation. Materials like titanium, stainless
steel, polymers, and hydrogels are essential for creating implants, prosthetics,
and surgical guides. Without these specialized materials, 3D printing would not
be viable for medical applications, making them a foundational component of the
market. The materials segment is driven by ongoing innovation, with new
materials being developed to meet the growing demand for specialized medical
uses, particularly in bioprinting. Advances in material science enable more
complex, precise 3D-printed structures, such as bioinks for tissue-like
creations, and optimization of materials for better body integration. The right
material choice is key to ensuring durability, performance, and long-term
success in implants and prosthetics, contributing to improved patient outcomes.
As bioprinting technology advances, the materials sector remains central to the
growth and innovation of the 3D printing medical devices market.
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Regional Insights
Based
on Region, North America emerged as the dominant region in the Global 3D
Printing Medical Devices Market in 2024. North
America, especially the United States, boasts one of the most sophisticated
healthcare systems globally, which facilitates the adoption of innovative
technologies such as 3D printing in medical applications like implants,
prosthetics, and surgical guides. The region has streamlined the integration of
3D printing into healthcare practices, positioning it as a leader in the
market. Regulatory bodies in North America, including the U.S. Food and Drug
Administration (FDA), have been proactive in approving 3D-printed medical
devices, which boosts manufacturers' confidence to innovate and expand their
product offerings. According to the CDC, six in ten Americans suffer from at
least one chronic disease, and four in ten have two or more. Chronic conditions
like heart disease, cancer, and diabetes are the leading causes of death and
disability in the U.S. and contribute significantly to the nation's USD 4.5
trillion healthcare costs. The U.S. also has one of the highest levels of
healthcare spending globally, creating opportunities for the adoption of
advanced technologies like 3D printing to improve patient care, reduce costs,
and enhance treatment outcomes. There is increasing demand for personalized
medical devices in North America, and 3D printing offers the ability to create
customized implants and prosthetics tailored to individual patient needs,
driving further market growth. These factors collectively establish North
America's dominant position in the 3D printing medical devices market.
Recent Developments
- In
December 2024, 3D bioprinting company BIO INX introduced BIORES INX, a new
resin for its bioprinting material portfolio. This resin offers
biocompatibility and is compatible with DLP (digital light processing)
bioprinting platforms. Originally developed at Ghent University, BIORES INX is
a gelatin methacrylamide (GelMA)-based resin, enhanced by BIO INX to closely
mimic the natural extracellular matrix. The sterile resin complies with ISO
10993-5 biocompatibility standards. A key feature of BIORES INX is its liquid
state at room temperature, eliminating the need for heated containers and
reducing water evaporation during printing.
- In
November 2024, Xolo, a volumetric 3D printing company, launched its Xell
bioprinter in Frankfurt. Priced starting at USD 20988.40, Xell is designed to make
volumetric bioprinting accessible to all labs, with a 59% academic discount
available until year-end. Featuring an optimized build chamber (10 x 17 x 10
mm³) for standard disposable cuvettes, Xell is ideal for high-value bio-inks.
The bioprinter utilizes full HD resolution with a high-intensity LED light
sheet, ensuring precise bioprinting of complex structures with smooth surfaces.
Xolo's layer-free Xolography process delivers isotropic properties, positioning
Xell as a powerful tool for developing advanced biomaterials.
- In
June 2024, Ricoh USA, Inc. unveiled its flagship Point of Care 3D medical
device manufacturing facility, the RICOH 3D for Healthcare Innovation Studio.
This on-site studio offers clinicians quick and easy access to development,
design, and manufacturing services for patient-specific 3D-printed anatomic
models, which aid in surgical planning and patient education. Located in the
Innovation Quarter of downtown Winston-Salem, N.C., it is the first of several
Point of Care 3D medical device manufacturing facilities that will be
integrated into health systems.
- In
June 2024, CTIBIOTECH is launching the innovative SAFESKIN3D project in
collaboration with SANOFI. This pioneering initiative seeks to develop flexible
3D bioprinted human skin models to assess the reactogenicity of vaccines,
focusing on the new generation of messenger RNA (mRNA) vaccines.
Key Market Players
- 3D
Systems, Inc.
- 3T Additive Manufacturing Ltd
- Carbon, Inc
- Cyfuse Biomedical K.K
- EnvisionTEC
- EOS GmbH Electro Optical Systems
- FabRx Ltd
- Prodways Group
- Renishaw plc
- Stratasys Ltd.
By
Component
|
By
Application
|
By Region
|
- 3 D Printer
- 3 D Bioprinter
- Material
- Software
- Services
|
- Surgical Guides
- Prosthetics
- Implants
|
- North America
- Europe
- Asia Pacific
- South America
- Middle East & Africa
|
Report Scope:
In this report, the Global 3D Printing Medical
Devices Market has been segmented into the following categories, in addition to
the industry trends which have also been detailed below:
- 3D Printing Medical Devices Market, By Component:
o Galsulfase
o Velaglucerase Alfa
o Laronidase
o Asfotasealfa
o Others
- 3D Printing Medical Devices Market, By Application:
o Exocrine Pancreatic Insufficiency (EPI)
o Pompe Disease
o Scheie Syndrome
o Maroteaux-Lamy Syndrome
o Gaucher Disease
o Others
- 3D Printing Medical Devices Market, By Region:
o North America
§ United States
§ Canada
§ Mexico
o Europe
§ France
§ United Kingdom
§ Italy
§ Germany
§ Spain
o Asia Pacific
§ China
§ India
§ Japan
§ Australia
§ South Korea
o South America
§ Brazil
§ Argentina
§ Colombia
o Middle East & Africa
§ South Africa
§ Saudi Arabia
§ UAE
§ Egypt
Competitive Landscape
Company Profiles: Detailed analysis of the major companies
present in the Global 3D Printing Medical Devices Market.
Available Customizations:
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Research offers customizations according to a company's specific needs. The
following customization options are available for the report:
Company Information
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profiling of additional market players (up to five).
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