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3D 列印医疗器材市场：按组件、类型、技术和地区划分，2024-2031 年

3D Printing Medical Devices Market By Component, Type, Technology (Laser Beam Melting Technology, Direct Metal Laser Sintering, Selective Laser Melting ), Region for 2024-2031

出版日期: 2024年08月08日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3个工作天内

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简介目录

3D 列印医疗器材市场评估，2024-2031

製造客製化植入物和义肢的能力正在推动 3D 列印医疗设备市场的成长。因此，个人化医疗设备需求的持续成长推动市场成长，到2024年将突破28.2亿美元，到2031年估值将达到89.9亿美元。

3D 列印的速度、精度和材料能力的不断改进正在扩大其在医疗保健领域的潜在应用。因此，由于3D列印技术的进步，2024年至2031年市场将以17.18%的复合年增长率成长。

3D 列印医疗器材市场定义/概述

3D 列印，也称为积层製造，透过生产高度客製化的设备、植入物、义肢和解剖模型，正在彻底改变医疗产业。该过程涉及将塑胶、金属和生物材料等材料分层，根据精确的电脑辅助设计 (CAD) 檔案创建三维物体。与通常涉及切割或挖空材料的传统製造不同，3D 列印逐层构建物体，可以根据每个患者的个人需求定制复杂的形状和几何形状。

3D 列印在医疗领域的功能可透过製造患者专用设备来提高治疗精度和结果。该技术还降低了製造成本和交货时间，使其成为製造复杂医疗设备的有吸引力的选择，而使用传统方法很难或不可能製造复杂的医疗设备。3D列印的多功能性在其在各种医疗领域的应用中显而易见，包括手术导板、骨科植入物、牙科修復体和组织工程支架的生产。它还在药物输送系统中发挥着重要作用，透过提高手术效率和最大限度地降低再手术成整体实现更好的患者护理。

3D列印小批量生产的成本效益将如何推动3D列印医疗器材市场的成长？

3D 列印可以经济高效地小批量製造医疗器械，使其成为罕见疾病和特殊需求的理想选择。2023年，欧洲药品管理局（EMA）预测，到2027年，3D列印可以将某些批量少于1000台的医疗器材的製造成本降低高达40%。

监管机构正在开发框架来支援 3D 列印医疗设备的采用。FDA 将于 2024 年发布有关 3D 列印医疗器材的更新指南，旨在简化审批流程。预计到 2026 年，3D 列印医疗设备应用将增加 30%。

3D 列印的解剖模型越来越多地用于手术规划和医疗培训。美国医学会 (AMA) 2024 年的一项研究发现，65% 的美国教学医院计划在 2028 年将 3D 列印模型纳入其培训计画。护理点 3D 列印的扩展：医院和诊所越来越多地在现场实施 3D 列印功能。世界卫生组织 (WHO) 2023 年的一份报告预测，到 2030 年，全球 40% 的大型医院将拥有用于医疗设备的内部 3D 列印设施。

高昂的初始投资成本会阻碍3D列印医疗器材市场的成长吗？

3D 列印设备和材料的初始成本高昂，令小型医疗保健提供者望而却步。根据美国卫生与公众服务部 2024 年的报告，医院建立综合 3D 列印实验室的平均初始投资预计为 250 万美元，到 2028 年，医院平均初始投资将达到预计到2028年建立综合3D列印实验室的比例将增加。儘管监管机构正在製定框架，但 3D 列印医疗设备的审批流程仍然很复杂。欧洲药品管理局 (EMA) 2023 年的一项研究预测，到 2026 年，3D 列印医疗器材的监管审批平均时间仍将比传统製造的器材长 1.5 倍，因此市场成长可能会放缓。

确保 3D 列印医疗设备的品质一致仍然是一个课题。2024年，国际标准化组织（ISO）报告称，现有医疗器材标准中只有40%完全适用于3D列印产品，预计要到2029年才能实现全面标准化。3D 列印设计可以轻鬆复製，这引起了人们对智慧财产权保护和设备故障时责任的担忧。世界智慧财产权组织（WIPO）2023年的一项调查发现，65%的医疗器材製造商在采用3D列印技术时将智慧财产权保护作为主要关注点，到2027年这一数字还将增加。年将超过50%。

3D printing, also known as additive manufacturing, is revolutionizing the medical industry by enabling the production of highly customized devices, implants, prosthetics, and anatomical models. This process involves the creation of three-dimensional objects by layering materials such as plastics, metals, or biomaterials according to precise computer-aided design (CAD) files. Unlike traditional manufacturing, which often involves cutting or hollowing materials, 3D printing builds objects layer by layer, allowing for complex shapes and geometries tailored to individual patient needs.

3D printing ability in the medical field to produce patient-specific devices, which improves treatment precision and outcomes. This technology also reduces manufacturing costs and lead times, making it an attractive option for producing intricate medical devices that are difficult or impossible to create using conventional methods. The versatility of 3D printing is evident in its application across various medical domains, including the production of surgical guides, orthopedic implants, dental restorations, and tissue engineering scaffolds. It also plays a vital role in drug delivery systems, ensuring better patient care through enhanced procedural efficiency and minimized reintervention costs.

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How the Cost-Effectiveness of 3D Printing for Small-Batch Production Foster the Growth of 3D Printing Medical Devices Market?

3D printing allows for the cost-effective production of small batches of medical devices, making it ideal for rare conditions or specialized needs. The European Medicines Agency (EMA) projected in 2023 that by 2027, 3D printing could reduce the cost of producing certain medical devices by up to 40% for batches under 1,000 units.

Regulatory bodies are developing frameworks to support the adoption of 3D-printed medical devices. The FDA released updated guidance for 3D-printed medical devices in 2024, aiming to streamline the approval process. This is expected to result in a 30% increase in 3D-printed device submissions by 2026.

3D-printed anatomical models are increasingly used for surgical planning and medical training. A 2024 survey by the American Medical Association (AMA) found that 65% of teaching hospitals in the U.S. planned to incorporate 3D-printed models into their training programs by 2028. Expansion of point-of-care 3D printing: Hospitals and clinics are increasingly adopting on-site 3D printing capabilities. A 2023 report by the World Health Organization (WHO) predicted that by 2030, 40% of major hospitals worldwide would have in-house 3D printing facilities for medical devices.

How the High Initial Investment Costs Impede the Growth of the 3D Printing Medical Devices Market?

The substantial upfront costs for 3D printing equipment and materials can be prohibitive for smaller healthcare providers. According to a 2024 report by the U.S. Department of Health and Human Services, the average initial investment for a hospital to set up a comprehensive 3D printing lab was estimated at USD 2.5 Million, with only 15% of U.S. hospitals expected to have such facilities by 2028. While regulatory bodies are working on frameworks, the approval process for 3D-printed medical devices remains complex. A 2023 study by the European Medicines Agency (EMA) projected that by 2026, the average time for regulatory approval of a 3D-printed medical device would still be 1.5 times longer than for traditionally manufactured devices, potentially slowing market growth.

Ensuring consistent quality across 3D-printed medical devices remains challenging. The International Organization for Standardization (ISO) reported in 2024 that only 40% of existing medical device standards were fully applicable to 3D-printed products, with complete standardization not expected until 2029. The ease of replicating 3D-printed designs raises concerns about intellectual property protection and liability in case of device failure. A 2023 survey by the World Intellectual Property Organization (WIPO) found that 65% of medical device manufacturers cited IP protection as a major concern in adopting 3D printing technologies, with this figure projected to remain above 50% through 2027.

Category-Wise Acumens

How does the Increasing Demand for Personalized Medical Solutions and Tailored Medical Devices Surge the Growth of the Software and Services Segment?

The software and services segment plays a dominant in the 3D printing medical devices market, driven by the increasing demand for personalized medical solutions in hospitals and surgical centers. The cost-effectiveness, precision, and consistency offered by 3D printing services are key factors propelling market growth. Medical professionals are increasingly adopting 3D printing technologies for creating highly customized surgical guides and implants, which enhances procedural accuracy and treatment outcomes. As the demand for tailored medical devices rises, software solutions become crucial for designing and manufacturing complex 3D-printed products, offering greater control over the production process.

Ongoing advancements in software solutions are further fueling the market, enabling the production of high-quality, patient-specific devices. These cutting-edge software tools streamline the design process and ensure the efficient manufacturing of intricate medical products, meeting the growing needs of the healthcare sector. Additionally, the utility of 3D printing in producing devices with uniformity and precision helps reduce overall costs and time, making it an attractive option for healthcare providers. With continued innovations in 3D printing software, the software and services segment is poised for significant expansion, solidifying its position as a key driver of growth in the 3D printing medical devices market.

How the Customized Designed Templates Surge the Growth of the Surgical Guides Segment?

The surgical guides segment dominates in the 3D printing medical devices market. Surgical guides, which are custom-designed templates used to enhance surgical accuracy, have become essential tools in procedures requiring precise implant placement, such as orthopedic, dental, neurosurgical, and maxillofacial surgeries. By using 3D-printed surgical guides, healthcare professionals significantly improve the precision of implant positioning, leading to more accurate restorations and better overall patient outcomes.

The increasing adoption of surgical guides is driven by their ability to improve surgical accuracy, reduce procedure times, and minimize post-surgical complications. As a result, there is a growing demand for these guides across various surgical disciplines, particularly for cost-effective options that meet the evolving needs of healthcare providers. Orthopedic and dental surgeries, in particular, benefit from the precision and customization offered by 3D-printed guides, making them a popular choice in these specialties.

Country/Region-wise Acumens

How the Strong Healthcare Infrastructure and Investment in Advanced Technologies Surge the Growth of 3D Printing Medical Devices Market in North America?

North America substantially dominates the 3D printing medical devices market driven by the well-established healthcare infrastructure. The well-established healthcare system in North America, particularly in the United States, has been quick to adopt 3D printing technologies. According to a 2022 report by the U.S. Food and Drug Administration (FDA), the number of 3D-printed medical devices receiving FDA clearance increased by 400% between 2020 and 2022, reflecting the region's leadership in adopting this technology.

The growing incidence of chronic diseases in North America has driven the need for customized medical devices. The Centers for Disease Control and Prevention (CDC) reported in 2021 that approximately 60% of adults in the U.S. had at least one chronic disease, with 40% having two or more. This has led to a 25% year-over-year increase in the demand for personalized 3D-printed medical devices from 2020 to 2022, according to a market analysis by the American Medical Association (AMA).

North American regulatory bodies have been proactive in developing guidelines for 3D-printed medical devices, facilitating market growth. Health Canada, in collaboration with the FDA, introduced a joint regulatory framework for 3D-printed medical devices in 2020. This initiative resulted in a 30% increase in approved 3D-printed medical device applications across North America by 2023, as reported by the Canadian Institute for Health Information (CIHI).

How did the Rapid Growth in Healthcare Expenditure and Infrastructure Development Escalate the Growth of the 3D Printing Medical Devices Market in Asia Pacific?

Asia Pacific is anticipated to witness the fastest growth in the 3D printing medical devices market during the forecast period. Countries in the Asia Pacific region have been significantly increasing their healthcare spending, driving the adoption of advanced technologies like 3D printing. According to the World Health Organization (WHO), healthcare expenditure in the Asia Pacific region grew by an average of 6.3% annually between 2020 and 2022, compared to a global average of 3.9%. In China specifically, the National Health Commission reported that healthcare spending increased from 6.6% of GDP in 2020 to 7.2% in 2022, with a significant portion allocated to medical device innovation.

The Asia Pacific region's large and rapidly aging population has created a substantial market for personalized medical devices. The United Nations Economic and Social Commission for Asia and the Pacific (UNESCAP) reported in 2021 that the number of people aged 65 and above in the region was expected to double from 395 million in 2020 to 790 million by 2050. This demographic shift has led to a 35% increase in demand for customized orthopedic and dental implants produced by 3D printing between 2020 and 2023, according to a market analysis by the Asia Pacific Medical Technology Association (APACMed).

Many Asian countries have implemented policies to promote the adoption of 3D printing in healthcare. For instance, Singapore's Agency for Science, Technology and Research (A*STAR) launched a USD 18 Million 3D printing program in 2020, focusing on biomedical applications. This initiative contributed to a 50% increase in 3D-printed medical device patents filed in Singapore from 2020 to 2022. Similarly, India's Department of Science and Technology initiated a National Additive Manufacturing Mission in 2021, which led to a 40% year-over-year growth in the country's 3D-printed medical device market from 2021 to 2023, as reported by the Indian Council of Medical Research (ICMR).

Competitive Landscape

The 3D Printing Medical Devices Market is a rapidly growing segment, driven by advancements in technology, increasing demand for personalized healthcare solutions, and the potential for cost reduction. The competitive landscape is characterized by a mix of established players, innovative startups, and research institutions.

The organizations are focusing on innovating their product line to serve the vast population in diverse regions. Some of the prominent players operating in the 3D printing medical devices market include:

Stratasys Ltd.
Envisiontec GmbH

3D Systems Corporation

EOS GmbH Electro Optical Systems
Renishaw plc
Materialise NV
Arcam AB

3T RPD Ltd.

Concept Laser GmbH
Prodways Group.

Latest Developments:

In May 2022, Organovo Holdings, Inc. announced the launch of a D tissue model for Crohn's disease.
In October 2022, Cyfuse Medical K.K. received approval to float on the Tokyo Stock Exchange.

1 INTRODUCTION OF GLOBAL 3D PRINTING MEDICAL DEVICES MARKET

1.1 Overview of the Market
1.2 Scope of Report
1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

3.1 Data Mining
3.2 Validation
3.3 Primary Interviews
3.4 List of Data Sources

4 GLOBAL 3D PRINTING MEDICAL DEVICES MARKET OUTLOOK

4.1 Overview
4.2 Market Dynamics
- 4.2.1 Drivers
- 4.2.2 Restraints
- 4.2.3 Opportunities
4.3 Porters Five Force Model

5 GLOBAL 3D PRINTING MEDICAL DEVICES MARKET, BY COMPONENT

5.1 Overview
5.2 Software and Services
5.3 Equipment
5.4 3D Printers
5.5 3D Bioprinters
5.6 Biomaterials
5.7 Others

6 GLOBAL 3D PRINTING MEDICAL DEVICES MARKET, BY TYPE

6.1 Overview
6.2 Surgical Guides
6.3 Dental Guides
6.4 Craniomaxillofacial Guides
6.5 Orthopedic Guides
6.6 Surgical Instruments
6.7 Retractors

7 GLOBAL 3D PRINTING MEDICAL DEVICES MARKET, BY TECHNOLOGY

7.1 Overview
7.2 Electron Beam Melting (EBM) Technology
7.3 Laser Beam Melting (LBM) Technology
7.4 Direct Metal Laser Sintering (DMLS)
7.5 Selective Laser Melting (SLM)
7.6 Selective Laser Sintering (SLS)
7.7 Photopolymerization

8 GLOBAL 3D PRINTING MEDICAL DEVICES MARKET, BY GEOGRAPHY

8.1 Overview
8.2 North America
- 8.2.1 U.S.
- 8.2.2 Canada
- 8.2.3 Mexico
8.3 Europe
- 8.3.1 Germany
- 8.3.2 U.K.
- 8.3.3 France
- 8.3.4 Rest of Europe
8.4 Asia Pacific
- 8.4.1 China
- 8.4.2 Japan
- 8.4.3 India
- 8.4.4 Rest of Asia Pacific
8.5 Rest of the World
- 8.5.1 Middle East and Africa
- 8.5.2 South America

9 GLOBAL 3D PRINTING MEDICAL DEVICES MARKET COMPETITIVE LANDSCAPE

9.1 Overview
9.2 Company Market Ranking
9.3 Key Development Strategies

10 COMPANY PROFILES

10.1 Stratasys Ltd.
- 10.1.1 Overview
- 10.1.2 Financial Performance
- 10.1.3 Product Outlook
- 10.1.4 Key Developments
10.2 Envisiontec GmbH
- 10.2.1 Overview
- 10.2.2 Financial Performance
- 10.2.3 Product Outlook
- 10.2.4 Key Developments
10.3 3D Systems Corporation
- 10.3.1 Overview
- 10.3.2 Financial Performance
- 10.3.3 Product Outlook
- 10.3.4 Key Developments
10.4 EOS GmbH Electro Optical Systems
- 10.4.1 Overview
- 10.4.2 Financial Performance
- 10.4.3 Product Outlook
- 10.4.4 Key Developments
10.5 Renishaw plc
- 10.5.1 Overview
- 10.5.2 Financial Performance
- 10.5.3 Product Outlook
- 10.5.4 Key Developments
10.6 Materialise NV
- 10.6.1 Overview
- 10.6.2 Financial Performance
- 10.6.3 Product Outlook
- 10.6.4 Key Developments
10.7 Arcam AB
- 10.7.1 Overview
- 10.7.2 Financial Performance
- 10.7.3 Product Outlook
- 10.7.4 Key Developments
10.8 3T RPD Ltd.
- 10.8.1 Overview
- 10.8.2 Financial Performance
- 10.8.3 Product Outlook
- 10.8.4 Key Developments
10.9 Concept Laser GmbH
- 10.9.1 Overview
- 10.9.2 Financial Performance
- 10.9.3 Product Outlook
- 10.9.4 Key Developments
10.10 Prodways Group
- 10.10.1 Overview
- 10.10.2 Financial Performance
- 10.10.3 Product Outlook
- 10.10.4 Key Developments