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3D列印

市場調查報告書

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1623455

3D 列印醫療器材市場：按組件、類型、技術和地區劃分，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個工作天內

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簡介目錄

3D 列印醫療器材市場評估，2024-2031

製造客製化植入物和義肢的能力正在推動 3D 列印醫療設備市場的成長。因此，個人化醫療設備需求的持續成長推動市場成長，到2024年將突破28.2億美元，到2031年估值將達到89.9億美元。

3D 列印的速度、精度和材料能力的不斷改進正在擴大其在醫療保健領域的潛在應用。因此，由於3D列印技術的進步，2024年至2031年市場將以17.18%的複合年增長率成長。

3D 列印醫療器材市場定義/概述

3D 列印，也稱為積層製造，透過生產高度客製化的設備、植入物、義肢和解剖模型，正在徹底改變醫療產業。該過程涉及將塑膠、金屬和生物材料等材料分層，根據精確的電腦輔助設計 (CAD) 檔案創建三維物體。與通常涉及切割或挖空材料的傳統製造不同，3D 列印逐層構建物體，可以根據每個患者的個人需求定制複雜的形狀和幾何形狀。

3D 列印在醫療領域的功能可透過製造患者專用設備來提高治療精度和結果。該技術還降低了製造成本和交貨時間，使其成為製造複雜醫療設備的有吸引力的選擇，而使用傳統方法很難或不可能製造複雜的醫療設備。3D列印的多功能性在其在各種醫療領域的應用中顯而易見，包括手術導板、骨科植入物、牙科修復體和組織工程支架的生產。它還在藥物輸送系統中發揮著重要作用，透過提高手術效率和最大限度地降低再手術成整體實現更好的患者護理。

3D列印小批量生產的成本效益將如何推動3D列印醫療器材市場的成長？

3D 列印可以經濟高效地小批量製造醫療器械，使其成為罕見疾病和特殊需求的理想選擇。2023年，歐洲藥品管理局（EMA）預測，到2027年，3D列印可以將某些批量少於1000台的醫療器材的製造成本降低高達40%。

監管機構正在開發框架來支援 3D 列印醫療設備的採用。FDA 將於 2024 年發佈有關 3D 列印醫療器材的更新指南，旨在簡化審批流程。預計到 2026 年，3D 列印醫療設備應用將增加 30%。

3D 列印的解剖模型越來越多地用於手術規劃和醫療培訓。美國醫學會 (AMA) 2024 年的一項研究發現，65% 的美國教學醫院計劃在 2028 年將 3D 列印模型納入其培訓計畫。護理點 3D 列印的擴展：醫院和診所越來越多地在現場實施 3D 列印功能。世界衛生組織 (WHO) 2023 年的一份報告預測，到 2030 年，全球 40% 的大型醫院將擁有用於醫療設備的內部 3D 列印設施。

高昂的初始投資成本會阻礙3D列印醫療器材市場的成長嗎？

3D 列印設備和材料的初始成本高昂，令小型醫療保健提供者望而卻步。根據美國衛生與公眾服務部 2024 年的報告，醫院建立綜合 3D 列印實驗室的平均初始投資預計為 250 萬美元，到 2028 年，醫院平均初始投資將達到預計到2028年建立綜合3D列印實驗室的比例將增加。儘管監管機構正在製定框架，但 3D 列印醫療設備的審批流程仍然很複雜。歐洲藥品管理局 (EMA) 2023 年的一項研究預測，到 2026 年，3D 列印醫療器材的監管審批平均時間仍將比傳統製造的器材長 1.5 倍，因此市場成長可能會放緩。

確保 3D 列印醫療設備的品質一致仍然是一個課題。2024年，國際標準化組織（ISO）報告稱，現有醫療器材標準中只有40%完全適用於3D列印產品，預計要到2029年才能實現全面標準化。3D 列印設計可以輕鬆複製，這引起了人們對智慧財產權保護和設備故障時責任的擔憂。世界智慧財產權組織（WIPO）2023年的一項調查發現，65%的醫療器材製造商在採用3D列印技術時將智慧財產權保護作為主要關注點，到2027年這一數字還將增加。年將超過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