3Dプリンティング医療機器市場：コンポーネント、タイプ、技術、地域別、2024年～2031年

3Dプリンティング医療機器市場の評価、2024年～2031年

カスタムフィットのインプラントや補綴物を作成する能力が、3Dプリンティング医療機器市場の成長を牽引しています。したがって、個別化された医療機器に対する需要の増加は、2024年に28億2,000万米ドルを突破し、2031年には89億9,000万米ドルの評価額に達するまで市場の成長を急増させました。

3Dプリンティングの速度、精度、材料能力の継続的な向上により、ヘルスケアにおける潜在的な用途が拡大しています。したがって、3Dプリンティング技術の進歩により、2024年から2031年にかけてCAGR 17.18%で市場は成長します。

3Dプリンティング医療機器市場定義/概要

アディティブ・マニュファクチャリングとしても知られる3Dプリンティングは、高度にカスタマイズされたデバイス、インプラント、補綴物、解剖学的モデルの製造を可能にすることで、医療業界に革命をもたらしています。このプロセスでは、精密なコンピュータ支援設計（CAD）ファイルに従って、プラスチック、金属、生体材料などの材料を積層して3次元物体を作成します。材料を切ったりくり抜いたりすることが多い従来の製造とは異なり、3Dプリンティングでは物体を層ごとに作り上げるため、患者一人ひとりのニーズに合わせた複雑な形状やジオメトリが可能になります。

医療分野における3Dプリンティングの能力は、患者に特化したデバイスを製造することで、治療の精度と治療成績を向上させます。この技術はまた、製造コストとリードタイムを削減するため、従来の方法では困難または不可能な複雑な医療機器を製造するための魅力的な選択肢となります。3Dプリンティングの多用途性は、外科手術用ガイド、整形外科用インプラント、歯科用修復物、組織工学用足場の製造など、さまざまな医療領域での応用を見れば明らかです。また、ドラッグデリバリーシステムにおいても重要な役割を果たしており、手技効率の向上と再手術コストの最小化を通じて、より良い患者ケアを実現しています。

少量生産における3Dプリンティングの費用対効果は、3Dプリンティング医療機器市場の成長をどのように促進するか？

3Dプリンティングは、小ロットの医療機器をコスト効率よく製造できるため、希少な疾患や特殊なニーズに最適です。欧州医薬品庁（EMA）は2023年、2027年までに3Dプリンティングによって、1,000台未満のロットで特定の医療機器の製造コストを最大40%削減できると予測しました。

規制機関は、3Dプリント医療機器の採用を支援する枠組みを開発しています。FDAは2024年に3Dプリント医療機器に関する最新のガイダンスを発表し、承認プロセスの合理化を目指しています。これにより、2026年までに3Dプリント医療機器の申請が30%増加すると予想されています。

3Dプリントされた解剖学的モデルは、手術計画や医療トレーニングにますます使用されるようになっています。米国医師会（AMA）による2024年の調査では、米国の教育病院の65%が2028年までに3Dプリントモデルをトレーニングプログラムに組み込む予定であることが判明しました。ポイントオブケア3Dプリントの拡大：病院や診療所では、現場での3Dプリント機能の導入が進んでいます。世界保健機関（WHO）の2023年の報告書では、2030年までに世界の主要病院の40%が医療機器用の3Dプリント設備を院内に設置すると予測しています。

初期投資コストの高さが3Dプリンティング医療機器市場の成長を阻害する？

3Dプリンティング機器や材料にかかる多額の初期費用は、小規模なヘルスケアプロバイダーにとっては法外なものです。米国保健福祉省の2024年の報告書によると、病院が包括的な3Dプリンティングラボを設置するための平均初期投資額は250万米ドルと推定され、2028年までにそのような設備を持つ米国の病院は15％にとどまると予想されています。規制機関は枠組み作りに取り組んでいるが、3Dプリント医療機器の承認プロセスは依然として複雑です。欧州医薬品庁（EMA）による2023年の調査では、2026年までに3Dプリント医療機器の規制当局による承認にかかる平均時間は、従来から製造されている機器に比べて依然として1.5倍かかると予測されており、市場の成長が鈍化する可能性があります。

3Dプリント医療機器全体で一貫した品質を確保することは、依然として課題です。国際標準化機構（ISO）は2024年、既存の医療機器規格のうち3Dプリント製品に完全に適用できるものは40%に過ぎず、完全な標準化は2029年まで見込めないと報告しています。3Dプリンターによる設計の複製が容易であることから、知的財産の保護や、機器に不具合が生じた場合の責任に関する懸念が生じる。世界知的所有権機関（WIPO）による2023年の調査では、医療機器メーカーの65%が3Dプリンティング技術を採用する際の主な懸念事項として知的財産権保護を挙げており、この数字は2027年まで50%を超えると予測されています。

目次

第1章 世界の3Dプリンティング医療機器市場のイントロダクション

• 市場概要
• 調査範囲
• 前提条件

第2章 エグゼクティブサマリー

第3章 VERIFIED MARKET RESEARCHの調査手法

• データマイニング
• バリデーション
• 一次資料
• データソース一覧

第4章 世界の3Dプリンティング医療機器市場の展望

• 概要
• 市場力学
  • 促進要因
  • 抑制要因
  • 機会
• ポーターのファイブフォースモデル

第5章 3Dプリンティング医療機器の世界市場：コンポーネント別

• 概要
• ソフトウェアとサービス
• 機器
• 3Dプリンター
• 3Dバイオプリンター
• バイオマテリアル
• その他

第6章 3Dプリンティング医療機器の世界市場：タイプ別

• 概要
• 手術用ガイド
• 歯科用ガイド
• 頭蓋顎顔面用ガイド
• 整形外科用ガイド
• 手術器具
• レトラクター

第7章 3Dプリンティング医療機器の世界市場：技術別

• 概要
• 電子ビーム溶解（EBM）技術
• レーザービーム溶解（LBM）技術
• 直接金属レーザー焼結（DMLS）
• 選択的レーザー溶融（SLM）
• 選択的レーザー焼結（SLS）
• 光重合

第8章 3Dプリンティング医療機器の世界市場：地域別

• 概要
• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • その他欧州
• アジア太平洋
  • 中国
  • 日本
  • インド
  • その他アジア太平洋地域
• 世界のその他の地域
  • 中東・アフリカ
  • 南米

第9章 3Dプリンティング医療機器の世界市場：競合情勢

• 概要
• 各社の市場ランキング
• 主な発展戦略

第10章 企業プロファイル

• 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

第11章 付録

• 関連調査

3D Printing Medical Devices Market Valuation - 2024-2031

The ability to create custom-fit implants and prosthetics is driving growth in the 3D printing medical devices market. Thus, the increasing demand for personalized medical devices surged the growth of the market surpassing USD 2.82 Billion in 2024 to reach a valuation of USD 8.99 Billion by 2031.

Ongoing improvements in 3D printing speed, accuracy, and material capabilities are expanding the potential applications in healthcare. Thus, the Advancements in 3D printing technologies enable the market to grow at aCAGR of 17.18% from 2024 to 2031.

3D Printing Medical Devices Market: Definition/ Overview

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.

TABLE OF CONTENTS

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

11 APPENDIX

• 11.1 Related Research