医疗器材市场趋势与机会：义肢、牙科、听力

3D列印医疗器材市场收入将从2023年的45亿美元成长到2034年的165亿美元，10年复合年增长率为12%。

3D列印技术的使用正在对医疗领域产生重大影响。製造个人化医疗设备变得更加容易，降低了开发成本，促进了先进设备的创新，并改善了义肢的使用。在过去的二十年中，医疗保健一体化显着改善了患者的治疗效果并扩大了获得医疗保健的机会。该技术在解决 COVID-19 大流行期间的医疗设备製造课题、简化供应链以及使设备设计和製造更接近患者和医疗保健提供者方面发挥了关键作用。未来，医疗器材产业，尤其是义肢、听力、牙科领域将持续受益于3D列印技术，预计将显着成长。

本报告分析了目前 3D 列印在义肢、听力和牙科领域的市场机会——3D 列印正在推动这三个最重要的医疗器材领域的创新、成长和采用。市场机会包括特定于牙科应用的 3D 列印平台的技术进步、医疗和医疗器材供应链的日益数位化以及美国食品和药物管理局 (FDA) 和欧洲药品管理局 (EMA) 的影响。持续发展，例如：这些组织一致发布有关医疗设备 3D 列印的指南。

该报告还研究了主要供应商（3D Systems、Formlabs、Stratasys、Materialise 等）适用于医疗器材领域的 3D 列印技术和材料。

该报告的购买者将收到一份内容广泛的 Excel 数据文件，其中包含该行业 10 年收入预测，依技术、材料和服务进行细分。

目录

执行摘要

第一章 趋势与问题

• 趋势
  • 随着慢性病的增加，患者专用设备预计将增加
  • 不断变化的监管环境
  • PoC（护理点）3D 列印：医疗保健领域 3D 列印的未来
• 任务
  • 关于定制设备的持续监管指南
  • 需要跨学科的专业知识
• 3D 列印在医疗设备中的价值主张：定义

第二章 战略部署模型

• 内部生产
• 与技术提供者和创新中心的合作
• 学术和临床研究合作伙伴关係
• PoC（护理点）生产

第三章 3D列印在医疗器材领域（义肢、听力、牙科）的应用实例

• 手术设备
• 义肢和植入物
  • 持续扩大经认证的植入设备
• 听力测试设备
• 数位化牙科
  • SmileDirectClub破产对3D列印牙齿矫正器的影响

第四章技术、材料和软体

• 硬件
  • 消费级3D列印：持续开发临床应用能力
  • 是否会转向专门用于医疗设备的印表机？
  • 牙科专用3D列印硬体系统领先
• 材料
  • 光聚合物
  • 热塑性树脂/热固性树脂
  • 金属
• 服务

关于Additive Manufacturing Research

The 3D printed medical device market will reach $16.5 billion in revenues in 2034 growing from $4.5 billion in 2023 at a 10 year CAGR of 12%.

The use of 3D printing technology has had a significant impact on the healthcare sector. It has facilitated the production of personalized medical devices, reduced development costs, fostered innovation in advanced devices, and improved accessibility to prosthetics. Over the past two decades, its integration into healthcare has notably enhanced patient outcomes and expanded healthcare accessibility. This technology has played a crucial role in addressing challenges related to the production of medical devices during the COVID-19 pandemic, streamlined the supply chain, and brought device design and production closer to both patients and providers. Looking ahead, the medical device industry, particularly in prosthetics, audiology, and dental fields, is expected to see significant growth as these segments continue to benefit from 3D printing technology.

This study examines the current opportunities for 3D printing in prosthetics, audiology, and dental - the three most significant medical device segments where 3D printing is driving innovation, growth, and adoption. These opportunities encompass technological advancements in application-specific 3D printing platforms, particularly in dental, the ongoing digitization of healthcare and medical device supply chains, and the continued progress of regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which are consistently releasing guidance for the 3D printing of medical devices.

Additionally, the report summarizes the 3D printing technologies and materials applicable to the medical device sector, from leading vendors such as 3D Systems, Formlabs, Stratasys, and Materialise.

Buyers of the report also receive an extensive Excel data file with a ten-year revenue forecast for the sector, segmented by technology, material, and services.

Table of Contents

Executive Summary

• E.1. Key Trends and Opportunities
  • E.1.1. Patient-Specific Devices
  • E.1.2. Regulatory Evolution
  • E.1.3. Point-of-Care 3D Printing
• E.2. Challenges
• E.3. Strategic Adoption
• E.4. Forecasting

Chapter One: Trends and Challenges

• 1.1. Trends
  • 1.1.1. Patient-specific Devices are Set to Increase to Meet a Rise In Chronic Disease
  • 1.1.2. Evolving Regulatory Landscape
    • 1.1.2.1. Regulation Focuses on Safety and Efficacy of Devices, Not Specific Manufacturing Processes
    • 1.1.2.2. Current Regulatory Guidelines Signal Confidence
    • 1.1.2.3. Patient-specific Devices Present a Challenge for Regulators
  • 1.1.3. Point-of-Care 3D Printing; the Future of 3D Printing in Healthcare
    • 1.1.3.1. A Distinct Trajectory for Future 3D Printing Hardware Development
• 1.2. Challenges
  • 1.2.1. Continuing Regulatory Guidance for Custom-Made Devices
  • 1.2.2. Need for Inter-disciplinary Expertise
• 1.3. Defining the Value Proposition for 3D Printing in the Medical Device Sector

Chapter Two: Models for Strategic Adoption

• 2.1. In-house Production
• 2.2. Collaborations with Technology Providers and Innovation Hubs
• 2.3. Academic and Clinical Research Partnerships
• 2.4. Point-of-Care Production

Chapter Three: Use Cases for 3D Printing in the Medical Device Sector; Prosthetics, Audiology, and Dental

• 3.1. Surgical Devices
• 3.2. Prosthetics and Implants
  • 3.2.1. Continuing Expansion of Certified Implants and Devices
• 3.3. Audiology Devices
• 3.4. Digital Dentistry
  • 3.4.1. What the Bankruptcy of SmileDirectClub Signals for 3D Printing Dental Aligners

Chapter Four: Technology, Material, Software 23

• 4.1. Hardware
  • 4.1.1. Consumer 3D Printing Continues to Develop In Capability For Clinical Applications
  • 4.1.2. Move Towards Specialized Medical Device Printers?
  • 4.1.3. Dedicated Dental 3D Printing Hardware Systems Leading the Way
• 4.2. Material
  • 4.2.1. Photopolymers
  • 4.2.2. Thermopolymers and Thermosets
    • 4.2.2.1. Thermoplastics in the Prosthetics Industry
  • 4.2.3. Metal
• 4.3. Services

About Additive Manufacturing Research

• About the Analyst
• Acronyms and Abbreviations Used In this Report

List of Exhibits

• Exhibit 1-1: Total Market Value for 3D-printed Medical Devices; Prosthetics, Dental, Audiology
• Exhibit 2-1: SWOT Analysis of the 3D Printing Medical Device Sector
• Exhibit 2-2: Value Propositions for 3D Printing Across the Medical Device Segment
• Exhibit 3-1: Adoption Strategies for Point-of-Care Device Manufacture
• Exhibit 4-1: Hardware Revenue by Technology Type
• Exhibit 4-2: Material Revenue by Material Type
• Exhibit 4-3: Service Revenue and Year-on-Year Growth