醫療器材市場趨勢與機會：義肢、牙科、聽力

3D列印醫療器材市場收入將從2023年的45億美元成長到2034年的165億美元，10年複合年增長率為12%。

3D列印技術的使用正在對醫療領域產生重大影響。製造個人化醫療設備變得更加容易，降低了開發成本，促進了先進設備的創新，並改善了義肢的使用。在過去的二十年中，醫療保健一體化顯著改善了患者的治療效果並擴大了獲得醫療保健的機會。該技術在解決 COVID-19 大流行期間的醫療設備製造課題、簡化供應鏈以及使設備設計和製造更接近患者和醫療保健提供者方面發揮了關鍵作用。未來，醫療器材產業，尤其是義肢、聽力、牙科領域將持續受益於3D列印技術，預計將顯著成長。

本報告分析了目前 3D 列印在義肢、聽力和牙科領域的市場機會——3D 列印正在推動這三個最重要的醫療器材領域的創新、成長和採用。市場機會包括特定於牙科應用的 3D 列印平台的技術進步、醫療和醫療器材供應鏈的日益數位化以及美國食品和藥物管理局 (FDA) 和歐洲藥品管理局 (EMA) 的影響。持續發展，例如：這些組織一致發佈有關醫療設備 3D 列印的指南。

該報告還研究了主要供應商（3D Systems、Formlabs、Stratasys、Materialise 等）適用於醫療器材領域的 3D 列印技術和材料。

該報告的購買者將收到一份內容廣泛的 Excel 數據文件，其中包含該行業 10 年收入預測，依技術、材料和服務進行細分。

目錄

執行摘要

第一章 趨勢與問題

• 趨勢
  • 隨著慢性病的增加，患者專用設備預計將增加
  • 不斷變化的監管環境
  • PoC（護理點）3D 列印：醫療保健領域 3D 列印的未來
• 任務
  • 關於定制設備的持續監管指南
  • 需要跨學科的專業知識
• 3D 列印在醫療設備中的價值主張：定義

第二章 戰略部署模型

• 內部生產
• 與技術提供者和創新中心的合作
• 學術和臨床研究合作夥伴關係
• PoC（護理點）生產

第三章 3D列印在醫療器材領域（義肢、聽力、牙科）的應用實例

• 手術設備
• 義肢和植入物
  • 持續擴大經認證的植入設備
• 聽力測試設備
• 數位化牙科
  • SmileDirectClub破產對3D列印牙齒矯正器的影響

第四章技術、材料和軟體

• 硬件
  • 消費級3D列印：持續開發臨床應用能力
  • 是否會轉向專門用於醫療設備的印表機？
  • 牙科專用3D列印硬體系統領先
• 材料
  • 光聚合物
  • 熱塑性樹脂/熱固性樹脂
  • 金屬
• 服務

關於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