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1938446

人工器官市場－全球產業規模、佔有率、趨勢、機會及預測（依器官類型、類型、材料類型、地區及競爭格局分類，2021-2031年）

Artificial Organs Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Organ Type, By Type, By Material Type, By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 185 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球人造器官市場預計將從 2025 年的 305.5 億美元成長到 2031 年的 541.5 億美元，年複合成長率為 10.01%。

這些人工裝置對於模擬衰竭的自身器官（例如心臟、肝臟和腎臟）的生理功能至關重要。推動這一市場發展的關鍵因素包括全球捐贈器官的嚴重短缺以及導致終末期器官衰竭的慢性疾病的增加。此外，全球人口老化導致器官退化速度加快，使得在無法進行生物移植的情況下，人們更需要機械解決方案來維持生命。

市場概覽
預測期 2027-2031
市場規模：2025年 305.5億美元
市場規模：2031年 541.5億美元
複合年成長率：2026-2031年 10.01%
成長最快的細分市場 機械的
最大的市場 北美洲

然而，該產業面臨許多重大障礙，包括嚴格的監管流程和高昂的研發成本，這些都會延緩產品進入市場。這些障礙限制了創新醫療設備惠及病患的速度。供體器官供應與患者需求之間持續存在的缺口凸顯了這些技術的迫切需求。根據器官取得與移植網路（OPTN）預測，到2024年，美國國家器官移植等待名單上的候選人將超過10萬人，這表明人工技術必須填補生物器官短缺的關鍵缺口。

市場促進因素

推動全球人工器官市場發展的關鍵因素是捐贈器官嚴重短缺和移植等待名單過長。隨著心臟衰竭和腎衰竭等慢性疾病發病率的不斷上升，有限的生物器官供應與巨大的需求之間的差距持續擴大。這種供需失衡不可避免地增加了對人工器官的需求，人工器官既可作為最終治療方法，也可作為移植前的過渡方案。美國衛生資源與服務管理局 (HRSA) 2025 年 1 月的數據也印證了供應緊張的嚴峻情況。數據顯示，2024 年美國醫療系統僅進行了 27,759 例腎臟移植手術，遠遠無法滿足龐大的腎臟替代治療患者群體的需求。這迫使臨床醫生依賴機械輔助系統來挽救患者的生命。

同時，3D生物列印技術和生物相容性材料的快速發展，透過提升設備的安全性和功能性，加速了市場擴張。利用鈦、生物列印支架和磁浮技術的創新已成功降低了排斥率並提高了耐用性。 2024年7月，德克薩斯心臟研究所宣布了一項突破性進展：全球首例BiVACOR全人工心臟在FDA早期可行性研究中成功植入人體。這些技術進步正帶來商業性的成功。例如，2025年1月，Carmat公司報告稱，其Ayson人工心臟2024年的年銷售額達到700萬歐元，比前一年成長了2.5倍，標誌著該產品已從實驗原型過渡到可行的商業解決方案。

市場挑戰

全球人工器官市場的成長受到巨額資金需求和嚴格法規結構的限制。開發這些維生設備需要複雜的工程技術和廣泛的安全測試，導致研發週期漫長，抑制了投資並延緩了商業化。臨床試驗和監管審查的高昂成本造成了“資金籌措缺口”，使得許多前景廣闊的技術在實現商業化之前就因缺乏資金而失敗。因此，企業被迫對其產品收取高價，限制了其在注重成本的醫療保健系統中的普及和應用。

這些延誤最明顯地體現在監管部門核准和實際報銷之間的滯後，而這實際上決定了產品是否能進入市場。根據先進醫療技術協會（AdvaMed）的數據，2024年，獲得FDA批准的新醫療技術獲得聯邦醫療保險（Medicare）報銷的平均等待時間約為5.7年。這種長期的不確定性阻礙了製造商快速惠及患者，導致大多數用戶因缺乏報銷而無法負擔昂貴的治療，最終抑制了市場成長並減緩了創新週期。

市場趨勢

攜帶式穿戴式人工腎臟設備的興起正在改變腎臟護理領域，這些設備消除了傳統血液透析帶來的行動不便。這一趨勢致力於研發輕巧緊湊的系統，在實現持續血液淨化的同時，讓患者能夠維持積極的生活方式，從而顯著提高生活品質。這些創新突破了固定臨床基礎設施的限制，提供以患者為中心的居家解決方案，模擬患者自身腎臟的持續過濾功能。例如，Medindia 於 2024 年 11 月報道，AWAK Technologies 已啟動一項關鍵性臨床試驗前期的穿戴式腹膜透析設備，該設備重量僅為 3 公斤，旨在讓患者擺脫頻繁前往診所接受治療的困擾。

同時，融合物聯網 (IoT) 和人工智慧的即時設備監控正在革新人工器官系統的管理和最佳化。業界領導企業正利用先進的演算法預測併發症、遠端監測患者健康指標並制定個人化治療方案，從而減輕醫療機構的負擔。這種數位轉型使機械輔助系統能夠動態適應生理變化，延長設備使用壽命並提高病患安全。費森尤斯醫療 (Fresenius Medical Care) 於 2024 年 11 月宣布，其人工智慧驅動的貧血管理模式入選美國醫療保險和醫療補助服務中心 (CMS) 的人工智慧演示日，充分體現了這一趨勢，凸顯了智慧軟體在推進腎臟替代療法方面日益受到重視。

目錄

第1章概述

第2章調查方法

第3章執行摘要

第4章：客戶評價

第5章 全球人工器官市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 依器官類型（人工心臟、人工腎臟、人工胰臟、人工肺、其他）
    • 依類型（機械式、生物力學式、生物學式）
    • 依材料類型（無機聚合物、無機聚合物和活細胞、僅活細胞）
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美人工器官市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國家分析
    • 美國
    • 加拿大
    • 墨西哥

第7章：歐洲人工器官市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國家分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太地區人工器官市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國家分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第9章：中東和非洲人工器官市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東和非洲：國家分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美洲人工器官市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國家分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章 市場動態

  • 促進要素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 最新進展

第13章 全球人工器官市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的可能性
  • 供應商電力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

  • SynCardia
  • Carmat
  • Abbott
  • Medtronic
  • Fresenius Medical Care
  • NxStage
  • Terumo
  • Boston Scientific
  • APL
  • Nipro

第16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
Product Code: 4842

The Global Artificial Organs Market is projected to expand from USD 30.55 Billion in 2025 to USD 54.15 Billion by 2031, reflecting a CAGR of 10.01%. These engineered devices are essential for mimicking the physiological duties of failing natural organs like the heart, liver, or kidneys. Key factors fueling this market include a critical worldwide scarcity of donor organs and a growing prevalence of chronic illnesses that lead to end-stage organ failure. Furthermore, aging global populations are experiencing higher rates of organ degeneration, increasing the need for mechanical solutions to sustain life when biological transplants are not an option.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 30.55 Billion
Market Size 2031USD 54.15 Billion
CAGR 2026-203110.01%
Fastest Growing SegmentMechanical
Largest MarketNorth America

However, the industry faces substantial hurdles due to stringent regulatory processes and exorbitant development costs that slow down market entry. These obstacles limit how quickly innovative devices can become available to patients. The pressing need for these technologies is highlighted by the continuing gap between the supply of donors and patient demand. According to the Organ Procurement and Transplantation Network, over 100,000 candidates were on the national transplant waiting list in the United States in 2024, demonstrating the vital gap artificial technologies must fill to mitigate the shortage of biological alternatives.

Market Driver

The primary force behind the Global Artificial Organs Market is the acute shortage of human donor organs combined with lengthening transplant waiting lists. As the incidence of chronic conditions like cardiac and renal failure rises, the gap between the limited availability of biological organs and the massive demand continues to grow. This disparity necessitates engineered alternatives acting as either destination therapies or bridges to transplantation. The severity of supply constraints is underscored by data from the Health Resources and Services Administration in January 2025, which noted that the U.S. healthcare system performed only 27,759 kidney transplants in 2024-a number insufficient to meet the needs of the large patient population requiring renal replacement, forcing clinicians to rely on mechanical support systems to prevent mortality.

Simultaneously, rapid progress in 3D bioprinting and biocompatible materials is accelerating market expansion by improving device safety and function. Innovations utilizing titanium, bio-printed scaffolds, and magnetic levitation are successfully lowering rejection rates and enhancing durability. A major breakthrough was reported by The Texas Heart Institute in July 2024, announcing the first-in-human implantation of the BiVACOR Total Artificial Heart during an FDA early feasibility study. Such technological strides are translating into commercial success; for example, Carmat reported in January 2025 that annual sales for its Aeson artificial heart reached €7 million in 2024, a 2.5-fold increase over the prior year, marking a transition from experimental prototypes to viable commercial solutions.

Market Challenge

High capital requirements and rigorous regulatory frameworks stand as significant barriers to the growth of the Global Artificial Organs Market. The development of these life-sustaining devices necessitates intricate engineering and extensive safety testing, resulting in prolonged timelines that discourage investment and delay commercial release. The substantial financial cost of clinical trials and regulatory reviews creates a "valley of death," causing many promising technologies to fail due to a lack of funding before generating revenue. Consequently, companies are often forced to set premium prices for their products, which restricts adoption and accessibility within cost-conscious healthcare systems.

These delays are notably apparent in the lag between regulatory clearance and actual reimbursement, which essentially defines market entry. According to the Advanced Medical Technology Association (AdvaMed), the median wait time for a Medicare coverage decision on a new FDA-cleared medical technology was approximately 5.7 years in 2024. This extended period of uncertainty prevents manufacturers from reaching patients quickly, as the lack of insurance coverage makes these expensive therapies unaffordable for most users, ultimately hindering market growth and slowing innovation cycles.

Market Trends

The renal care landscape is being transformed by the rise of portable and wearable artificial kidney devices, which address the mobility constraints of traditional hemodialysis. This trend emphasizes the creation of lightweight, compact systems that enable continuous blood purification while allowing patients to maintain active lifestyles, thereby vastly enhancing their quality of life. Moving beyond stationary clinical infrastructure, these innovations offer patient-centric, home-based solutions that replicate the natural kidney's continuous filtration. For instance, Medindia reported in November 2024 that AWAK Technologies began a pre-pivotal clinical trial for a wearable peritoneal dialysis device weighing just 3 kilograms, aiming to provide patients with greater freedom from clinic-based treatments.

Concurrently, the incorporation of the Internet of Things (IoT) and artificial intelligence for real-time device monitoring is revolutionizing the management and optimization of artificial organ systems. Industry leaders are utilizing advanced algorithms to predict complications, remotely monitor patient health markers, and personalize treatment plans, reducing the strain on healthcare facilities. This digital shift ensures mechanical support systems can dynamically adapt to physiological changes, improving device longevity and patient safety. Highlighting this trend, Fresenius Medical Care announced in November 2024 that its AI-powered Anemia Control Model was selected for the Centers for Medicare & Medicaid Services AI Demo Days, demonstrating the increasing dependence on intelligent software to enhance renal replacement therapies.

Key Market Players

  • SynCardia
  • Carmat
  • Abbott
  • Medtronic
  • Fresenius Medical Care
  • NxStage
  • Terumo
  • Boston Scientific
  • APL
  • Nipro

Report Scope

In this report, the Global Artificial Organs Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Artificial Organs Market, By Organ Type

  • Artificial Heart
  • Artificial Kidney
  • Artificial Pancreas
  • Artificial Lungs
  • Others

Artificial Organs Market, By Type

  • Mechanical
  • Biomechanical
  • Biological

Artificial Organs Market, By Material Type

  • Inanimate Polymers
  • Combination of Inanimate Polymers & Living Cells
  • Only Living Cells

Artificial Organs Market, By Region

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Artificial Organs Market.

Available Customizations:

Global Artificial Organs Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Artificial Organs Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Organ Type (Artificial Heart, Artificial Kidney, Artificial Pancreas, Artificial Lungs, Others)
    • 5.2.2. By Type (Mechanical, Biomechanical, Biological)
    • 5.2.3. By Material Type (Inanimate Polymers, Combination of Inanimate Polymers & Living Cells, Only Living Cells)
    • 5.2.4. By Region
    • 5.2.5. By Company (2025)
  • 5.3. Market Map

6. North America Artificial Organs Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Organ Type
    • 6.2.2. By Type
    • 6.2.3. By Material Type
    • 6.2.4. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Artificial Organs Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Organ Type
        • 6.3.1.2.2. By Type
        • 6.3.1.2.3. By Material Type
    • 6.3.2. Canada Artificial Organs Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Organ Type
        • 6.3.2.2.2. By Type
        • 6.3.2.2.3. By Material Type
    • 6.3.3. Mexico Artificial Organs Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Organ Type
        • 6.3.3.2.2. By Type
        • 6.3.3.2.3. By Material Type

7. Europe Artificial Organs Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Organ Type
    • 7.2.2. By Type
    • 7.2.3. By Material Type
    • 7.2.4. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Artificial Organs Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Organ Type
        • 7.3.1.2.2. By Type
        • 7.3.1.2.3. By Material Type
    • 7.3.2. France Artificial Organs Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Organ Type
        • 7.3.2.2.2. By Type
        • 7.3.2.2.3. By Material Type
    • 7.3.3. United Kingdom Artificial Organs Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Organ Type
        • 7.3.3.2.2. By Type
        • 7.3.3.2.3. By Material Type
    • 7.3.4. Italy Artificial Organs Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Organ Type
        • 7.3.4.2.2. By Type
        • 7.3.4.2.3. By Material Type
    • 7.3.5. Spain Artificial Organs Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Organ Type
        • 7.3.5.2.2. By Type
        • 7.3.5.2.3. By Material Type

8. Asia Pacific Artificial Organs Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Organ Type
    • 8.2.2. By Type
    • 8.2.3. By Material Type
    • 8.2.4. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Artificial Organs Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Organ Type
        • 8.3.1.2.2. By Type
        • 8.3.1.2.3. By Material Type
    • 8.3.2. India Artificial Organs Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Organ Type
        • 8.3.2.2.2. By Type
        • 8.3.2.2.3. By Material Type
    • 8.3.3. Japan Artificial Organs Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Organ Type
        • 8.3.3.2.2. By Type
        • 8.3.3.2.3. By Material Type
    • 8.3.4. South Korea Artificial Organs Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Organ Type
        • 8.3.4.2.2. By Type
        • 8.3.4.2.3. By Material Type
    • 8.3.5. Australia Artificial Organs Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Organ Type
        • 8.3.5.2.2. By Type
        • 8.3.5.2.3. By Material Type

9. Middle East & Africa Artificial Organs Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Organ Type
    • 9.2.2. By Type
    • 9.2.3. By Material Type
    • 9.2.4. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Artificial Organs Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Organ Type
        • 9.3.1.2.2. By Type
        • 9.3.1.2.3. By Material Type
    • 9.3.2. UAE Artificial Organs Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Organ Type
        • 9.3.2.2.2. By Type
        • 9.3.2.2.3. By Material Type
    • 9.3.3. South Africa Artificial Organs Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Organ Type
        • 9.3.3.2.2. By Type
        • 9.3.3.2.3. By Material Type

10. South America Artificial Organs Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Organ Type
    • 10.2.2. By Type
    • 10.2.3. By Material Type
    • 10.2.4. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Artificial Organs Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Organ Type
        • 10.3.1.2.2. By Type
        • 10.3.1.2.3. By Material Type
    • 10.3.2. Colombia Artificial Organs Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Organ Type
        • 10.3.2.2.2. By Type
        • 10.3.2.2.3. By Material Type
    • 10.3.3. Argentina Artificial Organs Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Organ Type
        • 10.3.3.2.2. By Type
        • 10.3.3.2.3. By Material Type

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global Artificial Organs Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. SynCardia
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. SWOT Analysis
  • 15.2. Carmat
  • 15.3. Abbott
  • 15.4. Medtronic
  • 15.5. Fresenius Medical Care
  • 15.6. NxStage
  • 15.7. Terumo
  • 15.8. Boston Scientific
  • 15.9. APL
  • 15.10. Nipro

16. Strategic Recommendations

17. About Us & Disclaimer