인공 장기 : 시장 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The artificial organs market is valued at USD 30.99 billion in 2025 and is on course to reach USD 47.09 billion by 2030, advancing at an 8.73% CAGR.

Strong demand stems from the rapid rise in chronic kidney disease, heart failure, diabetes and respiratory disorders, all of which strain existing donor-organ supply. Breakthroughs in biocompatible materials, nano-scale fluid management and wireless sensors have lifted product reliability, eased implantation and improved long-term patient outcomes. Shifts in reimbursement policies, especially the introduction of accelerated approval routes for breakthrough devices, are shortening time-to-market while rewarding designs that cut hospital stays. Home-based care models, powered by remote monitoring platforms, are expanding clinical reach beyond large hospitals and enabling personalized therapy adjustments. Together, these forces position the artificial organs market for durable double-digit growth through the decade.

Global Artificial Organ Market Trends and Insights

Increasing Prevalence of Chronic Diseases and Organ Failure

Kidney, cardiac and pulmonary diseases are climbing at rates that outpace organ donation, with 35.5 million adults in the United States already living with chronic kidney disease. End-stage renal disease treatment costs the US Medicare program USD 130 billion each year, pushing stakeholders toward durable artificial alternatives. Epidemiological modeling projects that up to 16.5% of the population in eight large economies will have chronic kidney disease by 2032, inflating dialysis demand by more than 75%. Similar pressures surface in cardiology, where a widening gap between listed transplant candidates and available hearts has pushed total artificial heart implant volume beyond 2,000 patients to date. As such, clinical urgency is directly feeding artificial organs market adoption.

Rising Investment in Research and Development

Federal grants, public-private alliances and venture capital are accelerating product pipelines. The National Institutes of Health awarded USD 459,824 in 2024 to refine the Wearable Artificial Kidney system, validating sustained public-sector support. Large med-tech firms are buying or partnering with niche innovators to gain access to 4D bioprinting and magnetically levitated pumps, while the broader biotechnology segment is forecast to reach USD 3.2 trillion by 2030. Capital is concentrating on miniaturization, hemocompatible coatings and AI-enabled control algorithms, key differentiators in the artificial organs market.

High Cost of Artificial Organs and Procedures Coupled with Limited Reimbursement Options

Total artificial hearts can exceed USD 200,000 per implant, and reimbursement frameworks vary widely, especially in low-income economies. Payers often require extensive real-world evidence before assigning permanent billing codes, slowing uptake. Trade groups now lobby regulators to formalize payment pathways, as outlined in a 2025 AI Policy Roadmap that calls on Medicare to reward life-cycle cost savings. Innovative value-based contracts are beginning to emerge but remain too scarce to offset near-term pricing pressure on the artificial organs market.

Other drivers and restraints analyzed in the detailed report include:

1. Shortage of Donor Organs and Ethical Concerns
2. Growing Aging Population Globally
3. Device Longevity and Biocompatibility Issues

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

The artificial kidney segment generated 57% of artificial organs market revenue in 2024, driven by the expanding chronic kidney disease population and the entrenched dialysis ecosystem. Growing preference for continuous renal replacement in outpatient settings keeps device utilization high. The artificial organs market size for wearable kidney systems is forecast to climb at a 14.4% CAGR from 2025-2030, supported by portable nanoelectrokinetic modules that permit 8-10 hours of daily mobility. Early clinical studies highlight improved patient satisfaction when therapy shifts from clinic-bound sessions to ambulatory self-care.

Clinicians are also trialing combined toxin removal and hormone-replacement cartridges, broadening indications beyond end-stage disease. Artificial pancreases are next in line, benefiting from mature continuous glucose monitors and closed-loop insulin pumps. Meanwhile, artificial lungs gained visibility during the COVID-19 crisis, and bio-artificial liver prototypes target acute fulminant hepatic failure. Together, these innovations diversify revenue streams and reduce reliance on a single dominant organ segment within the artificial organs market.

Mechanical platforms held 67% of 2024 revenue due to established clinical protocols and proven safety profiles. Dialysis machines, membrane oxygenators and centrifugal pumps remain hospital workhorses. Yet electronic and bionic architectures are scaling fast, and this sub-segment is predicted to grow at 11.2% CAGR through 2030. Smart sensors, closed-loop software and on-board power management allow dynamic flow regulation and real-time clot detection, properties now expected in premium cardiac support devices. As a result, hospital purchasing criteria increasingly consider connectivity and AI analytics, a shift that places electronic innovators at the center of artificial organs market momentum.

Vision-guided 4D bioprinting sits at the frontier, promising personalized soft-tissue grafts with microvascular networks. Success here would bring fully cellularized organs closer to mass-customization, bridging mechanical and biological paradigms.

The Artificial Organ Market Report is Segmented by Organ Type (Artificial Heart [Prosthetic Heart Valves, and More], Artificial Kidney, and More), Technology (Mechanical, Electronic / Bionics, and More), Fixation Method (Fully Implantable, and More), End User (Hospitals (>300 Beds), Hospitals (<300 Beds) and More) and Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America held 45% of global revenue in 2024, anchored by robust Medicare coverage for life-sustaining devices and a large installed base of dialysis clinics. The United States alone represents 40% of worldwide medical device consumption, with an extensive pipeline of FDA breakthrough-designated implants facilitating faster commercialization. Payer pilots now reimburse remote monitoring on a per-member-per-month basis, encouraging migration from hospital to home.

Asia-Pacific is the fastest growing region, advancing at a 12.3% CAGR through 2030. China and India are scaling universal health-insurance coverage, and national procurement programs are negotiating bulk prices for dialysis cartridges and ventricular assist devices. Population aging in Japan accelerates cardiac support demand, while South Korea's well-funded R&D incentives help local firms export miniaturized drive systems. Local manufacturing cuts cost by up to 30%, broadening access and propelling artificial organs market adoption across mid-income segments.

Europe remains influential, thanks to uniform quality standards under the Medical Device Regulation. Germany and the United Kingdom drive early adoption of bioprosthetic heart valves and long-wear insulin pumps, whereas newer European Society for Organ Transplantation initiatives seek to harmonize advanced-therapy reimbursement. Economic constraints persist, yet coordinated procurement at the EU level is expected to support wider diffusion across Southern and Eastern member states.

Middle East and Africa plus South America account for a smaller slice of revenue. Uptake is strongest in Saudi Arabia, the United Arab Emirates, Brazil and South Africa, where private networks finance sophisticated implants. Public hospital budgets remain under pressure, but strategic partnerships with multinational device suppliers are improving clinician training and warranty coverage. Over the forecast horizon, multicenter tele-ICU hubs and cross-border service models should narrow the accessibility gap, lifting regional participation in the artificial organs market.

1. Medtronic
2. Abbott Laboratories
3. Boston Scientific
4. Abiomed (Johnson & Johnson MedTech)
5. SynCardia Systems
6. Berlin Heart
7. CARMAT SA
8. Jarvik Heart
9. BiVACOR Pty Ltd
10. Terumo Corp.
11. Getinge
12. Fresenius Medical Care AG
13. AWAK Technologies Pte Ltd
14. ALung Technologies Inc.
15. Cochlear
16. Asahi Kasei
17. B. Braun
18. Baxter
19. Edwards Lifesciences Corp.
20. Tandem Diabetes Care
21. 3D Systems Healthcare

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Increasing Prevalence of Chronic Diseases and Organ Failure
  • 4.2.2 Rising Investment in Research and Development
  • 4.2.3 Shortage of Donor Organs and Ethical Concerns
  • 4.2.4 Growing Aging Population Globally
  • 4.2.5 Advancements in Technology and Biocompatibility
  • 4.2.6 Patient Preference for Improved Quality of Life
• 4.3 Market Restraints
  • 4.3.1 High Cost of Artificial Organs and Procedures Coupled with Limited Reimbursement Options
  • 4.3.2 Device Longevity and Biocompatibility Issues
  • 4.3.3 Limited Awareness and Skilled Healthcare Professionals
  • 4.3.4 Complex Surgical Procedures
• 4.4 Supply-Chain Analysis
• 4.5 Porter's Five Forces
  • 4.5.1 Threat of New Entrants
  • 4.5.2 Bargaining Power of Buyers
  • 4.5.3 Bargaining Power of Suppliers
  • 4.5.4 Threat of Substitutes
  • 4.5.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Organ Type
  • 5.1.1 Artificial Heart
    • 5.1.1.1 Prosthetic Heart Valves
    • 5.1.1.2 Ventricular Assist Devices
    • 5.1.1.3 Cardiac Pacemakers & ICDs
  • 5.1.2 Artificial Kidney
    • 5.1.2.1 Implantable Devices
    • 5.1.2.2 Wearable / Portable Systems
  • 5.1.3 Artificial Pancreas
  • 5.1.4 Artificial Lungs/ECMO
  • 5.1.5 Cochlear & Auditory Brain-stem Implants
  • 5.1.6 Bio-artificial Liver
  • 5.1.7 Other Organs (Cornea, Spleen, Bladder, Trachea)
• 5.2 By Technology
  • 5.2.1 Mechanical
  • 5.2.2 Electronic / Bionics
  • 5.2.3 Wearable / Externally Worn
  • 5.2.4 3D-Bioprinted Constructs
• 5.3 By Fixation Method
  • 5.3.1 Fully Implantable
  • 5.3.2 Partially Implantable
  • 5.3.3 Externally Worn / Percutaneous
• 5.4 By End User
  • 5.4.1 Hospitals (>300 Beds)
  • 5.4.2 Hospitals (<300 Beds)
  • 5.4.3 Ambulatory Surgical Centers
  • 5.4.4 Home-care & Remote Monitoring
• 5.5 Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 South Korea
    • 5.5.3.5 Australia
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Business Segments, Financials, Headcount, Key Information, Market Rank, Market Share, Products and Services, and analysis of Recent Developments)
  • 6.3.1 Medtronic plc
  • 6.3.2 Abbott Laboratories
  • 6.3.3 Boston Scientific Corp.
  • 6.3.4 Abiomed (Johnson & Johnson MedTech)
  • 6.3.5 SynCardia Systems LLC
  • 6.3.6 Berlin Heart GmbH
  • 6.3.7 CARMAT SA
  • 6.3.8 Jarvik Heart Inc.
  • 6.3.9 BiVACOR Pty Ltd
  • 6.3.10 Terumo Corp.
  • 6.3.11 Getinge AB
  • 6.3.12 Fresenius Medical Care AG
  • 6.3.13 AWAK Technologies Pte Ltd
  • 6.3.14 ALung Technologies Inc.
  • 6.3.15 Cochlear Ltd.
  • 6.3.16 Asahi Kasei Medical Co. Ltd
  • 6.3.17 B. Braun Melsungen AG
  • 6.3.18 Baxter International Inc.
  • 6.3.19 Edwards Lifesciences Corp.
  • 6.3.20 Tandem Diabetes Care
  • 6.3.21 3D Systems Healthcare

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment