Global Artificial Organs Market By Organ Type (Artificial Heart, Artificial Kidney, Artificial Pancreas, Artificial Lungs, Others), By Type (Mechanical, Biomechanical, Biological), By Material Type (Inanimate Polymers, Combination of Inanimate Polymers & Living Cells, Only Living Cells), By Region, Competition, Forecast & Opportunities, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 30.55 Billion
CAGR (2026-2031)	10.01%
Fastest Growing Segment	Mechanical
Largest Market	North America
Market Size (2031)	USD 54.15 Billion

Market Overview

The Global Artificial Organs Market will grow from USD 30.55 Billion in 2025 to USD 54.15 Billion by 2031 at a 10.01% CAGR. Artificial organs are engineered devices designed to replicate the physiological functions of failing natural organs, such as the heart, kidneys, or liver. The market is primarily driven by the critical global shortage of donor organs and the rising prevalence of chronic diseases that precipitate end-stage organ failure. Additionally, aging populations contribute to increased rates of organ degeneration, necessitating mechanical interventions to sustain life when biological transplantation is unavailable.

However, the industry encounters a significant challenge in the form of rigorous regulatory pathways and high development costs which delay market entry. These impediments restrict the speed at which new devices can reach patients. The urgency for these solutions is underscored by the persistent disparity between donor availability and demand. According to the Organ Procurement and Transplantation Network, in 2024, more than 100,000 candidates were registered on the national transplant waiting list in the United States. This statistic exemplifies the critical gap artificial technologies must bridge to address the shortage of biological options.

Key Market Drivers

The critical scarcity of human donor organs and expanding transplant waitlists serve as the primary impetus for the Global Artificial Organs Market. As the prevalence of chronic conditions such as renal and cardiac failure accelerates, the disparity between the limited supply of biological organs and the overwhelming demand continues to widen. This shortage creates an urgent clinical necessity for engineered alternatives that can function as destination therapies or bridges to transplantation. The severity of this supply constraints is highlighted by recent transplantation volume data. According to the Health Resources and Services Administration, January 2025, the United States healthcare system was only able to perform 27,759 kidney transplants in 2024, a figure that remains insufficient to address the needs of the vast patient population requiring renal replacement. Consequently, clinicians are increasingly reliant on mechanical support systems to sustain patients with end-stage organ failure who would otherwise face mortality while waiting for a biological donor.

Rapid advancements in biocompatible materials and 3D bioprinting technologies are simultaneously propelling market growth by enhancing the safety and functionality of implantable devices. Innovations in titanium construction, magnetic levitation, and bio-printed scaffolds are effectively reducing rejection rates and improving the durability of artificial substitutes. A significant milestone in this domain occurred when, according to The Texas Heart Institute, July 2024, in the 'BiVACOR Total Artificial Heart Makes History' press release, clinical researchers successfully completed the first-in-human implantation of the BiVACOR Total Artificial Heart as part of an FDA early feasibility study. These technological breakthroughs are rapidly translating into commercial adoption and financial growth for key industry players. For instance, according to Carmat, January 2025, the company achieved annual sales of €7 million for its Aeson artificial heart in 2024, representing a 2.5-fold increase compared to the previous year. These developments signal a definitive shift from experimental prototypes to commercially viable solutions.

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Key Market Challenges

The strict regulatory frameworks and substantial capital requirements for device development present a primary impediment to the expansion of the Global Artificial Organs Market. Developing these life-sustaining devices involves complex engineering and safety testing, leading to extended timelines that deter investment and delay commercialization. The financial burden of clinical trials and the subsequent regulatory review process creates a "valley of death" where many innovative technologies fail to secure necessary funding before they can generate revenue. This environment forces companies to price products at a premium, limiting accessibility and adoption rates in cost-sensitive healthcare systems.

These delays are quantitatively evident in the disparity between regulatory authorization and actual reimbursement, which effectively constitutes market entry. According to the Advanced Medical Technology Association (AdvaMed), in 2024, the median wait time for a Medicare coverage decision on a new FDA-cleared medical technology was approximately 5.7 years. This prolonged period of uncertainty prevents manufacturers from reaching the patient population promptly, as the absence of insurance coverage renders these expensive therapies unaffordable for most end-users, thereby stifling market growth and innovation cycles.

Key Market Trends

The emergence of wearable and portable artificial kidney devices is transforming the renal care landscape by addressing the mobility limitations associated with traditional hemodialysis. This trend focuses on developing compact, lightweight systems that allow patients to undergo continuous blood purification while maintaining an active lifestyle, thereby significantly improving quality of life. These innovations are moving beyond stationary clinical infrastructure to offer home-based, patient-centric solutions that mimic the natural kidney's continuous filtration capability. According to Medindia, November 2024, in the 'AWAK's Portable Dialysis Device Offers New Hope for Kidney Patients' article, AWAK Technologies initiated a pre-pivotal clinical trial for a wearable peritoneal dialysis device weighing only 3 kilograms, designed to grant patients greater freedom from clinic-bound treatments.

Simultaneously, the integration of artificial intelligence and IoT for real-time device monitoring is reshaping how artificial organ systems are managed and optimized. Market leaders are deploying sophisticated algorithms to predict complications, personalize treatment regimens, and remotely monitor patient health markers, thus reducing the burden on healthcare facilities. This digital evolution ensures that mechanical support systems can adapt dynamically to physiological changes, enhancing patient safety and device longevity. Validating this progression, according to Fresenius Medical Care, November 2024, in the 'Fresenius Medical Care's AI-Powered Application of the Anemia Control Model Selected for CMS AI Demo Days in the United States' press release, the company's AI-powered Anemia Control Model was selected for the Centers for Medicare & Medicaid Services AI Demo Days, underscoring the growing reliance on intelligent software to augment renal replacement therapies.

Segmental Insights

The Mechanical segment is currently emerging as the fastest-growing category within the Global Artificial Organs Market, driven primarily by the critical global shortage of biological donor organs. As the disparity between transplant candidates and available donors widens, medical professionals are increasingly prioritizing mechanical alternatives, such as ventricular assist devices and artificial heart valves, to manage end-stage organ failure. This demand is further supported by engineering advancements that have significantly improved the durability and biocompatibility of these implants. Additionally, the U.S. Food and Drug Administration (FDA) has accelerated this market expansion by providing expedited regulatory pathways for essential mechanical devices, streamlining their commercial availability.

Regional Insights

North America maintains a leading position in the global artificial organs market, driven by a well-established healthcare infrastructure and the high prevalence of chronic diseases requiring transplants. The region benefits from substantial investment in research and development alongside the presence of major industry players. Additionally, favorable reimbursement frameworks and clear regulatory guidelines from the U.S. Food and Drug Administration (FDA) support the rapid approval and commercialization of these medical devices. These combined factors create a conducive environment for market expansion and ensure the region remains the primary contributor to global revenue.

Recent Developments

• In February 2025, United Therapeutics received clearance from the U.S. Food and Drug Administration to initiate a clinical trial for its genetically modified porcine kidney, known as UKidney. The company announced plans to perform the first xenotransplantation procedure in a human patient by mid-2025 as part of a study enrolling individuals with end-stage renal disease. The trial aims to assess the safety and efficacy of the organ, which has been engineered to eliminate specific pig antigens and incorporate human transgenes to prevent immune rejection. This regulatory approval marked a pivotal development in the competitive landscape of xenotransplantation technologies.
• In January 2025, Carmat reported a significant increase in the commercial adoption of its Aeson total artificial heart, with 42 implants performed in 2024. The company announced that annual sales had reached €7 million, representing a substantial growth compared to the previous financial period. The update highlighted that 50 hospitals internationally had been trained to perform the implantation, signaling expanding market access and clinical acceptance across Europe. This commercial progress reinforced the company's objective to establish its bioprosthetic artificial heart as a standard therapeutic alternative for patients suffering from advanced biventricular heart failure who are not eligible for immediate transplant.
• In July 2024, the Texas Heart Institute and BiVACOR announced the successful first-in-human implantation of the BiVACOR Total Artificial Heart. The procedure marked the beginning of an FDA Early Feasibility Study to evaluate the safety and performance of the device as a bridge-to-transplant solution for patients with severe biventricular heart failure. The titanium-constructed device utilizes a rotary blood pump with a single moving part suspended by magnetic levitation technology, designed to minimize mechanical wear and blood trauma. This implantation represented a major advancement in the development of durable, mechanical circulatory support systems for patients awaiting donor hearts.
• In March 2024, eGenesis announced the world's first successful transplant of a genetically engineered porcine kidney into a living human recipient. The procedure was performed at Massachusetts General Hospital under a U.S. Food and Drug Administration (FDA) Expanded Access protocol. The recipient, a patient with end-stage renal disease, received the gene-edited organ which carried 69 genomic modifications designed to improve compatibility and reduce the risk of immune rejection. This landmark event represented a significant step forward in xenotransplantation research, aiming to address the critical global shortage of transplantable organs by providing a viable, sustainable alternative to human donor kidneys.

Key Market Players

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

By Organ Type	By Type	By Material Type	By Region
Artificial Heart Artificial Kidney Artificial Pancreas Artificial Lungs Others	Mechanical Biomechanical Biological	Inanimate Polymers Combination of Inanimate Polymers & Living Cells Only Living Cells	North America Europe Asia Pacific South America Middle East & Africa

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