United States Artificial Organs and Bionics Market to Reach $23.12 Billion by 2031, Driven by Biotechnology Innovation & Medical Devices

Leander, Texas and Tokyo, Japan - Dec.04.2025
As per DataM intelligence research report" The Global Artificial Organs and Bionics Market reached US$ 37.85 billion in 2023 and is expected to reach US$ 77.08 billion by 2031, growing at a CAGR of 9.3% during the forecast period 2024-2031." Advances in biomedical engineering and organ shortage challenges are driving innovation in artificial organs and bionic systems.

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United States: Recent Industry Developments

✅ In August 2025, BiVACOR received acceptance into the FDA's "Total Product Life Cycle Advisory Program" (TAP) for its Total Artificial Heart. The titanium, maglev-powered heart aims to replace the function of a failing human heart permanently. This regulatory milestone accelerates its path to market in the U.S.

✅ In October 2025, Abbott initiated a new clinical trial for a fully implantable left ventricular assist device (LVAD) with no external driveline. The system uses wireless power transfer to eliminate the risk of infection at the exit site. It represents the "holy grail" of mechanical circulatory support.

✅ In July 2025, a team at Carnegie Mellon University successfully 3D-bioprinted a functional heart ventricle using collagen. The breakthrough brings the U.S. one step closer to printing full-sized replacement organs. It highlights U.S. leadership in regenerative medicine and tissue engineering.

✅ In May 2025, SynCardia Systems received FDA approval for a smaller driver unit for its temporary Total Artificial Heart. The portable driver allows patients to be discharged home while waiting for a transplant. It improves the quality of life and reduces costs for U.S. heart failure patients.

Japan: Recent Industry Developments

✅ In June 2025, Sun Medical Technology showcased the "MAVIS" artificial heart at the Expo 2025 Osaka "Health Week." The device features a unique magnetic levitation pump designed for superior durability and blood compatibility. It positions Japan as a hub for next-generation cardiac device innovation.

✅ In November 2025, Cyberdyne Inc. announced a new clinical study for its "HAL" medical exoskeleton targeting stroke rehabilitation. The study focuses on using the robot suit to induce neuroplasticity in chronic stroke patients. It expands the indication of Japan's premier bionic technology.

✅ In September 2025, researchers at the University of Tokyo demonstrated a "bio-hybrid" robot finger powered by living muscle tissue. The actuator uses lab-grown rat muscle to create smooth, life-like movement. It pioneers the fusion of biological and mechanical systems in Japan.

✅ In July 2025, a Japanese startup, Jolly Good, partnered with a medical device firm to create VR training for artificial heart implantation. The simulation allows surgeons to practice the complex procedure in a risk-free environment. It enhances the training infrastructure for advanced cardiac surgery in Japan.

Artificial Organs and Bionics Market: Drivers
The artificial organs and bionics market is growing rapidly as technological advancements enable life-saving solutions for patients with organ failure, disabilities, and degenerative conditions. Innovations in bioengineered tissues, artificial hearts, retinal implants, and prosthetic limbs are transforming treatment outcomes. Rising prevalence of chronic diseases and organ shortages is driving strong demand for advanced alternatives. Miniaturization, improved biocompatibility, and robotic capabilities are enhancing device performance and patient comfort. Increasing adoption of AI-integrated and sensor-enabled bionic systems is expanding the market outlook.

Collaborations between biotech firms, medical device manufacturers, and research institutes accelerate R&D in tissue engineering and regenerative technologies. Growing acceptance of 3D printing in custom prosthetics is reducing costs and improving customization. Expanding rehabilitation services and patient support programs are strengthening adoption. Regulatory advancements are improving pathways for clinical approvals and commercialization. With ongoing innovation and rising patient needs, the artificial organs and bionics market is poised for strong future growth.

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Artificial Organs and Bionics Market: Major Players
Abiomed Inc. (Johnson & Johnson Services, Inc.), SynCardia Systems, LLC, Medtronic, Boston Scientific Corporation, Zimmer Biomet., Edwards Lifesciences Corporation., Jarvik Heart, Inc., Cochlear Ltd., Berlin Heart and Ekso Bionics among others.

Segment Covered in the Artificial Organs and Bionics Market:
By Type
Prosthetic organs dominate with 38% share, driven by demand for functional replacements in cardiovascular, orthopedic, and neurological applications. Implantable devices hold 27%, supported by advancements in bioengineered organs and integration with patient-specific treatment. Assistive bionic devices contribute 20%, benefiting from robotics and sensor-enabled innovations that enhance mobility and dexterity. Regenerative and hybrid organ systems account for 15%, reflecting early-stage adoption in research hospitals and specialty clinics. Collectively, all types advance patient care, functional recovery, and quality-of-life improvements.

By Material
Silicone and polymers lead with 32% share, widely used in prosthetics and soft tissue replacements due to biocompatibility and durability. Metals and alloys capture 28%, essential for structural implants and load-bearing prosthetics. Ceramics hold 18%, applied in orthopedic and dental implants for wear resistance and compatibility. Bioengineered tissues contribute 14%, driven by advances in regenerative medicine and scaffold-based organ replacements. Composite materials account for 8%, supporting hybrid systems that integrate mechanical and biological components.

By Fixation Type
Surgical implantation dominates with 55% share, as most artificial organs and bionics require invasive placement for long-term stability and function. Non-invasive fixation methods hold 30%, preferred for wearable bionic devices, external prosthetics, and temporary solutions. Adhesive and modular fixation account for 15%, enabling ease of use, adjustment, and rapid deployment in rehabilitation settings. Across all fixation types, patient safety, device reliability, and comfort remain key adoption drivers.

By Technology
Robotics-enabled devices lead with 36% share, improving precision, mobility, and functional performance in prosthetics and assistive devices. Bioengineering and tissue engineering hold 29%, enabling development of patient-specific organs and hybrid systems. Sensor integration and AI-based control contribute 20%, enhancing real-time responsiveness, monitoring, and adaptive functionality. Other technologies, including nanomaterials and additive manufacturing, account for 15%, supporting customization and innovation in organ and bionic solutions.

Regional Analysis
North America leads with 35% share, driven by advanced healthcare infrastructure, strong R&D in bionics, and high adoption of robotic-assisted prosthetics. The U.S. and Canada invest heavily in regenerative medicine, implantable devices, and clinical trials for hybrid organs.

Europe holds 28%, supported by Germany, the UK, and France, where technological adoption, bioengineering expertise, and public-private collaborations accelerate growth.

Asia Pacific captures 25%, expanding due to rising healthcare investments in China, Japan, and South Korea, coupled with growing patient awareness and technology-driven rehabilitation programs.

Latin America holds 7%, primarily in Brazil and Mexico, with gradual uptake of prosthetic and bionic devices. Middle East & Africa contribute 5%, led by GCC nations, focusing on imported advanced bionic solutions and early-stage adoption in specialty hospitals.

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