Artificial Heart Market

Market Overview

The global artificial heart market size was valued at USD  2.16 Billion in 2022 and is projected to reach USD 7.31 Billion by 2031, registering a CAGR of 14.5% during the forecast period (2023-2031). The continuously aging global population and increased deaths from cardiovascular illnesses drive the growth of the global artificial heart market.

Artificial hearts, also known as cardiac assist devices, are medical devices intended to replace or supplement the normal functions of the human heart. These devices are employed when a person's heart cannot adequately pump blood due to heart failure, cardiac disease, or other major medical issues. Artificial hearts might be temporary or permanent treatments depending on the patient's needs.

An increased frequency of cardiac diseases and the geriatric population drives the artificial heart market. Improper lifestyle choices contribute to deteriorating cardiac problems and are anticipated to provide new prospects for artificial heart producers. On the other hand, the expensive cost of artificial heart valves and tightly controlled treatment facilities are projected to limit the artificial heart market share.

Market Dynamics

Global Artificial Heart Market Drivers

Rising Incidence of Cardiovascular Diseases

Cardiovascular disorders (CVDs), including coronary artery disease, heart failure, and hypertension, remain a global health concern. These disorders can cause significant cardiac damage, demanding complex treatments such as prosthetic hearts. Heart disease is a major public health concern in the United States. Heart disease was the top cause of death in the United States in 2022, accounting for around 699,659 fatalities, according to the Centers for Disease Control and Prevention (CDC).

Governments, companies, and healthcare institutions have significantly invested in CVD research and efforts. These initiatives are aimed at preventing, diagnosing, and treating cardiovascular disorders. For example, the National Institutes of Health (NIH) in the United States devotes a major percentage of its funding to cardiovascular research, including studies on artificial hearts and advanced cardiac therapy. This is projected to boost the artificial heart market trend.

Global Artificial Heart Market Restraints

High Cost

The cost of artificial hearts includes the device itself, surgical procedures, continuing monitoring, maintenance, and any consequences. The exorbitant expenses of this life-saving treatment can be a substantial barrier to access. Artificial heart devices, particularly complete artificial hearts (TAHs), are technologically innovative and complex, contributing to high production costs. The device's components, materials, and engineering contribute to the cost. SynCardia Systems' Total Artificial Heart (TAH-t) was one of the market's leading TAHs. The device alone could cost USD 100,000 to USD 125,000, not adding any associated costs. 

The surgical procedure for implanting an artificial heart could cost several hundred thousand dollars or more in the United States. The overall cost is determined by factors such as the hospital, the state of the patient, and the necessity for post-operative care. The high cost of mechanical hearts can make them inaccessible, especially in areas with low healthcare resources or where patients lack insurance coverage.

Global Artificial Heart Market Opportunity

Technological Advancement

Technological advancements have allowed for the creation of smaller, more efficient artificial cardiac devices. Miniaturization enables less invasive surgical treatments and greater patient comfort. The SynCardia 50cc Total Artificial Heart, a smaller variant of the original TAH-t, displays miniaturization advances. This device is intended to fit a broader spectrum of patients, potentially broadening its application. Furthermore, materials science advances have resulted in the use of more biocompatible and long-lasting materials in artificial heart development. These materials can lower the risk of problems while extending the equipment's lifespan.

In addition, artificial intelligence and machine learning technologies are used to analyze data from artificial cardiac devices. This can aid in the prediction of future issues, the optimization of device settings, and the improvement of patient care. AI algorithms can evaluate patient data, such as heart rate and device characteristics, to find patterns that may suggest device malfunction or poor patient health, enabling preemptive interventions. These technical breakthroughs not only increase the performance and safety of artificial hearts, but they also have the potential to lower total healthcare costs by reducing problems and hospital readmissions. The outlook for artificial heart patients is projected to improve dramatically as technology advances.

Regional Analysis

The global artificial heart market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global artificial heart market shareholder and is estimated to grow at a CAGR of 4% over the forecast period. North America is expected to maintain its significant market share during the forecast period. The growing incidence of cardiovascular disorders, rising adoption of technologies, increasing product approvals, increasing investments, and major initiatives taken by key market participants are the fundamental driving factors for the growth of the North American artificial heart market. The United States is predicted to grow significantly within North America during the research period. The increased prevalence of cardiovascular disorders resulting from heart failure is projected to fuel improvements in the global market. For example, heart disease is one of the main causes of death in the United States, according to the Centers for Disease Control and Prevention's (CDC) article titled 'Heart Disease Facts,' updated in February 2022. According to the same source, over 659,000 Americans yearly experience a heart attack. As the mortality rate from heart illness rises, there is an ongoing need for devices to improve heart efficiency, boosting the researched market.

In addition, the introduction of new products and services in the region will also greatly impact the market. For example, the United States Food and Drug Administration (FDA) permitted Carmat to utilize the updated version of its mechanical heart in its United States early feasibility study (EFS) in February 2021. Based on clinical experience obtained in the PIVOTAL research, this updated device version contains enhancements to the prosthesis and the wearable system. This invention is intended to increase patient safety and quality of life. The market will be driven by increased research and development initiatives to develop technologies supporting cardiac function. For example, in February 2022, Harvard University researchers created a school of fish that swims autonomously by using the contractions of human heart cells. This trial could progress pacemaker technology and improve the development of human and mechanical hearts, driving the market.

Europe is anticipated to exhibit a CAGR of 4.3% over the forecast period. Globally, as new treatment facilities become available and healthcare unit costs grow, the global market thrives, and medical devices gain a significant market share. Heart failure will impact more than 10 million persons in the EU by 2023. Cardiovascular disease kills 3.9 million individuals annually in Europe, accounting for 45% of all deaths. 

According to the European Heart Network, more than 10 million people in the EU are at risk of developing heart failure. While transplants can provide a remedy, few patients are on waiting lists for such a procedure due to a significant global lack of donor hearts. As a result, the promise of a viable artificial alternative provides a lifeline for many. ArtOfHeart is investing 38 million Euros in clinical and pre-clinical testing of an artificial heart produced by the Swedish business Scandinavian Real Heart AB, with funding from the European Innovation Council (EIC). According to the European Society of Cardiology, prosthetic heart valve transplantation is common because cardiovascular disease is the primary cause of mortality and morbidity in various European regions. The price of artificial heart valves is a crucial factor pushing up market size.

The Asia-Pacific region is regarded as the fastest-growing region, owing to a large patient pool, the adoption of speedier healthcare technologies, and government measures to strengthen healthcare unit infrastructure. They have also implemented insurance policies that have contributed to the growth of the artificial heart sector. With lower clinical trial and research costs, market players have established their headquarters and production units in Singapore, South Korea, China, Australia, and Japan, among other places. These regions have shown positive exponential growth, which has helped market growth. 

Furthermore, a person's serum cholesterol level is the primary cause of the region's increasing number of coronary heart diseases (CHD). According to the National Center for Biotechnology Information National Library of Medicine, Asia-Pacific countries such as Australia and Singapore ranked high for coronary heart diseases (CHD) in 2020, with a mortality rate of over 150 fatalities per 100,000 people. Another critical factor that remains the top cause of death in Asia-Pacific is the rise in cardiovascular diseases (CVD). Doctors believe that artificial heart implantation is the most effective and life-saving treatment that can reduce the death rate in the region caused by cardiac problems. The rising mortality rate from cardiac illnesses will likely drive substantial growth in the Asia-Pacific Artificial Card Market over the forecast period.

The Middle East and Africa show stable increases due to a lack of knowledge, treatment facilities, and limited access, resulting in slower growth in these regions. The United Arab Emirates and some regions of Saudi Arabia cover a dominant market share in several Middle Eastern regions, which pushes up the development facilities of medicals and clinics and enhances the availability of healthcare centers.

Segmental Analysis

The global artificial heart market is segmented based on type, application, and region.

By type is further segmented into Total Artificial Heart and Ventricular Assist Device (VAD).

Total Artificial Heart (TAH) accounts for the largest share of the market. A Total Artificial Heart (TAH) is a medical device that replaces the natural heart's left and right ventricles. It is a total heart replacement that takes over the heart's pumping motion and provides circulatory assistance to individuals with end-stage heart failure. TAHs comprise two pump chambers for each ventricle and are linked to the patient's native atria. They are typically powered by an external pneumatic driver or console that controls the pumping activity and are surgically implanted in the chest. One of the most well-known commercial TAH devices is SynCardia Systems' Total Artificial Heart (TAH-t). It has been used in a variety of clinical settings around the world.

A Ventricular Assist Device (VAD), also known as a mechanical circulatory support device, is a medical device that aids in the pumping of blood by the left ventricle (LVAD), right ventricle (RVAD), or both (BiVAD). Unlike TAHs, VADs work in combination with the patient's normal heart rather than replacing it entirely.

By application, the segment can be further bifurcated into Clinics and hospitals.

Hospitals influenced the market growth. Hospitals are larger healthcare facilities that offer various medical services such as inpatient care, surgical operations, emergency care, and specialized therapies. Hospitals have the infrastructure for surgeries, intensive care, and equipment to treat more difficult cases. In hospitals, artificial hearts, such as total artificial hearts (TAHs) or ventricular assist devices (VADs), are surgically implanted. Hospitals are frequently utilized as transplant centers for heart transplants, and artificial hearts can be employed as bridge-to-transplant therapies.

Clinics are outpatient medical facilities where patients receive medical care, consultation, and treatment. Clinics range in size and expertise, from tiny private offices to bigger specialist clinics like cardiology or heart failure clinics.

Recent Developments

• March 2023- BiVACOR Receives USD 18 Million in Funding to Advance Total Artificial Heart Studies in Humans.
• September 2023- Abbott (NYSE: ABT) announced the completion of its acquisition of Bigfoot Biomedical, a leader in the development of smart insulin management devices for people with diabetes.