North America Heart-lung Machine Market Outlook to 2028

North America Heart-Lung Machine Market Overview

The North America heart-lung machine market is valued at USD 956 million, based on a five-year historical analysis. The market is driven by the increasing prevalence of cardiovascular diseases, particularly in older populations, leading to a rising number of surgeries requiring heart-lung machines. Significant advancements in healthcare infrastructure and improvements in cardiac surgery procedures also drive market demand.

Key regions dominating the market include the United States and Canada. The United States leads due to its highly advanced healthcare infrastructure, presence of top-tier medical device companies, and a large number of cardiac surgeries performed annually. Canada follows closely due to growing investments in healthcare and a robust surgical network.

In 2024, Medicaid programs across multiple states in the U.S. have expanded their coverage for cardiac surgeries. This includes providing subsidies to hospitals that purchase heart-lung machines. With nearly 70 million Medicaid beneficiaries, the expanded coverage for cardiac procedures is expected to drive the demand for heart-lung machines across the U.S.

North America Heart-Lung Machine Market Segmentation

By Product Type: The market is segmented by product type into Single Roller Pump Machines, Double Roller Pump Machines, and Microplegia Machines. Among these, Single Roller Pump Machines hold the dominant market share. This is due to their widespread usage in both cardiac and lung surgeries. The precision, reliability, and ease of use offered by single roller pump machines make them the preferred choice for complex cardiac procedures.

By Application: The market is also segmented by application into Cardiac Surgery, Lung Surgery, and ECMO Procedures. Cardiac Surgery dominates this segmentation, accounting for the highest market share. This dominance is primarily attributed to the high number of cardiovascular procedures performed each year, driven by the increasing prevalence of coronary artery disease and other heart conditions. Hospitals and specialized cardiac centers prefer heart-lung machines for procedures such as coronary artery bypass grafting (CABG) and valve replacements, further cementing the dominance of this application segment.

North America Heart-Lung Machine Market Competitive Landscape

The market is characterized by the presence of several major players, both global and local, with technological advancements and strategic partnerships shaping the competitive landscape. The market is consolidated, with leading players such as Medtronic, Liva Nova, and Getinge AB holding market shares.

Company

Established

Headquarters

No. of Employees

Revenue (USD Mn)

R&D Expenditure

Key Products

Strategic Initiatives

Certifications

Medtronic

1949

Minneapolis, USA

Liva Nova PLC

1988

London, UK

Terumo Cardiovascular

1971

Ann Arbor, USA

Getinge AB

1904

Gothenburg, Sweden

MAQUET Cardiovascular

1838

Rastatt, Germany

North America Heart-Lung Machine Market Analysis

Market Growth Drivers

Rising Cardiovascular Diseases: In 2024, cardiovascular diseases are estimated to impact over 17 million people in North America, driven by poor lifestyle choices and genetic factors. The increasing number of heart disease cases necessitates more heart-lung machines for surgeries. In the United States alone, over 500,000 cardiac surgeries are performed annually, directly correlating to the increasing demand for these machines. The macroeconomic environment in 2024, with increased healthcare spending by $4 trillion, further supports the investment in advanced cardiac care technologies, boosting the demand for heart-lung machines.

Aging Population in North America: The population of individuals aged 65 and older is expected to exceed 60 million in North America by 2024. As this demographic is more prone to cardiovascular diseases and requires more complex surgical procedures, there is a significant rise in demand for heart-lung machines. For example, the aging population in Canada is projected to require over 60,000 open-heart surgeries annually, which will directly increase the need for heart-lung machines in hospitals across the region.

Expansion of Specialized Cardiac Hospitals: North America is seeing a boom in the establishment of specialized cardiac care hospitals. By 2024, over 150 specialized cardiac centers are expected to operate in the U.S. alone. These centers require cutting-edge equipment, including heart-lung machines, to manage the growing patient volumes and to cater to complex surgeries. Furthermore, healthcare infrastructure investments of over $400 billion in 2024 provide a foundation for the expansion of these facilities, driving the adoption of advanced heart-lung machines.

Market Challenges

Lack of Skilled Technicians: The operation of heart-lung machines requires highly trained perfusionists, of which there is a shortage in North America. In 2024, only 4,000 certified perfusionists are active in the U.S., creating a bottleneck for healthcare providers looking to expand their cardiac care offerings. This lack of skilled technicians restricts the full utilization of heart-lung machines, even where demand for cardiac surgeries is high.

Regulatory Compliance and Approval Process: Stringent regulatory frameworks by bodies like the U.S. Food and Drug Administration (FDA) slow the approval and commercialization of heart-lung machines. In 2024, new machine designs face an average approval period of 18 months, which delays their entry into the market. Additionally, the high costs associated with meeting compliance regulations, including testing and certification, make it harder for manufacturers to launch new models quickly.

North America Heart-Lung Machine Market Future Outlook

Over the next five years, the North America heart-lung machine industry is expected to experience notable growth driven by a combination of increasing cardiac surgeries, technological advancements, and expanding healthcare infrastructure.

Future Market Opportunities

Increased Use of AI in Heart-lung Machines: Over the next five years, AI integration will dominate the heart-lung machine market, with over 80% of newly purchased machines incorporating AI for real-time monitoring and predictive analytics. By 2029, AI-powered machines are expected to reduce surgery errors by 30%, enhancing the efficiency and outcomes of cardiac surgeries.

Growing Adoption of Telemedicine in Cardiac Surgeries: By 2029, it is projected that telemedicine will play a larger role in assisting cardiac surgeries in remote regions of North America. Heart-lung machines will be integrated into remote-controlled surgery setups, allowing expert surgeons to perform procedures virtually, increasing access to advanced care in underserved areas.
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