North America Heart-lung Machine Market Outlook to 2030

Region:North America

Author(s):Yogita Sahu

Product Code:KROD7025

Published On

November 2024

Total pages

84

About the Report

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.

North America Heart-Lung Machine Market Size

  • 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.

North America Heart-Lung Machine Market Segmentation by Product Type

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 Segmentation by Application Type

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, LivaNova, 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

LivaNova 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.

Scope of the Report

By Product Type

Single Roller Pump Machines

Double Roller Pump Machines

Microplegia Machines

By Application

Cardiac Surgery

Lung Surgery

ECMO Procedures

By Component

Pumps

Oxygenators

Cannulae

Tubing Systems

By End User

Hospitals

Specialty Cardiac Centers

Ambulatory Surgery Centers

By Region

United States

Canada

Mexico

Products

Key Target Audience Organizations and Entities Who Can Benefit by Subscribing This Report:

  • Banks and Financial institution

  • Heart-Lung Machine Manufacturers

  • Government and Regulatory Bodies (e.g., FDA, Health Canada)

  • Healthcare Companies

  • Investor and Venture Capitalist Firms

  • Private Equity Firms

Companies

Players Mentioned in the Report:

  • Medtronic

  • LivaNova PLC

  • Terumo Cardiovascular Systems

  • Getinge AB

  • Braile Biomedica

  • HeartWare International

  • MAQUET

  • Sorin Group

  • Edwards Lifesciences

  • Xenios AG

Table of Contents

1. North America Heart-lung Machine Market Overview

1.1. Definition and Scope
1.2. Market Taxonomy
1.3. Market Growth Rate
1.4. Market Segmentation Overview

2. North America Heart-lung Machine Market Size (In USD Mn)

2.1. Historical Market Size
2.2. Year-On-Year Growth Analysis
2.3. Key Market Developments and Milestones

3. North America Heart-lung Machine Market Analysis

3.1. Growth Drivers (Increased Cardiovascular Surgeries, Technological Advancements in Cardiac Surgery, Hospital Infrastructure Investment, Rise in Geriatric Population)
3.2. Market Challenges (High Costs of Heart-lung Machines, Limited Skilled Personnel, Regulatory Barriers, Maintenance Requirements)
3.3. Opportunities (Integration with ECMO Systems, Miniaturization of Heart-lung Machines, Rise in Telemedicine and Remote Surgery Solutions, Cross-border Collaborations)
3.4. Trends (Adoption of AI and IoT in Heart-lung Machine Systems, Increasing Use of Disposable Circuits, Hybrid Operating Rooms, Growth in Outpatient Cardiac Procedures)
3.5. Government Regulation (FDA Approvals, Health Canada Regulations, Device Classification Changes, Medical Device Reporting Standards)
3.6. SWOT Analysis
3.7. Stakeholder Ecosystem
3.8. Porters Five Forces
3.9. Competition Ecosystem

4. North America Heart-lung Machine Market Segmentation
4.1. By Product Type (In Value %)
4.1.1. Single Roller Pump Machines
4.1.2. Double Roller Pump Machines
4.1.3. Microplegia Machines
4.2. By Application (In Value %)
4.2.1. Cardiac Surgery
4.2.2. Lung Surgery
4.2.3. ECMO Procedures
4.3. By Component (In Value %)
4.3.1. Pumps
4.3.2. Oxygenators
4.3.3. Cannulae
4.3.4. Tubing Systems
4.4. By End User (In Value %)
4.4.1. Hospitals
4.4.2. Specialty Cardiac Centers
4.4.3. Ambulatory Surgery Centers
4.5. By Region (In Value %)
4.5.1. United States
4.5.2. Canada
4.5.3. Mexico

5. North America Heart-lung Machine Market Competitive Analysis

5.1. Detailed Profiles of Major Companies
5.1.1. Medtronic
5.1.2. LivaNova PLC
5.1.3. Terumo Cardiovascular Systems
5.1.4. Getinge AB
5.1.5. MAQUET
5.1.6. Sorin Group
5.1.7. HeartWare International
5.1.8. Braile Biomedica
5.1.9. Fresenius SE & Co. KGaA
5.1.10. Biomedica GmbH
5.1.11. Spectrum Medical
5.1.12. Edwards Lifesciences
5.1.13. Abbott Laboratories
5.1.14. Medsphere Systems Corporation
5.1.15. Xenios AG

5.2. Cross Comparison Parameters (R&D Expenditure, Product Portfolio, Market Share, Product Launches, Number of Employees, Headquarters Location, Certifications, Partnerships/Collaborations)
5.3. Market Share Analysis
5.4. Strategic Initiatives
5.5. Mergers and Acquisitions
5.6. Investment Analysis
5.7. Venture Capital Funding
5.8. Government Grants
5.9. Private Equity Investments

6. North America Heart-lung Machine Market Regulatory Framework

6.1. Regulatory Bodies and Guidelines
6.2. Compliance Requirements
6.3. Certification Processes
6.4. Impact of Device Reclassifications

7. North America Heart-lung Machine Future Market Size (In USD Mn)

7.1. Future Market Size Projections
7.2. Key Factors Driving Future Market Growth

8. North America Heart-lung Machine Future Market Segmentation

8.1. By Product Type (In Value %)
8.2. By Application (In Value %)
8.3. By Component (In Value %)
8.4. By End User (In Value %)
8.5. By Region (In Value %)

9. North America Heart-lung Machine Market Analysts Recommendations

9.1. TAM/SAM/SOM Analysis
9.2. White Space Opportunity Analysis
9.3. Product Portfolio Enhancement Strategies
9.4. Marketing and Distribution Strategies

Disclaimer Contact Us

Research Methodology

Step 1: Identification of Key Variables

The initial phase involves constructing an ecosystem map encompassing all major stakeholders within the North America Heart-lung Machine Market. This step is underpinned by extensive desk research, utilizing a combination of secondary and proprietary databases to gather comprehensive industry-level information. The primary objective is to identify and define the critical variables that influence market dynamics.

Step 2: Market Analysis and Construction

In this phase, we will compile and analyze historical data pertaining to the North America heart-lung machine market. This includes assessing market penetration, revenue generation, and utilization of heart-lung machines in major hospitals. Additionally, an evaluation of device quality and functionality statistics will ensure the reliability of the revenue estimates.

Step 3: Hypothesis Validation and Expert Consultation

Market hypotheses will be developed and validated through interviews with industry experts from leading manufacturers and hospitals. These consultations will provide valuable insights into heart-lung machine applications and market strategies, refining the data collected during the initial phases.

Step 4: Research Synthesis and Final Output

The final phase involves direct engagement with healthcare institutions and machine manufacturers to acquire detailed insights into the product segments, sales performance, and consumer preferences. This interaction will ensure a comprehensive, accurate, and validated analysis of the North America heart-lung machine market.

 

Frequently Asked Questions

01. How big is the North America Heart-lung Machine Market?

The North America heart-lung machine market is valued at USD 956 million, driven by the increasing number of cardiovascular surgeries and the adoption of advanced medical technologies in cardiac care.

02. What are the challenges in the North America Heart-lung Machine Market?

Challenges in the North America heart-lung machine market include the high costs associated with heart-lung machines, the need for highly skilled operators, and stringent regulatory requirements that can slow down product approvals.

03. Who are the major players in the North America Heart-lung Machine Market?

Key players in the North America heart-lung machine market include Medtronic, LivaNova PLC, Terumo Cardiovascular Systems, Getinge AB, and Braile Biomedica, dominating due to their strong research pipelines and extensive market presence.

04. What are the growth drivers of the North America Heart-lung Machine Market?

The North America heart-lung machine market is driven by increasing cardiovascular surgeries, technological advancements in heart-lung machine design, and improvements in healthcare infrastructure, particularly in the U.S. and Canada.

05. What opportunities exist in the North America Heart-lung Machine Market?

Opportunities include the integration of heart-lung machines with ECMO systems, miniaturization of machines for broader hospital use, and international collaborations focusing on innovative cardiac care solutions.

 

Why Buy From Us?

RRR
Refine Robust Result (RRR) Framework

What makes us stand out is that our consultants follows Robust, Refine and Result (RRR) methodology. i.e. Robust for clear definitions, approaches and sanity checking, Refine for differentiating respondents facts and opinions and Result for presenting data with story

Our Reach Is Unmatched
Our Reach Is Unmatched

We have set a benchmark in the industry by offering our clients with syndicated and customized market research reports featuring coverage of entire market as well as meticulous research and analyst insights.

Research
Shifting the Research Paradigm

While we don't replace traditional research, we flip the method upside down. Our dual approach of Top Bottom & Bottom Top ensures quality deliverable by not just verifying company fundamentals but also looking at the sector and macroeconomic factors.

Insite
More Insights-Better Decisions

With one step in the future, our research team constantly tries to show you the bigger picture. We help with some of the tough questions you may encounter along the way: How is the industry positioned? Best marketing channel? KPI's of competitors? By aligning every element, we help maximize success.

Trust
Transparency and Trust

Our report gives you instant access to the answers and sources that other companies might choose to hide. We elaborate each steps of research methodology we have used and showcase you the sample size to earn your trust.

support
Round the Clock Support

If you need any support, we are here! We pride ourselves on universe strength, data quality, and quick, friendly, and professional service.

Why Client Choose Us?

400000+ Reports in repository
150+ Consulting project a year
100+ Analysts
8000+ Client Queries in 2022