North America Endomyocardial Biopsy Devices Market Size and Forecast (2021

Description

List of Tables

The North America Endomyocardial Biopsy Devices Market is projected to reach US$ 261,299.7 Thousand by 2034, up from US$ 181,617.3 Thousand in 2025. The market is anticipated to register a CAGR of 4.1% from 2026 to 2034.

Executive Summary and North America Endomyocardial Biopsy Devices Market Analysis:

The North America endomyocardial biopsy devices market is being supported by regulatory developments, technological advancements, and growing innovation in cardiac intervention and tissue-sampling technologies. Recent developments involving BioCardia, Inc. highlight the role of regulatory engagement in accelerating the development of advanced cardiac delivery systems. On March 17, 2026, BioCardia announced that the US Food and Drug Administration (FDA) had accepted its pre-submission package for the Helix Transendocardial Delivery Catheter following preliminary discussions with the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).

The development demonstrates increasing collaboration between medical device and biologics regulatory pathways, particularly for technologies that combine biopsy-guided diagnosis with targeted myocardial therapies. Under the anticipated regulatory framework, CDRH is expected to take the lead in reviewing the technology in consultation with CBER, while the CardiAMP Cell Therapy Breakthrough Designation provides additional regulatory support. Pre-submission consultations and breakthrough programs can reduce development uncertainty and encourage manufacturers to invest in minimally invasive cardiac biopsy technologies. These developments are expected to support innovation, commercialization, and adoption of advanced endomyocardial biopsy solutions throughout North America.

Strategic Insights

North America Endomyocardial Biopsy Devices Market Segmentation Analysis:

By Product Type, the North America Endomyocardial Biopsy Devices Market is segmented into Biopsy Forceps and Catheters, Guidance Systems, and Accessories. The Biopsy Forceps and Catheters segment dominated the market in 2025.

By Biopsy Forceps and Catheters, the market is divided into Standard Endomyocardial Biopsy Forceps and Flexible Biopsy Catheters. The Standard Endomyocardial Biopsy Forceps segment held the largest share in 2025.

By Guidance Systems, the market is categorized into Fluoroscopy-Guided Systems, Echocardiography-Guided Systems, and Emerging Robotic Navigation Systems. The Fluoroscopy-Guided Systems segment led the market in 2025.

By Accessories, the market includes Introducer Sheaths, Guidewires, and Localization Tools. The Introducer Sheaths segment accounted for the dominant share in 2025.

By Guidance Technique, the market is segmented into Fluoroscopy-Guided EMB, Echocardiography-Guided EMB, and Hybrid Techniques. The Fluoroscopy-Guided EMB segment dominated the market in 2025.

By Application, the market is divided into Transplant Rejection Monitoring, Myocarditis Diagnosis, Cardiomyopathy Evaluation, and Other Cardiac Pathologies. The Transplant Rejection Monitoring segment held the leading position in 2025.

By End User, the market is segmented into Cardiac Centers and Hospitals, Diagnostic and Research Institutes, and Academic Institutions. The Cardiac Centers and Hospitals segment dominated the market in 2025.

Market Report Scope

North America Endomyocardial Biopsy Devices Market Outlook

The increasing number of heart transplantation procedures is creating sustained demand for endomyocardial biopsy (EMB), which remains an important reference method for monitoring rejection following transplantation. Heart transplant recipients require regular surveillance to identify immune-mediated rejection at an early stage, as untreated rejection can compromise graft function and patient outcomes. EMB devices enable physicians to obtain myocardial tissue samples for histopathological evaluation, making them an important component of post-transplant monitoring. As transplant survival improves and patients remain under long-term clinical observation, the requirement for repeated biopsy procedures over the patient's lifetime also increases, supporting recurring demand for biopsy forceps and catheter-based devices.

Growth in transplantation is further supported by developments such as Donation after Circulatory Death (DCD) and improvements in organ preservation technologies. Data from the International Society for Heart and Lung Transplantation (ISHLT), covering more than 22,000 heart transplant recipients globally from 2015 to 2024, indicates that DCD represented approximately 8.8% of heart transplants in North America and around 19% in Europe. The difference highlights additional potential for DCD expansion in North America. Some transplant centers have reported transplant-volume increases of up to 30% following implementation of DCD programs. A larger donor pool translates into more transplant recipients entering long-term monitoring programs, thereby increasing the number of patients requiring EMB procedures, particularly during the first year following transplantation.

Although imaging technologies and biomarker-based approaches continue to advance, biopsy-based evaluation remains important for confirming and grading conditions such as acute cellular rejection and antibody-mediated rejection. Standardized transplant protocols therefore continue to generate consistent procedural demand. As transplant capabilities expand into additional geographic areas and healthcare systems develop more specialized cardiac centers, EMB devices remain an essential part of post-transplant care. The combined impact of rising transplantation volumes, longer patient survival, and repeated protocol-based biopsies is expected to sustain demand for endomyocardial biopsy devices across the broader cardiac care ecosystem.

North America Endomyocardial Biopsy Devices Market Country Insights

By country, the North America Endomyocardial Biopsy Devices Market is segmented into the United States, Canada, and Mexico. The United States held the largest market share in 2025.

The US market benefits from advanced healthcare infrastructure, stringent regulatory standards, and the presence of major medical device manufacturers. The US Food and Drug Administration (FDA), particularly through its Center for Devices and Radiological Health (CDRH), establishes rigorous requirements for the safety and effectiveness of biopsy technologies while providing regulatory mechanisms such as breakthrough device programs and pre-submission consultations that can facilitate innovation.

Clear regulatory processes help strengthen physician confidence and support the introduction of minimally invasive catheter-based biopsy technologies. Established reimbursement structures and clinical recommendations from organizations such as the American College of Cardiology further contribute to procedural adoption. Ongoing product development by major medical technology companies, including Abbott Laboratories, Boston Scientific Corporation, and Medtronic plc, is supporting innovation in areas such as disposable biopsy forceps, catheter navigation, and imaging-assisted systems. Combined with the substantial cardiovascular disease burden and continued requirements for heart transplant surveillance, these factors are sustaining demand for accurate myocardial tissue sampling across the US healthcare system.

North America Endomyocardial Biopsy Devices Market Company Profiles

Key companies operating in the market include Terumo Corp, Argon Medical Devices, Koninklijke Philips NV, GE HealthCare Technologies Inc, Siemens Healthineers AG, Cordis Corp, Scholten Surgical Instruments, Inc., Changzhou Lookmed Medical Instrument Co., Ltd., FEHLING INSTRUMENTS GmbH, and WILDmedical GmbH.

These companies are pursuing strategies such as business expansion, product development and innovation, strategic collaborations, and mergers and acquisitions to introduce advanced solutions, strengthen their competitive positioning, expand their customer base, and increase market share.

Product Code: TIPRE00043893

1. Executive Summary

1.1 Analyst Market Outlook

2. Global Endomyocardial Biopsy Devices Market Landscape

2.1 Overview
2.2 Value Chain Analysis
2.3 Supply Chain Analysis
- 2.3.1 List of Manufacturers/Suppliers
- 2.3.2 List of Potential Customers (Upto 50)
2.4 Porter's Five Forces Analysis
2.5 PEST Analysis

3. Competitive Landscape

3.1 Company Benchmarking by Key Players
3.2 Market Share Analysis, 2025 - By Key Players
3.3 Market Concentration

4. North America Endomyocardial Biopsy Devices Market - Key Industry Dynamics

4.1 Market Drivers
4.2 Market Restraints
4.3 Market Opportunities
4.4 Future Trends
4.5 Impact of Drivers and Restraints:

5. Endomyocardial Biopsy Devices Market - North America Analysis

5.1 North America Endomyocardial Biopsy Devices Market Revenue (US$ Thousand), 2021 - 2034
5.2 North America Endomyocardial Biopsy Devices Market Revenue Forecast and Analysis

6. North America Endomyocardial Biopsy Devices Market Revenue Analysis - by Product Type

6.1 North America Endomyocardial Biopsy Devices Market Forecast and Analysis by Product Type
- 6.1.1 Biopsy Forceps and Catheters
  - 6.1.1.1 Overview
  - 6.1.1.2 Biopsy Forceps and Catheters: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
- 6.1.2 Guidance Systems
  - 6.1.2.1 Overview
  - 6.1.2.2 Guidance Systems: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
- 6.1.3 Accessories
  - 6.1.3.1 Overview
  - 6.1.3.2 Accessories: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)

7. North America Endomyocardial Biopsy Devices Market Revenue Analysis - by Biopsy Forceps And Catheters

7.1 North America Endomyocardial Biopsy Devices Market Forecast and Analysis by Biopsy Forceps And Catheters
- 7.1.1 Standard endomyocardial biopsy forceps
  - 7.1.1.1 Overview
  - 7.1.1.2 Standard endomyocardial biopsy forceps: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
- 7.1.2 Flexible biopsy catheters
  - 7.1.2.1 Overview
  - 7.1.2.2 Flexible biopsy catheters: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)

8. North America Endomyocardial Biopsy Devices Market Revenue Analysis - by Guidance Systems - Product Type

8.1 North America Endomyocardial Biopsy Devices Market Forecast and Analysis by Guidance Systems - Product Type
- 8.1.1 Fluoroscopy-guided systems
  - 8.1.1.1 Overview
  - 8.1.1.2 Fluoroscopy-guided systems: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
- 8.1.2 Echocardiography-guided systems
  - 8.1.2.1 Overview
  - 8.1.2.2 Echocardiography-guided systems: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
- 8.1.3 Emerging robotic navigation systems
  - 8.1.3.1 Overview
  - 8.1.3.2 Emerging robotic navigation systems: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)

9. North America Endomyocardial Biopsy Devices Market Revenue Analysis - by Accessories

9.1 North America Endomyocardial Biopsy Devices Market Forecast and Analysis by Accessories
- 9.1.1 Introducer sheaths
  - 9.1.1.1 Overview
  - 9.1.1.2 Introducer sheaths: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
- 9.1.2 Guidewires
  - 9.1.2.1 Overview
  - 9.1.2.2 Guidewires: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
- 9.1.3 Localization tools
  - 9.1.3.1 Overview
  - 9.1.3.2 Localization tools: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)

10. North America Endomyocardial Biopsy Devices Market Revenue Analysis - by Guidance Technique

10.1 North America Endomyocardial Biopsy Devices Market Forecast and Analysis by Guidance Technique
- 10.1.1 Fluoroscopy-guided EMB
  - 10.1.1.1 Overview
  - 10.1.1.2 Fluoroscopy-guided EMB: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
- 10.1.2 Echocardiography-guided EMB
  - 10.1.2.1 Overview
  - 10.1.2.2 Echocardiography-guided EMB: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
- 10.1.3 Hybrid techniques
  - 10.1.3.1 Overview
  - 10.1.3.2 Hybrid techniques: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)

11. North America Endomyocardial Biopsy Devices Market Revenue Analysis - by Application

11.1 North America Endomyocardial Biopsy Devices Market Forecast and Analysis by Application
- 11.1.1 Transplant rejection monitoring
  - 11.1.1.1 Overview
  - 11.1.1.2 Transplant rejection monitoring: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
- 11.1.2 Myocarditis diagnosis
  - 11.1.2.1 Overview
  - 11.1.2.2 Myocarditis diagnosis: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
- 11.1.3 Cardiomyopathy evaluation
  - 11.1.3.1 Overview
  - 11.1.3.2 Cardiomyopathy evaluation: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
- 11.1.4 Other cardiac pathologies
  - 11.1.4.1 Overview
  - 11.1.4.2 Other cardiac pathologies: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)

12. North America Endomyocardial Biopsy Devices Market Revenue Analysis - by End User

12.1 North America Endomyocardial Biopsy Devices Market Forecast and Analysis by End User
- 12.1.1 Cardiac centers and hospitals
  - 12.1.1.1 Overview
  - 12.1.1.2 Cardiac centers and hospitals: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
- 12.1.2 Diagnostic and research institutes
  - 12.1.2.1 Overview
  - 12.1.2.2 Diagnostic and research institutes: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
- 12.1.3 Academic institutions
  - 12.1.3.1 Overview
  - 12.1.3.2 Academic institutions: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)

13. North America Endomyocardial Biopsy Devices Market - Country Analysis

13.1 North America
- 13.1.1 North America Endomyocardial Biopsy Devices Market Forecast and Analysis - by Country
  - 13.1.1.1 United States Market
    - 13.1.1.1.1 United States: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
    - 13.1.1.1.2 United States: North America Endomyocardial Biopsy Devices Market - By Segmentation
      - 13.1.1.1.2.1 Product Type
      - 13.1.1.1.2.2 Biopsy Forceps And Catheters
      - 13.1.1.1.2.3 Guidance Systems - Product Type
      - 13.1.1.1.2.4 Accessories
      - 13.1.1.1.2.5 Guidance Technique
      - 13.1.1.1.2.6 Application
      - 13.1.1.1.2.7 End User
  - 13.1.1.2 Canada Market
    - 13.1.1.2.1 Canada: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
    - 13.1.1.2.2 Canada: North America Endomyocardial Biopsy Devices Market - By Segmentation
      - 13.1.1.2.2.1 Product Type
      - 13.1.1.2.2.2 Biopsy Forceps And Catheters
      - 13.1.1.2.2.3 Guidance Systems - Product Type
      - 13.1.1.2.2.4 Accessories
      - 13.1.1.2.2.5 Guidance Technique
      - 13.1.1.2.2.6 Application
      - 13.1.1.2.2.7 End User
  - 13.1.1.3 Mexico Market
    - 13.1.1.3.1 Mexico: North America Endomyocardial Biopsy Devices Market - Revenue and Forecast, 2021 - 2034 (US$ Thousand)
    - 13.1.1.3.2 Mexico: North America Endomyocardial Biopsy Devices Market - By Segmentation
      - 13.1.1.3.2.1 Product Type
      - 13.1.1.3.2.2 Biopsy Forceps And Catheters
      - 13.1.1.3.2.3 Guidance Systems - Product Type
      - 13.1.1.3.2.4 Accessories
      - 13.1.1.3.2.5 Guidance Technique
      - 13.1.1.3.2.6 Application
      - 13.1.1.3.2.7 End User

14 Endomyocardial Biopsy Devices Market Industry Landscape

15 - Key Company Profiles

15.1 Terumo Corp
- 15.1.1 Key Facts
- 15.1.2 Business Description
- 15.1.3 Products and Services
- 15.1.4 Financial Overview
- 15.1.5 SWOT Analysis
- 15.1.6 Key Developments
15.2 Argon Medical Devices
- 15.2.1 Key Facts
- 15.2.2 Business Description
- 15.2.3 Products and Services
- 15.2.4 Financial Overview
- 15.2.5 SWOT Analysis
- 15.2.6 Key Developments
15.3 Koninklijke Philips NV
- 15.3.1 Key Facts
- 15.3.2 Business Description
- 15.3.3 Products and Services
- 15.3.4 Financial Overview
- 15.3.5 SWOT Analysis
- 15.3.6 Key Developments
15.4 GE HealthCare Technologies Inc
- 15.4.1 Key Facts
- 15.4.2 Business Description
- 15.4.3 Products and Services
- 15.4.4 Financial Overview
- 15.4.5 SWOT Analysis
- 15.4.6 Key Developments
15.5 Siemens Healthineers AG
- 15.5.1 Key Facts
- 15.5.2 Business Description
- 15.5.3 Products and Services
- 15.5.4 Financial Overview
- 15.5.5 SWOT Analysis
- 15.5.6 Key Developments
15.6 Cordis Corp
- 15.6.1 Key Facts
- 15.6.2 Business Description
- 15.6.3 Products and Services
- 15.6.4 Financial Overview
- 15.6.5 SWOT Analysis
- 15.6.6 Key Developments
15.7 Scholten Surgical Instruments, Inc.
- 15.7.1 Key Facts
- 15.7.2 Business Description
- 15.7.3 Products and Services
- 15.7.4 Financial Overview
- 15.7.5 SWOT Analysis
- 15.7.6 Key Developments
15.8 Changzhou Lookmed Medical Instrument Co., Ltd.
- 15.8.1 Key Facts
- 15.8.2 Business Description
- 15.8.3 Products and Services
- 15.8.4 Financial Overview
- 15.8.5 SWOT Analysis
- 15.8.6 Key Developments
15.9 FEHLING INSTRUMENTS GmbH
- 15.9.1 Key Facts
- 15.9.2 Business Description
- 15.9.3 Products and Services
- 15.9.4 Financial Overview
- 15.9.5 SWOT Analysis
- 15.9.6 Key Developments
15.10 WILDmedical GmbH
- 15.10.1 Key Facts
- 15.10.2 Business Description
- 15.10.3 Products and Services
- 15.10.4 Financial Overview
- 15.10.5 SWOT Analysis
- 15.10.6 Key Developments

16. Appendix

16.1 Glossary
16.2 Research Methodology and Approach
- 16.2.1 Secondary Research
- 16.2.2 Primary Research
- 16.2.3 Market Estimation Approach
  - 16.2.3.1 Supply Side Analysis
  - 16.2.3.2 Demand Side Analysis
- 16.2.4 Research Assumptions and Limitations
- 16.2.5 Currency Conversion
16.3 About The Insight Partners
16.4 Market Intelligence Cloud