Endomyocardial Biopsy Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Forceps, Accessories), By Tip (Maxi-curved, Straight, Pre-curved, Others), By End-Use (Hospitals, Ambulatory Surgical Centers, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 371.68 Million
CAGR (2026-2031)	6.73%
Fastest Growing Segment	Forceps
Largest Market	North America
Market Size (2031)	USD 549.41 Million

Market Overview

The Global Endomyocardial Biopsy Market will grow from USD 371.68 Million in 2025 to USD 549.41 Million by 2031 at a 6.73% CAGR. Endomyocardial biopsy is an invasive diagnostic procedure involving the extraction of small tissue samples from the heart muscle using a bioptome, primarily utilized to detect allograft rejection in transplant recipients and to diagnose specific cardiomyopathies. The market is fundamentally driven by the rising global incidence of heart failure and a concurrent increase in heart transplantation procedures, which necessitate frequent post-operative surveillance to ensure graft survival. Furthermore, continuous improvements in catheter guidance technologies and the safety profiles of biopsy forceps reinforce the adoption of this diagnostic standard in clinical settings.

According to the International Society for Heart and Lung Transplantation, in 2024, more than 6,000 heart transplant procedures were performed worldwide. This procedural volume directly sustains demand for biopsy devices, as recipients typically undergo multiple surveillance biopsies during the critical first year post-transplant. Despite this steady demand, the market faces a significant impediment regarding the invasive nature of the procedure, as the associated risks of complications such as perforation encourage the development and preference for non-invasive diagnostic alternatives like cardiac magnetic resonance imaging.

Key Market Drivers

The increasing volume of global heart transplant procedures acts as the primary catalyst for market growth, as these surgeries necessitate rigorous post-operative surveillance to detect allograft rejection. Since endomyocardial biopsy remains the clinical standard for this monitoring, every transplant creates a recurring need for device utilization throughout the patient's recovery. According to United Network for Organ Sharing, January 2024, in the 'All-time records again set in 2023 for organ transplants' news release, healthcare providers performed 4,519 heart transplants in the United States during 2023. This volume sustains high demand for surveillance, a trend mirrored globally; according to NHS Blood and Transplant, in 2024, the active waiting list for heart transplants in the United Kingdom reached 328 patients by year-end, indicating sustained pressure on cardiac units to maintain robust biopsy capabilities for future recipients.

Concurrently, the escalating prevalence of cardiomyopathies and myocarditis drives the necessity for precise tissue characterization to guide therapeutic interventions. When non-invasive imaging provides inconclusive results regarding heart failure etiology, clinicians rely on tissue extraction to differentiate between complex conditions like giant cell myocarditis and cardiac amyloidosis. According to the American Heart Association, January 2024, in the 'Heart Disease and Stroke Statistics—2024 Update' published in Circulation, approximately 6.7 million adults in the United States currently have heart failure. This substantial disease burden ensures a steady requirement for diagnostic biopsies, as physicians increasingly prioritize histological analysis to determine optimal management strategies for patients presenting with unexplained cardiac dysfunction.

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Key Market Challenges

The primary challenge hampering the Global Endomyocardial Biopsy Market is the procedure's invasive nature, which creates a substantial barrier to widespread adoption. The extraction of heart muscle tissue carries inherent risks of severe complications, including cardiac perforation, valve damage, and arrhythmias. These safety concerns deter clinicians from performing the procedure frequently, even when longitudinal monitoring is clinically indicated. Consequently, healthcare providers are increasingly favoring non-invasive diagnostic alternatives, such as cardiac magnetic resonance imaging, which offer safer profiles for detecting pathologies without the morbidity risks associated with physical tissue removal.

This operational limitation directly restricts the market's ability to capitalize on the growing prevalence of cardiovascular conditions. According to the Heart Failure Society of America, in 2024, approximately 6.7 million adults in the United States were living with heart failure. While this substantial disease burden represents a massive addressable market for diagnostic surveillance, the risks associated with biopsies prevent the procedure from becoming the routine standard of care for this expanding population. Instead, the market is constrained to a smaller subset of critical cases where invasive risks are deemed acceptable, thereby limiting overall growth momentum.

Key Market Trends

The transition to molecular and genomic-based rejection monitoring is fundamentally reshaping the Global Endomyocardial Biopsy Market by altering the clinical standard from routine procedural schedules to targeted surveillance. Instead of subjecting heart transplant recipients to frequent invasive interventions, providers are increasingly utilizing non-invasive liquid biopsies to screen for graft injury, reserving tissue extraction exclusively for patients presenting with elevated molecular markers. This protocol shift directly reduces the aggregate volume of unnecessary procedures while maintaining rigorous oversight of graft health. According to CareDx, Inc., May 2024, in the 'Landmark Study Shows CareDx's HeartCare Outperforms dd-cfDNA Alone' press release, findings from the SHORE registry indicated that cardiologists performed 40% fewer biopsies in the second year post-transplant when utilizing multimodal molecular surveillance strategies compared to standard biopsy-led protocols.

Simultaneously, the implementation of AI-driven digital pathology workflows is modernizing the post-procedural analysis phase, addressing the critical bottleneck of histological variability in biopsy interpretation. By transitioning from manual microscopy to digitized slide scanning integrated with deep learning algorithms, laboratories can automate the quantification of rejection markers such as lymphocyte infiltration, ensuring greater diagnostic consistency across different cardiac centers. This technological integration enhances the clinical utility of every biopsy performed, justifying the procedure's invasive nature through superior data extraction. According to CAP TODAY, December 2024, in the 'Digital pathology at 10% adoption and in lab plans' article, the adoption rate of digital pathology solutions in clinical laboratories has reached approximately 10%, indicating a pivotal move toward automated diagnostics that support high-precision tissue analysis.

Segmental Insights

The Forceps segment is currently recognized as the fastest-growing category within the Global Endomyocardial Biopsy Market due to a heightened focus on infection control and procedural safety. This growth is propelled by the widespread shift toward disposable biopsy forceps, which effectively eliminate the risk of cross-contamination associated with reusable instruments. Furthermore, guidelines from regulatory authorities such as the U.S. Food and Drug Administration regarding device sterilization have reinforced the clinical preference for single-use solutions. These factors, combined with design improvements that enhance navigation in vascular structures, are significantly driving the expansion of this segment.

Regional Insights

North America leads the Global Endomyocardial Biopsy Market due to the high prevalence of heart failure and a corresponding rise in heart transplant procedures. This demand is supported by a well-established healthcare infrastructure that ensures broad access to essential diagnostic tools. Furthermore, the region benefits from the strong presence of major medical device manufacturers, which drives consistent product availability. Regulatory oversight by the U.S. Food and Drug Administration ensures device safety, fostering provider confidence. Comprehensive reimbursement policies for cardiac monitoring also facilitate patient access, solidifying the region's dominant market position.

Recent Developments

• In August 2025, BioCardia, Inc. and CART-Tech, B.V. announced an exclusive partnership to develop and commercialize the Heart3D Fusion Imaging system. This collaboration aims to integrate the technology into cardiac biotherapeutic delivery and endomyocardial biopsy procedures. The system enhances procedural guidance by fusing 3D MRI or CT anatomical models with live fluoroscopy. Under the terms of the agreement, BioCardia obtained exclusive rights to distribute the technology for cardiac biopsy applications in the United States. This collaboration represents a significant advancement in improving the visualization and accuracy of complex cardiac interventions.
• In July 2025, Argon Medical Devices announced the grand opening of its new Distribution & Education Center in Derby, United Kingdom. This state-of-the-art facility serves as a central hub for the company's operations across Europe, the Middle East, Africa, and the Asia-Pacific regions. The initiative was designed to accelerate the distribution of Argon's comprehensive product portfolio, including its Jawz Endomyocardial Biopsy Forceps, and to foster stronger collaborative partnerships with regional stakeholders. Additionally, the center includes a Clinical Education Center to provide advanced training, supporting the effective use of Argon’s interventional technologies.
• In May 2024, EPflex Feinwerktechnik GmbH announced the publication of a significant research paper regarding its MR-conditional bioptome. The study, authored by collaborating clinical partners, evaluated the efficacy and safety of performing MRI-guided heart biopsies using the company's specialized device. This breakthrough research demonstrates the viability of using magnetic resonance imaging to guide endomyocardial biopsy procedures, offering a radiation-free alternative to traditional fluoroscopy. The publication reflects the company's ongoing dedication to developing innovative, MR-compatible instruments that enhance diagnostic accuracy and patient safety in the field of interventional cardiology.
• In March 2024, Merit Medical Systems, Inc. entered into an asset purchase agreement with Scholten Surgical Instruments, Inc. to acquire the assets associated with the Bioptome, Novatome, and Sensatome devices. These products are established technologies in the global endomyocardial biopsy market, known for their precision in obtaining heart tissue samples. The total purchase price included an up-front payment of $3 million, along with future deferred payments. This strategic acquisition allowed Merit Medical to strengthen its position in the cardiac intervention space by adding these specialized single-use biopsy forceps to its diverse portfolio of medical devices.

Key Market Players

• Argon Medical Devices Inc.
• Cordis
• Mermaid Medical Group
• Terumo Corp.
• Scholten Surgical Instruments, Inc.
• Changzhou Toolmed Medical Instrument Co., Ltd.
• Fehling Surgical Instruments Inc.
• SternMed GmbH
• Olympus Corporation of the Americas
• Heart Medical Europe BV

By Product	By Tip	By End-Use	By Region
Forceps Accessories	Maxi-curved Straight Pre-curved Others	Hospitals Ambulatory Surgical Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Endomyocardial Biopsy Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Endomyocardial Biopsy Market, By Product:

• Forceps
• Accessories

• Endomyocardial Biopsy Market, By Tip:

• Maxi-curved
• Straight
• Pre-curved
• Others

• Endomyocardial Biopsy Market, By End-Use:

• Hospitals
• Ambulatory Surgical Centers
• Others

• Endomyocardial Biopsy Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE