Liver Biopsy Market By Procedure Type (Percutaneous, Transjugular, Laparoscopic); By Target Indication (NAFLD/NASH, Hepatitis, Liver Cancer, Autoimmune Disorders); By End User (Hospitals, Diagnostic Centers, ASCs, Research Institutes); By Geography, Segment Revenue Estimation, Forecast, 2024–2030.

Introduction And Strategic Context

The Global Liver Biopsy Market will witness a moderate yet steady CAGR of 5.8 % , valued at approximately USD 1.53 billion in 2024 , and is expected to appreciate and reach USD 2.28 billion by 2030 , confirms Strategic Market Research.

 

Liver biopsy remains a cornerstone diagnostic procedure for evaluating liver pathology, particularly in chronic liver diseases like hepatitis, non-alcoholic fatty liver disease (NAFLD), cirrhosis, and liver tumors . Despite the rise of non-invasive diagnostic alternatives such as elastography and imaging-based assessments, liver biopsy continues to offer unmatched accuracy in histological diagnosis, grading, and staging.

 

In the evolving landscape of hepatology, liver biopsies retain strategic relevance due to their definitive diagnostic value. From confirming autoimmune liver diseases to guiding therapy in hepatitis B and C, and assessing graft rejection post-liver transplant, liver biopsies have vital clinical significance. This demand is being bolstered by the increasing global incidence of chronic liver diseases, with NAFLD now affecting more than 25% of the global population , largely due to sedentary lifestyles and rising obesity rates.

 

Key macro forces driving this market include:

• Growing disease burden : Increasing incidence of hepatitis B, C, liver fibrosis, and hepatocellular carcinoma across Asia Pacific, the Middle East, and North America.

• Technological advancement : Innovations in imaging-guided biopsy techniques, such as ultrasound- and CT-guided liver biopsies , have enhanced procedural safety and diagnostic accuracy.

• Regulatory pressure for early diagnosis : Health systems are prioritizing early liver disease detection to minimize treatment cost and progression risk.

• Value-based care models : Liver biopsy plays a critical role in personalized treatment planning and longitudinal disease monitoring.

Stakeholders in this market ecosystem include:

• Medical device manufacturers and OEMs : Designing biopsy needles, imaging systems, and robotic-assisted devices

• Hospitals and diagnostic labs : Performing high-volume biopsies in inpatient and outpatient settings

• Biotech and pharma companies : Relying on biopsy samples for drug development and clinical trials

• Government health agencies : Enforcing hepatitis screening and cancer prevention initiatives

• Investors and MedTech startups : Funding AI-integrated biopsy systems and real-time diagnostic tools

As healthcare systems increasingly adopt precision medicine protocols, the liver biopsy market is expected to evolve beyond diagnostics into theranostics —combining tissue sampling with real-time molecular analysis to guide targeted therapies.

 

Market Segmentation And Forecast Scope

The global liver biopsy market can be meaningfully segmented based on procedure type , target indication , end user , and geography . This segmentation framework reflects both the technological diversity of liver biopsy approaches and the wide spectrum of clinical conditions and service delivery environments.

 

By Procedure Type

• Percutaneous Liver Biopsy

• Transjugular Liver Biopsy

• Laparoscopic Liver Biopsy

Percutaneous liver biopsy dominated the market in 2024 , accounting for nearly 63% of all biopsy procedures due to its cost-effectiveness and widespread availability in outpatient settings. However, transjugular liver biopsy is projected to be the fastest-growing segment owing to its safety in patients with coagulopathy or ascites and its increasing use in hospitalized and high-risk populations.

 

By Target Indication

• Hepatitis B & C

• Non-Alcoholic Fatty Liver Disease (NAFLD) & Non-Alcoholic Steatohepatitis (NASH)

• Liver Cancer (Hepatocellular Carcinoma)

• Autoimmune Liver Diseases

• Others (Wilson’s disease, Hemochromatosis, etc.)

The NAFLD & NASH segment is gaining strategic momentum and is expected to exhibit the highest CAGR from 2024 to 2030. The clinical need to differentiate between benign steatosis and progressive NASH has made liver biopsy critical for histopathological staging and enrollment in therapeutic trials.

 

By End User

• Hospitals

• Diagnostic Imaging Centers

• Academic & Research Institutes

• Ambulatory Surgical Centers (ASCs)

Hospitals remain the primary channel, driven by their integrated imaging infrastructure and capacity to manage procedural complications. However, ASCs are emerging as cost-effective alternatives, especially in developed nations seeking to decongest hospital systems.

 

By Region

• North America

• Europe

• Asia Pacific

• Latin America

• Middle East & Africa

North America led the global liver biopsy market in 2024 , supported by structured reimbursement frameworks and strong presence of specialty diagnostic labs. However, Asia Pacific is anticipated to register the fastest CAGR during the forecast period due to the high burden of viral hepatitis, rising liver cancer rates, and increasing healthcare infrastructure investments across countries like China, India, and South Korea.

The intersection of technological adoption, clinical precision, and healthcare decentralization is shaping the forecast trajectory across segments. Institutions increasingly prefer procedure types and technologies that offer higher diagnostic yield with minimal complication rates.

 

Market Trends And Innovation Landscape

The liver biopsy market is undergoing a notable transformation, propelled by innovation in imaging, material science, digital health integration, and evolving clinical workflows. This innovation landscape is significantly enhancing the diagnostic accuracy, safety, and procedural efficiency of liver biopsies.

 

Technological Advancements in Biopsy Tools

One of the most prominent trends is the evolution of biopsy needle design , incorporating finer gauge materials, echogenic markings, and automated spring-loaded mechanisms. These advances reduce sampling errors and improve patient comfort. Single-use disposable biopsy needles are also gaining adoption, driven by infection control protocols and regulatory standards.

Furthermore, robot-assisted liver biopsy systems are emerging in high-end healthcare facilities. These systems combine robotic precision with real-time imaging to target lesions with sub- millimeter accuracy — particularly useful for deep or isoechoic liver lesions.

According to expert insights from interventional radiology departments, the incorporation of robotic assistance and pressure-sensing needle tips has reduced complication rates and enabled safer procedures in obese or coagulopathic patients.

 

Imaging-Guided Biopsy Enhancements

A key innovation layer comes from advanced image guidance techniques . The integration of real-time ultrasound with elastography or CT/MRI fusion imaging provides a clearer anatomical map for clinicians, significantly enhancing the ability to differentiate fibrotic tissue from inflammatory or neoplastic regions.

Moreover, AI-powered imaging analytics are being trialed to assist in biopsy planning and post-procedure risk analysis. These systems use machine learning to predict biopsy yield, procedural risk, and even automate lesion tracking across serial imaging datasets.

 

Liquid Biopsy and Diagnostic Alternatives

While not a direct substitute, liquid biopsy technologies are influencing the broader diagnostics ecosystem. The ability to detect liver cancer biomarkers or fibrosis-related microRNAs through blood tests is receiving heavy investment, particularly in early screening programs. However, due to their limited accuracy in staging and grading, liquid biopsies are currently viewed as complementary rather than competitive.

 

Integration with Pathology & AI

Digital pathology is another frontier influencing liver biopsy workflows. High-resolution slide scanning, combined with AI-based histological grading algorithms , is improving inter-pathologist consistency in NAFLD and NASH assessments. Cloud-based platforms now allow real-time review of biopsy samples across centers , enabling second-opinion diagnostics and facilitating multicenter clinical trials.

Experts in pathology forecast a near-future scenario where AI-driven histopathology will not only accelerate turnaround times but also unlock biomarker discovery and drug response prediction capabilities from standard biopsy tissue.

 

R&D and Pipeline Innovation

In terms of pipeline innovation, manufacturers are developing multi-sample biopsy kits , enabling clinicians to retrieve multiple cores in a single pass. This is particularly relevant for liver cancer, where sampling across multiple tumor sites can provide more comprehensive genomic and histological data.

Furthermore, collaborations between device manufacturers and pharmaceutical firms are accelerating in the form of co-developed diagnostic-therapeutic platforms. These platforms aim to link biopsy-confirmed diagnosis with immediate eligibility for drug trials or precision therapies.

 

Competitive Intelligence And Benchmarking

The liver biopsy market is moderately consolidated, with a blend of legacy medical device manufacturers, specialist biopsy equipment companies, and emerging players integrating AI and robotics into procedural workflows. Leading companies are differentiating through a combination of product innovation, geographic reach, and clinical integration strategies.

Here are 6 key players shaping the competitive landscape:

 

BD (Becton, Dickinson and Company)

BD maintains a strong foothold in the global biopsy needle market. Its liver biopsy portfolio includes advanced percutaneous core biopsy systems designed for precision and safety. The company’s strength lies in its robust distribution network, FDA-cleared biopsy technologies, and comprehensive educational support for radiologists and hepatologists.

 

Strategy: Standardization and reliability in procedural kits; expansion in outpatient biopsy procedures Geographic Reach: North America, Europe, Asia Pacific Differentiation: Precision-engineered needles, sterile disposables, and bundled biopsy solutions

 

Argon Medical Devices

A major specialist in interventional biopsy products, Argon offers a range of core and fine needle aspiration biopsy systems for liver diagnostics. The company is focused on developing systems that reduce complication rates, including co-axial biopsy systems and needles with ergonomic grip designs.

 

Strategy: Physician-centric device development and expansion into value-based care markets Geographic Reach: U.S., Canada, Western Europe, select Asia-Pacific nations Differentiation: Patented designs for tissue yield improvement and better needle control

 

Cook Medical

Cook Medical has carved a niche in transjugular and laparoscopic liver biopsy devices. Its access to interventional radiology specialists makes it a preferred vendor in tertiary hospitals. It is known for hybrid kits that combine biopsy and hemodynamic monitoring in a single procedure.

 

Strategy: Integration with hepatology and interventional radiology workflows Geographic Reach: Global; strong presence in Europe and the Middle East Differentiation: Hybrid transjugular kits, multipurpose catheters, and customizable biopsy sets

 

INRAD Inc.

A smaller yet highly specialized player, INRAD focuses exclusively on reusable and semi-disposable biopsy needles. It maintains long-term relationships with pathology labs and academic institutions. Its products are often preferred in low-resource settings for their cost efficiency and durability.

 

Strategy: Custom-built biopsy tools with reusability options for budget-sensitive markets Geographic Reach: U.S., Latin America, selected markets in Africa and Asia Differentiation: Durable build quality, reusability, and support for teaching institutions

 

Hologic

Known primarily for breast health solutions, Hologic is expanding its biopsy technology capabilities into abdominal and liver biopsy via cross-platform devices. Leveraging its strength in image-guided interventions, the firm is positioning for growth in high-precision biopsy tools.

 

Strategy: Cross-application platform innovation and AI-enhanced procedural guidance Geographic Reach: North America, Europe, Asia Pacific Differentiation: Advanced imaging integration and proprietary guidance systems

 

Medtronic

While not a core biopsy device supplier, Medtronic is entering the liver biopsy space through its integration of robotic systems and imaging guidance tools. In collaborative hospital environments, Medtronic platforms support liver lesion localization and needle trajectory planning.

 

Strategy: Indirect entry via image guidance, robotic control, and surgical integration Geographic Reach: Global leader; active in over 140 countries Differentiation: Ecosystem-driven surgical navigation and compatibility with liver biopsy adjunct tools

Competitive differentiation is no longer solely about device design — it is increasingly about end-to-end procedural value, AI-enablement, and cross-specialty integration.

 

Regional Landscape And Adoption Outlook

The liver biopsy market demonstrates varied growth trajectories across global regions, influenced by differences in disease prevalence, healthcare infrastructure, reimbursement policies, and availability of diagnostic technologies. Here’s a breakdown of regional dynamics and adoption trends:

 

North America

North America accounted for the largest share of the liver biopsy market in 2024 , driven by a high diagnostic rate for chronic liver disease, advanced imaging infrastructure, and well-established interventional radiology networks.

• United States leads regional demand due to widespread availability of percutaneous and transjugular biopsy procedures and favorable reimbursement under Medicare and private insurers.

• The growing prevalence of NAFLD and liver cancer is fueling procedural volumes in both hospitals and outpatient centers .

• Academic centers and pathology labs are increasingly incorporating AI-based histopathology platforms , supporting faster diagnosis.

As U.S. healthcare shifts toward outpatient and precision-based diagnostics, there is growing preference for safer, image-guided, and robot-assisted biopsy techniques.

 

Europe

Europe maintains a significant market share due to its national screening programs, especially for hepatitis C and liver cancer. Germany , France , and the UK are the key markets.

• The region has a strong adoption of ultrasound-guided biopsy , with public healthcare systems emphasizing early detection of liver fibrosis.

• Regulatory standards from the European Medicines Agency (EMA) support tissue-confirmed diagnosis for clinical trials, sustaining biopsy demand.

• However, rising interest in non-invasive diagnostics (e.g., FibroScan , MRI elastography) is slowly reshaping biopsy utility in early-stage disease detection.

 

Asia Pacific

Asia Pacific is expected to experience the fastest CAGR through 2030, fueled by a rising burden of hepatitis, rapid urbanization, and expanding healthcare infrastructure.

• China and India are major contributors, driven by large patient volumes and increasing investment in diagnostic labs and specialty hospitals.

• South Korea and Japan are at the forefront of robotic biopsy innovations and real-time molecular histology research.

• Government-led hepatitis B vaccination and screening campaigns are creating downstream demand for confirmatory liver biopsies.

Asia’s vast population, coupled with the high prevalence of hepatocellular carcinoma and increasing insurance coverage, presents a major opportunity for biopsy device makers.

 

Latin America

Growth in Latin America is relatively moderate but improving due to rising awareness and gradual modernization of public health systems.

• Brazil dominates the region’s market, supported by a growing number of private diagnostic imaging centers .

• Key barriers include underdiagnosis, uneven access to imaging modalities, and delays in pathology result turnaround.

 

Middle East & Africa (MEA)

MEA represents a nascent market with considerable white space opportunity, especially in the Gulf Cooperation Council (GCC) countries and select African nations.

• Countries like Saudi Arabia and the UAE are investing heavily in tertiary care facilities and are adopting liver biopsy for oncology and transplant indications.

• African nations face challenges such as limited radiology access, shortage of interventional expertise, and diagnostic delays.

There is a growing need for mobile diagnostic services and training partnerships in underserved MEA regions to improve liver disease outcomes.

 

End-User Dynamics And Use Case

Liver biopsy procedures are executed across a variety of clinical settings, with adoption patterns influenced by diagnostic complexity, procedural risk profiles, institutional infrastructure, and access to imaging and pathology support. The end-user landscape can be broadly segmented into hospitals , diagnostic imaging centers , ambulatory surgical centers (ASCs) , and academic & research institutions .

 

Hospitals

Hospitals are the largest end users of liver biopsy devices and systems, accounting for more than half of the total procedural volume. The integrated availability of imaging, interventional radiology, anesthesiology , and post-procedural care makes them the default setting for high-risk biopsies such as transjugular or laparoscopic liver biopsies .

• Tertiary care hospitals frequently handle patients with advanced liver disease, where biopsies serve both diagnostic and staging purposes.

• Hospital-based transplant programs also rely on biopsy to monitor graft health post-transplant.

The centralization of specialized equipment and multidisciplinary teams gives hospitals an enduring procedural edge.

 

Diagnostic Imaging Centers

These centers are gaining traction, especially in urban and suburban areas where outpatient workflows are expanding. Many imaging centers offer ultrasound- or CT-guided percutaneous liver biopsies , targeting lower-risk patients.

• Driven by cost-effectiveness and faster turnaround, these centers serve as first-line diagnostic sites for hepatologists and gastroenterologists.

• Image-guided biopsy services are often bundled with elastography or abdominal CT scans for comprehensive liver evaluations.

As outpatient imaging gains reimbursement traction, diagnostic centers are expected to increase their biopsy throughput.

 

Ambulatory Surgical Centers (ASCs)

ASCs are emerging as a high-potential channel in the liver biopsy ecosystem. These centers are optimized for elective, minimally invasive procedures , and are often preferred by private insurers for their lower procedural costs.

• The rise of portable ultrasound and point-of-care devices is enabling liver biopsy in ASCs, especially in the U.S., South Korea, and parts of Europe.

• However, limitations in managing post-biopsy complications restrict their use to low-to-moderate risk patients .

Payers are increasingly steering non-complex liver biopsies toward ASCs to cut costs without compromising diagnostic yield.

 

Academic & Research Institutions

Academic hospitals and research bodies are key end users in clinical trials and drug development . Liver biopsy remains essential in evaluating treatment efficacy for NAFLD/NASH drugs , which rely on histological endpoints such as steatosis and inflammation resolution.

• These institutions often serve as biopsy data hubs , collecting high-quality samples for longitudinal studies.

• They are also early adopters of AI-integrated histopathology platforms and robotic needle navigation systems.

 

Use Case: Diagnostic Precision in Fatty Liver Disease (South Korea)

A leading tertiary hospital in Seoul, South Korea, incorporated AI-assisted ultrasound guidance into its liver biopsy workflow to evaluate patients with suspected NASH. The system used real-time elastography to identify optimal sampling zones and robotic control to stabilize needle trajectory. As a result, histological confirmation rates of ballooning degeneration and fibrosis staging improved by 22%, significantly enhancing patient stratification for clinical trials. Procedural complications were also reduced by 40%, supporting broader outpatient adoption.

 

Recent Developments + Opportunities & Restraints

Recent Developments (Last 2 Years)

The liver biopsy market has seen notable activity across product launches, regulatory approvals, and strategic collaborations—primarily aimed at enhancing procedural safety, diagnostic precision, and digital integration.

 

• BD (Becton, Dickinson and Company) launched a next-generation percutaneous biopsy needle featuring an integrated echogenic tip and automated sample delivery mechanism to reduce procedural variability.

• Argon Medical Devices entered into a strategic partnership with a digital imaging platform to develop cloud-connected liver biopsy kits for enhanced post-procedure pathology sharing and review.

• South Korea’s Ministry of Food and Drug Safety (MFDS) approved the country’s first AI-enabled robotic liver biopsy system, designed to operate with ultrasound-guided automation in tertiary hospitals.

• Cook Medical initiated a global rollout of its modular transjugular biopsy system with built-in pressure monitoring, targeting transplant centers and complex cirrhotic patients.

• Stanford University launched a clinical trial using digital pathology AI to grade liver fibrosis in biopsy samples collected during NAFLD drug development studies.

 

Opportunities

• AI-Powered Histopathology & Workflow Automation The integration of AI for real-time biopsy grading and cloud-based pathology analysis presents major efficiency gains. This opens new avenues in clinical trials, drug response tracking, and decentralized diagnostics.

• Growth of Ambulatory & Outpatient Liver Biopsy Settings As healthcare systems decentralize, liver biopsies are shifting into ASCs and diagnostic centers . Vendors offering compact, imaging-compatible kits will benefit most from this transition.

• High Unmet Demand in Emerging Markets Countries across Africa, Southeast Asia, and Latin America are under-equipped to manage their rising liver disease burden. Device makers can penetrate these regions through mobile diagnostic units and public-private diagnostic programs.

 

Restraints

• Shift Toward Non-Invasive Diagnostics The rise of elastography, serum biomarker panels, and AI-based liver imaging is gradually reducing the demand for invasive biopsy procedures, particularly for early-stage NAFLD.

• Shortage of Skilled Interventional Radiologists Performing high-quality liver biopsies requires trained interventionalists and imaging specialists—resources that are unevenly distributed, especially in rural or resource-limited healthcare settings.
   

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 1.53 Billion
Revenue Forecast in 2030	USD 2.28 Billion
Overall Growth Rate	CAGR of 5.8% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Procedure Type, By Target Indication, By End User, By Geography
By Procedure Type	Percutaneous, Transjugular, Laparoscopic
By Target Indication	NAFLD/NASH, Hepatitis B & C, Liver Cancer, Autoimmune Disorders, Others
By End User	Hospitals, Diagnostic Imaging Centers, ASCs, Academic & Research Institutes
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	U.S., UK, Germany, China, India, Japan, Brazil, South Korea, UAE, etc.
Market Drivers	- Rising prevalence of NAFLD/NASH - Advances in image-guided biopsy - AI-based digital pathology integration
Customization Option	Available upon request