Endobronchial Ultrasound Biopsy Market By Product Type (Convex Probe EBUS, Radial Probe EBUS, EBUS Needles and Accessories); By Application (Lung Cancer Diagnosis and Staging, Granulomatous and Infectious Disease Evaluation, Other Thoracic Pathologies); By End User (Hospitals and Specialty Cancer Centers, Ambulatory Surgical Centers, Diagnostic Imaging and Biopsy Centers); By Geography, Segment Revenue Estimation, Forecast, 2024–2030

Introduction And Strategic Context

The Global Endobronchial Ultrasound Biopsy Market is emerging as a pivotal diagnostic segment within the broader interventional pulmonology and thoracic oncology landscape. Endobronchial ultrasound-guided biopsy, commonly known as EBUS biopsy, has revolutionized the way clinicians diagnose and stage lung cancer and other mediastinal pathologies. It offers a minimally invasive alternative to traditional mediastinoscopy by enabling real-time, ultrasound-guided tissue sampling from lymph nodes and surrounding thoracic structures.

 

As of 2024, the global market for endobronchial ultrasound biopsy is estimated to be valued at USD 796.4 million and is projected to reach approximately USD 1380.6 million by 2030, growing at a CAGR of 9.7% over the forecast period.

 

Multiple macro-level factors are driving this growth. Firstly, the rising global burden of lung cancer, particularly non-small cell lung cancer, continues to fuel the demand for early, accurate, and safe diagnostic modalities. The World Health Organization estimates that lung cancer accounts for over 2.2 million new cases annually, positioning EBUS biopsy as an essential tool in timely diagnosis and treatment planning.

 

Secondly, technological advancements in ultrasound imaging resolution, needle flexibility, and bronchoscopic maneuverability are enhancing the success rates and procedural confidence among pulmonologists. Furthermore, growing awareness of guideline-driven practices issued by organizations such as the American College of Chest Physicians and the European Respiratory Society has resulted in increased EBUS integration across tertiary hospitals and cancer centers.

 

Key stakeholders in the market include:

• Medical device manufacturers and OEMs, focused on innovation in biopsy needles, EBUS bronchoscopes, and image processing software

• Hospitals and academic medical centers, which are major procurement hubs and centers of procedural training

• Diagnostic labs and pathology service providers, which support cytopathology and biomarker analysis from EBUS-obtained tissue

• Health insurers and government agencies, which influence adoption through reimbursement coverage and cancer screening policies

• Investors and venture capital firms, who are increasingly funding minimally invasive diagnostic platforms in oncology

The market is also shaped by global regulatory approvals, regional lung cancer screening mandates, and efforts to decentralize thoracic diagnostics into community settings. As healthcare systems pivot toward value-based oncology care, EBUS biopsy systems are gaining recognition not only as diagnostic tools but also as enablers of cost-effective, patient-centric care.

 

Market Segmentation And Forecast Scope

The global endobronchial ultrasound biopsy market is segmented based on product type, procedure application, end user, and geography. This segmentation framework is critical for understanding adoption dynamics across diverse clinical settings, technological modalities, and health system maturity levels.

By Product Type

Endobronchial ultrasound biopsy systems rely on a combination of advanced imaging and precision sampling tools. Key product types include:

• Convex Probe Endobronchial Ultrasound (CP-EBUS) Scopes
  These bronchoscopes integrate a convex ultrasound transducer and are commonly used for transbronchial needle aspiration in mediastinal lymph nodes. CP-EBUS systems dominate the market due to their ability to reach deeper thoracic structures with real-time visualization.

• Radial Probe Endobronchial Ultrasound (RP-EBUS) Scopes
  Used mainly for peripheral lung lesion assessment, RP-EBUS offers a 360-degree radial image. It requires a guide sheath and is frequently paired with fluoroscopy for lung nodule evaluation.

• EBUS Needles and Accessories
  Includes disposable aspiration needles, biopsy forceps, cytology brushes, and needle guide kits that are essential for tissue collection.

In 2024, convex probe EBUS systems account for approximately 52.4% of global revenue due to their widespread use in lung cancer staging and mediastinal diagnosis.

 

By Application

EBUS biopsy is primarily utilized in thoracic diagnostics, but its clinical utility is expanding.

• Lung Cancer Diagnosis and Staging
  The core application, where EBUS enables real-time, minimally invasive sampling of mediastinal and hilar lymph nodes for TNM staging.

• Granulomatous and Infectious Disease Evaluation
  Includes tuberculosis, sarcoidosis, and fungal infections where lymphadenopathy is evaluated using EBUS-guided biopsy.

• Other Thoracic Pathologies
  Covers pleural effusions, lymphoma evaluation, and paratracheal mass assessment.

Lung cancer diagnosis remains the most strategic sub-segment, given its role in treatment decision-making and reimbursement alignment across global oncology guidelines.

 

By End User

End users reflect the clinical and infrastructural contexts where EBUS procedures are performed.

• Hospitals and Specialty Cancer Centers
  These institutions account for the majority of global EBUS procedures due to their access to pulmonologists, pathologists, and advanced imaging capabilities.

• Ambulatory Surgical Centers (ASCs)
  EBUS is increasingly being adopted in ASCs with respiratory diagnostic programs, especially in North America and select parts of Europe.

• Diagnostic Imaging and Biopsy Centers
  Private diagnostic labs and chain-based pathology centers are incorporating EBUS as part of integrated oncology diagnostic services.

Hospitals and tertiary care centers are expected to remain the largest end-user segment, but ASCs are projected to grow at a faster rate due to outpatient care expansion and procedural reimbursement evolution.

 

By Region

Regional segmentation includes:

• North America

• Europe

• Asia Pacific

• LAMEA (Latin America, Middle East, and Africa)

Each region presents distinct adoption drivers such as regulatory approvals, lung cancer prevalence, procedural reimbursement policies, and diagnostic infrastructure availability.

This segmentation structure provides a comprehensive lens to evaluate the demand, clinical relevance, and strategic importance of each component within the endobronchial ultrasound biopsy ecosystem, supporting accurate forecasting and commercialization decisions.

 

Market Trends And Innovation Landscape

The global endobronchial ultrasound biopsy market is evolving rapidly with innovations that are redefining procedural accuracy, diagnostic speed, and physician usability. The demand for safer, less invasive, and more precise lung cancer diagnostics is fueling investment and research across imaging hardware, biopsy tools, and adjunct technologies.

1. Advancements in Ultrasound Imaging and Scope Design

One of the most impactful trends is the development of high-definition ultrasound transducers with improved tissue resolution. These allow better delineation of vascular structures and lymph node borders, reducing false negatives in transbronchial needle aspiration.

Manufacturers are also enhancing scope maneuverability, making EBUS procedures easier for pulmonologists and thoracic surgeons to perform in anatomically complex cases. Innovations in flexible distal tip articulation and reduced scope diameter have improved access to deep mediastinal regions and upper lobe lesions.

According to interventional pulmonologists, future probe systems will be integrated with live elastography and tissue stiffness analytics to distinguish malignant from benign nodes during the procedure itself.

 

2. Integration with Artificial Intelligence and Navigation Technologies

AI is beginning to impact the EBUS ecosystem through decision support systems and real-time image interpretation tools . Early-stage software platforms are being developed to:

• Classify ultrasound image patterns suggestive of malignancy

• Highlight vascular landmarks automatically

• Assist with target localization for improved first-pass yield

Furthermore, virtual bronchoscopy navigation systems and electromagnetic guidance platforms are increasingly integrated with EBUS, particularly for targeting peripheral pulmonary nodules. These technologies reduce procedural time and increase the likelihood of obtaining diagnostic samples in a single session.

 

3. Innovations in Biopsy and Needle Technologies

Needle manufacturers are refining needle gauge design, bevel angle, and internal channel architecture to maximize sample yield with minimal trauma . Newer needles are being engineered for:

• Core tissue extraction instead of cytology-only material

• Compatibility with molecular biomarker testing and next-generation sequencing

• Single-hand operation for ease in narrow bronchial lumens

The ability to reliably obtain core biopsy specimens from EBUS procedures is becoming critical, especially with the rise of targeted therapies in non-small cell lung cancer and immuno-oncology.

 

4. Industry Collaborations and R&D Programs

Key players are collaborating with academic centers to develop next-generation EBUS platforms:

• In 2023, a leading Japanese manufacturer entered a strategic partnership with a university hospital to pilot real-time elastography -capable EBUS systems

• A US-based diagnostics company launched a trial for AI-assisted EBUS cytology grading using deep learning models

• European manufacturers are exploring low-cost, reusable needle systems for emerging markets

These partnerships are focused on making EBUS more accessible, intelligent, and compatible with evolving oncology workflows.

As the emphasis on lung cancer screening and early diagnosis intensifies worldwide, EBUS technology is transitioning from a specialty procedure to a cornerstone of multidisciplinary oncology diagnostics.

 

Competitive Intelligence And Benchmarking

The global endobronchial ultrasound biopsy market is moderately consolidated, with a few key players dominating product innovation and global distribution. These companies compete on the basis of product performance, ease of use, clinical integration, and regulatory reach . Strategic collaborations, incremental upgrades, and regional partnerships define the competitive landscape as firms aim to expand both footprint and procedural adoption.

1. Olympus Corporation

A clear leader in the EBUS biopsy segment, Olympus holds a significant share due to its widely adopted CP-EBUS and RP-EBUS systems. The company has focused on systematic upgrades to its bronchoscope platforms, emphasizing improved navigation and image clarity.

• Strategy : Continuous innovation in imaging probes and scope ergonomics

• Global Reach : Strong in Japan, the United States, and Europe

• Differentiation : Deep integration of EBUS systems with digital video processors and training support programs

 

2. Fujifilm Holdings Corporation

Fujifilm is expanding its presence in the endoscopic ultrasound space through its interventional bronchoscopy platforms . It is investing in scope innovation, improved needle design, and AI-enabled imaging overlays.

• Strategy : Portfolio diversification and AI-driven diagnostics

• Strengths : Proprietary imaging enhancements and core biopsy-compatible scopes

• Market Penetration : Growing in Europe and select Asia Pacific countries

 

3. Medtronic

While Medtronic is better known for surgical and cardiovascular solutions, it has entered the bronchoscopy space through partnerships and distribution agreements for advanced pulmonary imaging systems.

• Strategy : Strategic acquisitions and collaborations with diagnostic device firms

• Differentiation : Focus on interoperability with robotic-assisted bronchoscopy

• Geographic Focus : North America and Latin America

 

4. Pentax Medical (HOYA Corporation)

Pentax Medical is building traction with its EBUS bronchoscope and needle systems, targeting institutions focused on advanced thoracic diagnostics .

• Strategy : Integrated scope platforms bundled with pathology support

• Key Markets : Europe and Middle East

• Differentiation : Flexible control section design and tissue retrieval optimization

 

5. Boston Scientific Corporation

Through its investment in bronchoscopic technologies and navigation tools, Boston Scientific is positioning itself in the adjacent EBUS segment with emphasis on peripheral lesion biopsy systems .

• Strategy : AI navigation integration and disposable device development

• Strengths : Procedural standardization tools for outpatient diagnostics

• Expansion Mode : Primarily North America and R&D collaborations in Asia

 

6. Cook Medical

A niche but specialized player, Cook Medical focuses primarily on the biopsy needle segment, offering multiple sizes and styles tailored for both convex and radial EBUS procedures.

• Strategy : Cost-effective, high-performance biopsy tools

• Customer Base : Academic centers and procedural training institutions

• Key Strength : Consistent quality in needle-based tissue acquisition

Across the board, companies are working to combine diagnostic precision with workflow simplicity, making EBUS biopsy more accessible beyond high-end tertiary hospitals. Future competition is likely to revolve around AI integration, biomarker-ready tissue acquisition, and regional customization for emerging markets.

 

Regional Landscape And Adoption Outlook

The adoption of endobronchial ultrasound biopsy technology varies significantly across regions, driven by factors such as lung cancer prevalence, diagnostic infrastructure, reimbursement frameworks, and the availability of trained pulmonologists. While high-income countries have established EBUS biopsy as a standard of care for mediastinal staging and diagnosis, emerging markets are steadily expanding their capabilities through public-private initiatives and training partnerships.

North America

North America remains the largest and most mature market for endobronchial ultrasound biopsy, led by the United States.

• The high prevalence of lung cancer and the implementation of low-dose CT screening programs have increased referrals for EBUS as a non-invasive first-line staging procedure.

• The US healthcare system supports EBUS adoption through favorable Medicare and private insurance reimbursement, particularly in hospitals and ambulatory surgery centers.

• Training infrastructure in North American academic centers ensures a steady pipeline of interventional pulmonologists skilled in EBUS techniques.

Canada follows similar patterns, with provincial cancer agencies endorsing EBUS in diagnostic algorithms, although technology diffusion is slower due to centralized procurement systems.

 

Europe

Europe is the second largest market, marked by strong procedural uptake in Western European countries.

• Nations such as Germany, the United Kingdom, France, and the Netherlands have high procedural volumes due to widespread inclusion of EBUS in national lung cancer guidelines.

• Centralized healthcare systems in Europe enable bulk procurement and uniform technology dissemination, making EBUS accessible even in smaller regional centers.

• Reimbursement frameworks under public insurance systems support EBUS as a cost-effective alternative to surgical mediastinoscopy .

However, Eastern Europe remains a largely untapped opportunity due to limited access to trained personnel and delayed approvals of newer devices.

 

Asia Pacific

Asia Pacific is the fastest-growing regional market, fueled by rising disease awareness and investments in cancer diagnostics.

• Japan is at the forefront of EBUS adoption, benefiting from its domestic manufacturers, extensive hospital network, and early use of real-time bronchoscopy systems.

• China and India are expanding rapidly due to national cancer screening programs and urban-centric hospital development, though rural access remains limited.

• South Korea and Australia have integrated EBUS into thoracic oncology workflows, supported by subspecialty training and reimbursement support.

Local manufacturing partnerships and cost-effective product innovations are expected to unlock further adoption in Asia Pacific.

 

LAMEA (Latin America, Middle East, and Africa)

LAMEA presents a mix of nascent demand and structural limitations .

• Brazil and Mexico are the leading adopters in Latin America, with private sector hospitals driving EBUS uptake, especially in oncology-focused institutions.

• In the Middle East, countries like Saudi Arabia and the UAE are investing in advanced pulmonary diagnostic centers as part of health diversification programs.

• Africa remains underpenetrated, with very limited access to EBUS biopsy tools outside of a few teaching hospitals in South Africa and Kenya.

This region represents a white-space opportunity where partnerships with government and nonprofit organizations could catalyze access to minimally invasive diagnostics.

Overall, while North America and Europe lead in procedural standardization and volume, Asia Pacific and Latin America are poised to drive the next wave of growth, particularly through localized production, regulatory harmonization, and training capacity building.

 

End-User Dynamics And Use Case

The demand for endobronchial ultrasound biopsy systems is deeply influenced by the type of healthcare facility, the presence of skilled personnel, and the procedural infrastructure available. Each end-user segment brings a unique set of expectations and constraints related to diagnostic throughput, procedural cost, and care quality. The end-user landscape is becoming increasingly diversified as EBUS transitions from a niche specialty to a mainstream diagnostic tool in thoracic oncology.

Hospitals and Specialty Cancer Centers

This segment accounts for the majority of global EBUS procedures . Hospitals, especially those with thoracic surgery or oncology departments, use EBUS as a standard procedure for:

• Mediastinal lymph node sampling

• Lung cancer staging

• Evaluation of hilar abnormalities

Tertiary centers are often early adopters of advanced EBUS systems integrated with elastography, core biopsy, and navigation technology. These institutions typically maintain in-house pathology units, enabling rapid on-site cytological evaluation, which improves procedural yield and minimizes repeat biopsies.

 

Ambulatory Surgical Centers (ASCs)

In the United States and parts of Europe, ASCs are gaining traction as efficient outpatient settings for EBUS-guided biopsy procedures. These facilities:

• Offer faster scheduling and shorter procedure times

• Operate with streamlined workflows and lower per-procedure cost

• Are increasingly staffed by pulmonologists trained in EBUS through fellowship programs

Due to reimbursement reforms and healthcare decentralization trends, ASCs are forecasted to grow at a higher rate than traditional hospitals in the EBUS segment.

 

Diagnostic Imaging and Biopsy Centers

These centers offer specialized biopsy and imaging services and are often equipped to handle a high volume of interventional diagnostics. In urban regions of Asia Pacific and Latin America, such centers are emerging as primary access points for lung cancer diagnosis, particularly where hospital access is constrained.

They typically partner with external pulmonologists or thoracic oncologists and rely on referral-based workflows . The availability of rapid pathology and digitized imaging transfer systems makes these centers attractive for cross-specialty collaborations.

 

Use Case Scenario

A tertiary hospital in Bangalore, India implemented a protocol to perform EBUS-guided biopsies for all suspected stage I to III non-small cell lung cancer patients. With the introduction of convex probe EBUS and in-house cytopathology support, the hospital reported a 62 percent reduction in the number of mediastinoscopies over a 12-month period. The average turnaround time for pathology reports fell by 35 percent, enabling faster initiation of therapy for eligible patients.

This case underscores the impact of end-user investment in diagnostic infrastructure and pathology coordination, resulting in both clinical efficiency and cost reduction .

As the use of EBUS becomes more democratized across settings, manufacturers and service providers must tailor training models, pricing strategies, and technical support to meet the evolving needs of each end-user profile.

 

Recent Developments plus Opportunities and Restraints

Recent Developments (Last 2 Years)

The global endobronchial ultrasound biopsy market has witnessed multiple strategic shifts, product upgrades, and clinical validations that have accelerated its growth and adoption.

• Olympus launched a next-generation convex probe EBUS system in 2023
  Featuring improved image clarity, a narrower outer diameter, and enhanced angulation, the system was designed to improve access to difficult-to-reach nodal stations and enable high-yield sampling.

• Fujifilm initiated clinical trials for an AI-assisted EBUS biopsy guidance software in 2024
  The tool leverages pattern recognition to assist pulmonologists during transbronchial needle aspiration by highlighting high-suspicion zones and optimizing target selection.

• Pentax Medical introduced a flexible core biopsy-compatible EBUS needle in late 2023
  This needle enables extraction of tissue cores suitable for biomarker and genetic testing in non-small cell lung cancer patients.

• Medtronic expanded its partnership with Intuitive Surgical to integrate EBUS systems into robotic-assisted bronchoscopy platforms
  The collaboration is focused on unifying real-time ultrasound feedback with navigation systems for improved lung nodule access.

• South Korea’s Health Insurance Review and Assessment Service updated its coverage in 2023
  EBUS procedures for lung cancer staging and sarcoidosis were included under expanded national reimbursement, increasing procedural access in secondary hospitals.

 

Opportunities

• Growing Focus on Molecular Testing in Lung Cancer
  As biomarker testing becomes standard in NSCLC diagnosis, the need for high-quality tissue samples through EBUS biopsy will continue to rise, driving demand for core-compatible needles and advanced image guidance .

• Expansion in Emerging Markets through Public Health Initiatives
  Governments in Asia and Latin America are funding cancer screening and diagnosis centers. These initiatives create opportunities for cost-efficient EBUS platforms and training-based sales models .

• Integration with AI and Navigation Platforms
  Companies that integrate EBUS systems with AI diagnostic software, real-time elastography, or virtual bronchoscopy navigation are well-positioned to differentiate and lead the next wave of innovation.

 

Restraints

• High Capital Investment and Maintenance Cost
  Advanced EBUS systems require significant upfront capital, service contracts, and consumable purchases, which limits adoption in resource-constrained hospitals and outpatient centers.

• Shortage of Skilled Interventional Pulmonologists
  EBUS biopsy is a technically demanding procedure requiring training and credentialing. In many regions, lack of trained specialists restricts procedural adoption and utilization.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 796.4 Million
Revenue Forecast in 2030	USD 1380.6 Million
Overall Growth Rate	CAGR of 9.7 percent (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Product Type, By Application, By End User, By Geography
By Product Type	Convex Probe EBUS, Radial Probe EBUS, EBUS Needles and Accessories
By Application	Lung Cancer Diagnosis and Staging, Granulomatous and Infectious Disease Evaluation, Other Thoracic Pathologies
By End User	Hospitals and Specialty Cancer Centers, Ambulatory Surgical Centers, Diagnostic Imaging and Biopsy Centers
By Region	North America, Europe, Asia Pacific, Latin America, Middle East and Africa
Country Scope	United States, United Kingdom, Germany, China, India, Japan, Brazil, South Korea, etc
Market Drivers	Rising lung cancer incidence, demand for non-invasive diagnostics, technological innovations in EBUS scope systems
Customization Option	Available upon request