관상동맥 플라크 회전식 동맥경화증 제거술 시장 : 제품 유형별, 시술 유형별, 직경 카테고리별, 용도별, 최종사용자별, 유통 채널별 - 예측(2026-2032년)

The Coronary Plaque Rotational Atherectomy Market was valued at USD 885.43 million in 2025 and is projected to grow to USD 945.84 million in 2026, with a CAGR of 7.69%, reaching USD 1,487.65 million by 2032.

An authoritative introduction that frames how device innovation, procedural technique refinement, and clinical demand are reshaping coronary plaque rotational atherectomy practice

Rotational atherectomy for coronary plaque modification has evolved from a niche procedural adjunct to a core option for complex coronary intervention, driven by demographic shifts, advancing device technology, and refined operator techniques. Clinicians now face an increasing incidence of highly calcified coronary disease within aging populations, requiring tools and workflows that enable safe lesion preparation, enable stent delivery and expansion, and ultimately improve procedural success. In parallel, improvements in burr design, catheter maneuverability, and accessory instrumentation have enhanced the ability to treat variable vessel diameters and lesion morphologies, thereby broadening clinical applicability.

The introduction sets the stage by clarifying how devices and consumables integrate into contemporary catheterization laboratory ecosystems. Patient selection criteria have become more granular and are increasingly informed by intravascular imaging modalities. Reimbursement landscapes and procedural coding frameworks are adapting slowly to these clinical realities, influencing procurement strategies at hospitals, ambulatory surgical centers, and high-volume cardiac catheterization labs. Taken together, these trends underscore the strategic importance of understanding product differentiation, procedural workflows, and end-user needs across the full spectrum of care settings.

The clinical, technological, and operational inflection points that are driving a fundamental reshaping of the coronary plaque rotational atherectomy ecosystem

The landscape for coronary plaque rotational atherectomy is experiencing transformative shifts that extend beyond incremental device enhancements to systemic changes in clinical pathways, distribution, and value propositions. Technological advances in burr materials and coating technologies are improving wear characteristics and lesion engagement, while refinements in guide catheter compatibility and catheter torque control are lowering procedural complexity. Concurrently, intravascular imaging and lesion assessment tools have become integral to procedural planning, enabling more precise indication selection and tailored burr sizing strategies across varying diameter categories.

Operationally, procedural pathways are shifting toward greater adoption in ambulatory surgical centers and hybrid catheterization environments as efficiency demands and care-site diversification accelerate. This change redefines service models and inventory management, prompting manufacturers and distributors to rethink product bundles and supply-chain responsiveness. Strategic partnerships between device makers and clinical centers are also rising in prominence to support training, proctoring, and real-world evidence generation. Collectively, these shifts are expanding the role of rotational atherectomy from a specialized backup tool to a predictable component of complex coronary intervention algorithms.

How the 2025 tariff adjustments in the United States prompted supply chain reengineering, procurement recalibration, and strategic commercial responses across the device value chain

Tariff adjustments in the United States in 2025 have introduced new dynamics across supply chains for medical devices and associated consumables, with implications for sourcing strategies, pricing models, and distribution approaches. Manufacturers and distributors dependent on cross-border supply of precision components, including burr assemblies and specialized catheters, have recalibrated procurement and inventory strategies to mitigate input cost volatility. Some organizations accelerated localization of manufacturing for critical subcomponents, while others explored alternate suppliers and regionalized warehousing to preserve delivery reliability and margin integrity.

These trade policy shifts also influenced purchasing behavior among hospitals, cardiac catheterization labs, and ambulatory surgical centers, where budgetary pressures and procurement review cycles prompted closer scrutiny of total cost of ownership. In response, suppliers emphasized value propositions tied to device longevity, clinical outcomes, and bundled service offerings that reduce downstream costs. Regulatory and contracting teams intensified engagement to align supply contracts with contingency provisions, and distributors designed tiered service levels to support both direct sales relationships and intermediary distribution channels. The cumulative effect was a more diversified supply posture and a recalibration of commercial strategies across the value chain.

A detailed segmentation framework connecting product types, clinical settings, lesion subsets, procedure urgency, vessel diameter considerations, and distribution pathways to strategic priorities

Segmentation insights clarify where clinical need, procurement complexity, and commercial opportunity intersect, requiring differentiated strategies across product families, end users, applications, procedure types, diameter categories, and distribution channels. Product differentiation separates systems from consumables, with consumables spanning accessories, burrs, catheters, and guide wires; within burrs, design and selection vary further by large vessel, medium vessel, and small vessel applications, which demand distinct engineering and clinical guidance. End users comprise ambulatory surgical centers, cardiac catheterization labs, and hospitals, each with unique purchasing protocols, inventory constraints, and procedural volumes that influence product adoption and training requirements.

Application segmentation distinguishes bifurcation lesions, calcified lesions, chronic total occlusions, and diffuse disease, with chronic total occlusions further delineated into hard tissue occlusions and soft tissue occlusions, each dictating different device approaches and adjunctive strategies. Procedure types-elective, emergency, and urgent-create divergent readiness and stocking imperatives that affect preferred product configurations and service agreements. Diameter categories across large, medium, and small vessel anatomies drive device sizing, clinical trial design, and market education priorities. Finally, distribution channels split between direct sales and distributor sales, where distributor networks are itself differentiated into specialized distributors and wholesale distributors; these channels shape go-to-market cadence, training provision, and regional availability. Together, these segmentation layers inform product road mapping, clinical support models, and commercial segmentation for targeted uptake.

Regional differentiation in clinical adoption, regulatory pathways, and commercial approaches across the Americas, Europe Middle East and Africa, and Asia Pacific that shape uptake trajectories

Regional dynamics are pivotal to understanding where adoption accelerates and where structural barriers remain, with three macro regions showing distinct clinical, regulatory, and commercial characteristics. The Americas exhibit concentrated centers of interventional excellence with high procedural volumes in tertiary hospitals and an expanding footprint of ambulatory surgical centers; this environment favors comprehensive training programs, bundled consumable offerings, and close collaboration with cardiac catheterization labs to optimize procedural throughput and outcomes. Supplier relationships in this region emphasize responsiveness and regulatory compliance, while payer dynamics shape the uptake of advanced lesion preparation techniques.

In Europe, Middle East & Africa, heterogeneous regulatory frameworks and varied hospital procurement models require flexible distribution strategies and localized clinical evidence generation to support product adoption. Training infrastructure varies by market, and partnerships with regional distributors or specialized clinical centers can accelerate penetration. Asia-Pacific presents rapid procedural volume growth driven by aging populations and rising cardiovascular disease prevalence, coupled with an expanding network of high-volume hospitals and specialized centers. In this region, manufacturers often prioritize scalable manufacturing and competitive pricing, paired with investments in training and local clinical data to build clinician confidence and support long-term uptake.

Competitive and collaborative dynamics among device innovators, niche challengers, and distribution partners that define product differentiation and adoption vectors

Competitive dynamics are characterized by a blend of established device manufacturers, agile challengers, and specialized component suppliers, each pursuing differentiated strategies across product innovation, clinical evidence generation, and service offerings. Leading organizations are investing in iterative device enhancements, such as refined burr geometries and catheter torque responsiveness, while also developing comprehensive training programs and clinical support infrastructures to reduce learning curves and enhance procedural safety. Emerging companies are focusing on niche design features or targeted clinical segments, such as small-vessel burr optimization or specialized accessory kits tailored for bifurcation and complex calcified lesions, to carve defensible positions.

Partnerships and collaborations are increasing between device developers and hospital systems, imaging technology providers, and regional distributors to accelerate real-world experience generation and optimize supply chain resilience. Companies that align their product strategies with end-user workflows-integrating consumables into bundled offerings for ambulatory surgical centers or ensuring rapid replenishment models for high-volume hospitals-tend to achieve stronger adoption. Intellectual property around burr materials, coating processes, and catheter interface mechanisms remains a competitive differentiator, while service and training ecosystems are emerging as important components of the overall value proposition.

Actionable strategic recommendations for manufacturers, distributors, and clinical leaders to drive adoption, strengthen supply resilience, and align commercial models with clinical workflows

Industry leaders should prioritize an integrated strategy that aligns product design, clinical engagement, and commercial infrastructure to accelerate adoption and mitigate supply risks. First, invest in iterative product development that addresses the full breadth of vessel diameter categories and lesion complexities, ensuring that burr designs and catheter offerings are optimized for large, medium, and small vessel anatomies and for lesion types ranging from calcified plaques to chronic total occlusions of differing tissue consistency. Next, enhance clinical support by developing modular training programs and proctoring initiatives tailored to hospitals, cardiac catheterization labs, and ambulatory surgical centers, reducing procedural variability and improving outcomes.

Commercially, diversify distribution strategies to balance direct sales relationships with robust partnerships with both specialized and wholesale distributors, adapting channel models to regional regulatory and procurement realities. Strengthen supply chain resilience by qualifying secondary suppliers, considering regional manufacturing hubs for critical components, and building contingency stocks for consumables. Finally, generate targeted real-world evidence that demonstrates procedural efficacy across applications-bifurcation lesions, diffuse disease, and CTO subtypes-and translate those data into clear messaging for payers and procurement stakeholders to support adoption within elective, urgent, and emergency procedural pathways.

A transparent, multi-source research methodology blending secondary literature, expert interviews, and data triangulation to produce clinically grounded and operationally actionable insights

The research methodology combines systematic secondary research, primary expert engagement, and rigorous triangulation to ensure robustness and clinical relevance. Secondary research encompassed peer-reviewed literature, regulatory filings, procedural guidelines, device labeling, and clinical registry analyses to map device attributes, procedural indications, and evolving clinical standards. Primary research included structured interviews with interventional cardiologists, cath lab directors, procurement officers, and distribution partners to capture practical insights on device selection, inventory management, and training needs. These qualitative inputs were synthesized with technical device specifications and clinical outcome data to form an evidence-backed perspective.

Data were triangulated across sources to validate assumptions, and segmentation frameworks were applied to align analysis with product types, end-user categories, clinical applications, procedure types, diameter categories, and distribution channels. Regional analyses were informed by regulatory landscapes and care delivery models across the Americas, Europe Middle East & Africa, and Asia-Pacific. The methodology prioritized transparency in assumptions, recurrent validation with clinical experts, and an emphasis on operational realities such as procurement cycles, supply chain constraints, and training infrastructure to ensure practical utility for decision-makers.

A concise conclusion synthesizing how clinical innovation, operational transformation, and strategic commercial alignment will determine the future role of rotational atherectomy in complex coronary care

In conclusion, coronary plaque rotational atherectomy stands at an inflection point where device refinement, clinical practice evolution, and commercial strategy converge to influence its role in complex coronary intervention. Advances in burr and catheter technology, together with growing reliance on intravascular imaging and more nuanced lesion classification, enable clinicians to address a wider array of lesion types and vessel sizes with greater predictability. Operational shifts toward ambulatory settings and the need for resilient supply chains are redefining commercial approaches and demanding closer alignment between manufacturers, distributors, and end users.

To capitalize on these dynamics, stakeholders must adopt integrated approaches that marry technical innovation with comprehensive clinical support and agile distribution models. Focused evidence generation across lesion subtypes and procedure categories, combined with tailored training and localized supply strategies, will determine winners in this evolving landscape. Ultimately, a practical, clinician-centered approach that respects procedural realities and procurement constraints will be essential for advancing patient outcomes and driving sustainable adoption.

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Definition
• 1.3. Market Segmentation & Coverage
• 1.4. Years Considered for the Study
• 1.5. Currency Considered for the Study
• 1.6. Language Considered for the Study
• 1.7. Key Stakeholders

2. Research Methodology

• 2.1. Introduction
• 2.2. Research Design
  • 2.2.1. Primary Research
  • 2.2.2. Secondary Research
• 2.3. Research Framework
  • 2.3.1. Qualitative Analysis
  • 2.3.2. Quantitative Analysis
• 2.4. Market Size Estimation
  • 2.4.1. Top-Down Approach
  • 2.4.2. Bottom-Up Approach
• 2.5. Data Triangulation
• 2.6. Research Outcomes
• 2.7. Research Assumptions
• 2.8. Research Limitations

3. Executive Summary

• 3.1. Introduction
• 3.2. CXO Perspective
• 3.3. Market Size & Growth Trends
• 3.4. Market Share Analysis, 2025
• 3.5. FPNV Positioning Matrix, 2025
• 3.6. New Revenue Opportunities
• 3.7. Next-Generation Business Models
• 3.8. Industry Roadmap

4. Market Overview

• 4.1. Introduction
• 4.2. Industry Ecosystem & Value Chain Analysis
  • 4.2.1. Supply-Side Analysis
  • 4.2.2. Demand-Side Analysis
  • 4.2.3. Stakeholder Analysis
• 4.3. Porter's Five Forces Analysis
• 4.4. PESTLE Analysis
• 4.5. Market Outlook
  • 4.5.1. Near-Term Market Outlook (0-2 Years)
  • 4.5.2. Medium-Term Market Outlook (3-5 Years)
  • 4.5.3. Long-Term Market Outlook (5-10 Years)
• 4.6. Go-to-Market Strategy

5. Market Insights

• 5.1. Consumer Insights & End-User Perspective
• 5.2. Consumer Experience Benchmarking
• 5.3. Opportunity Mapping
• 5.4. Distribution Channel Analysis
• 5.5. Pricing Trend Analysis
• 5.6. Regulatory Compliance & Standards Framework
• 5.7. ESG & Sustainability Analysis
• 5.8. Disruption & Risk Scenarios
• 5.9. Return on Investment & Cost-Benefit Analysis

6. Cumulative Impact of United States Tariffs 2025

7. Cumulative Impact of Artificial Intelligence 2025

8. Coronary Plaque Rotational Atherectomy Market, by Product Type

• 8.1. Consumables
  • 8.1.1. Accessories
  • 8.1.2. Burrs
    • 8.1.2.1. Large Vessel
    • 8.1.2.2. Medium Vessel
    • 8.1.2.3. Small Vessel
  • 8.1.3. Catheters
  • 8.1.4. Guide Wires
• 8.2. Systems

9. Coronary Plaque Rotational Atherectomy Market, by Procedure Type

• 9.1. Elective Procedure
• 9.2. Emergency Procedure
• 9.3. Urgent Procedure

10. Coronary Plaque Rotational Atherectomy Market, by Diameter Category

• 10.1. Large Vessel
• 10.2. Medium Vessel
• 10.3. Small Vessel

11. Coronary Plaque Rotational Atherectomy Market, by Application

• 11.1. Bifurcation Lesions
• 11.2. Calcified Lesions
• 11.3. Chronic Total Occlusions
  • 11.3.1. Hard Tissue Occlusions
  • 11.3.2. Soft Tissue Occlusions
• 11.4. Diffuse Disease

12. Coronary Plaque Rotational Atherectomy Market, by End User

• 12.1. Ambulatory Surgical Centers
• 12.2. Cardiac Catheterization Labs
• 12.3. Hospitals

13. Coronary Plaque Rotational Atherectomy Market, by Distribution Channel

• 13.1. Direct Sales
• 13.2. Distributor Sales
  • 13.2.1. Specialized Distributors
  • 13.2.2. Wholesale Distributors

14. Coronary Plaque Rotational Atherectomy Market, by Region

• 14.1. Americas
  • 14.1.1. North America
  • 14.1.2. Latin America
• 14.2. Europe, Middle East & Africa
  • 14.2.1. Europe
  • 14.2.2. Middle East
  • 14.2.3. Africa
• 14.3. Asia-Pacific

15. Coronary Plaque Rotational Atherectomy Market, by Group

• 15.1. ASEAN
• 15.2. GCC
• 15.3. European Union
• 15.4. BRICS
• 15.5. G7
• 15.6. NATO

16. Coronary Plaque Rotational Atherectomy Market, by Country

• 16.1. United States
• 16.2. Canada
• 16.3. Mexico
• 16.4. Brazil
• 16.5. United Kingdom
• 16.6. Germany
• 16.7. France
• 16.8. Russia
• 16.9. Italy
• 16.10. Spain
• 16.11. China
• 16.12. India
• 16.13. Japan
• 16.14. Australia
• 16.15. South Korea

17. United States Coronary Plaque Rotational Atherectomy Market

18. China Coronary Plaque Rotational Atherectomy Market

19. Competitive Landscape

• 19.1. Market Concentration Analysis, 2025
  • 19.1.1. Concentration Ratio (CR)
  • 19.1.2. Herfindahl Hirschman Index (HHI)
• 19.2. Recent Developments & Impact Analysis, 2025
• 19.3. Product Portfolio Analysis, 2025
• 19.4. Benchmarking Analysis, 2025
• 19.5. Abbott Laboratories
• 19.6. AngioDynamics, Inc.
• 19.7. Avinger, Inc.
• 19.8. B. Braun SE
• 19.9. Becton, Dickinson and Company
• 19.10. Biotronik SE & Co. KG
• 19.11. Boston Scientific Corporation
• 19.12. Cardinal Health
• 19.13. Koninklijke Philips N.V.
• 19.14. Lepu Medical Technology (Beijing) Co., Ltd.
• 19.15. Medtronic plc
• 19.16. Nipro Corporation
• 19.17. Rex Medical, L.P.
• 19.18. Straub Medical AG
• 19.19. Terumo Corporation