관상동맥질환 치료 기기 시장 : 기기 유형, 치료 유형, 접근법, 최종사용자별 - 세계 예측(2025-2032년)

The Coronary Artery Disease Treatment Devices Market is projected to grow by USD 7.26 billion at a CAGR of 5.92% by 2032.

An authoritative overview of clinical complexities, device innovation pathways, and healthcare priorities reshaping coronary artery disease treatment approaches

The clinical and commercial landscape for coronary artery disease treatment devices is evolving rapidly under the combined influence of technological innovation, shifting procedural preferences, and changing healthcare delivery models. Patients present with increasingly complex anatomies including heavily calcified lesions, chronic total occlusions, and comorbidities that demand nuanced therapeutic approaches. At the same time, clinicians are integrating higher-resolution intravascular imaging and physiology tools into routine decision-making to improve procedural precision and long-term outcomes.

Against this clinical backdrop, device developers and healthcare systems are balancing several imperatives: improving acute procedural success, reducing repeat interventions, and demonstrating durable patient benefit that aligns with payor expectations. Advances in device design, such as refined atherectomy modalities for calcified plaque modification and enhanced drug-delivery balloon technologies to limit restenosis, are complemented by procedural shifts favoring minimally invasive access and shorter hospital stays. These dynamics necessitate cross-functional strategies that link clinical evidence generation, regulatory pathways, reimbursement positioning, and supply chain resilience.

This executive summary synthesizes current drivers affecting coronary devices and highlights structural shifts likely to influence product adoption, clinical practice, and commercial strategy. The analysis places clinical innovation in the context of health system priorities and operational realities, offering a structured foundation for executives and clinical leaders to align investments with evolving unmet needs.

How imaging, physiology, plaque modification, and procedural access trends are converging to redefine therapeutic benchmarks and device adoption in coronary care

Several transformative shifts are reshaping how coronary interventions are conceived, designed, and delivered, and these shifts are accelerating the convergence of imaging, physiology, and therapeutic device capabilities. First, intravascular imaging and physiologic assessment are moving from optional adjuncts to central components of case planning and optimization. The broader adoption of intravascular ultrasound and optical coherence tomography, alongside fractional flow reserve-guided decision-making, has increased lesion-level diagnostic precision and enabled more targeted device selection and deployment strategies.

Second, the growth in complex lesion subsets, particularly calcified coronary disease, has strengthened demand for specialized plaque-modification tools. Atherectomy technologies, including laser, orbital, and rotational modalities, are being refined to improve safety profiles and integration with adjunctive therapies. Concurrently, drug-eluting stent technologies and drug-coated balloons continue to evolve with refined polymer and drug formulations intended to extend durability while minimizing late adverse events. These converging device advancements are prompting hybrid procedural strategies where multiple complementary technologies are deployed within a single case.

Third, procedural access preferences are shifting toward radial approaches in many centers, reducing vascular complications and supporting faster patient throughput. This change is altering device design considerations related to profile, deliverability, and torque control. Finally, the digital and data-driven transformation in healthcare, including procedural analytics and real-world evidence generation, is enabling manufacturers to demonstrate value beyond immediate procedural success by documenting longitudinal outcomes, economic impact, and quality-of-life improvements. Collectively, these shifts are reconfiguring competitive dynamics and establishing new benchmarks for clinical evidence and device performance.

Assessing the cumulative operational, procurement, and regulatory consequences of United States tariff adjustments on coronary device supply chains and pricing strategies

The introduction of tariffs and trade policy changes in the United States in 2025 has exerted a cumulative influence across device sourcing, pricing strategies, and supply chain architecture, prompting industry actors to reassess operational models. Manufacturers with significant component or finished-goods exposure to affected jurisdictions experienced margin pressure, which in turn accelerated initiatives to diversify suppliers and examine nearshoring alternatives. These adaptations emphasized dual-sourcing strategies, qualification of alternative suppliers, and inventory optimization to sustain clinical supply continuity.

In parallel, procurement departments and health systems revisited contracting frameworks to account for potential cost volatility. Longer-term agreements and price-protection clauses have been negotiated to mitigate exposure, while some purchasers adopted more active inventory management and demand forecasting to reduce procurement friction. The tariffs also intensified focus on manufacturing footprint resilience, encouraging investment in regional manufacturing capacity and contract manufacturing partnerships in the Americas.

Regulatory and compliance burdens increased as well, since product relabeling, changes in country-of-origin documentation, and logistics re-routing added administrative complexity. Companies responded by strengthening cross-functional teams combining regulatory affairs, quality, and supply chain expertise to accelerate change controls and maintain regulatory compliance. Strategically, the cumulative impact of tariffs compelled many players to prioritize product designs and sourcing strategies that minimize tariff-exposed components, accelerate local qualification efforts, and use evidence of clinical effectiveness to defend pricing power within constrained reimbursement environments.

Insightful segmentation analysis linking device modalities, treatment pathways, access strategies, and care settings to adoption levers and product positioning

A nuanced segmentation lens reveals distinct opportunity zones and operational considerations across device type, treatment modality, procedural approach, and end-user setting. When devices are categorized by type, the analysis must account for atherectomy systems-which include laser, orbital, and rotational iterations-each optimized for different plaque morphologies and clinical scenarios. Balloon catheter technologies span cutting, drug-coated, and standard designs, with drug-coated balloons growing in relevance for in-stent restenosis and small-vessel disease. Guidewire variants such as polymer-jacketed, PTFE-coated, and untreated options continue to serve differentiated procedural roles depending on lesion complexity and deliverability needs. Intravascular imaging systems encompass fractional flow reserve platforms, intravascular ultrasound, and optical coherence tomography, each contributing unique diagnostic resolution that informs device selection and deployment technique. Stent platforms include bare metal constructs, bioresorbable scaffolds, and drug-eluting designs, with trade-offs in acute scaffolding, long-term vessel healing, and device longevity shaping clinician preference.

Examining treatment types reveals that coronary artery bypass grafting remains an essential option for specific anatomic and multivessel presentations, with off-pump and on-pump strategies retaining particular clinical rationales. Percutaneous coronary intervention continues to expand in scope through adjunctive technologies and procedural refinements, whether performed with balloon angioplasty alone or combined with stenting. The choice between surgical and percutaneous pathways is increasingly individualized through multidisciplinary heart team assessment and enhanced lesion-level diagnostics.

Approach selection between transfemoral and transradial access frames device design and procedural logistics, since radial-first practices prioritize low-profile, highly deliverable devices, while femoral access may accommodate bulkier adjunctive tools. End-user segmentation across ambulatory surgical centers, cardiac centers, and hospitals reflects varying procedural complexity, resource intensity, and reimbursement considerations, creating differentiated adoption pathways. Each segmentation axis requires tailored evidence generation, pricing strategies, and service models to optimize uptake across heterogeneous clinical settings.

Regional dynamics across the Americas, Europe Middle East & Africa, and Asia-Pacific that influence regulatory pathways, adoption priorities, and localized commercialization strategies

Regional dynamics create differentiated demand drivers and operational imperatives across the Americas, Europe Middle East & Africa, and Asia-Pacific, shaping regulatory pathways, reimbursement landscapes, and clinical practice patterns. In the Americas, procedural innovation often intersects with consolidated payer systems and large hospital networks that emphasize real-world outcomes and cost-effectiveness; there is strong appetite for demonstrable improvements in procedural efficiency and reduction in repeat interventions. This context incentivizes manufacturers to invest in robust post-market evidence and provider education programs that translate device advantages into measurable clinical and economic value.

In Europe, the Middle East and Africa, heterogeneous regulatory and reimbursement frameworks necessitate localized market-entry strategies. Western European markets frequently require rigorous health technology assessments and country-specific clinical evidence, while emerging markets in the broader region may prioritize cost containment and scalable solutions that support expanding procedural capacity. Manufacturers navigating this geography must align pricing, clinical support, and regulatory submissions to the expectations of diverse national health systems.

The Asia-Pacific region presents a combination of high-volume procedural markets and rapidly advancing clinical capabilities, with several countries investing significantly in interventional cardiology infrastructure. Local manufacturing and partnerships are particularly influential here, as regional supply chain integration and regulatory alignment can accelerate adoption. Across all regions, demographic shifts toward aging populations and rising cardiovascular disease burden drive sustained clinical demand, but regional reimbursement, provider training, and health system priorities will determine the pace and nature of device uptake.

How product integration, clinical evidence, supply chain robustness, and commercialization expertise define competitive advantage among coronary device manufacturers

Competitive dynamics among companies active in coronary device development are defined by a blend of technology leadership, clinical evidence generation, manufacturing scale, and go-to-market sophistication. Leading firms prioritize integrated portfolios that pair therapeutic devices with diagnostic platforms, enabling bundled procedural solutions that support better case selection and optimization. Investment in clinical trials, registries, and post-market surveillance continues to be a differentiator, as health systems increasingly reward demonstrable long-term outcomes and economic value.

Strategic partnerships, licensing agreements, and selective acquisitions are common tools to access complementary technologies, expand geographic reach, or accelerate entry into emerging procedural niches. Supply chain resilience and regulatory agility are prominent operational priorities, with companies enhancing redundancy through contract manufacturing networks and regional production capacity. Talent investment in clinical affairs, evidence generation, and reimbursement expertise is equally important to translate device performance into adoption and favorable procurement outcomes.

Product differentiation increasingly centers on deliverability, lesion-specific performance, and adjunctive diagnostic compatibility. Companies that offer clinician training programs, procedural support, and robust data capture capabilities are better positioned to shorten adoption curves and build long-term clinical endorsement. As the competitive landscape matures, winners will be those who can integrate technical innovation with pragmatic commercialization models that reflect clinician workflows and payer expectations.

Practical strategic imperatives for leaders to align product innovation, supply chain resilience, and evidence-driven commercialization for sustainable growth

Industry leaders should prioritize a portfolio strategy that emphasizes clinically meaningful differentiation, regulatory foresight, and supply chain adaptability to capture sustained value. First, invest selectively in device improvements that address high-impact clinical gaps such as calcified lesions, small-vessel disease, and restenosis, while ensuring that design changes enhance deliverability for radial approaches. Coordinated clinical programs that generate both randomized evidence and real-world registry data will strengthen value propositions with clinicians and payers, supporting broader adoption and reimbursement alignment.

Second, build resilient sourcing architectures by qualifying multiple suppliers, exploring regional manufacturing partnerships, and embedding tariff-aware procurement clauses to mitigate policy-driven cost shocks. Cross-functional teams should own rapid change-control processes to accelerate supplier onboarding while maintaining regulatory compliance. Third, couple product launches with comprehensive clinician education and procedural training that integrate intravascular imaging and physiology tools, thereby shortening learning curves and improving procedural outcomes. Digital platforms that capture procedural metrics and patient outcomes can support iterative improvement and strengthen post-market evidence.

Finally, adopt flexible commercial models that align pricing with demonstrated outcomes and system-level value, including bundled agreements and outcome-linked contracts where appropriate. Collaboration with health systems to pilot integrated care pathways can surface operational efficiencies and provide reference cases for wider adoption. These actions, executed in parallel, will enhance resilience and create defensible differentiation in an increasingly outcome-driven environment.

A rigorous, multi-modal research methodology integrating clinical evidence, stakeholder interviews, regulatory insights, and supply chain analysis to ensure robust conclusions

This analysis synthesizes insights drawn from a multi-modal research approach designed to reflect clinical practice, regulatory context, and supply chain realities. The methodology combined a comprehensive review of peer-reviewed clinical literature, procedural registries, and device labeling to establish device performance characteristics and clinical application patterns. In addition, structured interviews were conducted with interventional cardiologists, hospital procurement leaders, regulatory specialists, and device development executives to capture frontline perspectives on adoption drivers, unmet needs, and operational constraints.

Supplementary sources included a review of regulatory filings, standards guidance, and published health technology assessments to understand evidence expectations across jurisdictions. Supply chain analysis incorporated import-export data trends, published policy updates related to trade and tariffs, and anonymized insights from contract manufacturers to map procurement and manufacturing risk. Patent landscaping and pipeline tracking were used to identify emerging technologies and R&D focus areas.

Throughout the research process, findings were triangulated across sources to ensure robustness and to minimize single-source bias. Evidence synthesis emphasized clinical relevance, regulatory plausibility, and commercial applicability, providing a balanced foundation for the insights and recommendations presented herein.

A concise synthesis of clinical, operational, and strategic drivers that will determine which device strategies deliver enduring clinical and commercial value

The trajectory of coronary artery disease treatment devices is defined by technological refinement, procedural evolution, and an environment that rewards demonstrable clinical and economic value. Advances in intravascular imaging and physiology are enabling more precise, lesion-level decision-making, while targeted therapeutic devices-ranging from advanced atherectomy systems to drug-delivery balloons and modern stent platforms-are addressing increasingly complex clinical presentations. These clinical drivers intersect with operational realities such as access trends, payer scrutiny, and supply chain pressures, creating a landscape that favors integrated solutions and evidence-rich commercialization strategies.

Organizations that align device design with clinician workflow, invest in outcome-focused evidence generation, and build supply chain resilience will be best positioned to capture durable adoption. Regulatory agility and region-specific market approaches remain essential as jurisdictions vary in evidence requirements and reimbursement dynamics. Ultimately, sustained success will hinge on the ability to translate technical performance into clear clinical benefit and system-level value, enabling providers and payers to justify adoption amid competing budgetary and operational priorities.

The recommendations in this summary provide a roadmap for aligning R&D, regulatory, supply chain, and commercial actions to meet evolving clinician expectations and health system demands. Executives and clinical leaders can leverage these insights to prioritize investments that yield meaningful improvements in patient care and organizational outcomes.

Table of Contents

1. Preface

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

2. Research Methodology

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Adoption of bioresorbable vascular scaffolds for reduced long-term complications
• 5.2. Implementation of AI-guided imaging algorithms for real-time lesion assessment
• 5.3. Development of polymer-free drug-coated balloons for in-stent restenosis management
• 5.4. Growth of robotic PCI platforms for enhanced procedural precision and reduced fluoroscopy exposure
• 5.5. Rise of patient-specific 3D printed coronary artery models for pre-operative planning
• 5.6. Emergence of dual therapy stents combining antithrombotic and antiproliferative agents
• 5.7. Integration of wearable cardiac monitoring devices for post-PCI patient surveillance
• 5.8. Expansion of microcatheter technologies for complex bifurcation and chronic total occlusion interventions
• 5.9. Use of optical coherence tomography fused with intravascular ultrasound for detailed plaque characterization
• 5.10. Advancements in biodegradable polymer coatings to minimize inflammatory response after stent implantation

6. Cumulative Impact of United States Tariffs 2025

7. Cumulative Impact of Artificial Intelligence 2025

8. Coronary Artery Disease Treatment Devices Market, by Device Type

• 8.1. Atherectomy Device
  • 8.1.1. Laser Atherectomy
  • 8.1.2. Orbital Atherectomy
  • 8.1.3. Rotational Atherectomy
• 8.2. Balloon Catheter
  • 8.2.1. Cutting Balloon Catheter
  • 8.2.2. Drug-Coated Balloon Catheter
  • 8.2.3. Standard Balloon Catheter
• 8.3. Guidewire
  • 8.3.1. Polymer-Jacketed
  • 8.3.2. PTFE-Coated
  • 8.3.3. Untreated
• 8.4. Intravascular Imaging System
  • 8.4.1. Fractional Flow Reserve
  • 8.4.2. Intravascular Ultrasound
  • 8.4.3. Optical Coherence Tomography
• 8.5. Stent
  • 8.5.1. Bare Metal Stent
  • 8.5.2. Bioresorbable Scaffold
  • 8.5.3. Drug Eluting Stent

9. Coronary Artery Disease Treatment Devices Market, by Treatment Type

• 9.1. Coronary Artery Bypass Grafting
  • 9.1.1. Off Pump
  • 9.1.2. On Pump
• 9.2. Percutaneous Coronary Intervention
  • 9.2.1. With Balloon Angioplasty
  • 9.2.2. With Stenting

10. Coronary Artery Disease Treatment Devices Market, by Approach

• 10.1. Transfemoral Approach
• 10.2. Transradial Approach

11. Coronary Artery Disease Treatment Devices Market, by End User

• 11.1. Ambulatory Surgical Centers
• 11.2. Cardiac Centers
• 11.3. Hospitals

12. Coronary Artery Disease Treatment Devices Market, by Region

• 12.1. Americas
  • 12.1.1. North America
  • 12.1.2. Latin America
• 12.2. Europe, Middle East & Africa
  • 12.2.1. Europe
  • 12.2.2. Middle East
  • 12.2.3. Africa
• 12.3. Asia-Pacific

13. Coronary Artery Disease Treatment Devices Market, by Group

• 13.1. ASEAN
• 13.2. GCC
• 13.3. European Union
• 13.4. BRICS
• 13.5. G7
• 13.6. NATO

14. Coronary Artery Disease Treatment Devices Market, by Country

• 14.1. United States
• 14.2. Canada
• 14.3. Mexico
• 14.4. Brazil
• 14.5. United Kingdom
• 14.6. Germany
• 14.7. France
• 14.8. Russia
• 14.9. Italy
• 14.10. Spain
• 14.11. China
• 14.12. India
• 14.13. Japan
• 14.14. Australia
• 14.15. South Korea

15. Competitive Landscape

• 15.1. Market Share Analysis, 2024
• 15.2. FPNV Positioning Matrix, 2024
• 15.3. Competitive Analysis
  • 15.3.1. Abbott Laboratories
  • 15.3.2. Boston Scientific Corporation
  • 15.3.3. Medtronic plc
  • 15.3.4. Terumo Corporation
  • 15.3.5. Biotronik SE & Co. KG
  • 15.3.6. Lepu Medical Technology (Beijing) Co., Ltd.
  • 15.3.7. Meril Life Sciences Pvt. Ltd.
  • 15.3.8. OrbusNeich Medical Company Limited
  • 15.3.9. MicroPort Scientific Corporation
  • 15.3.10. Cardinal Health, Inc.