경피적 관상동맥 중재술 유도 장치 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the percutaneous coronary intervention guidance devices market size is projected to expand from USD 1.96 billion in 2025 and USD 2.14 billion in 2026 to USD 3.33 billion by 2031, registering a CAGR of 9.23% between 2026 to 2031.

This report is Segmented by Product Type (Intravascular Ultrasound (IVUS) Systems, and More), Technology (IVUS-Based Guidance, OCT-Based Guidance, and More), Application (Lesion Assessment, and More), End User (Hospitals, Ambulatory Surgical Centers, and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Value (USD).

Global Percutaneous Coronary Intervention Guidance Devices Market Trends and Insights

Increasing Burden of Complex Coronary Lesions and Calcified Disease

The percutaneous coronary intervention guidance devices market is benefiting from a larger pool of patients with calcified and anatomically complex lesions that are difficult to assess with angiography alone. Moderate to severe calcification is present in 20% to 30% of patients undergoing invasive coronary angiography, and prevalence rises sharply in older men, which keeps imaging demand structurally tied to aging populations. The same pattern appears in chronic total occlusion treatment, where the PROGRESS-CTO Registry reported moderate or severe calcification in 49.6% of lesions across 16,916 CTO PCI procedures enrolled between 2012 and 2025. Clinical evidence has also become harder for hospitals to ignore because the ECLIPSE Trial showed that intravascular imaging guidance lowered 1-year target vessel failure to 9.3% from 13.2% in severely calcified lesions. That outcome keeps the percutaneous coronary intervention guidance devices market tied not only to procedure volume growth, but also to the rising share of procedures that require better lesion preparation, calcium scoring, and post-stent assessment.

Shift Toward Image-Guided and Physiology-Guided PCI

The percutaneous coronary intervention guidance devices market is also being lifted by a wider shift from angiography-only workflows toward imaging-guided and physiology-guided PCI. Integrated systems now let physicians access IVUS, OCT, and pressure-based tools on one console, which reduces setup burden and supports more consistent cath lab workflows. A 2025 meta-analysis covering 22 clinical trials found that intravascular imaging-guided PCI reduced cardiac death by 45%, target lesion failure by 29%, and definite stent thrombosis by 48% against angiography guidance alone. The OCTIVUS Trial also showed that patients who achieved stent optimization had a 52% relative reduction in target vessel failure, and the benefit was strongest under OCT guidance. These results are changing procurement behavior because hospitals now see guidance platforms as tools that support both better outcomes and closer compliance with updated practice standards.

High Capital and Recurring Catheter Cost

The percutaneous coronary intervention guidance devices market remains constrained by the full ownership cost of consoles, software, and single-use catheters. Hospitals do not only evaluate the base platform price, but they also judge whether recurring catheter use can be justified across a broad PCI caseload under bundled payment structures. Boston Scientific's 2026 reimbursement guide notes that IVUS and FFR are not separately billable in ambulatory surgical centers, which leaves institutions to recover costs through coding structures that many ASC administrators still find difficult to use. That issue is even more acute in emerging markets, where capital budgets are tighter, and imaging is reserved for the highest-risk cases rather than normalized across routine procedures. As a result, the percutaneous coronary intervention guidance devices market still depends heavily on premium hospitals and referral centers that can support both hardware acquisition and steady disposable pull-through.

Other drivers and restraints analyzed in the detailed report include:

1. AI-Assisted Lesion Assessment and Workflow Automation
2. Reimbursement Support for Intravascular Imaging in Mature Markets
3. Shortage of Trained Interventional Cardiologists

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Intravascular ultrasound systems accounted for 36.74% of the percutaneous coronary intervention guidance devices market share in 2025, which kept IVUS as the leading product type. That lead reflected long physician familiarity, a mature catheter supply chain, and strong use in ostial and left-main disease, where OCT flush requirements can limit practicality. The segment also benefited from the shift toward higher-definition IVUS catheters in complex PCI, where physicians want deeper vessel assessment together with clearer plaque and calcium visualization. OCT remained the second-largest product category, and comparative evidence continued to narrow perceived outcome differences between the two modalities. A 2024 meta-analysis across 6 randomized controlled trials and 4,402 patients found no significant difference between OCT-guided and IVUS-guided PCI in MACE, cardiac mortality, or stent thrombosis.

The percutaneous coronary intervention guidance devices market is seeing its fastest product-type momentum in iFR systems, which are projected to grow at a 10.45% CAGR through 2031. The main appeal is the adenosine-free workflow, since it reduces procedure time, avoids added drug use, and simplifies the protocol for routine physiology assessment. FFR systems still hold a complementary role, but the competitive pressure around wire-free and angio-derived options is becoming clearer. The FLAVOUR II Trial published in 2025 showed that an angiography-derived FFR-guided strategy was non-inferior to IVUS guidance for 12-month clinical outcomes, which supports a gradual shift away from some wire-based cases. Accessories and disposables remain central to the percutaneous coronary intervention guidance devices industry because guidewires, imaging catheters, and flush kits keep recurring revenue tied closely to console placement and physician loyalty.

IVUS-based guidance held a 34.68% technology share in 2025, supported by its installed base and its practical value in lesions that need plaque burden and calcification depth assessment. The modality remains especially important in cases where OCT contrast flushing is less suitable, which gives IVUS a durable role in more complex coronary anatomy. This leadership also reflects the fact that many hospitals have already built their workflow around IVUS consoles before the current wave of AI and multimodality launches. At the same time, the technology mix is widening as hospitals compare image-led guidance with physiology-led strategies for selected lesions. This leaves the percutaneous coronary intervention guidance devices market less dependent on a single guidance method than it was only a few years ago.

FFR and iFR physiological guidance is forecast to grow at a 12.89% CAGR through 2031, which makes it the fastest-growing technology group. The CathWorks ALL-RISE Trial, presented at ACC.26, randomized 1,930 patients across 59 global sites and showed that FFRangio delivered similar clinical outcomes to invasive wire-based physiology assessment. AI-enabled PCI guidance is also becoming more credible as a technology layer rather than a marketing feature. A study in the Journal of the Society for Cardiovascular Angiography & Interventions found that Abbott's Ultreon AI platform produced more accurate, less variable, and more time-efficient PCI planning decisions than conventional software across operator experience levels. This shift gives the percutaneous coronary intervention guidance devices industry a broader competitive field, where imaging depth, physiology integration, and software productivity all influence capital spending decisions.

Complete Report Scope:

• By Product Type
  • Intravascular Ultrasound (IVUS) Systems
  • Optical Coherence Tomography (OCT) Systems
  • Fractional Flow Reserve (FFR) Systems
  • iFR Systems
  • Hybrid IVUS-OCT Systems
  • Accessories and Disposables
• By Technology
  • IVUS-Based Guidance
  • OCT-Based Guidance
  • FFR/iFR Physiological Guidance
  • AI-Enabled PCI Guidance
  • Others
• By Application
  • Lesion Assessment
  • Stent Selection and Optimization
  • Post-PCI Expansion Assessment
  • Complex PCI Guidance
  • Others
• By End User
  • Hospitals
  • Ambulatory Surgical Centers
  • Specialty Cardiology Centers
  • Cardiac Catheterization Laboratories
  • Others
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 39.58% of the percutaneous coronary intervention guidance devices market share in 2025, which kept it as the largest regional contributor. The region benefits from mature reimbursement architecture, a dense base of high-volume PCI centers, and the commercial presence of the leading platform vendors. U.S. guideline changes continue to support capital and consumable demand because hospitals increasingly link imaging use with expected standards of care in complex PCI. Payment support also remains stronger here than in most other regions, even if coding details still vary by site of care. Canada and Mexico add to regional volume, though procurement timelines and uneven tertiary access still limit the pace of broader adoption.

Europe remained the second-largest region in 2025, with Germany, France, and the United Kingdom acting as the main centers for advanced intravascular guidance use. The region combines an established interventional cardiology base with growing demand for system refreshes as older platforms approach replacement cycles. Philips strengthened its European position in March 2026 by launching IntraSight Plus with both FDA and CE marks, which supports hospitals seeking a combined IVUS and physiology workflow on one screen. Adoption is still uneven across the region because high-volume centers move faster than community hospitals where capital constraints keep angiography-guided practice more common.

Asia-Pacific is projected to grow at a 14.73% CAGR in the percutaneous coronary intervention guidance devices market size through 2031, making it the fastest-growing region. Japan remains the benchmark market because more than 80% of PCI procedures are already performed under intravascular imaging guidance. That level of use shows how reimbursement alignment and clinical culture can reinforce each other over time. The broader region also benefits from procedural volume growth, expanding cath lab infrastructure, and rising interest in integrated and hybrid platforms. South Korea is important because it has contributed pivotal evidence in AI-assisted PCI workflow validation, including the FLASH Trial. India and Southeast Asia remain longer-conversion markets where private hospital networks are adding capability, but reimbursement support for adjunct imaging is still inconsistent. The Middle East and Africa are growing from a small base, led by tertiary investment in Gulf countries and early adoption in South Africa. South America remains anchored by Brazil, though reimbursement limits and approval friction still constrain wider use across public systems.

1. Abbott Laboratories
2. ACIST Medical Systems, Inc.
3. ACUTUS Medical (Acutus Medical, Inc.)
4. Avinger, Inc.
5. Boston Scientific
6. Canon
7. CathWorks Ltd.
8. Conavi Medical Corp.
9. Esaote S.p.A.
10. HeartFlow, Inc.
11. Infraredx, Inc.
12. Insight Lifetech
13. Koninklijke Philips
14. Magnetecs, Inc.
15. Medis Medical Imaging B.V.
16. Opsens Inc.
17. Pie Medical Imaging
18. Sino Medical Sciences Technology Inc. (SINOMED)
19. Stereotaxis, Inc.
20. Terumo

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Increasing Burden of Complex Coronary Lesions and Calcified Disease
  • 4.2.2 Shift Toward Image-Guided and Physiology-Guided PCI
  • 4.2.3 AI-Assisted Lesion Assessment and Workflow Automation
  • 4.2.4 Reimbursement Support for Intravascular Imaging in Mature Markets
  • 4.2.5 Hybrid IVUS-OCT and Multimodality Console Adoption
  • 4.2.6 Cath Lab Standardization in High-Volume Tertiary Centers
• 4.3 Market Restraints
  • 4.3.1 High Capital and Recurring Catheter Cost
  • 4.3.2 Shortage of Trained Interventional Cardiologists
  • 4.3.3 Variable Reimbursement and Prior Authorization Friction in Emerging Markets
  • 4.3.4 Limited Intra-Procedure Reimbursement for Adjunct Analytics Software
• 4.4 Value and Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product Type
  • 5.1.1 Intravascular Ultrasound (IVUS) Systems
  • 5.1.2 Optical Coherence Tomography (OCT) Systems
  • 5.1.3 Fractional Flow Reserve (FFR) Systems
  • 5.1.4 iFR Systems
  • 5.1.5 Hybrid IVUS-OCT Systems
  • 5.1.6 Accessories and Disposables
• 5.2 By Technology
  • 5.2.1 IVUS-Based Guidance
  • 5.2.2 OCT-Based Guidance
  • 5.2.3 FFR/iFR Physiological Guidance
  • 5.2.4 AI-Enabled PCI Guidance
  • 5.2.5 Others
• 5.3 By Application
  • 5.3.1 Lesion Assessment
  • 5.3.2 Stent Selection and Optimization
  • 5.3.3 Post-PCI Expansion Assessment
  • 5.3.4 Complex PCI Guidance
  • 5.3.5 Others
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Ambulatory Surgical Centers
  • 5.4.3 Specialty Cardiology Centers
  • 5.4.4 Cardiac Catheterization Laboratories
  • 5.4.5 Others
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 India
    • 5.5.3.3 Japan
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 ACIST Medical Systems, Inc.
  • 6.3.3 ACUTUS Medical (Acutus Medical, Inc.)
  • 6.3.4 Avinger, Inc.
  • 6.3.5 Boston Scientific Corporation
  • 6.3.6 Canon Medical Systems Corporation
  • 6.3.7 CathWorks Ltd.
  • 6.3.8 Conavi Medical Corp.
  • 6.3.9 Esaote S.p.A.
  • 6.3.10 HeartFlow, Inc.
  • 6.3.11 Infraredx, Inc.
  • 6.3.12 Insight Lifetech Co., Ltd.
  • 6.3.13 Koninklijke Philips N.V.
  • 6.3.14 Magnetecs, Inc.
  • 6.3.15 Medis Medical Imaging B.V.
  • 6.3.16 Opsens Inc.
  • 6.3.17 Pie Medical Imaging B.V.
  • 6.3.18 Sino Medical Sciences Technology Inc. (SINOMED)
  • 6.3.19 Stereotaxis, Inc.
  • 6.3.20 Terumo Corporation

7 Market Opportunities & Future Outlook

• 7.1 White-space and Unmet-Need Assessment