심혈관 OCT 이미징 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the cardiovascular OCT imaging market size is expected to grow from USD 1.13 billion in 2025 to USD 1.23 billion in 2026 and is forecast to reach USD 1.87 billion by 2031 at 8.78% CAGR over 2026-2031.

Global Cardiovascular OCT Imaging Market Trends and Insights

Increasing Use of Intravascular Imaging in Complex PCI

The cardiovascular OCT imaging market is gaining traction as OCT-guided PCI becomes more established for complex coronary lesions. A 2025 network meta-analysis of 17 randomized trials involving 13,751 patients found that OCT guidance reduced major adverse cardiovascular events by 37% compared with angiography alone, with consistent outcomes across chronic total occlusions, left main disease, bifurcations, and severe calcification. The 2025 ECLIPSE trial enrolled 2,005 patients with severely calcified lesions and reported a 1-year target vessel failure rate of 7.7% with OCT guidance, compared with 13.2% with angiography guidance alone. As complex PCI procedures involving multivessel disease, multiple stents, and heavily calcified lesions increase, hospitals have stronger incentives to invest in imaging systems and operator training.

AI-Assisted Stent Sizing and Optimization

Artificial intelligence is expanding the potential user base for the cardiovascular OCT imaging market by reducing the interpretation burden on less experienced physicians. A 2025 study found that Abbott's Ultreon AI software improved physician accuracy in selecting stent diameter by a factor of 2.83 compared with conventional OCT software and reduced variation in landing-zone assessment. Abbott received FDA 510(k) clearance and CE Mark for Ultreon 3.0 on April 28, 2026, offering automated plaque tissue characterization, stent-size recommendations, and a 1-second pullback using low or zero contrast. Standardized workflows, integrated reporting, co-registration, and software updates can help hospital networks improve consistency across catheterization laboratories.

Contrast Use and Renal-Risk Concerns in Conventional OCT Workflows

The cardiovascular OCT imaging market faces a gap between evidence supporting saline use and catheterization laboratory protocols. Complex procedures involving multiple OCT pullbacks can require more than 200 mL of iodinated contrast when combined with diagnostic angiography, increasing acute kidney injury risk in patients with renal impairment, diabetes, or heart failure. Most fellowship programs do not offer standardized saline-based OCT training, limiting operator familiarity with the workflow. Hospitals may continue to avoid OCT for patients who could benefit from detailed imaging until guideline updates, vendor-supported education, and local protocols establish contrast-minimizing practices.

Other drivers and restraints analyzed in the detailed report include:

1. Rising Cardiovascular Disease and Complex Lesion Burden
2. Saline-Compatible and Low-Contrast OCT Workflows
3. Procedure-Time, Training, Reimbursement, and Governance Variability

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

Segment Analysis

Intravascular OCT imaging systems held 58.66% of the cardiovascular OCT imaging market in 2025, reflecting the high upfront investment required for catheterization laboratory hardware. Hospitals typically procure consoles with multiyear service agreements, software road maps, and clinical training, making vendor relationships and system integration key purchasing considerations. The installed base results in long replacement cycles and high switching costs. OCT imaging catheters are the fastest-growing product category and are projected to expand at a 10.12% CAGR through 2031, supported by PCI procedure volumes and recurring demand.

Gentuity received FDA 510(k) clearance in January 2025 for the Vis-Rx PRIME micro-imaging catheter for use with its HF-OCT imaging system. Its 1.8F profile enables imaging of severely stenotic vessels without pre-dilation and provides 100 mm of coronary coverage in 1 second. Accessories and consumables support connection and flushing workflows, with demand generally following catheter adoption. FDA classification distinguishes diagnostic intravascular catheters under 21 CFR 870.1200 from imaging systems under 21 CFR 892.1560, affecting software modification requirements and Predetermined Change Control Plan eligibility.

Frequency-domain OCT and Fourier-domain OCT held a 47.76% share in 2025, supported by an established clinical evidence base and broad commercial availability. However, limited penetration through lipid-rich or heavily calcified plaque and the need for contrast flushing remain key limitations. High-frequency OCT is projected to grow at a 9.80% CAGR through 2031, driven by smaller catheter profiles and reduced vessel-preparation requirements. Optical frequency-domain imaging also improves imaging speed for larger-vessel assessment.

Gentuity's HF-OCT system features a 1.8F catheter profile that images narrow lesions before pre-dilation, where conventional OCT catheters may require vessel preparation. Philips acquired SpectraWAVE in December 2025, adding the HyperVue system, which combines DeepOCT, near-infrared spectroscopy, and X1-FFR single-angiogram wire-free FFR technology. Conavi Medical received FDA 510(k) clearance in April 2026 for the Novasight Hybrid System, which supports co-registered, simultaneous IVUS and OCT imaging in a single pullback. These developments position the cardiovascular OCT imaging market toward integrated multimodal platforms.

Complete Report Scope:

• By Product Type
  • Intravascular OCT Imaging Systems
  • OCT Imaging Catheters
  • Accessories and Consumables
• By Technology / Imaging Architecture
  • Frequency-Domain OCT / Fourier-Domain OCT
  • Optical Frequency Domain Imaging
  • High-Frequency OCT
  • OCT-NIRS Hybrid Imaging
  • OCT-IVUS Hybrid Imaging
• By Application
  • Pre-PCI Lesion and Vessel Assessment
  • Stent Optimization
  • Expansion Failure Assessment
  • Plaque Characterization and Vulnerable Plaque Assessment
  • Acute Coronary Syndrome and MINOCA Assessment
• By End User
  • Hospitals and Tertiary Care Centers
  • Ambulatory Surgical Centers
  • Specialty Cardiology Clinics
  • Academic and Research Institutes
  • 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 39.44% of the cardiovascular OCT imaging market share in 2025, supported by established reimbursement systems, high catheterization laboratory capacity, and clinical trial participation. The United States performed more than 600,000 PCI procedures annually, and the 2025 U.S. guideline recommendation for intravascular imaging in complex lesions supported broader institutional adoption. Canada and Mexico were smaller contributors, while cardiac centers in Toronto and Montreal adopted practices aligned with U.S. clinical evidence. Europe was the second-largest regional market, led by Germany, the United Kingdom, and France, although reimbursement remained inconsistent despite the 2024 ESC Class I, Level A recommendation.

Asia-Pacific was the fastest-growing region, with the cardiovascular OCT imaging market projected to expand at a CAGR of 11.88% through 2031. Japan reimbursed intravascular imaging under its national health insurance system, and its 2025 clinical guidance provided OCT recommendations for calcium assessment and rotational atherectomy planning. China drove procedure-volume growth and saw the emergence of domestic OCT suppliers, while South Korea and India expanded catheterization laboratory capacity. However, uneven reimbursement, regulatory approvals, and operator training continued to create significant variation in adoption across the region.

The Middle East and Africa and South America represented smaller but improving opportunities for the cardiovascular OCT imaging market. Saudi Arabia's Vision 2030 supported cardiac center installations in Riyadh and Jeddah, while Dubai expanded cardiac care infrastructure; South Africa led adoption in Sub-Saharan Africa, although reimbursement and training limitations persisted. Brazil led South American adoption through its public-private cardiology system and major cardiac centers in Sao Paulo and Rio de Janeiro, while Argentina had lower penetration. Market entry required compliance with ANVISA, INVIMA, and SAHPRA requirements, which could extend the introduction timeline for FDA- or CE-certified products.

1. Abbott Laboratories
2. Boston Scientific
3. Canon
4. Carl Zeiss
5. CONAVI Medical Inc.
6. Forssmann Medical Technology Co., Ltd.
7. Gentuity
8. Heidelberg Engineering
9. Koninklijke Philips
10. Danaher
11. LightLab Imaging, Inc.
12. Medtronic
13. MicroPort
14. NIPRO CORPORATION
15. Olympus
16. Shenzhen Vivolight Medical Device & Technology Co., Ltd.
17. SpectraWAVE, Inc.
18. Terumo
19. Thorlabs
20. TOPCON CORPORATION

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 Use of Intravascular Imaging in Complex PCI
  • 4.2.2 AI-Assisted Stent Sizing and Optimization
  • 4.2.3 Rising Cardiovascular Disease and Complex Lesion Burden
  • 4.2.4 Saline-Compatible and Low-Contrast OCT Workflows
  • 4.2.5 Cath-Lab Integration, Co-Registration, and Automated Reporting
• 4.3 Market Restraints
  • 4.3.1 Contrast Use and Renal-Risk Concerns in Conventional OCT Workflows
  • 4.3.2 Procedure-Time, Radiation, and Operator-Training Burden
  • 4.3.3 Evidence, Reimbursement, and Governance Variability
• 4.4 Value / 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 Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE, USD)

• 5.1 By Product Type
  • 5.1.1 Intravascular OCT Imaging Systems
  • 5.1.2 OCT Imaging Catheters
  • 5.1.3 Accessories and Consumables
• 5.2 By Technology / Imaging Architecture
  • 5.2.1 Frequency-Domain OCT / Fourier-Domain OCT
  • 5.2.2 Optical Frequency Domain Imaging
  • 5.2.3 High-Frequency OCT
  • 5.2.4 OCT-NIRS Hybrid Imaging
  • 5.2.5 OCT-IVUS Hybrid Imaging
• 5.3 By Application
  • 5.3.1 Pre-PCI Lesion and Vessel Assessment
  • 5.3.2 Stent Optimization
  • 5.3.3 Expansion Failure Assessment
  • 5.3.4 Plaque Characterization and Vulnerable Plaque Assessment
  • 5.3.5 Acute Coronary Syndrome and MINOCA Assessment
• 5.4 By End User
  • 5.4.1 Hospitals and Tertiary Care Centers
  • 5.4.2 Ambulatory Surgical Centers
  • 5.4.3 Specialty Cardiology Clinics
  • 5.4.4 Academic and Research Institutes
  • 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 Boston Scientific Corporation
  • 6.3.3 Canon Medical Systems Corporation
  • 6.3.4 Carl Zeiss Meditec AG
  • 6.3.5 CONAVI Medical Inc.
  • 6.3.6 Forssmann Medical Technology Co., Ltd.
  • 6.3.7 Gentuity
  • 6.3.8 Heidelberg Engineering GmbH
  • 6.3.9 Koninklijke Philips N.V.
  • 6.3.10 Leica Microsystems GmbH
  • 6.3.11 LightLab Imaging, Inc.
  • 6.3.12 Medtronic plc
  • 6.3.13 MicroPort Scientific Corporation
  • 6.3.14 NIPRO CORPORATION
  • 6.3.15 Olympus Corporation
  • 6.3.16 Shenzhen Vivolight Medical Device & Technology Co., Ltd.
  • 6.3.17 SpectraWAVE, Inc.
  • 6.3.18 Terumo Corporation
  • 6.3.19 Thorlabs, Inc.
  • 6.3.20 TOPCON CORPORATION

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment