스코어링 풍선 카테터 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the scoring balloon catheters market size is expected to grow from USD 450.27 million in 2025 to USD 487.35 million in 2026 and is forecast to reach USD 726.08 million by 2031 at 8.31% CAGR over 2026-2031.

This report is Segmented by Balloon Type (Semi-Compliant, Non-Compliant, Other), Material (Nylon, PET, Polyurethane, Other), Diameter (Less Than 3 Mm, 3-5 Mm, Greater Than 5 Mm), Application (Coronary, Peripheral), End Use (Hospitals, Cardiac Centers, and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Scoring Balloon Catheters Market Trends and Insights

Rising Burden Of Calcified Coronary Lesions

Calcified coronary disease is becoming harder to ignore because published evidence shows calcium in 25% to 30% of patients presenting for PCI, and that burden rises with older age, diabetes, chronic kidney disease, and dyslipidemia. The scoring balloon catheters market gains from this pattern because rigid lesions often do not respond well to plain balloon dilation and require more controlled focal force before stent placement. It is also noted that severely calcified lesions were associated with a 62% higher risk of 1-year adverse outcomes after PCI, which makes lesion preparation more central to routine procedural planning. Intravascular ultrasound adds to the demand picture because it reveals more calcium than angiography alone, and the rising IVUS-guided PCI use in Medicare cases leads to stronger recognition of lesions that need specialized preparation. The scoring balloon catheters market, therefore, benefits not only from a larger disease burden but also from better detection of lesion complexity during case planning.

Shift Toward More Predictable Lesion Preparation Before Stenting

Physicians are placing more value on a more predictable preparation step because inadequate lesion modification remains one of the clearest causes of stent underexpansion, restenosis, and thrombosis in complex coronary work. The scoring balloon catheters market is supported by the meta-analysis, which found a 33% lower target lesion revascularization risk for cutting and scoring balloons versus conventional balloons in native coronary disease. That pattern matters at the hospital level because operators increasingly want the lesion addressed well before the stent is placed, rather than relying on a bailout step after suboptimal stent expansion is already visible. Naviscore first-in-man study across 10 European centers, where 85 patients recorded a 94% procedural success rate and 7.50% residual stenosis after stent implantation, with no in-hospital major adverse cardiac events. The scoring balloon catheters market, therefore, gains when hospitals and physicians judge lesion preparation by total case efficiency and final implant quality, not only by the acquisition cost of the balloon.

High Per-Procedure Cost Versus Conventional Balloons

The scoring balloon catheters market still faces a clear pricing hurdle because scoring balloons carry a premium over standard PTCA balloons, and that difference matters in systems operating under fixed or tightly managed reimbursement. This pressure is sharper in hospitals that do not handle large calcified case volumes, because procurement teams may default to plain balloons unless clinical protocols clearly define when scoring devices are necessary. China's procurement environment as structurally tougher for imported devices, with domestic alternatives such as MicroPort's FireFalcon adding pricing pressure in coronary intervention. That makes premium positioning harder to defend, even when multinational products have established clinical familiarity or broader global brand recognition. The scoring balloon catheters market, therefore, needs hospitals to see a clear procedural value in better lesion preparation if suppliers want to hold pricing above conventional balloon levels.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion Of PCI-Capable Cath Labs And Ambulatory Settings
2. Clinical Preference For Lower Dissection And Better Stent Expansion Outcomes
3. Competition From Intravascular Lithotripsy And Atherectomy Platforms

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

Segment Analysis

Non-compliant scoring balloons held 58.32% of the market by balloon type in 2025, which kept this format at the center of current lesion preparation practice. The scoring balloon catheters market continues to favor non-compliant designs because they are better suited to the precise, high-pressure inflation cycles needed to crack dense coronary calcium without overstretching the vessel wall. Abbott's Scoreflex NC, as a practical example, has a rated burst pressure of 20atm and a crossing profile of 0.0343 inches, which reflects the category's focus on controlled expansion and deliverability. Its external nitinol scoring wires are designed to generate focal stress that fractures calcium at lower nominal pressures than a plain non-compliant balloon while maintaining dimensional control.

The scoring balloon catheters market still leaves room for semi-compliant designs, but their role remains narrower and more selective. Their position in lesions where some controlled vessel compliance is preferred, especially in bifurcation disease or sequential vessel engagement strategies. That niche matters, but it has not displaced the stronger physician preference for rigid, predictable inflation in dense calcified disease. The scoring balloon catheters market therefore remains anchored in non-compliant formats because operator familiarity and cath lab protocols still support that design as the default for difficult coronary preparation. This concentration in one balloon type also gives established suppliers a durable advantage, because once a design is embedded in routine workflow, switching behavior tends to slow unless a clearly better outcome or cost profile appears.

Nylon accounted for 52.19% of the material segment in 2025, which kept it in the lead across the present installed product base. The scoring balloon catheters market has relied on nylon because it offers a useful balance between trackability in tortuous coronary anatomy and radial strength that remains suitable for many coronary scoring applications. That balance matters because many operators still judge a balloon first by how well it crosses the lesion and follows the wire through tight anatomy. Nylon also fits the current coronary-heavy volume pattern in the scoring balloon catheters market, where deliverability often decides whether a device is practical in real cases. For those reasons, nylon continues to hold a large share even as material preferences evolve around tighter dimensional behavior.

PET is the fastest-growing material segment and is projected to expand at an 8.60% CAGR through 2031, which reflects the rising value of dimensional precision in high-pressure use. Growth to a greater need for balloons that resist deformation and hold a more exact profile during inflation, especially in complex calcified lesions. This shift matters in the scoring balloon catheters market because more demanding lesion preparation leaves less tolerance for shape drift at peak pressure. It is also noted that ISO 10555-1 and related standards are pushing manufacturers toward more traceable performance certification, which can raise the qualification bar for newer entrants while favoring suppliers with validated polymer systems. Polyurethane and other materials still remain relevant in more flexible peripheral or smaller-gauge catheter designs, but the scoring balloon catheters market is clearly giving more attention to materials that support tighter control under demanding inflation conditions.

Complete Report Scope:

• By Balloon Type
  • Semi-Compliant Scoring Balloons
  • Non-Compliant Scoring Balloons
  • Other Balloon Types
• By Material
  • Nylon
  • Polyethylene Terephthalate
  • Polyurethane
  • Other Material
• By Diameter
  • Less Than 3 Mm
  • 3 To 5 Mm
  • Greater Than 5 Mm
• By Application
  • Coronary
  • Peripheral
    • Carotid
    • Lower Limb
    • Renal
    • Others
• By End Use
  • Hospitals
  • Cardiac Centers
  • Ambulatory Surgical Centers
  • Other End Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • 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 38.10% of the scoring balloon catheters market share in 2025, which made it the largest regional segment by value. The scoring balloon catheters market in North America is anchored by the United States, where PCI volumes remain high and private hospital infrastructure is dense across leading interventional networks. Another important support comes from reimbursement and site-of-care policy, because CMS added hundreds of cardiovascular procedure codes to the ASC Covered Procedures List in January 2026, which widened the settings where scoring balloons can be used. It is pointed to BD's UltraScore clearance in February 2026, and the 30-day FDA review cycle suggested rising regulatory familiarity with this device class for iterative product improvement.

Europe remains the second-largest regional market, and the scoring balloon catheters market there is supported by countries such as Germany, the United Kingdom, France, Italy, and Spain. Procedure demand is linked to established statutory coverage for coronary and peripheral interventions, while regulatory expectations under the EU Medical Device Regulation keep evidence standards high for new device entry. That creates a market structure that favors companies with stronger clinical data packages and broader post-market support. The Naviscore first-in-man study across 10 centers in Spain and Portugal, which added regional clinical evidence for a next-generation axial scoring design and can influence hospital procurement thinking in Europe.

Asia-Pacific is the fastest-growing region at a 9.91% CAGR through 2031, and the scoring balloon catheters market is benefiting there from larger procedure volumes, expanding hospital capacity, and a wider mix of domestic and imported devices. China supports that growth through a dual-track structure where premium imported devices serve major urban centers, while domestically approved products move more aggressively into provincial hospitals. MicroPort's FireFalcon coronary scoring balloon approval in November 2024 as a clear example of how domestic offerings are expanding in the Chinese market. Japan remains important because device uptake there depends heavily on local evidence and physician confidence in specialized coronary tools. India and South Korea also add to the scoring balloon catheters market through hospital expansion and technology-ready cath lab infrastructure in high-growth urban systems. The Middle East and Africa remain smaller in absolute terms, but GCC investment in advanced cardiac intervention capacity gives the region strategic importance. South America is improving from a lower base, though the reimbursement and economic pressure as limits on faster movement away from conventional balloons in public hospital networks.

1. Abbott Laboratories
2. B. Braun
3. Beckton Dickinson
4. BIOTRONIK SE and Co. KG
5. Boston Scientific
6. Cagent Vascular
7. Cardinal Health
8. Cook Group
9. Cordis
10. DK Medical Technology Co., Ltd
11. ENDOCOR
12. Hexacath
13. Jotech GmbH
14. Medtronic
15. Meril Life Science
16. Merit Medical Systems
17. MicroPort
18. Teleflex
19. Terumo
20. Tokai Medical Products Inc.

Additional Benefits:

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

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & 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 Rising Burden of Calcified Coronary Lesions
  • 4.2.2 Shift Toward More Predictable Lesion Preparation Before Stenting
  • 4.2.3 Expansion of PCI-Capable Cath Labs and Ambulatory Settings
  • 4.2.4 Clinical Preference for Lower Dissection and Better Stent Expansion Outcomes
  • 4.2.5 Under-Used Intravascular Imaging Creates Upside for Precision Scoring Use
  • 4.2.6 Refinements in Catheter Shaft Design Reducing Friction and Enhancing Trackability
• 4.3 Market Restraints
  • 4.3.1 High Per-Procedure Cost Versus Conventional Balloons
  • 4.3.2 Competition From Intravascular Lithotripsy and Atherectomy Platforms
  • 4.3.3 Limited Operator Familiarity in Lower-Volume Centers
  • 4.3.4 Reimbursement Pressure for Adjunctive Plaque Modification Devices
• 4.4 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 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Balloon Type
  • 5.1.1 Semi-Compliant Scoring Balloons
  • 5.1.2 Non-Compliant Scoring Balloons
  • 5.1.3 Other Balloon Types
• 5.2 By Material
  • 5.2.1 Nylon
  • 5.2.2 Polyethylene Terephthalate
  • 5.2.3 Polyurethane
  • 5.2.4 Other Material
• 5.3 By Diameter
  • 5.3.1 Less Than 3 Mm
  • 5.3.2 3 To 5 Mm
  • 5.3.3 Greater Than 5 Mm
• 5.4 By Application
  • 5.4.1 Coronary
  • 5.4.2 Peripheral
    • 5.4.2.1 Carotid
    • 5.4.2.2 Lower Limb
    • 5.4.2.3 Renal
    • 5.4.2.4 Others
• 5.5 By End Use
  • 5.5.1 Hospitals
  • 5.5.2 Cardiac Centers
  • 5.5.3 Ambulatory Surgical Centers
  • 5.5.4 Other End Users
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East and Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 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 B. Braun Melsungen AG
  • 6.3.3 Becton, Dickinson and Company
  • 6.3.4 BIOTRONIK SE and Co. KG
  • 6.3.5 Boston Scientific Corporation
  • 6.3.6 Cagent Vascular
  • 6.3.7 Cardinal Health, Inc.
  • 6.3.8 Cook Medical Inc.
  • 6.3.9 Cordis Corporation
  • 6.3.10 DK Medical Technology Co., Ltd
  • 6.3.11 Endocor GmbH
  • 6.3.12 Hexacath
  • 6.3.13 Jotech GmbH
  • 6.3.14 Medtronic Plc
  • 6.3.15 Meril Life Sciences Pvt Ltd
  • 6.3.16 Merit Medical Systems
  • 6.3.17 MicroPort Scientific Corporation
  • 6.3.18 Teleflex Incorporated
  • 6.3.19 Terumo Corporation
  • 6.3.20 Tokai Medical Products Inc.

7 Market Opportunities & Future Outlook

• 7.1 White-Space and Unmet-Need Assessment