“The US peripheral CTO (chronic total occlusion) device market is expected to develop at a 7.2% CAGR from 2024 to 2031. The market value is predicted to rise from USD XX million in 2024 to USD YY million in 2031.”
The increased prevalence of peripheral artery disease (PAD) and coronary artery disease (CAD) in the United States is the primary driver of this industry. Key factors include increased use of minimally invasive surgeries, technological developments in CTO devices, and a growing geriatric population. The industry is rising rapidly because of improved reimbursement rules for peripheral therapies and the increasing use of CTO devices in complex cardiovascular surgeries.
Market Trend: Advanced imaging technologies enhance CTO device efficiency and procedural success rates.
The U.S. peripheral CTO device market is seeing a substantial shift towards the integration of modern imaging technologies with CTO devices. This integration significantly improves the efficiency of CTO treatments while increasing success rates. Cutting-edge imaging techniques, like intravascular ultrasound (IVUS) and optical coherence tomography (OCT), are increasingly being employed in tandem with CTO devices to give real-time, high-resolution visualization of occluded vessels. This trend allows interventionalists to more precisely negotiate difficult anatomies, lowering operation time and increasing patient outcomes.
A recent study in the Journal of Interventional Cardiology, for example, found that using IVUS-guided CTO procedures resulted in a 90% success rate compared to 63% with angiography alone. Major device makers are responding to this trend by producing CTO devices that can work with these sophisticated imaging modalities, which is boosting market growth.
Market Driver: Rising prevalence of peripheral artery disease fuels demand for CTO devices.
The rising prevalence of peripheral artery disease (PAD) in the United States is a key driver of the peripheral CTO device market. According to the American Heart Association, PAD affects approximately 8.5 million Americans aged 40 and up, and the frequency is predicted to climb as the population ages. This high prevalence is immediately translating into increased demand for peripheral CTO devices.
PAD cases are also becoming more severe, with more patients presenting with complicated lesions requiring treatment with specialised CTO devices. For example, a recent epidemiological study published in the Journal of the American College of Cardiology discovered that the number of PAD-related hospitalisations has increased by 23% in the last decade. This trend is prompting healthcare providers to invest in sophisticated CTO devices to successfully manage the growing patient population, resulting in market growth.
Market Restraint: High cost of CTO devices and procedures limits widespread adoption
The high cost of peripheral CTO devices and procedures limits industry growth. The complex technologies built into these devices, such as specialised guidewires and crossing devices, contribute to their high cost. For example, a single CTO guidewire can cost up to $600, while more complicated devices such as re-entry catheters can cost more than $2,000 per unit. These charges have a substantial impact on hospital budgets and patient affordability.
Furthermore, the complexities of CTO treatments frequently necessitate longer operation periods and specialised training for physicians, raising the entire cost of therapy. According to an American Journal of Managed Care study, the average cost of a peripheral CTO intervention ranges from $10,000 to $20,000, depending on the case's intricacy and the devices employed.
Guidewires dominate the device type segment in the U.S. peripheral CTO device market:
Guidewires are the most popular device type in the U.S. peripheral CTO device market, accounting for over YY% of the market share. This supremacy is due to their vital role in traversing complicated occlusions, as well as their adaptability across diverse CTO methods. Guidewires are frequently the first devices utilised in CTO procedures, and they are critical in determining the procedure's effectiveness.
Continuous improvement in guidewire technology has been a fundamental driver of this segment's growth. Manufacturers are creating guidewires with better torque control, crossability, and visibility under fluoroscopy. A multi-centre study published in the Journal of Invasive Cardiology found that Boston Scientific's Fielder XT-R guidewire, built exclusively for CTO surgeries, had a 93% success rate in traversing difficult lesions.
According to MedTech Dive, the coronary CTO market, which mainly relies on specialized guidewires, is predicted to grow to $350 million in the United States alone by 2025. This expansion is partly due to the growing use of the hybrid approach in CTO treatments, which depends substantially on sophisticated guidewire techniques.
Major businesses such as Abbott Laboratories and Medtronic have claimed strong growth in their peripheral intervention divisions, with guidewires playing a vital role. For example, Medtronic's coronary and peripheral vascular segment, which includes CTO devices, saw a 7% growth in revenue in the most recent fiscal year, hitting $2.9 billion.
The Northeast leads the U.S. peripheral CTO device market with significant growth potential.
The Northeast area dominates the US peripheral CTO device market, contributing for over YY% of total market share. This dominance stems mostly from the region's high concentration of modern healthcare facilities, the presence of significant market participants, and the greater adoption rates of revolutionary medical technologies.
States such as Massachusetts, New York, and Pennsylvania are important contributors to market growth in this region. The Northeast is home to numerous famous cardiovascular centers of excellence that were early adopters of modern CTO procedures and technologies. For example, the CTO program at Columbia University Medical Centre in New York reports executing over 200 difficult CTO procedures each year, with a success rate of more than 90%.
The region's superiority in medical research and clinical trials adds to its market supremacy. According to the National Institutes of Health, the Northeast accounts for roughly 40% of all cardiovascular clinical studies undertaken in the United States, with many involving CTO devices and procedures.
Another driver of market expansion is the Northeast's aging population. According to the United States Census Bureau, by 2030, more than 20% of the population in the Northeastern states will be 65 and older, making them especially vulnerable to peripheral and coronary artery disorders.
The US peripheral CTO device market is characterized by fierce rivalry among a few prominent companies, with a focus on technological innovation and strategic alliances. Leading organizations are investing considerably in research and development to create more efficient and user-friendly CTO devices.
Market leaders such as Boston Scientific Corporation and Abbott Laboratories have been working to increase their product ranges through internal research and strategic acquisitions. For example, in 2021, Boston Scientific acquired Baylis Medical Company for $1.75 billion, greatly strengthening their CTO device capabilities.
In terms of market share, the top three competitors control over 60% of the US market. To meet rising demand, these companies are extending their sales and distribution networks, particularly in high-PAD-prevalence areas.
Financial performance varies among important players, with the majority reporting consistent development in their peripheral intervention segments. For example, Abbott Laboratories reported a 14.6% rise in vascular business sales in 2022, totalling $3.2 billion, owing in part to their CTO device segment.
The industry's future prognosis remains bright, with a focus on creating devices for more difficult lesions and enhancing procedure success rates. Companies are also investigating the use of artificial intelligence and machine learning technologies to improve CTO device performance and procedure outcomes.
The U.S. peripheral CTO device market is expected to expand rapidly, owing to the rising prevalence of peripheral artery disease and the increased acceptance of minimally invasive techniques. The development of hybrid CTO devices that combine several characteristics, such as guidewires and integrated crossing capabilities, is an important trend to keep an eye on. These sophisticated devices are predicted to improve procedural efficiency and reduce the number of device changes required during difficult treatments.
Furthermore, the market is shifting towards value-based healthcare, with an emphasis on devices that can show improved long-term results and cost-effectiveness. This could result in more funding for real-world evidence studies and post-market surveillance to validate the long-term advantages of CTO interventions.
Boston Scientific Corporation
Abbott Laboratories
Medtronic plc
Terumo Corporation
Becton, Dickinson, and Company (C.R. Bard)
Asahi Intecc Co., Ltd.
Cardinal Health, Inc.
Teleflex Incorporated
Cook Medical
Philips Healthcare
June 2023: Boston Scientific Corporation introduces a new CTO crossover device with improved penetration capability for complicated lesions.
Abbott Laboratories gained FDA approval in March 2023 for their next-generation CTO guidewire system, which improves torque control and visibility.
1. INTRODUCTION
1.1. Market Definitions & Study Assumptions
1.2. Market Research Scope and Segment
1.3. Research Methodology
2. EXECUTIVE SUMMARY
2.1. Market Overview & Insights
2.2. Segment Outlook
2.3. Region Outlook
3. COMPETITIVE INTELLIGENCE
3.1. Companies Financial Position
3.2. Company Benchmarking—Key Players
3.3. Market Share Analysis -- Key Companies
3.4. Recent Companies Key Activities
3.5. Pricing Analysis
3.6. SWOT Analysis
4. COMPANY PROFILES (Key Companies List by Country) (Premium)
5. COMPANY PROFILES
5.1. Boston Scientific Corporation
5.2. Abbott Laboratories
5.3. Medtronic plc
5.4. Terumo Corporation
5.5. Becton, Dickinson, and Company (C.R. Bard)
5.6. Asahi Intecc Co., Ltd.
5.7. Cardinal Health, Inc.
5.8. Teleflex Incorporated
5.9. Cook Medical
5.10. Philips Healthcare (*LIST NOT EXHAUSTIVE)
6. MARKET DYNAMICS
6.1. Market Trends
6.1.1. Advanced imaging technologies enhance CTO device efficiency and procedural success rates
6.1.2. Integration of artificial intelligence in CTO device guidance systems
6.1.3. Development of bioresorbable CTO devices for improved long-term outcomes
6.2. Market Drivers
6.2.1. Rising prevalence of peripheral artery disease fuels demand for CTO devices
6.2.2. Increasing adoption of minimally invasive procedures in cardiovascular interventions
6.2.3. Growing geriatric population susceptible to chronic total occlusions
6.3. Market Restraints
6.3.1. High cost of CTO devices and procedures limits widespread adoption
6.3.2. Stringent regulatory approval process for new CTO devices
6.4. Market Opportunities
6.5. Porter's Five Forces Analysis
6.5.1. Threat of New Entrants
6.5.2. Bargaining Power of Buyers/Consumers
6.5.3. Bargaining Power of Suppliers
6.5.4. Threat of Substitute Products
6.5.5. Intensity of Competitive Rivalry
6.6. Supply Chain Analysis
6.7. Value Chain Analysis
6.8. Trade Analysis
6.9. Pricing Analysis
6.10. Regulatory Analysis
6.11. Patent Analysis
6.12. SWOT Analysis
6.13. PESTLE Analysis
7. BY DEVICE TYPE (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
7.1. Guidewires
7.1.1. Hydrophilic guidewires
7.1.2. Hydrophobic guidewires
7.2. Microcatheters
7.2.1. Single-lumen microcatheters
7.2.2. Dual-lumen microcatheters
7.3. Crossing Devices
7.3.1. Radiofrequency-based devices
7.3.2. Laser-based devices
7.4. Re-entry Devices
7.4.1. Intravascular ultrasound (IVUS)-guided devices
7.4.2. Fluoroscopy-guided devices
8. BY INDICATION (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH)--2020-2031)
8.1. Peripheral Artery Disease
8.1.1. Femoropopliteal artery disease
8.1.2. Iliac artery disease
8.1.3. Below-the-knee artery disease
8.2. Coronary Artery Disease
8.2.1. Chronic total occlusions
8.2.2. Complex bifurcation lesions
9. BY END USER (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
9.1. Hospitals
9.1.1. Catheterisation laboratories
9.1.2. Operating rooms
9.2. Ambulatory Surgical Centres
9.3. Speciality Clinics
9.3.1. Cardiovascular clinics
9.3.2. Vascular surgery clinics
10. REGION (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
10.1. Northeast
10.1.1. New York
10.1.2. Massachusetts
10.1.3. Pennsylvania
10.1.4. Rest of Northeast
10.2. Midwest
10.2.1. Illinois
10.2.2. Ohio
10.2.3. Michigan
10.2.4. Rest of Midwest
10.3. South
10.3.1. Texas
10.3.2. Florida
10.3.3. Georgia
10.3.4. Rest of South
10.4. West
10.4.1. California
10.4.2. Washington
10.4.3. Colorado
10.4.4. Rest of West
*NOTE: All the regions mentioned in the scope will be provided with (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (2020-2031)
By Device Type:
Guidewires
Microcatheters
Crossing Devices
Re-entry Devices
By Indication:
Peripheral Artery Disease
Coronary Artery Disease
By End User:
Hospitals
Ambulatory Surgical Centres
Speciality Clinics
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