심혈관 중재시술 기기 시장 평가 : 제품 유형별, 최종 사용자별, 지역별, 기회 및 예측(2017-2031년)

Global interventional cardiology devices market is projected to witness a CAGR of 8.37% during the forecast period 2024-2031, growing from USD 16.22 billion in 2023 to USD 30.86 billion in 2031. The interventional cardiology devices market is thriving due to factors like a growing prevalence of cardiovascular disorders, technological advancements in cardiology devices, an increasing number of regulatory approvals, a growing geriatric population, rising awareness about cardiac conditions and treatment options, and increasing healthcare expenditure. Government initiatives and contributions from non-profit medical organizations to reduce the cardiac disease burden and strengthen the healthcare infrastructure are some other factors positively impacting the interventional cardiology devices market growth.

However, the dominance of first-line alternative treatment options pushes back the demand for interventional cardiology devices. The high cost of surgical procedures and instruments used for cardiac surgery makes it the terminal choice for middle and lower-class patients. Alongside, risks associated with cardiac surgeries and interventional devices hinder the growth of this market.

In November 2023, Argon Medical Devices, a trusted provider of device solutions for interventional radiology, vascular surgery, interventional cardiology, and oncology, introduced the Kodiak Dual Port Coaxial Introducer Kit. This innovative kit enables precise and streamlined introduction of diagnostic and therapeutic devices into the vasculature, ensuring optimum results for patients.

Technological Advancements in Cardiology Devices

Technological advancements in interventional cardiology devices have been significant in recent years. These advancements include the use of robotic technologies, miniature surgical robots controlled by surgeons, navigational sensors for precision, and wireless technologies with biosensors. Additionally, advancements in robotic percutaneous coronary intervention (PCI) technology, including improvements in wire manipulation, guide catheter control, and IVUS imaging, have been observed. Furthermore, wireless technologies and biosensors hold promise for interventional cardiology, as they can be used for various applications such as monitoring and diagnosis. These advancements are enhancing the precision, safety, and effectiveness of interventional cardiology procedures, ultimately benefiting interventional cardiology devices. Key players are designing products with enhanced technologies to cater to the market needs.

In September 2023, Canon Medical launched the Alphenix Sky 12 HD interventional system with the new high-definition (Hi-Def) detector. The Alphenix Sky 12 HD features a 12"X12" Hi-Def detector to improve visualization for interventional procedures, including pediatric cases, in cardiology, neurology, oncology, and radiology.

Growing Prevalence of Cardiovascular Diseases

Cardiovascular diseases are the leading cause of death globally, taking an estimated 17.9 million lives each year. The prevalence of cardiovascular diseases is expected to increase substantially due to factors such as population growth and aging. The rise in cardiovascular disease cases is attributed to a lack of translation of existing knowledge about cardiovascular diseases and risk factors into practice. The burden of cardiovascular diseases is particularly heavy on low- and middle-income countries, where they contribute to poverty and place a significant economic strain. Unhealthy diet, physical inactivity, tobacco use, and alcohol consumption are among the most important behavioral risk factors for cardiovascular diseases. The demand for interventional cardiology devices is expected to increase significantly with the growing prevalence of cardiovascular diseases.

For instance, according to the World Heart Report 2023 published by the World Heart Federation, cardiovascular diseases have been the leading cause of death worldwide for many years. In 2021, more than 20 million people died from a cardiovascular condition, which accounted for about one-third of all global deaths. This figure is significantly higher than the 12.1 million cardiovascular disease deaths recorded in 1990. Ischemic heart disease is now the leading cause of premature death in 146 countries for men and 98 countries for women.

Dominance of Stents Segment

The stents segment is anticipated to be the leading segment in the interventional cardiology devices market. Stents are commonly used in interventional cardiology to treat coronary artery disease. They are expandable tubular metallic devices introduced into clogged coronary arteries, a procedure known as percutaneous coronary intervention (PCI) or coronary stenting. The most widely used stents are drug-eluting stents (DES), which have significantly reduced the incidence of restenosis in native stable coronary arteries. Stents have been shown to reduce angina and improve survival in patients with coronary artery disease. Innovative stent products from market players have significantly developed the market.

In October 2023, Medinol announced the United States Food and Drug Administration (FDA) approval for its EluNIR-PERL drug-eluting stent (DES), which is meant for the treatment of coronary artery disease. EluNIR-PERL has four radiopaque markers, two at each end, and a hybrid polymer-metal radiopaque catheter tip. These unique features allow excellent visualization during PCI procedures, whether navigating through complex anatomies or placing the stent precisely.

Ambulatory Surgical Centers to be the Fastest Growing End-user Segment

Cardiology procedures are increasingly being performed in ambulatory surgery centers (ASCs) due to various factors such as improved patient experiences, strong reimbursement rates, and cost savings. These procedures include the placement of pacemakers, loop recorders, AICD, diagnostic and interventional coronary procedures, peripheral vascular interventions, right and left heart catheterizations, coronary interventions, and defibrillator and pacemaker implants. The Centers for Medicare and Medicaid Services (CMS) support this shift to ASCs by adding cardiology procedures to the ASC-covered procedure list. This has led to a faster growth rate for ambulatory surgical centers. For instance, as per an article published by HMP Global in July 2023, around 2% of major cardiovascular procedures are being performed in ambulatory surgical centers and the traction is steadily rising.

North America to be the Dominating Region

North America is anticipated to be the leading region in interventional cardiology devices. The region has a high prevalence of cardiovascular diseases, leading to a significant demand for cardiology devices. Additionally, North America has a high adoption rate of minimally invasive procedures and a strong presence of top manufacturers in the interventional cardiology device market. The rising healthcare expenditure and high disposable incomes in North America also contribute to the dominance of the region in the interventional cardiology devices market. Alongside, prominent players in the interventional cardiology device market, such as Medtronic, Boston Scientific Corporation, and Abbott, have a strong presence in North America, further contributing to its dominance.

As per the American Heart Association, by 2035, almost 45% of the United States population is expected to experience heart disease due to unhealthy factors such as high obesity rates, smoking, and poor lifestyle choices. These factors may increase the risk of heart attacks and other related health issues.

Future Market Scenario (2024 - 2031F)

In recent years, notable regulatory emphasis has been helpful for novel marketed products. Several reforms have been made to speed up the approval process of interventional cardiology devices. The FDA has been granting several regulatory approvals for interventional cardiology devices. The classification of interventional cardiovascular implant simulation software devices has been updated to class II (special controls). Most class III devices require FDA approval of a PMA before they can be legally marketed. The classification of cardiovascular devices intended for human use that are in commercial distribution is outlined in 21 CFR Part 870. The number of cardiac device approvals for children seems to be growing, with most approvals being granted through the humanitarian device exemption (HDE) pathway.

In November 2023, Medtronic plc received approval from the United States Food and Drug Administration (FDA) for its Symplicity Spyral renal denervation (RDN) system, which is also known as the Symplicity blood pressure procedure. This system has been approved for use in treating hypertension. As a result of the approval, Medtronic will start the commercialization of the product right away. The device is mainly meant to reduce hypertension through relaxing nerves connected to the kidneys and reducing its activity.

Key Players Landscape and Outlook

The key players in the interventional cardiology devices market include Abbott Laboratories, Terumo Corporation, Teleflex Incorporated, and B. Braun SE, among others. Many companies are working on developing new products and expanding their business through collaborations, partnerships, mergers, and strategic alliances. The market value of these players is driven by the successful implementation of these strategies. Additionally, regulatory approvals for new products and services also contribute to the growth of both the players and the market.

In October 2023, Haemonetics offered USD 253 million for sensor equipped TAVR guidewire maker OpSens. The deal is expected to close in January 2024. Haemonetics is a Boston-based medical device maker, while OpSens is a Canadian developer of optical sensor-equipped devices for both medical and industrial uses.

Table of Contents

1. Research Methodology

2. Project Scope & Definitions

3. Executive Summary

4. Global Interventional Cardiology Devices Market Outlook, 2017-2031F

• 4.1. Market Size & Forecast
  • 4.1.1. By Value
  • 4.1.2. By Volume
• 4.2. By Product Type
  • 4.2.1. Stents
    • 4.2.1.1. Bare-Metal Stents
    • 4.2.1.2. Drug-Eluting Stents
    • 4.2.1.3. Bio Absorbable Stent
    • 4.2.1.4. Others
  • 4.2.2. Catheters
    • 4.2.2.1. Angiography Catheters
    • 4.2.2.2. Atherectomy Catheters
    • 4.2.2.3. Thrombectomy Catheters
    • 4.2.2.4. Ablation Catheters
    • 4.2.2.5. IVUS Catheters
    • 4.2.2.6. Others
  • 4.2.3. Balloons
    • 4.2.3.1. PTCA Balloons
    • 4.2.3.2. Valvuloplasty Balloons
    • 4.2.3.3. Others
  • 4.2.4. Sheaths
  • 4.2.5. Valves
  • 4.2.6. Accessories and others
• 4.3. By End-user
  • 4.3.1. Hospitals
  • 4.3.2. Ambulatory Surgical Centers
  • 4.3.3. Cardiology Clinics
• 4.4. By Region
  • 4.4.1. North America
  • 4.4.2. Europe
  • 4.4.3. Asia-Pacific
  • 4.4.4. South America
  • 4.4.5. Middle East and Africa
• 4.5. By Company Market Share (%), 2023

5. Global Interventional Cardiology Devices Market Outlook, By Region, 2017-2031F

• 5.1. North America*
  • 5.1.1. Market Size & Forecast
    • 5.1.1.1. By Value
    • 5.1.1.2. By Volume
  • 5.1.2. By Product Type
    • 5.1.2.1. Stents
    • 5.1.2.1.1. Bare-Metal Stents
    • 5.1.2.1.2. Drug-Eluting Stents
    • 5.1.2.1.3. Bio Absorbable Stent
    • 5.1.2.1.4. Others
    • 5.1.2.2. Catheters
    • 5.1.2.2.1. Angiography Catheters
    • 5.1.2.2.2. Atherectomy Catheters
    • 5.1.2.2.3. Thrombectomy Catheters
    • 5.1.2.2.4. Ablation Catheters
    • 5.1.2.2.5. IVUS Catheters
    • 5.1.2.2.6. Others
    • 5.1.2.3. Balloons
    • 5.1.2.3.1. PTCA Balloons
    • 5.1.2.3.2. Valvuloplasty Balloons
    • 5.1.2.3.3. Others
    • 5.1.2.4. Sheaths
    • 5.1.2.5. Valves
    • 5.1.2.6. Accessories and others
  • 5.1.3. By End-user
    • 5.1.3.1. Hospitals
    • 5.1.3.2. Ambulatory Surgical Centers
    • 5.1.3.3. Cardiology Clinics
  • 5.1.4. United States*
    • 5.1.4.1. Market Size & Forecast
    • 5.1.4.1.1. By Value
    • 5.1.4.1.2. By Volume
    • 5.1.4.2. By Product Type
    • 5.1.4.2.1. Stents
    • 5.1.4.2.1.1. Bare-Metal Stents
    • 5.1.4.2.1.2. Drug-Eluting Stents
    • 5.1.4.2.1.3. Bio Absorbable Stent
    • 5.1.4.2.1.4. Others
    • 5.1.4.2.2. Catheters
    • 5.1.4.2.2.1. Angiography Catheters
    • 5.1.4.2.2.2. Atherectomy Catheters
    • 5.1.4.2.2.3. Thrombectomy Catheters
    • 5.1.4.2.2.4. Ablation Catheters
    • 5.1.4.2.2.5. IVUS Catheters
    • 5.1.4.2.2.6. Others
    • 5.1.4.2.3. Balloons
    • 5.1.4.2.3.1. PTCA Balloons
    • 5.1.4.2.3.2. Valvuloplasty Balloons
    • 5.1.4.2.3.3. Others
    • 5.1.4.2.4. Sheaths
    • 5.1.4.2.5. Valves
    • 5.1.4.2.6. Accessories and others
    • 5.1.4.3. By End-user
    • 5.1.4.3.1. Hospitals
    • 5.1.4.3.2. Ambulatory Surgical Centers
    • 5.1.4.3.3. Cardiology Clinics
  • 5.1.5. Canada
  • 5.1.6. Mexico

All segments will be provided for all regions and countries covered

• 5.2. Europe
  • 5.2.1. Germany
  • 5.2.2. France
  • 5.2.3. Italy
  • 5.2.4. United Kingdom
  • 5.2.5. Russia
  • 5.2.6. Netherlands
  • 5.2.7. Spain
  • 5.2.8. Turkey
  • 5.2.9. Poland
• 5.3. Asia-Pacific
  • 5.3.1. India
  • 5.3.2. China
  • 5.3.3. Japan
  • 5.3.4. Australia
  • 5.3.5. Vietnam
  • 5.3.6. South Korea
  • 5.3.7. Indonesia
  • 5.3.8. Philippines
• 5.4. South America
  • 5.4.1. Brazil
  • 5.4.2. Argentina
• 5.5. Middle East & Africa
  • 5.5.1. Saudi Arabia
  • 5.5.2. UAE
  • 5.5.3. South Africa

6. Market Mapping, 2023

• 6.1. By Product Type
• 6.2. By End-user
• 6.3. By Region

7. Macro Environment and Industry Structure

• 7.1. Demand Supply Analysis
• 7.2. Import Export Analysis
• 7.3. Value Chain Analysis
• 7.4. PESTEL Analysis
  • 7.4.1. Political Factors
  • 7.4.2. Economic System
  • 7.4.3. Social Implications
  • 7.4.4. Technological Advancements
  • 7.4.5. Environmental Impacts
  • 7.4.6. Legal Compliances and Regulatory Policies (Statutory Bodies Included)
• 7.5. Porter's Five Forces Analysis
  • 7.5.1. Supplier Power
  • 7.5.2. Buyer Power
  • 7.5.3. Substitution Threat
  • 7.5.4. Threat from New Entrant
  • 7.5.5. Competitive Rivalry

8. Market Dynamics

• 8.1. Growth Drivers
• 8.2. Growth Inhibitors (Challenges and Restraints)

9. Regulatory Framework and Innovation

• 9.1. Clinical Trials
• 9.2. Patent Landscape
• 9.3. Regulatory Approvals
• 9.4. Innovations/Emerging Technologies

10. Key Players Landscape

• 10.1. Competition Matrix of Top Five Market Leaders
• 10.2. Market Revenue Analysis of Top Five Market Leaders (in %, 2023)
• 10.3. Mergers and Acquisitions/Joint Ventures (If Applicable)
• 10.4. SWOT Analysis (For Five Market Players)

11. Pricing Analysis

12. Case Studies

13. Key Players Outlook

• 13.1. Abbott Laboratories
  • 13.1.1. Company Details
  • 13.1.2. Key Management Personnel
  • 13.1.3. Products & Services
  • 13.1.4. Financials (As reported)
  • 13.1.5. Key Market Focus & Geographical Presence
  • 13.1.6. Recent Developments
• 13.2. Terumo Corporation
• 13.3. Teleflex Incorporated
• 13.4. B. Braun SE
• 13.5. Biosensors International Group
• 13.6. ACIST Medical Systems
• 13.7. Cook Medical
• 13.8. Merit Medical Systems
• 13.9. Boston Scientific Corporation
• 13.10. Medtronic plc

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

14. Strategic Recommendations

15. About Us & Disclaimer