心血管デバイスの世界市場 - 2024年～2031年

心血管デバイスの世界市場は、2023年に614億5,000万米ドルに達し、2031年には1,131億6,000万米ドルに達すると予測され、予測期間2024年～2031年のCAGRは8.1%で成長すると予測されています。

心血管デバイスは、さまざまな心臓の問題や障害の診断、モニタリング、治療に使用される機器です。心臓血管の健康管理、特に心調律異常、心不全、心臓構造疾患の治療において重要な役割を果たしています。これらの機器市場には、心臓植込み型電子機器（CIED）、ステント、除細動器、人工心臓弁など、多種多様な医療機器が含まれます。

心血管疾患の有病率の増加と技術の進歩によるデバイスの進化が、予測期間中の市場を牽引する要因です。例えば、British Heart Foundation 2023によると、世界中で約6億2,000万人が心臓や循環器系の疾患を抱えながら生活しており、この数はライフスタイルの変化、高齢化、人口の増加、心臓発作や脳卒中からの生存率の向上により増加しており、これらの動向が続けば今後も増加し続けると述べています。

市場力学：

促進要因と抑制要因

心血管疾患の有病率の増加

心血管デバイスの有病率の増加は、世界の心血管デバイス市場の成長において重要な要因となることが予想されます。心血管疾患の有病率の増加は、ヘルスケアシステムに新しい診断・治療アプローチを求める原動力となっています。心血管機器市場には、ステント、ペースメーカー、除細動器、心臓弁など、患者の予後を改善し、心臓の問題を効果的に管理するための幅広い商品が含まれます。技術の飛躍的進歩により、より複雑で侵襲の少ない技術が生み出され、ヘルスケアプロバイダーはこれらの技術革新を患者の治療に徐々に取り入れています。例えば、薬剤溶出ステントは再狭窄のリスクを低下させ、長期的な治療成績を向上させることで、冠動脈疾患の管理を一変させました。

心血管疾患の増加に伴い、市場は急速に拡大しています。例えば、米国疾病予防管理センターによると、心臓病は米国の男性、女性、ほとんどの人種・民族の人々の主な死因です。米国では33秒ごとに1人が心血管疾患で死亡しています。米国では約695,000人が心臓病で死亡しており、これは死亡者5人に1人の割合です。増加する心血管疾患の蔓延を克服するため、大手企業は最新技術を導入して心血管デバイスを立ち上げました。例えば、2023年10月、マシモはLiDCOボードインケーブル（BIC）モジュールの欧州連合医療機器規則に基づくCEマーク取得を発表しました。LiDCO BICモジュールは、Masimo Root Patient Monitoring and Connectivity Hubのようなマルチ患者モニタリングプラットフォームに接続し、高度な血行動態モニタリングを提供するように設計されています。このソリューションにより、臨床医はLiDCO血行動態モニタリングを簡単に追加することができます。さらに、2023年4月には、フランスの医療機器会社であるVygon India社が、チャンディガルで開催された重症治療学会（ISCCM）のシンポジウムにおいて、高度血行動態モニタリングシステムであるMostcare Upを北インドで発売しました。Mostcare Upシステムは、Pressure Recording Analytical Method（PRAM）に基づく特許取得済みのアルゴリズムを搭載した、低侵襲の動脈圧ベースのモニターです。これは、わずかな血行動態の変化さえもリアルタイムで、しかも拍動から拍動へと追跡できる唯一のモニターです。

厳しい規制要件

厳しい規制要件などの要因が、世界の心血管デバイス市場を阻害すると予想されます。厳しい規制上の制約が、世界の心血管デバイス市場の成長を大きく妨げると予測されています。患者の安全性と有効性を保証するため、米国食品医薬品局（FDA）や欧州医薬品庁（EMA）などの規制当局は、医療機器の承認と商業化に対して高い基準を設定しています。こうした規制は公衆衛生を守るために必要なものではあるが、革新的な製品を提供しようとする企業にとっては大きな課題でもあります。長くて複雑な規制プロセスは、しばしば遅延を引き起こし、イノベーションを阻害し、画期的な心血管技術をタイムリーに市場に提供する妨げとなります。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • 心血管疾患の罹患率の増加
  • 抑制要因
    • 厳格な規制要件
  • 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析
• 償還分析
• 特許分析
• SWOT分析
• DMIの見解

第6章 診断および監視デバイス別

• 心電図
• 遠隔心臓モニタリング
• その他

第7章 治療および外科用機器

• 心室補助装置（VAD）
• CRMデバイス
• カテーテル
• ステント
• 心臓弁
• その他

第8章 用途別

• 冠動脈疾患
• 不整脈
• 心不全
• その他

第9章 エンドユーザー別

• 病院
• 専門クリニック
• その他

第10章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他欧州地域
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• 中東・アフリカ

第11章 競合情勢

• 競合シナリオ
• 市況・シェア分析
• M&A分析

第12章 企業プロファイル

• B. Braun SE
  • 会社概要
  • 製品ポートフォリオと概要
  • 財務概要
  • 主な発展
• Medtronic
• Abbott
• Boston Scientific Corporation
• Edwards Lifesciences Corporation
• Johnson & Johnson Services, Inc.
• GE HealthCare
• LivaNova, Inc.
• Koninklijke Philips N.V.
• Terumo Cardiovascular Systems Corporation

第13章 付録

The global cardiovascular devices market reached US$ 61.45 billion in 2023 and is expected to reach US$ 113.16 billion by 2031, growing at a CAGR of 8.1% during the forecast period 2024-2031.

Cardiovascular devices are devices that are used to diagnose, monitor, and treat a variety of heart problems and disorders. They play an important role in cardiovascular health management, particularly in the treatment of cardiac rhythm abnormalities, heart failure, and structural heart diseases. The market for these devices includes a diverse variety of medical devices such as cardiac implantable electronic devices (CIEDs), stents, defibrillators, and prosthetic heart valves.

The increasing prevalence of cardiovascular diseases and device evolution due to technological advancements is the driving factor that drives the market over the forecast period. For instance, according to the British Heart Foundation 2023, stated that around 620 million people live with heart and circulatory diseases across the world and this number has been rising due to changing lifestyles, an aging, and growing population, and improved survival rates from heart attacks and strokes and will continue to rise if these trends continue.

Market Dynamics: Drivers & Restraints

Increasing prevalence of cardiovascular diseases

The increasing prevalence of cardiovascular devices is expected to be a significant factor in the growth of the global cardiovascular devices market. The increased prevalence of cardiovascular diseases is driving healthcare systems to seek novel diagnostic and treatment approaches. The cardiovascular device market includes a wide range of goods, such as stents, pacemakers, defibrillators, and heart valves, all of which are meant to improve patient outcomes and effectively manage heart problems. With technological breakthroughs resulting in the creation of more complex and less invasive technologies, healthcare providers are progressively incorporating these innovations into patient treatment. For instance, drug-eluting stents have transformed the management of coronary artery disease by lowering the risk of restenosis and enhancing long-term results.

The market is expanding rapidly as a result of the rise in cardiovascular diseases. For instance, according to the Centers for Disease Control and Prevention, heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. One person dies every 33 seconds in the United States from cardiovascular disease. About 695,000 people in the United States died from heart disease, that's 1 in every 5 deaths. To overcome the increasing prevalence of cardiovascular diseases, the major players have launched cardiovascular devices by inculcating the latest technologies. For instance, in October 2023, Masimo announced the CE mark, under the European Union Medical Device Regulation, for the LiDCO board-in-cable (BIC) module. The LiDCO BIC module is designed to connect to multi-patient monitoring platforms, like the Masimo Root Patient Monitoring and Connectivity Hub, to provide advanced hemodynamic monitoring. With this solution, clinicians can easily add LiDCO hemodynamic monitoring. Moreover, in April 2023, French medical device company, Vygon India launched its advanced hemodynamic monitoring system, Mostcare Up, in North India during a Society of Critical Care Medicine (ISCCM) symposium in Chandigarh. The Mostcare Up system is a minimally invasive arterial pressure-based monitor powered by a patented algorithm based on the Pressure Recording Analytical Method (PRAM). It is the only monitor that can follow even the slightest hemodynamic variations in real-time and from beat to beat.

Stringent regulatory requirements

Factors such as stringent regulatory requirements are expected to hamper the global cardiovascular devices market. Stringent regulatory constraints are projected to severely hamper the growth of the global cardiovascular devices market. To assure patient safety and efficacy, regulatory authorities such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) set high standards for medical device approval and commercialization. While these restrictions are necessary to protect public health, they can also pose significant challenges for firms looking to offer innovative products. The lengthy and complex regulatory processes frequently cause delays, which can discourage innovation and hinder the timely availability of breakthrough cardiovascular technologies on the market.

Segment Analysis

The global cardiovascular devices market is segmented based on diagnostic and monitoring devices, therapeutic and surgical devices, application, end user, and region.

Therapeutic and surgical devices segment is expected to dominate the global cardiovascular devices market share.

The therapeutic and surgical devices segment is expected to dominate the global cardiovascular devices market due to a number of compelling factors such as the increasing prevalence of cardiovascular diseases, technological advancements, and recent launches. This segment includes a diverse variety of devices, such as stents, pacemakers, defibrillators, heart valves, and ventricular assist devices (VADs), all of which play important roles in the treatment and management of various cardiovascular diseases. The increasing prevalence of diseases such as coronary artery disease (CAD), heart failure, and cardiac arrhythmias has increased demand for these devices, which are critical for successful patient care and intervention.

There are recent launches of various therapeutic and surgical devices with technological advancements inculcated in them. For instance, in May 2024, Abbott, the global healthcare company, announced the launch of the XIENCE Sierra Everolimus (drug) Eluting Coronary Stent System in India. According to the company, XIENCE Sierra is one of the latest generation stents in the XIENCE family, now available to people suffering from blocked coronary arteries. Moreover, in June 2024, Philips announced the first implant of the Duo Venous Stent System, an implantable medical device indicated to treat symptomatic venous outflow obstruction in patients with chronic venous insufficiency (CVI), following premarket approval (PMA) from the U.S. Food and Drug Association (FDA).

Geographical Analysis

North America is expected to hold a significant position in the global cardiovascular devices market share.

North America is expected to hold a significant portion of the global cardiovascular devices market. North America's large position in the worldwide cardiovascular devices market may be ascribed to the high prevalence of cardiovascular disorders, the presence of prominent manufacturers, advanced healthcare infrastructure, supportive regulatory frameworks, and rising healthcare expenditures. As these variables come together, they create an ideal atmosphere for extending growth and innovation in the cardiovascular devices sector, establishing North America as a vital participant in the global cardiovascular device market.

For instance, according to the National Institute of Health, approximately 82.6 million people in the United States currently have one or more forms of cardiovascular disease (CVD), making it a leading cause of death for both men and women. Common types of cardiovascular disease include coronary heart disease (CHD), stroke, hypertension, and congestive heart failure. An estimated 16.3 million Americans aged 20 and older have CHD, a prevalence of 7 percent.

There are recent launches and approvals in this region, making North America hold a significant portion of the global cardiovascular devices market. For instance, in March 2024, Silk Road Medical, Inc. announced the launch of its Tapered ENROUTE Transcarotid Stent System in hospitals across the United States. This launch builds on the company's previous ENROUTETranscarotid Stent System, providing more options to better customize the Transcarotid Artery Revascularization (TCAR) treatment to patient anatomy. TCAR is a minimally invasive surgical method that aims to deliver best-in-class stroke protection while minimizing complications.

Asia Pacific is growing at the fastest pace in the global cardiovascular devices market

Asia Pacific is experiencing the fastest growth in global cardiovascular devices owing to the increasing incidence of cardiovascular diseases and technological advancements in the region. For instance, according to the National Institute of Health, India has one of the highest rates of cardiovascular disease (CVD) worldwide. The annual number of CVD fatalities in India is expected to increase from 2.26 million to 4.77 million. Coronary heart disease prevalence rates in India have been estimated over several decades and have ranged from 1.6% to 7.4% in rural populations and from 1% to 13.2% in urban populations.

Competitive Landscape

The major global players in the global cardiovascular devices market include B. Braun SE, Medtronic, Abbott, Boston Scientific Corporation, Edwards Lifesciences Corporation, Johnson & Johnson Services, Inc., GE HealthCare, LivaNova, Inc., Koninklijke Philips N.V., Terumo Cardiovascular Systems Corporation among others.

Emerging Players

Vectorious Medical Technologies, FibriCheck, and Magicardio among others

Key Developments

• In December 2023, Terumo India, the Indian part of Japan-based Terumo Corporation, a global leader in medical technology, announced the launch of Ultimaster Nagomi, a Drug-Eluting Stent designed for the treatment of coronary artery disease.
• In March 2024, Prevounce Health, Boston Scientific Corporation announced that the AGENT Drug-Coated Balloon (DCB) has been approved by the United States Food and Drug Administration (FDA) for the treatment of coronary in-stent restenosis (ISR) in coronary artery disease patients. ISR is defined as the obstruction or narrowing of a stented artery caused by plaque or scar tissue.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global cardiovascular devices market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2023

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Diagnostic and Monitoring Devices
• 3.2. Snippet by Therapeutic and Surgical Devices
• 3.3. Snippet by Snippet by Application
• 3.4. Snippet by End User
• 3.5. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Increasing Prevalence of Cardiovascular Diseases
  • 4.1.2. Restraints
    • 4.1.2.1. Stringent Regulatory Requirements
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. Reimbursement Analysis
• 5.6. Patent Analysis
• 5.7. SWOT Analysis
• 5.8. DMI Opinion

6. By Diagnostic and Monitoring Devices

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Diagnostic and Monitoring Devices
  • 6.1.2. Market Attractiveness Index, By Diagnostic and Monitoring Devices
• 6.2. Electrocardiogram*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Remote Cardiac Monitoring
• 6.4. Others

7. By Therapeutic and Surgical Devices

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic and Surgical Devices
  • 7.1.2. Market Attractiveness Index, By Therapeutic and Surgical Devices
• 7.2. Ventricular Assist Devices (VAD)*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. CRM Devices
• 7.4. Catheters
• 7.5. Stents
• 7.6. Heart Valves
• 7.7. Others

8. By Application

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 8.1.2. Market Attractiveness Index, By Application
• 8.2. Coronary Artery Diseases*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Cardiac Arrhythmia
• 8.4. Heart Failure
• 8.5. Others

9. By End User

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 9.1.2. Market Attractiveness Index, By End User
• 9.2. Hospitals*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Specialty Clinics
• 9.4. Others

10. By Region

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 10.1.2. Market Attractiveness Index, By Region
• 10.2. North America
  • 10.2.1. Introduction
  • 10.2.2. Key Region-Specific Dynamics
  • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Diagnostic and Monitoring Devices
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic and Surgical Devices
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.2.7.1. The U.S.
    • 10.2.7.2. Canada
    • 10.2.7.3. Mexico
• 10.3. Europe
  • 10.3.1. Introduction
  • 10.3.2. Key Region-Specific Dynamics
  • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Diagnostic and Monitoring Devices
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic and Surgical Devices
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.7.1. Germany
    • 10.3.7.2. UK
    • 10.3.7.3. France
    • 10.3.7.4. Italy
    • 10.3.7.5. Spain
    • 10.3.7.6. Rest of Europe
• 10.4. South America
  • 10.4.1. Introduction
  • 10.4.2. Key Region-Specific Dynamics
  • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Diagnostic and Monitoring Devices
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic and Surgical Devices
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.7.1. Brazil
    • 10.4.7.2. Argentina
    • 10.4.7.3. Rest of South America
• 10.5. Asia-Pacific
  • 10.5.1. Introduction
  • 10.5.2. Key Region-Specific Dynamics
  • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Diagnostic and Monitoring Devices
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic and Surgical Devices
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.7.1. China
    • 10.5.7.2. India
    • 10.5.7.3. Japan
    • 10.5.7.4. South Korea
    • 10.5.7.5. Rest of Asia-Pacific
• 10.6. Middle East and Africa
  • 10.6.1. Introduction
  • 10.6.2. Key Region-Specific Dynamics
  • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Diagnostic and Monitoring Devices
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapeutic and Surgical Devices
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

11. Competitive Landscape

• 11.1. Competitive Scenario
• 11.2. Market Positioning/Share Analysis
• 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

• 12.1. B. Braun SE*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. Medtronic
• 12.3. Abbott
• 12.4. Boston Scientific Corporation
• 12.5. Edwards Lifesciences Corporation
• 12.6. Johnson & Johnson Services, Inc.
• 12.7. GE HealthCare
• 12.8. LivaNova, Inc.
• 12.9. Koninklijke Philips N.V.
• 12.10. Terumo Cardiovascular Systems Corporation

LIST NOT EXHAUSTIVE

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us