세계의 심장 이식형 전자기기 시장(2023-2030년)

Overview

An arrhythmia, or uneven heartbeat, is a trouble with the rate or rhythm of the heartbeat. The heart may beat too fast, too slow, or with an odd rhythm. It is typical for the heart rate to race up in physical exercise and to slow down while relaxing or resting. Cardiac implantable electronic devices (CIEDs) are battery-powered medical devices employed for the treatment of a variety of cardiac conditions these devices include permanent pacemakers (PPMs), automated implantable cardioverter defibrillators (AICDs), and cardiac resynchronization therapy devices (CRTs).

CIEDs are utilized to monitor and manage arrhythmias (PPMs, AICDs, CRTs) and enhance systolic function (CRTs). Presently, it is assessed that up to 1.4 million cardiac implantable electronic devices (CIED) are implanted worldwide annually. According to the American College of Cardiology, roughly 200,000 pacemakers are implanted in the United States in individuals with bradycardic annually.

The growing cases of cardiovascular diseases including arrhythmias, increasing product authorizations, positive outcomes from research activities, market developments including mergers, acquisitions, products introductions, growing awareness among other factors are expected to boost the global cardiac implantable electronic devices market growth in the forecast period. Further, the new product launches and technological advancements also expected to contribute to the global market growth in the forecast period.

Dynamics

Increasing Cardiac Implantable Electronic Devices Authorizations

The increasing cardiac implantable electronic devices authorizations from distinct regulatory bodies are expected to boost the global market growth during the forecast period. For instance, in May 2023, Biotronik, a global cardiovascular biomedical research and technology corporation, obtained CE (Conformite Europeenne) clearance for the World's foremost pacemaker and (cardiac resynchronization therapy-pacemaker) CRT-P Cardiac Implantable Electronic Devices line authorized for left bundle branch pacing.

Moreover, in January 2022, Medtronic, a medical technology corporation involved in the designing, cardiac implantable electronic devicesion, distribution, and commercialization of device-based medical treatments, obtained Japan's Ministry of Health, Labor, and Welfare authorization for the commercialization and repayment of the Micra AV Transcatheter Pacing System (TPS). This authorization extends the number of patients in Japan, one of the most extensive markets in the globe, who are suitable to obtain the Micra TPS, the globe's tiniest pacemaker. The Micra AV is suggested to treat patients with AV block, a state in which the electrical signals between the chambers of the heart (the atria and the ventricle) are deformed.

Growing Cases of Cardiovascular Diseases

The growing cases of cardiovascular diseases including cardiac arrhythmias are expected to boost the demand for cardiac implantable electronic devices in the forecast period. For instnace, according to the NIH study published in 2020, the global preponderance of atrial fibrillation was around 37,574 million cases (0.51% of the global inhabitants), which grew again by 33% in the last two decades. The most elevated load is witnessed in nations with high socio-demographic index, though the most extensive current gain transpired in middle socio-demographic index nations.

Atrial fibrillation is a highly typical cardiac arrhythmia. It has been assessed that around 6-12 million individuals globally are expected to suffer from this disorder in the US by 2050 and 17.9 million individuals in Europe by 2060. Atrial fibrillation is a significant threat element for ischemic stroke and evokes a critical economic load along with substantial morbidity and mortality.

Again, according to the NIH, the preponderance of arrhythmias is anticipated to be 1.5% to 5% in the widespread population, with atrial fibrillation being highly expected. Further, according to the British Heart Foundation UK Factsheet 2023, over 1.5 million people in the UK have been diagnosed with atrial fibrillation, but a substantial number of them are not treated effectively. It is assessed that there are at the minimum 270,000 individuals aged above 65 with undiagnosed (or silent) atrial fibrillation in the UK.

Cardiac Implantable Electronic Devices Recalls

The cardiac implantable electronic devices recalls from the market owing to patient health safety concerns are expected to hamper the global market growth during the forecast period. For instance, in April 2021, the U.S. Food and Drug Administration (FDA) declared that Medtronic recalled almost 350,000 implantable cardiac devices owing to persistent problems with their capability to deliver high-voltage therapy when required.

According to the FDA declaration, a reduced-energy shock, or no shock at all, may fail to fix a life-threatening arrhythmia, which can lead to cardiac arrest, other severe injury, or death. Moreover, there are other threats of injury if an individual with one of these devices requires additional surgical processes to remove and replace the device. Specific cardiac implantable electronic devices included in the recall were the Cobalt XT, Cobalt and Crome ICDs and CRT-Ds; Claria MRI, Amplia MRI, Compia MRI, Viva, and Brava CRT-Ds; and Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, and Mirro MRI ICDs.

High Device Costs

The high cost of devices and implant procedures is expected to hamper the global market growth during the forecast period. For instance, the pacemaker's costs typically range from $19,000 to $96,000. The expense is also expected to include implantation costs, X-rays, or other imaging tests expenses that might be required before and post the procedure, and the follow-up visit and any adjustments that are required to be completed.

Moreover, the cost can differ anywhere from approximately $20,000 and $100,000, without insurance. For individuals without any insurance coverage, a pacemaker and heart-assist implant can cost around $19,000-$96,000 or above, depending on the kind of pacemaker, the site, and the span of the hospital stay. Thus, owing to the high costs majority of low earning population is unable to undergo implant procedure slowing the market growth in the forecast period.

Segment Analysis

The global cardiac implantable electronic devices market is segmented based on product, indication, end-user and region.

Implantable cardioverter-defibrillators (ICDs) Product Expected to Dominate Market

Owing to the increase in cardiac implantable electronic devices launches and approvals the Implantable cardioverter-defibrillators (ICDs) segment is estimated to hold the majority of the global market share in the forecast period. For instance, in October 2020, Abbott introduced its unique ICD and CRT-D in India, thus expanding its cardiac implantable electronic devices line in the nation. The corporation even obtained CE Mark clearance for its Gallant ICD and CRT-D devices in February 2020.

Moreover, in August 2022, Medtronic plc introduced an investigational extravascular implantable cardioverter defibrillator (EV ICD) system defibrillator with the tip positioned under the breastbone, beyond the heart and veins attained a defibrillation success rate of 98.7%, and satisfied its safety endpoints in global clinical investigations.

Further, in February 2023, Medtronic plc, obtained CE (Conformite Europeenne) Mark for its Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation lead for the treatment of dangerously rapid cardiac beats that can direct to premature cardiac arrest. The Aurora EV-ICD system delivers the life-saving advantages of conventional ICDs while dodging specific threats as its lead (thin wire) is positioned outside the heart and veins.

Geographical Penetration

Growing Cases of Cardiovascular Diseases

Owing to the increasing cases of cardiovascular disease in North America the region is estimated to dominate the global market during the forecast period. For instance, according to the Centers for Disease Control and Prevention, in the US, approximately 805,000 individuals have heart attacks, and one individual dies every 33 seconds from cardiovascular disease yearly. Moreover, according to the Arrhythmia Alliance Atrial fibrillation impacts nearly 1 out of 50 Americans under the age of 65 and about 1 out of 10 Americans over age 65. The prevalence of ventricular arrhythmias differs widely.

Furthermore, the increase in initiatives to support better practices and awareness in individuals with atrial fibrillation is expected to boost the regional market growth in the forecast period. For instance, the North American Thrombosis Forum's Atrial Fibrillation Action Initiative recognizes multidisciplinary most promising approaches for stroke precluding atrial fibrillation (Afib). The task is to deliver a comprehensive yet straightforward consensus record concentrated on stroke and bleeding threat examination in individuals with Afib and anticoagulation choices and management. The organization intends for this practical record to function as a reference for the whole medical society concerned with the care of individuals with Afib: primary care, emergency medicine, pharmacy, and cardiovascular medicine.

COVID-19 Impact Analysis

The COVID-19 pandemic inflicted challenges to the standard management of access and delivery of health care worldwide. It promoted the adoption of telemedicine and digital health, establishing a fresh epoch in the management of CIED patients. Patient results could be enhanced with device-based intensive monitoring corresponding with standard in-clinic follow-up at periodic intervals.

The pandemic background encouraged the quest for alternative solutions for practical patient follow-up, like validation of digital technologies, data management techniques, implementation of predictive analytics, cybersecurity, growth of restricted forms of remote CIED programming, and reimbursement. However, the pandemic disturbed the planned implant procedures which were rescheduled or cancelled negatively influencing the global market during the pandemic.

Key Developments

• In April 2023, Aziyo Biologics, Inc., a corporation that designs and trades biologic developments to enhance compatibility between medical devices and patients, formed a distribution deal with LeMaitre Vascular, Inc., a provider of vascular devices, implants, and services.
• In December 2021, LifeTech Scientific Corporation expanded its deals with Medtronic to advance the strategic partnership on the "HeartTone domestic pacemaker project" and to begin the partnership on domestically-made MRI-conditional pacemakers.
• In June 2021, Medtronic Private Limited, India, launched the Micra AV, a miniaturized fully self-contained pacemaker that provides state-of-the-art pacing technology to atrioventricular (AV) block patients by a minimally invasive approach.

Competitive Landscape

The major global players in the market include: Abbott, Medtronic plc, Boston Scientific Corporation, Biotronic AG, Stryker, Microport Scientific Corporation, Koninklijke Philips N.V., Lepu Medical Technology (Beijing)Co.,Ltd., MEDICO S.R.L., and Vitatron among others.

Why Purchase the Report?

• To visualize the global cardiac implantable electronic devices market segmentation based on product, indication, end-user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of cardiac implantable electronic devices market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global cardiac implantable electronic devices market report would provide approximately 61 tables, 58 figures and 186 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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 Product
• 3.2. Snippet by Indication
• 3.3. Snippet by End-User
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Increasing Cardiac Implantable Electronic Devices Authorizations
    • 4.1.1.2. Growing Cases of Cardiovascular Diseases
  • 4.1.2. Restraints
    • 4.1.2.1. Cardiac Implantable Electronic Devices Recalls
    • 4.1.2.2. High Device Costs
  • 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. Patent Analysis
• 5.6. Technology Trend
• 5.7. End-User Trend
• 5.8. SWOT Analysis
• 5.9. DMI Opinion

6. COVID-19 Analysis

• 6.1. Analysis of COVID-19
  • 6.1.1. Scenario Before COVID
  • 6.1.2. Scenario During COVID
  • 6.1.3. Scenario Post COVID
• 6.2. Pricing Dynamics Amid COVID-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion

7. By Product

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product
  • 7.1.2. Market Attractiveness Index, By Product
• 7.2. Pacemaker*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.2.3. Single-chamber
  • 7.2.4. Dual-chamber
  • 7.2.5. Biventricular
• 7.3. Implantable Cardioverter Defibrillators
  • 7.3.1. Transvenous ICD
  • 7.3.2. Subcutaneous ICD
• 7.4. Implantable Cardiac Loop Recorders

8. By Indication

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 8.1.2. Market Attractiveness Index, By Indication
• 8.2. Arrhythmia*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Heart Rhythm Monitoring
• 8.4. Heart Block/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. Ambulatory Surgery Centers
• 9.5. Academic Research Institutes
• 9.6. 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 Product
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.2.6.1. U.S.
    • 10.2.6.2. Canada
    • 10.2.6.3. 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 Product
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.6.1. Germany
    • 10.3.6.2. UK
    • 10.3.6.3. France
    • 10.3.6.4. Italy
    • 10.3.6.5. Spain
    • 10.3.6.6. 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 Product
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.6.1. Brazil
    • 10.4.6.2. Argentina
    • 10.4.6.3. 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 Product
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.6.1. China
    • 10.5.6.2. India
    • 10.5.6.3. Japan
    • 10.5.6.4. Australia
    • 10.5.6.5. 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 Product
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Indication
  • 10.6.5. 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. Abbott*
  • 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 plc
• 12.3. Boston Scientific Corporation
• 12.4. Biotronic AG
• 12.5. Stryker
• 12.6. Microport Scientific Corporation
• 12.7. Koninklijke Philips N.V.
• 12.8. Lepu Medical Technology (Beijing)Co.,Ltd.
• 12.9. MEDICO S.R.L.
• 12.10. Vitatron

LIST NOT EXHAUSTIVE

13. Appendix

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