2상 외부 제세동기 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the biphasic external defibrillator market is expected to grow from USD 1.50 billion in 2025 to USD 1.63 billion in 2026 and is forecast to reach USD 2.57 billion by 2031 at 9.45% CAGR over 2026-2031.

This report is Segmented by Product Type (Manual External Defibrillators, Automated External Defibrillators), Technology (Biphasic Truncated Exponential (BTE) Waveform, Rectilinear Biphasic Waveform, and More), End-User (Hospitals and Clinics, Pre-Hospital, and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Biphasic External Defibrillator Market Trends and Insights

Rising Sudden Cardiac Arrest Burden

Sudden cardiac arrest remains one of the least resolved emergency conditions in acute care, which keeps the need for fast defibrillation high across both clinical and public settings. In the United States, more than 250,000 EMS-treated out-of-hospital cardiac arrest events were recorded in 2024, which shows the continuing scale of the care gap. In Europe, the 2025 resuscitation guidelines reported that EMS services treated 55 cases per 100,000 inhabitants each year, which confirms that the burden is not limited to one health system. Each minute of delayed defibrillation reduces survival probability by 7% to 10%, and only 37.9% of CARES-reported out-of-hospital cardiac arrest events in 2025 were witnessed by bystanders, which narrows the window for successful intervention. In the biphasic external defibrillator market, this burden keeps demand tied to a persistent clinical need rather than a short replacement cycle. The biphasic external defibrillator market is also supported by the fact that organizations face greater operational and legal exposure when no defibrillation option is available at the point of care or at the site of collapse.

Expansion of Public Access Defibrillation Programs

The biphasic external defibrillator market is gaining support from legislation that is steadily moving automated external defibrillator placement from optional practice to a more formal safety obligation. A 2024 analysis in JACC: Advances showed that public access defibrillation laws still vary widely across countries, which leaves room for more formal deployment mandates and program expansion. In the United States, the CDC continued to track state-level public access defibrillation laws in 2025, which reflects ongoing policy attention and uneven local adoption patterns. California Assembly Bill 365 expanded workplace AED availability expectations for electrical utility sites, while Maryland required AED placement in food service facilities and extended coverage to additional public venues on the timelines already set by law. The American Heart Association continues to frame workplace and community AED implementation as a practical survival measure rather than a niche intervention, which supports broader administrative buy-in. For the biphasic external defibrillator market, this shift matters because compliance-led purchases are usually less discretionary and less sensitive to short-term budget hesitation than purely elective capital spending.

High Acquisition and Lifecycle Maintenance Costs

High unit cost remains one of the clearest limits on adoption in the biphasic external defibrillator market, especially outside large hospital systems and well-funded enterprise accounts. A standalone AED from established vendors typically ranges from USD 1,200 to USD 3,500, and total 10-year ownership cost can rise to USD 4,000 to USD 8,000 once pad replacements, battery changes, and compliance activities are included. That cost profile makes first-time placement harder for small institutions, local governments, and multi-site organizations that need broad coverage rather than a small number of premium units. The problem is not only the purchase price, because fragmented fleet oversight can also lead to missed pad expiry dates, uneven audit performance, and extra service spend. Subscription models help reduce the upfront burden, but the strongest uptake has been concentrated in markets with better service infrastructure and more mature managed-safety procurement models. For the biphasic external defibrillator market, cost remains a major reason why clinically justified deployment still does not always translate into timely purchasing.

Other drivers and restraints analyzed in the detailed report include:

1. Shift Toward Biphasic, Impedance-Compensated Waveforms
2. Connected AED Adoption and Remote Compliance Monitoring
3. Limited Reimbursement and Budget Constraints in Emerging Markets

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

Segment Analysis

Automated external defibrillators accounted for 58.64% of revenue in 2025, and this segment of the biphasic external defibrillator market size is projected to expand at 10.21% CAGR through 2031. The same segment is leading in both scale and growth because most new procurement outside hospitals is centered on devices that can be used by non-clinical responders. Schools, workplaces, retail sites, transit hubs, and community venues generally prefer automated models because those systems reduce the need for advanced operator training. That pattern is widening the commercial base of the biphasic external defibrillator industry beyond the traditional hospital buyer. It also makes first-install demand more important than replacement demand in this part of the market.

Manual external defibrillators still hold an essential role in clinical care because hospitals, intensive care units, operating rooms, and EMS teams require ECG visibility, synchronized cardioversion, and direct energy selection during treatment. The biphasic external defibrillator market, therefore, has a clear product split, where automated devices compete on usability, connectivity, and deployment breadth, while manual systems compete on clinical depth and workflow integration. That split is likely to remain stable because the two product types solve different operational problems even when they share the same core resuscitation purpose.

Complete Report Scope:

• By Product Type
  • Manual External Defibrillators
  • Automated External Defibrillators
• By Technology
  • Biphasic Truncated Exponential (BTE) Waveform
  • Rectilinear Biphasic Waveform
  • Advanced Smart Energy Optimization Systems
• By End-User
  • Hospitals and Clinics
  • Pre-Hospital and EMS
  • Public Access Settings
  • Home Care Settings
• 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 41.83% of global revenue in 2025, which made it the largest regional block in the biphasic external defibrillator market. The region benefits from an established installed base, stronger emergency care budgets, and a mature culture of workplace and community AED awareness. In 2025, the CDC continued to document state-level public access defibrillation laws, which shows that the legal framework remains active and still differs meaningfully across states. California's Assembly Bill 365 added new support for AED availability at electrical utility worksites, which broadened the workplace use case further. The American Heart Association also reported that only 50% of workers can locate a workplace AED, which means awareness and placement gaps remain even in the most developed regional market.

Asia-Pacific is projected to post the fastest CAGR at 11.87% through 2031, which gives the region the strongest growth profile in the biphasic external defibrillator market. Regional demand is supported by large unmet need, wide differences in deployment density, and strong room for first-time installation in public and semi-public settings. In China, recent peer-reviewed research on sudden cardiac arrest mortality showed a continuing disease burden and reinforced the need for broader early-response capacity. Japan added an important regulatory catalyst when the Ministry of Health, Labor and Welfare lifted restrictions around auto-shock AED distribution, which lowered one operating barrier for public-space use. Across the Asia-Pacific, this means growth is likely to come more from widening access and first deployment than from mature replacement cycles alone.

Europe remains a significant revenue region in the biphasic external defibrillator market, supported by aging populations, established care systems, and continued reliance on regulated procurement pathways. The EU MDR compliance cycle is pushing healthcare providers to prioritize certified platforms and is encouraging portfolio rationalization among suppliers with broad professional offerings. The European Emergency Number Association has also highlighted wide legislative differences in public access defibrillation across countries, which keeps placement density uneven even within a relatively mature region. The Middle East and Africa and South America remain earlier-stage parts of the biphasic external defibrillator market, but rising cardiovascular burden and health infrastructure expansion are supporting gradual adoption in institutional settings.

1. Asahi Kasei
2. Avive Solutions, Inc.
3. Bexen Cardio
4. BPL
5. CU Medical Systems, Inc.
6. Defibtech, LLC
7. Fukuda Denshi
8. GE Healthcare
9. HeartHero Inc.
10. Koninklijke Philips
11. Mediana Co., Ltd.
12. Medtronic
13. Metrax GmbH
14. Nihon Kohden
15. Progetti S.r.l.
16. Schiller
17. Shenzhen Comen Medical Instruments Co., Ltd.
18. Mindray
19. Stryker

Additional Benefits:

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

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions and 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 Sudden Cardiac Arrest Burden
  • 4.2.2 Expansion of Public Access Defibrillation Programs
  • 4.2.3 Shift Toward Biphasic, Impedance-Compensated Waveforms
  • 4.2.4 Connected AED Adoption and Remote Compliance Monitoring
  • 4.2.5 Corporate Workplace AED Mandates and ESG Safety KPIs
  • 4.2.6 AED-as-a-Service Models Lowering Upfront Purchase Barriers
• 4.3 Market Restraints
  • 4.3.1 High Acquisition and Lifecycle Maintenance Costs
  • 4.3.2 Limited Reimbursement and Budget Constraints in Emerging Markets
  • 4.3.3 Battery, Pad, and Consumable Waste Compliance Burden
  • 4.3.4 Recalls, Documentation Burden, and Post-Market Surveillance Risk
• 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 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product Type
  • 5.1.1 Manual External Defibrillators
  • 5.1.2 Automated External Defibrillators
• 5.2 By Technology
  • 5.2.1 Biphasic Truncated Exponential (BTE) Waveform
  • 5.2.2 Rectilinear Biphasic Waveform
  • 5.2.3 Advanced Smart Energy Optimization Systems
• 5.3 By End-User
  • 5.3.1 Hospitals and Clinics
  • 5.3.2 Pre-Hospital and EMS
  • 5.3.3 Public Access Settings
  • 5.3.4 Home Care Settings
• 5.4 By Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 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 for key companies, Products & Services, Recent Developments)
  • 6.3.1 Asahi Kasei Corporation
  • 6.3.2 Avive Solutions, Inc.
  • 6.3.3 Bexen Cardio
  • 6.3.4 BPL Medical Technologies
  • 6.3.5 CU Medical Systems, Inc.
  • 6.3.6 Defibtech, LLC
  • 6.3.7 Fukuda Denshi
  • 6.3.8 GE HealthCare
  • 6.3.9 HeartHero Inc.
  • 6.3.10 Koninklijke Philips N.V.
  • 6.3.11 Mediana Co., Ltd.
  • 6.3.12 Medtronic
  • 6.3.13 Metrax GmbH
  • 6.3.14 Nihon Kohden Corporation
  • 6.3.15 Progetti S.r.l.
  • 6.3.16 Schiller AG
  • 6.3.17 Shenzhen Comen Medical Instruments Co., Ltd.
  • 6.3.18 Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
  • 6.3.19 Stryker Corporation

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment