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Market Overview

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The global market for wearable ECG devices surpassed USD 12.28 billion in 2021 and is projected to reach USD 35.45 billion by 2027, experiencing a compound annual growth rate (CAGR) of 19.32% from 2021 to 2027. This market represents one of the fastest-growing segments within the global cardiac monitoring industry and is expected to maintain a similar growth rate throughout the forecast period. The surge in growth can be attributed to the increasing worldwide prevalence of atrial fibrillation (AF) and cardiovascular diseases (CVDs).

Over the past few years, the prevalence of CVDs has significantly risen on a global scale, with CVDs becoming the most commonly diagnosed disease in clinical practice. According to the American College of Cardiology Foundation, estimates indicate that the global prevalence of CVDs increased from 271 million in 1990 to 523 million in 2019, while the number of CVD-related deaths rose from 12.1 million in 1990 to 18.6 million in 2019.

The research predicts that several factors will continue to influence the growth of the global wearable ECG devices market. One such factor is the increasing adoption of advanced sensor and artificial intelligence (AI)-based wearable ECG devices, which offer widely available clinical data. Leading players in this market include Apple, Alphabet, Samsung Electronics, Withings, Boston Scientific, Koninklijke Philips, GE Healthcare, OSI Systems, Hill-Rom Services, and iRhythm Technologies. While key players currently dominate the market, the industry presents significant growth opportunities for vendors, particularly in the development of next-generation devices, attracting start-ups and small MedTech investigating companies.

The utilization of advanced sensors and AI in wearable ECG devices is on the rise. These technologies have the potential to transform cardiac care by enabling high-quality ECG acquisition and automatic signal interpretation with accuracy comparable to that of cardiologists. Various arrhythmias, including AF, can be detected, and their diagnosis holds therapeutic implications that may improve patient outcomes.

Wearable ECG sensors are integrated into various forms of wearable devices such as smartwatches (e.g., Apple Watch, AliveCor Kardia), patches (iRhythm Zio), bands (Fitbit Sense), necklaces (toSense CoVa), clothing, rings, and others. When selecting a device, key considerations include electrode type and configuration, storage capacity, power consumption, battery life, signal processing electronics, and wireless communication capabilities. While most mobile remote monitoring (RM) devices use a 1-lead ECG configuration for ease of use, some devices offer six or more lead configurations. The adoption of advanced sensors, AI, machine learning (ML), and deep learning (DL) in wearable ECG devices contributes to the growth of the market.

The inclusion of an ECG feature in smartwatches, such as the Apple Watch (Series 4, 5, and 6), Fitbit Sense, Samsung Galaxy Watch3, and Galaxy Watch Active2, has significantly enhanced health monitoring capabilities. These devices have received FDA clearance for detecting AF, allowing users to take an electrocardiogram at any time and provide the data to their doctors for analysis. By integrating ECG data with other physiological indicators and offering streamlined data storage and transmission capabilities, smartwatches contribute to the expansion of the wearable ECG devices market.

Ambulatory monitors, which collect and analyze long-term data for reliable diagnosis, enable a new paradigm in healthcare. These devices are increasingly popular for continuous cardiac monitoring, providing critical alerts about events requiring urgent medical attention or hospitalization while allowing individuals to carry out their daily activities. Wearable ambulatory monitoring devices, particularly Holter monitors, are equipped with electrocardiogram sensors to monitor irregular heartbeats. Compared to conventional ECG devices, Holter monitors address the challenge of detecting arrhythmic disorders characterized by intermittent short episodes, resulting in higher successful diagnosis outcomes. Market players are focused on developing user-friendly, safe, and accurate ambulatory ECG devices, such as the latest-generation patch-based Holter monitors that can be worn for longer periods, up to a few weeks, ensuring optimal patient comfort.

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Market Segmentation

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The market is segmented based on various factors, including product, frequency, and geography.

Segmentation By Product
Smartwatch-Based ECG
Mobile Cardiac Telemetry
Holter Monitoring
Cardiac Event Monitoring

Segmentation By Frequency
Episodic & Adhoc
Continuous

Segmentation by Geography
North America – US, Canada
Europe – Germany, France, UK, Italy, Spain
APAC – China, Japan, India, South Korea, Australia
Latin America – Brazil, Mexico, Argentina
Middle East & Africa – South Africa, Saudi Arabia, Turkey

The product segment of smartwatch-based ECG dominated the global wearable ECG devices market in 2021, holding the largest share of 83.31%. This can be attributed to the prominent health feature of ECG in smartwatches. Apple, a key player in this segment, introduced their first smartwatch in 2018 and received FDA clearance for automatic AF detection. Other leading players such as Samsung, Withings, and Alphabet (Fitbit) also incorporate ECG recordings and alerts for AF detection in their smartwatches. The process of acquiring an electrocardiogram, analyzing it for AF diagnosis, and communicating the results to the wearer’s physician is similar across smartwatch makers. In September 2022, Apple launched the Apple Watch Series 8 and the new Apple Watch SE, both equipped with the ECG app capable of recording heartbeats and rhythms for AF detection.

The global wearable ECG devices market is segmented into episodic & ad hoc and continuous based on frequency. The episodic & ad hoc segment is projected to reach USD 22.28 billion by 2027, growing at a CAGR of 19.48% during the forecast period. Ad hoc monitoring has been utilized in various research studies to address different medical settings using different types of ECG sensors and monitoring platforms. Researchers emphasize that ad hoc non-ambulatory monitoring can reduce the burden of post-ablation outpatient visits and atrial fibrillation-related hospital visits. As smartwatch-based ECG holds the largest market share of 83.31%, the episodic & ad hoc segment also accounts for the largest share, 62.36%, in the global wearable ECG devices market.

North America held the largest share of 34.08% in the global wearable ECG devices market in 2021 and is expected to witness the highest incremental growth of approximately USD 9.01 billion during the forecast period. The United States contributes the most significant revenue to the North American market, accounting for a share of 91.30% in 2021. The growth in this region is primarily driven by the increasing incidence of AF and cardiovascular diseases (CVDs) such as coronary artery disease (CAD), as well as an increase in diagnosis procedures for these conditions. The presence of advanced wearable ECG device developers, continuous technological innovations, and growing acceptance of technologically advanced devices further contribute to the market’s growth in North America.

The APAC region is experiencing significant growth in the wearable ECG devices market and is expected to continue at a similar pace during the forecast period. Factors contributing to this growth include a large population of patients, improvements in healthcare infrastructure, and increased healthcare expenditure. Additionally, the rising prevalence of cardiac diseases, including AF, the aging population, and the adoption of smart wearables among the younger generation are key drivers for the wearable ECG devices market in this region.

In 2021, Europe accounted for 25.09% of the global wearable ECG devices market share. The increasing awareness of ambulatory ECG devices for AF and CVDs, coupled with improved healthcare infrastructure, favorable guidelines, and the availability of technologically advanced ECG-based smartwatches and patches, are driving the market growth in this region. Germany, France, the UK, Italy, and Spain are the major revenue generators in Europe, collectively accounting for approximately 65.03% of the European wearable ECG devices market in 2021.

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Competitive Landscape

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Vendors operating in the global wearable ECG device market are actively engaged in research and development efforts to bring forth novel and advanced wearable ECG devices. Over the past five years, several vendors have successfully obtained regulatory approvals for their wearable ECG devices. As an example, Withings obtained clearance from the US Food and Drug Administration (FDA) for the launch of their ScanWatch in the United States. This watch had previously been launched in Europe and Australia in 2020 and was subsequently released in the US in November 2021.

In November 2020, VitalConnect, a prominent player in remote and in-hospital wearable biosensor technology, announced the introduction of their VitalPatch RTM cardiac monitoring solution. This offering aims to cater to users seeking to expand their Holter monitoring capabilities.

To foster growth in the coming years, vendors in the wearable ECG device market are pursuing diverse strategies. These strategies include collaborations, partnerships, mergers, acquisitions, product launches, and other initiatives undertaken by market participants.

Key companies profiled in this report include Apple, Alphabet, Samsung Electronics, Withings, Boston Scientific, GE Healthcare, iRhythm Technologies, Hill-Rom, Koninklijke Philips, OSI Systems, BPL Medical Technologies, Bardy Diagnostics, Bittium, CardiacSense, Cortrium, FUKUDA DENSHI, Masimo, Medicalgorithmics, Advanced Instrumentations, AMEDTEC MEDIZINTECHNIK AUE, ASPEL, Hangzhou Beneware Medical Equipment, Biotricity, Borsam Biomedical Instruments, BTL, Contec Medical System, Custo Med, Oy Diagnostic Devices Development – DDD, DMS-Service, EB-Neuro, Edan Instruments, Forest Medical, Holter Supplies, Labtech, LPU Medical, LIVEWELL, Lumed, medical ECONET, Medicomp, Meditech KFT, Meditech Equipment, Midmark, Monitor, Nasan Medical Electronics, Nasiff Associates, Neurosoft, Norav Medical, Northeast Monitoring, Recorders & Medicare Systems, Scottcare Cardiovascular Solutions, Schiller, Shenzhen Biocare Bio-Medical Equipment, Suzuken Company, Trimpeks, UPOLife, VivaLNK.

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Recent Industry Developments

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In September 2022, Apple introduced the Apple Watch Series 8 and the new Apple Watch SE to the market.

During April 2022, Biotricity, a prominent player in the medical diagnostic and healthcare technology industry, commenced commercial sales of their Biotres product. Biotres is an FDA-approved wireless wearable extended Holter monitor designed for up to 30 days of continuous wear.

In the year 2021, Philips successfully completed the acquisition of BioTelemetry, a leading vendor specializing in the mobile cardiac telemetry segment.

Also in 2021, Boston Scientific acquired Preventice Solutions, further enhancing their position in the market.

In December 2021, Baxter International completed the acquisition of Hill-Rom Services, consolidating their presence in the healthcare sector.

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Key Questions Answered

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How large is the market for wearable ECG devices?

The market size of wearable ECG devices globally was valued at USD 12.28 billion in 2021 and is projected to reach USD 35.45 billion by 2027.

What is the growth rate of the global wearable ECG devices market?

The global wearable ECG devices market is expected to grow at a compound annual growth rate (CAGR) of 19.32% from 2021 to 2027.

Which region dominates the global wearable ECG devices market?

In 2021, North America held the largest share of 34.08% in the global wearable ECG devices market. This growth can be attributed to the increasing incidence of conditions such as atrial fibrillation (AF), cardiovascular diseases (CVDs) like coronary artery disease (CAD), and the rise in diagnostic procedures for these diseases.

Who are the key players in the global wearable ECG devices market?

The key players in the global wearable ECG devices market include Apple, Alphabet, Samsung Electronics, Withings, Boston Scientific, GE Healthcare, iRhythm Technologies, Hill-Rom, Koninklijke Philips, and OSI Systems.

What are the opportunities for growth in the wearable ECG devices market?

Some significant growth opportunities in the wearable ECG devices market include the increasing utilization of advanced sensors and artificial intelligence in these devices, the emergence of smartwatches equipped with ECG capabilities, the approval and launch of new wearable ECG devices, and the growing popularity of smart wearable technology in ECG monitoring.