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Forecast Period
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2024-2028
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Market Size (2022)
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USD 7.54 Billion
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CAGR (2023-2028)
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7.70%
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Fastest Growing Segment
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Resting ECG Devices
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Largest Market
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North America
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Market Overview
Global Diagnostic Electrocardiograph Market has valued at USD 7.54
Billion in 2022 and is anticipated to project impressive growth in the forecast
period with a CAGR of 7.70% through 2028. The Diagnostic electrocardiogram
(ECG) is a medical device used to capture the electrical activity of the heart
in waveforms by placing electrodes in contact with the chest. These waveforms
are then amplified on an ECG monitor. The analysis of these waveforms plays a
crucial role in identifying conditions such as atrioventricular reentrant
tachycardia, arrhythmia, and symptoms of acute coronary syndrome. On the other
hand, an implantable loop recorder (ILR) is a cardiac monitoring device that is
implanted beneath the skin of the chest. It serves various monitoring purposes,
including evaluating the causes of fainting, palpitations, abnormal heartbeats,
and hidden rhythms that can lead to strokes. The increasing prevalence of
cardiovascular diseases and lifestyle-related disorders, such as ischemic heart
disease (IHD), hypertensive heart disease, stroke, and peripheral artery
disease, is expected to drive the growth of the Diagnostic ECG industry.
Factors such as the growing geriatric population, improved healthcare
infrastructure, and favorable reimbursement policies are predicted to
contribute to the expansion of the diagnostic ECG market.
Key Market Drivers
High Prevalence of Cardiovascular Diseases
Cardiovascular diseases (CVDs) such as heart attacks, arrhythmias, and
heart failure are major causes of morbidity and mortality worldwide. Due to the
increasing prevalence of these conditions, accurate diagnostic tools such as
electrocardiograms (ECGs) are essential for timely intervention and treatment
planning. The world's aging population, with its higher susceptibility to
cardiovascular problems, underscores the need for diagnostic ECG devices to
monitor and manage cardiac health effectively. As individuals age, their risk
of heart-related disorders escalates, creating a steady demand for advanced ECG
devices capable of providing accurate readings.
Continuous technological advancements in ECG devices have led to
improved accuracy, ease of use, and enhanced connectivity features. The
integration of wireless monitoring, cloud-based data storage, and mobile
applications has expanded the utilization of ECG systems in both clinical and
home care settings. These advancements empower healthcare professionals to
remotely monitor patients' cardiac health and facilitate prompt intervention,
improving overall patient outcomes.
Furthermore, emerging economies are making substantial investments in
healthcare infrastructure, including the establishment of diagnostic centers.
This infrastructure expansion not only improves access to healthcare services
but also creates opportunities for the widespread adoption of ECG devices.
These advancements are particularly significant in areas where access to
advanced medical technologies was previously limited, bridging the gap in
healthcare disparities and improving the quality of care for underserved
populations.
The increasing prevalence of cardiovascular diseases, the aging
population, and continuous technological advancements in ECG devices are
driving the demand for accurate diagnostic tools. The integration of wireless
monitoring, cloud-based data storage, and mobile applications, coupled with
healthcare infrastructure expansion, opens up new avenues for the adoption of
ECG devices globally, ensuring better monitoring and management of cardiac
health for individuals around the world.
Increasing Trend for Early Disease Detection
The increasing trend for early disease detection is expected to drive
the growth of the diagnostic electrocardiograph market. In today's world,
individuals are becoming more conscious about their health and are seeking
better care and diagnostic treatments. This growing awareness and demand for
quality healthcare services will further accelerate the expansion of the
market.
It is important to note that symptoms of certain diseases may not
persist in some patients; instead, they may be intermittent in nature. These
intermittent symptoms have a tendency to come and go over time. In order to
effectively monitor and diagnose such patients, healthcare providers often
recommend the use of remote or continuous ECG machines. These devices allow for
continuous monitoring of the heart rhythm throughout the day, providing
valuable insights for accurate diagnosis and treatment planning.
By embracing advanced technologies and prioritizing early detection, the
healthcare industry is paving the way for improved patient outcomes and better
overall healthcare management. The diagnostic electrocardiograph market is
poised to benefit from these advancements, as it plays a crucial role in
facilitating timely and accurate diagnosis of cardiovascular conditions.
Rising Cases of Diabetes
Diabetes and hypertension are significant risk factors that drive the
demand for Diagnostic ECG equipment. Diabetes is often associated with other
comorbidities that increase the risk of coronary heart disease. Prolonged high
blood sugar levels can damage the arteries that regulate blood flow to the
heart. The International Diabetes Federation (IDF) projects that the global
number of diabetics will reach 700 million by 2045, up from 463 million in
2019. Additionally, the American Diabetes Association reports that 1.5 million
Americans are diagnosed with diabetes annually in the United States alone. The
prevalence of diabetes is on the rise, primarily due to the growing geriatric
population. According to the American Diabetes Association, approximately 25% of
all older adults in the United States have diabetes.
Moreover, the expanding incidence of diabetes in emerging countries,
coupled with a significant geriatric population, presents substantial growth
opportunities for the diagnostic ECG market. The IDF estimates that in 2019,
77.0 million individuals in India alone suffered from diabetes, and this number
is projected to increase to 101.0 million by 2030. Similarly, China is expected
to see a rise in diabetes cases from 116.4 million in 2019 to 140.5 million by
2030. Furthermore, the growing health awareness in these countries is likely to
boost the demand for diagnostic ECGs.
Increase in R&D Activities
The increase in research and development activities targeted at advanced
technology for electrocardiograph devices is playing a significant role in
driving the market forward. This surge is primarily fueled by the pressing need
for new product development and innovation in designing electrocardiograph
devices, which, in turn, contributes to the overall growth of the market. For
instance, in 2020, AliveCor, a U.S.-based company, introduced the KardiaMobile
6L, a personal ECG device, to the Indian market, thereby further expanding
accessibility to this advanced technology and fostering its adoption among
patients. Moreover, the market is also witnessing the introduction of remote
monitoring devices with single lead and portable ECG systems, which are expected
to not only enhance patient care and monitoring but also accelerate the growth
of the market. These technological advancements and the widening range of
product offerings are revolutionizing the application and utilization of
electrocardiograph devices, paving the way for improved patient outcomes and
more effective monitoring of cardiac health.
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Key Market Challenges
Strict Product Approval Processes and Safety Regulations Enforced by The
FDA
Manufacturers face numerous challenges when it comes to launching new
diagnostic ECG devices. These challenges arise from the strict product approval
processes and safety regulations enforced by the FDA. The FDA has implemented a
rigorous regulatory framework for cardiac monitors, classifying ECG software
applications as Class III devices and traditional diagnostic ECG devices as
Class II devices based on risk factors.
The FDA's regulations serve an important purpose - to ensure that only
safe and effective devices enter the market. However, these regulations can
also lead to delays in the approval and launch of new products, impacting
vendors' profitability. Compliance with regulations such as device description,
performance testing, and in-vitro safety testing is crucial for obtaining
approval.
It's worth noting that mobile applications are also subject to
regulatory scrutiny. In fact, mobile applications that fall under the category
of 'mobile medical applications' are classified as Class III devices and
undergo strict evaluation before receiving approval. Overall, the strict
product approval processes and safety regulations enforced by the FDA present
both challenges and opportunities for manufacturers of diagnostic ECG devices.
Navigating these regulations while ensuring the development of innovative and
effective products is a balancing act that requires expertise and adherence to
regulatory requirements.
High Costs of Diagnostic Electrocardiographs
ECG equipment, especially the advanced and feature-rich models, can
often come with a hefty price tag, making it a significant financial barrier
for healthcare facilities operating with limited budgets. This issue is
particularly pronounced in resource-constrained regions, where the availability
of funds for purchasing cutting-edge ECG technology may be scarce. Moreover,
the stringent regulatory and quality standards that medical devices, including
ECG equipment, must adhere to can further complicate the situation. Navigating
the complex and ever-evolving regulatory landscape can potentially cause
manufacturers to experience delays in product launches and face increased
compliance costs, adding to the challenges faced by healthcare facilities.
The cost-effectiveness aspect of ECG technology poses a unique challenge
for clinicians in many third-world nations. Due to the high costs associated
with purchasing and maintaining the most advanced ECG devices, healthcare
providers in these regions often find themselves working with older and less
sophisticated ECG machines. This limitation not only hinders their ability to
provide accurate and timely diagnoses but also restricts the potential growth
of the diagnostic ECG market in emerging nations. Additionally, a lack of
technical skills and resources further exacerbates the situation, making it
difficult for healthcare providers to bridge the gap and embrace the latest
advancements in ECG technology.
Key Market Trends
Advancement in Technologies
Advanced technologies have significantly contributed to the increased
sales of diagnostic ECG devices, thereby enhancing disease diagnosis and
treatment. These devices now integrate sophisticated technologies to streamline
workflow, enhance flexibility, and improve portability, enabling physicians to
position workstations conveniently during examinations. Continuous digitization
has prompted vendors to enhance data connectivity for various management
solutions, facilitating widespread access and interoperability with other
software systems, including cloud and smartphones. Prominent vendors are
dedicated to providing diagnostic ECG devices with advanced applications and features,
such as the CASE exercise testing system by GE Healthcare. The integration of
ECG devices with compatible technologies will have a positive impact on the
global market growth of diagnostic ECG devices.
Technological advancements and increased availability of innovative
treatment procedures will drive the electrocardiograph (ECG) industry. The
implementation of the Exercise Testing system and cardio data management
enables efficient management of rising cases of arrhythmia, coronary artery
disease, and cardiomyopathy through Resting ECG, Ambulatory ECG, pacemaker,
Holter monitor, and Event monitor. According to a study conducted by NCBI, more
than 2.6 per 1000 people in the United States of America have pacemakers
implanted to treat various heart conditions. The use of pacemakers is more
prevalent among the elderly, with 0.4 per 1000 people in the age group of 18-64
using pacemakers, while 26 per 1000 people in the age group of 65+ rely on
pacemakers. The adoption of new technological advancements and accessibility to
innovative treatment procedures can significantly boost the mobile ECG devices,
home ECG, and ECG equipment industry.
Increase In the Government Funding
The projected increase in government funding is expected to create significant
opportunities for the growth of the diagnostic electrocardiograph (ECG) market
in the upcoming years. This financial support will not only enable advancements
in ECG technology, but also foster research and development efforts to enhance
its accuracy, introduce innovative features, and improve overall accessibility.
With these advancements, healthcare providers will be better equipped to
diagnose and monitor cardiac conditions, leading to more precise and
personalized patient care. This will not only benefit individuals by ensuring
early detection and effective management of heart-related issues, but also
contribute to the expansion and evolution of the ECG market as a whole.
Segmental Insights
Product Type Insights
Based on product
type, the resting electrocardiograph has emerged as the largest market due to
its high demand, which is expected to persist in the future. This significant
factor contributes to its rapid growth during the forecast period.
Electrocardiograph devices are primarily designed to record cardiac activities,
aiding in the monitoring of heart conditions. The market has experienced
substantial growth driven by intensive research and development efforts by key
players to enhance electrocardiograph systems for accurate diagnosis of
disorders. Another product in this segment, the holter monitor, is anticipated
to exhibit faster growth during the forecast period.
The escalating
demand for this product in the market, particularly for detecting cardiac
arrhythmias and ensuring precise diagnosis, presents a significant opportunity.
Stress electrocardiographs also demonstrate notable growth, attributed to the
expanding geriatric population. The elderly age group has witnessed a
remarkable increase in recent years, driven by improved life expectancy.
Consequently, there is an elevated demand for accurate and precise
electrocardiograph devices. Key market players are keen to seize opportunities
in this developing market to achieve substantial revenue during the forecast
period.
End User Insights
Based on the end user
analysis, hospitals and clinics have demonstrated significant revenue returns
and therefore have dominated this segment. This trend is expected to persist
due to the extensive availability of cardiac facilities in these healthcare
centres. Electrocardiograph machines are commonly found in hospitals and
clinics, enabling them to provide prompt services and facilities to consumers.
These establishments serve as primary healthcare centres where patients seek
assistance during cardiac discomfort. The rapid availability of services and
diverse facilities in these centres serves as a key driver for the market.
Ambulatory surgical
centres also play a role in this segment by providing electrocardiograph
machines for monitoring patients' cardiac activities. This segment is
anticipated to witness substantial growth in the future. The market is expected
to generate higher revenue returns during the forecast period, primarily due to
the growing demand for electrocardiograph reports prior to surgeries. In rural
areas where major facilities are lacking, other primary healthcare centres that
offer electrocardiograph devices serve as driving forces for the market. With
the increasing prevalence of cardiac disorders and irregularities, the
availability of electrocardiograph devices has become a primary necessity.
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Regional Insights
Based on geographical factors, the North America region has emerged as
the dominant segment globally, primarily due to the significant number of
cardiac patients residing in this area. The adoption of modern lifestyles has
adversely affected the dietary habits of individuals, leading to a substantial
increase in the prevalence of various cardiovascular disorders. Similarly, the
Asia Pacific region has witnessed notable growth, largely driven by the high
volume of cardiac patients seeking healthcare services. The global phenomenon
of rapid urbanization has served as a major catalyst for the electrocardiograph
market, with the increasing demand for advanced technologies in this field.
European nations have also demonstrated significant demand for
electrocardiograph devices, primarily attributable to the advanced healthcare
facilities provided by the government. Furthermore, the expanding geriatric
population presents a substantial growth opportunity for the market throughout
the forecast period.
Recent Developments
- In February 2022,
AliveCor introduced the KardiaMobile Card, the slimmest and most convenient
personal ECG device available in the United States. It is the only personal ECG
device that is slim enough to fit in a wallet, providing instant feedback on
heart health anytime, anywhere.
- In January 2022,
Koninklijke Philips unveiled a pioneering, 12-lead ECG integrated solution for
at-home use in decentralized clinical trials. The goal of this innovation is to
enhance patient retention, compliance, and trial outcomes by reducing the need
and burden associated with traditional clinical trials.
- In December 2021,
Baxter International, Inc. announced its acquisition of Hillrom for USD 12.5
billion. This acquisition marks a significant milestone in Baxter's
transformation, promising to deliver even greater impact for patients,
clinicians, workers, shareholders, and communities worldwide that the company
serves.
- In July 2021,
Medtronic obtained FDA clearance for two of its AccuRhythm™ AI Algorithms with
the LINQ II™ insertable cardiac monitor. The application of AccuRhythm AI to
LINQ II data represents a major breakthrough in insertable cardiac monitors,
enabling Medtronic to reduce clinical inefficiencies caused by false alarms and
aiding physicians in focusing on the relevant patient data needed for effective
treatment.
Key Market Players
- General Electric Company
- Koninklijke Philips N.V.
- Nihon Kohden Corporation
- Ambu A/S
- Spacelabs Healthcare
- AliveCor, Inc.
- Mindray Bio-Medical Electronics Co., Ltd.
- Hill-Rom Holdings, Inc.
- BPL Medical Technologies
- Cardonet, Inc.
|
By Product Type
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By Channel
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By End User
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By Region
|
|
- Resting ECG Devices
- Stress ECG Devices
- Holter Monitors
- Others
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- 12-channel
- 6-channel
- 5- channel
- 3- channel
- Single- channel
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- Hospitals & Clinics
- Ambulatory Surgical Centers
- Cardiac Care Centers
- Others
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- North America
- Europe
- Asia Pacific
- South America
- Middle East & Africa
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Report Scope:
In this report, the Global Diagnostic Electrocardiograph Market has been
segmented into the following categories, in addition to the industry trends
which have also been detailed below:
- Diagnostic Electrocardiograph Market, By Product Type:
o
Resting ECG Devices
o
Stress ECG Devices
o
Holter Monitors
o
Others
- Diagnostic Electrocardiograph Market, By Channel:
o
12-channel
o
6-channel
o
5- channel
o
3- channel
o
Single- channel
- Diagnostic Electrocardiograph Market, By End User:
o
Hospitals & Clinics
o
Ambulatory Surgical Centres
o
Cardiac Care Centres
o
Others
- Diagnostic Electrocardiograph Market,
By Region:
o North America
§ United States
§ Canada
§ Mexico
o Europe
§ France
§ United Kingdom
§ Italy
§ Germany
§ Spain
o Asia-Pacific
§ China
§ India
§ Japan
§ Australia
§ South Korea
o South America
§ Brazil
§ Argentina
§ Colombia
o Middle East & Africa
§ South Africa
§ Saudi Arabia
§ UAE
§ Kuwait
§ Turkey
§ Egypt
Competitive Landscape
Company Profiles: Detailed
analysis of the major companies present in the Global Diagnostic Electrocardiograph
Market.
Available Customizations:
Global Diagnostic Electrocardiograph market report with the given
market data, Tech Sci Research offers customizations according to a company's
specific needs. The following customization options are available for the
report:
Company Information
- Detailed analysis and profiling of
additional market players (up to five).
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