U.S. And Europe Clinical Wearable Medical Devices Market Size, Share & Trends Analysis Report By Product (Insulin Pumps & Continuous Glucose Monitors), By Application (Chronic Disease Management), By Connectivity Type, By End Use, And Segment Forecasts, 2025 - 2030

Market Size & Trends

The U.S. and Europe clinical wearable medical devices market size was valued at USD 45.29 billion in 2024 and is expected to grow at a CAGR of 12.10% from 2025 to 2030. The increasing prevalence of chronic diseases like diabetes, heart disorders, and kidney disorders, along with advancements in clinical wearable medical devices, is expected to drive market growth. According to data from the American Heart Association, by June 2024, approximately 184 million individuals-over 61% of adults in the U.S.-are projected to be affected by some form of cardiovascular disorder by 2050. Such a high burden of chronic diseases is anticipated to drive the demand for clinical wearable medical devices in the coming years.

The rise in the prevalence of diabetes, driven by factors such as aging, obesity, and unhealthy lifestyles, is a significant contributor to market growth. This trend is increasing the demand for convenient and effective insulin delivery methods. In addition, the growing incidence of prediabetes is also fueling market expansion. For instance, according to data published by the CDC in May 2024, approximately 38 million people in the U.S. have diabetes, while about 98 million American adults are classified as pre-diabetic.

By 2030, the highest prevalence of diabetes is estimated to be in Spain, followed by Germany, with the second highest prevalence, while Norway will have the lowest prevalence. The increasing rates of diabetes in various European countries and the U.S. are expected to boost the demand for clinical wearable medical devices, such as connected insulin pumps and glucose monitoring systems.

Moreover, the increasing geriatric population is a significant factor driving the market for clinical wearable medical devices. Older adults are more vulnerable to chronic health conditions such as hypertension, heart disease, diabetes, and various pulmonary and neurological disorders. According to data published by the National Council on Aging, Inc. in May 2024, over 94% of individuals aged 60 and older have at least one chronic condition, while approximately 78% suffer from two or more such diseases.

In addition, people aged 65 and older are currently the fastest-growing segment of the U.S. population. The U.S. CDC's 2024 report projects that nearly a quarter of the population will be over 65 by 2060. Aging can weaken the immune system and increase susceptibility to various health issues, negatively impacting individuals' quality of life. Many in this age group are primarily dependent or semi-dependent, making frequent hospital visits challenging. Implementing effective strategies, such as the use of clinical wearable medical devices, can enhance the quality and longevity of life for older adults, promoting greater independence. As a result, the adoption of these devices is expected to rise among older individuals. They help them monitor key health indicators like blood pressure and respiratory rate, improving their overall health and quality of life.

Market Concentration & Characteristics

The market growth stage is high, and the pace of growth is accelerating. The U.S. and Europe clinical wearable medical devices market is characterized by a high degree of growth owing to the rising focus on wearable medical devices, growing demand for remote monitoring, and rising number of clinical trials focusing on wearable medical devices.

The degree of innovation in the industry is high, as companies prioritize developing new products to enhance their offerings and improve performance. Manufacturers are focusing on increasing sensor accuracy and creating advanced, miniaturized designs. They also address critical issues such as timely dose administration and dosage accuracy. For instance, in February 2024, Tandem Diabetes Care, Inc. launched Tandem Mobi, the world's smallest and most durable automated insulin delivery system. It features Control-IQ technology, which adjusts the required insulin dose to prevent overdosing and under-dosing.

The level of mergers and acquisitions activity in the industry is moderate. Established market players are acquiring emerging companies to enhance their presence and expand their offerings. Some of the companies engaging in this merger and acquisition strategy include Boston Scientific Corporation, Nevro Corporation, Abbott, Insulet Corporation, and Tandem Diabetes Care, among others.

Regulatory bodies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration oversee clinical wearable medical device regulations. These authorities are focusing on faster approvals of medical devices. For instance, according to the study published by Healio in October 2024, AWAK Technologies has received breakthrough designation from the FDA for its Automated Wearable Artificial Kidney Peritoneal Dialysis (AWAK PD) device.

Manufacturers operating in the U.S. and Europe in the clinical wearable medical devices industry are continuously expanding their product reach by launching products in numerous geographies, such as the U.S., Austria, Spain, and France, among others. For instance, in September 2023, Dexcom launched its latest continuous glucose monitoring (CGM) sensor, the Dexcom ONE, in France. This device is designed to provide real-time glucose data, helping users manage diabetes more effectively. The launch aims to enhance accessibility to advanced diabetes management tools for patients in the French with reimbursement. Such expansion is anticipated to propel the market growth in the coming years.

Product Insights

The other wearable medical devices segment dominated the market, accounting for 25.22% of the revenue in 2024 due to increasing awareness about advancements in healthcare technology. The increasing emphasis on preventive healthcare, along with the rising prevalence of sleep and mental health disorders, is expected to drive the adoption of these devices. According to data published by the National Alliance on Mental Illness (NAMI) in February 2025, approximately 20% of U.S. adults suffer from mental illness each year. This significant burden of mental health issues is anticipated to support the growth of this segment over the forecast period.

The respiratory monitoring devices segment is expected to grow at the fastest rate over the forecast period. This segment includes devices such as wearable spirometers and connected inhalers. The demand for this segment is anticipated to be driven by the rising focus on pulmonary disease management and the increasing incidence of respiratory disorders such as asthma and chronic obstructive pulmonary disease (COPD), which require continuous and precise monitoring. According to the data published by the CDC in June 2024, COPD is 1 of the top 10 leading causes of death in the U.S.

Application Insights

The chronic disease management segment dominated the market in 2024 owing to the rising prevalence of chronic diseases such as diabetes, hypertension,  cardiovascular disorders, and respiratory diseases. The aging population and sedentary lifestyles have significantly increased the prevalence of chronic conditions. For instance, data published by Eurostat in February 2024 reveals that Italy has the highest percentage of residents over the age of 65 in the European Union, alongside Portugal, with both countries having 24% of their populations in this age group. As European countries experience rapid growth in their geriatric populations, the incidence of age-related chronic disorders also rises, leading to a higher demand for clinical wearable medical devices for treatment.

The remote patient monitoring (RPM) segment is projected to grow at the fastest rate in the coming years due to demographic shifts and health-related challenges. A substantial proportion of elderly individuals live alone or lack access to emergency medical assistance, making it difficult for them to maintain their independence. Clinical wearable medical devices allow these individuals to track, monitor, and share real-time health data with professionals without needing to visit hospitals or clinics. For instance, a report from the U.S. Census Bureau in May 2024 noted that, in 2023, 27% of women aged 65-74 in the U.S. lived alone. Therefore, remote patient monitoring is a vital tool for these patients. As the number of older adults living independently continues to rise, the demand for remote patient monitoring systems is expected to increase significantly.

Connectivity Type Insights

The Bluetooth-connected segment dominated the market in 2024 due to a growing demand for user-friendly devices that easily integrate with smartphones and other digital health platforms. Bluetooth connectivity allows these devices to connect with mobile apps, enabling users to track their health readings in real time and access historical data for better health management. For example, Stelo by Dexcom is an integrated continuous glucose monitor that continuously analyzes, measures, and records glucose levels in the body. It obtained FDA regulatory approval in March 2024 and is designed for patients who are not on insulin. Stelo device can connect via Bluetooth to share data with a smartphone app. Thus, such rising approvals for Bluetooth-connected clinical wearable medical devices are anticipated to support the segment growth over the forecast period.

The IoT-based segment is expected to grow fastest over the forecast period due to the increasing demand for real-time, connected healthcare solutions. Also, the rising prevalence of chronic diseases that require continuous monitoring fuels the demand for such medical devices. Integration of IOT in medical devices provides benefits such as better patient monitoring by real-time monitoring, better treatment results, improved operational efficiencies, and remote patient monitoring. These benefits associated with IoT-based devices are expected to propel the segment's growth.

End Use Insights

The home healthcare segment dominated the market and accounted for the largest revenue share, at 40.76% in 2024. It is also anticipated to witness the fastest growth over the forecast period. This segment's growth can be attributed to the rising demand for home-based monitoring devices and growing approvals for clinical wearable medical devices for homecare settings. Several industry players are focusing on gaining regulatory approvals for these devices to be used in home settings. For instance, in February  2024, the U.S. FDA approved the X-trades System M, a wireless wearable technology designed for electrophysiological monitoring. This skin patch-based monitoring platform allows patients to move freely in home settings. Such approvals for advanced devices intended for homecare use and favorable regulations are expected to drive significant growth in this segment in the coming years.

The other settings segment is expected to witness significant growth during the forecast period. This segment includes research institutions, long-term care facilities, and academic organizations. It is driven by increasing research activities focused on developing clinical wearable medical devices and a growing aging population with a rising prevalence of chronic diseases that necessitate continuous monitoring.

Regional Insights

U.S. Clinical Wearable Medical Devices Market Trends

The clinical wearable medical devices market in the U.S. is expected to experience significant growth due to the presence of various companies such as Abbott, GE HealthCare, Medtronic, OMRON Healthcare Inc., and Dexcom Inc., among others. In addition, the increasing prevalence of chronic diseases, such as renal disorders, cardiovascular diseases, and diabetes among the U.S. population, is anticipated to drive market growth.

The graph below illustrates the percentage of adults diagnosed with kidney disease in different states in 2023. Nevada has the highest percentage at 6.5%. The top five states with a high burden of kidney disease are Nevada (6.5%), West Virginia (5.2%), Tennessee (4.9%), Florida (4.9%), and Ohio (4.7%). Due to the rising burden of kidney diseases, the demand for clinical wearable devices in the U.S. market is expected to increase.

Europe Clinical Wearable Medical Devices Market Trends

The clinical wearable medical devices market in Europe is expected to experience significant growth in the coming years. Increased consumer awareness of personal health management and the prevention of chronic diseases is driving higher adoption rates of wearable devices for clinical use. These devices enable users to monitor vital signs and chronic conditions. European nations like Norway and Spain recognize the importance of preventive healthcare and encourage investments in medical technology and home monitoring solutions. For instance, in May 2024, Koninklijke Philips N.V. launched its ePatch and AI-driven Cardiologs analytics platform in 14 hospitals across Spain to improve the monitoring of heart patients. Such rising adoption of clinical wearable devices is anticipated to drive the European market over the forecast period.

The UK clinical wearable medical devices market is expected to grow significantly over the forecast period, driven by factors such as an aging population, increasing prevalence of chronic diseases, and advancements in wearable technology. In addition, the growing number of clinical trials being conducted across the UK for clinical wearable medical devices is anticipated to drive market growth in the coming years.

Table 1 Some Of The Clinical Trials Involving Clinical Wearable Medical Devices In UK

Source: ClinicalTrials.Gov

The clinical wearable medical devices market in Germany is experiencing rapid growth due to an aging population, the rising burden of long-term illness and associated hospitalizations, and growing product launches. For instance, in April 2024, Dr. Reddy's Laboratories introduced Nerivio, a drug-free, non-invasive wearable device for migraine treatment, in Germany through its subsidiary Betapharm. This launch signifies the company's entry into digital therapeutics in Europe. Nerivio employs Remote Electrical Neuromodulation (REN) technology to provide acute and preventive treatment for migraines, with or without aura, in individuals aged 12 and above. Such developments and the availability of healthcare infrastructure in Germany are anticipated to support the country's market growth in the coming years.

Medical Facilities, Hospital Beds, And Movement Of Patients In Germany

Source: Statistisches Bundesamt (Destatis)

Rising Number of Clinical Trials for Clinical Wearable Medical Devices in the U.S.

The increasing number of clinical trials focused on the safety and efficacy of wearable medical devices is expected to create attractive opportunities for industry participants and healthcare providers. Researchers, industry participants, and academic institutions are actively conducting these trials.

Table 2 Some Clinical Studies Conducted In The U.S. For Clinical Wearable Medical Devices.

Source: ClinicalTrials.Gov

Key U.S. And Europe Clinical Wearable Medical Devices Company Insights

Players in the U.S. and Europe clinical wearable medical devices market are undertaking several strategic initiatives such as acquisitions, expansion, product launches, and collaborations. Moreover, the growing number of product approvals is anticipated to boost the competitive rivalry in the industry for clinical wearable medical devices in the U.S. and Europe.

Recent Developments

• In February 2025, Tandem Diabetes Care, Inc. announced that its next-generation automated insulin delivery (AID) system, Control-IQ+ technology, has received clearance from the U.S. Food and Drug Administration (FDA) for people with type 2 diabetes aged 18 and older. Previously approved for use by those with type 1 diabetes, Control-IQ+ enhances the existing Control-IQ algorithm by allowing for a broader range of weight and total daily insulin inputs. The company anticipates that Control-IQ+ will be available to both new and current customers in the United States by March 2025.

• In October 2024, Inogen launched the Rove 4 Portable Oxygen Concentrator, featuring a lightweight design under 3 lbs and a new fourth flow setting that delivers up to 840ml/min of oxygen. With a battery life of up to 5 hours and 45 minutes, it aims to enhance mobility for patients requiring oxygen therapy.

• In September 2024, Abbott announced a partnership with Beta Bionics to integrate its Freestyle Libre 3 Plus CGM with Beta Bionics' iLet Bionic Pancreas. This collaboration aims to automate insulin delivery.

U.S. And Europe Clinical Wearable Medical Devices Market Report Scope

U.S. And Europe Clinical Wearable Medical Devices Market Report Segmentation

This report forecasts revenue growth at regional and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. and Europe clinical wearable medical devices market report based on product, application, connectivity type, and end use:

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Insulin Pumps and Continuous Glucose Monitors (CGMs)

    • Connected Insulin Pumps

    • Continuous Glucose Monitoring Devices

  • Cardiac Monitors

    • Portable ECG Monitors

    • Cardiac Event Monitors

  • Respiratory Monitoring Devices

    • Wearable Spirometers

    • Connected Inhalers

  • Neurostimulators

    • Wearable Vagus Nerve Stimulators (VNS)

    • Wearable Deep Brain Stimulators (DBS)

  • Blood Pressure Monitors

    • Ambulatory Blood Pressure Monitors

    • Smart Blood Pressure Cuffs

  • Wearable Dialysis Devices

  • Wearable Oxygen Therapy Devices

  • Other Wearable Medical Devices

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Chronic Disease Management

    • Diabetes

    • Cardiovascular Disorders

    • Respiratory Disorders

    • Neurological Disorders

    • Other Chronic Conditions

  • Post-operative Care

  • Remote Patient Monitoring (RPM)

  • Other Applications

• Connectivity Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Bluetooth-connected

  • Wi-Fi-enabled

  • Cellular-connected

  • IoT-based

• End Use Outlook (Revenue, USD Million, 2018 - 2030)

  • Home Healthcare

  • Hospitals and Clinics

  • Ambulatory Care Settings

  • Other Settings