Smart Diagnostics And Monitoring Devices Market Size, Share & Trends Analysis Report By Product (Blood Glucose Monitors, Pulse Oximeters, Breath Analyzers), By Distribution channel, By End-use, By Region, And Segment Forecasts, 2025 - 2030

Smart Diagnostics & Monitoring Devices Market Summary

The expanding adoption of blood glucose monitors, wearable ECGs, and smart thermometers reflects a broader shift toward personalized and preventive healthcare. Technological advancements, particularly in embedded sensors, AI-enabled analytics, and wireless connectivity, have enabled seamless integration of devices like smart clothing, contact lenses, and medical tricorders into consumer health ecosystems. The global increase in chronic conditions such as diabetes, hypertension, and cardiovascular diseases is a significant driver for the smart diagnostics and monitoring devices industry. These conditions require continuous management and monitoring, leading to a higher demand for advanced diagnostic tools. For instance, in December 2024, the World Health Organization reported that chronic diseases are responsible for 75% of all deaths globally, highlighting the urgent need for effective diagnostic and monitoring solutions.

The rising incidence of diabetes, driven by factors such as aging, obesity, and unhealthy lifestyles, is significantly the growth of the blood glucose monitoring devices market. Obesity, in particular, is a leading contributor to the development of diabetes. According to the World Health Organization (WHO), over 1 billion people will be classified as obese in 2022, including 650 million adults, 340 million adolescents, and 39 million children, a figure that continues to rise. If current trends continue, WHO projects that by 2025, around 167 million individuals, both adults and children, will face worsening health issues linked to excess weight.

Progress in mobile-based blood pressure monitoring technology is anticipated to fuel the market growth significantly. Companies are prioritizing the development of innovative, affordable, and easy-to-use solutions that meet the requirements of both patients and healthcare professionals. Enhancements in devices such as digital sphygmomanometers are central to this advancement. For instance, in July 2024, Smart Meter launched the first cellular-connected blood pressure monitor, tailored explicitly for remote patient monitoring and chronic care management through cellular networks.

“Accurate transmission of a patient’s blood pressure is crucial for healthcare providers to track trends and make care plan adjustments when needed. “We listened carefully to our customers who serve tens of thousands of providers to develop this new version of our iBloodPressure Classic monitor that is now compatible with three different cuff sizes. These new cuff sizes will not only help a broader range of patients but also help improve the accuracy of those readings.”

- Smart Meter CEO Casey Pittock

Case Study: “Smart clothing: The next evolution for wearables”

Overview:

The study explored the rapid growth and potential of smart clothing garments embedded with sensors and digital technology to transform health monitoring and management. With wearables already popular, smart clothing is positioned as the next evolution, offering more integrated and convenient health tracking than wrist-worn devices. Applications range from chronic disease management to fitness and environmental monitoring, with examples such as smart socks for diabetics and self-heating jackets for athletes.

Challenges:

• Cost and Durability: High manufacturing costs and concerns about the longevity and washability of smart textiles.

• Usability: Ensuring comfort, ease of use, and widespread adoption beyond elite athletes.

• Data Accuracy: Signal noise and movement artifacts can limit the accuracy of biometric readings.

• Integration: Difficulty in combining multiple sensor functions into a single, reliable garment.

• Regulatory and Clinical Acceptance: Need for clinical validation and regulatory approval to be used in medical settings.

• Economic Viability: Healthcare system changes are needed to support widespread adoption and reimbursement.

Outcome:

• Enhanced Health Monitoring: Smart clothing has the potential to provide more robust, continuous health data, enabling proactive disease management and early detection of health issues.

• Improved Patient Engagement: By integrating health monitoring into everyday life, patients and clinicians can make more informed decisions and improve adherence to treatment plans.

• Current Adoption: While adoption is still limited to niche markets (elite athletes, infants, diabetics), the technology is progressing toward broader use.

• Future Potential: With further advances in technology, cost reduction, and clinical validation, smart clothing could become a standard tool for health monitoring, driving better outcomes and reducing healthcare costs.

Market Concentration & Characteristics

The degree of innovation in the smart diagnostics and monitoring devices market is high. Advancements such as wireless connectivity and longer battery life created compact, portable, and easy-to-use smart diagnostic and monitoring devices, enhancing patient mobility and convenience. Integrating technologies enables real-time data tracking, remote patient management, and personalized treatment, improving diagnostic precision and more efficient healthcare delivery within the innovative diagnostics and monitoring devices market. For instance, in May 2024, Smart Meter introduced the iGlucose Plus. This enhanced cellular-connected glucose meter improves diabetes management by enabling real-time blood glucose monitoring independently, without needing smartphones or Wi-Fi, benefiting patients and healthcare providers.

Mergers, acquisitions, and partnerships allow companies to grow their geographic reach, financial capabilities, and technological expertise. For instance, in June 2024, BD (Becton, Dickinson, and Company) acquired Edwards Lifesciences' Critical Care product group, which will now operate under BD Advanced Patient Monitoring.

Regulatory trends in the market involve increased oversight and changing standards from bodies such as the FDA and EMA. Key advancements include the introduction of guidelines for software-as-a-medical-device (SaMD) and using real-world evidence in regulatory reviews. In addition, regional regulations focus on streamlining approvals to enhance market access for innovative medical devices. For instance, in October 2024, Happy Health gained FDA clearance for its consumer platform delivering clinical-grade care at home, featuring the Happy Ring. This comfortable wearable tracks vital signs like sleep, heart rate, blood oxygen, brain activity, and temperature on the finger.

Geographic expansion drives the growth of the smart diagnostics and monitoring devices industry by providing access to varied resources, increasing market reach and revenue, and supporting regulatory compliance and standardization. It encourages partnerships, enhances localized healthcare delivery, and drives investment in advanced technological infrastructure.

Product Insights

The blood glucose monitors segment dominated the market with the largest revenue share of 18.13% in 2024 due to the rising global prevalence of diabetes and the growing demand for real-time health tracking. Increasing adoption of continuous glucose monitoring (CGM) systems, driven by technological advancements and smartphone integration, enhances patient convenience and compliance. For instance, in August 2024, Dexcom launched Stelo over-the-counter continuous glucose monitoring sensors in the U.S. This innovation enhances accessibility and convenience for diabetes patients by allowing them to monitor glucose levels without a prescription, driving increased adoption of advanced glucose monitoring technologies.

The pulse oximeter segment is expected to grow at the fastest CAGR for the forecast period. The rising incidence of respiratory and cardiovascular diseases worldwide is expected to drive the segment's growth. According to World Heart Federation 2023 insights, cardiovascular diseases impact over 500 million individuals globally and lead to 20.5 million fatalities in a year, which represents nearly one-third of all deaths worldwide. In addition, innovation in pulse oximeters have enhanced accuracy and ease of use by integrating compact optical sensors, wireless connectivity, and intelligent algorithms. This allows continuous, real-time oxygen monitoring with flexible sensor placement on areas such as the forehead, chest, or ear for better patient care. For instance, in March 2023, OxiWear, a U.S. health tech startup, introduced a wireless ear-mounted pulse oximeter featuring an optical sensor and Bluetooth LE, continuously tracking oxygen levels and sending real-time data with low-oxygen alerts to a connected smartphone app.

Distribution Channel Insights

The pharmacies segment held the largest revenue share in 2024 due to their widespread accessibility and trusted role in healthcare. Pharmacies emerged as key distribution channels in the market due to their widespread accessibility. With more patients looking for convenient ways to manage chronic conditions from home, pharmacies are ideally placed to meet this growing demand. By incorporating smart diagnostic and monitoring devices into their product range, pharmacies increase patient engagement and support better adherence to treatment plans through effective health monitoring.

The online channel is expected to grow at the fastest CAGR during the forecast period. Online platforms enabled manufacturers to expand their reach and allow customers to buy devices conveniently from home. Marketplaces such as Medtronic’s online store let users explore and purchase products directly from the manufacturer. This move toward online sales has enhanced customer accessibility and convenience while lowering costs and streamlining supply chain operations.

End-use Insights

The hospitals segment dominated the smart diagnostics and monitoring devices industry in 2024 due to the high demand for advanced diagnostic tools and continuous patient monitoring in clinical settings. This segment's growth is driven by rising demand for remote patient monitoring, increasing chronic disease rates, favorable regulations supporting telehealth, and a greater emphasis on personalized healthcare. Hospitals utilize wearable health trackers, smart infusion pumps, and connected imaging systems to collect real-time patient data.

The home care segment is expected to grow at the fastest CAGR for the forecast period. Rising hospital care costs, technological advancements, a growing emphasis on remote patient monitoring, and expanded telehealth adoption have notably shifted patient preferences toward receiving treatment at home instead of hospitals. In addition, industry players are partnering to deliver advanced technologies tailored for home healthcare environments. For instance, in September 2024, Nonin collaborated with Medicine to create remote digital monitoring solutions to improve patient-centered diagnosis of chronic illnesses. This partnership combines Medixine’s remote patient monitoring software with Nonin’s pulse oximetry devices for the U.S. market.

Regional Insights

North America dominated the smart diagnostics and monitoring devices market with a share of 35.94% in 2024. This growth is attributed to vital government initiatives promoting the development and integration of innovative diagnostic and monitoring technologies, including wearable health devices. In addition, supportive regulatory frameworks facilitated the adoption of innovations, while strategic moves by key industry players have accelerated market growth. For instance, in August 2024, Stryker announced its acquisition of Care.ai, a company focused on AI-enabled healthcare solutions such as continuous patient monitoring, virtual rounds, and sensor-based decision support systems. This acquisition is poised to bolster Stryker’s portfolio in connected health technologies and intelligent monitoring solutions, further solidifying its position in the market.

U.S. Smart Diagnostics And Monitoring Devices Market Trends

The smart diagnostics and monitoring devices industry in the U.S. held the largest revenue share in 2024. The increasing adoption of advanced technologies such as AI and machine learning drives the development of innovative, connected diagnostic and monitoring devices that improve patient care. Supportive government initiatives accelerated the adoption and expansion of these innovative solutions throughout the healthcare industry.

Asia Pacific Smart Diagnostics And Monitoring Devices Market Trends

The smart diagnostics and monitoring devices industry in Asia Pacific is poised for substantial growth during the forecast period. This expansion is driven by rapid progress in digital healthcare technologies, increasing healthcare demands, and a rising prevalence of chronic diseases. In addition, developing smart hospitals across the region is a significant growth factor, as these facilities incorporate advanced technologies such as AI, IoT, and robotics into diagnostic and monitoring processes. For instance, in January 2022, Advantech partnered with Intel to launch Vietnam’s first innovative hospital project, emphasizing the integration of advanced medical diagnostic and monitoring technologies.

The smart diagnostics and monitoring devices market in China is set for significant growth over the forecast period. This expansion is driven by advancements in digital healthcare technologies and rising demand for personalized monitoring solutions. Innovations such as wearable diagnostic devices, AI-powered platforms for chronic disease management, and data analytics are revolutionizing healthcare delivery, enabling more accurate diagnostics and tailored treatment.

Europe Smart Diagnostics And Monitoring Devices Market Trends

The Europe smart diagnostics and monitoring devices industry is characterized by strong innovation and increasing adoption of AI and machine learning technologies. The region is witnessing growth in wearable diagnostic devices and remote monitoring solutions, driven by an aging population and the rising prevalence of chronic diseases. Robust healthcare infrastructure and favorable reimbursement policies support market expansion. Moreover, Europe’s stringent regulatory standards, such as compliance with the Medical Device Regulation (MDR), ensure high product quality and safety, increasing consumer confidence and encouraging technological advancements.

The UK smart diagnostics and monitoring devices market is growing, due to the government initiatives promoting innovative digital health transformation and healthcare solutions. Innovation is a key trend, emphasizing the integration of AI and data analytics to enhance patient monitoring and predictive diagnostics. The UK’s National Health Service (NHS) is adopting remote monitoring technologies to improve healthcare delivery and reduce hospital visits. In addition, the UK benefits from a flexible regulatory environment that supports faster approvals for innovative medical devices, facilitating market growth and encouraging investment in advanced diagnostics and monitoring technologies.

Latin America Smart Diagnostics And Monitoring Devices Market Trends

The smart diagnostics and monitoring devices industry in Latin America is driven by increasing demand for advanced solutions to manage chronic conditions effectively. In addition, strategic efforts by key players to innovate technologies boosted the adoption of these devices across the region. Government initiatives focused on expanding healthcare access and modernizing infrastructure support market growth. Furthermore, integrating digital health technologies and promoting telemedicine creates a favorable environment for the widespread adoption of innovative diagnostics and monitoring devices throughout Latin America.

Middle East & Africa Smart Diagnostics And Monitoring Devices Market Trends

The Middle East & Africa smart diagnostics and monitoring devices industry is driven by increased healthcare digitization, a rising prevalence of chronic diseases, and a growing demand for advanced monitoring technologies. Wearable devices such as fitness trackers and continuous glucose monitors are becoming increasingly popular as patients and healthcare providers emphasize remote monitoring and preventive care. For instance, in February 2024, Dexcom launched the ONE+, a customizable continuous glucose monitoring device worn on three different body locations. Dexcom plans to expand the availability of the Dexcom ONE+ across the Middle East and Africa

“By building Dexcom ONE+ based on user and healthcare professional feedback we know we have a CGM system that is flexible, easy to get started with, and intuitive to use; a system that people with either Type 1 or Type 2 diabetes, and their care teams, can benefit from.”

- Teri Lawver, Executive Vice President and Chief Commercial Officer at Dexcom.

Key Smart Diagnostics And Monitoring Devices Company Insights

Key participants in the industry are focusing on developing innovative business growth strategies in the form of product portfolio expansions, partnerships & collaborations, mergers & acquisitions, and business footprint expansions.

Recent Developments

• In May 2024, Masimo partnered with Medable Inc. to integrate medical-grade wearable devices into clinical research. Medable incorporated Masimo’s MightySat Rx pulse oximeter in its evidence-generation platform for eight large-scale pharmaceutical clinical trials. These trials, involving over 3,000 patients across 25 countries, are focused on two oncology indications: breast and lung cancer.

“Masimo’s SET pulse oximetry is sensitive enough to capture key vitals on the very ill like cancer patients, plus it works on all skin tones, all ages, and is easy to use.”

- Musaddiq Khan, Medable’s Vice President of Digital Outcomes and TA Strategy

• In May 2024, Masimo announced FDA clearance for a baby monitoring system, Stork, designed for healthy infants aged 0 to 18 months without the need for a prescription. Stork utilizes the pulse oximetry technology used in Neonatal Intensive Care Units (NICU) to monitor key vital signs such as PR, Oxygen Saturation Level (SpO2), and skin temperature, providing alarms to parents or caregivers.

“I believe that by empowering parents and caregivers with the same Masimo pulse oximetry technology that hospitals have been using on babies for decades, we can help them feel more informed and confident when caring for their baby. It is particularly fitting that we received this clearance and are making this announcement as we celebrate the 35th anniversary of the company I founded with a mission to improve lives everywhere, especially those of the youngest and most fragile among us. Thirty-five years ago I envisioned Stork. I am so proud of our team for Stork - it is a culmination of science and design at its best.”

- Joe Kiani, Founder and CEO of Masimo.

• In May 2023, GenWorks unveiled its new product, FenomPro, a breath analyzer designed to measure FeNO levels in patients, aid in detecting asthma, and help more individuals identify if they are affected by the condition.

Smart Diagnostics And Monitoring Devices Market Report Scope

Global Smart Diagnostics And Monitoring Devices Market Report Segmentation

This report forecasts revenue growth at global, 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 global smart diagnostics and monitoring devices market report based on product, distribution channel, end-use, and region:

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

  • Blood Glucose Monitors

  • Pulse Oximeters

  • Breath Analyzers

  • Medical Tricorders

  • Blood Pressure Monitors

  • Smart Thermometers

  • Heart Rate Monitors

  • Smart Contact Lenses

    • Glucose Monitoring

    • Intraocular Pressure Monitoring

  • Smart Clothing

    • Embedded Health Sensors

    • Fitness Monitoring

  • Wearable ECG Monitors

    • Chest Straps

    • Patches

• Distribution Channel Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmacies

  • Online Channel

  • Direct-to-Consumer (DTC)

  • Others (Hypermarkets, Specialty Retailers)

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

  • Hospitals

  • Clinics

  • Home Care

  • Others (Sports, Fitness Centers, Assisted Living)

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

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Sweden

    • Denmark

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa

    • Saudi Arabia

    • South Africa

    • UAE

    • Kuwait