Smart Medical Devices Market Size, Share, and Trends 2025 to 2034

Smart Medical Devices Market Size and Forecast 2025 to 2034

The global smart medical devices market size was estimated at USD 52.66 billion in 2024 and is predicted to increase from USD 59.26  billion in 2025 to approximately USD 168 billion by 2034, expanding at a CAGR of 12.30% from 2025 to 2034. The rising technological integration in the medical industry drives the growth of the market.

Smart Medical Devices Market Key Takeaways

• North America dominated the global market with the largest market share of 41.6% in 2024%.
• Asia Pacific is observed to have the fastest CAGR of growth during the forecast period.
• By product, the diagnostics and monitoring segment segment contributed the highest market share of 87% in 2024.
• By end-use, the homecare settings segment is projected the highest growth in the market in 2024.

U.S. Smart Medical Devices Market Size and Growth 2025 to 2034

The U.S. smart medical devices market size was estimated at USD 17.53 billion in 2024 and is projected to surpass around USD 56.33 billion by 2034 at a CAGR of 12.38% from 2025 to 2034.

North America led the smart medical devices market in 2024, the region is observed to have a sustained growth during the forecast period. The dominance of the market in the region is attributed to the early adoption of technologies in the medical sector and the higher investments in the development of healthcare in the countries like the United States and Canada are driving the expansion of the market. The higher presence of the major market players in smart medical gadgets is further propelling the growth of the market.

The rising chronic disease among the geriatric population also acts as a major factor for the higher demand for smart medical devices in the region. Additionally, North America is home to multiple manufacturers and investors for healthcare devices. This factor brings a significant opportunity for the region to sustain dominance in the smart medical devices market.

Asia Pacific is observed to witness the fastest rate of expansion in the smart medical devices market during the forecast period. The growth of the market in the region is increasing owing to the rising population and the chronic diseases in the geriatric population such as diabetes, asthma, and others that need to be regularly monitored that enhance the demand for smart medical devices. Technological integration in medical devices enhances the quality of the results and provides real-time insights into the health condition to the doctors or patients to make an informed decision.

The rising investments in the development of healthcare facilities and technological advancements are driving the growth of the market. Additionally, the rising research and development activities in innovation and the launch of new categories of smart medical devices are driving the growth of the market in the region.

• Indian Institute of Technology (IIT) Jodhpur researchers introduced the lower priced paper-based analytical devices that can monitor and detect the glucose level and it can be connected to the smartphones. The devices contain lab based biodegradable paper that change the color depend upon the glucose level.
• China Medical University Hospital (CMUH, Taiwan) Sleep Medicine Center has recently launched the iDREAM (Intelligent Detection of Respiratory Events through Automated Monitoring), with the Quanta's QOCA Portable ECG Monitoring Device, for the efficient detection of the apnea patient during the sleep at the home.
• Calcutta Salt Lake's HP Ghosh Hospital had taken the revolutionary step in by combining smart technologies in the ICUs. It is the first faculity in the eastern India that adopted this system for enhancing the patience experience and decreases mortality rates.

Market Overview

Smart medical devices are automated machines, equipment, and instruments that use artificial intelligence and machine learning for the detection of the stages of diseases and give real-time insight into the patient’s health condition. Smart medical devices help in the diagnosis and treatment of patients. Smart devices are an efficient device that helps in remote health monitoring by the ehealth initiatives and reduce the visit to hospital readmission and doctor visits.

The smart devices have the two categories such as automated health management, and informational management. Automated health management provides real-time insights into the health of the patients to the physicians and informational devices are designed to collect the health information and display it to the patients to make an informed decision regarding their health. The rapid adoption of the technologies in medical devices is driving the growth of the smart medical devices market.

Smart Medical Devices Market Growth Factors

• The growing prevalence of chronic diseases in the geriatric population and the rising number of infectious diseases are driving the demand for smart medical devices for the early detection and diagnosis of diseases.
• The rising awareness about health and the surging spending mentality in healthcare by the population due to the rise in disposable income and living standards are driving the expansion of the market.
• The rising awareness regarding real-time insights about health and diseases that help in early diagnosis and treatment in hospitals and other healthcare institutions is fueling the demand for the smart medical devices market.
• The rising advancement in healthcare technologies and the rising investments in the innovations of advanced and smart medical devices also accelerate the demand for the market.
• The rising government initiative for developing healthcare sectors and supporting regulations and policies that make medical facilities more reachable and affordable to the people contribute to the growth of the smart medical devices market.

Market Scope

Market Dynamics

Driver

Increasing demand for efficient healthcare operations

The integration of technologies in healthcare settings is driving the growth of the smart medical devices market. The rising prevalence of chronic diseases such as diabetes, asthma, and cardiovascular disorders which need regular monitoring drives the demand for smart medical devices. Smart devices are also known as IoT healthcare devices which include smart tools such as connectivity, sensors, and data analytics capabilities and are widely being used in the healthcare industry. Smart medical devices provide real-time data about the patient’s health condition, increase patient engagement, and maintain their healthcare process. Smart devices include gadgets like smartwatches, wearable fitness trackers to remote monitoring systems.

The increasing demand for remote monitoring systems that help to monitor the condition of patients with chronic disorders at home with the integration of various devices and sensors to monitor. These tools can track the symptoms, vital signs, and medical adherence, which are sent to medical professionals for proactive interventions. Thus these factors are positively influencing the growth of the smart medical devices market.

Restraint

Lack of proper infrastructure

The insufficient amount of infrastructure and the lack of skilled professionals in technology development restrains the growth of the smart medical devices market. This factor generally acts as a hampering one in underdeveloped areas, where lack of healthcare infrastructure, absence of skilled professionals and slow pace of adoption for such devices create a major restraint for manufacturers and investors from expanding business in such areas. The challenge is observed to get addressed with government initiatives and private investments that can boost the adoption of smart medical devices in such parts.

Opportunity

Innovations in medical devices

The ongoing advancements in the medical devices and the healthcare sectors are observed to offer lucrative opportunities for the smart medical devices market. The integration of smart technologies helps healthcare professionals to make informed and strategic decisions about the health of the patients. There are some of the smart medical devices that are observed as emerging trends in the healthcare system such as wearables, medical robots, immersive technologies, 3D printing, and artificial intelligence, the internet of medical things, cybersecurity, medical waste management, minimally invasive devices, and 5G.

The rising focus and interest in automation of healthcare devices promotes the implementation of AI, medical robots, and immersive technologies in the medical devices industry. Additionally, the rising investments in the innovation of technologies in the healthcare industry also contributes to the growth of the smart medical devices market.

Product Insights

The diagnostics and monitoring segment dominated the smart medical devices market with the largest market share in 2024. The dominance of the segment is attributed to the rising demand for smart medical devices for the diagnostics and monitoring of chronic diseases such as diabetes and others. Smart medical devices give real-time information about the condition of the diseases of the patient which helps to take an informed decision regarding the diseases. The diagnostics and monitoring segment is further divided into the blood glucose, pulse, blood pressure, and heart rate monitoring.

The rising investments in technological advancements and the supportive government initiatives with subsidies and policies for the development and implementation of smart medical gadgets are driving the growth of the segment.

Among all diagnostic and monitoring tools, blood glucose monitoring tools are considered to be the most prominent ones. The rising cases of diabetes across the globe act as a major factor for the increasing utilization of blood glucose monitoring tools across the health industry. Along with this, the rising emphasis on utilizing diabetes detection tools at home by patients under the trend of home-health care settings creates a significant opportunity for the segment to grow.

End-User Insights

The hospitals segment held a considerable share of the smart medical devices market in 2024. Hospitals operate within a highly regulated environment, with strict requirements for patient safety, data security, and regulatory compliance. Smart medical devices that meet regulatory standards and quality certifications are preferred by hospitals, as they offer assurance of reliability, accuracy, and data integrity.

The homecare settings segment is expected to have a significant rate of growth in the smart medical devices market in 2023.

The growth of the segment is attributed to the rising number of the geriatric population having the chronic diseases and need the regular monitoring driving the demand for the high-quality medical services at their home comfort that boosts the growth of the segment. The rising adoption of telehealth, e-healthcare initiatives and smart medical devices that gives accurate results for the health condition in homecare enhances the expansion of the homecare settings segment.

Smart Medical Devices Market Companies

• Abbott
• Apple, Inc
• Fitbit, Inc.
• Dexcom, Inc
• F. Hoffmann-La Roche Ltd
• Zephyr
• Sonova, NeuroMetrix, Inc.
• Medtronic
• Johnson & Johnson.

Recent Developments

• In March 2024, Associate Head, Prof. Michael Tin Cheung YING, and Dr Ziman CHEN, of the Department of Health Technology and Informatics at PolyU came in the parternship with the Fifth Affiliated Hospital of Sun Yat-sen University, Dr Zhongzhen SU’s Vice President, to launch S-CKD, the launch is helps to improve diseases process monitoring and the CKD’s clinical management using information technology.
• In March 2024, Masimo granted the FDA clearance for its consumer-focused business which focuses on telehealth platforms and professional patients monitoring. It also included a high-tech Stork baby monitor system and the health focused smartwatches line.

Segments Covered in the Report

By Product

• Diagnostics and Monitoring
  • Blood Glucose Monitor
  • Heart Rate Monitors
  • Pulse Oximeters
  • Blood Pressure Monitors
• Therapeutics Devices
  • Portable Oxygen Concentrators and Ventilators
  • Insulin Pumps
  • Hearing Aids

By End-User

• Homecare Settings
• Hospitals
• Others

By Modality

• Portable
• Wearable

By Distribution Channel

• Pharmacies
• Online Channel

By Geography

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa