PUBLISHER: The Business Research Company | PRODUCT CODE: 1877598
PUBLISHER: The Business Research Company | PRODUCT CODE: 1877598
A decentralized trial wearable is a digital device designed to capture and transmit real-time health, physiological, or activity data from participants in decentralized or hybrid clinical trials. It enables remote monitoring and data collection without the need for in-person site visits. These wearables enhance data reliability, participant convenience, and overall trial efficiency by providing continuous data flow, reducing logistical challenges, and improving engagement throughout the study period.
The primary product types of decentralized trial wearables include smartwatches, fitness trackers, biosensors, smart clothing, and other devices. They are distributed through both online and offline channels and are used for applications such as remote patient monitoring, clinical trials, disease management, and more. End-users include pharmaceutical companies, contract research organizations (CROs), healthcare providers, and others.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.
The decentralized trial wearable market research report is one of a series of new reports from The Business Research Company that provides decentralized trial wearable market statistics, including decentralized trial wearable industry global market size, regional shares, competitors with the decentralized trial wearable market share, decentralized trial wearable market segments, market trends, and opportunities, and any further data you may need to thrive in the decentralized trial wearable industry. This decentralized trial wearable market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The decentralized trial wearable market size has grown exponentially in recent years. It will grow from $2.01 billion in 2024 to $2.43 billion in 2025 at a compound annual growth rate (CAGR) of 20.9%. The growth during the historic period can be attributed to the rising demand for real-time data collection, growing patient engagement in decentralized trials, increasing use of wearable biosensors, heightened focus on clinical trial efficiency, and expanding collaboration between technology and pharmaceutical companies.
The decentralized trial wearable market size is expected to see exponential growth in the next few years. It will grow to $5.13 billion in 2029 at a compound annual growth rate (CAGR) of 20.6%. The growth during the forecast period can be attributed to the increase in decentralized clinical trials, rising adoption of cloud-based trial management systems, growing funding for digital therapeutics, innovations in biosensors, and a greater focus on patient-centric trials. Key trends in the forecast period include advanced wearable sensors for real-time data collection, innovations in patient engagement platforms, integration of cloud-based clinical trial management systems, advancements in personalized healthcare insights, and wearables with improved battery life and energy efficiency.
The increasing demand for real-time patient monitoring is expected to drive the growth of the decentralized trial wearable market. Real-time patient monitoring involves the continuous collection and transmission of health data through connected medical devices that automatically relay physiological measurements to healthcare providers for immediate assessment and intervention. The demand for real-time monitoring is rising due to the growing prevalence of chronic diseases such as diabetes, cardiovascular disorders, and respiratory illnesses, which require continuous tracking to enable early intervention and better disease management. Decentralized trial wearables support real-time monitoring by continuously collecting and transmitting patient data from their natural environments to centralized databases, allowing researchers and healthcare professionals to remotely track health, detect anomalies early, and make timely, data-driven clinical decisions. For example, in August 2023, a survey by Vivalink, a US-based healthcare technology company, reported that 84% of current remote patient monitoring (RPM) users plan to expand usage in 2024, 45% of healthcare providers use RPM for acute monitoring in hospital-at-home programs, and 77% believe RPM-based care will surpass traditional inpatient hospital care within five years. The rising demand for real-time patient monitoring is therefore driving the decentralized trial wearable market.
Leading companies in the decentralized trial wearable market are developing ultra-compact health monitoring devices to enhance patient comfort and improve remote data collection. Ultra-compact devices are small wearables designed to continuously track physiological and behavioral data with minimal intrusion, improving patient compliance and enabling high-quality data collection for clinical trials. For instance, in June 2025, Empatica Inc., a US-based medical technology company, launched EmbraceMini, the world's smallest wrist-worn actigraphy device for clinical research. Measuring just 12mm thick and 14mm wide, comparable to a USB flash drive or AA battery, it provides ultra-comfortable, non-invasive monitoring of over 200 digital measures, including activity, sleep, gait, and light exposure. The device wirelessly transmits data to Empatica's FDA-cleared Health Monitoring Platform, supporting remote data collection, digital biomarker analysis, and integration with existing clinical trial systems, while prioritizing participant experience and adherence. Designed for studies on sleep disorders, movement disorders, obesity, depression, and pain, it delivers high-resolution insights into physiological and behavioral patterns. Its long battery life allows at least seven days of continuous monitoring, reducing participant burden, and its modular design enables placement on the wrist, ankle, leg, or waist, with multiple units used simultaneously for richer datasets.
In May 2024, Medable Inc., a US-based biotechnology company, partnered with Masimo Corporation to advance decentralized clinical trials using medical-grade wearable devices. This partnership aims to enable decentralized trials by integrating medical-grade wearables to capture both objective and subjective patient data, reduce patient burden, and improve data quality. Masimo Corporation is a US-based medical technology company specializing in wearable technology for decentralized clinical trials.
Major players in the decentralized trial wearable market are Oracle Corporation, IQVIA Holdings Inc., LabCorp Drug Development Inc., ICON Public Limited Company, Garmin Ltd., Clario Inc., Medidata Solutions Inc., BioTelemetry Inc., Signant Health Holding Corp, Withings France SA, Medable Inc., Science 37 Holdings Inc., THREAD Research Inc., Huma Therapeutics Ltd., Empatica S.r.l., Clinical Ink Inc., VivaLNK Inc., Sempulse Ltd., Activinsights Ltd., Mahalo Health Inc.
North America was the largest region in the decentralized trial wearable market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in decentralized trial wearable report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the decentralized trial wearable market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The decentralized trial wearable market consists of sales of smart rings, wearable patches, glucose monitors, respiratory sensors, and smart clothing. Values in this market are 'factory gate' values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Decentralized Trial Wearable Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on decentralized trial wearable market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for decentralized trial wearable ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The decentralized trial wearable market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.