세계의 분산형 임상시험용 웨어러블 시장 보고서(2025년)
Decentralized Trial Wearable Global Market Report 2025
상품코드 : 1877598
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

분산형 임상시험용 웨어러블 시장 규모는 최근 급격히 확대되고 있습니다. 2024년 20억 1,000만 달러에서 2025년에는 24억 3,000만 달러에 달할 것으로 추정되며, CAGR 20.9%로 성장이 전망되고 있습니다. 이러한 성장은 실시간 데이터 수집에 대한 수요 증가, 분산형 임상시험에서의 환자 참여 확대, 웨어러블 생체 센서의 이용 확대, 임상시험 효율에 대한 주목 증가, 기술 기업 및 제약 기업 간 연계 강화에 기인할 것으로 예측됩니다.

분산형 임상시험용 웨어러블 시장 규모는 향후 수년간 급격한 성장이 예상됩니다. 2029년에는 51억 3,000만 달러에 달할 것으로 예측되며, CAGR 20.6%로 성장할 전망입니다. 예측 기간 동안 성장 요인으로는 분산형 임상시험 증가, 클라우드 기반 시험 관리 시스템의 보급 확대, 디지털 치료제에 대한 자금 투입 증가, 바이오센서 기술 혁신, 환자 중심 시험에 대한 주력 강화 등이 있습니다. 예측 기간 주요 동향으로는 실시간 데이터 수집을 위한 고급 웨어러블 센서, 환자 참여 플랫폼의 혁신, 클라우드 기반 임상시험 관리 시스템과의 통합, 개인화된 헬스케어 인사이트의 진전, 배터리 수명 및 에너지 효율이 향상된 웨어러블 장비 등이 있습니다.

실시간 환자 모니터링 수요 증가는 분산형 임상시험용 웨어러블 시장의 성장을 이끌 것으로 예측됩니다. 실시간 환자 모니터링은 연결된 의료기기를 통해 건강 데이터를 지속적으로 수집 및 전송하고 생리적 측정치를 자동으로 의료 제공업체에게 중계함으로써 즉각적인 평가와 개입을 가능하게 하는 것입니다. 당뇨병, 심혈관 질환, 호흡기 질환 등 만성 질환의 유병률이 증가함에 따라 조기 개입과 더 나은 질병 관리를 가능하게 하는 지속적인 추적이 필요하기 때문에 실시간 모니터링에 대한 수요가 증가하고 있습니다. 분산형 임상시험용 웨어러블은 환자의 자연 환경으로부터 환자 데이터를 지속적으로 수집 및 송신하고, 집중 관리 데이터베이스에 송신함으로써 실시간 모니터링을 지원합니다. 이를 통해 연구자와 의료 전문가는 원격으로 건강 상태를 추적하고 이상을 조기에 감지하고 적시에 데이터를 기반으로 임상 판단을 내릴 수 있습니다. 예를 들어 2023년 8월 미국 의료기술 기업 Vivalink가 실시한 조사에서는 현재 원격 환자 모니터링(RPM) 이용자의 84%가 2024년에 이용 확대를 계획하고 있는 것, 의료 제공업체의 45%가 재택 치료 프로그램에서의 급성기 모니터링에 RPM을 활용하고 있다는 점, 77%가 RPM 기반 케어가 5년 이내에 종래의 입원 의료를 상회할 것이라고 생각하고 있는 것이 보고되었습니다. 이와 같이 실시간 환자 모니터링에 대한 수요 증가가 분산형 임상시험용 웨어러블 시장을 견인하고 있습니다.

분산형 임상시험용 웨어러블 시장의 주요 기업은 환자의 안락성을 높이고 원격 데이터 수집을 개선하기 위해 초소형 건강 모니터링 장치를 개발하고 있습니다. 초소형 디바이스는 최소한의 부담으로 생리적 및 행동 데이터를 지속적으로 추적하는 소형 웨어러블 기기로, 환자의 컴플라이언스 향상과 임상시험용 고품질 데이터 수집을 실현합니다. 예를 들어 2025년 6월, 미국 의료 기술 기업 엠파티카사는 임상 연구를 위한 세계 최소의 리스트웨어형 액티그래피 디바이스 'EmbraceMini'를 발표했습니다. 두께 불과 12mm, 폭 14mm와 USB 플래시 드라이브나 AA 배터리와 동등한 사이즈이면서, 활동량, 수면, 보행 및 광 노출 등 200항목 이상의 디지털 측정치를 초쾌적인 비침습적 모니터링으로 제공합니다. 이 디바이스는 데이터를 Empatica사의 FDA 승인된 헬스 모니터링 플랫폼에 무선 송신해, 원격 데이터 수집, 디지털 바이오마커 분석, 기존 임상시험 시스템과의 제휴를 실현합니다. 참가자의 경험과 준수율을 최우선으로 설계되었습니다. 수면 장애, 운동 장애, 비만, 우울증, 통증에 대한 연구를 위해 설계되었으며 생리적 및 행동 패턴에 대한 고해상도 지식을 제공합니다. 긴 수명 배터리로 최소 7일간의 연속 모니터링이 가능하여 참가자의 부담을 경감합니다. 모듈식 설계에 의해 손목, 발목, 다리, 허리에 장착이 가능하며, 복수의 유닛을 동시에 사용하는 것으로 보다 풍부한 데이터 세트의 취득을 실현합니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향 및 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역전쟁 및 관세, 그리고 코로나 및 회복이 시장에 미치는 영향을 포함한 거시경제 시나리오

제5장 세계의 성장 분석 및 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별 및 국가별 분석

제8장 아시아태평양 시장

제9장 중국 시장

제10장 인도 시장

제11장 일본 시장

제12장 호주 시장

제13장 인도네시아 시장

제14장 한국 시장

제15장 서유럽 시장

제16장 영국 시장

제17장 독일 시장

제18장 프랑스 시장

제19장 이탈리아 시장

제20장 스페인 시장

제21장 동유럽 시장

제22장 러시아 시장

제23장 북미 시장

제24장 미국 시장

제25장 캐나다 시장

제26장 남미 시장

제27장 브라질 시장

제28장 중동 시장

제29장 아프리카 시장

제30장 경쟁 구도 및 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹 및 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문 및 전략

제36장 부록

AJY
영문 목차

영문목차

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.

Reasons to Purchase

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.

Scope

Table of Contents

1. Executive Summary

2. Decentralized Trial Wearable Market Characteristics

3. Decentralized Trial Wearable Market Trends And Strategies

4. Decentralized Trial Wearable Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Decentralized Trial Wearable Growth Analysis And Strategic Analysis Framework

6. Decentralized Trial Wearable Market Segmentation

7. Decentralized Trial Wearable Market Regional And Country Analysis

8. Asia-Pacific Decentralized Trial Wearable Market

9. China Decentralized Trial Wearable Market

10. India Decentralized Trial Wearable Market

11. Japan Decentralized Trial Wearable Market

12. Australia Decentralized Trial Wearable Market

13. Indonesia Decentralized Trial Wearable Market

14. South Korea Decentralized Trial Wearable Market

15. Western Europe Decentralized Trial Wearable Market

16. UK Decentralized Trial Wearable Market

17. Germany Decentralized Trial Wearable Market

18. France Decentralized Trial Wearable Market

19. Italy Decentralized Trial Wearable Market

20. Spain Decentralized Trial Wearable Market

21. Eastern Europe Decentralized Trial Wearable Market

22. Russia Decentralized Trial Wearable Market

23. North America Decentralized Trial Wearable Market

24. USA Decentralized Trial Wearable Market

25. Canada Decentralized Trial Wearable Market

26. South America Decentralized Trial Wearable Market

27. Brazil Decentralized Trial Wearable Market

28. Middle East Decentralized Trial Wearable Market

29. Africa Decentralized Trial Wearable Market

30. Decentralized Trial Wearable Market Competitive Landscape And Company Profiles

31. Decentralized Trial Wearable Market Other Major And Innovative Companies

32. Global Decentralized Trial Wearable Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Decentralized Trial Wearable Market

34. Recent Developments In The Decentralized Trial Wearable Market

35. Decentralized Trial Wearable Market High Potential Countries, Segments and Strategies

36. Appendix

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