세계의 분산형 임상시험 시장 보고서(2025년)
Decentralized Clinical Trials Global Market Report 2025
상품코드 : 1855846
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

분산형 임상시험 시장 규모는 최근 급속도로 확대되고 있습니다. 2024년 74억 4,000만 달러에서 2025년에는 87억 7,000만 달러에 달하고, CAGR 17.8%로 확대될 전망입니다. 실적기간 내 성장은 전자 데이터 수집 시스템의 채용 증가, 웨어러블 건강 모니터링 장치의 사용 증가, 환자 중심 시험에 대한 규제 당국의 지원 증가, 비용 효율적인 시험 모델에 대한 수요 증가, 원격 모니터링 기술 확대로 발생하였습니다.

분산형 임상시험 시장 규모는 향후 수년간 급성장할 것으로 전망됩니다. 2029년에는 CAGR 17.5%로 166억 8,000만 달러로 성장할 전망입니다. 예측기간 내 성장은 임상시험에서의 인공지능과 머신러닝의 통합, 데이터 보안을 위한 블록체인 채용 확대, 분산형 시험 모델을 촉진하는 희소질환과 만성질환의 유병률 상승, 시험 설계에서 실세계 증거의 사용 증가, 원활한 시험 운용을 가능하게 하는 5G 연결 확대에 의해 지원될 것으로 예측됩니다. 예측 기간 동안 예상되는 주요 동향으로는 AI와 머신러닝 통합, 웨어러블 및 바이오센서 기술 채택, 원격 의료 및 원격 모니터링 사용 증가, 블록체인 지원 데이터 보안 및 투명성, 클라우드 기반 임상시험 관리 플랫폼의 성장 등이 있습니다.

원격 의료가 점점 더 중시되면서 분산형 임상시험 시장의 향후 성장이 기대되고 있습니다. 원격 의료는 디지털 통신 도구를 통해 의료 서비스를 원격으로 제공하는 것으로, 환자는 의료 서비스 시설을 직접 방문하지 않고도 진찰과 모니터링을 받을 수 있습니다. 이러한 원격 의료로의 전환은 세계적인 건강 과제와 사회적 거리의 축소에 대응하기 때문에 이용하기 쉬운 헬스케어에 대한 수요가 큰 요인이 되고 있습니다. 분산형 임상시험은 원격의료를 활용하여 참가자가 원격으로 참가하고 그 경과를 모니터링함으로써 물리적 시설 방문의 필요성을 줄이는 동시에 실시간 데이터 수집, 보다 광범위한 참여, 지속적인 모니터링을 가능하게 합니다. 예를 들어 미국에 본사를 두고 있는 헬스케어 기술 기업인 Vivalink는 2023년 8월 81%의 임상의가 원격 환자 모니터링을 이용하였고 2021년의 20%에서 크게 증가하였다고 보고했습니다. 또한 원격 환자 모니터링을 사용하는 인구의 84%가 2024년에도 그 사용을 확대할 의향을 보였습니다. 따라서, 원격의료에 대한 관심 증가가 분산형 임상시험 시장의 확대에 기여하고 있습니다.

분산형 임상시험 시장에서 사업을 전개하는 기업은 임상시험 셋업을 간소화하고 효율성과 환자 참여를 향상시키는 올인원 로우코드 임상시험 소프트웨어 솔루션을 개발함으로써 자사 제품을 제공합니다. 이러한 플랫폼을 통해 연구자는 코드를 작성하지 않고 임상시험을 생성하고 관리할 수 있으며 동시에 환자 모집, 데이터 수집, 모니터링, 분석 등의 중요한 기능을 하나의 사용하기 쉬운 시스템에 통합할 수 있습니다. 예를 들어 미국에 본사를 두고 있는 임상 기술 기업인 Medable은 2024년 8월 임상시험에서 전자 임상 결과 평가, 전자 동의, 원격 상담, 센서 통합 설정, 번역, 검증 및 시작을 간소화하기 위해 설계된 올인원 코드리스 소프트웨어 플랫폼인 Medable Studio를 발표했습니다. 이 도구를 사용하면 바이오 의약품 기업이 프로토콜에 특화된 테스트 디자인을 수개월이 아닌 수시간 내에 개발할 수 있어 관리, 속도, 투명성이 향상됩니다. 사용자는 셀프서비스, 풀서비스 또는 하이브리드 옵션 중에서 선택할 수 있으며, 테스트 시작까지의 기간을 크게 단축하고 비용을 절감할 수 있습니다. 이 플랫폼은 테스트 설정 프로세스를 가속화하고 외부 서비스에 의존하지 않도록 함으로써 테스트 구현을 변화시키는 것을 목표로 합니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

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

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별/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 구도와 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹과 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문, 전략

제36장 부록

CSM
영문 목차

영문목차

Decentralized clinical trials are an innovative approach to conducting clinical research that utilizes digital tools and remote processes to engage participants outside traditional trial sites. They streamline data collection and monitoring in real time, improving trial efficiency. Decentralized clinical trials also enhance accessibility, allowing broader and more diverse participation, and accelerate research timelines while reducing operational challenges.

The primary types of decentralized clinical trials are interventional, observational, and expanded access. Interventional trials involve assigning participants to specific interventions to assess their effects on health outcomes. Key technologies include wearable devices, mobile health applications, telemedicine platforms, and electronic data capture systems. These trials span study phases from phase I through phase IV and are applied across therapeutic areas such as oncology, cardiology, neurology, and infectious diseases. End-users include pharmaceutical companies, biotechnology firms, contract research organizations, regulatory authorities, and academic and research institutions.

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 clinical trials market research report is one of a series of new reports from The Business Research Company that provides decentralized clinical trials market statistics, including decentralized clinical trials industry global market size, regional shares, competitors with a decentralized clinical trials market share, detailed decentralized clinical trials market segments, market trends and opportunities, and any further data you may need to thrive in the decentralized clinical trials industry. The decentralized clinical trials market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The decentralized clinical trials market size has grown rapidly in recent years. It will grow from $7.44 billion in 2024 to $8.77 billion in 2025 at a compound annual growth rate (CAGR) of 17.8%. Growth in the historic period was driven by the rising adoption of electronic data capture systems, increasing use of wearable health monitoring devices, growing regulatory support for patient-centric trials, higher demand for cost-efficient trial models, and expansion of remote monitoring technologies.

The decentralized clinical trials market size is expected to see rapid growth in the next few years. It will grow to $16.68 billion in 2029 at a compound annual growth rate (CAGR) of 17.5%. Growth in the forecast period is expected to be supported by the integration of artificial intelligence and machine learning in clinical trials, greater adoption of blockchain for data security, rising prevalence of rare and chronic diseases promoting decentralized trial models, increased use of real-world evidence in trial design, and expansion of 5G connectivity enabling seamless trial operations. Key trends anticipated for the forecast period include the integration of AI and machine learning, adoption of wearable and biosensor technologies, increased use of telemedicine and remote monitoring, blockchain-enabled data security and transparency, and growth of cloud-based clinical trial management platforms.

The increasing emphasis on telemedicine is expected to support the growth of the decentralized clinical trials market in the years ahead. Telemedicine refers to the remote delivery of healthcare services through digital communication tools, allowing patients to receive consultations and monitoring without visiting healthcare facilities in person. This shift toward telemedicine is largely driven by the demand for accessible healthcare in response to global health challenges and social distancing measures. Decentralized clinical trials leverage telemedicine to remotely engage participants and monitor their progress, reducing the need for physical site visits while enabling real-time data collection, broader participation, and continuous oversight. For example, in August 2023, Vivalink, a healthcare technology company based in the United States, reported that eighty-one percent of clinicians were using remote patient monitoring, a significant increase from twenty percent in 2021. In addition, eighty-four percent of those currently using remote patient monitoring intended to expand their use in 2024. As a result, the growing focus on telemedicine is contributing to the expansion of the decentralized clinical trials market.

Companies operating in the decentralized clinical trials market are advancing their offerings by developing all-in-one, no-code clinical trial software solutions that simplify trial setup and improve efficiency and patient engagement. These platforms enable researchers to create and manage trials without writing code, while incorporating essential functions such as patient recruitment, data collection, monitoring, and analytics into one user-friendly system. For example, in August 2024, Medable, a clinical technology company based in the United States, introduced Medable Studio, an all-in-one, no-code software platform designed to streamline the configuration, translation, validation, and launch of electronic Clinical Outcome Assessments, electronic consent, remote consultations, and sensor integrations in clinical trials. This tool allows biopharmaceutical companies to develop protocol-specific study designs in a matter of hours rather than months, offering increased control, speed, and transparency. Users can choose from self-service, full-service, or hybrid options, which significantly shorten study startup timelines and reduce costs. The platform aims to transform trial execution by making the study setup process faster and less reliant on external services.

In July 2023, Signant Health, a United States-based provider of evidence generation solutions for modern clinical trials, completed the acquisition of DSG Incorporated for an undisclosed sum. This acquisition is intended to expand Signant Health's suite of electronic clinical solutions by incorporating DSG's unified electronic data capture and direct data capture platform. The integration of these technologies offers flexible and comprehensive support for both traditional and decentralized clinical trials. This move enhances operational efficiency, simplifies trial workflows, and improves digital tools available to sponsors, research sites, and clinical research organizations. DSG Incorporated is a United States-based company that provides electronic data capture and direct data capture technology within a unified clinical platform for use in site-based and decentralized clinical trials.

Major players in the decentralized clinical trials market are Walgreens Boots Alliance Inc., Pfizer Inc., Oracle Corporation, Thermo Fisher Scientific Inc., IQVIA Holdings Inc., Labcorp Holdings Inc., ICON Public Limited Company, Dassault Systemes SE, LEO Pharma A/S, Verily Life Sciences LLC, ProPharma, Signant Health Holding Corp., PCM Trials, Huma Therapeutics Limited, Medable Inc., Science 37 Inc., Obvio Health, EmVenio Research Inc., Grove AI Inc., Phesi Inc.

North America was the largest region in the decentralized clinical trials market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in decentralized clinical trials report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the decentralized clinical trials market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The decentralized clinical trials market consists of revenues earned by entities by providing services such as patient recruitment and retention, site management and monitoring, data management and analytics, regulatory compliance support, and telemedicine or virtual care solutions. The market value includes the value of related goods sold by the service provider or included within the service offering. The decentralized clinical trials market also includes sales of wearable health monitoring devices, electronic data capture systems, biosensors, remote patient monitoring equipment, and clinical trial management software. 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, 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 Clinical Trials 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 clinical trials 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 clinical trials ? 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 clinical trials 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 Clinical Trials Market Characteristics

3. Decentralized Clinical Trials Market Trends And Strategies

4. Decentralized Clinical Trials 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 Clinical Trials Growth Analysis And Strategic Analysis Framework

6. Decentralized Clinical Trials Market Segmentation

7. Decentralized Clinical Trials Market Regional And Country Analysis

8. Asia-Pacific Decentralized Clinical Trials Market

9. China Decentralized Clinical Trials Market

10. India Decentralized Clinical Trials Market

11. Japan Decentralized Clinical Trials Market

12. Australia Decentralized Clinical Trials Market

13. Indonesia Decentralized Clinical Trials Market

14. South Korea Decentralized Clinical Trials Market

15. Western Europe Decentralized Clinical Trials Market

16. UK Decentralized Clinical Trials Market

17. Germany Decentralized Clinical Trials Market

18. France Decentralized Clinical Trials Market

19. Italy Decentralized Clinical Trials Market

20. Spain Decentralized Clinical Trials Market

21. Eastern Europe Decentralized Clinical Trials Market

22. Russia Decentralized Clinical Trials Market

23. North America Decentralized Clinical Trials Market

24. USA Decentralized Clinical Trials Market

25. Canada Decentralized Clinical Trials Market

26. South America Decentralized Clinical Trials Market

27. Brazil Decentralized Clinical Trials Market

28. Middle East Decentralized Clinical Trials Market

29. Africa Decentralized Clinical Trials Market

30. Decentralized Clinical Trials Market Competitive Landscape And Company Profiles

31. Decentralized Clinical Trials Market Other Major And Innovative Companies

32. Global Decentralized Clinical Trials Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Decentralized Clinical Trials Market

34. Recent Developments In The Decentralized Clinical Trials Market

35. Decentralized Clinical Trials Market High Potential Countries, Segments and Strategies

36. Appendix

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