시장보고서 | 연간정보서비스 | 맞춤형시장조사 | 메일링 | 샘플 요청 목록
임상시험 관리 시스템 시장 보고서 : 구성요소, 전개 방식, 최종사용자, 지역별(2025-2033년)
Clinical Trial Management Systems Market Report by Component, Deployment Mode, End User, and Region 2025-2033
상품코드 : 1722674
리서치사 : IMARC
발행일 : 2025년 05월
페이지 정보 : 영문 139 Pages
 라이선스 & 가격 (부가세 별도)
US $ 2,999 ￦ 4,372,000
PDF & Excel (Single User License) help
PDF & Excel 보고서를 1명만 이용할 수 있는 라이선스입니다. 인쇄 불가능하며, 텍스트 등의 Copy&Paste도 불가능합니다.
US $ 3,999 ￦ 5,830,000
PDF & Excel (5 User License) help
PDF & Excel 보고서를 동일 기업의 5명까지 이용할 수 있는 라이선스입니다. 텍스트 등의 Copy&Paste가 불가능합니다. 인쇄는 5부까지 가능하며, 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.
US $ 4,999 ￦ 7,288,000
PDF & Excel (Corporate License) help
PDF & Excel 보고서를 동일 기업의 5명까지 이용할 수 있는 라이선스입니다. 텍스트 등의 Copy&Paste가 불가능합니다. 인쇄는 5부까지 가능하며, 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.


ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.

한글목차

세계 임상시험 관리 시스템 시장 규모는 2024년에 12억 5,800만 달러에 달했습니다. 향후 IMARC Group은 이 시장이 2033년까지 28억 9,480만 달러에 달할 것으로 예상하며, 2025년부터 2033년까지 9.22%의 연평균 성장률(CAGR)을 기록할 것으로 예측하고 있습니다. 임상시험 관리 시스템(CTMS) 시장은 임상시험의 복잡성 증가, 원격 협업을 위한 클라우드 기반 CTMS 솔루션의 채택 증가, 규제 요건 강화, 효율성 및 데이터 품질 향상을 위한 환자 중심 임상시험에 대한 중요성 증가 등의 요인에 의해 주도되고 있습니다.

임상시험 관리 시스템 시장 분석:

임상시험 관리 시스템 시장 동향:

임상시험의 복잡성

CTMS 플랫폼은 임상시험 계획, 프로토콜 설계, 환자 등록, 데이터 관리를 위한 종합적인 솔루션을 제공함으로써 프로세스를 간소화하고 이해관계자 간 협업을 촉진하여 복잡한 임상시험을 관리하는 데 매우 중요한 역할을 수행합니다. CTMS 플랫폼은 프로세스를 간소화하고 이해관계자 간의 협업을 촉진함으로써 조직이 현대의 복잡한 임상 연구를 효과적으로 진행하고, 엄격한 프로토콜을 준수하며, 혁신적인 치료법 개발을 가속화할 수 있도록 돕습니다. 혁신적인 치료법 개발을 가속화하는 데 도움이 됩니다. 이 플랫폼은 인공지능과 머신러닝과 같은 첨단 기술을 활용하여 임상시험의 설계와 수행을 최적화하고 효율성을 높여 임상시험 관리 시스템 수익을 창출합니다.

엄격한 규제 요건

규제 당국은 환자 안전과 데이터 무결성을 유지하기 위해 엄격한 가이드라인을 제시하고 있으며, CTMS 플랫폼이 제공하는 강력한 컴플라이언스 관리를 필요로 합니다. CTMS 플랫폼은 프로토콜 준수 및 문서 관리부터 감사 준비 및 규제 당국 보고에 이르기까지 조직이 복잡한 규제 환경을 자신 있게 탐색하고, 컴플라이언스 리스크를 줄이고, 규제 표준을 준수할 수 있도록 지원합니다. 또한, CTMS 플랫폼은 자동화된 컴플라이언스 모니터링 및 실시간 리스크 평가와 같은 기능이 내장되어 있어 규제 문제를 사전에 식별하고 해결함으로써 전체 컴플라이언스의 효율성과 효과성을 높일 수 있습니다. 예를 들어, 미국 내 임상시험 규제는 2022년 식품의약품 옴니버스 개혁법(FDORA), 1974년 프라이버시법, 프라이버시 및 기밀성 관련 NIH 정책 매뉴얼 등 엄격한 가이드라인에 의해 관리되고 있습니다.

환자 중심 임상시험의 중요성

환자 중심주의로의 전환에 따라 CTMS 플랫폼은 환자 모집 포털 및 원격 모니터링과 같은 기능을 우선순위에 두고 환자 참여와 시험의 성공률을 높이고 있습니다. CTMS 플랫폼은 환자 모집 포털, 원격 모니터링 기능, 전자 환자 보고 결과(ePRO) 등의 기능을 통합하여 이러한 패러다임 전환을 지원합니다. 패러다임 전환을 지원합니다. CTMS 플랫폼은 환자들에게 적극적인 참여와 소통을 위한 도구를 제공함으로써 환자의 순응도를 높이고, 데이터 품질을 향상시키며, 궁극적으로 환자 중심의 임상시험의 성공에 기여합니다. 이를 통해 시장 개요에 긍정적인 임상시험 관리 시스템 시장이 형성되고 있습니다.

목차

제1장 서문

제2장 조사 범위와 조사 방법

제3장 주요 요약

제4장 소개

제5장 세계의 임상시험 관리 시스템 시장

제6장 시장 내역 : 구성요소별

제7장 시장 내역 : 전개 방식별

제8장 시장 내역 : 최종사용자별

제9장 시장 내역 : 지역별

제10장 SWOT 분석

제11장 밸류체인 분석

제12장 Porter's Five Forces 분석

제13장 가격 분석

제14장 경쟁 구도

ksm
영문 목차

영문목차

The global clinical trial management systems market size reached USD 1,258.0 Million in 2024. Looking forward, IMARC Group expects the market to reach USD 2,894.8 Million by 2033, exhibiting a growth rate (CAGR) of 9.22% during 2025-2033. The clinical trial management systems (CTMS) market is propelled by factors such as increasing clinical trial complexity, rising adoption of cloud-based CTMS solutions for remote collaboration, stringent regulatory requirements, and the growing emphasis on patient-centric trials for improved efficiency and data quality.

Clinical Trial Management Systems Market Analysis:

Clinical Trial Management Systems Market Trends:

Increasing Clinical Trial Complexity

The evolution of precision and personalized medicine has intensified the intricacies of clinical trials, demanding sophisticated management solutions. CTMS platforms play a pivotal role in managing these intricate trials by providing comprehensive solutions for study planning, protocol design, patient enrollment, and data management. By streamlining processes and facilitating collaboration among stakeholders, CTMS platforms help organizations effectively navigate the complexities of modern clinical research, ensuring adherence to rigorous protocols and accelerating the development of innovative therapies. These platforms leverage advanced technologies such as artificial intelligence and machine learning to optimize trial design and execution, enhancing efficiency and generating clinical trial management systems revenue.

Stringent Regulatory Requirements

Regulatory bodies impose rigorous guidelines to uphold patient safety and data integrity, necessitating robust compliance management offered by CTMS platforms. CTMS solutions offer robust tools and functionalities to assist organizations in meeting these regulatory obligations. From ensuring protocol adherence and documentation management to facilitating audit readiness and regulatory reporting, CTMS platforms help organizations navigate the complex regulatory landscape with confidence, reducing compliance risks and ensuring adherence to regulatory standards. Additionally, CTMS platforms incorporate features such as automated compliance monitoring and real-time risk assessment to proactively identify and address regulatory issues, enhancing overall compliance efficiency and effectiveness. For instance, the regulations for clinical trials in the United States are governed by stringent guidelines such as the Food and Drug Omnibus Reform Act of 2022 (FDORA), Privacy Act of 1974, and the NIH Policy Manual on Privacy and Confidentiality.

Emphasis on Patient-Centric Trials

With a shift toward patient-centricity, CTMS platforms prioritize features like patient recruitment portals and remote monitoring to enhance patient engagement and trial success. There is a growing recognition of the importance of patient-centricity in clinical research, with a focus on enhancing patient engagement, experience, and retention. CTMS platforms support this paradigm shift by incorporating features such as patient recruitment portals, remote monitoring capabilities, and electronic patient-reported outcomes (ePRO). By empowering patients with tools for active participation and communication, CTMS platforms improve patient compliance, enhance data quality, and ultimately contribute to the success of patient-centric trials. This is creating a positive clinical trial management systems market overview.

Clinical Trial Management Systems Market Segmentation:

Breakup by Component:

Software accounts for the majority of the market share

The expanding penetration of software in the CTMS market is mainly induced by the potential for added flexibility, scalability, and customization. Software offerings provide bespoke functions for trial design, subject recruitment, data management, and regulatory conformity as clinical trial ecosystem has different stakeholders. Apart from this, SaaS models facilitate in having cost-effective deployment and easy accessibility, especially for the small and mid-sized organizations. The growing sophistication of the clinical trials and implicit need for advanced analytics and real-time insights has placed software at the heart of trial workflow management, process improvement, and drug development speedup. For instance, the U.S. Federal Government, through the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH), has proposed policy changes to improve clinical trial transparency by expanding trial registration requirements and data sharing to enhance research transparency.

Breakup by Deployment Mode:

Web-based CTMS holds the largest share of the industry

The web-based CTMS as a deployment mode dominates the CTMS market as web-based methods provide more availability and convenience as users can access the system from any location worldwide where there is internet connection. This makes it possible for a stakeholder team to work remotely and have ready data access, ensuring the smooth running of trials. Moreover, online CTMS systems typically have lower initial costs and fewer IT infrastructure investments than on-site installations making them to be terrific options to small and mid-sized organization looking for an economical and scalable trials management solutions. For instance, Sitero recently acquired the Clario eClinical suite including, Mentor CTMS, a web-based CTMS solution offer benefits, such as easy and affordable third-party eTMF integration, unrestricted access, a familiar Microsoft Office-based interface, rapid implementation, and mobility-enabled features, catering to the demand for efficient and user-friendly CTMS platforms.

Breakup by End User:

Pharmaceutical and biotechnology firms represent the leading market segment

Clinical trials are becoming more complex and highly scrutinized making it necessary for pharmaceuticals and biotechnology companies to incorporate CTMS solutions on a daily basis as the end users. CTMS platforms furnish with all-encompassing features that are meant to be customized for the use of the pharmaceutical and biotech companies, and hence trials operations can be seamlessly carried out. The collaboration of different stakeholders is enhanced and, besides, regulatory compliance is maintained, and therapies developed much faster. Furthermore, CTMS systems are useful to these entities in reducing resources utilization, controlling the clinical trial costs and improving the overall organization productivity, thus improving the clinical trial management systems market statistics.

Breakup by Regional:

North America leads the market, accounting for the largest clinical trial management systems market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America holds the leading position in the market for clinical trial management systems.

North America drives the CTMS market due to its robust healthcare infrastructure, extensive clinical research activities, and stringent regulatory standards. The region hosts numerous pharmaceutical, biotechnology, and medical device companies conducting clinical trials, creating a significant demand for CTMS solutions. Additionally, the prevalence of chronic diseases and the need for innovative therapies further fuel the adoption of advanced trial management tools. Moreover, North America's substantial investments in research and development, coupled with its technological advancements and focus on precision medicine, contributing to the the CTMS market growth.

Competitive Landscape:

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

Key Questions Answered in This Report

Table of Contents

1 Preface

2 Scope and Methodology

3 Executive Summary

4 Introduction

5 Global Clinical Trial Management Systems Market

6 Market Breakup by Component

7 Market Breakup by Deployment Mode

8 Market Breakup by End User

9 Market Breakup by Region

10 SWOT Analysis

11 Value Chain Analysis

12 Porters Five Forces Analysis

13 Price Analysis

14 Competitive Landscape

(주)글로벌인포메이션 02-2025-2992 kr-info@giikorea.co.kr
ⓒ Copyright Global Information, Inc. All rights reserved.
PC버전 보기