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시장보고서
상품코드
1867517
세계의 임상 데이터 관리 시스템 : 시장 점유율과 순위, 전체 판매량 및 수요 예측(2025-2031년)Clinical Data Management System - Global Market Share and Ranking, Overall Sales and Demand Forecast 2025-2031 |
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QYResearch
세계의 임상 데이터 관리 시스템 시장 규모는 2024년에 26억 1,800만 달러로 평가되었고, 2025-2031년의 예측 기간에 CAGR 10.7%로 성장하여 2031년까지 52억 5,700만 달러에 이를 것으로 예측됩니다.
임상 데이터 관리 시스템(CDMS)은 의약품, 의료기기, 생명공학 분야의 임상시험에서 데이터의 효율적이고 표준화된 안전한 수집, 관리, 분석을 목적으로 설계된 전문 정보 플랫폼입니다. CDMS는 전자 데이터 수집(EDC), 데이터 클리닝, 감사 추적, 의료 코딩, 쿼리 처리 등의 핵심 모듈을 포괄하여 시험 초기 설정부터 데이터베이스 잠금까지 엔드 투 엔드 시험 데이터 관리를 지원합니다. GCP, FDA, EMA 등 국제 규제 기준 준수를 보장하고, 디지털화되고 컴플라이언스에 부합하는 의약품 개발을 위한 중요한 기반이 됩니다. 시험의 복잡성과 분산형 시험의 출현에 따라 CDMS는 기존 On-Premise형 시스템에서 클라우드 기반의 AI 통합 플랫폼으로 진화하여 의약품 연구개발의 디지털 혁신을 주도하고 있습니다.
시장 개척 기회와 주요 촉진요인 세계 제약 연구개발은 혁신이 주도하는 새로운 시대를 맞이하고 있으며, 임상 데이터의 품질이 승인 속도와 시험의 성공 여부를 직접적으로 결정하는 요인이 되고 있습니다. 전 세계 규제 당국이 데이터의 진위성과 추적성에 대한 기준을 강화함에 따라 제약사 및 CRO는 CDMS 플랫폼에 많은 투자를 해야 하는 상황입니다. AI, 자연어 처리(NLP), 머신러닝의 통합으로 수동적인 데이터 기록에서 지능적인 통찰력으로의 전환이 가속화되고 있습니다. 미국, EU, 중국 등 주요 시장에서는 디지털 전환 노력이 IT 영역을 넘어 핵심 연구개발 및 컴플라이언스 기능까지 확대되고 있으며, CDMS는 효율성과 비용 관리를 위한 전략적 기반이 되고 있습니다.
시장 과제, 위험 및 제약 조건 유망한 성장에도 불구하고, CDMS 시장은 높은 도입 비용, 가파른 학습 곡선, 강력한 사용자 의존성과 관련된 과제에 직면해 있습니다. 고객은 벤더에게 더 높은 시스템 안정성과 서비스 대응력을 요구하고 있습니다. 규제가 빠르게 진화하고 국경 간 데이터 규제가 강화됨에 따라 더욱 민첩한 컴플라이언스 역량이 요구되고 있습니다. 한편, 예산이 한정된 많은 소규모 바이오텍 기업들은 경량 또는 모듈형 CDMS 옵션을 선호하고 있으며, 업계 전반의 제품 전략을 재구성하고 있습니다.
다운스트림 수요 동향 최종 사용자 수요는 크게 세 가지 방향으로 이동하고 있습니다. 첫째, 가상 요소와 현장 요소를 결합한 하이브리드 시험으로의 전환이 원격 액세스 및 실시간 모니터링에 대한 수요를 주도하고 있습니다. 둘째, 사용자는 독립형 도구에서 통합형 엔드투엔드 시스템으로 전환하고 있으며, EDC, CTMS, eTMF 모듈 간의 데이터 상호연결성에 대한 요구가 증가하고 있습니다. 셋째, 구조화된 임상 데이터는 컴플라이언스의 필요성에서 전략적 자산으로 변모하고 있으며, 적응증 확대, 위험 예측, 상업적 의사결정을 위해 CDMS에서 얻은 통찰력을 활용하는 것에 대한 관심이 높아지고 있습니다. 이러한 추세는 CDMS 제공업체들이 보다 스마트하고, 협업적이며, 적응력이 뛰어난 솔루션으로 진화할 것을 요구하고 있습니다.
이 보고서는 임상 데이터 관리 시스템 세계 시장에 대해 총 매출액, 주요 기업의 시장 점유율 및 순위에 초점을 맞추고 지역/국가, 유형 및 용도별 분석을 종합적으로 제시하는 것을 목적으로 합니다.
임상 데이터 관리 시스템 시장 규모, 추정 및 예측은 매출액 기준으로 제시되며, 2024년을 기준 연도로 하여 2020년부터 2031년까지의 기간의 과거 데이터와 예측 데이터를 포함합니다. 정량적 분석과 정성적 분석을 통해 독자들이 임상 데이터 관리 시스템에 대한 사업/성장 전략 수립, 시장 경쟁 평가, 현재 시장에서의 포지셔닝 분석, 정보에 입각한 사업적 판단을 내릴 수 있도록 돕습니다.
시장 세분화
기업별
- Medidata
- Oracle
- IBM
- PAREXEL Informatics
- BioClinica
- Medrio
- Forte Research Systems
- Taimei Technology
- Ofni Systems
- Fortress Medical Systems
- OpenClinica
- ClinCapture
유형별 부문
- 소프트웨어
- 서비스
용도별 부문
- 병원
- CRO
- 제약 기업 및 바이오테크놀러지 기업
- 기타
지역별
- 북미
- 미국
- 캐나다
- 아시아태평양
- 중국
- 일본
- 한국
- 동남아시아
- 인도
- 호주
- 기타 아시아태평양
- 유럽
- 독일
- 프랑스
- 영국
- 이탈리아
- 네덜란드
- 북유럽 국가
- 기타 유럽
- 라틴아메리카
- 멕시코
- 브라질
- 기타 라틴아메리카
- 중동 및 아프리카
- 튀르키예
- 사우디아라비아
- 아랍에미리트(UAE)
- 기타 중동 및 아프리카
자주 묻는 질문
The global market for Clinical Data Management System was estimated to be worth US$ 2618 million in 2024 and is forecast to a readjusted size of US$ 5257 million by 2031 with a CAGR of 10.7% during the forecast period 2025-2031.
Clinical Data Management System (CDMS) is a specialized information platform designed for the efficient, standardized, and secure collection, management, and analysis of data in pharmaceutical, medical device, and biotechnology clinical trials. CDMS supports end-to-end trial data management-from initial study setup to database lock-covering core modules such as electronic data capture (EDC), data cleaning, audit trail, medical coding, and query handling. It ensures compliance with international regulatory standards such as GCP, FDA, and EMA, and is a critical infrastructure for digitized and compliant drug development. With increasing trial complexity and the emergence of decentralized trials, CDMS is evolving from traditional on-premise systems to cloud-based, AI-integrated platforms, powering the digital transformation of drug R&D.
Market Development Opportunities & Main Driving FactorsGlobal pharmaceutical R&D is entering a new era where innovation dominates, and clinical data quality directly determines approval speed and trial success. Regulatory agencies worldwide are raising the bar for data authenticity and traceability, driving pharma companies and CROs to invest heavily in CDMS platforms. The integration of AI, NLP, and machine learning is accelerating the shift from passive data recording to intelligent insights. In major markets such as the U.S., EU, and China, digital transformation initiatives are expanding beyond IT into core R&D and compliance functions, making CDMS a strategic enabler for efficiency and cost control.
Market Challenges, Risks, & Restraints Despite promising growth, the CDMS market faces challenges related to high deployment costs, steep learning curves, and strong user dependency. Customers demand higher system stability and service responsiveness from vendors. Rapid regulatory evolution and tightening cross-border data regulations further necessitate agile compliance capabilities. Meanwhile, many small biotech companies, constrained by limited budgets, prefer lightweight or modular CDMS options-reshaping product strategies across the industry.
Downstream Demand Trends End-user demands are shifting in three main directions. First, the move toward hybrid trials combining virtual and on-site elements is driving demand for remote access and real-time monitoring. Second, users are moving from standalone tools to integrated end-to-end systems, with rising needs for data interconnectivity among EDC, CTMS, and eTMF modules. Third, structured clinical data is becoming a strategic asset rather than a compliance necessity, with growing interest in leveraging CDMS-derived insights for indication expansion, risk forecasting, and commercial decision-making. These trends are pushing CDMS providers to evolve toward smarter, more collaborative, and highly adaptable solutions.
This report aims to provide a comprehensive presentation of the global market for Clinical Data Management System, focusing on the total sales revenue, key companies market share and ranking, together with an analysis of Clinical Data Management System by region & country, by Type, and by Application.
The Clinical Data Management System market size, estimations, and forecasts are provided in terms of sales revenue ($ millions), considering 2024 as the base year, with history and forecast data for the period from 2020 to 2031. With both quantitative and qualitative analysis, to help readers develop business/growth strategies, assess the market competitive situation, analyze their position in the current marketplace, and make informed business decisions regarding Clinical Data Management System.
Market Segmentation
By Company
- Medidata
- Oracle
- IBM
- PAREXEL Informatics
- BioClinica
- Medrio
- Forte Research Systems
- Taimei Technology
- Ofni Systems
- Fortress Medical Systems
- OpenClinica
- ClinCapture
Segment by Type
- Software
- Services
Segment by Application
- Hospitals
- CROs
- Pharma & Biotech Organizations
- Other
By Region
- North America
- United States
- Canada
- Asia-Pacific
- China
- Japan
- South Korea
- Southeast Asia
- India
- Australia
- Rest of Asia-Pacific
- Europe
- Germany
- France
- U.K.
- Italy
- Netherlands
- Nordic Countries
- Rest of Europe
- Latin America
- Mexico
- Brazil
- Rest of Latin America
- Middle East & Africa
- Turkey
- Saudi Arabia
- UAE
- Rest of MEA
Chapter Outline
Chapter 1: Introduces the report scope of the report, global total market size. This chapter also provides the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by manufacturers in the industry, and the analysis of relevant policies in the industry.
Chapter 2: Detailed analysis of Clinical Data Management System company competitive landscape, revenue market share, latest development plan, merger, and acquisition information, etc.
Chapter 3: Provides the analysis of various market segments by Type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter 4: Provides the analysis of various market segments by Application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter 5: Revenue of Clinical Data Management System in regional level. It provides a quantitative analysis of the market size and development potential of each region and introduces the market development, future development prospects, market space, and market size of each country in the world.
Chapter 6: Revenue of Clinical Data Management System in country level. It provides sigmate data by Type, and by Application for each country/region.
Chapter 7: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product revenue, gross margin, product introduction, recent development, etc.
Chapter 8: Analysis of industrial chain, including the upstream and downstream of the industry.
Chapter 9: Conclusion.
Table of Contents
1 Market Overview
- 1.1 Clinical Data Management System Product Introduction
- 1.2 Global Clinical Data Management System Market Size Forecast (2020-2031)
- 1.3 Clinical Data Management System Market Trends & Drivers
- 1.3.1 Clinical Data Management System Industry Trends
- 1.3.2 Clinical Data Management System Market Drivers & Opportunity
- 1.3.3 Clinical Data Management System Market Challenges
- 1.3.4 Clinical Data Management System Market Restraints
- 1.4 Assumptions and Limitations
- 1.5 Study Objectives
- 1.6 Years Considered
2 Competitive Analysis by Company
- 2.1 Global Clinical Data Management System Players Revenue Ranking (2024)
- 2.2 Global Clinical Data Management System Revenue by Company (2020-2025)
- 2.3 Key Companies Clinical Data Management System Manufacturing Base Distribution and Headquarters
- 2.4 Key Companies Clinical Data Management System Product Offered
- 2.5 Key Companies Time to Begin Mass Production of Clinical Data Management System
- 2.6 Clinical Data Management System Market Competitive Analysis
- 2.6.1 Clinical Data Management System Market Concentration Rate (2020-2025)
- 2.6.2 Global 5 and 10 Largest Companies by Clinical Data Management System Revenue in 2024
- 2.6.3 Global Top Companies by Company Type (Tier 1, Tier 2, and Tier 3) & (based on the Revenue in Clinical Data Management System as of 2024)
- 2.7 Mergers & Acquisitions, Expansion
3 Segmentation by Type
- 3.1 Introduction by Type
- 3.1.1 Software
- 3.1.2 Services
- 3.2 Global Clinical Data Management System Sales Value by Type
- 3.2.1 Global Clinical Data Management System Sales Value by Type (2020 VS 2024 VS 2031)
- 3.2.2 Global Clinical Data Management System Sales Value, by Type (2020-2031)
- 3.2.3 Global Clinical Data Management System Sales Value, by Type (%) (2020-2031)
4 Segmentation by Application
- 4.1 Introduction by Application
- 4.1.1 Hospitals
- 4.1.2 CROs
- 4.1.3 Pharma & Biotech Organizations
- 4.1.4 Other
- 4.2 Global Clinical Data Management System Sales Value by Application
- 4.2.1 Global Clinical Data Management System Sales Value by Application (2020 VS 2024 VS 2031)
- 4.2.2 Global Clinical Data Management System Sales Value, by Application (2020-2031)
- 4.2.3 Global Clinical Data Management System Sales Value, by Application (%) (2020-2031)
5 Segmentation by Region
- 5.1 Global Clinical Data Management System Sales Value by Region
- 5.1.1 Global Clinical Data Management System Sales Value by Region: 2020 VS 2024 VS 2031
- 5.1.2 Global Clinical Data Management System Sales Value by Region (2020-2025)
- 5.1.3 Global Clinical Data Management System Sales Value by Region (2026-2031)
- 5.1.4 Global Clinical Data Management System Sales Value by Region (%), (2020-2031)
- 5.2 North America
- 5.2.1 North America Clinical Data Management System Sales Value, 2020-2031
- 5.2.2 North America Clinical Data Management System Sales Value by Country (%), 2024 VS 2031
- 5.3 Europe
- 5.3.1 Europe Clinical Data Management System Sales Value, 2020-2031
- 5.3.2 Europe Clinical Data Management System Sales Value by Country (%), 2024 VS 2031
- 5.4 Asia Pacific
- 5.4.1 Asia Pacific Clinical Data Management System Sales Value, 2020-2031
- 5.4.2 Asia Pacific Clinical Data Management System Sales Value by Region (%), 2024 VS 2031
- 5.5 South America
- 5.5.1 South America Clinical Data Management System Sales Value, 2020-2031
- 5.5.2 South America Clinical Data Management System Sales Value by Country (%), 2024 VS 2031
- 5.6 Middle East & Africa
- 5.6.1 Middle East & Africa Clinical Data Management System Sales Value, 2020-2031
- 5.6.2 Middle East & Africa Clinical Data Management System Sales Value by Country (%), 2024 VS 2031
6 Segmentation by Key Countries/Regions
- 6.1 Key Countries/Regions Clinical Data Management System Sales Value Growth Trends, 2020 VS 2024 VS 2031
- 6.2 Key Countries/Regions Clinical Data Management System Sales Value, 2020-2031
- 6.3 United States
- 6.3.1 United States Clinical Data Management System Sales Value, 2020-2031
- 6.3.2 United States Clinical Data Management System Sales Value by Type (%), 2024 VS 2031
- 6.3.3 United States Clinical Data Management System Sales Value by Application, 2024 VS 2031
- 6.4 Europe
- 6.4.1 Europe Clinical Data Management System Sales Value, 2020-2031
- 6.4.2 Europe Clinical Data Management System Sales Value by Type (%), 2024 VS 2031
- 6.4.3 Europe Clinical Data Management System Sales Value by Application, 2024 VS 2031
- 6.5 China
- 6.5.1 China Clinical Data Management System Sales Value, 2020-2031
- 6.5.2 China Clinical Data Management System Sales Value by Type (%), 2024 VS 2031
- 6.5.3 China Clinical Data Management System Sales Value by Application, 2024 VS 2031
- 6.6 Japan
- 6.6.1 Japan Clinical Data Management System Sales Value, 2020-2031
- 6.6.2 Japan Clinical Data Management System Sales Value by Type (%), 2024 VS 2031
- 6.6.3 Japan Clinical Data Management System Sales Value by Application, 2024 VS 2031
- 6.7 South Korea
- 6.7.1 South Korea Clinical Data Management System Sales Value, 2020-2031
- 6.7.2 South Korea Clinical Data Management System Sales Value by Type (%), 2024 VS 2031
- 6.7.3 South Korea Clinical Data Management System Sales Value by Application, 2024 VS 2031
- 6.8 Southeast Asia
- 6.8.1 Southeast Asia Clinical Data Management System Sales Value, 2020-2031
- 6.8.2 Southeast Asia Clinical Data Management System Sales Value by Type (%), 2024 VS 2031
- 6.8.3 Southeast Asia Clinical Data Management System Sales Value by Application, 2024 VS 2031
- 6.9 India
- 6.9.1 India Clinical Data Management System Sales Value, 2020-2031
- 6.9.2 India Clinical Data Management System Sales Value by Type (%), 2024 VS 2031
- 6.9.3 India Clinical Data Management System Sales Value by Application, 2024 VS 2031
7 Company Profiles
- 7.1 Medidata
- 7.1.1 Medidata Profile
- 7.1.2 Medidata Main Business
- 7.1.3 Medidata Clinical Data Management System Products, Services and Solutions
- 7.1.4 Medidata Clinical Data Management System Revenue (US$ Million) & (2020-2025)
- 7.1.5 Medidata Recent Developments
- 7.2 Oracle
- 7.2.1 Oracle Profile
- 7.2.2 Oracle Main Business
- 7.2.3 Oracle Clinical Data Management System Products, Services and Solutions
- 7.2.4 Oracle Clinical Data Management System Revenue (US$ Million) & (2020-2025)
- 7.2.5 Oracle Recent Developments
- 7.3 IBM
- 7.3.1 IBM Profile
- 7.3.2 IBM Main Business
- 7.3.3 IBM Clinical Data Management System Products, Services and Solutions
- 7.3.4 IBM Clinical Data Management System Revenue (US$ Million) & (2020-2025)
- 7.3.5 IBM Recent Developments
- 7.4 PAREXEL Informatics
- 7.4.1 PAREXEL Informatics Profile
- 7.4.2 PAREXEL Informatics Main Business
- 7.4.3 PAREXEL Informatics Clinical Data Management System Products, Services and Solutions
- 7.4.4 PAREXEL Informatics Clinical Data Management System Revenue (US$ Million) & (2020-2025)
- 7.4.5 PAREXEL Informatics Recent Developments
- 7.5 BioClinica
- 7.5.1 BioClinica Profile
- 7.5.2 BioClinica Main Business
- 7.5.3 BioClinica Clinical Data Management System Products, Services and Solutions
- 7.5.4 BioClinica Clinical Data Management System Revenue (US$ Million) & (2020-2025)
- 7.5.5 BioClinica Recent Developments
- 7.6 Medrio
- 7.6.1 Medrio Profile
- 7.6.2 Medrio Main Business
- 7.6.3 Medrio Clinical Data Management System Products, Services and Solutions
- 7.6.4 Medrio Clinical Data Management System Revenue (US$ Million) & (2020-2025)
- 7.6.5 Medrio Recent Developments
- 7.7 Forte Research Systems
- 7.7.1 Forte Research Systems Profile
- 7.7.2 Forte Research Systems Main Business
- 7.7.3 Forte Research Systems Clinical Data Management System Products, Services and Solutions
- 7.7.4 Forte Research Systems Clinical Data Management System Revenue (US$ Million) & (2020-2025)
- 7.7.5 Forte Research Systems Recent Developments
- 7.8 Taimei Technology
- 7.8.1 Taimei Technology Profile
- 7.8.2 Taimei Technology Main Business
- 7.8.3 Taimei Technology Clinical Data Management System Products, Services and Solutions
- 7.8.4 Taimei Technology Clinical Data Management System Revenue (US$ Million) & (2020-2025)
- 7.8.5 Taimei Technology Recent Developments
- 7.9 Ofni Systems
- 7.9.1 Ofni Systems Profile
- 7.9.2 Ofni Systems Main Business
- 7.9.3 Ofni Systems Clinical Data Management System Products, Services and Solutions
- 7.9.4 Ofni Systems Clinical Data Management System Revenue (US$ Million) & (2020-2025)
- 7.9.5 Ofni Systems Recent Developments
- 7.10 Fortress Medical Systems
- 7.10.1 Fortress Medical Systems Profile
- 7.10.2 Fortress Medical Systems Main Business
- 7.10.3 Fortress Medical Systems Clinical Data Management System Products, Services and Solutions
- 7.10.4 Fortress Medical Systems Clinical Data Management System Revenue (US$ Million) & (2020-2025)
- 7.10.5 Fortress Medical Systems Recent Developments
- 7.11 OpenClinica
- 7.11.1 OpenClinica Profile
- 7.11.2 OpenClinica Main Business
- 7.11.3 OpenClinica Clinical Data Management System Products, Services and Solutions
- 7.11.4 OpenClinica Clinical Data Management System Revenue (US$ Million) & (2020-2025)
- 7.11.5 OpenClinica Recent Developments
- 7.12 ClinCapture
- 7.12.1 ClinCapture Profile
- 7.12.2 ClinCapture Main Business
- 7.12.3 ClinCapture Clinical Data Management System Products, Services and Solutions
- 7.12.4 ClinCapture Clinical Data Management System Revenue (US$ Million) & (2020-2025)
- 7.12.5 ClinCapture Recent Developments
8 Industry Chain Analysis
- 8.1 Clinical Data Management System Industrial Chain
- 8.2 Clinical Data Management System Upstream Analysis
- 8.2.1 Key Raw Materials
- 8.2.2 Raw Materials Key Suppliers
- 8.2.3 Manufacturing Cost Structure
- 8.3 Midstream Analysis
- 8.4 Downstream Analysis (Customers Analysis)
- 8.5 Sales Model and Sales Channels
- 8.5.1 Clinical Data Management System Sales Model
- 8.5.2 Sales Channel
- 8.5.3 Clinical Data Management System Distributors
9 Research Findings and Conclusion
10 Appendix
- 10.1 Research Methodology
- 10.1.1 Methodology/Research Approach
- 10.1.1.1 Research Programs/Design
- 10.1.1.2 Market Size Estimation
- 10.1.1.3 Market Breakdown and Data Triangulation
- 10.1.2 Data Source
- 10.1.2.1 Secondary Sources
- 10.1.2.2 Primary Sources
- 10.1.1 Methodology/Research Approach
- 10.2 Author Details
- 10.3 Disclaimer
