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시장보고서
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1304482

세계의 임상시험 관리 시스템 시장(2023-2030년)

Global Clinical Trial Management System Market -2023-2030
발행일: | 리서치사: DataM Intelligence | 페이지 정보: 영문 195 Pages | 배송안내 : 1-2일 (영업일 기준)

    
    
    




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시장 개요

임상시험 관리 시스템 세계 시장은 2022년 15억 달러, 2030년에는 42억 달러에 달할 것으로 예상되며, 수익성 있는 성장이 예상됩니다. 세계 임상시험 관리 시스템 시장은 예측 기간(2023-2030) 동안 14.6%의 CAGR을 보일 것으로 예상됩니다.

임상시험 관리 시스템(CTMS)은 임상시험의 관리 및 조정을 지원하기 위해 개발된 소프트웨어 솔루션으로, 임상시험의 설계, 수행, 추적, 임상시험 데이터 관리 및 분석을 위한 중앙 집중식 플랫폼을 제공합니다. 임상 연구에서 CTMS의 중요성은 아무리 강조해도 지나치지 않습니다.

임상시험은 자원이 많이 소요되는 작업이므로 적절한 자원 관리가 매우 중요하며, CTMS는 연구팀이 비용을 추적하고, 시험기관에 대한 지불을 추적하고, 계약을 관리하고, 자원 배분을 최적화할 수 있도록함으로써 예산 책정, 재무 추적 및 자원 관리를 지원합니다.

시장 역학

다양한 만성질환의 확산이 시장 성장을 주도

많은 만성 질환이 사람들 사이에 만연함에 따라 주요 시장 진입 기업의 임상시험 및 연구 프로그램에 대한 요구가 증가함에 따라 임상시험 관리 시스템을 사용하여 관리해야 할 필요성이 증가하고 있습니다.

예를 들어, WHO에 따르면 NCD로 인한 사망의 대부분(연간 1,800만 명)을 심혈관 질환이 차지하고 있으며, 악성 종양(950만 명), 만성 호흡기 질환(430만 명), 당뇨병(당뇨병 관련 신장 질환 사망자 포함 250만 명)이 그 뒤를 잇고 있습니다. 이 네 가지 질병군은 NCD로 인한 조기 사망자의 80% 이상을 차지합니다. 결과적으로 질병은 증가 추세에 있으며, 이는 시장 성장을 견인하고 있습니다.

주요 기업의 투자와 전략으로 시장 성장 촉진

주요 기업들의 투자와 전략이 시장 성장에 기여하고 있습니다. 예를 들어, 2022년 12월 7일, 클라우드 기반 임상연구 소프트웨어 솔루션의 선구자인 RealTime Software Solutions, LLC는 임상연구기관, 학술의료센터(AMC), 병원, 의료 시스템, 스폰서, 임상시험수탁기관(CRO) 를 위한 전자 규제(eReg)/전자 임상시험 시설 파일(eISF) 솔루션의 선도적 제공업체인 컴플라이언(Complion, Inc.)을 인수한다고 발표했습니다.

또한, 2022년 4월 11일, 통합적인 기능을 갖추고 빠르게 확장하고 있는 임상 연구 개발 솔루션 제공업체인 Cloudbyz는 바이오의약품, 백신, 의료기기, 화장품, 건강보조식품, 소비재 고객에게 고품질 원스톱 서비스를 제공하는 데 특화되어 있는 전문화된 세계 풀서비스 임상 CRO인 ClinChoice와의 제휴를 발표했습니다. 이에 따라 최근 주요 경쟁사들의 주요 전략이 시장 확대에 힘을 실어줄 것으로 보입니다.

고가의 임상시험 관리 시스템 비용이 시장 성장의 걸림돌

임상시험 관리 시스템과 관련된 높은 비용은 시장 확대를 저해합니다. 조달, 설치, 유지보수가 모두 CTMS 솔루션 도입의 총비용을 증가시킵니다. 설치 비용은 온-프레미스 및 SaaS 솔루션 모두에 포함됩니다.

기업은 자체 조직 및 연구별 요구 사항에 따라 설정 및 커스터마이징에 대한 추가 요금이 부과됩니다. 또한, 사용자 수와 위치 수에 따라 여러 가지 가격 체계가 존재합니다. 이러한 요인들은 시장 성장에 걸림돌이 될 것으로 보입니다.

COVID-19 영향 분석

COVID-19 사태로 인해 의약품 임상시험의 중요성이 부각되었습니다. 한마디로 임상시험은 의약품, 수술, 행동 중재 등을 평가하기 위해 개인을 대상으로 실시하는 조사다.

임상시험은 새로운 약물, 식이요법, 의료기기(심박조율기 등)와 같은 새로운 치료법이 인간에게 안전하고 효과적인지 여부를 연구자들이 판단하기 위한 1차 연구입니다. 임상시험은 새로운 치료법이 더 성공적인지, 그리고/또는 기존 치료법보다 부작용이 적은지 여부를 판단하기 위해 자주 실시됩니다.

러시아-우크라이나 분쟁 영향 분석

러시아-우크라이나 분쟁은 이 지역의 주요 시장 참여자 수가 적기 때문에 세계 임상시험 관리 시스템 시장에 미치는 영향은 미미할 것으로 추정됩니다. 그러나 원자재 수입 및 수출의 영향은 예측 기간 동안 세계 임상시험 관리 시스템 시장의 성장에 거의 영향을 미치지 않을 것으로 예상됩니다.

인공지능의 영향 분석

인공지능이 탑재된 기기와 웨어러블은 임상시험 중 실시간으로 환자 데이터를 수집할 수 있기 때문에 인공지능이 긍정적인 영향을 미칠 것으로 예상됩니다. 이 데이터는 AI 알고리즘에 의해 분석되어 환자의 건강 상태를 모니터링하고, 부작용의 초기 징후를 감지하고, 프로토콜 준수를 보장할 수 있으며, AI는 개인화된 알림, 교육 자료 및 가상 지원을 제공하여 환자 참여를 촉진할 수 있습니다.

목차

제1장 조사 방법과 조사 범위

제2장 정의와 개요

제3장 주요 요약

제4장 시장 역학

  • 영향요인
    • 성장 촉진요인
      • 임상시험 증가
      • 주요 기업에 의한 투자와 전략
    • 성장 억제요인
      • 숙련된 전문가 부족
    • 기회
      • 전자 데이터 캡처(EDC) 시스템과 eClinical 솔루션 채용
    • 영향 분석

제5장 산업 분석

  • Porter's 5 Force 분석
  • 공급망 분석
  • 미충족 수요
  • 규제 분석

제6장 COVID-19 분석

제7장 러시아·우크라이나 전쟁 분석

제8장 인공지능의 영향 분석

제9장 유형별

  • 온사이트 CTMS
  • 전사 CTMS

제10장 전개별

  • 웹 기반
  • 온프레미스
  • 클라우드 기반

제11장 컴포넌트별

  • 소프트웨어
  • 서비스

제12장 최종사용자별

  • 제약·바이오테크놀러지 기업
  • CRO
  • 조사 병원
  • 기타

제13장 지역별

  • 북미
    • 미국
    • 캐나다
    • 멕시코
  • 유럽
    • 독일
    • 영국
    • 프랑스
    • 이탈리아
    • 스페인
    • 기타 유럽
  • 남미
    • 브라질
    • 아르헨티나
    • 기타 남미
  • 아시아태평양
    • 중국
    • 인도
    • 일본
    • 호주
    • 기타 아시아태평양
  • 중동 및 아프리카

제14장 경쟁 상황

  • 경쟁 시나리오
  • 시장 점유율 분석
  • M&A 분석

제15장 기업 개요

  • Oracle
    • 기업 개요
    • 제품 포트폴리오와 개요
    • 재무 개요
    • 주요 발전
  • IQVIA Inc.
  • RealTime Software Solutions, LLC
  • Bio-Optronics
  • Medidata(Dassault Systemes)
  • BioClinica
  • Clario
  • Forte Research Systems
  • SimpleTrials
  • Calyx.

제16장 부록

ksm 23.07.28

Market Overview

The Global Clinical Trial Management System Market reached US$ 1.5 billion in 2022 and is projected to witness lucrative growth by reaching up to US$ 4.2 billion by 2030. The global clinical trial management system market is expected to exhibit a CAGR of 14.6% during the forecast period (2023-2030).

A Clinical Trial Management System (CTMS) is a software solution developed to help with clinical trial management and coordination. It provides a centralized platform for clinical trial design, execution, and tracking, as well as trial data management and analysis. The significance of a CTMS in clinical research cannot be emphasized.

Clinical trials are resource-intensive endeavors, and good resource management is critical. CTMS aids in budgeting, financial tracking, and resource management by enabling research teams to track expenses, track payments to sites, manage contracts and optimize resource allocation.

Market Dynamics

The Prevalence of a Number of Chronic Diseases will Drive The Market Growth

The prevalence of a number of chronic diseases among people has increased the need for clinical trials and research programs to be carried out by major market players and managed using clinical trial management systems.

For instance, according to WHO, cardiovascular illnesses account for the majority of NCD mortality, or 18 million people per year, followed by malignancies (9.5 million), chronic respiratory diseases (4.3 million), and diabetes (2.5 million including diabetes-related kidney disease deaths). These four disease groups account for more than 80% of all premature NCD fatalities. As a result, diseases are on the rise, which serves to boost the market.

Investments And Strategies by the Key Players Help to Drive the Market Growth

Key firms' investments and strategies contribute to market growth. For instance, on December 07, 2022, RealTime Software Solutions, LLC, a pioneer in cloud-based clinical research software solutions, announced the acquisition of Complion, Inc., a leading provider of electronic regulatory (eReg)/electronic Investigator Site Files (eISF) solutions for clinical research sites, academic medical centers (AMCs), hospitals, health systems, sponsors, and contract research organizations (CROs).

Additionally, on April 11, 2022, Cloudbyz, a rapidly expanding integrated clinical research and development solution provider with integrated capabilities, announced a collaboration with ClinChoice, a global full-service clinical CRO dedicated to providing high-quality one-stop service to biopharmaceutical, vaccine, medical device, cosmetics, nutraceuticals, and consumer products clients. As a result, recent major strategies by key competitors will fuel market expansion.

High Cost of Clinical Trial Management System Hamper the Market Growth

The high costs associated with clinical trial management systems stifle market expansion. Procurement, installation, and maintenance all add to the overall cost of implementing CTMS solutions. Installation fees are included in both on-premise and SaaS-based solutions.

Companies are charged additional setup and customization fees based on their unique organizational and study-specific requirements. There are several pricing structures found depending on the number of users and the number of locations under consideration. Those factors will hamper the market growth.

COVID-19 Impact Analysis

The COVID-19 epidemic has highlighted the significance of clinical trials for medicinal remedies. In a nutshell, clinical trials are research investigations conducted in individuals with the goal of evaluating a medicinal, surgical, or behavioural intervention.

They are the primary means by which researchers determine whether a novel treatment, such as a new medicine, diet, or medical equipment (such as a pacemaker), is safe and effective in humans. A clinical trial is frequently performed to determine whether a novel treatment is more successful and/or has fewer harmful side effects than the treatment.

Russia-Ukraine War Impact Analysis

The Russia-Ukraine conflict is estimated to have a moderate impact on the global clinical trial management system market, owing to the low number of key market players in this region. However, the impact of the import and export of raw materials is expected to have little influence over the global clinical trial management system market growth over the forecast period.

Artificial Intelligence Impact Analysis

Artificial intelligence is anticipated to impact positively as AI-powered devices and wearables can collect real-time patient data during clinical trials. This data can be analyzed by AI algorithms to monitor patient health, detect early signs of adverse events, and ensure protocol compliance. AI can also facilitate patient engagement by providing personalized reminders, educational materials, and virtual support.

Segment Analysis

The global clinical trial management system market is segmented based on type, mode of delivery, component, end user and region.

Pharmaceuticals & Biotechnology Companies from End-user Segment Accounts for 41.3% of Market Share

Due to the increased demand for new solutions to treat chronic ailments, pharmaceutical and biotechnology companies have the biggest market share. The rising prevalence of coronavirus is driving up demand for clinical trial management systems in pharmaceutical and biotech companies.

For instance, on December 06, 2022, Medidata, a Dassault Systemes subsidiary, introduced a new patient-centric native myMedidata app, which is intended to give trial participants another alternative for a seamless platform experience and a single login for all of their remote trial activities. The app will include all of myMedidata's patient-centric solutions, with a focus on eCOA (electronic clinical outcome assessments) at first. The myMedidata app is available for both iOS and Android and may be used on either the patient's own device (BYOD) or a supplied device.

Geographical Analysis

North America Accounted for Approximately 40.7% of the Market Share

Pharmaceutical companies' R&D expenses in the region have also expanded in recent years, owing to a greater emphasis on regulating markets, complicated compounds, and therapy segments. Pharmaceutical companies in the United States spend more money, time, and energy on research and development than others.

According to the 2021 PhRMA Annual Membership Survey, the total amount spent on R&D by its member companies in 2020 was USD 91 billion. As a result, the region's increased research and development activities and clinical trials are likely to drive market expansion for clinical trial management systems.

Competitive Landscape

The major global players in the clinical trial management system market include: Oracle, IQVIA Inc., RealTime Software Solutions, LLC, Bio-Optronics, Medidata (Dassault Systemes), BioClinica, Clario, Forte Research Systems, SimpleTrials, and Calyx among others.

Why Purchase the Report?

  • To visualize the global clinical trial management system market segmentation based on type, mode of delivery, component, end user and region, as well as understand key commercial assets and players.
  • Identify commercial opportunities by analyzing trends and co-development.
  • Excel data sheet with numerous data points of clinical trial management system market-level with all segments.
  • PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
  • Product mapping available as Excel consisting of key products of all the major players.

The global clinical trial management system market report would provide approximately 53 tables, 54 figures and 195 pages.

Target Audience 2023

  • Manufacturers/ Buyers
  • Industry Investors/Investment Bankers
  • Research Professionals
  • Emerging Companies

Table of Contents

1. Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

  • 3.1. Snippet by Type
  • 3.2. Snippet by Mode of Delivery
  • 3.3. Snippet by Component
  • 3.4. Snippet by End User
  • 3.5. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Rising clinical trials will drive the market growth
      • 4.1.1.2. Investments and strategies by the key players
    • 4.1.2. Restraints
      • 4.1.2.1. Lack of skilled professionals
    • 4.1.3. Opportunity
      • 4.1.3.1. The adoption of Electronic Data Capture (EDC) systems and eClinical solutions
    • 4.1.4. Impact Analysis

5. Industry Analysis

  • 5.1. Porter's 5 Forces Analysis
  • 5.2. Supply Chain Analysis
  • 5.3. Unmet Needs
  • 5.4. Regulatory Analysis

6. COVID-19 Analysis

  • 6.1. Analysis of COVID-19
    • 6.1.1. Scenario before COVID-19
    • 6.1.2. Scenario during COVID-19
    • 6.1.3. Scenario Post COVID-19
  • 6.2. Pricing Dynamics Amid COVID-19
  • 6.3. Demand-Supply Spectrum
  • 6.4. Government Initiatives Related to the Market During the Pandemic
  • 6.5. Manufacturers' Strategic Initiatives
  • 6.6. Conclusion

7. Russia-Ukraine War Analysis

8. Artificial Intelligence Impact Analysis

9. By Type

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 9.1.2. Market Attractiveness Index, By Type
  • 9.2. On-Site CTMS
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Enterprise-wide CTMS

10. By Mode of Delivery

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode of Delivery
    • 10.1.2. Market Attractiveness Index, By Mode of Delivery
  • 10.2. Web-based
    • 10.2.1. Introduction
    • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 10.3. On-premise
  • 10.4. Cloud-based

11. By Component

  • 11.1. Introduction
    • 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Component
    • 11.1.2. Market Attractiveness Index, By Component
  • 11.2. Software
    • 11.2.1. Introduction
    • 11.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 11.3. Services

12. By End User

  • 12.1. Introduction
    • 12.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 12.1.2. Market Attractiveness Index, By End User
  • 12.2. Pharmaceuticals & Biotechnology Companies
    • 12.2.1. Introduction
    • 12.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 12.3. CROs
  • 12.4. Research Hospitals
  • 12.5. Others

13. By Region

  • 13.1. Introduction
    • 13.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 13.1.2. Market Attractiveness Index, By Region
  • 13.2. North America
    • 13.2.1. Introduction
    • 13.2.2. Key Region-Specific Dynamics
    • 13.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 13.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode of Delivery
    • 13.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Component
    • 13.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 13.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 13.2.7.1. The U.S.
      • 13.2.7.2. Canada
      • 13.2.7.3. Mexico
  • 13.3. Europe
    • 13.3.1. Introduction
    • 13.3.2. Key Region-Specific Dynamics
    • 13.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 13.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode of Delivery
    • 13.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Component
    • 13.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 13.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 13.3.7.1. Germany
      • 13.3.7.2. The U.K.
      • 13.3.7.3. France
      • 13.3.7.4. Italy
      • 13.3.7.5. Spain
      • 13.3.7.6. Rest of Europe
  • 13.4. South America
    • 13.4.1. Introduction
    • 13.4.2. Key Region-Specific Dynamics
    • 13.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 13.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode of Delivery
    • 13.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Component
    • 13.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 13.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 13.4.7.1. Brazil
      • 13.4.7.2. Argentina
      • 13.4.7.3. Rest of South America
  • 13.5. Asia-Pacific
    • 13.5.1. Introduction
    • 13.5.2. Key Region-Specific Dynamics
    • 13.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 13.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode of Delivery
    • 13.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Component
    • 13.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 13.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 13.5.7.1. China
      • 13.5.7.2. India
      • 13.5.7.3. Japan
      • 13.5.7.4. Australia
      • 13.5.7.5. Rest of Asia-Pacific
  • 13.6. Middle East and Africa
    • 13.6.1. Introduction
    • 13.6.2. Key Region-Specific Dynamics
    • 13.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
    • 13.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Mode of Delivery
    • 13.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Component
    • 13.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

14. Competitive Landscape

  • 14.1. Competitive Scenario
  • 14.2. Market Share Analysis
  • 14.3. Mergers and Acquisitions Analysis

15. Company Profiles

  • 15.1. Oracle
    • 15.1.1. Company Overview
    • 15.1.2. Type Portfolio and Description
    • 15.1.3. Financial Overview
    • 15.1.4. Key Developments
  • 15.2. IQVIA Inc.
  • 15.3. RealTime Software Solutions, LLC
  • 15.4. Bio-Optronics
  • 15.5. Medidata (Dassault Systemes)
  • 15.6. BioClinica
  • 15.7. Clario
  • 15.8. Forte Research Systems
  • 15.9. SimpleTrials
  • 15.10. Calyx.

LIST NOT EXHAUSTIVE

16. Appendix

  • 16.1. About Us and Services
  • 16.2. Contact Us
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