세계의 임상시험 관리 시스템 시장 보고서(2025년)
Clinical Trial Management System Global Market Report 2025
상품코드 : 1824360
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

임상시험 관리 시스템 시장 규모는 향후 수년간 급성장할 것으로 전망됩니다. 2029년에는 CAGR 13.2%로 36억 9,000만 달러로 성장할 것으로 예상됩니다. 예측기간의 성장은 환자 중심의 임상검사의 중시, 리스크 기반 모니터링의 도입, 정밀의료의 성장, 적응적 검사 설계의 도입, 임상검사 업무의 아웃소싱 증가, 임상검사에 있어서의 모바일 헬스(m 헬스)의 통합, 클라우드 기반 CTMS 솔루션의 도입, 데이터의 표준화와 상호 운용성의 중시 등에 기인하는 것으로 예측됩니다. 예측 기간 중 주요 동향으로는 IT 기술의 진보, 실시간 데이터 액세스 및 관리, CTMS의 인공지능 통합, 데이터 보안을 위한 블록체인 활용, 제약기업과 CRO의 연계 등을 들 수 있습니다.

향후 5년간의 성장률 13.2%라고 하는 예측은 전회 예측으로부터 0.2%의 소폭 감소를 반영하고 있습니다. 이 감소는 주로 미국과 다른 국가 간의 관세의 영향 때문입니다. 무역마찰은 인도와 에스토니아에서 개발된 클라우드 기반 임상시험 관리 시스템(CTMS) 플랫폼과 리스크 기반 모니터링 툴의 가격을 늘려 검사 모니터링 능력의 저하와 운영 비용의 상승을 초래하여 미국의 연구 효율을 저해할 수 있습니다. 또한 상호관세와 무역의 긴장과 한계 증가로 인한 세계 경제와 무역에 대한 악영향으로 인해 그 영향이 보다 광범위하게 이어질 수 있습니다.

임상시험 관리 시스템 시장의 성장은 임상 검사 증가에 의해 견인될 것으로 예측됩니다. 이러한 임상 검사는 새로운 치료, 개입, 약물의 안전성, 효능 및 잠재적 이익을 평가하기 위해 인간을 대상으로 실시되는 조사 연구입니다. 임상시험 관리 시스템(Clinical Trials Management Systems: CTMS)은 이러한 임상검사의 관리를 합리화 및 원활화하기 위해 설계된 특수 소프트웨어 플랫폼입니다. 미국 국립보건실(NIH)의 일부문인 ClinicalTrials.gov의 데이터로부터 등록된 임상검사수가 2022년 39만 9,499건에서 미국 전 50주와 221개국에서 43만 7,533건으로 증가하고 있음이 밝혀졌습니다. 이 중 140,492개 검사(31%)가 미국에서 등록되었고, 241,498개 검사(53%)가 미국 이외에서 실시되었습니다. 따라서 임상검사 수 증가가 임상시험 관리 시스템 시장의 성장을 가속할 것으로 예측됩니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역전쟁과 관세, 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, 전략

제36장 부록

SHW
영문 목차

영문목차

A clinical trial management system (CTMS) is a software system utilized by the biotechnology and pharmaceutical industries for the management of clinical trials in clinical research. It serves as a comprehensive solution to centralize, organize, and automate various aspects of the clinical trial process, facilitating efficient study planning, execution, monitoring, and reporting.

The primary types of clinical trial management systems include enterprise-based and site-based systems. An enterprise-based CTMS is a software solution implemented and operated across an entire organization or enterprise, providing a centralized platform for managing all clinical trials conducted by the organization. The components of a clinical trial management system encompass software, services, and hardware, delivered in cloud-based, web-based, and on-premises modes for use by pharmaceutical and biopharmaceutical companies, medical device manufacturers, clinical research organizations (CROs), and other relevant entities.

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 sharp rise in U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the healthcare sector, especially in the supply of essential medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are grappling with higher costs for imported surgical tools, imaging systems, and consumables like syringes and catheters, many of which have limited domestic substitutes. These escalating expenses are putting pressure on healthcare budgets, prompting some providers to delay equipment upgrades or pass increased costs on to patients. Furthermore, tariffs on raw materials and components are disrupting the manufacturing of vital drugs and devices, leading to supply chain delays. In response, the industry is adopting diversified sourcing strategies, expanding local production where feasible, and pushing for tariff exemptions on critical medical products.

The clinical trials management system research report is one of a series of new reports from The Business Research Company that provides clinical trials management system market statistics, including the clinical trials management system's global market size, regional shares, competitors with a clinical trials management system market share, detailed clinical trials management system market segments, market trends and opportunities, and any further data you may need to thrive in the clinical trials management system. This clinical trials management system 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 clinical trial management system market size has grown rapidly in recent years. It will grow from $1.98 billion in 2024 to $2.25 billion in 2025 at a compound annual growth rate (CAGR) of 13.1%. The growth in the historic period can be attributed to increase in clinical trial complexity, growing globalization of clinical trials, rise in clinical trial volume, adoption of electronic data capture (etc), demand for cost and time-efficient trials.

The clinical trial management system market size is expected to see rapid growth in the next few years. It will grow to $3.69 billion in 2029 at a compound annual growth rate (CAGR) of 13.2%. The growth in the forecast period can be attributed to emphasis on patient-centric clinical trials, adoption of risk-based monitoring, growth in precision medicine, introduction of adaptive trial designs, increased outsourcing of clinical trial operations, mobile health (mhealth) integration in clinical trials, implementation of cloud-based CTMS solutions, focus on data standardization and interoperability. Major trends in the forecast period include advances in information technology, real-time data access and management, integration of artificial intelligence in CTMS, utilization of blockchain for data security, collaboration between pharma companies and CROs.

The forecast of 13.2% growth over the next five years reflects a slight reduction of 0.2% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. Trade tensions could hinder U.S. research efficiency by inflating prices of cloud-based Clinical Trial Management System(CTMS) platforms and risk-based monitoring tools developed in India and Estonia, resulting in reduced trial oversight capabilities and higher operational costs. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.

The growth of the clinical trial management system market is anticipated to be driven by the increasing number of clinical trials. These trials involve research studies conducted on human participants to assess the safety, effectiveness, and potential benefits of new medical treatments, interventions, or drugs. Clinical Trials Management Systems (CTMS) are specialized software platforms designed to streamline and facilitate the management of these clinical trials. Notably, data from ClinicalTrials.gov, a component of the National Institutes of Health (NIH), revealed a rise in registered clinical trial studies from 399,499 in 2022 to 437,533 across all 50 states in the United States and 221 countries. Of these, 140,492 studies (31%) were registered in the U.S., and 241,498 studies (53%) were conducted in non-U.S. locations. Therefore, the increasing number of clinical trials is expected to propel the growth of the clinical trial management system market.

The growth of the clinical trial management system market is further expected to be boosted by the increasing healthcare expenditure. Healthcare expenditure refers to the total amount of money spent on healthcare goods and services within a specified time frame, encompassing spending by individuals, communities, or governments. As healthcare budgets expand, there is a corresponding increase in resources allocated to clinical research, resulting in a surge in the number of conducted clinical trials. This heightened demand for robust CTMS is driven by the need to manage the intricate logistics and data associated with these trials. According to the 2021-2030 National Health Expenditure (NHE) report by the Centers for Medicare & Medicaid Services, national health spending is projected to increase by an average of 5.1% annually between 2021 and 2030, reaching nearly $6.8 trillion. During the same period, Medicare spending is expected to rise at a 7.2% annual pace, while Medicaid spending will increase at a 5.6% annual rate. Thus, the increasing healthcare expenditure is a key driver of the growth of the clinical trial management system market.

A significant trend in the clinical trial management system market is the focus on technological advancements by major companies. These companies are actively involved in developing innovative product technologies to strengthen their market positions. For instance, Saama Technologies, Inc., a U.S.-based provider of clinical development software and services, launched a unified platform of Software as a Service (SaaS)-based products in June 2023. This platform complements existing artificial intelligence and machine learning-based solutions, facilitating faster clinical development and commercialization. It automates critical clinical trial management processes, reducing query generation times by up to 90% and achieving substantial time savings in study data transformation and analysis. The platform provides a comprehensive view of trial operations and patient progress in a single location.

Major companies in the clinical trial management system market are prioritizing the development of technologically innovative solutions, such as clinical trial technology platforms, to streamline trial processes, improve data accuracy, and ensure regulatory compliance. A clinical trial technology platform is a comprehensive digital ecosystem designed to manage and simplify the complex processes involved in clinical trials. For example, in June 2024, IQVIA, a US-based health information technology company, launched the One Home for Sites platform, a holistic technology solution intended to streamline clinical trial management by integrating multiple applications into a single sign-on dashboard. This platform alleviates the administrative burdens faced by clinical research sites, enabling staff to concentrate more on patient care and recruitment while efficiently managing multiple trials. The platform aims to enhance operational efficiency, accelerate trial processes, and ultimately increase the availability of new treatments for patients.

In July 2023, RealTime Software Solutions, LLC, a US-based company and leading provider of cloud-based software solutions, acquired Devana Solutions, LLC, for an undisclosed amount. This acquisition is strategically aimed at leveraging complementary technologies to enhance clinical trial processes, improve operational efficiencies, and better support both researchers and participants. Devana Solutions, LLC is a US-based cloud software company specializing in clinical trial workflow and analytics.

Major companies operating in the clinical trial management system market include International Business Machines Corporation, Oracle Corporation, Cognizant Technology Solutions India Private Limited, Laboratory Corporation of America Holdings, Wipro Limited, Veeva Systems Inc, Medidata Solutions, BioClinica Inc., Calyx, Clario, Advarra Inc, ArisGlobal LLC, MasterControl Solutions Inc., Medrio Inc., Anju Software Inc., Forte Research System Inc, Cmed Clinical Services, OmniComm Systems Inc., MedNet Solutions Inc., DSG Inc., eClinical Solutions LLC, Bioclinical Partners (BCP), Flex Databases, DataTrak International Inc., OpenClinica LLC, SimpleTrials, PHARMASEAL International Ltd, Dacima Software Inc., RealTime Software Solutions LLC

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

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

The clinical trials management system market consists of revenues earned by entities by providing Web-based clinical trials management system, End-to-end clinical trials management system, Integrated clinical trials management system, and Cloud-based clinical trials management system. The market value includes the value of related goods sold by the service provider or included within the service offering. The clinical trials management system market also includes sales of clinical trial analytics tools, scanners, printers, and electronic data capture devices that are used in providing clinical trials management services. 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.

Clinical Trial Management System 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 clinical trial management system 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 clinical trial management system ? 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 clinical trial management system 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. Clinical Trial Management System Market Characteristics

3. Clinical Trial Management System Market Trends And Strategies

4. Clinical Trial Management System 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 Clinical Trial Management System Growth Analysis And Strategic Analysis Framework

6. Clinical Trial Management System Market Segmentation

7. Clinical Trial Management System Market Regional And Country Analysis

8. Asia-Pacific Clinical Trial Management System Market

9. China Clinical Trial Management System Market

10. India Clinical Trial Management System Market

11. Japan Clinical Trial Management System Market

12. Australia Clinical Trial Management System Market

13. Indonesia Clinical Trial Management System Market

14. South Korea Clinical Trial Management System Market

15. Western Europe Clinical Trial Management System Market

16. UK Clinical Trial Management System Market

17. Germany Clinical Trial Management System Market

18. France Clinical Trial Management System Market

19. Italy Clinical Trial Management System Market

20. Spain Clinical Trial Management System Market

21. Eastern Europe Clinical Trial Management System Market

22. Russia Clinical Trial Management System Market

23. North America Clinical Trial Management System Market

24. USA Clinical Trial Management System Market

25. Canada Clinical Trial Management System Market

26. South America Clinical Trial Management System Market

27. Brazil Clinical Trial Management System Market

28. Middle East Clinical Trial Management System Market

29. Africa Clinical Trial Management System Market

30. Clinical Trial Management System Market Competitive Landscape And Company Profiles

31. Clinical Trial Management System Market Other Major And Innovative Companies

32. Global Clinical Trial Management System Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Clinical Trial Management System Market

34. Recent Developments In The Clinical Trial Management System Market

35. Clinical Trial Management System Market High Potential Countries, Segments and Strategies

36. Appendix

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