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세계의 전자 임상시험 마스터 파일(eTMF) 시스템 시장 보고서(2025년)
Electronic Trial Master File (eTMF) Systems Global Market Report 2025
상품코드 : 1824655
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

전자 임상시험 마스터 파일(eTMF) 시스템 시장 규모는 향후 수년간 급성장할 것으로 전망됩니다. 2029년에는 CAGR 11.6%를 나타내 24억 달러로 성장할 전망입니다. 예측 기간의 성장은 전자차단(eTMF)과의 통합, 임상시험의 급성장, 환자 중심의 시험에 대한 주력, 실시간 모니터링과 리포팅의 중시 등에 기인한다고 생각됩니다. 예측 기간의 주요 동향으로는 AI를 탑재한 eTMF 시스템 수요 증가, 데이터 분석 및 통찰에 대한 주목 증가, 환자 중심의 임상시험의 중요성 증가, 클라우드 기반의 eTMF 솔루션의 채용 등이 있습니다.

향후 5년간의 성장률 11.6%라고 하는 예측은 전회 예측으로부터 0.2%의 소폭의 감소를 반영하고 있습니다. 이 감소는 주로 미국과 다른 국가 간의 관세의 영향 때문입니다. 관세 장벽은 네덜란드나 프랑스에서 개발된 문서 관리 플랫폼 및 감사 추적 소프트웨어의 비용을 증가시키고 임상시험의 운영 비용을 증가시켜 규정 준수를 방해할 수 있습니다. 또한 상호관세와 무역의 긴장과 한계 증가로 인한 세계경제와 무역에 대한 악영향으로 인해 그 영향이 더욱 광범위해질 것으로 보입니다.

임상시험 건수 증가는 전자 임상시험 마스터 파일(eTMF) 시스템 시장의 향후 성장을 가속할 것으로 예측됩니다. 임상시험은 인간의 의료 개입, 치료, 치료의 안전성, 효능 및 효능을 평가하기 위해 수행되는 체계적인 조사 및 연구입니다. 이러한 임상시험은 신약, 치료법, 의료기기, 개입이 특정 환자 집단에 사용하기에 안전하고 효과적인지 여부를 결정하기 위한 신뢰할 수 있는 데이터와 증거를 얻기 위한 것입니다. 임상시험의 급증은 전자 임상시험 마스터 파일(eTMF) 시스템의 보급과 밀접한 관련이 있습니다. 임상 연구의 양과 복잡성이 확대되는 가운데, eTMF 시스템은 문서화 프로세스를 간소화하고, 규제 규정 준수를 보장하고, 이해관계자간의 효율적인 협업을 촉진하는데 매우 중요한 역할을 하고 있습니다. 예를 들어 영국의 산업단체인 영국제약공업협회가 2023년 11월에 발표한 보고서에 따르면 임상시험의 총수는 2022년에 411시험, 2021년에 394시험으로 증가했습니다. 영국의 제약업계 임상시험에 대한 연간 참가자 수는 2022-2023년에는 연간 5,366명 증가한 4만 2,088명이었습니다. 따라서 임상시험 증가는 전자 임상시험 마스터 파일(eTMF) 시스템 시장 성장을 가속할 것으로 예측됩니다.

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

KTH
영문 목차

영문목차

An electronic trial master file (eTMF) is a trial master file in electronic or digital format, serving as a content management system for the pharmaceutical industry. The eTMF system manages, stores, tracks, and archives essential clinical study documents electronically. It is designed to ensure compliance with regulatory requirements, such as the FDA's Title 21 CFR Part 11, and to provide a secure, centralized, and easily accessible repository for clinical trial documents.

The main components of electronic trial master file (eTMF) systems are services and services. The electronic trial master file (eTMF) system services refer to functionalities or features provided by the eTMF system to support the management of clinical trial documentation in electronic format. It is delivered on-premise and cloud-based and used in pharmaceutical and biotechnology companies, contract research organizations, and other users.

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 main components of electronic trial master file (eTMF) systems are services and services. The electronic trial master file (eTMF) system services refer to functionalities or features provided by the eTMF system to support the management of clinical trial documentation in electronic format. It is delivered on-premise and cloud-based and used in pharmaceutical and biotechnology companies, contract research organizations, and other users.

The electronic trial master file (etmf) systems market size has grown rapidly in recent years. It will grow from $1.36 billion in 2024 to $1.55 billion in 2025 at a compound annual growth rate (CAGR) of 13.6%. The growth in the historic period can be attributed to increasing regulatory compliance requirements, rise in clinical trial complexity, globalization of clinical trials, paper-based document challenges, and increasing emphasis on data quality and integrity.

The electronic trial master file (etmf) systems market size is expected to see rapid growth in the next few years. It will grow to $2.4 billion in 2029 at a compound annual growth rate (CAGR) of 11.6%. The growth in the forecast period can be attributed to integration with electronic health records (eTMF), rapid growth in clinical trials, focus on patient-centric trials, and emphasis on real-time monitoring and reporting. Major trends in the forecast period include growing demand for AI-powered eTMF systems, increasing focus on data analytics and insights, growing importance of patient-centric trials, and adoption of cloud-based eTMF solutions.

The forecast of 11.6% 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. Tariff barriers could hamper regulatory compliance by increasing costs for document management platforms and audit trail software developed in the Netherlands and France, elevating clinical trial 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 increase in the number of clinical trials is expected to propel the growth of the electronic trial master file (eTMF) systems market going forward. Clinical trials are systematic investigations or studies conducted to assess the safety, efficacy, and effectiveness of human medical interventions, treatments, or procedures. These trials aim to generate reliable data and evidence to determine whether a new drug, therapy, medical device, or intervention is safe and effective for use in a specific patient population. The upsurge in clinical trials is intricately linked to the widespread adoption of electronic trial master file (eTMF) systems. As the volume and complexity of clinical research expand, eTMF systems play a pivotal role in streamlining documentation processes, ensuring regulatory compliance, and facilitating efficient collaboration among stakeholders. For instance, in November 2023, according to a report published by the Association of the British Pharmaceutical Industry, a UK-based trade association, the total number of clinical trials increased to 411 trials in 2022 and 394 trials in 2021. The annual recruitment to industry clinical trials in the UK is up by 5,366 participants yearly to 42,088 in 2022-23. Therefore, the increase in clinical trials is expected to propel the growth of the electronic trial master file (eTMF) systems market.

Major companies operating in the electronic trial master file (eTMF) systems market are focused on developing innovative products such as cloud-based eTMF to meet the growing demand. Cloud-based eTMF (electronic trial master file) refers to a digital platform or system hosted on cloud infrastructure and specifically designed to manage and organize essential documents and data related to clinical trials in the life sciences and pharmaceutical industries. For instance, in September 2022, Montrium Inc., a Canada-based cloud-based software solutions company, launched cloud-based trial master file (TMF) services and TMF maturity educational training. These offerings are designed to support clinical operations and TMF teams at every stage of the clinical development journey. The comprehensive service offerings are backed by years of experience in TMF processes and cutting-edge technology, leveling the playing field for scaling organizations by allowing them to achieve the highest standard of TMF excellence.

In September 2023, Florence Healthcare Inc., a US-based provider of clinical trial management software solutions, acquired VersaTrial for an undisclosed amount. The acquisition was intended to strengthen site enablement for clinical trials by combining complementary strengths. This strategic initiative aims to optimize the efficiency and capacity of research sites, alleviate the technology load, accelerate feasibility responses, and enhance communication among study personnel. VersaTrial is a clinical trial solutions provider based in the United States.

Major companies operating in the electronic trial master file (eTMF) systems market are Veeva Systems, Oracle, TransPerfect, Phlexglobal, SureClinical Inc., Aurea, Inc., MasterControl, Inc, Clinevo Technologies, Covance Inc., Ennov, Care Lex, ePharma Solutions, Database Integrations, Inc, Aris Global LLC, Mayo Foundation for Medical Education and Research, Montrium Inc., StrelingBio Inc., PHARMAVIGILANT, Forte research, IQVIA, Labcorp Drug Development, NCGD Inc, arivis AG, Wingspan Technology, Dell EMC, Paragon Solutions, Freyr, SAFE-BioPharma, BIOVIA Corp

North America was the largest region in the electronic trial master file (eTMF) systems market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the electronic trial master file (eTMF) systems market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the electronic trial master file (eTMF) systems market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The electronic trial master file (eTMF) Systems market includes revenues earned by entities through implementation and integration services, document migration services, quality control and compliance services and regulatory submission support. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included. The electronic trial master file (eTMF) Systems market consists of sales of cloud-based eTMF solutions, eTMF software solutions, mobile applications, collaboration and communication tools. 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.

Electronic Trial Master File (eTMF) Systems 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 electronic trial master file (etmf) systems 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 electronic trial master file (etmf) systems ? 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 electronic trial master file (etmf) systems 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. Electronic Trial Master File (eTMF) Systems Market Characteristics

3. Electronic Trial Master File (eTMF) Systems Market Trends And Strategies

4. Electronic Trial Master File (eTMF) Systems 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 Electronic Trial Master File (eTMF) Systems Growth Analysis And Strategic Analysis Framework

6. Electronic Trial Master File (eTMF) Systems Market Segmentation

7. Electronic Trial Master File (eTMF) Systems Market Regional And Country Analysis

8. Asia-Pacific Electronic Trial Master File (eTMF) Systems Market

9. China Electronic Trial Master File (eTMF) Systems Market

10. India Electronic Trial Master File (eTMF) Systems Market

11. Japan Electronic Trial Master File (eTMF) Systems Market

12. Australia Electronic Trial Master File (eTMF) Systems Market

13. Indonesia Electronic Trial Master File (eTMF) Systems Market

14. South Korea Electronic Trial Master File (eTMF) Systems Market

15. Western Europe Electronic Trial Master File (eTMF) Systems Market

16. UK Electronic Trial Master File (eTMF) Systems Market

17. Germany Electronic Trial Master File (eTMF) Systems Market

18. France Electronic Trial Master File (eTMF) Systems Market

19. Italy Electronic Trial Master File (eTMF) Systems Market

20. Spain Electronic Trial Master File (eTMF) Systems Market

21. Eastern Europe Electronic Trial Master File (eTMF) Systems Market

22. Russia Electronic Trial Master File (eTMF) Systems Market

23. North America Electronic Trial Master File (eTMF) Systems Market

24. USA Electronic Trial Master File (eTMF) Systems Market

25. Canada Electronic Trial Master File (eTMF) Systems Market

26. South America Electronic Trial Master File (eTMF) Systems Market

27. Brazil Electronic Trial Master File (eTMF) Systems Market

28. Middle East Electronic Trial Master File (eTMF) Systems Market

29. Africa Electronic Trial Master File (eTMF) Systems Market

30. Electronic Trial Master File (eTMF) Systems Market Competitive Landscape And Company Profiles

31. Electronic Trial Master File (eTMF) Systems Market Other Major And Innovative Companies

32. Global Electronic Trial Master File (eTMF) Systems Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Electronic Trial Master File (eTMF) Systems Market

34. Recent Developments In The Electronic Trial Master File (eTMF) Systems Market

35. Electronic Trial Master File (eTMF) Systems Market High Potential Countries, Segments and Strategies

36. Appendix

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