글로벌 전자 재판 마스터 파일(eTMF) 시스템 시장 – 2031년까지의 산업 동향 및 예측

전자 시험 마스터 파일(eTMF) 시스템 시장 분석 및 규모

전자 시험 마스터 파일(eTMF) 시스템에서 문서 관리가 기본적인 응용 프로그램입니다. 이러한 시스템은 연구 프로토콜과 규제 제출물에서 환자 기록과 부작용 보고서에 이르기까지 필수적인 시험 문서를 효율적으로 정리, 저장 및 추적합니다. 중앙 집중화된 디지털 저장소를 제공하는 eTMF 시스템은 문서 액세스 및 검색을 간소화하여 스폰서, CRO 및 규제 기관과 같은 이해 관계자 간의 협업을 강화합니다. eTMF 시스템 내의 문서 관리로 임상 시험 운영의 효율성이 향상되고 오류가 줄어들며 규제 준수가 강화됩니다.

글로벌 전자 시험 마스터 파일(ETMF) 시스템 시장 규모는 2023년에 16억 3천만 달러로 평가되었으며, 2031년까지 42억 9천만 달러에 도달할 것으로 예상되며, 2024년에서 2031년까지의 예측 기간 동안 CAGR은 12.9%입니다. Data Bridge Market Research에서 큐레이팅한 시장 보고서에는 시장 가치, 성장률, 세분화, 지리적 범위, 주요 업체와 같은 시장 시나리오에 대한 통찰력 외에도 심층적인 전문가 분석, 지리적으로 표현된 회사별 생산 및 용량, 유통업체 및 파트너의 네트워크 레이아웃, 자세하고 업데이트된 가격 추세 분석, 공급망 및 수요의 적자 분석이 포함됩니다.

보고 범위 및 시장 세분화       

Market Definition

Electronic trial master file (eTMF) systems are digital solutions designed to manage and store essential documents and data related to clinical trials in the life sciences industry. They provide a centralized platform for organizing, tracking, and accessing trial documentation, ensuring compliance with regulatory standards such as good clinical practice (GCP).

Electronic Trial Master File (eTMF) Systems Market Dynamics

Drivers                                                                                          

• High Demand of eTMF Systems due to Globalization of Clinical Trials

As clinical trials increasingly span across diverse geographic regions, there is a growing need for efficient data management and collaboration tools such as eTMF systems. These systems facilitate seamless sharing of trial documentation among global stakeholders, including sponsors, CROs, and regulatory authorities, ensuring consistency and compliance across different jurisdictions. Moreover, eTMF systems help address logistical challenges associated with managing trial documentation across multiple sites and countries, thereby supporting the globalization trend by streamlining trial operations and enhancing efficiency.

According to the European Medicines Agency, underscores the growing demand for efficient trial management solutions such as the eTMF system. With over 37,000 trials expected by 2021, the need to effectively manage patient and drug data becomes paramount, driving the adoption of eTMF systems to streamline documentation, ensure regulatory compliance, and enhance overall efficiency in clinical trial operations.

• Rapid Technological Advancements Promotes Seamless Data Integration

Innovations such as cloud computing, artificial intelligence (AI), and machine learning have revolutionized trial management, enabling the development of more sophisticated eTMF solutions. These advancements empower eTMF systems with enhanced functionalities such as automation, predictive analytics, and real-time monitoring, improving efficiency and accuracy in document management, collaboration, and compliance. Furthermore, the integration of cutting-edge technologies facilitates seamless data integration, analysis, and reporting, driving the adoption of eTMF systems by life sciences companies and clinical research organizations seeking to optimize their trial operations.

Opportunities

• Increased the Adoption of eTMF Systems due to Streamlining Operations

The eTMF systems offer centralized platforms for organizing, tracking, and accessing trial documentation, reducing administrative burdens and minimizing errors. Automating manual processes and providing features such as version control and electronic signatures, eTMF systems optimize workflow efficiency and enhance overall productivity. This streamlining of operations enables life sciences companies and clinical research organizations (CROs) to conduct trials more effectively, saving time and resources while maintaining compliance with regulatory standards such as Good Clinical Practice (GCP) and 21 CFR Part 11..

• High Demand for Cost-Effective Solutions Increases Adoption of  eTMF Systems

As the healthcare industry faces escalating costs, stakeholders seek efficient ways to manage clinical trial documentation without compromising quality or compliance. The eTMF systems offer a cost-effective alternative to traditional paper-based methods by reducing the need for physical storage space, minimizing administrative overheads, and streamlining document processing workflows. These systems enable remote access and collaboration, further enhancing efficiency and reducing travel expenses associated with manual document handling. The demand for cost-effective solutions incentivizes the adoption of eTMF systems, driving their growth in the market.

Restraints/Challenges

• High Regulatory Uncertainty Limits the Adoption of eTMF Systems

The dynamic nature of regulatory requirements in the life sciences industry, including changes to GCP standards and regional regulations, creates challenges for eTMF system vendors and users asuch as. Adapting eTMF systems to evolving regulatory expectations requires continuous updates and investment in resources, leading to increased complexity and compliance risks. Regulatory uncertainty may deter organizations from investing in eTMF systems, as they seek assurance of long-term compliance and regulatory alignment.

• Growing Data Security Concerns limits the Demand of eTMF Systems

The sensitive nature of clinical trial data, including patient information and proprietary research data, raises concerns about data breaches, unauthorized access, and regulatory non-compliance. However, the complexity of maintaining data security in eTMF systems, coupled with the potential reputational and financial consequences of security breaches, may deter some organizations from adopting or expanding their use of eTMF solutions.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Impact and Current Market Scenario of Raw Material Shortage and Shipping Delays

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Apart from the standard report, we also offer in-depth analysis of the procurement level from forecasted shipping delays, distributor mapping by region, commodity analysis, production analysis, price mapping trends, sourcing, category performance analysis, supply chain risk management solutions, advanced benchmarking, and other services for procurement and strategic support.

Expected Impact of Economic Slowdown on the Pricing and Availability of Products

When economic activity slows, industries begin to suffer. The forecasted effects of the economic downturn on the pricing and accessibility of the products are taken into account in the market insight reports and intelligence services provided by DBMR. With this, our clients can typically keep one step ahead of their competitors, project their sales and revenue, and estimate their profit and loss expenditures.

Recent Developments

• In February 2023, Vial collaborated with Egnyte to integrate the Egnyte eTMF solution into its platform, aiming to streamline document and data processing, ensure compliance with 21 CFR Part 11, and bolster audit readiness for life sciences companies
• In September 2022, Montrium launched expert-led TMF services and educational training to bolster clinical operations and TMF teams throughout the clinical development process, providing support at various stages
• In June 2022, Anju Software Inc. launched eTMF Master, a cloud-based eTMF software facilitating collaboration between sponsors, CROs, and sites for efficient and secure management of clinical trial content while adhering to regulatory standards
• In April 2021, Phlexglobal announced their TMF Quality Review solution, aimed at pharmaceutical companies, especially the top global players, to assess and minimize regulatory risks during mergers and acquisitions while enhancing inspection readiness

Electronic Trial Master File (eTMF) Systems Market Scope

The market is segmented on the basis of component, delivery mode, and end-user. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Component

• Services
• Software

 Delivery Mode

• Cloud-Based eTMF
• On-Premise eTMF

 End-User

• Pharmaceutical and Biotechnology Companies
• CROs
• Others

Electronic Trial Master File (eTMF) Systems Market Regional Analysis/Insights

The market is analysed and market size insights and trends are provided by country, component, delivery mode, and end-user as referenced above.

The countries covered in the market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America dominates in the market can be attributed to the region's stringent regulatory environment, characterized by robust oversight from regulatory authorities such as the FDA and Health Canada. These regulations necessitate the adoption of eTMF systems to ensure compliance and streamline documentation processes in clinical trials. Additionally, North America boasts a mature life sciences industry with a high concentration of pharmaceutical and biotech companies, further driving the demand for advanced eTMF solutions. The region's focus on innovation and technology adoption in healthcare also contributes to its leadership in the eTMF systems market.

Asia-Pacific is expected to experience the highest growth rate in the adoption of eTMF systems. This growth is primarily attributed to the increasing involvement of major companies in the region in the adoption of electronic trial master file solutions. As the life sciences sector expands in the Asia-Pacific region, fueled by advancements in healthcare infrastructure and regulatory frameworks, there's a heightened demand for streamlined and compliant processes, driving the uptake of eTMF systems to manage clinical trial documentation efficiently.

보고서의 국가 섹션은 또한 개별 시장 영향 요인과 국내 시장의 현재 및 미래 트렌드에 영향을 미치는 규제 변화를 제공합니다. 다운스트림 및 업스트림 가치 사슬 분석, 기술 트렌드 및 포터의 5가지 힘 분석, 사례 연구와 같은 데이터 포인트는 개별 국가의 시장 시나리오를 예측하는 데 사용되는 몇 가지 포인터입니다. 또한 글로벌 브랜드의 존재 및 가용성과 지역 및 국내 브랜드와의 대규모 또는 희소한 경쟁으로 인해 직면한 과제, 국내 관세 및 무역 경로의 영향이 국가 데이터에 대한 예측 분석을 제공하는 동안 고려됩니다.

의료 인프라 성장 설치 기반 및 신기술 침투

이 시장은 또한 자본 장비에 대한 의료 지출의 모든 국가별 성장, 시장에 대한 다양한 종류의 제품의 설치 기반, 수명선 곡선을 사용한 기술의 영향, 의료 규제 시나리오의 변화 및 시장에 미치는 영향에 대한 자세한 시장 분석을 제공합니다. 이 데이터는 2016-2021년의 과거 기간에 대해 제공됩니다.

경쟁 환경 및 전자 시험 마스터 파일(eTMF) 시스템 시장 분석

시장 경쟁 구도는 경쟁자별 세부 정보를 제공합니다. 포함된 세부 정보는 회사 개요, 회사 재무, 창출된 수익, 시장 잠재력, 연구 개발 투자, 새로운 시장 이니셔티브, 글로벌 입지, 생산 현장 및 시설, 생산 용량, 회사의 강점과 약점, 제품 출시, 제품 폭과 범위, 애플리케이션 우세입니다. 위에 제공된 데이터 포인트는 시장과 관련된 회사의 초점에만 관련이 있습니다.

시장에서 활동하는 주요 기업은 다음과 같습니다.

• IQVIA Inc.(미국)
• Labcorp 약물 개발(미국)
• 트랜스퍼펙트(미국)
• 오라클(미국)
• 플렉스글로벌(미국)
• 슈어클리니컬 주식회사 (미국)
• Aurea, Inc. (미국)
• Veeva Systems (미국)
• MasterControl Solutions, Inc. (미국)
• Clinevo Technologies(인도)
• 메이요 의학 교육 및 연구 재단(MFMER)(미국)
•  몬트리움 주식회사(미국)
•  NCGD 주식회사 (미국)
•  PharmaVigilance(미국)

SKU-46635