Clinical Data Management Systems (CDMS) Market - By Delivery Mode (Licensed Enterprise Solutions, Cloud-based Solutions), By End-use (Contract Research Organizations, Medical Device Companies), Global Forecast (2023 – 2032)

Clinical Data Management Systems Market Size

Clinical Data Management Systems Market accounted for USD 2.3 billion in 2022 and is estimated to grow at 11.2% between 2023 and 2032 to be valued at USD 6.8 billion. The increasing volume and complexity of clinical trials and research studies necessitate advanced data management solutions to efficiently collect, organize, and analyse the vast amount of patient data generated.
 

For instance, as per the ClinicalTrials.gov, as of May 2023, there were 452,604 registered clinical trials globally. Such rising number of clinical trials is surging the demand for rapid and innovative technologies for effective management of clinical trial data. Additionally, the growing emphasis on data quality, integrity, and compliance with stringent regulatory requirements has propelled the demand for sophisticated data management systems.
 

Clinical data management system (CDMS) is one of the most important parts of digital clinical solutions that help deliver valid, error-free, and statistical database. The tool is used in clinical research to store and manage the data of a clinical trial. The clinical trial data is then gathered at the investigator site in the case report form (CRF) and is stored in the CDMS.
 

COVID-19 Impact

The COVID-19 pandemic had a minimal impact on clinical data management systems market. With the emergence of the pandemic, most of the pharmaceutical and biotechnological companies placed all the existing and new trials on hold. This affected the outsourcing activities to CROs and thus decreased the revenue at initial stage of outbreak. However, during the latter months of 2020, rapid recovery was observed due to an increased demand for CDMS solutions to efficiently collect, manage, and analyse clinical trial data of vaccine related clinical trials. Additionally, the pandemic accelerated the adoption of remote and virtual clinical trials, which further escalated the demand for CDMS platforms for remote data collection and monitoring. This, in turn, spurred growth and investment in the market.
 

CDMS Market Trends

• Technological advancements in clinical data management systems are expected to fuel the market growth. Technologies such as artificial intelligence (AI), robotic process automation, natural language processing (NLP), and machine learning (ML) can assist in standardization and getting actionable insights from data produced throughout clinical research activities, leading to effective clinical data management.
   
• Artificial intelligence (AI) assists in enhancing clinical data management processes by identifying trends, recognizing risks, and predicting results. It assists sponsors to understand the efficiency of drugs, predict the success rate of a clinical trial, and improve subject identification and registration.
   

Thus, the adoption of technologies such as AI and ML in clinical data management systems is expected to boost the adoption rate and upsurge the market expansion.
 

• Additionally, as the pharmaceutical, biotechnology, and healthcare sectors continue to expand their research and development efforts, there has been an increased demand for efficient and compliant data management solutions.
   
• CDMS platforms have become essential tools for collecting, processing, and analyzing the vast amounts of clinical data generated during these trials.
   

However, the rising exchange of databases amongst CROs, research institutions, software companies, and different stakeholders increases the risk of data breach.
 

• This can expose elements of a company to digital security threats potentially resulting into incidents such as data breach affecting the confidentiality, integrity or availability of data and information systems on which social and economic activities rely. Such rising concerns of data leakage may limit the adoption of clinical data management systems, thereby hampering the market share.
   

Clinical Data Management Systems Market Analysis

Based on delivery mode, the clinical data management systems market is classified into licensed enterprise (on-premise) solutions, cloud based (SaaS) solutions, and web-hosted (on-demand) solutions. The cloud-based (SaaS) solution segment held highest market share of 55.6% in 2022. The high segmental growth is attributed to technological developments in the healthcare sector and rising adoption of cloud-based solutions.
 

• The cloud-based model offers various advantages such as flexibility, collaboration, and scalability, among others. Such advantages associated with cloud-based solution will foster the market progression.
   
• Additionally, the cloud-based model also eliminates the need for purchasing, maintaining, and deploying on-premises services, thus reducing installation and maintenance cost, thereby contributing to the market size.
   

Based on end-use, the clinical management data system market is segmented into contract research organization (CROs), medical device companies, pharma/biotech companies and others. The contract research organization (CRO) segment is expected to register a higher growth rate of 11.7% during the forecast period.
 

• Growing number of contract research organizations (CROs) across the globe is expected to supplement the market growth. In addition, an increasing trend for outsourcing clinical trials to CROs, as it reduces the overall cost of drug development, is expected to further fuel the market trends.
   
• Further, clinical data management system (CDMS) along with electronic data capture (EDC) are one of the most prominent digital solutions adopted by several CROs to manage increasing volume of data. Thus, deployment of CDMS in several clinical research activities is anticipated to spur the market demand.
   

North America accounted for 45.9% of the global clinical data management systems market in 2022.
 

• North America is anticipated to retain its dominance throughout the forecast period owing to the strong foothold of prominent pharma & biopharmaceutical companies along with CROs.
   
• Moreover, wide-ranging drug development activities in North America is expected to further boost the usage of clinical data management system. Additionally, increasing clinical research studies in the U.S. and a paradigm shift from manual data collection & analysis to real-time data analysis while conducting clinical research is anticipated to spur the expansion of the market in the region.
   

Clinical Data Management Systems Market Share

The industry leaders operating in this market have established themselves through innovation, diverse product portfolio, and a strong market presence. Oracle Corporation, IBM Watson Health, and Veeva System are significant players in this market and account for largest market share. These market players implement various strategies such as mergers and acquisitions, collaborations, new product launch, etc. to capture high revenue share in the clinical data management system market.
 

Market players operating in the Clinical Data Management Systems (CDMS) industry is as mentioned below:

• eClinical Solutions LLC
• CIMS Global
• Axiom Real-Time Metrics
• IBM Watson Health
• Veeva System
• Oracle Corporation
• Ennov
• Medidata Solutions (Dassault Systems)
• Fortress Medical
• OpenClinica, LLC
   

Clinical Data Management Systems (CDMS) Industry News:

• In June 2022, MMS Holdings, a data-focused Contract Research Organization (CRO) announced a strategic partnership with Medidata, to offer clients with a full range of Medidata’s solutions for clinical data management (CDM) and decentralized clinical trial (DCT) technologies including Medidata’s unified platform and Rave EDC. This strategy helped the company to expand their customer base.
   
• In April 2022, Ennov acquired MACRO from Elsevier, a provider of advanced EDC (Electronic Data Capture) software for clinical research. MACRO serves research institutions in Austria, Ireland, Spain, Sweden, Germany, and Switzerland This acquisition helped the company offer clinical trial and compliance solutions in the Europe region, thereby strengthening its market position.
   

The clinical data management systems market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2018 to 2032, for the following segments:

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By Delivery Mode, 2018 – 2032 (USD Million)

• Licensed enterprise (on-premise) solutions
• Cloud-based (SaaS)solutions
• Wed-hosted (on-demand) solutions

By End-use, 2018 – 2032 (USD Million)

• Contract research organization (CROs)
• Medical device companies
• Pharma/biotech companies
• others

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • Rest of MEA