Clinical Data Management Systems (CDMS) Market Size By Delivery Mode (Licensed Enterprise Solutions, Cloud-based Solutions, Web-hosted Solutions), By End-use (Contract Research Organizations, Medical Device Companies, Pharma/Biotech Companies), Industry Analysis Report, Regional Outlook, Application Potential, Competitive Market Share & Forecast, 2022 – 2030

Industry Overview

Clinical Data Management System Market size accounted for USD 1,996.6 million in 2021 and is estimated to grow at 11.4% CAGR between 2022 and 2030. Increasing number of clinical trials especially in Asia Pacific region is expected to surge the demand for the clinical data management systems industry.
 

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As per the ClinicalTrials.gov, the number of clinical trials registered studies by August 2021 was 387,363 worldwide. This is increasing the demand for rapid and innovative technologies for conducting the clinical trials. Therefore, clinical data management tool is used in clinical research for managing such high volumes of data, as this is noted to be one of most valuable assets for sponsors. Similarly, rising benefits of electronic clinical outcomes assessments in CDMS is also driving the market growth, as it offers advance and improved patient compliance, experience, real time, and diversified data.
 

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.
 

Furthermore, owing to the COVID-19 pandemic, healthcare industry was under massive pressure and suppliers around the world were noted to have affected by the growing number of cases. However, the COVID-19 pandemic was observed to have had a minimal impact on clinical data management systems market as most of the pharmaceutical and biotechnological companies placed all the new trials on hold and revised R&D spending for clinical trials in comparison to the earlier spending. This affected the outsourcing activities to CROs and further decrease the revenue at initial stage of outbreak.
 

However, during the latter months of 2020, rapid recovery was observed due to the proliferation of new clinical trial approaches or models, that employing virtual trial tools including data management and analytical based software and evolving regulatory policies. Thus, owing to aforementioned factors, the pandemic posed a minimal impact on market growth in 2020 of clinical data management systems.
 

Growing demand for clinical data management systems in clinical trials is expected to spur the market statistics

Several benefits offered by cloud and web-based data collection tools are primarily expected to spur the market size. The tools offer benefits such as ease in data entry and reduced time, flexibility in format, low cost, and the capability to capture extra response-set information. Previously, the data collected from medical research used to be stored in physical form and was not readily accessible. However, in recent years, the clinical data management (CDM) field has exhibited significant advancements shifting over 95% paper-based data entry to electronic data capture (EDC), moving towards digital-enabled trials.
 

Also, the CDMS is noted to discover several ways to effectively consolidate different data sources into one centralized location and ensure that the user can review and validate data according to existing demands. Such advancements in CDMS along with the rising underlying demand from clinical trials is expected to foster the market forecasts.
 

Privacy issues associated with data may potentially restrain the market growth

Data collection leads to concerns surrounding patient privacy especially in electronic data capture segment that may act as barrier in the market growth. The rising exchange of databases amongst CROs, research institutions, software companies, and different stakeholders increases the risk of data breach. Smooth access and easy sharing usually require opening data so that data can be used and shared.
 

This can further 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 expansion.
 

Cloud-based solution is expected to show significant growth during the analysis period

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Based on delivery mode, the clinical data management system market is classified into licensed enterprise (on-premise) solutions, cloud based (SaaS) solutions and web-hosted (on-demand) solutions. Cloud-based (SaaS) solution segment accounted for USD 1.1 billion in 2021 and is poised to grow at a significant CAGR over the forecast period.
 

The 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 expansion.
 

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 overall market statistics.
 

Increasing trend for outsourcing clinical trials to CROs is expected to spur the segmental expansion

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 12% during the forecast period. Growing number of contract research organizations (CROs) across the globe is expected to supplement the market revenue.
 

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 demand. 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 outlook over the coming years.
 

Strong foothold of prominent pharma & biopharmaceutical companies and CROs in the North America region will drive the market statistics

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North America accounted for 46.5% of the global clinical data management systems market in 2021 and 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.
 

Furthermore, rising concerns regarding effective management of large volumes of confidential data is expected to surge the acceptance of clinical data management system solutions, thereby augmenting the industry development.
 

Growth strategies of market players are focused on increasing the customer base

Few of the notable players operating in global clinical data management systems (CDMS) industry are eClinical Solutions LLC, CIMS Global, Axiom Real-Time Metrics, IBM Watson Health, Veeva System, Oracle Corporation, Ennov, among others. These market players implemented various strategies such as mergers and acquisitions, collaborations, new product launch, etc. to capture high revenue share in the clinical data management system market.
 

Some of the recent industry developments:

• 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 is expected to expand the customer base for Medidata with new opportunities to support sponsors through the MMS team’s expertise.
   
• In April 2022, Ennov acquired MACRO from Elsevier, a provider of advanced EDC (Electronic Data Capture) software for clinical research. The MACRO serves research institutions in Austria, Ireland, Spain, Sweden, Germany and Switzerland This acquisition is expected to help 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 2017 to 2030, for the following segments:

By Delivery Mode

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

By End-use

• 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
  • Italy
  • Spain
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
• Latin America
  • Brazil
  • Mexico
• Middle East & Africa
  • South Africa
  • Saudi Arabia