Research Methodologies Followed for This Study:

Primary Research:

Primary research was conducted after acquiring extensive knowledge about the global Clinical Trial Management System Market scenario through secondary research. Primary interviews were conducted with market experts from both the demand-side (such as hospitals, ambulatory surgery centers, outpatient facilities, clinics, research universities, academic institutions, and government institutions, among others) and supply-side respondents (such as presidents, CEOs, vice presidents, directors, general managers, heads of business units, and senior managers) across five major geographies, namely, North America, Europe, the Asia Pacific, Latin America, and the Middle East, and Africa.

Secondary Research:

The secondary research process involves the widespread use of secondary sources, directories, databases (such as Bloomberg Businessweek, Factiva, and D&B), white papers, annual reports, companies house documents, investor presentations, and SEC filings of companies. Secondary research was used to identify and collect information useful for the extensive, technical, market-oriented, and commercial study of the clinical trial management system market. A database of the key industry leaders was also prepared using secondary research.

Major Growth Driving Factors:

Growth in this market is primarily driven by rising industry-academia collaborations, the increasing number of clinical trials, rising technology adoption, and government support for research trials. However, budget constraints and limited knowledge about advanced CTMS solutions restrain the market growth.

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Projected Surge in Revenue Generation:

The clinical trial management system market is projected to reach USD 1,590 million by 2025, at a CAGR of 14.7 % during the forecast period.

COVID-19 Impact on the global Clinical Trial Management Market

Due to the COVID-19 outbreak, medical practices across all specialties and practices are under immense pressure; providers worldwide have been overwhelmed by the large and increasing number of patients. The emergence of this pandemic has posed severe financial constraints on pharma-biopharma companies in several countries. In this regard, CTMS has proven to be very helpful, as it allows industrial & academic researchers to monitor patients using digitally connected platforms while helping to organize & evaluate the clinical data for regulatory submissions.

The COVID-19 pandemic has also increased the need for social distancing among physicians and patients, which has driven the demand for remote patient monitoring and digital solutions for clinical research data gathering and analysis. Various players in this market have introduced COVID-19-associated features into their existing EHRs, which are being made available to users free of cost.

Challenge: Lack of skilled professionals

The dearth of skilled professionals for handling sophisticated digital solutions in research teams is restraining the growth of the CTMS market. With severe time constraints and increasing cost cuts, CROs and pharmaceutical companies are reluctant to invest in training their research employees. Hence, a huge gap exists between the available and required skilled manpower in the clinical research industry, restricting the adoption and utilization of complex software solutions in clinical trials. The development of user-friendly software solutions could act as a key growth opportunity for software vendors in this market.

Opportunity: Investment in effective digital infrastructure and agility in technological adoption

The need to comply with stringent regulations has been crucial to expediting the adoption of new technology in research. Although the supply of technology has been increasing and the regulation of innovative methods is easing, pharmaceutical companies have been slow to use emerging technologies due to the uncertainty prevailing around this space and a highly fragmented supply market. Lately, pharma companies have increased expenditure on AI and big data analytics, given their transformative supremacy over the R&D process and cost savings.

Fear of rivalry in the market and the need for business transformation and agility are key forces driving huge investments in R&D technologies. Hence, pharma companies must recognize outward innovation through supplier benchmarking in each of these categories and be involved in early engagement through co-development to stay competitive.

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Large pharma-biotech companies segment is expected to account for the largest share of the clinical trial management system market, by the end user

Based on end users, the clinical trial management system market has been segmented based on end-user category—large pharma-biotech companies, small & mid-sized pharma-biotech companies, CROs, medical device manufacturers, and other end users. One of the key factors driving the use of CTMS is an increasing emphasis on R&D. For instance, PhRMA member companies in the US increased their R&D expenditure from ~USD 26.0 billion in 2000 to USD 58.8 billion in 2015 (Source: Pharmaceutical Research and Manufacturers of America). Due to rising pressure of R&D costs, outcomes-based reimbursement, and stricter regulations imposed on large pharma companies, a part of their R&D functions is outsourced to smaller pharmaceutical companies, which increases the growth of companies in this category.

Leading Companies:

Oracle Corporation (US), Medidata Solutions (US), Parexel International (US), Bioclinica (US), and IBM (US), Bio-Optronics (US), Datatrak (US), Veeva Systems (US), DSG (US), MasterControl (US), ERT (US), Advarra Technology Solutions (US), MedNet Solutions (US), ArisGlobal (US), DZS Clinical Services (US), Crucial Data Solutions (US), Ennov (France), DataStat (US), and RealTime Software Solutions LLC (US) among others are some of the major players operating in the global clinical trial management system market.