Overview of This Study:

This study involved the extensive use of both primary and secondary sources. The research process involved the study of various factors affecting the industry to identify the segmentation types, industry trends, key players, competitive landscape, fundamental market dynamics, and key player strategies.

Market Size Estimation:

A detailed market estimation approach was followed to estimate and validate the size of the global clinical trial management system market and other dependent submarkets.

# The key players in the global clinical trial management system market were identified through secondary research, and their global market shares were determined through primary and secondary research.

# The research methodology includes the study of the annual and quarterly financial reports of the top market players as well as interviews with industry experts for key insights on the global clinical trial management system market.

# All percentage shares, splits, and breakdowns were determined by using secondary sources and verified through primary sources.

# All the possible parameters that affect the market segments covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

The above-mentioned data was consolidated and added with detailed inputs and analysis from MarketsandMarkets and presented in this report.

Data Triangulation:

After deriving the overall clinical trial management system market value data from the market size estimation process, the total market value data was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all the segments, data triangulation and market breakdown procedures were employed wherever applicable. The data was triangulated by studying various qualitative and quantitative variables as well as by analyzing regional trends for both the demand- and supply-side macroindicators.

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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. Approximately 30% of the primary interviews were conducted with stakeholders from the demand side, while those from the supply side accounted for the remaining 70%. Primary data for this report was collected through questionnaires, emails, and telephonic interviews.

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.

Projected Surge in Revenue Generation:

The clinical trial management system market is projected to reach USD 1,590 Million by 2025 from USD 801 Million in 2020, at a CAGR of 14.7% during the forecast period.

Driver: The rising number of clinical trials and the availability of advanced CTMS solutions

The life science industry is annually witnessing a global increase in the number of clinical trials. The growth in the number of clinical trials can be attributed to factors such as the high prevalence of chronic diseases, the expiry of blockbuster drugs, the availability of government funds for clinical trials, and fierce competition in the pharmaceutical industry. In recent years, leading players have launched many CTMS solutions in the market that boast superior performance than their traditional counterparts. These products are cost-effective, easy to use, provide effective patient safety and regulatory compliance, and enhance the financial management capabilities of users. They enable organizations to implement a full-featured CTMS without the complex configuration and heavy capital investment associated with traditional solutions.

Restraint: Budget Constraints

Small and mid-sized customer facilities often face financial constraints for clinical trials due to limited private funding, rigorous regulatory mandates, and financial outlook. This also includes ineffective site selection, poor study design & trial execution, safety issues, and dropouts due to practical or financial issues. Furthermore, the time and capital required to complete a trial increase at each phase.

The total cost of a Phase III failure includes the cost of all previous phases, plus the time that could have been used to trial a different drug. Each failed trial contributes to the rising costs of biopharma R&D. Although R&D spending in the life science industry is rising, start-ups and SMEs still face budget constraints, which affect their decision to purchase CTMS solutions. Due to uncertainties in product approvals, undue delays in product approvals, and long gestation periods, private investors usually prefer established firms to invest in rather than start-ups and SMEs.

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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.