Research Methodologies Followed in This Study:
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.
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.
Major Growth Boosting Factors:
The growth of the CTMS market is driven by increasing number of clinical trials, and government support for research trials. However, budget constraints and limited knowledge about advanced CTMS solutions restrain the market growth.
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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.
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.
End Users:
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.
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North America is expected to dominate the global clinical trial management system market in 2019
North America, comprising the US and Canada, accounted for the largest share of the clinical trial management system market in 2019. The large share of this region can primarily be attributed to factors such as the high number of ongoing clinical trials (especially in the US), the presence of leading players from both the demand and supply sides, and the presence of a favorable government funding scenario for clinical research.
Recent Developments:
# In June 2019, Parexel International Corporation (US) launched an enhanced integrated outsourcing delivery model for functional service provider (FSP) services at the DIA 2019 Global Annual Meeting in San Diego, US.
# In May 2019, Bio-optronics (US) launched three products to the CCTrialSuite basket application—CCeSource, CCeReg & CCeConsent.
# In June 2018, Bioclinica (US) launched eClinical Solution namely the SMART Technology Suite.
