Recent Developments in the Global CTMS Market:
# 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.
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.
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.
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Projected Revenue Growth:
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.
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.
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.
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.
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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.
