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.

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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.

Projected Monetary Gains:

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.

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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Asia Pacific market is expected to grow at the highest CAGR during the forecast period.

The Asia Pacific market is projected to register the highest CAGR during the forecast period. In 2019, Asia Pacific region is expected to offer significant opportunities for the growth of the clinical trial management system market. The major factors driving the growth of the Asia Pacific market include increasing government funding to support clinical trials, the presence of less stringent regulatory guidelines as compared to developed nations, a large patient base, faster rate of patient recruitment for clinical trials than mature nations, low operating costs for conducting clinical trials, a shortage of trial volunteers in Europe and North America, and the growing number of pharmaceutical companies and CROs in the region.