U.S. Clinical Trial Data Management Service Market - Focused Insights 2023-2028

The clinical trial data management service market in the US witnessed a valuation of $0.82 billion in 2022 and is forecasted to touch $1.29 billion by 2028, growing at a CAGR of 7.85%. As new diseases continue to emerge, the number of clinical trials has seen a consistent rise, with over 8000 ongoing trials in the US alone. Notably, the duration for phase 3 clinical trials has expanded, leading to a surge in data generated. This data influx, available in structured and unstructured formats, necessitates robust data management services.

The demand for clinical trial data management is fueled by factors like:

• Large data sets require effective governance.
• The time-intensive nature of manual data entry.
• Constant regulatory shifts demand advanced data management capabilities.

Given the intricate nature of data management, many companies, especially startups, rely on outsourcing. These small pharmaceutical firms, while excelling in drug discovery, often lack the resources or infrastructure for data management, making outsourcing a viable option. Interestingly, large biopharmaceutical firms have a contrasting approach. Their R&D spending is relatively lesser than smaller counterparts, yet they also observe the merits of outsourcing clinical trials, leading to a growing demand for these services.

A significant shift in the industry is the movement away from full-service models, primarily due to concerns regarding data transparency, security, and the associated high costs. Currently, pharma & biopharmaceutical entities heavily depend on outsourcing for new drug development ventures, with large companies even considering outsourcing from the initial stages of drug development.

Artificial Intelligence (AI) has introduced a revolution in clinical trial data management. It facilitates combining phase 1 and phase 2 trials, real-world data analysis, and the development of innovative patient-centric endpoints. Such technological advancements not only streamline data collection and analysis but also significantly improve patient monitoring and retention.

The modern shift towards patient-centric and decentralized clinical trials has reshaped global clinical trial conduct, emphasizing real patient feedback. This approach, though beneficial, produces vast data volumes, underscoring the need for specialized clinical data management services.

Costs associated with drug development constitute approximately two-thirds of total R&D expenses. With many leading players in pharmaceuticals, biopharmaceuticals, and medical device manufacturing turning to contract-based manufacturing and outsourcing, the demand for data management services has soared.

However, challenges like inadequate medical infrastructure, stringent patient recruitment guidelines, and paucity of trial management frameworks hinder market growth in the US. Despite these challenges, investments in clinical research remain high, with an increasing number of vendors in the market.

Dominant players are strategically partnering with emerging entities to penetrate the US clinical trial support services market more effectively. For instance, the acquisition of PRA Health Sciences by ICON plc in 2021 epitomizes this trend. With key players ramping up their investments and the growing adoption of cutting-edge technologies, the future of clinical trial support services in the US looks promising.

Key Highlights:

• Lack of in-house experience, expanding new drug-pipeline, increasing complexity in clinical trials, and duration of clinical trials are forcing the companies to choose clinical data management service providers.
• Phase 1 clinical trials take almost several months to a year to complete. Clinical trial outsourcing services play a vital role in minimizing time and cost. The collection of data from the clinical trials will also help in future studies. 70% of drugs move from phase 1 to the next phase, as stated by the US FDA.
• Small pharmaceutical start-ups are highly focused on drug discovery, and the lack of development infrastructure and capital has compelled small biopharmaceutical companies to rely on clinical trial outsourcing services, including data management services.
• The majority of the middle-sized companies are running their trials. When the working scale is beyond their ability to run effectively, but they want to remain involved, they choose the functional service provider model to augment their internal team. This is one of the unique ways to control the data with security. This is increasing the demand for the functional service provider model.
• Small biotech and pharma companies accounted for 40% of the contribution for new drug approval by the FDA. It shows the high market opportunities for clinical trial outsourcing market players, including data management service providers.
• In 2019, more than 3000 contract research organizations were operating worldwide, of which more than 80% of medical device clinical trials happened in high-income countries, including the US. This number is constantly increasing. This is increasing the demand for US Clinical trial data management.