According to a recent report by Business Research Insights, the total size of the global decentralized clinical trials market was $7.14 billion in 2023, a figure that is projected to grow to $8.19 billion by the end of 2024. The report forecasts that the decentralized clinical trials market will continue growing to reach $24.97 billion by 2032, with a compound annual growth rate (CAGR) of 14.8%.
Decentralized clinical trials are studies where some or all of the trial activities happen at locations other than a traditional clinical trial site, such as the participant’s own home or a local healthcare facility. Often, these decentralized trials involve digital health technologies that allow clinicians to monitor and collect information from the study participants remotely.
“We are finding that many clinical trial participants like to receive treatments at home or at their local clinic, rather than to travel far distances to a traditional clinical trial site. It can be easier to recruit people and keep them enrolled if they don’t have the burden of travel,” said Leonard Sacks, Associate Director at the Office of Medical Policy of the FDA’s Center for Drug Evaluation and Research (CDER).
“In addition to convenience, digital health technologies can collect data much more frequently than scheduled trial visits, sometimes even continuously. These technologies also capture information during participants’ routine activities, providing insight into the effectiveness and safety of the treatment in ‘real life.’”
As of 2023, the Asia-Pacific region holds the largest market share in this market in 2023. However, the report forecasts the US to become the leading region within the next decade.
This shift and rapid growth in decentralized clinical trials has been accelerated by the COVID-19 pandemic. While the technology that enables decentralized trials existed before the pandemic, lockdowns highlighted the potential of this technology to enable remote treatment and monitoring activities, as well as facilitating the filling and submission of paperwork electronically.
“Aware of both the promise and challenges of [decentralized clinical trials], the FDA has been working on resources for sponsors, patients, health care providers, and the broader community,” said Sacks. “We are working on electronic methods to track drug application submissions containing digital health technology-derived data.”
“This area will continue to grow as technology advances and people become even more comfortable with DHTs and remote medicine. However, I don’t see all clinical trials moving to an entirely remote setting; people will need to go to a clinical trial site at times. I think hybrid models will be more common, where some trial activities will take place at clinical trial sites and others at patients’ homes or other convenient locations.”