One of the hardware cornerstones that will accelerate the shift from paper-based medicine to digital healthcare is the proliferation of wearable devices connected to the mobile web, says a new study from healthcare technology research firm Tractica LLC.

In the new report Tractica forecasts that shipments of health-related wearables market will grow to as many as 97.6 million units by 2021 from an estimated one million units in 2015. The types of wearables being manufactured and shipped include fitness trackers, smart watches with health applications, to web-enabled wearable patches, pain management devices and other wrist devices and monitors.

“The market for healthcare wearables is very much in its infancy and will grow at a compound annual growth rate of 114%,” says Tractica research director Aditya Kaul. “Wearables are seen as an extension of the digital transformation of healthcare–helping pharmaceutical companies to expand clinical trials, enabling insurance companies to engage with customers by incentivizing healthier living and helping healthcare providers improve the delivery of healthcare.”

The global market for wearable devices in healthcare also will generate substantial annual sales reaching an estimated $17.8 billion in 2021 from an estimated $105.3 million in 2015. The outlook for the growth of the healthcare wearables market is robust because of the diversity and range of devices being manufactured and utilized, Kaul says.

“Healthcare wearables are a key part of the ongoing revolution of the broader wearables market as they move from being fitness devices to being able to directly impact medical conditions and improve diagnosis and care,” Kaul says. “Wearable devices are starting to be deployed for a wide range of healthcare applications such as treatment of chronic illness, remote patient monitoring, and eldercare and wellness programs.”

But even as healthcare wearable sales grow at an accelerated pace there are broader adoption issues the healthcare industry has yet to overcome, according to the Tractica report. Healthcare is a heavily regulated industry and it often takes the U.S. Food and Drug Administration a year or more to accept or reject a wearables device or mobile app that collects data in tandem with a device, Tractica says. “The time delays and difficulties of obtaining government approval can be a problem for especially smaller healthcare wearable companies that are unfamiliar with the regulatory process,” Kaul says.

Today there are nearly 300 clinical trials underway involving wearable devices in the U.S. that are being monitored by the U.S. National Institutes of Health, the Tractica report says. But research and development costs for wearable device manufacturers can be high and subject to big increases because of the uncertainty of collecting and measuring new sources of data such as for monitoring chronic diseases like diabetes. “In the case of clinical trials, especially those that are targeting the at-risk population, educating and counseling patients can be an extra cost and an expense of time and effort,” Kaul says.

But over time the use of wearable devices and mobile apps will become much more widespread across the U.S., Kaul says. “The direction is clear in terms of how wearables will eventually become a cornerstone of digital healthcare,” Kaul says.

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