Regulated medical apps market to reach $12.1 billion by 2030

Hand holding smartphone
Sheila Zabeu -

March 14, 2023

Digital health was a growth sector even before the Covid-19 pandemic, which intensified the need for remote medical assistance and faster, more accurate diagnosis and treatment. The segment mainly brings together technology in the shape of hardware and software that is patient- as well as provider-centric, exploiting increasingly voluminous and distributed data sets to present information in real-time, now with a dash of Artificial Intelligence (AI).

One particular area is getting more attention, that of mobile applications (apps), often used in conjunction with medical devices. According to research by GlobalData, the market for regulated medical apps will reach $12.1 billion by 2030. The remote patient monitoring market, which brings together vital sign monitoring devices, implantable devices, and specialized handheld devices used with mobile apps, is expected to reach $760 million.

In general, regulated medical apps address-specific diseases or conditions that are proven to be effective for treatment by a doctor with a prescription. Regulation helps ensure that apps meet strict safety standards and that users receive accurate health information.

The regulated medical apps market can be split between those with clinical approaches, valued at $3.9 billion by 2030, and a second with indication focus, valued at $8 billion by 2030. Most apps with clinical approaches are geared toward nursing. The indication-focused app market includes conditions such as diabetes, obesity, depression, and irritable bowel syndrome.

At the end of 2022, the US Federal Trade Commission (FTC) released an updated version of an interactive tool that helps determine which federal laws and regulations may apply to healthcare apps. The first version was released in 2016, but as one year equals a century in technology, as the FTC itself points out, it was about time to revise the tool to reflect the regulatory changes that have occurred in recent times. However, the entity stresses that this feature is not a substitute for personalized legal advice, but only a kick-start to ensure compliance.

In addition to the regulated medical apps, there are those aimed at monitoring general health conditions, which have been increasingly adopted largely because the Covid-19 pandemic has changed patients’ attitudes. They are used to helping track and manage, for example, physical activity, heart rate, sleep, and nutrition. This is the largest category of health apps because it is accessible to anyone with a smartphone and requires little research and design, often relying only on information provided by the user.

Diagnostic testing apps have also grown in popularity in recent years. They typically collect data from external sensors and send it to doctors or AI and machine learning tools for analysis.

More Numbers

In the United States in particular, nearly two-thirds (63.4%) of adults have used health apps in the past 12 months, according to a survey by Insider Intelligence. Apps associated with exercise or fitness were the most downloaded, followed by the general wellness category, which includes nutrition, weight loss, and sleep.

Only one in five respondents said they were using apps for mental health.

Health app developers have shown more activity since the early days of the pandemic. More than 90,000 options were released in major app stores in 2020, according to IQVIA, a company providing advanced analytics, technology solutions, and clinical research services to the life sciences industry.

Admittedly, interest in health apps increased when in-person doctor visits were postponed, with 32% of users increasing their use during the health crisis. However, health apps and wearables did not see the same increase as virtual care. Telehealth was the only way for many patients to get care.

According to a Morning Consult survey, among users of health apps, 45% said they now use them about the same as before the pandemic, compared with 32% who said they use them “a lot” or “a little” more. Among wearables users, 44% use the devices at the same rate, and 37% use them more.

There is a “greater interest in wellness or personal health that is driving the market,” according to Ismene Grohmann, product head of Abbott Laboratories’ Lingo bio-wearables line. People may be more interested in wearing wearable devices or monitoring health conditions after the pandemic, when they may have developed harmful habits. In talking to consumers in different countries, Abbott identified that “people are very, very interested not only in classic weight loss, but also in ‘why do they want to lose weight?’

Abbott’s Lingo sensor technology is being developed to track key signals from the body, such as glucose, ketones, and lactate, and may also be used in the future to track alcohol levels.