Clinical Wearables

Clinical Wearables Global Market Outlook:

MARKET OVERVIEW

Market Value: $25.67 billion (2022)

Market Forecasted Value: $57.67 Billion (2026F)

CAGR: 20–25 percent (2021–2026)

• The market for clinical wearables is significantly driven by the increase in remote monitoring and real-time data in all modes of clinical trials

• North America and Europe had a comparatively lesser growth rate since they have the technology and adoption rate is normalizing. The number of players providing one solution, or a complete end-to-end solution is significantly increasing

• Due to an increase in non-communicable diseases and clinical trials as well as increased government financing for research, Asia is a region that is expanding in this area

Clinical Wearables Market Trends

Wearables will become an essential part of everyday life, like smartphones and mobile apps, as technology becomes more affordable and reachable, paving a path for remote patient monitoring.

Wearable IoT in Healthcare

• The wearable devices and apps is a powerful tool to save both cost and time at hospitals by providing physicians with easy track of patient’s condition, thereby allowing them to develop critical insights and provide advanced diagnosis. Certain wearable devices are capable of measuring ECG samples on periodic basis, aiding the healthcare professionals to monitor the patients virtually and remotely.

AI-based Movement Assessment Software

• NERVTEX's MoDAS (Movement Dysfunction Assessment Software) system, which is a First-in-Class AI/ML-based SaMD for the analysis of motor symptoms of Parkinson's disease, has been approved by the China National Medical Products Administration, making it the first video-based AI-powered medical device for the assessment of movement disorders.

Data collection and Real World Evidence (RWE)

• Wearable devices will enable advanced data collection and creation of more diverse datasets. This information can be aggregated, linked, and processed by digital marketers to understand key aspects, such as buying habits, location of target audience, clinical trial related data and can be processed to produce key conclusions in the form of RWE.

Clinical Wearables Market Overview

• The Center for Technology and Aging, has stated that $200 billion can be saved for the next 25 years by the US healthcare system by the adoption of remote patient monitoring technologies. However, the implementation of these technologies like wearable medical devices in the clinical trials is at infancy

• Mobile Health Technology, though in early stages, has attracted pharma industry to utilize them in clinical trial for better trial outcomes and also to shorten the trial timeline. In a survey, which included respondents from sponsors, consultants, CROs, academia, and labs said that the ~78 percent of them have been using mHealth in clinical trials for more than a year (Sources: Applied Clinical Trials, SCORR Marketing)

• Activity monitors and tracker segment captured the largest market share among others, the growth is mainly attributed to the sedentary and unhealthy lifestyle, increased adoption of self monitoring of vitals, and huge market of activity trackers which are available at low cost

Challenges in Using Wearables

Difficulty in obtaining reimbursement

• The adoption of healthcare services is impacted by a lack of reimbursement options as well as rising medical diagnosis and therapy costs. By encouraging early disease detection and prompt intervention, it helps to save healthcare costs. Wearable medical devices used for activity tracking, routine monitoring, and data collecting of vital parameters, such as fitness trackers, smart watches, wrist bands, and headgear, are not covered by insurance. Therefore, the only prospective consumers of these products now are those with high disposable money, which restricts their growth.

Data security/privacy concerns and misuse

• The current demand for wearables accelerates the actions of regulators and device manufacturers to pack in data security protocols into wearable devices to prevent patients from encountering cybersecurity attacks. As these data are stored in clouds, they could be retrieved without the knowledge of the user and sold to a third party. User data, like location, email, age or sex, that is registered on the wearable’s app poses a huge threat to the users.

• The market is still in its early stages, so significant actions must be made to accelerate its growth, in terms of regulations.

• E.g., insurance providers, who can either cancel the policy or quote high health insurance price.

Reluctance in adoption of wearable devices.

• Though the use of mobile phones and apps might advance, there will be only less than ten percent of clinical trials that will use wearables by 2017, according to Gartner. Wider adoption of wearables could be a challenge and barriers to recommendation to the patients are:

1. Unavailability of smart phones with all patients

2. Device used inconsistently hence incomplete data

3. Integration of the wearable data with the existing e-health management systems

4. Reluctance showed by the physicians to adopt this technology as the data collected are large and data analysis is a challenge to them as they don’t have time or does not have the skill set

5. During clinical trials asking the patient to charge the device or manage the uploads

Lack of guidance from FDA to use wearable devices in CTs.

• With the upsurge in use of wearables for health monitoring and social media for patient recruitment in clinical trials Association of Clinical Research (ACRO) has asked the FDA to update the guidelines for the wearables and softwares, so that the sponsor and CRO can be encouraged to use it.

1. Issue a public statement for the use of new technologies in a clinical trial conduct

2. To analyze the barriers and benefits with the help of the industry (pharma, CRO, patients, and technology providers)

3. Provide clear guidance documents for use of tech-driven solutions in terms of data security and monitoring parameters/requirements

4. Proving the FDA that a clinical trial will measure RWD that corresponds to patient outcome without raw data is difficult