Trends in Point of Care Diagnostics and Continuous Monitoring
Nov 02, 2022 Dr Nadia Tsao
IDTechEx Reflects on Trends in 2022
For the past decade, the healthcare industry has looked towards decentralization as a means of relieving the pressure placed on healthcare systems. Efforts were greatly accelerated over the past two years as a result of lockdowns imposed to address the COVID-19 pandemic. Digital health and remote patient monitoring (RPM) companies were driven to new heights as the technologies became key modes of healthcare delivery. In parallel, demand for point-of-care testing (POCT) skyrocketed, doubling the market for POC biosensors. Moving forward into 2023, IDTechEx takes a look back at 2022.
Remote Patient Monitoring Continues Its Focus on Key Chronic Diseases
The RPM industry has shined through the pandemic, having enabled remote consultations and long-term patient management where in-person meetings were previously required. Major telehealth and RPM companies have benefitted from the increased interest and support, whether that is increases in users, increased reimbursement, relaxed regulations, through to exits in the form of initial public offerings and acquisitions.
While many RPM applications related to the pandemic will disappear into the background, the industry's key focuses on chronic conditions will remain. Today, the majority of patients receiving remote monitoring are people with diabetes or hypertension. Both chronic diseases pose a high burden on the healthcare system and benefit from well-established medical technologies that allow patients to monitor and record their vitals at home. In diabetes, patients are able to monitor their blood glucose via glucose test strips and continuous glucose monitors (CGMs) at home and on the move. In hypertension, portable, automated blood pressure cuffs are readily available in pharmacies and big box stores. To demonstrate the potential impact that can be delivered by RPM - over one billion people in the world have hypertension, but good management of the health condition can reduce up to 80% of heart attacks and strokes.
Market Forecast, RPM Devices 2023-2033 (US$ Billions). Source - IDTechEx
Reaching New Market Segments With Non-invasive Monitoring
One potential approach, which start-ups and established consumer electronics companies are both investigating, is non-invasive technologies that can provide early diagnostics and serve as low-friction options in ongoing disease management. Just as Apple and Fitbit smartwatches have been cleared by the Food and Drug Administration (FDA) to monitor for atrial fibrillation in the background using the watches' optical sensors, companies envision the same for diabetes and hypertension.
While current CGMs are already minimally invasive as compared to traditional glucose test strips, companies such as Alertgy, Afon Technology, and Know Labs are investigating entirely new technologies to take this even further. Currently, all three companies are investigating RF spectroscopy technology and are including in their development plans a smartwatch form factor. Both Alertgy and Know Labs are positioning their devices as a low-cost (vs. CGM) option for non-invasive glucose monitoring. This combination of non-invasive technology, convenient form factor, and low cost makes them ideal for targeting new patient populations, such as diagnosing and monitoring those who are unsuspecting or just on the cusp of developing type 2 diabetes (prediabetes).
Please refer to IDTechEx's research report, "Diabetes Management Technologies 2022-2032: Markets, Players, Forecasts" for more information about these innovative start-ups and the wider diabetes management technologies market.
Similarly, a non-invasive wearable blood pressure monitor can help to alert consumers who are unaware of their hypertension or to provide ongoing management of those who have been diagnosed. Today, companies active in this area are largely utilizing the pulse wave analysis technique. The technique leverages a low-cost technology - an optical sensor - to obtain a signal which can be manipulated to derive a blood pressure reading. Companies such as Biobeat, Biospectal, Cosinuss, and Valencell are active in this field, with form factors including smartwatches, in-ear sensors, and even smartphones. While there are already a could of devices cleared by the FDA today, IDTechEx expects more devices to receive FDA clearance over the next few years.
For more information about wearable heart rate sensors, please refer to IDTechEx's research report, "Wearable Sensors 2023-2033".
Wearable RPM Need to Provide Value in Continuous Monitoring
While RPM programs will remain focused on key chronic conditions such as diabetes and hypertension, there are several opportunities emerging for wearable RPM technologies. One disease area in which they can provide valuable information is Parkinson's disease (PD), enabled by the ubiquity of movement sensors, the advancement of artificial intelligence, and the specific nature of the disease itself.
Wearable RPM technologies offer the most value, where continuous monitoring provides additional insights over discrete monitoring events. For example, in addition to comfort and convenience, the CGM provides continuous blood glucose data that test strips may miss. In PD, the drug levodopa induces very obvious "on" and "off" states in patients, and thus snapshots of a patient's symptoms can be misleading. Continuous assessment, particularly in the home, can provide a truer reflection of a patient's health status, allowing for better management of dosages and a better understanding of disease progression. Removing the need to make stressful long-distance journeys to specialists is particularly helpful for patients who struggle with fatigue.
To date, wearables for PD monitoring have been examined extensively in clinical trials. While there are specialist providers, consumer electronics companies such as Apple and Verily (Alphabet) are conducting their own studies to enter the space. An interesting startup is Rune Labs, which utilizes data obtained from Apple Watches, and has already received FDA clearance.
IDTechEx's report on remote patient monitoring includes additional RPM applications for smartwatches, including elderly monitoring, decentralized clinical trials, and health insurance. For more information, please visit the report website at www.IDTechEx.com/RPM.
Continuous Glucose Monitoring vs. Test Strip Readings. Source: IDTechEx
Electronic Skin Patches: Form Factor of Choice for Continuous Monitoring
A form factor that has seen significant commercial success in continuous monitoring is the electronic skin patch. In addition to continuous monitoring, the form factor allows for close contact with the body, consistent positioning, and, generally, higher patient comfort over incumbent options.
Detection of infrequent cardiac arrhythmias:
The electronic skin patch form factor has enabled longer-term monitoring of patients with suspected cardiac arrhythmias. Patients can be diagnosed in the clinic, or via wired Holter monitors, but these electrocardiogram (ECG) readings, measured in minutes and hours, are often too short to catch infrequent arrhythmias. Electronic skin patches such as extended-wear Holter monitors and mobile cardiac telemetry (MCT) devices offer sufficient comfort for patients to wear for longer periods of time, resulting in higher diagnostic yields when compared with conventional Holter monitors.
~Post-chemotherapy temperature monitoring://
Electronic skin patches for temperature monitoring can enable better care of cancer patients by detecting infections earlier. Chemotherapy-induced neutropenia puts cancer patients at heightened risk of life-threatening infections, and delays in detecting the infection can result in more intensive treatments and higher risks. Monitoring post-chemotherapy patients at home with a continuous temperature monitor can potentially detect impending hospitalizations by more than 18 hours in advance, as demonstrated by Vivalink's electronic skin patch.
IDTechEx has produced the most comprehensive report on the electronic skin patches form factor, analyzing over 13 applications and 130 companies, and providing 10 years of historic data and market forecast. Please refer to the report "Electronic Skin Patches 2023-2033" for more information.
What Is Next for Biosensors at the Point-Of-Care?
Finally, it is remiss to discuss point-of-care (POC) diagnostics without covering COVID-19 testing. The demand for COVID-19 point-of-care tests effectively doubled the market for all POC biosensors between 2019 and 2021, with COVID-19 testing surpassing the combined diabetes test strip and CGM markets. While sales have since quietened down in 2022, the tail end of this demand has been larger than anticipated. Still, IDTechEx forecasts the COVID-19 market to continue its decline in 2023.
However, that does not necessarily mean that COVID-19 testing will stop. As we enter the winter season in the Northern Hemisphere, we will be seeing the deployment of POC tests that combine testing for influenzas A and B, respiratory syncytial virus (RSV), and COVID-19. Such tests will enable doctors to efficiently triage patients who present with respiratory symptoms. Rather, the drive of the downturn for COVID-19 testing has been the gradual elimination of travel testing and for most countries around the world, regular testing requirements for the general public.
For more information about biosensors across bioreceptors, transducers, and applications, please refer to the IDTechEx report "Biosensors for Point-of-Care Diagnostics 2022-2032: Technology, Opportunities, Players and Forecasts".
PoC Biosensor Market Breakdown by Application: 2019 vs. 2021. Source: IDTechEx
IDTechEx have been covering the health and wellness spaces for the past 10 years. IDTechEx offer reports on topics spanning multiple fields including wearable technologies, digital health, DNA sequencing, antimicrobial technology, and many more. Please refer to our website at www.IDTechEx.com for more information.