Those of us of a certain age remember the Jetsons Peek-a-Boo Prober Capsules. A form of this went from science fiction to reality in 2014 when the U.S. Food and Drug Administration (FDA) approved the PillCam. It’s a pill-sized camera that the patient swallows. It makes its way through the digestive system in about 8 hours taking pictures. The data is then sent to a receiver the patient wears around his or her waist. Later, a doctor can review the results. This type of pill is meant to be an alternative to a colonoscopy or endoscopy.
Another type of smart pill has an indigestible sensor built into the pill that monitors when a patient takes a dose. The sensor is activated when it comes in contact with stomach fluid. It sends a message to a wearable patch which in turn sends a message to an app on a patient’s smartphone. If the patient allows, the information can be sent to the patient’s doctor. Smart pills of this sort are created with the purpose of making it easier for patients to remember to take their medications and to let doctors know if their patients are complying.
In the United States, up to 50% of people do not take their medication as prescribed. In developing countries, adherence is even less. Medication nonadherence can account for up to 50% of treatment failures. According to the Office of the United States Inspector General, 125,000 deaths from cardiovascular diseases such as heart attack and stroke are caused by nonadherence to long-term drug therapies. Also, up to 23% of admissions to nursing homes, 10% of hospital admissions and many doctors’ visits, diagnostic tests and treatments are due to nonadherence. An estimated $100 to $300 billion in healthcare costs can be saved annually if medication adherence rates were higher. “Adherence rates of 80% or more are needed for optimal therapeutic efficacy.”1
In November 2017 the FDA approved the first drug with a digital ingestion tracking system, Abilify MyCite, a medication used to treat bipolar disorder and schizophrenia. Those who have schizophrenia have one of the highest medication noncompliance rates on average. However, some argue that suggesting people with schizophrenia swallow a digital pill that will send signals outside their body will only worsen their condition, especially for those who already experience paranoia or persistent feelings about being watched or persecuted. Others like Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research state: “Being able to track ingestion of medications prescribed for mental illness may be useful for some patients.” Regardless, according to the FDA, “Abilify MyCite’s prescribing information notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown. Abilify MyCite should not be used to track drug ingestion in ‘real-time’ or during an emergency because detection may be delayed or may not occur.” Abilify MyCite retails for, in some cases, twice the amount of the generic, non-digital equivalent.
Since the advent of this drug, smart pills have been designed for conditions such as uncontrolled hypertension, type-2 diabetes, and more recently cancer. According to a research study by Proteus Digital Health, the manufacturer of the drugs, those taking smart pills for uncontrolled hypertension and type 2 diabetes had better results when compared to people taking standard therapies.
Today’s market size shows the global smart pill revenue figures for 2016, 2018 and projected for 2025. As of 2016, more than 75% of smart pill revenue came from capsule endoscopy versus less than 25% for drug delivery. North America led the world in the share of smart pill revenue with 57.1%. North America is expected to continue its lead into the future due to technological advances in the healthcare sector, increases in the incidence of colorectal cancer and regulatory approval of new products. Major companies include Medtronic PLC; Proteus Digital Health; CapsoVision, Inc.; Olympus Corporation; and Medisafe. In December 2019, etectRx received FDA approval for its ID-Capsule system to compete with Proteus’s system. etectRx’s system has a lanyard rather than a wearable patch.
1 Source: Jennifer Kim, et. al., “Medication Adherence: The Elephant in the Room,” U.S. Pharmacist, January 19, 2018 available online here
Geographic reference: World
Year: 2016, 2018 and 2025
Market size: $779.4 million, $850 million and $1.5 billion, respectively
Sources: “Smart Pills Market Analysis by Application (Products [Capsule Endoscopy, Drug Delivery], Tools, and Patient Monitoring Software), by Region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa), and Segment Forecasts, 2018 – 2025,” Grand View Research Report Summary, December 2017 available online here; “Smart Pills Market by Component (Smart Pills and Workstations), by Application (Imaging and Monitoring), and by End-User (Hospitals, Clinics, Research Institutes, and Home Healthcare): Global Industry Perspective, Comprehensive Analysis, and Forecast, 2018–2025,” Zion Market Research, June 7, 2019 available online here; Matt Novak, “George Jetson Gets a Check-Up,” Smithsonian Magazine, January 2, 2013 available online here; “The FDA Approved a PillCam the Jetsons Predicted 50 Years Ago,” Paleofuture, February 7, 2014 available online here; Adherence to Long-Term Therapies, World Health Organization, 2003 available online here; Jennifer Kim, et. al., “Medication Adherence: The Elephant in the Room,” U.S. Pharmacist, January 19, 2018 available online here; Michael Rucker, “Digital Pills are Coming to Health Care,” Verywell Health, December 6, 2019 available online here; “FDA Approves Pill with Sensor That Digitally Tracks If Patients Have Ingested Their Medication,” FDA News Release, November 13, 2017 available online here; Erin Brodwin, “A Silicon Valley Company Just Launched ‘Smart’ Cancer Pills That Track You With Tiny Sensors Stamped Into Your Medication,” Business Insider, January 19, 2019 available online here; Sam Draper, “How Smart Pills Could Revolutionize Healthcare,” Wearable Technologies, May 23, 2018 available online here; Elise Reuter, “New ‘Smart Pill’ Maker Gains FDA Approval,” MedCity News, December 9, 2019 available online here; Richard Staines, “FDA Approves etectRx ‘digital pill’ as Rivals Struggle,” Pharmaphorum, December 10, 2019 available online here; “Abilify,” GoodRx available online here; Christina Farr, “Digital Health Start-Up Once Worth $1.5 Billion is Racing to Keep Lights on as Investors Flee,” CNBC, December 8, 2019 available online here.
Image source: Steve Buissinne, “medicine-pills-prescription-4097308,” PIxabay, April 2, 2019 available online here. Picture does not show smart pills. Image is used for illustration purposes only. See the picture in the MedCity News source for a picture of one type of smart pill.