Introduction

Pharmaceuticals products that contain ingestible sensors will bring about a revolution in the patient compliance challenge. Many elderly patients find it hard to keep track of medication simply because they tend to forget taking pills, medication or prescription compliance is also a challenge for the mentally ill patients.

Digital pills also have a significant opportunity in the compliance of oral chemotherapy. Oral chemotherapy has seen only about 50% compliance, thus resulting in lower favorable results after treatment. Increasing the compliance for oral chemotherapy can offer increased treatment response.

The sensor in the digital pills is designed to transmit data post consumption, thus tracking if the patient has ingested the medication or not. Although digital pills are currently more inclined for the application of medicine adherence or patient compliance, they have potential application in data collection in clinical trials as well.

This is because the pills can not only digitally maintain a log of time ingested but also can monitor a number of other parameters post ingestion that could offer more insights for drug development process.

These digital pills are currently regulated as the digital medicine. Most regulations around the world do not have specific regulations for digital pills. However with the approval and launch of Abilify MyCite will offer insights to regulatory authorities to consider updating regulations to incorporate digital pills.

This product was approved for schizophrenia treatment, treatment for manic and mixed episodes associated with bipolar disorder as well as for the use as an add-on treatment for depression in adults. The recently launched digital pills are prescribed for mental disorders and chemotherapy (colorectal cancer).

However, there a studies that focus on digital pills for TB and cardiovascular conditions as well. Digital pills are a very good option of the elderly patients, patients with mental disorders, or patients that have potential to not adhere to medication prescribed.

However, the adoption of digital pills is currently low, due to a number of factors including unclear regulations, long term side effects, and risk of breach of data privacy. Additionally, cost and reimbursement of these products with be a major factor that will influence its adoption in the near future.

A number of parameters need to be addressed by regulatory bodies such as the method of incorporation of the sensor in the tablet or capsule. For an instance, the Abilify MyCite developed by Proteus, had to undergo complete clinical investigation to receive its FDA approval while its digital chemotherapy product did not require a new round for regulatory approval primarily due to the fact that the digital component was loosely packed within the capsule.

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Market Segmentation

By product type	Tablet Capsule Microchip delivery device
By Indication	Mental Disorders Cancer Infectious Diseases Others
By distribution channel	Hospital Pharmacies Retail Pharmacies Specialty Pharmacies Mail Order Pharmacies

ABILIFY MYCITE System developed by Otsuka America Pharmaceutical, Inc. and Proteus was the first smart pill approved by the FDA. Some of the other digital pills include, ID-Capsule™ by etectRx™, a gelatin capsule that has an ingestible wireless sensor embedded.

Another interesting device, although not exactly a pill, Keratin Biosciences has developed a microchip that has a compartment to hold upto 1mg of the drug component that can then be released by a preprogramed dosing schedule.

Furthermore, Proteus, the manufacturer of the Abilify MyCite technology announced in the beginning of this year that the first cancer patient was treated. The chemotherapy drug of choice for the company to incorporate its sensor was capecitabine.

The company is expected to take the lead in the chemotherapy digital pills market with this launch. Although there are a number of products understudy, approval from regulatory bodies is a long complex and expensive procedure that the new entrants will have to face. Proteus has already launched its digital pill taking the lead in the market.

Furthermore, since the chemotherapy digital pill offered by the company is capecitabine, one of the most common chemotherapy drug prescribed, will offer a serious challenge for new entrants in the digital cancer pills market.