The future of 'digital' pills

Innovators in this field are poised to grapple with hurdles

In November 2017, the US Food and Drug Administration approved a groundbreaking “digital” pill. Named Abilify MyCite, it contained aripiprazole, a medication prescribed for schizophrenia and mania, and had an ingestible sensor that would track medicine intake.

The sensor would transmit data to a wearable patch, which would forward it to a mobile application. This convenient setup would help patients monitor their medicine intake; they could also share this data with their caregivers and medical practitioners.

The pill was developed by American firm Proteus Digital Health and Japanese company Otsuka Pharmaceutical. Notably, Proteus, headquartered in California, created both sensor and patch. The company swiftly forged substantial partnerships within the pharmaceutical industry, amassing nearly $500 million in funding and achieving a valuation of around $1.5 billion.

However, Proteus encountered a series of challenges. Abilify had been an FDA-approved antipsychotic medication since 2002, and Abilify MyCite, twice as costly, was introduced as an adjunct to the generic Abilify. Moreover, the concept of an ingestible sensor did not resonate with many at the time. Proteus filed for bankruptcy in mid-2020.

However, the spark it lit, in terms of digital pills, continues to glow. Health care investors are optimistic about this niche domain as digital pills could improve treatment outcomes, increase compliance and reduce hospital stays. A recent market study published by Precision Reports underscores this optimism, projecting a robust compound annual growth rate (CAGR) of +8 per cent for the global digital pills market from 2023 to 2029. In July 2022, a study conducted using various internet databases showed that, by the end of June 2021, close to 250 products in this domain were at different stages of development.

This period also saw an increase in the number of patents related to digital pills, notably those featuring ingestible sensors tailored for mobile clinical monitoring, intelligent drug delivery and endoscopy diagnostics. The patent activity was mostly happening in areas of mental health, cardiovascular disorders, diabetes, gastroenterology, oncology, tuberculosis and transplantology.

Innovators in this field, however, are poised to grapple with hurdles, including pricing. An even more formidable obstacle is the fear surrounding the potential compromise of privacy―in 2018, cardiologist Lisa Rosenbaum had likened the use of digital pills to “swallowing a spy”. So, the establishment of an ethical and legal framework is imperative to ensure principled ownership and utilisation of medicinal data.

Currently, the US, Europe, China, Canada and Australia account for approximately 72 per cent of the global patent landscape. Indian researchers are also active in the field. According to Frontiers in Pharmacology, between 2012 and 2022, 977 research papers related to digital pills were published. Indian researchers, with 46, ranked third in terms of number of papers. Given India's status as a pharmaceutical leader and its ability to provide cost-effective IT resources, it has the potential to become a pivotal force in combining pharma with digital. This potential aligns with the core challenge that companies will inevitably face―that of making these smart pills more accessible and affordable.