Apps and AI Trigger Digital Transformation in Healthcare

Diseases are treated with smartphone apps prescribed by the doctor—that’s the world we now live in. In August 2020, the healthcare startup CureApp (Tokyo) received approval for its smoking cessation (nicotine addiction) treatment app. After gaining insurance coverage in December that year, the app was released. According to CureApp, over 100 medical institutions have introduced smoking cessation treatment using the app.

Apps for High Blood Pressure and Insomnia

This is the first time in Japan a therapeutic app was approved as a medical device and covered by insurance. American and European firms are ahead in launching therapeutic apps, but many areas are still untapped, leaving plenty of room for Japanese companies to compete. In fact, CureApp was the first in the world to release a smoking cessation treatment app for practical use. With a U.S. subsidiary established in 2019, the company plans to take the domestic therapeutic apps and expand them overseas as Japanese digital treatments.

CureApp’s smoking cessation package includes the app and an IoT device for measuring breath carbon monoxide (CO) and is used together with medication. The treatment is available for patients diagnosed with nicotine addiction, prescribed like a medicine based on the doctor’s judgment.

Patients can download the app on their smartphones, and enter the prescription code issued by the doctor to log in. By entering their daily physical condition and cessation status on the app, the patient receives personalized advice on suppressing smoking temptations, that encourages behavioral change. In a clinical trial in Japan conducted by CureApp, 63.9% of patients who used the app remained tobacco-free 24 weeks after starting treatment. This was 13.4% higher than the patients who did not use the app.

Therapeutic app development has been active in Japan over the last few years. Following the revision of the Pharmaceutical Affairs Law to the Pharmaceutical and Medical Device Act (PMD Act) in 2014, a program by itself became eligible for approval as a medical device in Japan. Since then, startups, such as CureApp, as well as pharmaceuticals and other major companies, have also begun development.

According to the Indian research firm KBV Research, the global market for digital treatments, including therapeutic apps, is projected to grow from 3.4 billion USD in 2020 to 14.5 billion USD in 2027. The Ministry of Health, Labour and Welfare has also set guidelines in Japan to encourage development.

Besides the one for smoking cessation, CureApp is developing four other therapeutic apps. In May 2021, it applied for the approval of its hypertension treatment app. Like in smoking cessation, the app encourages changes in awareness and behavior by delivering optimal treatment guidance for each patient. A clinical trial conducted on patients before they received drug treatment confirmed the antihypertensive effect of the app. This is said to be the world’s first proven case for the effectiveness of a hypertension app.

There are other leading startups. The telemedicine provider MICIN (Tokyo) has been co-developing a diabetes treatment support app with Terumo from 2020, and in September 2021, began joint research with the University of Tokyo and others for an app to treat irritable bowel syndrome. SUSMED (Tokyo) is working on the final clinical trial of its insomnia treatment app.

Among major pharmaceutical companies, Shionogi has gained the right to develop an ADHD treatment game app from the U.S. startup Akili Interactive Labs and is conducting a clinical trial in Japan. Astellas Pharma plans to start a domestic clinical trial of the diabetes treatment app developed by Welldoc in the U.S. by the end of FY 2021. Both apps have been approved in the U.S. and are used for treatment.

For major pharmaceutical companies, in addition to diversified income, the development of therapeutic apps also implicates enhancing the value of its own drugs used with the app. The data obtained through the apps can also be used for new drug development.

Meanwhile, profitability is uncertain, and the insurance reimbursement price of CureApp’s smoking cessation treatment app was far below the company’s expectations. With the revision of medical fees coming up in April 2022, the Ministry of Health, Labour and Welfare is studying how insurance should be applied for treatment apps. CureApp CEO Kohta Satake said, “To nurture the industry of therapeutic apps, we should refer to the preceding overseas cases when considering insurance points.”

As a technological innovation in the medical field, the use of artificial intelligence (AI) is also in the spotlight. There has been a succession of cases for practical use in diagnostic imaging, and AI is also used for drug development.

In January 2020, Sumitomo Pharma (former Sumitomo Dainippon Pharma) began a clinical trial in Japan for an obsessive-compulsive disorder (OCD) candidate drug discovered by AI. The drug was created using the company’s AI in joint research with the U.K. startup, Exscientia. The exploratory research, which typically takes about four and a half years, was completed in less than a year.

Seeking Standardization of In-House Technology

By calculating for just 90 minutes, the U.K. startup BenevolentAI identified the treatment potential of the rheumatoid drug baricitinib on COVID-19. The drug received an emergency use approval in the U.S. in November 2020 and was approved in Japan as a COVID-19 drug in April 2021. Use of AI is expected to streamline the vast time and cost invested in drug development.

Advancements are also seen in Japan. LPIXEL, which provides AI-driven image diagnosis, has developed a technology to analyze cell images with AI and evaluate the effects of compounds in collaboration with Daiichi Sankyo and Takeda Pharmaceutical. MOLCURE (Kawasaki City) is at the forefront of AI-based antibody design and its technology is used by multiple pharmaceutical companies in Japan and abroad.

FRONTEO, which specializes in natural language processing, launched an AI that can instantly extract the target information for researchers from a huge number of medical papers, or visualize the relationships between molecules and genes involved in diseases. Chugai Pharmaceutical has also developed an original AI that selects the optimal sequence for a new drug candidate from a huge number of antibody amino acid sequences and has achieved positive outcomes.

According to U.S. research firm Report Ocean, the AI drug development market is projected to grow at an annual rate of 40.8% from 2021 to 2027. Companies outside Japan are leading in development, but domestic companies are aiming to catch up, with LPIXEL and MOLCURE seeking to standardize their in-house technologies.

(Yuki Maeda, Answers News Editor-in-Chief)