Points of View Trends in the Development of Digital Medicine and the Involvement of the Pharmaceutical Industry Based on Trends in Clinical Trials and Alliances

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Junya Tsujii, Senior Researcher, National Institute of Biomedical Innovation Policy

1. Introduction

Movements toward the spread of "digital health," which utilizes rapidly advancing digital technology to intervene in health from everyday life, are gaining momentum in many countries.

In the United States, for example, the Digital Health Innovation Action Plan1) ( issued in 2017) has been formulated, and the Digital Health Software Precertification The United States has been promoting various initiatives, including the formulation of the Digital Health Innovation Action Plan1) (issued in 2017), the Digital Health Software Precertification Pilot Program (Pre-cert) 2) that certifies companies involved in software products, and the establishment of the Digital Health Center of Excellence (DHCoE) 3) that promotes the development of digital health technologies. In addition, as an emergency measure during the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) will issue in April 2020 an "Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency" was issued in April 2020, allowing temporary clinical use for digital health and other devices for treating psychiatric disorders that meet certain requirements4).

Also in the United Kingdom, the National Institute for Health and Care Excellence (NICE) released the first edition of the Evidence standards framework for digital health technologies in 2018. The framework clearly presents the required evidence framework and case studies for digital health, which are classified based on the purpose of use and impact on the human body, in order to promote development5).

In Japan, discussions are underway in various places regarding the establishment of systems for approval review and insurance reimbursement7), 8) with the aim of medical deployment of programmed medical devices6). In addition, the "Basic Policies for Economic and Fiscal Management and Reform 2021: Four Driving Forces for Japan's Future - Green, Digital, Vibrant Regional Development, and Measures to Cope with Declining Birthrate" (Kottai Seisaku 2021), 9) approved by the Cabinet on June 18, 2021, and the Growth Strategy Action Plan10) also indicate a policy to promote the development and practical application of programmed medical devices. It can be said that digital health is being recognized by society as one of the new medical modalities.

This trend toward the digitalization of healthcare is a trend that the pharmaceutical industry, which has been contributing to healthcare by providing "pharmaceuticals," should keep a close eye on. The "Pharmaceutical Manufacturers Association of Japan (hereafter referred to as "Pharmaceutical Manufacturers Association of Japan") announced on May 20, 2021 the "Pharmaceutical Manufacturers Association of Japan Industrial Vision 2025 Supplementary Edition," in which support for "the realization of healthy living through the use of mobile devices" is stated11). The pharmaceutical industry also aims to contribute to medical care, including improving the therapeutic effects of pharmaceuticals, by promoting the practical application of mobile devices that contribute to health and medical care, and the relationship between the pharmaceutical industry and digital technology is expected to increase further in the future.

In this report, we will review the global development trend of "digital medicine (also called digital medicine)," which is expected to have therapeutic effects when used alone and synergistic effects when used in combination with pharmaceuticals. In addition, we will compare the approaches to digital technology (status of partnerships) of pharmaceutical companies in Japan, the U.S., and Europe, and discuss the involvement of the pharmaceutical industry in the practical application of digital medicine in Japan.

2. Definition of Digital Health

Various organizations have provided interpretations of digital health, but this paper will refer to the definition12) co-proposed by the Digital Medicine Society (DiMe) and others in the United States.

According to the definition published by DiMe, digital therapeutics ("DTx") are "digital products that provide evidence-based therapeutic interventions for the prevention, management, and treatment of medical and other diseases" and digital medicine are "evidence-based software and hardware products" (Figure 1). In other words, while the former is a therapeutic intervention backed by clear efficacy and risk assessment, the latter is a broad definition that includes "support" for medical treatment through measurement and other means. However, both are characterized by the need for clinical evidence, albeit to varying degrees. Outside of digital medicine is "digital health," which refers to a broad range of health-related solutions, but clinical evidence is not required. This paper investigates the "clinical evidence" required for the development of digital medicine, including DTx, from the aspect of clinical trials to estimate the progress of development. In addition, access to digital technology was surveyed and the involvement of the pharmaceutical industry was organized.

Figure 1 Definition of Digital Health

3. Survey Methods for Clinical Trials13)

In addition to "mobile apps" and "games," which have been utilized as digital medicine in recent years, this survey also examines "Virtual Reality (VR)/Augmented Reality (AR)," which was designated as a Breakthrough Device Program by the FDA last year14) and is being developed for use in medicine. The survey also covered "Virtual Reality (VR)/Augmented Reality (AR)," which was designated as a Breakthrough Device Program by the FDA last year14 ) and is being developed for medical use15). For these tools, the International Clinical Trials Registry Platform (ICTRP) provided by the World Health Organization (WHO) was used to extract clinical trial data by using the search terms in Note 17) 16), 17). The scope of data was all information listed as of July 29, 2021, and included information from 2007 onward for mobile apps, 2005 onward for games, and 2002 onward for VR/AR. In addition, tests that used more than one technology among mobile apps, games, and VR/AR were counted for each tool. (e.g., "app-based games" were counted for each of mobile apps and games.) Please note that this survey was based on a sampling of specific search terms and may differ from the exact number of development items.

4. Survey results

4-1. Mobile Apps

For mobile apps, 824 clinical trials were extracted, with 762 (92%) being intervention studies and 62 (8%) being observational studies18). The number of clinical trials has been increasing every year, with more than 100 trials registered each year since 2018 (Figure 2a)).

From the perspective of technology creation, when the primary sponsor, which refers to the organization or entity that conducts the clinical trial, is classified by nationality (829 trials in total, with some trials including multiple primary sponsors), Australia had the largest number of trials (175), followed by the United States (118) and Iran (63) ( Figure 2b)). Japan registered 29 cases, ranking 10th overall (51 countries/regions). By region, Europe had the highest number of registrations, followed by Oceania and Asia19 ) (Fig. 2c)). On the other hand, looking at annual trends, Europe, Oceania, and North America were the main regions for development in the early to mid-2010s, but registrations in Asia have been increasing in recent years (Figure 2d)). Especially since 2019, the region has overtaken Europe as the number one region, with Thailand, India, South Korea, China, and Japan among the top five countries by year (Table 1).

In addition, the classification of the type of primary sponsor showed that universities (including university hospitals) and medical institutions accounted for more than 80% of the total (Figure 2e)). Only 57 (7%) were companies, of which 8 were pharmaceutical companies. Including secondary sponsors (co-sponsors) and research funders, the involvement of pharmaceutical companies was not significant, totaling 27 cases.

Figure 2f) shows the disease areas covered by the mobile application20). The largest number of trials were for "mental and behavioral disorders," followed by "endocrinology, nutrition and metabolism" and "cardiovascular system. In particular, the number of clinical trials in "mental and behavioral disorders," such as depression and substance abuse disorders, which have a high affinity with cognitive-behavioral therapy, is increasing every year, and development in this area is becoming more active (Figure 2g)).

In addition, focusing on the research objectives described in the intervention studies (762 studies) and classifying them by purpose, many of the clinical trials were aimed at treatment or prevention21 ) (Figure 2h)). By disease area, the largest number of studies in both disease areas were for "mental and behavioral disorders," with 81 (34% for treatment purposes) and 38 (25% for prevention purposes), respectively (data not shown).

Fig. 2 Trends in mobile app clinical trials a）Number of clinical trial registrations b）Primary sponsor nationality
c）Primary sponsor region d）Primary sponsor region by year
e）Type of primary sponsor f）Disease areas covered
g) Yearly change in target disease h) Study objective
Table 1 Trends in mobile app registrations by primary country

4-2. Games

For the games, 308 clinical trials were extracted, with 301 (98%) intervention studies and 7 (2%) observational studies; an increasing trend in clinical trial enrollment was observed in the mid to late 2010s, but slowing in 2019 and 20 (Figure 3a)).

When primary sponsors were classified by nationality (309 trials overall, with trials including multiple primary sponsors), the United States had the largest number of trials with 69, followed by Australia (35) and Brazil (31) (Figure 3b)). However, the growth in the number of clinical trials in these countries has also slowed (Table 2). Japan had 5 registrations, ranking 14th overall (31 countries/regions). By region, North America had the highest number of registrations, followed by Europe and Oceania, with zero registrations in Africa (Fig. 3c)). (Yearly trend data for primary sponsor regions are omitted.)

The primary sponsor type of clinical trials is shown in Figure 3d). Approximately 90% of all sponsors were universities (including university hospitals) and medical institutions, while only 7 (2%) were companies. In addition, pharmaceutical companies were the primary sponsors in only one case and were not involved as secondary sponsors or research funders.

Figure 3e) also shows the target disease areas by game. As with the mobile apps, the largest number of trials were for "mental and behavioral disorders" such as depression, followed by "endocrine, nutrition and metabolism" and "cardiovascular system. In addition, the use of games to promote physical activity for diseases related to the "musculoskeletal system and connective tissue" was also common. However, for both diseases, the growth in the number of clinical trials has slowed in recent years (Figure 3f)).

When the intervention studies (301 studies) were categorized by research purpose, treatment was the most common (125 studies) (Figure 3g)). Mental and behavioral disorders were the most common disease area targeted for treatment, with 37 cases (30% of treatment objectives) (data not shown).

Figure 3 Gaming Clinical Trial Trends a) Number of Clinical Trial Registrations b) Primary Sponsor Nationality
c）Primary sponsor region d）Primary sponsor type
e）Target disease areas f）Annual trends in target diseases
g) Study objectives
Table 2 Number of game registrations in primary sponsor countries

VR/AR

For VR/AR, 983 clinical trials were extracted, with 942 intervention studies (96%, VR: 898, AR: 44) and 41 observational studies (4%, VR: 40, AR: 1) (Figure 4a). The number of clinical trials increased each year, with more than 100 studies enrolled each year since 2018.

When the primary sponsors were classified by nationality (983 in total), the United States was prominent with 209 cases, followed by France (69) and Brazil (67) (Figure 4b)). Note that Japan registered 24 cases, ranking 15th overall (50 countries/regions). Meanwhile, by region, Europe had the largest number of trials, followed by North America and Asia (Figure 4c)); since 2019, Europe has had the largest number of trials by year (Figure 4d)), and France and Germany were among the top five countries in recent years (Table 3).

In addition, the type of primary sponsor is shown in Figure 4e). Approximately 90% of all sponsors were universities (including university hospitals) and medical institutions, while 12 (1%) were companies. Of these, no pharmaceutical companies were primary sponsors, and four were involved as secondary sponsors or research funders.

Figure 4f) shows the disease areas covered by VR/AR. The largest number of trials were for "mental and behavioral disorders," which included the alleviation of anxiety and the treatment of post-traumatic stress disorder. Mobile apps and games have also been studied for the treatment of depression and substance abuse disorders by promoting changes in awareness and behavior, and VR/AR has been studied for anxiety reduction for severe trauma such as post-traumatic stress disorder by taking advantage of its high immersive experience. It can be seen that the characteristics of each tool are being considered for use in the treatment of "mental and behavioral disorders. In addition, looking at the annual changes in each disease area, the increase in the number of clinical trials for "mental and behavioral disorders" was particularly remarkable (Fig. 4g)). In addition, VR/AR is characterized by a large number of clinical trials for "not elsewhere classified" and "musculoskeletal system and connective tissue. In these disease areas, pain relief is expected to be achieved by utilizing the immersive sensation of VR/AR, and many trials verified the reduction of acute and chronic pain caused by diseases and medical procedures.

When the intervention studies (942 studies) were categorized by purpose of study, treatment was the most common, with 532 studies (Figure 4h)). The most common disease area for treatment was "mental and behavioral disorders," with 183 (34% of treatment purposes) enrolled (data not shown). In "Cardiovascular system" and "Injury, poisoning and other external causes," clinical trials aimed at functional recovery, such as rehabilitation after stroke or brain injury, were included even when classified as treatment.

Figure 4 VR/AR Clinical Trial Trends a) Number of clinical trial registrations b) Primary sponsor nationality
c）Primary sponsor region d）Primary sponsor region by year
e）Type of primary sponsor f）Disease areas covered
g) Yearly change in target disease h) Study objective
Table 3 Trends in VR/AR Registrations in Major Countries

Supplement 1 About ShamTools

Standard therapies or similar digital tools may be used to control digital medicine clinical trials. On the other hand, to ensure blinding, it is desirable that the subjects cannot discriminate the use of digital medicine.

Sham (pseudo) tools, equivalent to placebos, are sometimes used to address this issue. In the present study, patientMpower, an Irish digital healthcare company, used a sham application that does not record monitoring results in a clinical trial that tested the usefulness of a self-monitoring application for weight, blood pressure, etc. for hemodialysis patients22). In addition, a clinical trial for autism spectrum disorder (ASD) conducted by Pennsylvania State University in the U.S., which aimed to detect changes in eye gaze unique to ASD patients by means of a game, used a sham game as the control, with the basic specifications intact, except for the learning opportunity to detect eye gaze cues only (23).

In digital medicine, which measures biometric and other information, the presence or absence of data recording and detection functions as described above makes pseudoization possible, while in the case of tools using cognitive behavioral therapy, a sham tool that brings awareness of behavior change to the examinee but does not actually promote effective behavior change is required. Currently, the technical hurdle to satisfy these two conflicting objectives is expected to be high, and we believe this is one of the reasons why the use of sham tools is limited.

In Japan, the "Report of the Study Group on Medical Device Programs with Behavioral Changes" issued in March 2021 indicates the need for consideration of whether or not to set sham or placebo in clinical trials and the evaluation of sham validity24). It is expected that technical improvements in sham tools and the accumulation of further case studies will advance the discussion on control groups in clinical trials.

5. Approaches to digital technology by pharmaceutical companies

5-1. Purpose and Survey Methodology

A survey of clinical trial trends in digital medicine revealed limited involvement of pharmaceutical companies as primary sponsors, etc., in any of these tools. On the other hand, some readers may feel that in recent years there have been more opportunities to hear news of pharmaceutical companies forming alliances with or acquiring companies involved in digital medicine and other related fields. In order to understand trends in approaches to digital technology, we surveyed alliances involving pharmaceutical companies in Japan, the U.S., and Europe through press releases and news sites25). The data collection period was from January 1, 2010 to August 19, 2021.

The data collected covered the period from January 1, 2010 to August 19, 2021. There was no overlap between the alliances identified for foreign pharmaceutical companies in Japan and those identified for global headquarters in the U.S. or Europe, and alliances involving each were selected. Please note that the aggregate results also include alliances related to digital health.

5-2. Japan

A survey of 73 member companies of the Pharmaceutical Manufacturers Association of Japan revealed a total of 68 cases in 32 companies where digital technology-related partnerships were observed (Table 4). Of these, 17 companies had 42 cases of domestic investment and 15 companies had 26 cases of foreign investment, showing a rise in the number of alliances from around 2018 (Figure 5). The number of partnerships for each company was mostly 1 case/company, with a maximum of 6 cases/company.

A survey of the tools with which each company partnered revealed that mobile apps were the most common, with 51 cases (33 domestic, 18 foreign), and were intended for treatment, medication and disease symptom management, and lifestyle improvement. Games and VR/AR were in small numbers, with 2 cases each in total (Figure 5).

Table 4 Number of digital technology-related partnerships among Japanese pharmaceutical companies

Focusing on domestic companies, we confirmed the type of alliances and found that alliances related to joint research and development with external parties and introduction of existing products stood out (Figure 6). The products targeted by the alliances included disease management applications utilizing Personal Health Record (PHR), diagnostic assistance tools, and DTx (Table 5), and the majority of the alliances were with Japanese nationalities (Figure 7).

Figure 5 [Japan] Number of digital technology-related partnerships among pharmaceutical companies (by tool)
Figure 6: Percentage of digital technology-related partnerships among Japanese, U.S., and European pharmaceutical companies

Fig. 7 Nationality of digital technology-related alliances among pharmaceutical companies in Japan, the U.S., and Europe

Table 5【Japan】Number of digital technology-related alliances by pharmaceutical companies in recent years (example)

5-3. U.S.A.

A survey of seven U.S. pharmaceutical companies26) revealed that all of them had digital technology-related alliances, with a total number of 45. In addition, a rise in the number of partnerships was observed around 2015 (Figure 8).

The most common tool with which the companies partnered was mobile apps, with 28 cases (Figure 8), which were intended for treatment, disease symptom management, and biomonitoring. Games and VR/AR were in a small number of cases (5 and 0, respectively).

In addition to joint research/development and introduction of existing products, many external partnerships were aimed at business investment in specific companies or startup support (29% of all partnerships, 5% in Japan (domestic capital)) (Figure 6). Specifically, they are holding accelerator programs such as pitch contests to incorporate startup technologies that match their own issues and provide support for commercialization (Table 6). Examples of product-related partnerships included those aimed at acquiring disease management applications and DTx (Table 5). The majority of the partners' nationalities were U.S., and there were no partnerships with Japan (Figure 7).

Figure 8 [U.S.] Number of digital technology-related alliances among pharmaceutical companies (by tool)
Table 6 Investments and start-up support by pharmaceutical companies (example)

Europe

A survey of eight European pharmaceutical companies27) revealed that all companies had digital technology-related alliances, with a total number of 67. In addition, a rise in the number of alliances was observed around 2015 (Figure 9).

The most common tool with which the companies partnered was mobile apps, with 47 cases (Figure 9), which were intended for treatment and management of medication and disease symptoms. On the other hand, games and VR/AR were used in a small number of cases (5 and 1, respectively).

As in the U.S., external alliances were characterized by business investment in specific companies and efforts to support startups (21% of all alliances, 5% in Japan (domestic capital)) (Figure 6). In addition, examples of product-related alliances included those aimed at acquiring disease management applications and DTx (Table 5). The majority of the partners were from the U.S., indicating global collaboration, but there were no partnerships with Japan (Fig. 7).

Looking at the average number of partnerships per company, Europe and the U.S. had 8.4 (67/8) and 6.4 (45/7) partnerships per company, respectively, which was higher than the 2.5 (42/17) partnerships per company for Japan (domestic capital). Even when limited to the 8 major Japanese (domestic) companies (28), the number was 3.1 cases/company (25 cases/8 companies), which was different from those in Europe and the U.S. (data not shown).

Fig. 9 [Europe] Number of digital technology-related alliances among pharmaceutical companies, by tool

6. Summary and Discussion

6-1. Summary

We summarize the survey results in Sections 4 and 5.

Trends in Digital Medicine Clinical Trials

  • The number of mobile app clinical trial registrations has been increasing year by year, with 153 registrations in 2020. Australia had the highest number of nationalities of primary sponsors during the period covered (2007-2021) (by year, the highest number of registrations on 10 occasions since 2011), and by region, Europe had the highest number of registrations. However, enrollment in Asia has been increasing in recent years, and since 2019 it has been the number one region by region.
  • The number of clinical trial registrations for games peaked in 2018 and has slowed down, with 32 registrations in 2020. The United States (8 most registrations by year since 2011) and North America were the most common nationalities and regions of primary sponsors during the period covered (2005-2021).
  • The number of VR/AR clinical trial registrations increased each year, with 229 registrations in 2020. The United States was the most common nationality of primary sponsor during the period covered (2002-2021) (by year, the most registrations in all years since 2011). By region, Europe has the highest number of registrations, especially in France in recent years
  • On the other hand, Japan's number of registrations and ranking are as follows: mobile apps: 29/ranked 10th (51 countries/regions), games: 5/ranked 14th (31 countries/regions), VR/AR: 24/ranked 15th (50 countries/regions), and development is not as active as in other countries.
  • While many of the primary sponsors were universities and medical institutions, the involvement of pharmaceutical companies was limited, with only a few cases for each tool.
  • In terms of disease areas, all tools have a high affinity with "mental and behavioral disorders," and many clinical trials have been registered, especially in recent years. Outside of "mental and behavioral disorders," many mobile apps were developed to improve lifestyle habits such as obesity and hypertension, games to provide exercise therapy, and VR/AR for pain relief and rehabilitation.

Status of approaches to digital technology among pharmaceutical companies in Japan, the U.S., and Europe

  • Looking at the number of alliances, the number of alliances in Europe and the U.S. was allowed to start up around 2015, while the number of alliances in Japan started up around 2018, showing a delay of several years.
  • As for the purpose of partnerships, pharmaceutical companies in Europe and the U.S. were more likely to make business investments in specific companies or to support startups, with 29% (13 cases) in the U.S. and 21% (14 cases) in Europe (Japan (domestic capital) accounted for 5% (2 cases)).
  • As for the nationality of the partner, Japan had a large number of cases where a domestic partner was selected. On the other hand, in the U.S. and Europe, the U.S. was the most common partner country.
  • Mobile apps were the most common tools acquired through partnerships in both Japan, the U.S., and Europe.

6-2. Involvement of the Pharmaceutical Industry in the Practical Application of Digital Medicine in Japan

Based on the survey results in this paper, we believe that the challenges for the practical application of digital medicine in Japan, including from the perspective of the pharmaceutical industry, are "slow start-up of clinical trials and digital technology-related alliances," "few global alliances," and "little business investment and start-up support.

Currently, the involvement of pharmaceutical companies in clinical trials of digital medicine is limited, and there are not as many digital technology-related alliances among Japanese pharmaceutical companies as there are in Europe and the United States. Under these circumstances, it is essential for Japanese pharmaceutical companies to collaborate with a wide variety of players, including start-ups and academia that generate seeds, medical institutions that generate evidence, and IT companies that handle data to visualize value, and to build a development system that takes advantage of their respective strengths in order to put digital medicine to practical use in the future. It is essential to build a development system that leverages the strengths of each player. In promoting the development of digital medicine, for which clinical evidence and regulatory approval are required, strengths in pharmaceutical affairs, drug pricing, intellectual property, and disease understanding, which pharmaceutical companies have cultivated through drug development, can be important elements. The active involvement of pharmaceutical companies through alliances with startups and academia may be the key to accelerating the development of digital medicine.

In terms of digital technology-related alliances in which pharmaceutical companies are involved, Europe has many alliances with the U.S., confirming that global collaboration is making progress. In addition, the fact that the majority of alliances in the U.S. were formed within the U.S. is expected to be due in no small part to the high level of technological development in the U.S., which leads the world in the number of digital medicine clinical trials. In Japan, on the other hand, many of the partnerships were in Japan. Given the differences in language and cultural backgrounds between Japan and Europe and the U.S., it is arguable that collaboration within Japan, where the characteristics of the Japanese people are understood, is an option, but it is also important to consider collaboration from a "technology perspective," including a global perspective. This paper has shown the status of clinical trials for each tool, but it can be said that grasping the technological trends in countries where digital medicine is being developed and the characteristics of each tool, and incorporating the appropriate technology to meet the objectives to be achieved, will lead to the creation of new medical solutions.

The creation of seeds is a prerequisite for the promotion of digital medicine development, and the fostering and support of startups that generate seeds is also an important issue. However, the state of nurturing and support in Japan is far from leading other countries. 150 of the world's most promising digital health startups selected by CB Insights for 2020 are mostly in the U.S. (77% are U.S. companies), and only one Japanese company (CureApp) was selected. CureApp) ,29) and 30). In addition, although the data is from 2017, the amount of funding for healthcare-related startups is about 580 billion yen in the U.S. versus 32.7 billion yen in Japan, a difference of about 18 times31), and further support is needed.

31) Further support is needed. Examples of support measures in Japan include the Japan Healthcare Business Contest by the Ministry of Economy, Trade and Industry (METI) 32) and the New Energy and Industrial Technology Development Organization (NEDO)'s R&D startup support program (budget scale: approximately 2 billion yen (FY2021) )33). The results of the survey in section 5 show that pharmaceutical companies in Europe and the U.S. are actively engaged in business investment and start-up support for specific companies. In the results of the survey in section 5, it was found that Western pharmaceutical companies are actively engaged in business investment and start-up support for specific companies (Figure 6). Specifically, Japanese domestic pharmaceutical companies' involvement in investment and start-up support was 5% (2) of all partnerships, while in the US it was 29% (13) and in Europe it was as high as 21% (14). In Japan, too, there are several support programs (Table 6), but not many are led by pharmaceutical companies. In order for Japan to compete globally in creating the seeds of digital medicine, further support from the public and private sectors will be important. In addition, since most of the primary sponsors in this survey were universities, it can be said that, as with start-ups, collaboration with and support from academia, which generates seeds, is an important element for the practical application of digital medicine.

7. Summary

With the development of digital technology as a backdrop, new medical solutions utilizing various scientific technologies are being deployed, and the nature of medicine is changing from "treatment" to "preemptive medicine including prevention and diagnosis," and from "uniform medicine" to "individualized and stratified medicine. This trend cannot be ignored by the pharmaceutical industry, which has traditionally focused on the provision of "products" in the form of pharmaceuticals. In addition, the Pharmaceutical Industry Vision 2021 issued by the Ministry of Health, Labor and Welfare on September 13, 2021, includes the pharmaceutical industry's "commitment to research and development based on a series of actions as a patient, including preventive and unwellness measures" and "utilization of IT, including programmed medical devices. In addition to pharmaceuticals, pharmaceutical companies are expected to make appropriate use of digital technology to contribute to a wide range of areas, including prevention from everyday life, early diagnosis, and improvement of the usefulness of pharmaceuticals.

Against this backdrop, this report examines trends in clinical trials of digital medicine and access to digital technology by pharmaceutical companies, and discusses issues for the practical application of digital medicine in Japan, such as collaboration with various players and fostering and supporting startups to accelerate the practical application of digital medicine, and the relationship between the pharmaceutical industry and the digital medicine industry. The paper also discusses the relationship between the pharmaceutical industry and the challenges for the practical application of digital medicine in Japan. In the future, based on the suggestions made in this report, we would like to further examine various issues surrounding Japan, such as the system for the creation of digital medicine and various systems that support medical development.

In addition, while this paper focuses on mobile apps, games, and VR/AR, which are currently being utilized as digital medicines, digital medicines with different technologies and mechanisms of action are also emerging. Remedee Labs, a French health tech startup, has developed a bracelet-type "endorphin stimulation device" that stimulates the secretion of endorphins, endogenous morphine-like neuropeptides, by stimulating peripheral nerves with ultra-high frequency electronic signals, thereby alleviating pain. The "endorphin" is a neurotransmitter that is produced in the brain. The mechanism is to externally control the secretion of neurotransmitters in the brain, and clinical trials are currently planned for fibromyalgia and other conditions34), 35).

While keeping abreast of the characteristics of existing technologies, it will be important for the pharmaceutical industry to quickly catch up with new trends such as those mentioned above, to appropriately incorporate technologies that match the company's strategies and objectives, and to develop a discerning ability to acquire new technologies.

Japan is one of the few countries in the world that create new drugs, and has produced many innovative drugs based on its high drug discovery capabilities. On the other hand, Japan does not currently lead the world in the field of digital medicine, a new medical modality. Currently, several pharmaceutical companies are referring to the use of digital technology in their mid-term business plans, and the pharmaceutical industry is expanding its efforts based on the strategies of individual companies. It is hoped that the practical application of digital medicine will be further accelerated in the future through the establishment of a framework for collaboration among various players in industry, academia, and government, including those overseas, as well as the development of measures to foster and support startups in the public and private sectors.

Supplement 2 Target Diseases and Number of Clinical Trial Registrations for Digital Medicine

As an aid to understanding the development trend of digital medicine, Appendix Tables 1 through 3 provide details on the number of clinical trial registrations per disease area for mobile apps, games, and VR/AR. The disease examples in the tables show the names of the main diseases extracted in this survey. It should be added that further development is assumed to be underway if trials that were not linked to the current search terms are also included.

Appendix Table 1 Target diseases and clinical trial enrollments using mobile apps
Appendix Table 2 Target Diseases and Clinical Trial Registrations Using Games
Appendix Table 3 Target diseases and clinical trial enrollments using VR/AR

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