Topics The State of Next-Generation Health Care in Japan The current status of next-generation health care in Japan - Focusing on trends in pharmaceutical companies, government, and ministries from 2010 to 2020 - The current status of next-generation health care in Japan

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Minoru Ito, Senior Researcher, Pharmaceutical and Industrial Policy Research Institute

1. Introduction

There are various ways of thinking about next-generation healthcare, but the vision presented by the Nippon Keidanren in its "Healthcare in the Society 5.0 Era " ¹⁾ seems to be one that appropriately describes the future of healthcare. In other words, next-generation health care will be viewed along two axes: (1) the deepening and advancement of medical technology and (2) the expansion of the range of health care services.

In this report, we conducted a survey and analysis of the current status of next-generation health care for pharmaceutical companies by focusing on these two axes and contrasting the trends of pharmaceutical companies and government and ministries in Japan from 2010 to the first half of 2020.

2. Survey Methodology

The survey period was from January 1, 2010 to June 30, 2020, and information was collected from various ^media2). In selecting the media, we focused on medical media that are relatively rich in information on pharmaceutical companies.

Next-generation healthcare was considered by dividing it into three phases: (1) pre-disease/prevention, (2) diagnosis/treatment, and (3) prognosis/symbiosis. Information was collected from keywords such as "pre-disease," "prevention of disease onset," and "prevention of serious illness" for (1), "personalized medicine," "precision medicine," and "tailor-made medicine" for (2), and "prognosis" and "symbiosis" for (3), and duplication was eliminated. The collected information was followed up as much as possible, and information from pharmaceutical companies was obtained from press releases and other sources, while information from government and ministries was obtained from publicly available information and materials.

The entities were categorized into "pharmaceutical companies and wholesalers," "academia and research institutions," "government and ministries," "Japan Medical Association and health ^insurance3)," "ventures and other industries (companies other than those affiliated with pharmaceutical associations)," and "others (patient groups, etc.).

It should be noted at the outset that this survey was conducted on a limited number of media and may only provide a limited view of next-generation healthcare trends.

Trends in the "pre-disease/prevention" phase

The "pre-disease/prevention" phase will be one of the two axes of next-generation health care, and will be particularly relevant to the expansion of the scope of health care services. It has been pointed out that the center of gravity of health care will shift from medical care focused on curing illness to pre-symptomatic care and prevention ^.1)

A total of 156 cases of information were identified using the keywords "pre-symptomatic + disease onset prevention + prevention of serious illness". Figure 2 shows the results.

From 2010 to 2018, the trends of "pharmaceutical companies and pharmaceutical wholesalers" (hereafter, "pharmaceutical companies, etc.") were not very active, and the trends of "government and ministries" tended to stand out. In 2012, in particular, the number of such cases increased rapidly, and the same trend was seen in 2013. The following are representative examples.

In July 2012, the Ministry of Health, Labour and Welfare (MHLW) announced the "Second National Health Promotion Campaign in the 21st Century (Healthy Japan 21 (Second Phase)). The "Healthy Japan 21 (Second Phase)" calls for the extension of healthy life expectancy and reduction of health disparities, as well as thorough prevention of the onset and severity of lifestyle-related diseases, with emphasis on primary prevention of cancer, cardiovascular disease, diabetes, and COPD, and prevention of complications and severity of symptoms. ⁴⁾

In December 2013, the Ministry of Economy, Trade and Industry (METI) held the first meeting of the "Next Generation Healthcare Industry Council." The Council was established as a forum for the public and private sectors to work together to discuss specific measures to create a market and develop industries in the field of extending healthy life expectancy, as well as expectations for the healthcare industry as a growth industry. ⁵⁾

From 2016 to 2018, the "government and ministries" have also been relatively active: In March 2016, the Ministry of Health, Labor, and Welfare concluded a partnership agreement with the Japan Medical Association and the Japan Diabetes Prevention Council, and began formulating a program to prevent severe diabetic nephropathy, which was published as a national version of the program in April ²⁰¹⁶⁶⁾, In September 2018, the interim evaluation report of "Healthy Japan 21 (Second Phase)" was compiled, which presented the status, efforts, and future issues and measures for cancer, cardiovascular disease, diabetes, and COPD separately. ⁷⁾

The background of the above-mentioned active movements of "government and ministries" seemed to be influenced by the concept of the "Revitalization Strategy of Japan" presented in the "Basic Policies for Economic and Fiscal Management and Reform" (Cabinet decision on June 14, 2013) ⁸⁾. The Strategy identified "extending healthy life expectancy" as one of the themes of the Strategic Market Creation Plan, and in August of the same year, the Strategic Headquarters for Health and Medical Care was established. ⁸⁾

In the year 2040, the decline in the working-age population is seen as the biggest challenge, and the "Prevention of disease" has become increasingly important as a means of achieving this goal. The "Plan for Extending Healthy Life Expectancy" was presented as one of the measures that should be promoted toward the establishment of an all-generation social security system that will enable all citizens to remain active and healthy for a longer period of time. The Plan identified (1) the formation of healthy lifestyles for all people, including the next generation, (2) disease prevention and prevention of serious illness, and (3) prevention of nursing care, prevention of frailty, and prevention of dementia as three areas to be promoted. ¹⁰⁾

Thus, in the "Prevention and Prevention of Disease" phase, the trends of the government and ministries have long been central, but since 2018, the number of information cases has tended to increase in "pharmaceutical companies, etc." as well. The following are representative examples.

In July 2019, Towa Pharmaceutical started joint research with the National Cerebral and Cardiovascular Center, with one of the themes being "disease prevention, health maintenance and promotion": clinical and epidemiological research aimed at building evidence for the use of health foods and other products for the prevention of lifestyle-related diseases and health maintenance and promotion in the cardiovascular field. ¹¹⁾

In September 2019, it was announced that AstraZeneca Corporation agreed to a joint research partnership with Hitachi, Ltd. on the circumstances leading to the onset of COPD and prognosis after the onset of COPD, and that risk factor analysis of COPD will be conducted based on health examination data of tens of thousands of people held by Hitachi, Ltd. ¹²⁾

When considering the background to the increase in the number of information cases in the "pre-disease/prevention" phase among "pharmaceutical companies, etc." after 2018, the aforementioned active activities of the government and ministries are considered to have had no small influence. In addition, changes in the social environment that tolerates the acceptance of technological progress and its results, especially in digital technology, are also thought to have had an impact.

Furthermore, changes in the market environment may be driving the efforts of "pharmaceutical companies and others. While Japan's healthcare expenditures are expected to grow in the future, the Japanese pharmaceutical market is expected to enter a period of negative growth. There is a limit to the business model of providing only pharmaceuticals, and there are moves to expand the scope of business outside of public medical insurance, such as "pre-symptomatic and preventive" services. ⁽ Some are considering this expansion of the scope of healthcare services as a business model for providing healthcare solutions. ¹³⁾ In addition, the ability to reduce development costs compared to conventional drug discovery is also thought to be facilitating these efforts.

However, there are issues that need to be carefully monitored in the future, such as whether it is feasible from a business feasibility standpoint and whether synergies with the conventional pharmaceutical business can be expected.

4. trends in the "diagnosis and treatment" phase

The "diagnosis and treatment" phase seems to be closely related to the axis of deepening and upgrading of medical technology, one of the two axes of next-generation health care. It has been pointed out that advances in digital and biotechnological technologies will enable the conventional uniform diagnosis and treatment of average patients and symptoms to be personalized in next-generation healthcare, so that patients can receive the healthcare services they need at the right time. ¹⁾

The total number of information identified with the keywords "personalized medicine + precision medicine + tailor-made medicine (hereinafter referred to as "personalized medicine, etc.")" was 119. Figure 3 shows the results.

The situation differs from that of the "Prevention/Prevention" phase; the "Government/Ministry" trend was observed only after 2014. Representative examples are shown below.

In April 2014, the Ministry of Health, Labour and Welfare (MHLW), the Ministry of Education, Culture, Sports, Science and Technology (MEXT), and the Ministry of Economy, Trade and Industry (METI) formulated the "10-year strategy for cancer research," which stated that R&D should be strongly promoted for cancer diagnostic agents, including companion diagnostic agents originating from Japan, and therapeutic agents contributing to personalized treatment, including molecular targeted therapies. ¹⁴⁾

In September 2015, the Ministry of Health, Labour and Welfare (MHLW) released the "Comprehensive Strategy for Strengthening the Pharmaceutical Industry," which states that in order to further promote the practical application of genomic medicine, a center for the accumulation of whole genome information should be established and the information accumulated and analyzed should be provided to medical institutions to promote personalized medicine. The government ^also indicated that it would accelerate clinical research and development in Japan by promoting the use of this information by companies, etc ^{. (15)}

When looking over these "government and ministry" developments, it is assumed that the formulation of the "Revitalization of Japan Strategy 2016" at the 8th Joint Meeting of the Council on Economic and Fiscal Policy and the Council on Industrial Competitiveness held in June 2016 and the major policies it outlines had no small impact on the subsequent development of personalized medicine and other areas. The strategy states that the Japan Agency for Medical Research and Development (AMED), established in April 2015, will promote research and development aimed at creating innovative pharmaceuticals and other products originating in Japan by providing seamless research management and support from basic research to practical application, with the following specific themes One of the specific themes is "tailor-made genome medicine. One of the specific themes was "order-made genome medicine." The committee also stated that effective medical care would be realized by utilizing advanced technologies such as personalized medicine based on individual differences among patients. ¹⁶⁾

In December 2019, the Ministry of Health, Labour, and Welfare (MHLW) formulated the "Whole Genome Analysis and Other Action Plan (1st Edition)" to steadily promote drug discovery and personalized medicine for cancer utilizing whole genome analysis, etc., aiming to overcome cancer, and research for early diagnosis of intractable diseases using whole genome analysis, etc. ^The "Government and Ministries and Agencies" are now entering the stage of concrete implementation after the decision of the major policy.

On the other hand, an overview of "pharmaceutical companies, etc." shows a slight increase in the number of information cases from 2018, but there was no characteristic trend as in the "pre-disease/prevention" phase. The majority of the trends of "pharmaceutical companies, etc." toward personalized medicine, etc. were related to molecular-targeted drugs and companion diagnostics, mainly in the field of oncology, and the contribution of "pharmaceutical companies, etc." to personalized medicine in the field of oncology could be seen. On the other hand, specific movements of personalized medicine in other diseases such as lifestyle-related diseases were not seen much in this review.

As mentioned above, national projects such as whole genome analysis have only just begun, and more time will be needed before the results can be utilized by "pharmaceutical companies, etc.". We will continue to monitor future trends with the expectation that more personalized, efficient, effective, and risk-reduced personalized medicine will be realized for a wider range of diseases as soon as possible.

5. trends in the "prognosis/symbiosis" phase

The "prognosis/symbiosis" phase will mainly concern the expansion of the scope of healthcare services, one of the two axes of next-generation healthcare. In order to extend healthy life expectancy, the importance of prevention as well as diagnosis and treatment is increasing, and at the same time, it has been pointed out that it is desirable to take measures to live with disease, that is, to live with disease with as few restrictions as possible, and the importance of the "prognosis and symbiosis" phase is discussed in the phrase "living with disease. ¹⁸⁾

A total of 232 cases of information were identified using the keywords "prognosis + symbiosis. Figure 4 shows the results.

Although the "government/agency" trend can be seen since 2010, most of the information was related to life prognosis in health economic evaluation and cost-effectiveness evaluation, and it was not until 2015 that information related to "prognosis and symbiosis" that would contribute to expanding the scope of health care services could be seen. Representative examples are shown below.

In December 2015, the Ministry of Health, Labour and Welfare (MHLW) released the "Accelerated Cancer Control Plan," which presented the three pillars of the plan: cancer prevention, cancer treatment and research, and "symbiosis" with cancer. ¹⁹⁾

Subsequently, the Ministry of Health, Labor and Welfare's Council for the Promotion of Cancer Control continued its deliberations, and in March 2018, the "Basic Plan for the Promotion of Cancer Control (Third Phase)" (approved by the Cabinet on March 9, 2018) was released. In the plan, "coexistence with cancer" was set as one of the overall goals, and the plan stated the realization of a society in which people can live their lives as they wish even if they have cancer. ²⁰⁾

In June 2019, the Council of Ministers for the Promotion of Dementia Policies formulated the "Outline for the Promotion of Dementia Policies," which positioned "symbiosis" and "prevention" as the two wheels of the cart, aiming to delay the onset of dementia and create a society where people can live their daily lives with hope even after developing dementia. ²¹⁾

Looking at the trends of "government and ministries," the "Health and Medical Strategy" (approved by the Cabinet on March 27, 2020), which was approved by the Cabinet in June 2020, is expected to have a significant impact in the future. The Health and Medical Strategy has been formulated in a version approved by the Cabinet on July 22, 2014, and in a partially revised version on February 17, 2017, but there is no mention of "prognosis and symbiosis" in these versions. The March 27, 2020 Cabinet decision version indicated for the first time that the goal was to establish a health and medical care system that is "prognostic, prophylactic, and symbiotic.

In addition, the concept of "symbiosis," which until then had been limited to measures for individual diseases such as cancer and dementia, was expanded at a stroke. In order to extend healthy life expectancy, the report indicated that the challenges to be addressed are lifestyle-related diseases such as cancer, diabetes, and hypertension; diseases of the musculoskeletal system, bone fractures, ophthalmology, and other musculoskeletal and sensory systems; diseases associated with aging; and mental and neurological disorders such as dementia. In addition to diagnosis and treatment, prevention is becoming increasingly important in dealing with these diseases, and at the same time, it is desirable to take measures to live "symbiotically" with diseases so that people can live with as few restrictions as possible in their daily lives even if they suffer from them. Furthermore, it was clearly stated that health care services are not limited to efforts that contribute to health care in the narrow sense (maintenance and promotion of health), but also include efforts that contribute to disease prevention and symbiosis. ¹⁸⁾

Thus, in the "prognosis and symbiosis" phase, it appears that the direction of "government and ministries" is finally being set. On the other hand, when looking at "pharmaceutical companies," there was a fair amount of information throughout the survey period, but most of it was related to the development of therapeutic drugs to deal with diseases with poor prognosis, and there was not much movement toward taking measures to "coexist" with diseases in the current review.

Under these circumstances, Eisai Co., Ltd. made a distinctive move in September 2019. The company announced that it had entered into a business alliance agreement with Tokio Marine & Nichido Fire Insurance Co. ²²⁾ In the future, it is expected that other "pharmaceutical companies" will expand their efforts to enable people to live without restrictions even if they suffer from various diseases, in other words, to live "in harmony" with diseases.

Summary

In this report, we focus on the two axes of next-generation health care: (1) the deepening and advancement of medical technology and (2) the expansion of the scope of health care services, and examine trends in Japan by comparing the trends of "pharmaceutical companies, etc." with those of "governments and ministries. The survey and analysis were conducted with the aim of clarifying the current status of next-generation health care for "pharmaceutical companies, etc.

In the "Prevention of disease" phase, the government and ministries were initially focused on the industry promotion aspect of strategic market creation, but later, the aspect of maintaining the social security system grew in importance, and "Prevention of disease" seemed to have increased in importance as one of the means to achieve this goal. On the other hand, the trend of "pharmaceutical companies, etc." showed a tendency to expand from 2018 onward. This was thought to be due to the influence of the trends of "governments and ministries," changes in the social environment accepting the results of digital technology, etc., as well as changes in the market environment that is expected to plunge into negative growth in the future. It was assumed that "pharmaceutical companies, etc." are trying to expand the scope of their business to "pre-disease/prevention" as one of the strategies for their own survival and sustainable growth. ¹³⁾, 23

The "government and ministries" in the "diagnosis/treatment" phase seems to have begun in earnest with the formulation of the "Revitalization of Japan Strategy 2016" and its major policies. This set the direction of the Japan Agency for Medical Research and Development (AMED), which clearly stated its intention to realize effective medical care through the use of cutting-edge technologies such as personalized medicine based on individual patient differences. In recent years, the "Action Plan for Whole Genome Analysis (Version 1)" has been formulated, and it seems to be reaching a concrete stage. In terms of trends in "pharmaceutical companies," it was possible to see their contributions to personalized medicine in the field of oncology, such as the development of molecular-targeted drugs and companion diagnostic reagents. On the other hand, there was little concrete movement toward personalized medicine in other diseases such as lifestyle-related diseases. We hope that the day will come soon when "pharmaceutical companies and others" will be able to utilize the results of national projects such as whole genome analysis. Although this phase seems to be deeply related to the deepening and advancement of medical technology, the fact that the scope of consideration remained on personalized medicine and genomic medicine is a major limitation of this paper. This is because "pharmaceutical companies, etc." were active in the oncology field, and "government and ministries" were more specific in genomic medicine in the same field. However, in "Healthcare in the Society 5.0 Era II: COVID-19 Response through DX and Beyond," published by the Japan Business Federation on July 14, 2020, it was stated that the outbreak of new coronavirus infection has made it urgent to respond through DX (Digital Transformation) in the healthcare sector. ⁽²⁴⁾ In the future, it will be even more important to consider the deepening and advancement of digital technology. We would like to discuss this point again.

In the "Prognosis/Symbiosis" phase, there were fewer concrete developments from the "government and ministries" compared to the other two phases. With the formulation of the Health and Medical Care Strategy (approved by the Cabinet on March 27, 2020), it appears that the direction is finally being set, and that the future specific measures for diseases other than cancer and dementia, which are already in the lead, should be closely monitored. In terms of trends among "pharmaceutical companies," with the exception of a few leading companies, it seems that efforts to coexist with disease are still in the early stages.

There is no doubt that extending healthy life expectancy, one of the goals of next-generation health care, is a desirable direction for both individuals and society. We will continue to pay attention to trends in next-generation health care.

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