Policy Research Institute page Drug lag: Impact on business investment priorities -Results of a survey of pharmaceutical companies on business investment priorities in Japan

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In order to investigate the background to the increase in the number of unapproved drugs in Japan, we conducted a survey of pharmaceutical companies operating in Japan regarding their investment priorities for Japanese business and the status of off-label and unapproved drugs. As a result, we found signs of reluctance to invest in the Japanese market, especially in terms of economic rationality and return on investment, which are influenced by NHI drug prices, and we infer that this may have an impact on the expansion of the drug lag.

1. Introduction

Since the late 2010s, the number of unapproved drugs in Japan has been increasing and a new drug lag is emerging*2-6, many of which are being developed by emerging biopharmaceutical companies and many of which are of high clinical importance. The Japanese region is not included in pivotal trials (key studies to evaluate efficacy) at the time of U.S. Food and Drug Administration (FDA) approval*3, 4, 6, and the unapproval rate is higher than in Europe, and the unapproval rate is higher among startup companies*5, 6. These reasons include the environment for global clinical trials and pharmaceutical regulations in the region, which are expected to be a challenge for the supply of new drugs in R&D, as well as the declining attractiveness of the Japanese market, which is expected to lower the priority of investment in Japanese operations. Since many of the products developed by emerging companies have also been introduced into Japan through acquisitions and product introductions by major global and Japanese pharmaceutical companies after FDA approval, the status of investment priorities of these major companies may have an impact on the overall drug lag expansion.

In the late 2010s, the Japanese pharmaceutical market showed negative growth, with its share of the global market dropping to 6.0% (in 2021)*7. According to the IQVIA Institute*8, while market growth in the 10 developed countries will expand between 2% and 5% through 2026, the average annual growth rate of the Japanese market is The only negative growth rate is projected to be -0.6% (-2% to 1%). In general, aggressive business investment activity is not expected in a shrinking market, and there is concern that the attractiveness of the Japanese business and drug market within the global context will decline, leading to lower penetration of new drugs in the Japanese market.

Although this news does not extend to a survey on investment decisions of emerging companies, we focus on major global and Japanese pharmaceutical companies and report the results of a survey on investment priorities for Japanese operations, product introductions from overseas, and the status of off-label and unapproved drugs, as well as the business to unapproved drug increases. The survey also provides insight into the impact of the business environment on the increase in unapproved drugs from the perspective of business activities and corporate decision-making for individual products.

2. research methods

The survey was conducted at the Pharmaceutical Manufacturers Association of Japan (PMAJ) from June 30 to August 23, 2022, targeting a total of 86 member companies of PMAJ, the Pharmaceutical Research and Manufacturers of America (PhRMA) operating in Japan, and the European Federation of Pharmaceutical Manufacturers and Associations (EFPIA Japan) operating in Japan. Questionnaires were sent to company representatives via e-mail, and after collection by the Policy Research Institute, they were anonymized, tabulated, and analyzed.

The questions were structured into the following categories: 1) priority of investment in Japanese business, 2) domestic in-licensing from overseas third parties, 3) status of off-label drugs, and 4) status of unapproved drugs, each of which was requested according to the company attributes shown in Figure 1. For unapproved drugs, each individual company was surveyed for the relevant items selected by the NIHS.

Valid responses were obtained from 59 (69%) and 43 (73%) of the 86 companies and 59 unapproved drugs (25 companies), respectively, and were tabulated and analyzed.

Figure 1 Number of valid responses by company attribute
Note: Overseas 10% or more and overseas less than 10% refer to the ratio of overseas sales in the pharmaceutical business of 10% or more and less than 10%, respectively.

For the detailed analysis of "major global companies," we selected domestic companies with consolidated sales of 300 billion yen or more and overseas sales of 10% or more, and global pharma group companies with pharmaceutical business sales of 10 billion dollars or more (24 of 37 companies).

The term "off-label drugs" used in this news release refers to drugs (new active ingredients) launched in Japan after 2010 that do not have a U.S. approved indication in Japan as of the end of 2021. Unapproved drugs" are drugs (new active ingredients) approved by the FDA between 2016 and 2021 that are not approved in Japan as of the end of 2021. For detailed study coverage and methodology, please refer to previous reports*2, 5.

Results

3-1. investment priority in japanese pharmaceutical business

While the global pharmaceutical market is growing at a CAGR of 5.1%, the Japanese market has been growing at a negative CAGR of -0.5% since 2016. The share of the Japanese market in the global market has declined from 8% to 6%*7 Under these market conditions, we asked pharmaceutical companies with business portfolios in Japan and abroad, "Under the Japanese pharmaceutical market environment, what is the priority of investment in the Japanese pharmaceutical business segment in the overall global market compared to before 2015? decreased?" The question was asked.

Of the 37 companies included in the tally, the total number of companies that have lowered their business priorities since 2016 was 10 (27%), while 27 (73%) have not lowered their priorities ( Figure 2 ).

When the 10 companies that lowered their priorities were asked about the first and second largest Japanese value chains that they had reduced in size, seven were in domestic sales in Japan, followed by four in clinical development/regulatory affairs ( Figure 3).

Figure 2 Investment Priority in Japan Business
Note: 37 valid responses

Figure 3 Domestic Value Chain Shrunken by Lower Investment Priority
Note: The first and second largest scale of shrinkage were asked. Valid responses: 9 companies (1 of which responded only to the first question)

When the same 10 companies were asked why their Japanese operations were not a priority for investment, 9 companies answered that the economic rationale/business feasibility/profitability of their Japanese operations was low, and none answered that there was no medical need ( Figure 4). When further asked about the reasons for low economic rationality/business potential, 8 companies answered that the drug price/expected drug price was low, followed by 5 companies that the cost or investment was large in relation to the revenue/expected profit ( Figure 5 ). The other two responses, both from two companies, were lower revenue predictability due to NHI price revisions.

Figure 4 Reasons for Lower Investment Priority
Note: 10 valid responses. The response option "No drug needs in Japan or drug needs are being met" is indicated as "No drug needs" and the response option "Low economic rationale/business potential/profitability of Japan operations" is indicated as "Low economic rationale" in the figure.

Figure 5: Factors that have low economic rationale/business potential
Note: The first and second most influential factors were asked. Nine companies responded validly (one of them responded only to the first question). The response options "small volume/expected volume (number of patients and number of treatments)" is indicated as "small volume," "low drug price/expected drug price" is indicated as "low drug price," "high cost/investment relative to revenue/expected revenue of product/development" is indicated as "high investment," and "low probability of success of development product" is indicated as "low probability of success" in the chart. Figure 6: Prospects for Japan Business Investment Priorities

In an environment of negative growth in the Japanese pharmaceutical market, about 30% of the companies lowered their investment priority in their Japan operations after 2016, citing low economic rationale. This was due to low NHI and assumed NHI prices and lower revenue predictability resulting from NHI price revisions. For some pharmaceutical companies, it became clear that the growth potential of the Japanese market, especially the low NHI and NHI price predictability, influenced their management and business policy reviews, and as a matter of fact, led to a change in investment priorities.

Furthermore, given that the Japanese market is the only one expected to experience negative growth*7 amidst the 2% to 5% market growth forecast for the 10 developed countries through 2026, we asked the respondents about the expected investment priorities for the Japanese business in the future ( Figure 6 ). Assuming negative growth, 11 (31%) of the 36 firms that responded expected their investment priority to decline in 2022 and beyond.

Similar to Figure 3, sales in Japan (9 companies) and clinical development/regulatory affairs (7 companies) were the most frequently cited value chains where investment priority is expected to decline after 2022 ( Figure 7 ).

Figure 6: Prospects for Investment Priority in Japan Business
Note: 36 valid responses

Figure 7: Value Chain Expected to Shrink as Investment Priority Decreases
Note: 11 valid responses (1 of the 11 companies responded only to the first question)

For large pharmaceutical companies with global operations, the economic rationale for the pharmaceutical business is likely to be viewed in terms of the overall global pharmaceutical market. In doing so, they are expected to be more sensitive to investment priorities in their regional territories. Therefore, we focused on a group of companies with high scale and degree of business development in overseas markets and analyzed them as major global companies.

Among the 24 largest global companies, 10 (42%) have lowered or will lower their investment priorities in Japan. Of these, seven (70%) have revised their priorities and expect to raise them to the same level or higher than in other countries, assuming positive market growth ( Figure 8 ). The results suggest that major global pharmaceutical companies tend to make decisions on investment priorities based on the growth potential of the Japanese market.

Figure 8 Impact of market growth potential on investment priority decisions
Note: 24 valid responses. With decline indicates the total number of firms that have declined or expect to decline since 2016 (left chart). The "expected recovery" category represents the total number of companies that expect to increase their priority to the same level or higher than that of other countries, assuming that the Japanese market will achieve positive growth similar to that of the 10 leading countries (right graph). The 24 major global companies selected were domestic companies with consolidated sales of 300 billion yen or more and an overseas sales ratio of 10% or more, as well as global pharma group companies with sales of 10 billion dollars or more.

3-2. in-licensing from foreign third parties

The number of new drugs approved overseas is increasing and the number of drugs unapproved in Japan is also increasing*2. Under these circumstances, we asked the respondents about changes in the frequency of introduction of developments and products for the Japanese market compared to before 2015. Figure 9 shows the responses from 42 domestic companies.

Seven companies (17%) have increased the introduction of developed products and products for the Japanese market between 2016 and 2021 compared to before 2015, and 11 companies (26%) expect it to increase in the future, for a total of 18 companies (43%). On the other hand, 16 (38%) of the respondents expected no change, while five (5) and three (3) expected a decrease in the future and between 2016 and 2021, respectively, for a total of eight (19%).

Figure 9 Frequency of introductions from overseas third parties
Note: 42 valid responses; the question asked whether the frequency of introductions has changed between 2016 and 2021 compared to 2015 and before, and whether it will change in the future.

Since the number of domestic introductions is expected to increase in response to the increase in the number of foreign new drug approvals, we asked 24 companies (57%), the total of those that have decreased or expect to decrease, about the situation of no increase ( Figure 10 ). The majority of the respondents, 8 companies (38%), responded that their needs were not being met but that the return on investment was poor. When we categorized the free-response responses, we found that the low priority given to domestic adoption within the business (5 companies) and the lack of opportunities for adoption (4 companies) were cited as reasons for the lack of adoption due to business strategies and resource allocation within each company and the external environment, respectively.

When the eight companies that cited poor return on investment as the reason for not increasing adoption were asked about the reasons ( Figure 11 ), most cited low profitability due to low prices (5 companies), followed by low profitability due to the small number of patients (4 companies).

Figure 10 Reasons for no increase in introductions from foreign third parties
Note: 21 valid responses (3 companies did not respond). The response options "Drug needs are being met in Japan or alternative drugs exist" is indicated as "Drug needs are being met" and "Needs are not being met but the return on investment is poor (e.g., profitability is low for the additional investment)" is indicated as "Return on investment is poor" in the figure. There were 11 "Other" response options. The free responses were categorized into the above reasons by the National Institute of Biomedical Innovation Policy.

Figure 11: Factors contributing to poor return on investment for introduction
Note: Seven companies responded validly (one company did not respond). The response options "low profitability: due to small number of patients" is indicated as "small number of patients," "low profitability: due to low price of the product" is indicated as "low price," and "large additional investment: due to large additional development and other costs" is indicated as "large additional investment" in the figure.

More than half of the companies either had no change in the status of domestic introduction or expected a decrease or decrease. Reasons given for not increasing were that medical needs were not being met but that the return on investment was poor, with the main reasons being low profitability due to small price and volume (number of target patients). Other responses cited low priority for adoption and lack of opportunities for adoption as reasons for not increasing adoption. The low priority for adoption can be attributed to the fact that Japanese companies place a high priority on developing their own originals and overseas development. It is possible that the lack of in-licensing opportunities is due to a lack of matching opportunities with overseas startups, as well as a difference between the strategic disease areas of individual companies and the increasing number of overseas-approved drugs, but this is not a matter of conjecture.

3-3. status of off-label drugs

Among drugs approved as new drugs (new active ingredients) both overseas and in Japan, "off-label drugs," i.e., new drugs for which indications have been obtained and used for various diseases overseas but not in Japan, are also an issue in the drug lag*2. 2 When asked whether any of the new products launched in 2010 or later would fall under the category of off-label drugs by the end of 2021, 20 of the 59 companies (34%) had such products. Of these, 15 companies listed 32 indications for which there are no plans to develop, file, or obtain approval in Japan.

When asked why there were no plans to develop, file, or approve these 32 indications ( Figure 12 ), the majority of the responses, 24 (75%), were due to a poor return on investment, although the needs were not being met. The most common reason for this poor return on investment was the large additional investment (due to the high cost of additional development, etc.) (9 responses), followed by low profitability (due to the small number of patients) (7 responses) ( Figure 13 ). Although there was no mention of drug prices in the results of this question, drug prices are recognized as a factor that cannot be changed when additional indications are added (since drug prices are determined at the time of initial approval), and it is possible that drug prices were not associated with the issue of low profitability for additional indications.

Figure 12 Reasons for Off-label Drugs with No Planned Development
Note: 32 valid responses. In the response options, "Because drug needs are met in Japan or alternative drugs exist" is indicated as "Drug needs are met," "Because needs are not met but the return on investment is poor (e.g., profitability is low for the additional investment)," "Because the company has no rights to develop and market the drug in Japan," and "Because the company has no rights to develop and market the drug in Japan. The figure also shows "because the company does not have the right to develop and market the drug in Japan" and "because the company does not have the right to develop and market the drug in Japan".

Figure 13: Factors for poor return on investment for off-label drugs
Note: 13 valid responses (5 of which were only No. 1). The response options "Low profitability: because of the small number of patients" is indicated as "small number of patients," "Low profitability: because of the low price of the product" is indicated as "low price," and "Large additional investment: because of the large cost of additional development, etc." is indicated as "large additional investment" in the figure.

3-4. status of unapproved drugs

The "unapproved drugs" in this news refers to drugs approved by the FDA between 2016 and 2021 (new active ingredients) that are not approved in Japan as of the end of 2021, and are extracted in the same way as previously reported*5. A total of 278 drugs were approved, of which 183 (171 excluding diagnostics) were unapproved in Japan as of the end of 2021. Of these, 59 items had been submitted to the FDA by companies in the Pharmaceutical Manufacturers Association of Japan/PhRMA/EFPIA group. We conducted a survey of these 59 items, and received responses for 43 items.

Of the 43 products, 5 (12%) had Japan included in the pivotal trials at the time of FDA approval and were scheduled to be filed in Japan. For 18 (42%) of the 43 products, Japan was not included in the pivotal trials at the time of FDA approval, but an application was scheduled to be submitted due to additional domestic trials. Although there will be a lag, it is suggested that the product will be delivered to Japan. On the other hand, 15 items (35%) were not planned to be developed or filed in Japan ( Figure 14 ), and there is a concern that these items may not reach Japanese patients.

Figure 14: Development status of unapproved drugs
Note: 43 valid responses. In the response options, "Japan region is participating in pivotal trials at the time of FDA approval and has submitted or is planning to submit an application in Japan with the data from this trial" is indicated as "Pivotal participation: Development is planned" and "Japan region is not participating in pivotal trials at the time of FDA approval but plans to submit an application through additional domestic trials in Japan, etc. separately. The term "not participating in pivotal studies at the time of FDA approval in Japan, but plans to submit an application for approval through additional studies in Japan, etc." is indicated as "not participating in pivotal studies: plans to develop", "no plans to develop or submit an application for approval in Japan" as "no plans to develop or submit", and "no rights in Japan (e.g. sale, licensing out, no Japanese rights)" as "no rights in Japan" in the figure.

When asked about the reasons for the 15 items that are not planned for development or submission, 6 items are because the drug needs are being met in Japan, and 6 items are because the needs are not being met but the return on investment is poor ( Figure 15 ). Factors contributing to the poor return on investment ( Figure 16 ) included the large additional investment and the small number of patients expected to receive the drug. The reason for the poor return on investment was not cited as a reason for the low expected drug price in Japan.

Figure 15 Reasons why unapproved drugs are not planned to be developed or filed in Japan
Note: 15 valid responses. The response option "There is no need for the drug in Japan or the need is being met" is indicated as "No need for the drug" and "The need is not being met, but the return on investment is poor (e.g., low profitability for the additional investment)" is indicated as "Poor return on investment" in the figure.

Figure 16: Factors for Poor ROI of Unapproved Drugs
Note: 5 valid responses (1 no response). The response options "Low profitability: Due to small expected number of patients in Japan" is indicated as "Small number of patients", "Low profitability: Due to low expected price of the product in Japan" is indicated as "Low price", and "Large additional investment: Due to large additional costs for development, etc. in Japan" is indicated as "Large additional investment" in the figure.

As for unapproved drugs, the lack of inclusion of Japan in pivotal trials at the time of FDA approval is a factor in the increase in unapproved drugs*4. Of the 37 valid responses, the most common reason among the response options was that the expected business value of the Japanese business was small for 14 items (38%) ( Figure 17 ).

Other responses were the most common response, and the main reasons given in the open-ended responses were that the relevant items were low priority (6 items) and that they were planned to be incorporated from Phase 3 (3 items). As for the factors in the 14 items with the smallest expected business value ( Figure 18 ), the main factors cited were low profitability due to the small number of expected patients (10 items) and low profitability due to the large additional costs (8 items). For 8 of the 45 products, we were unable to trace back to the person in charge of development at the time to obtain a response.

Figure 17 Reasons for lack of Japan regional inclusion in pivotal trials for unapproved drugs
Note: 37 valid responses (12 no responses). In the response options, "Because there is no drug need in Japan or the drug need has been met" was selected as "No drug need", "Because the expected business value of the Japanese business was small (including cases where the Japanese business was not considered)" was selected as "Expected business value was small", "Because there were challenges in clinical trials and pharmaceutical regulations in Japan" was selected as "Because there were challenges in clinical trials and pharmaceutical regulations in Japan", and "Because there were The "because the developer did not have the rights to the Japanese territory at the time (e.g., out-licensing, sale, not holding the rights, etc.)" is indicated as "no Japanese rights" in the figure. There were 17 "Other" response options. The free answers were categorized into the above reasons by the Pharmaceutical and Industrial Policy Research Institute (PIIPRI).

Figure 18: Factors for Japan's small expected business value at the time of pivotal trials for unapproved drugs
Note: 14 valid responses. The response options "Low profitability: because of the small number of expected patients in Japan" was classified as "small number of patients," "Low profitability: because of the low expected price of the product in Japan" was classified as "low price," "Large additional investment: because of the large additional cost of development, etc. in Japan" was classified as "large additional investment," and "Low probability of success in development" was classified as "low probability of success. The "Probability of success is low" is indicated as "Low" in the figure.

4. summary and discussion

In order to understand why the Japanese pharmaceutical market has been stagnant and the number of unapproved drugs has increased since the late 2010s, we conducted a survey on the status of pharmaceutical companies at the management level and at the level of individual products. The results are summarized in Table 1 and their impact on the increase in unapproved drugs is discussed.

Business and In-licensing Strategy

In terms of management/business strategy and implementation strategy, the survey revealed that approximately 40% of the major global companies have decreased their investment priorities in their Japanese operations. In addition, approximately 80% of the companies expect to revise their investment priorities when assuming positive growth of the Japanese pharmaceutical market in the future. This suggests that the growth potential of the Japanese pharmaceutical market influences the decision-making process of major global pharmaceutical companies in terms of their investment priorities. Among the factors that may reduce investment priorities, low drug prices were cited, indicating that drug prices are an issue in ensuring the profitability of Japanese operations. It was also inferred that the shrinkage of the clinical development and regulatory value chain indicates a reduction in R&D activities for the latest drugs for Japan, which may represent one aspect of the increase in off-label and unapproved drugs. The increase in off-label and unapproved drugs was a concern due to the decline in business priorities against the backdrop of stagnant and negative market growth.

Given the reality that access to drugs in Japan for overseas-approved products by emerging companies is being carried by global pharmaceutical companies and Japanese companies through M&A and in-licensing*4, the in-licensing strategies of these companies play an important role in accessing drugs. For more than half of the Japanese companies, the frequency of in-licensing from overseas third parties has not increased, and poor economic rationale and return on investment, as well as low expected product prices, were the main reasons for the lack of increase in the frequency of in-licensing. The reality that it is difficult to secure profitability by introducing products only for the Japanese domestic market was expressed, suggesting that the business attractiveness of the Japanese market is low.

It is also considered that drug development and markets have been centralized globally, and the value of innovation is being evaluated based on global standards. In other words, when introducing a developed product or products to the Japanese market, it is considered important that it be a business-to-business transaction with introduction economic conditions based on profitability in Japan, and that the investment market be competitive with the global level, taking into consideration the return on investment that occurs uniquely in Japan.

In "Research and Study on the Actual Conditions of the Drug Development and Distribution Environments in Relation to the Fundamental Reform of the NHI Drug Price System, "*9 Professor Mamoru Narukawa of Kitasato University School of Pharmaceutical Sciences and his colleagues reported the results of a survey of pharmaceutical company NHI drug price managers. In the survey, 80% of the companies reported that the recent NHI overhaul had affected their business operations, and the most common system change that had an impact was the review of the additional payment for new drug creation, etc. The results of this survey were similar to those of the current survey, indicating that NHI drug price reform is an important factor influencing business priorities for Japan, and the actual state of corporate behavior in the business environment of the Japanese drug market.

Table 1: Summary of Corporate Survey Results
Note: The main reason is the one that received the highest number of responses for each question in the following response options: whether the drug needs in Japan are being met, economic rationale for the project, and return on investment. The main reasons are indicated by the highest number of responses for each question, including profitability (volume), profitability (price), additional investment, or probability of success.

Individual Product Strategy

Fifteen companies listed 32 indications for which they had no development plans, and 15 unapproved drugs (35% of the 43 drugs surveyed) were identified as having no development plans. In both cases, the majority of respondents cited poor return on investment as the reason for not planning development. For unapproved drugs, the small expected business value of Japan was often cited as a reason for not including Japan in pivotal studies at the time of FDA approval.

For companies with global operations (surveyed as foreign companies and domestic companies with overseas sales ratio of 10% or more), it was clear that return on investment had a significant impact on development decisions for individual products and indications. Factors that were cited as the reason why unapproved drugs were not planned for development in Japan were low expected patient numbers as well as large additional investment, but low expected drug prices were rarely cited. We assume that the additional cost and the expected number of patients were associated with the daily business perspective, rather than the awareness of pricing, since the issues faced by development staff in drug development are development costs and the targeted patient segment. In any case, since expected revenue is composed of the expected number of patients and the expected price, it is clear that the setting of the expected drug price is important to ensure profitability.

Since low expected patient numbers were cited as a factor contributing to low profitability, we reviewed the status of the number of approved new drugs for rare diseases in the U.S. and Japan. The number of FDA approvals for orphan-designated products (including new drugs and indication extensions) had increased rapidly from 50-60 products/3 years until 2012 to 135, 218, and 258 products/3 years. The number of FDA approvals of Japanese orphan drug designations also increased from 30-40 products/3 years to 78, 94, and 113 products/3 years, respectively, clearly indicating an increase in approvals of drugs for rare diseases since the mid-2010s ( Figure 19 ).

In addition, according to a report by Masao Yoshida, a senior researcher at the National Institute for Policy Studies, the ratio of U.S. orphan designations for drugs not approved in Japan also increased, exceeding 50% in the late 2010s*3. 3 This means that the scale of profits will be compressed for new drugs with a small expected number of patients per new product, and thus it is analogous to the fact that securing profitability through price has become even more important. In addition, a study by Yuya Imai et al. at Kitasato University School of Pharmaceutical Sciences*10 shows that one factor for new drugs approved in Japan with small projected sales is the delay in obtaining approval in Japan, which is similar to the result in terms of profitability issues behind the drug lag.

Figure 19: Approval status of orphan drugs
Source: Created by the Pharmaceutical Industry Policy Institute based on the FDA Orphan Drug DB, PMDA Orphan Drug Designation List, and Orphan Regenerative Medicine Product List

The increase in the number of drugs for rare diseases can be attributed to the trend of drug development based on the progress in understanding the molecular mechanisms of diseases. Drugs for rare diseases such as intractable diseases, genetic diseases, and rare cancers are being shifted to diseases that are subdivided by genetic mutations and other biomarkers. The innovation value of personalized medicine, which is tailored to each individual and scientifically more predictable in its efficacy, is high, and its widespread use is desirable.

On the other hand, it is undoubtedly important to set prices that are commensurate with the value of this innovation in order to ensure profitability as a business. Given that policies in the U.S. have promoted the development of rare disease drugs*11, it is hoped that policies will be considered to ensure both access to and profitability of the latest drugs, including improved designation requirements and pull/push incentives in Japan's orphan drug designation system.

Since the increase in unapproved drugs in the late 2010s were the items of emerging biotech companies, we would like to know how these companies view their Japanese business and its profitability, and how they relate to their exit strategies for pharmaceuticals. It is also important to understand how these companies view their Japanese business and its profitability, and how it relates to their exit strategies to the pharmaceutical industry, which we believe is one of the issues to be considered in the future.

Diseases are becoming more segmented due to innovation, and the pharmaceutical market is becoming global. As an industry responsible for maintaining and ensuring access to the latest pharmaceuticals in Japan, we cannot help but expect that the Japanese market will grow, that business profitability can be secured, and that the market structure is comparable to global market trends.

( Hiroshi Azuma, Senior Researcher, Pharmaceutical and Industrial Policy Research Institute)

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