The Pharmaceutical Industry at a Glance The Current Position of Japanese Drug Discovery Research as Seen in the Number of Development Pipelines in the U.S.

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Chie Yoshiura, Senior Researcher, Pharmaceutical and Industrial Policy Research Institute
Kiyoshi Morimoto, Senior Researcher, Pharmaceutical and Industrial Policy Research Institute
Daisuke Kanai, Senior Researcher, Pharmaceutical and Industrial Policy Research Institute

SUMMARY

1. Introduction

The Pharmaceuticals and Industrial Policy Research Institute (PIIPRI) conducts a variety of analyses to assess the current status of Japan's drug discovery capabilities, regularly reporting on trends in products approved in Japan, the United States, and ^Europe1) and the number of products of Japanese origin in the top 100 pharmaceutical products in terms of global ^sales2). In addition, as a comparative study of Japan's drug discovery capabilities, we have focused on products originating from Emerging Biopharma in the U.S. and have reported on the characteristics of products already on the market and the characteristics of their ^{founders3, 4)}. Both of these studies used the number of approved products as an evaluation index. In addition to these surveys, this paper attempts to examine Japan's position by comparing Japan's drug discovery capabilities with those of other major drug discovery countries in terms of the number of pipelines currently under development.

The analysis in this paper is based on the pipeline information in Citeline's ^{PharmaprojectsⓇ}. While Citeline's annual ^report5) analyzed the number of pipelines from the preclinical stage using the same database, this report is limited to pipelines that have entered the clinical stage and include the U.S. as a development region, with an emphasis on comparisons with other countries, especially Japan.

Survey Methodology

In this report, we analyzed the development pipelines listed as of July 2025 by originator nationality, based on Citeline's ^{PharmaprojectsⓇ} database. In 3-1 and 3-2, the originator nationality is defined as the nationality of the headquarters of the originator company listed in ^{the PharmaprojectsⓇ database}, and the nationality of the originator company is used in this report. ⁶⁾ In 3-1 and 3-2, we extracted components that are in the development stage in the United States, Japan, Europe, and China as major development regions. The number of pipelines by originator nationality and the ratio of development regions were ^tabulated7). In 3-4 and 3-5, the percentages of each ^{modality8) and} each target ^disease9) in the pipelines tabulated in 3-3 were tabulated by originator nationality. In 3-6, the number of pipeline runs in which the target site of action ("Target") of each component does not match that of the marketed component was analyzed as a percentage of the number of pipelines tabulated in 3-5. ¹⁰⁾

Results

3-1. Number of Development Pipelines by Originator Nationality

We extracted from the pipelines listed in ^{PharmaprojectsⓇ} the ingredients that are in the development stage in the U.S., Japan, Europe, or China, and found 8,428 hits. The originator nationalities of these ingredients are shown in Figure 1, and in descending order of number, they were the U.S., China, Japan, the U.K., Switzerland, Germany, France, and South Korea. Japan ranked third in terms of the number of pipelines in the development stage, but was separated from the first and second-ranked U.S. and China by more than 2,000 components.

Figure 2 shows the pipelines by originator nationality in Figure 1, classified by the most advanced development phase, and the percentage of each country's pipelines. In Japan, 38% of the pipelines were in Phase 1, 43% in Phase 2, 15% in Phase 3, and 4% in the application stage, and the distribution was similar in the other countries.

3-2. Percentage of Development Regions in the Number of Pipelines by Originator Nationality

Figure 1 shows the pipeline by originator nationality, and Figure 3 shows a breakdown of the pipeline by development region. Many of the development pipelines discussed in this paper have components that are being developed in multiple regions. In this report, development regions are classified into the following five categories: (1) the United States or multiple regions including the United States, (2) China, (3) Europe, (4) Japan, and (5) others (multiple regions: Japan and Europe, China and Europe, Japan and China, and Japan, Europe, and China).

As a result, 55.5% (4,681 components) of the total were developed in the US or multiple regions including the US, and 27.9% (2,353 components) were developed in China only. The development pipeline with China as the originator nationality accounted for 84.4% (2,156 components) of the components developed exclusively in China, while components developed in the U.S. or multiple regions including the U.S. accounted for the largest percentage in each of the other countries. As for the development pipeline originating from Japanese companies ("Japan-derived products"), 47.9% (206 components) were developed in the U.S. or in multiple regions including the U.S.

As shown in 3-1, the number of products derived from Chinese nationality companies ("China-derived products") in the overall development pipeline was similar to that of products derived from US nationality companies ("US-derived products"), but as shown in Figure 3, most of the China-derived products were considered to have been developed only in China. On the other hand, many of the globally developed products originating from Japanese, U.S., and European companies are considered to be developed in the U.S. or in multiple regions including the U.S. Therefore, we will analyze components that include the U.S. as a development region in the following sections.

3-3. number of development pipelines in the u.s.

When limited to the 4,681 ingredients developed in the U.S. or multiple regions including the U.S., the nationalities of these originators were, as shown in Figure 4, the U.S., China, Japan, the U.K., Switzerland, South Korea, Germany, and France, in order of the number of pipelines. The ranking of the top countries was similar to the result in 3-1, but the difference between the U.S. in first place and China in second place was larger, and the difference between China and the countries from third place onward, including Japan, was smaller.

Figure 5 shows the percentage of each development phase in the number of pipelines in each country, classifying the pipelines by originator nationality in Figure 4 by the most advanced development phase. As in the analysis in 3-1, there were some differences by country, such as slightly more Phase 1 in the U.S. and China and slightly less in France, but there were no countries where the distribution was extremely different from other countries.

3-4. share of each modality in the u.s. development pipeline

The U.S. development pipeline by originator nationality in Fig. 4 was classified by modality and is shown in Fig. 6. For products originating in the U.S., which accounted for approximately 60% of the analysis, small molecules accounted for 38%, antibodies and ADCs for 15%, and cell therapy, gene therapy, etc. for 16%, whereas small molecules accounted for 62% for products originating in Japan. The percentage of each modality was characteristic of each country. For example, the percentage of small molecules, antibodies and ADCs was higher for products from China than for those from the U.S., while nucleic acids accounted for 20% of the total in Germany. The UK and Korea were similar to the U.S., and Switzerland was similar to China.

3-5. share of each target disease in the u.s. development pipeline

The U.S. development pipeline by originator nationality in Fig. 4 was categorized by target disease and is shown in Fig. 7. The U.S.-originated products, which accounted for approximately 60% of the analysis, were 35% for Anticancer, 15% for Neurological, 9% for Anti-infective, 8% for Alimentary/Metabolic, and 8% for Nutritional/Metabolic. The percentage of "Alimentary/Metabolic" (8%) was 15%. In contrast, the Japanese-derived products accounted for 34% for anticancer agents, 24% for neurological diseases, 6% for infectious diseases, 7% for nutritional/metabolic diseases, and 7% for sensory diseases, with a large number of pipeline products for neurological diseases and sensory organs. The percentage of each target disease was also unique to each country, with China-derived products, for example, accounting for an outstandingly high 60% of anticancer drugs, and the United Kingdom accounting for 16% of infectious diseases, a higher percentage than in any other country. Germany and France were similar to the United Kingdom, and South Korea was similar to the United States.

3-6. percentage of "not yet on the market" ingredients in each country's pipeline

The information listed as "Target" in ^{PharmaprojectsⓇ} was extracted from ^the U.S. development pipeline by originator nationality and target disease in Figure 7, and pipelines with targets that do not match the targets of marketed components were aggregated and defined as "not yet marketed targets. The pipelines with targets that did not match the targets of marketed components were aggregated and defined as "not yet marketed targets " ¹⁰⁾. The pipelines with such targets were aggregated by originator nationality and target disease (anticancer drug and neurological disease) and are shown in Figure 8.

As a result, the overwhelming majority of the U.S. development pipelines that fell into the "Not yet marketed" category were from the U.S. However, when looking at the percentage of "Not yet marketed" pipelines in the number of pipelines from each country, Japan and Europe were comparable to the U.S. (46% in Japan). Japan had the second largest number of unlisted targets in the neurological disease pipeline after the U.S., and the percentage of unlisted targets in the anticancer pipeline was similar to that of other countries, although the number of unlisted targets was smaller.

Summary and Discussion

In this paper, we investigated the number of development pipelines by the nationality of the originator company's headquarters using Citeline's database ( ^{PharmaprojectsⓇ)}. The number of pipelines under development in the United States, the largest drug discovery country, was also surveyed by modality and target disease.

First, as shown in 3-1, the overall characteristics, the number of development pipelines by originator nationality was, in descending order, the United States, China, Japan, the United Kingdom, Switzerland, Germany, France, and South Korea. Japan was in third place, but there was a large difference from the number of pipelines originating from the top two countries, the U.S. and China. As has been noted in various literatures in recent years, China's research capabilities, including in the healthcare field, have been growing ^{significantly11)}, and the survey results in this report show that China's drug discovery activities are becoming more and more active. As for the number of pipelines by development phase, although the ratio of Phase 1 was slightly higher for China-derived products, there was no significant difference by country, and in Figures 2 and 5, some pipelines reached the submission stage. As shown in Figure 8, the percentage of unlisted targets in the U.S. development pipeline is comparable to that of developed countries, suggesting that pipelines originating from China are in the late-stage development stage as well as those from Japan, the U.S. and Europe. In addition, Citeline's annual ^report5) showed the number of pipelines including those in preclinical stages, and the number of pipelines is so large that South Korea ranks third after China. In Figure 1 of this report, Korea was ranked 8th because the analysis was limited to pipelines after entering the clinical stage and development regions were Japan, the U.S., Europe, and China, but if development regions were not limited to Japan, the U.S., Europe, and China, the number of pipelines in Korea was around 700, which was more than that of Japan. Although we do not refer further to Korea in this report, it is considered to indicate that Korea, along with China, has been active in drug discovery in the Asian region.

Regarding the distribution of development regions shown in 3-2, while Japan, the U.S., Europe, and South Korea have the largest number of pipelines developed in Europe or Japan after the U.S., China alone has an outstandingly large number of pipelines developed exclusively in China. Since many of the pipelines originating from China are considered to be developed with an eye toward the domestic Chinese market, which differs from the conventional global strategy of many Japanese companies, we decided to limit our analysis to pipelines that include the U.S. as a development region in the following sections. Even when limited to pipelines developed in the U.S. as shown in 3-3, China ranked second in the number of pipelines by originator nationality, although the difference with Japan, which ranked third, was smaller. In 3-4 and 3-5, we show the modality and the percentage of target diseases for the pipelines originated from each country. 3-4 and 3-5 show the modalities and the percentage of target diseases for each country-derived pipeline. For reference, the modality of 430 components of the development pipeline derived from Japan, the U.S., Europe, and China, and the ratio of target diseases are shown as a supplement.

As shown in 3-4, the percentage of each modality in the U.S. development pipeline is characterized by the fact that small molecules account for more than 60% in Japan-derived products compared to other countries. On the other hand, antibodies and ADCs accounted for 13% of the total, the smallest percentage among all originator countries. The percentage of cell and gene therapies was the third highest at 9%, but the number of pipelines in Japan, China, South Korea, and France was comparable to that of the U.S. and the U.K., and the number of pipelines was not as large as that of other countries. In the U.S. development pipeline, small molecules accounted for 42.3%, antibodies and ADCs for 26.7%, and cell and gene therapies for 10.3%, indicating that small molecules were still the most common development pipeline targeting new target sites. In particular, small molecules accounted for 71.3% of the total number of targets in the U.S. development pipeline that originated in Japan but have not yet been launched (not shown in the chart). Thus, Japan-derived development pipelines contained a large number of small molecules and also accounted for a large proportion of the unmarketed targets. While it is important for Japan as a whole to provide appropriate support to increase the number of biopharmaceutical development pipelines, continued support for small molecule development projects is also considered necessary to improve Japan's drug discovery capabilities.

As for the percentage of each target disease in the U.S. development pipeline shown in 3-5, Japan has the largest number of anticancer drugs, neurological diseases, nutrition/metabolism-related diseases, sensory organs, and infectious diseases, in that order, and the percentage of neurological diseases was larger than that of other countries, which is characteristic of Japan, and the number of pipelines was second only to that of the United States. In addition, as shown in 3-6, the ratio of unlaunched targets to the total number of pipelines in the U.S. development pipeline was similar in each country, but the ratio was particularly high in Japan, the U.K., Switzerland, and South Korea. This may reflect the fact that these countries, including Japan, are focusing on the challenge of developing new drugs with novel mechanisms. For Japan-derived products, the overall number of anticancer pipelines in the U.S. and the number of unlaunched targets in those pipelines were smaller than in other competing countries, but the percentage of unlaunched targets was comparable to that of other countries. For neurological diseases, the U.S. development pipeline had the second highest number of unlaunched targets in the pipeline after the U.S. This situation is characteristic of Japan. This situation is characteristic of Japan, and it is expected that appropriate support will be provided for the promotion of advanced research as well as for the promotion of solid development by each company, so that this situation will grow as a strength of Japan's drug discovery capabilities, and so that many first-in-class drugs will be produced from products of Japanese origin, including anti-cancer drugs. This report is based on the results as of July 2025.

Conclusion

This report provides an overview of the number of development pipelines in major drug-discovery countries as of July 2025. It is striking that China's presence as a competitor in drug discovery has grown significantly. Japan is in third place among the major drug discovery countries, with a distinct advantage over other countries in terms of both modality and target disease, and is also advancing development aimed at novel mechanisms more rapidly than its competitors. We hope that Japan as a whole will invest appropriately in drug discovery research to further improve its drug discovery capabilities, and that each pipeline will make steady progress in its development.

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