Pharmaceutical Industry at a Glance Survey of Originator Companies in the U.S. Development Pipeline

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The Office of Pharmaceutical Industry Research Chie Yoshiura, Principal Investigator
The Office of Pharmaceutical Industry Research Kiyoshi Morimoto, Principal Investigator
The Office of Pharmaceutical Industry Research Daisuke Kanai, Principal Investigator

Summary

1. Introduction

The Office of Pharmaceutical Industry Research The "Japan Drug Discovery Industry" (JDIC) has conducted various analyses to assess the current status of Japan's drug discovery capabilities. In the previous issue, we surveyed the number of development pipelines by the nationality of the originator company's headquarters ^using Citeline's database ( ^{PharmaprojectsⓇ )} and reported on the modalities and target ^diseases1). Following the previous issue, this paper focuses on the pipelines developed in the U.S. or multiple regions including the U.S. as global development-oriented drug pipelines, and investigates the distribution of pharmaceutical companies and Emerging Biopharma (EBP) as originators of these pipelines. The study was conducted in the U.S. in recent years. The influence of pharmaceutical companies and EBPs as organizations responsible for the creation of the recent U.S. development pipeline, or global development pipeline, is discussed.

Survey Methodology

As in the previous issue, this paper analyzes the development pipelines listed as of July 2025 in Citeline's ^{PharmaprojectsⓇ} database by originator nationality. In this report, pipelines that either include the U.S. or are solely developed in the U.S. are considered to be global pipelines, and only those pipelines that fall under this category were included in the ^survey2). 2) In this paper, the U.S. development pipeline will be referred to as the U.S. development pipeline. The U.S. development pipeline was classified by modality based on ^{PharmaprojectsⓇ} as in the previous ^issue3).

For company classification, information on the year of establishment of the originator company of each U.S. development pipeline was extracted ^using Evaluate ^{PharmaⓇ of} Evaluate, Inc. and classified as follows, considering sales in 2024. The companies were classified by year of establishment as follows: "pharmaceutical companies" for companies established before 1989, "companies established between 1990 and 2009" for companies established between 1990 and 2009, and Companies established in 2010 or later are defined as "established in 2010 or later. Companies and non-profit organizations for which the year of incorporation information was not available were classified as "unknown and other. Companies with sales of $1 billion or more in 2024 were included in the "pharmaceutical companies" category, even if they were established in 1990 or later. In this report, "EBPs" are defined as "established between 1990 and 2009" and "established after 2010" with sales of less than $1 billion in 2024. PharmaprojectsⓇ .

Results

3-1. Number of U.S. Development Pipelines by Originator Nationality and Company Category

From the pipelines listed in ^{PharmaprojectsⓇ} as of July 2025, 4,681 components were extracted from the U.S. development pipeline, which were either under development in the U.S. alone or in multiple regions including the U.S. As reported in the previous issue ¹⁾, the originator countries are, in descending order, the U.S., China, Japan, the U.K., Switzerland, South Korea, Germany, and France, and these eight countries are also included in this report as major drug discovery countries.

The number and percentage of U.S. development pipelines in each country by originator company category are shown in Figure 1, and the number of originators is shown in Table 1. Of the total, 32.2% of the U.S. development pipeline originated from pharmaceutical companies and 64.3% from EBPs. In addition, 42.2% were EBP-derived pipelines established after 2010. Compared to the total, 79.1% of pipelines in Japan were from pharmaceutical companies, and 20.3% were from EBPs. Although Japan had the largest proportion of pharmaceutical companies, Germany, Switzerland, the U.K., and France also had a large proportion of pipelines derived from pharmaceutical companies compared to the total. Conversely, the United States, China, and South Korea had a large proportion of EBP-derived pipelines.

There were 2,219 originators of U.S. development pipelines in the analysis, of which about half were U.S. companies. Chinese and Korean companies were next in number, followed by the United Kingdom, Japan, France, Switzerland, and Germany. Comparing the UK, France, and Switzerland with Japan, the number of EBPs that are originators of the US development pipeline is 28 in Japan, while 59 in the UK, 42 in France, and 34 in Switzerland, all higher than in Japan. In terms of the number of EBPs established since 2010, there were 33 in the U.K., 21 in France, and 21 in Switzerland, compared to 6 in Japan.

3-2. number of u.s. development pipelines by modality and company classification

The U.S. development pipeline is classified by modality, and the number and percentage of pipelines for each modality by company category are shown in Figure 2, while the number of originator companies is shown in Table 2.

Looking at the number of originator companies in the U.S. development pipeline by modality, there were 944 small molecule originator companies, of which more than half were established in 2010 or later. This was followed by cells, gene therapy, etc. with 383 companies, and antibodies or ADCs with 365 companies. Nucleic acids accounted for 99 companies.

The number of EBP-derived pipelines was larger than 60% for small molecules, cells, gene therapy, reformulation, peptides, and proteins other than antibodies, and the proportion of relatively new EBP-derived pipelines established in 2010 or later was large.

For nucleic acids, the proportion of pipelines originating from pharmaceutical companies was large at 56.9%, and for antibodies or ADCs, the proportion of pipelines originating from pharmaceutical companies was also relatively large at 40.0%. In the case of nucleic acids, since this report considered sales in 2024 in addition to the year of establishment as a condition for a pharmaceutical company, even relatively new companies established after the 2000s were treated as pharmaceutical companies, and relatively new companies accounted for the largest number of nucleic acid pipeline creation among the pharmaceutical companies. In the nucleic acid field, EBPs, which were once an emerging force, succeeded in development and grew as a company.

3-3. number of development pipelines by modality and company classification by country

Of the number of pipelines by company category for each modality shown in 3-2, we focused on the following five categories: small molecules, antibodies or ADCs, cells, gene therapy, etc., peptides, proteins other than antibodies, and nucleic acids, and tabulated them by originator company nationality. Figure 3 shows 2,712 components from U.S. companies, 206 components from Japanese companies, and 201 components from British companies.

In the U.S., the number of EBP-derived pipelines accounted for a large proportion of all modalities other than nucleic acids, in descending order of the percentage of EBP-derived products: cell, gene therapy, etc., peptide, protein other than antibody, small molecule, antibody or ADC, and nucleic acid. On the other hand, Japan accounted for a high percentage of the number of pipelines derived from pharmaceutical companies in all modalities. Of the 42 components in the Japan EBP-derived pipeline, 11 were from EBPs established after 2010. By modality, small molecules accounted for the majority (9 components), cells, gene therapy, etc. accounted for 1 component, and other modalities accounted for 1 component. The United Kingdom had a large proportion of pharmaceutical pipelines, but by modality, a large proportion of EBP-derived pipelines were for cells, gene therapy, etc., and proteins other than peptides and antibodies.

Similarly, in China, Korea, Switzerland, Germany, and France, the percentages of U.S. development pipelines by company category for the five modalities focused on were tabulated, and the modalities in which more than 50% of the pipelines in each country were derived from pharmaceutical companies and more than 50% from EBPs are shown in Table 3. As shown in Table 3-1, Japan and European countries have a large proportion of pipelines originating from pharmaceutical companies, while the United States, China, and South Korea have a large proportion of pipelines originating from EBPs. Conversely, Korea had a large proportion of pipelines derived from pharmaceutical companies for proteins other than peptides and antibodies.

3-4. cumulative number of EBPs in Japan, UK, France, and Switzerland, and in-house development ratio

Figure 4 focuses on the United Kingdom, France, and Switzerland, where the number of originator companies is close to that of Japan, and shows the cumulative number of EBP companies that have become originators of the U.S. development pipeline for each year of establishment of each EBP. In Figure 5, the number of domestic EBP companies surveyed in the previous ^study4) at The Office of Pharmaceutical Industry Researchis restated. Compared to the number of EBPs established domestically, the growth in the number of originator companies in the U.S. development pipeline was small, and after the 2010s, they were overtaken by the number of EBPs in France and Switzerland, with a larger gap with the U.K.

Table 4 shows the percentage of EBP-derived pipelines that are developed in the U.S. by EBPs themselves. In the Japanese EBP-derived pipeline, the percentage of EBPs themselves conducting development was 52.4%, compared to 75.3% in the UK, 76.7% in France, and 61.1% in Switzerland, all of which were higher than in Japan.

Summary and Discussion

In this report, we defined a global development pipeline as one that is developed in the U.S. or in multiple regions including the U.S., and investigated whether the originator companies were pharmaceutical companies or EBPs at the time of the survey, i.e., the size of contribution by company category.

The previous issue of this report reported that the number of pipelines originating from the U.S. and China was significantly high at the time of the survey, and Citeline's ^report5 including preclinical pipelines showed that the number of pipelines originating from South Korea was second to those two ^countries1), The results of this paper, as shown in 3-1, also indicate that there are many EBPs, especially those established after 2010, in South Korea, indicating that new companies are actively participating in the pharmaceutical industry.

As in Japan, many pipelines in European countries were derived from pharmaceutical companies, but as shown in 3-3, the contribution of pharmaceutical companies was large in Japan in all modalities, while in the UK and France, the number of EBP pipelines was larger than that of pharmaceutical companies in cell, gene therapy, and other proteins other than peptides and antibodies. The number of originator EBPs in the U.S. development pipeline for cell, gene therapy, etc. was 13 in the U.K. and 8 in France, compared to 6 in Japan, suggesting that EBP entry into this area is more active than in Japan.

In Figure 4, looking at the cumulative number of EBPs in Japan, the UK, France, and Switzerland by year of establishment of each EBP, the number of EBPs that have created a US development pipeline since 2010 is lower in Japan than in European countries. As shown in Figure 5, the number of EBPs in Japan has been increasing since 2010, but the growth of EBPs as originators of U.S. development pipelines has been slow, partly because the number of EBPs established in Japan around 2010 was sluggish, but also because many pipelines created by EBPs in Japan have not reached clinical development. In addition, many of the pipelines created by EBPs in Japan may not have reached clinical development or may have been developed only in Japan.

As shown in Table 4, the ratio of EBPs themselves as the originator company in the U.S. was also higher in the U.K., France, and Switzerland than in Japan. Although the development phase was not taken into account in this report, the fact that there was no significant difference in the percentage of development phase in the pipeline of each country in the previous report ⁽ No. ¹⁾ suggests that EBPs in the U.K. and France in particular are pursuing development in the clinical phase by themselves, including in the U.S., and that support for development, policies, and other external factors may be effective in promoting development. It is possible that external factors, such as support policies to promote development, may be having an effect.

From the previous issue, Japan was the third largest originator of the U.S. development pipeline at the time of the survey, following the U.S. and China. The results of this report indicate that approximately 80% of the development pipeline originating from Japanese companies was created by pharmaceutical companies, and while Japan has the largest contribution from pharmaceutical companies compared to other countries, the contribution to new drug creation by EBPs is very small compared to other countries. However, while the lack of drug discovery startups in Japan is recognized as an issue, further measures are still ^needed6,7). The support measures in European countries, where pharmaceutical companies are making a large contribution while EBPs are also being promoted, may be useful as a subject of comparative study with Japan's policies. As an example, the United Kingdom has organized a support plan for the life science ^field8). The plan is not limited to financial support for the creation of seeds in the early stages of development, but is comprehensive, including existing systems such as the use of IT, development of clinical trial environments, and investment in the manufacturing industry. The report also presented specific goals, such as "to become the third largest company in the world after the U.S. and China. In particular, the report included the strengthening of support for commercial R&D (commercial research and development), and the EBP should not be limited to the out-licensing of seeds to pharmaceutical companies or acquisitions, but should also consider strengthening support from the late development stage to post-marketing. I hope that the discussion will develop in the future. It is hoped that this discussion will continue to evolve in the future.

5. conclusion

Continuing from the previous issue, this report analyzes the U.S. development pipeline as of July 2025 by originator company classification. We have once again recognized that the composition of companies creating pipelines in Japan is completely different from that in the U.S., which has the highest drug discovery capacity, and in China and South Korea, which have been growing rapidly in recent years. In addition, European countries are close to Japan in terms of the number of pipelines created, and EBPs are also considered to be on the rise. In discussing the enhancement of drug discovery capabilities, we should refer not only to the U.S. but also to multiple regions such as China and Europe, and we hope that the discussion will appropriately refer to the excellent measures taken in each region while comparing them with the current situation in Japan.

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