The Pharmaceutical Industry at a Glance Drug Discovery Modality Development Trend Survey By Company Type From the Perspective of Drug Discovery, Acquisition, and In-licensing

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Hideyuki Kagii, Senior Researcher, Pharmaceutical Industry Policy Institute

Background and Objectives

In recent years, pharmaceuticals utilizing various novel drug discovery platform technologies, such as nucleic acid medicine, cell therapy, and gene therapy, have been developed and approved, demonstrating efficacy against diseases that could not be approached by small molecule or antibody drugs in the past.

Currently, the originators of these new modalities are often start-up companies. Pharmaceutical companies, on the other hand, have been focusing on the development of biopharmaceuticals, mainly recombinant proteins and antibody drugs, in addition to small molecule drugs, but there is a high level of interest in new modalities, and many companies are accessing these technologies through alliances and acquisitions with academia and startups that require advanced technologies. and startups that require advanced technologies.

Against this background, we investigated the creation, acquisition, and introduction of new active pharmaceutical ingredients (NMEs) currently being developed and marketed, focusing on the new modality and company type.

Method

The pharmaceutical database EvaluatePharma was used to tabulate the corporate classification of companies holding NME rights for each modality for items classified as NMEs and in the development stage from P1 onward.

Results

(1) Number of NMEs covered

The number of NMEs currently under development and on the market for this survey is shown in Table 1-1. For each of these NMEs, Table 1-2 shows the total number of companies that hold the rights to the NME through "in-house discovery" and "corporate acquisition" (i.e., companies that are considered to have the underlying technology that enables drug discovery in the corresponding modality). Normally, one NME is created by one company, and when the company that created the NME is acquired by a company, the status is switched from "in-house" to "acquired by a company." Therefore, the total number of "in-house" and "acquired by a company" NMEs is approximately the same as the number of NMEs. The development stage of "acquired companies" is the current status of the NME in question, and does not indicate the development stage at the time of the acquisition.

(2) Trends in "In-house Creation" and "Acquisition" Activities by Modality (Figure 1-1)

Figure 1-1 shows a breakdown of the companies listed in Table 1-2 by company category and rights holding status ("in-house creation" or "corporate acquisition").

In the P1 and P2 stages, which are the early stages of development in all modalities, companies classified as Biotechnology are the source of NMEs.

By modality, many of the antibody drugs were acquired by Global Major through acquisitions in the filing/approval/launch stages, but in the early development stage, Global Major has NMEs through "in-house drug discovery. The reason for this may be that the fundamental technologies for antibody drugs acquired by Global Major through acquisitions have led to in-house originations in the early development stage.

In the case of nucleic acid drugs, many products in the early development stage are developed by companies falling under the category of "Specialty," and the number of "in-house originations" and "acquisitions" by Global Major and Regional Major is small. In addition, Biotechnology and Specialty companies tend to hold the rights until the approval and launch stages, although the absolute number is small.

Biotechnology companies play a central role in all development stages of gene therapy and cell therapy, and Specialty companies tend to acquire many companies at the launch stage of cell therapy, while Global and Regional Major companies tend to create their own products and acquire companies only to a limited extent. However, "in-house discovery" and "acquisitions" by Global Major and Regional Major are limited.

(3) In-licensing" Activity Trends by Modality (Figure 1-2)

Figure 1-2 shows the status of "in-licensing" such as co-development and sales collaboration. In all modalities, in-licensing by Biotechnology tends to be slightly higher than other company categories in the early development stage, but the absolute number of in-licensing by Biotechnology is small compared to the number of "In-house Discovery" and "Acquisition" in Figure 1-1.

Global Major and Specialty are also in-licensed from the early development stage (P1 and P2) for antibody drugs and nucleic acid drugs, but the number of in-licensed gene therapy and cell therapy is small in comparison.

(4) Modality ownership of global and domestic pharmaceutical companies

Tables 2-1 and 2-2 show the development status (development stage: P1 to launch) by modality for the top 10 global prescription drug ^sales2) and top 10 domestic prescription drug ^sales3) by EvaluatePharma, respectively.

In the case of antibody drugs, all global companies have NMEs either through "in-house discovery," "corporate acquisition," or "in-licensing," while only about half of the companies have NMEs for gene therapy and cell therapy (see "A or B or C" in the table). The number of companies that own NMEs by "in-house discovery" or "acquisition" ("A or B" in the table), i.e., in terms of having drug discovery infrastructure, also accounts for about half of the nucleic acid medicine companies.

The number of domestic companies holding NMEs for cell therapy ("A or B or C") was about the same as that of the top 10 global companies, although both the number of products and the number of companies holding NMEs were generally smaller than those of the top 10 global companies.

(5) "In-house Creation" and "Corporate Acquisition" of Global Companies

In the case of antibody drugs shown in Figure 1-1, a larger percentage of Global Major firms engaged in "company acquisition" in the late development stage, while a larger percentage engaged in "in-house discovery" in the early development stage. This suggests the possibility that "corporate acquisition" is linked to "in-house creation. Therefore, we investigated the relationship between the number of acquisitions and in-house creation for the top 10 global sales companies targeted in Table 2. (Figure 2)

The results showed that companies that have made acquisitions tend to have in-house drug discovery capabilities, and that the larger the size (number of products) of acquisitions, the greater the number of "in-house discoveries".

Summary and Discussion

With the emergence of various new drug discovery platform technologies due to recent scientific and technological advances, it is not realistic for even global companies to address all modalities with their own research resources. In fact, Biotechnology companies play the leading role in creating seeds that utilize these modalities, and pharmaceutical companies acquire new technologies and pipelines through "acquisitions" and "in-licensing.

From this survey, it was confirmed that in the field of antibody drugs, Global Major has in-house developed products of a scale comparable to Biotechnology ^{from the} early development stage (P1 and ^P2 ), suggesting that they are utilizing fundamental technologies acquired through corporate acquisitions. On the other hand, in nucleic acid medicine, gene therapy, and cell therapy, the number of acquisitions and in-licensing activities by Global Major and Regional Major was limited.

In recent years, there have been large-scale acquisitions of Biotechnology companies by Global Major companies in the areas of gene therapy and cell therapy (mainly CAR-T) ⁴⁾. The fundamental technologies acquired through these acquisitions are expected to lead to the creation of new gene therapy drugs by Global Major companies in the future, as has been seen in the field of antibody drugs.

In the case of gene therapy and cell therapy, it is conceivable that Biotechnology companies may proceed with in-house development until the later stages of development due to the small number of target patients, etc. As a pharmaceutical company, it is important to consider whether to adopt a strategy of introducing the technology after the Proof of Concept has been obtained or before that time, and whether to conduct in-house research and development as well as evaluate the new technology. It is becoming increasingly important for pharmaceutical companies to develop a discerning ability to evaluate new technologies as well as their own research and development.

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