Report on BioJapan 2025 Opening Ceremony, Keynote Speech and Biopharmaceutical Seminar
BioJapan 2025" was held at Pacifico Yokohama for three days from October 8 (Wed.) to 10 (Fri.), 2025. As in previous years, "Regenerative Medicine JAPAN 2025" and "healthTECH JAPAN 2025" were also held at the same time, and in 2025, a record 22,167 people visited the exhibition, a large number of organizations exhibited, and a record 25,498 interviews were conducted in partnering. As in 2024, the event was energized by the large number of international participants. The Pharmaceutical Manufacturers Association of Japan (PMAJ) also participated as one of the sponsoring organizations, and many presentations were made by member companies. In addition, many companies and organizations exhibited alliance booths, where they met with academia and venture companies for active information exchange and interaction.
Opening Ceremony and Keynote Speech
After opening remarks by Mr. Minoru Yoshida, Chairman of BioJapan Organizing Committee, Mr. Ryo Minami, Deputy Director-General for Commerce and Services, Ministry of Economy, Trade and Industry; Mr. Masahiro Mori, Deputy Director-General for Pharmaceutical Industry Promotion and Medical Information, Minister's Secretariat, Ministry of Health, Labor and Welfare; Mr. Suzuka Sakashita, Deputy Director-General (Research Promotion Bureau and Higher Education Policy Coordination), Minister's Secretariat, Ministry of Education, Culture, Sports, Science and Technology; and Mr. Yuji Kuroiwa, Governor of Kanagawa Prefecture. The keynote speech was given by Mr. Yuji Kuroiwa, Governor of Kanagawa Prefecture. The keynote speeches were followed by "Development of Fujifilm Bio-CDMO Business" by Mr. Teiichi Goto, President & CEO, Fujifilm Holdings Corporation, and "The Future of Global Biomedical Research: Inserm's Strategic Vision and International Collaboration Opportunities" by Mr. Yoshiharu Kuroiwa, Governor, Kanagawa Prefectural Government. Strategic Vision and International Collaboration Opportunities (Chairman and Chief Executive Officer Inserm Prof. Didier Samuel), and "The Future of the Fusion of Life Science and Technology: Tokyo The Pharmaceutical Sciences Committee of the Pharmaceutical Manufacturers Association of Japan (PBCJAJ) is a member of the Biopharmaceuticals Committee of the Pharmaceutical Sciences Society of Japan (PSCJ).
Opening Ceremony
Biopharmaceutical Committee Seminar (Organizer's Seminar)
Efforts to Secure Human Resources for Biopharmaceutical Manufacturing and Expectations for the Domestic Engineering Industry
The Biopharmaceutical Committee of the Pharmaceutical Manufacturers Association of Japan (PBCJ) has continuously held seminars on the theme of "human resources" several times at BioJapan, and in FY2025 it held a session on the theme of "engineering human resources for biopharmaceutical manufacturing," which is unprecedented as a subject for a seminar organized by the pharmaceutical industry. The session was held under the theme of "Engineering Human Resources for Biopharmaceutical Manufacturing.
As the development of biopharmaceutical manufacturing bases in Japan accelerates, securing biomanufacturing personnel who can work immediately and training the next generation of biomanufacturers are viewed as challenges. Furthermore, a challenging activity to train personnel for CDMO*1 using actual production facilities of pharmaceutical companies has been initiated from FY2025. However, in addition to manufacturing personnel, it is also necessary to secure specialized personnel involved in CMC*2 in a wide range of fields, including formulation method development, QA/QC, and pharmaceutical affairs. In addition, automation of production facilities, DX promotion, and increasingly sophisticated GMP requirements have made it necessary to secure engineering and digital human resources who understand pharmaceutical manufacturing and GMP.
In light of these changes in the environment, this seminar will share the status of securing and training manufacturing personnel that the Pharmaceutical Manufacturers Association and pharmaceutical companies are working on, and as an agenda proposal, pharmaceutical companies will share their sense of the issues caused by the shortage of engineering personnel. The engineering industry then shared quantitative analysis of pharmaceutical manufacturing equipment investment in the industry as a whole, comparison and discussion with the semiconductor industry, the importance of developing "user engineers" (engineers who have a user's perspective and understand pharmaceutical manufacturing and GMP), and the importance of further collaboration between the pharmaceutical engineering industry and pharmaceutical users. The importance of further cooperation between the pharmaceutical engineering industry and pharmaceutical users was also discussed.
1 CDMO: Contract Development and Manufacturing Organization
*2 CMC: Chemistry, Manufacturing and Control
Panel Discussion
Introduction to the Seminar
Kazuhisa Uchida, Specially Appointed Professor, Graduate School of Science, Technology and Innovation, Kobe University, Executive Director, BCRET
Mr. Uchida explained the background of this session, including the growing demand for biotech human resource development, activity items initiated by the Ministry of Economy, Trade and Industry (METI) and the Ministry of Health, Labour and Welfare (MHLW), and the progress of quantitative research on human resource development needs initiated by BCRET. In addition, various initiatives were introduced, including BCRET's establishment of classroom and practical courses that include new modalities*3 and the start of CDMO human resource development using actual equipment from pharmaceutical companies. In addition, the importance of seamless collaboration between the engineering and pharmaceutical industries was discussed, and the purpose of holding this session was explained.
3 New Modalities: ADC, Bispecific Antibody, Cell Medicine, Gene Therapy, Nucleic Acid Drugs, etc.
Contents of each speaker's presentation
1) Chugai's efforts to develop human resources for biomanufacturing and challenges for engineering human resources
Tetsuya Isono, Senior Professional in charge of Biotechnology, Production Engineering Division, Chugai Pharmaceutical Co. Mr. Isono introduced the company's CDMO human resource development efforts, including a program that provides basic education followed by multiple work experiences in actual production activities at the Ukima and Utsunomiya sites, as well as technical discussions with MSAT/QA/QC and a mentor support system. As for the issue of internal human resource development, he explained that it is difficult to achieve the goal of training managers only with the uniform systematic training that has already been established, and that it is important to have various programs to enhance the ability to make appropriate judgments in response to deviations and inspections. The key word is "experience of challenge," and a mindset and supportive environment are essential requirements.
As for challenges in the engineering field, he mentioned the lack of interest in engineering in pharmaceutical companies among new graduate students, the difficulty of career recruitment, and the need for high English proficiency. In light of the shrinking workforce due to population decline and shrinking capacity due to changes in work styles, he also pointed out the importance of ingenuity, equalization, and standardization of equipment specifications and work procedures based on the assumption that supply capacity is limited.
2) Kyowa Kirin's human resource development and engineering initiatives
Toshiyuki Kurazaki, Managing Executive Officer, CSCO and Global Manufacturing Head, Kyowa Kirin Company, Limited Mr. Kuraczar gave an overview of the CDMO human resource development support that he has been working on as a member of the Biopharmaceutical Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) and introduced Kyowa Kirin's support activities. Regarding Kyowa Kirin's internal human resource development, he shared the urgent need for education as a result of continuous career recruitment, as well as the results of establishing an internal Human Resource Development Office & Knowledge Center to develop human resources for global activities. The center features practical training and know-how transfer using mimicry equipment. He also explained that a new biopharmaceutical plant is under construction in the U.S., and that an approach of exchanging people and technology with Japan and studying through circulation is being promoted.
He also shared the current situation where repair costs are increasing due to continuous large investments, and efforts are being made to increase the number of employees in the in-house engineering department in order to maintain the current level of operations. As for engineering challenges, delivery time issues, increasingly sophisticated specification requirements due to the expansion of modalities, and the importance of measures against aging were pointed out, and the shortage of skilled workers, rising material costs, and competition with construction for semiconductors and data centers were cited as causes.
Finally, as expectations for the engineering industry as a cooperative partner of pharmaceutical companies, he indicated the importance of integrated support from design to maintenance, prevention support, partnership building, and know-how sharing.
3) The state of the pharmaceutical industry as inferred from the data
Rei Kurihara, General Manager, Life Science Project Department, Chiyoda CorporationMr. Kurihara presented data and discussion on the state of the pharmaceutical industry. The construction industry's order volume has expanded from 12 trillion yen to 18 trillion yen over the past 10 years, with domestic construction orders for the manufacturing industry accounting for about 20% of the total, suggesting that the industry is easily affected by construction projects as a whole. The challenges facing the construction industry include a serious decline in the number of workers and the aging of the workforce, stricter work-limit regulations due to reforms of work styles, and pressure on business due to rising material prices. Capital investment in the pharmaceutical manufacturing industry has also increased 1.5-fold over the past five years, from approximately 400 billion yen to 600 billion yen. However, this investment only accounts for 2.5~5% of the total industry, suggesting that market conditions in all industries are also affecting pharmaceutical capital investment.
The government-related budget for the pharmaceutical industry is approximately 1.16 trillion yen, as extracted from budget information provided by the Ministry of Health, Labor and Welfare and the Ministry of Economy, Trade and Industry. In contrast, the semiconductor industry, which is considered comparable in terms of the establishment of clean areas, the use of high-quality water, and the high quality control required, has a budget of 5.7 trillion yen, a difference of approximately five times. Considering the similarity, it can be inferred that the semiconductor industry's aggressive investment may affect not only the overall construction work in the pharmaceutical industry, but also the human resource aspect, such as securing operators.
In light of these circumstances, Mr. Kurihara stated that it is difficult for individual companies to solve the problem, and stressed the importance of cooperation across industry boundaries, as well as maintaining outstanding technology in Japan and communicating its attractiveness.
4) Necessity of training user engineers for biopharmaceutical manufacturing and improvement of production efficiency
CEO, Biopharmaceutical Facility Engineering & Consulting Mr. Yu Uone Mr. Uone explained the necessity and value of "user engineers," who serve as a bridge and conduit for engineering not only between users and the engineering industry, but also within users themselves, based on his many years of experience in the construction, start-up, and maintenance of biopharmaceutical manufacturing facilities and equipment, with the user perspective as the foundation. The "User Engineer" is a person who is responsible for the GMP and the maintenance of the GMP. A "user engineer" is an engineer who understands GMP, processes, and the user's "point of view" and has a user perspective.
In the expanding biopharmaceutical industry, as the burden on users increases, fostering user engineers with care is attracting attention as an effective solution. In training them, in addition to learning GMP and processes and project management skills, high communication skills are important. Among these, he emphasized the importance of "knowledge retention and first-hand experience through manufacturing experience.
In addition, he explained the key points that the education system should be widely established to make the industry more attractive, and that not only engineers but also users should learn from other departments, using actual examples of troubles and their impact on the industry. The presence of user engineers can also be expected to discover added value that users are not even aware of and to simplify equipment design. Finally, he gave hints on the use of "digital twin" as a training tool.
Panel Discussion
In the final panel discussion, the following topics were discussed
🔹 Challenges for the engineering industry to contract facility construction from the biopharmaceutical industry
🔹 Can the above issues be resolved by training personnel to understand mutual issues
🔹 What are the mutual expectations of biopharmaceutical industry companies and the engineering industry
The challenges include lack of mutual understanding of changing requirement specifications, excessive specification The challenges identified include a lack of mutual understanding of changing specifications, excessive specifications and associated increased maintenance burdens, different involvement methods for each client, and the spread of single-use facilities that allow for building construction without engineering knowledge. The importance of standardization and information sharing in response to changes was discussed, and it was also suggested that users can expect efficiency gains by learning engineering.
The importance of securing and fostering engineering personnel and user engineers was also emphasized, and the importance of active interaction between manufacturing and engineering, shorter delivery times through improved construction approaches, and open discussion of the industry's overall concerns about investment in pharmaceutical equipment was discussed. Expectations were also raised for organizations such as the International Society for Pharmaceutical Engineering (ISPE) to foster a sense of unity among those involved in engineering and to serve as a forum for user and engineering discussions.
Exhibition booth
For 2025, a joint task force of the R&D and Biopharmaceutical Committees has again been established to plan and prepare for the Pharmaceutical Cooperative exhibition booth. At the exhibition booth, the activities of both committees were introduced through posters, documents, and projected images. New initiatives for 2025 include the implementation of a slump rally and collaboration with the Public Relations Committee and the Asuka Miyabashira Chairperson's Team. In addition to the Pharmaceutical Cooperative Association, visitors to the exhibition booths of five biotech-related organizations - Toyama Pharmaceutical Consortium, Fukuoka Bio-Community, Osaka Bio-Headquarter (including Nakanoshima Cross), Institute for Glycobiology Core Research (iGCORE) and Okinawa Institute of Science and Technology (OIST) - were presented with a commemorative gift: stamps. More than 200 people participated in the rally. In addition, multiple visits to the Pharmaceutical Cooperative Association booth by Chairman Miyabashira and timely X postings throughout the three days in collaboration with the Public Relations Committee further contributed to the effectiveness of the advocacy activities and attracted more visitors.
A view of the Pharmaceutical Manufacturers Association booth
The next BioJapan 2026 is scheduled for October 7-9, 2026 at Pacifico Yokohama.
(Yasushiro Nakagawa, Chairman of the Policy and Working Committee, Biopharmaceuticals Committee, and Junko Tsukada, Director, Pharmaceutical Affairs and Biopharmaceuticals Department)