September / October 2021

ISPE Japan Affiliate: Growing to Meet Market Needs

Marcy Sanford
ISPE Japan Affiliate: Growing to Meet Market Needs

Japan’s pharmaceutical market is one of the world’s largest and the ISPE Japan Affiliate is helping its members stay connected and current in the ever-changing pharmaceutical industry.

With a population of more than 126 million, Japan is the third largest pharmaceutical market in the world.1  According to figures from the Ministry of Health, Labour, and Welfare’s Annual Pharmaceutical Production Statistics, the Japanese market for prescription and nonprescription pharmaceutical products in 2019 totaled $105 billion, up 18 percent from 2018. Imports of foreign pharmaceuticals accounted for approximately 30 percent of the total Japanese market.2

Although Japan’s population has started decreasing over the past 10 years, it continues to have one of the world’s highest life expectancy rates and its pharmaceutical market is expected to remain one of the strongest worldwide due to continued demands for innovative therapies. Antitumor agents are among the top selling pharmaceuticals in the country.2 Other top sellers include diabetes agents, antithrombotic agents, immunosuppressants, and ophthalmic agents.2 Pharmaceutical companies continue to enter the Japan market including Takeda, Daiichi Sankyo, Pfizer, Chugai, Astellas, Otsuka, MSD, Mitsubishi Tanabe, GSK, and Novartis.3

A Growing Market

“Japan occupies one of the few global drug development bases and the stable supply of medicines for our citizens is the responsibility of the pharmaceutical industry,” said Ayako Nakajima, ISPE Japan Affiliate Past Chair. “The promotion of innovation in the industry in Japan will continue. However, in order for the pharmaceutical industry to drive the Japanese economy as one of the growth industries, the new drug market here must be as attractive as the ones overseas.” Nakajima said strategies in place to strengthen the pharmaceutical industry in Japan include efforts to:

  • Improve the research and development environment
  • Reduce cost and improve efficiency through regulatory reforms
  • Improve pharmaceutical productivity and manufacturing infrastructure
  • Develop an environment and infrastructure for proper evaluation
  • Promote international expansion of Japanese drugs
  • Create global ventures that promote the growth of the drug discovery industry
  • Improve distribution of medical drugs

Affiliate Initiatives

Formed in 2002, the ISPE Japan Affiliate strives to meet the educational and networking needs of its members by offering a comprehensive program of continuing education seminars and conferences for pharmaceutical professionals. The Affiliate has translated 41 ISPE Guidance Documents into Japanese, and written a Pest Control Manual.

“ISPE’s Guidance Documents provide a huge value to our members and lead them in the right direction when they have questions,” said Nakajima. “You also learn a lot when you work on the translation of one of the ISPE Guides.”

During the COVID-19 pandemic, the Japan Affiliate like many others had to change from in-person to online activities. But they were able to continue to provide robust programming for their members, which helped them have an almost 75 percent renewal rate among members. Because of this renewal rate, the Affiliate won third prize in the ISPE October 2020 Member Renewal Contest. “We began contacting our members three months before it was time for them to renew and our board is continually considering new ideas to encourage membership renewal as well as ways to entice new members to join,” said Nakajima.

Offerings the Japan Affiliate provides to its members include:

  • 12 conferences, technical webinars, plant tours, or networking events each year
  • 15 Communities of Practice (CoPs) that meet monthly to work on projects
  • Ongoing opportunities to connect with regulators, academia, and industry members.

Japan Affiliate members were able to hear a presentation from Lawrence Yu, Deputy Director, Center for Drug Evaluation and Research’s Office of Pharmaceutical Quality, US FDA, at the Affiliate’s Annual Meeting in May. Typically held in person, this year’s annual meeting was held virtually with more than 300 attendees. The theme was “Pharma Society 5.0 ‘Moonshot’–Our Strategic Path Forward.” In addition to guest speakers from regulatory agencies, academia, and industry, workshops were provided by the Affiliate’s CoPs.

Future Plan

The Affiliate is planning a Winter Meeting in December in Osaka to focus on cutting-edge technologies, and is hoping to bring back their popular US Pharmaceutical Plant Tour in 2022.

Nakajima said that the board encourages Affiliate members to give feedback about the topics they are interested in learning more about so that the board can best determine which educational opportunities to provide. One of the most popular recent webinars covered the topic of remote inspections.

“Next, we are planning to publish a newsletter via email in order to keep our relationships strong, share valuable information on time, and to compensate for the lack of communication under COVID-19. Webinars, electronic information sharing, and web networking have worked very well to keep and increase our membership.”

In addition to providing members with educational opportunities, the Japan Affiliate has an Emerging Leaders group, a Women in Pharma® Mentor Circle, and hosts plant tours for students to interest them in the pharmaceutical industry. Nakajima said these groups serve not just to educate but to encourage and inspire.

“Our goals with ISPE are to share international knowledge, to develop young talent, to improve our own expertise and share information with others around the world, and to contribute globally to the development of the pharmaceutical industry.”

Quick Facts about the ISPE Japan Affiliate

  • Founded: 2002
  • Region: Asia Pacific
  • Membership: 727


  • Chair: Hiroshi Yamaguchi, Fresenius Medical Care
  • Vice Chair: Hiroshi Sakai, Kokando Co., Ltd.
  • Treasurer: Tetsuro Noguchi, Nobelpharma Co., Ltd.
  • Secretary: Akihiro Matsuki, Mitsubishi Chemical Engineering Corp.
  • Past Chair and Emerging Leaders Chair: Ayako Nakajima, Q&EHS Solutions Co., Ltd.
  • Advisory Board: Hirokazu Kisaka, Kyowa Kirin Co., Ltd.
  • Board Liaison: Hirofumi Suzuki, Bayer Yakuhin, Ltd.
  • Affiliate Manager: Natsumi Sahara, ISPE Japan Affiliate
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