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Kyoto Biken: A wide-ranging approach to animal health problems

Interview - March 1, 2022

Kyoto Biken is an all-in-one manufacturing business when it comes to the field of animal health. The Japanese firm’s corporate philosophy, “Animal Well-being Matters”, originates from the active role it played in securing public hygiene and a stable food supply thanks to its various products at a time when Japan was facing a food crisis. In this conversation with president, Dr. Yasutaka Igari, we learn how Kyoto Biken has contributed to animal health through its holistic approach, comprising R&D, manufacturing and marketing of veterinary vaccines and diagnostics.


Can you please briefly introduce your company to our audience?

Kyoto Biken, headquartered in southern Kyoto, was established in 1948 with 243 employees, including 14 pharmacists and 45 veterinarians. In 2020, our sales turnover was about 4.6 billion JPY. Our business is mainly dedicated to animal vaccines. We are an all-in-one type of manufacturing company that includes R&D, production, quality assurance/control, medical affairs, clinical examination laboratory, and import/export. Furthermore, we also have a manufacturing company in Vietnam, close to Hanoi.

We have a total of 34 vaccines including bovine, poultry, porcine, fish and plant vaccines. We are focusing on cattle: in Japan, there are 2.5 million beef cattle and 1.3 million dairy cattle, totalling about 4 million, and our vaccines cover most of them(our domestic market share is 67.2 percent for bovine vaccines as of Mar. 2021).  To be noted is that 1)we have a 100 percent market share for bovine to be the world renowned Kobe beef; 2) our bovine vaccine line-up includes unique toxoid vaccines to prevent Clostridium and Botulism.

At present, we export two bovine vaccine products to the United Arab Emirates and Egypt.  Now, we are preparing to launch our products in Korea, Taiwan, and Israel. Also, we are in the process of registering our products in Pakistan and hoping to start exporting this year. In addition, this year, depending on how the situation with the COVID-19 pandemic progresses, we are planning to take part in an international exhibition to enhance our presence in the world (the last one we joined was held in China in 2019).


Your company was established shortly after the Second World War and you were the main veterinary vaccine manufacturer in Japan to develop vaccines for rabies and swine flu at that time period. Could you tell us about the origins of Kyoto Biken?

Kyoto Biken was established as Japan’s first private veterinary vaccine manufacturer inspired by the mission of safeguarding public hygiene during the immediate post-World War II period. At that time, infectious diseases such as rabies, classical swine fever, and Newcastle disease, were rampant, posing threats to the health of the Japanese people. Against this backdrop, the government of the day gave approval for privately owned veterinary vaccine manufacturers to operate as suppliers of preventive medicines, and they have played important roles, ever since. Kyoto Biken played an active role in securing public hygiene and stable food supply through its development of various products for protecting animals against diseases at a time when Japan was facing a food crisis. Therein lies the origin of Kyoto Biken’s corporate philosophy: “Animal Well-being Matters.”


Japan is known for its long life expectancy, an average of 85 years, and aging population, and countries such as Sweden, Italy, and Germany are also ageing rapidly. How are these demographic pressures affecting your company?

Our focus is providing vaccines to animals, especially cattle and other livestock, as well as pets. We foresee that the ageing society will lead to two main changes. One is a decrease in population that could lead to a decrease in food (or meat) consumption and the second is an increase in the age of farmers. There will be fewer small-scale private cattle farmers and livestock will be concentrated in the hands of larger companies. This will mean that animals such as cows and pigs will be kept in more densely packed conditions, therefore heightening the risk of infectious diseases. This means our vaccines will become even more important. While it is hard to say what major changes this will bring to Japan and globally, our focus is on developing high-quality vaccines for animals and using them to support livestock farmers.


The Food and Agricultural Organisation has identified antimicrobial resistance (AMR) as a growing concern for human health: in fact, by 2050 it is expected to cause 10 million deaths globally every year. How does your company, which helps prevent diseases through immunostimulation, contribute to contrasting AMR?

AMR is a serious issue and vaccines play a crucial role in decreasing antibiotic use. However, we are not promoting vaccines as a replacement for antibiotics. Our goal is to spread awareness. It is inevitable that antibiotics – such as those sold by our partner company Fujita Pharmaceutical – are used to treat diseases, but it is important to think about when to use them and for how long. Spreading awareness on the benefits of veterinary vaccines will contribute to decreasing antibiotic use, but we must have a balanced approach.

You have many different types of vaccines. Which are you looking to focus on?

The recent biggest growth we have seen both domestically and globally is in the pet or companion animal market. Therefore, we want to make the pet or companion animal market our focus while we would like to maintain our large market share for bovine vaccines. In addition, we want to take on the challenge and develop new projects in the area of porcine and poultry vaccine. In order to achieve this goal, we are collaborating and partnering with other companies as well and we will boost those efforts. There is also potential for growth in the plant vaccine market, where we have a product line-up that is unique not only in Japan but also globally.


One of the reasons for your success in securing the largest market share for bovine vaccines in Japan is that you have developed strong relationships with farmers. You work closely with them, performing on-site visits and analyses, and giving recommendations. Are you planning on replicating this model overseas?

The answer is simply No. I don’t think we can apply the same business model that we have developed in Japan. Unlike other global companies, we cannot just develop a vaccine and distribute it around the world. Currently, our export business consists of exporting products that we have developed for Japan to limited countries. However, we need to reconsider our strategy to adapt to different markets where a few to several big pharmaceutical companies are already operating. Our goal is to work with local wholesalers and local governments in determining the diseases that are of most concern in local areas and help tackle them with our vaccines or even develop vaccines tailored to local needs with them. Prior to Japan’s rapid economic growth, farms in Japan were not sanitary. With time, Japan has developed cleaner farming operations, and we would like to bring this experience and expertise, along with our vaccines, to help livestock farmers in developing countries.

Also, we may need to conduct comparative testing of our products to find good markets that we can compete in.  In the long run we are looking into developing a hybrid model where we export our products made in Japan and develop and produce products tailored to local needs made outside Japan. I hope our Vietnamese company will play an important role as a base for our expansion for the latter. In conclusion, we aim to use our Vietnamese factory to expand overseas and target emerging countries with growing populations.


As a pharmaceutical company, you must abide by different standards and regulations depending on the market in which you operate. How does this affect your operations?

We already received GMP (Good Manufacturing Practice) accreditation from the Japanese government for the Kyoto factory and from the Vietnamese government for our factory in Vietnam, respectively. In order to fortify the compliance of our facility in Vietnam, we are now collaborating with an external consultant in asking for GMP evaluation and accreditation for our factory in Vietnam. I have had experience with strict GMP compliance situation in the pharmaceutical industry sector for human use in the past and would like to use that experience to bring that to all our factories in line with the GMP standards for animal use. In this regard, a project for building a new plant for filling, lyophilization, packaging and cold storage next to the existing plant in Kyoto for producing bulk vaccine will soon be commenced. Operation of the new plant will start at the beginning of 2024.


As an integrated manufacturer, you conduct everything from R&D, production, and delivery of your vaccines. What synergies are there between the different parts of your business?

The advantage of an integrated business model is the strong collaboration and sharing of information throughout the entire process. If we were to work with other companies in R&D and production, for example, it would take more time to transfer or exchange technical knowledge. Our business model reduces this time, therefore resulting in shorter lead times. However, we cannot simply apply this integrated model to overseas markets. We need to create alliances or partnerships with local companies, academic and government sectors, and it is important for us to find ways to cut lead times and bridge communication gaps.


The first mRNA vaccines have been adopted for use in humans to combat Covid-19. Can you tell us where we are now in the veterinary vaccine field in terms of technological development? What is your R&D strategy currently focused on?

Currently, our original vaccines are 100 percent of the conventional type. While most of our R&D information is confidential, what I can tell you is that conventional type vaccines are essential when it comes to bovine, porcine, poultry, dog and fish vaccines. With the successful introduction of mRNA vaccines for Covid-19, we are planning to expand our R&D into developing new types of vaccines, for example, DNA or mRNA and recombinant vaccines. We are currently collaborating with external consultants to help us determine the most effective products to introduce to the market. After gathering information and conducting research, we aim to provide new vaccines produced with short lead times and with levels of efficacy higher than those of conventional vaccines. In order to achieve this goal, it is inevitable for us to collaborate with the academic sector as well as emerging venture companies. We understand that this area is highly competitive and as such we will need to be careful to be pro-patent.

It usually takes a decade to develop a new vaccine, and there is a significant time lag between developing a product and launching the finished product. Therefore, we are making strategic plans to fill this time gap, including providing products such as diagnostic drugs, specifically catering to the period of the lack of brand-new vaccines and even supplementing the value of existing vaccine products already in the market based on the strategy made by the recently established strategic product planning body.


You recently founded the Sasaeah Group. What are the advantages of this alliance?

The Sasaeah Group was established on January 1st 2020, consisting of three companies: Kyoto Biken, which is focused on vaccines, Fujita Pharmaceutical, located in Tokyo, which is focused on medicine, and Sasaeah Pharmaceutical in Tokyo as a sales function for both of these manufacturers. In addition, Sasaeah Holdings has become a new member as of January 1st 2022. A big advantage is that we can provide a one-stop solution. Sasaeah Pharmaceutical is the contact point for farmers and veterinarians, providing them with our vaccines as well as medicine. Kyoto Biken and Fujita used to conduct strategic product planning separately, but we have been able to create synergy by combining our vaccines with their medicine. We are now working as a group to develop a new product strategy for building a strong product portfolio.


You established your research and manufacturing facility in Vietnam in 2011. In terms of your international business, what countries are you targeting moving forward?

Currently, all products made in the Vietnamese factory are exported to Japan, but we would like to take advantage of this base and contribute to Vietnam first and then start expanding to neighbouring countries. We are now working on how we could provide our products to the Southeast Asian market. We are also targeting East Asia, i.e. Taiwan, Korea, and China, which is an attractive though challenging market. We must determine the best approaches to enter these markets. We will need more resources, finances, and personnel to establish operations there and comply with local regulations. There are many things we need to do but becoming a group has created synergies and advantages that we can leverage on.


If we were to come back on the last day of your presidency, what goals or dreams would you like to have achieved by then?

Establishment of the Sasaeah Group was a big step for Kyoto Biken. Looking at the experience of other small companies that achieved turnovers of 50 to 100 billion JPY in 10 to 20 years after establishment, we believe that the Sasaeah Group could also experience that kind of growth. If I come back, perhaps in five years’ time, I would hope to say that Kyoto Biken and the Sasaeah Group has doubled its turnover. In addition, DX (digital transformation) has been implemented in all the business processes and the communication between Kyoto Biken and farmers, veterinarians, pet owners is free flowing without limitation in order to support the stakeholders.