According to recent statistics on the prevalence rate of rare diseases, per 10,000 individuals, the United States has 7.5, Japan 4, and Australia 1.2 patients with rare diseases. The most important challenge drug developers and pharmaceutical companies face with any rare disease is the scarcity of literature and guidelines. It is difficult for developers to decide on an endpoint to the examination process and to anticipate any potential effects of treatment. Without information on the natural history of the disease, designing a clinical trial is tricky. Rare diseases represent both a challenge and an opportunity for drug developers and regulators.

Globally, authorities have aimed to facilitate growth of the rare disease pharmaceutical industry, planting the seeds of success for companies so that more of the millions who suffer from rare diseases can find relief. Global entities like the International Rare Diseases Research Consortium (IRDiRC) have made notable contributions to improving public health through faster and better diagnostic capabilities and novel therapies for people living with rare diseases and conditions throughout the world. In Japan, to continue the advancement of research on rare diseases and to assist pharmaceutical companies with R&D for orphan medicines, or drugs for the people, the Rare Disease Bank (RDB) was established in 2009 at the National Institute of Biomedical Innovation (NIBIO; now known as the National Institutes of Biomedical Innovation, Health and Nutrition).

After a few decades, those companies working on development and innovation today will enjoy the perks of market leadership. According to a recent survey, the Japanese government and three large Japanese pharmaceutical companies (Fujifilm, Takeda Pharmaceutical, and Astellas) have made some strategic collaborative agreements regarding rare diseases R&D, leading to several advances in this emerging pharmaceutical area. Corporate executives’ and drug developers’ choice to take these steps represents a breakthrough for the long-term growth and future stability of the Japanese pharmaceutical industry. However, the Japanese government and associated companies are also working on the budgetary impact and cost drivers of drugs for rare and ultra-rare diseases. They are seeking solutions that can be incorporated without an increased regulatory burden on firms or tax burden on citizens, while still providing increased availability and access to orphan drugs for patients.

Domestic and international pharmaceutical companies in Japan are operating beyond their flexible zones, thereby generating an atmosphere of high market competition. Consequently, a greater demand for highly skilled, experienced, and competitive human resources (HR), and a workforce that can attain market leadership is the key driver for recruitment. Given the prevailing trends in the pharmaceutical industry, it is not hard to see that the demand for Japanese HR will continue to increase as competition in the industry grows. As companies seek to fulfill the demand for drugs for rare diseases in the global market, they are looking to hire people with related skill sets and experience in the same niche to cut down on costs and training time. This high demand for a Japanese workforce also provides Japanese workers with real grounds for earning competitive compensation from companies.

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