Japan Cell Therapy Market

Growing Cases Of Chronic Diseases 

According to the World Health Organization (WHO), in Japan chronic diseases accounted for 80% of deaths in 2002. Chronic diseases are increasing three fold in the country due to a large number of smoking population, a prominent section of the population being old and rising population in the country.

The most common reason for the prevalence of chronic diseases such as cancer and respiratory diseases in Japan is smoking. According to the National Cancer Centre, smoking is one of the biggest health concerns in Japan and kills more than 100,000 people per year and is responsible for one in ten deaths. Cancer has been the leading cause of death in Japan for more than 30 years, and the mortality rate is further increasing year by year. Total mortality from cancer has been steadily and steeply increasing. Cell therapy has proven effective in treating cancer. CAR T-cell therapy is a form of immunotherapy that uses specially altered T cells, a part of the immune system to fight cancer. Another example is multiple sclerosis, which is a chronic, autoimmune demyelinating disease of the central nervous system, which causes lifetime physical disability and the number of multiple sclerosis patients in Japan has been steadily increasing in recent years. Cellular therapies hold a potential for autoimmune disorders repair and may be able to provide protection from inflammatory damage caused after injury.

Various studies have shown that cell therapy has potential in treating several incurable neurological disorders like spinal cord injury, cerebral palsy, Parkinson’s disease, and many more. The remarkable properties of cell therapy in treating various terminal conditions both in vitro and in vivo could be used as first-line therapy in the future. Japan has the highest percentage of geriatric population in the world. Seniors accounted for 28.4% of Japan’s population and 12.9% of its labor force in 2018. The National Institute of Population and Social Security Research projects that Japan’s elderly will make up 30% of the population in 2025 and 35.3% in 2040. Geriatric population is easily susceptible to a large number of chronic diseases. With rapid increase in industrialization in the large cities air pollution in Japan has become a public health concern. About 20% of the population of Japan is constantly exposed to high levels of air pollution which is another prominent reason for the increase in lung cancer in the country.

Favourable Government Initiatives

Cell therapies, like other medicines, require reimbursement in order to become broadly available to patients at the end of the development process and similar to the considerations for clinical trial, manufacturing and meeting regulatory standards, early planning for reimbursement is essential. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority responsible for ensuring the safety, efficacy, and quality of pharmaceuticals (including biological products) and medical devices in Japan. PMDA conducts scientific reviews of marketing authorization applications for medicinal products and monitors post-marketing safety data. PMDA works with the Ministry of Health, Labor, and Welfare (MHLW) to protect the public health safety of Japan. Within PMDA, the Office of Cellular and Tissue-based Products is responsible for regulating cellular therapy products. Favorable government policies such as The Regenerative Medicine Promotion Law passed in 2013 detailed the development of two additional acts, Safety and Regenerative Medicine Act (RM Act) and Pharmaceuticals, Medical Devices and Other Therapeutic Products Act (PMD Act), which provide two regulatory pathways for regenerative medicine products, including cell therapy products. These initiatives help the development of novel technologies.

The novel features of cell-based therapies and their potential to treat diseases which cannot be addressed adequately with current medicines have led to their incorporation into accelerated approvals systems and schemes for access to unlicensed medicines. Examples of this are the new system for the regulation of regenerative medicines in Japan which came into force in November 2014. This Act provides marketing authorization specific to regenerative medicine products that is conditional and time controlled. A collaborative approach among academia, government and industry is central to Japan's regenerative medicine ecosystem. The Forum for Regenerative Medicine (FIRM) embodies this approach, bringing together more than 200 members, including industry, nonprofits, academic institutes and clinics to encourage and accelerate the development of regenerative medicines.

Japan is a country eager to build its presence in the cell therapy segment, hence the government is providing favorable policies and initiatives for faster development and approval. As of 2017, Japan has approved two regenerative medicine treatments under the new laws. One is JCR Pharmaceuticals Co. Ltd. 's Temcell for steroid refractory graft-vs.-host disease, an allogeneic stem cell therapy based on mesenchymal stem cells, whose technology came from Osiris Therapeutics Inc. and partner Mesoblast Ltd. (An equivalent product, Prochymal, is approved in Canada and New Zealand.) The second is HeartSheet, an autologous skeletal myoblast therapy for heart failure due to IHD, manufactured by Terumo Corp.

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