The research study covers the present scenario and growth prospects of the regenerative medicine market in Japan for 2016-2020. To calculate the market size, Technavio analysts have used the revenue generated from the sales of various types of regenerative medicine products to end-users like hospitals, ambulatory surgical centers (ASCs), and clinical research laboratories.
Regenerative medicine market in Japan is highly regulated, and the dynamics of regulations for regenerative medicine have changed since 2014. The Japanese government introduced Act on the Safety of Regenerative Medicine (ASRM) and revised the Pharmaceutical and Medical Device Act (PMD Act) in 2014 to increase the number of product approvals in regenerative medicine field.
The growing R&D activities in regenerative medicine will also contribute to the rapid market growth during the forecast period and is expected to generate significant revenues for vendors in the future. For instance, there are approximately 79 new clinical research plans and 2,634 medical care plans in the market.
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Technavio healthcare and life sciences analysts highlight the following four factors that are contributing to the growth of the regenerative medicine market in Japan:
- Transformation of regulatory landscape fostering quick approval of regenerative medicines
- Growing partnerships of MNCs with local vendors in Japan
- Recent product approvals fuel the market growth
- Government initiatives driving regenerative medicine market in Japan
Transformation of regulatory landscape fostering quick approval of regenerative medicines
Favorable government regulations in Japan are expected to fuel the market growth. The new legislation for regenerative medicine will foster the safe and fast provision of the innovative products to individuals with intractable diseases. In 2006, the MHLW issued an ethical guideline associated with the use of human somatic stem cells in clinical research. In 2010, it was further revised to cover the use of human embryonic stem cells and iPSC in clinical research. However, the guideline was purely advisory and was not legally bounded.
Barath Palada, a lead orthopedics and medical devices analyst at Technavio, says, “The ASRM covers the field of the previous ethical guideline for non-commercial clinical research and daily practice using unapproved cell-based products such as cancer therapies with immune cells and cosmetic cell therapies.”
Growing partnerships of MNCs with local vendors in Japan
Japan is aiming to become a global leader in the field of regenerative medicine. Therefore, the local vendors are collaborating with foreign companies to foster product development activities. In addition, favorable regulations have fueled the infusion of foreign companies into Japanese regenerative medicine market. Athersys, Avita Medical, Cynata, Cytori, Mesoblast, Pluristem, RepliCel, and Regeneus are some of the foreign companies, which are focusing on collaboration with Japanese vendors. This collaboration enables the generation of substantial capital into the Japanese regenerative medicine market.
“In June 2016, StemBioSys signed a three-year marketing and distribution agreement with Funakoshi to bring its stem cell therapy products into Japanese regenerative medicine market,” adds Barath.
Recent product approvals fuel the market growth
The market has been witnessing new product approvals, which are expected to drive the growth. The new product approvals have the potential to generate substantial revenue in the market. For instance, in September 2015, Mesoblast's partner JCR Pharmaceuticals received approval of its product TEMCELL for the treatment of pediatric acute GVHD in Japan. This was the first product to be approved under the Japanese regenerative medicine law that enables cell therapy treatment to go directly from the first phase to commercialization.
In the same month, Terumo Corporation received conditional approval for manufacturing and commercialization of its product HeartSheet autologous skeletal myoblast sheets. Prior to the new acts in regenerative medicine, J-TEC received approval for commercialization of autologous cultured epidermis JACE and autologous cultured cartilage JACC in 2007 and 2012, respectively. Such approvals for new products are expected to generate substantial revenue.
Government initiatives driving regenerative medicine market in Japan
The government has undertaken various initiatives to facilitate the development of regenerative medicine. For instance, in 2015, three government ministries such as the Ministry of Education, Culture, Sports, Science and Technology; MHLW; and the Ministry of Economy, Trade and Industry collaborated to establish the Japan Agency for Medical Research and Development. Through this agency, these organizations have created a unified setup for the promotion of R&D. In addition, the Japan External Trade Organization has taken the initiative to support foreign companies that invest in regenerative medicine in Japan.
- JCR Pharmaceuticals
- Japan Tissue Engineering
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