DUBLIN, Ireland, October 10, 2014 /PRNewswire/ --
Research and Markets (http://www.researchandmarkets.com/research/pq2tw9/the_overview_of) has announced the addition of the "The Overview of Japanese CMO Market" report to their offering.
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When it comes to drug manufacturing, the foundational principle is, starting with the procurement of raw materials, to manage the process from beginning to end while maintaining quality.
According to the Pharmaceutical Affairs Act, drug manufacturing is regulated by the Regulations for Buildings and Facilities of Pharmacies (hard regulation) and GMP (soft regulation), which assign responsibility for the production and quality control of drugs to manufacturers.
CMOs emerged in the U.S. and Europe from 1990 and the market for them rapidly expanded. However, since the former Pharmaceutical Affairs Act unified manufacturing and sales in Japan until 2005, Japan was not fertile soil for CMOs to develop. Once manufacturing and sales were recognized as separate by the revised Pharmaceutical Affairs Act, the Japanese CMO market showed 30% growth compared to the previous year, and the growth trend has been continuing ever since.
The 2011 CMO market scale reached approximately 510 billion Yen, an increase of 10% compared to the year before.
Japanese companies are leading the domestic CMO market. As for foreign companies, despite having corporate status in Japan, they have not seen much growth and presence in Japan.
Due to the 2005 revisions to the Pharmaceutical Affairs Act, it has become possible to have 100% of the drug production process done by external contractors. As a result, many generic pharmaceutical companies have taken advantage of their production capabilities to enter the contracting business and diversify their revenue sources.
Pharmaceutical companies will strengthen their survival strategies and external contracting of production will continue.
In the foreseeable future, Japanese CMOs will continue growing until the stage where foreign manufacturing quality control is recognized and a price war ensues.
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For more information visit http://www.researchandmarkets.com/research/pq2tw9/the_overview_of
Media Contact: Laura Wood , +353-1-481-1716, press@researchandmarkets.net
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