The Ministry of Economy, Trade and Industry (METI) will establish a “review meeting for life science technology strategies” to discuss about necessary policies for practical use of biopharmaceuticals and regenerative medicine products in the next fiscal year. To enhance the competitive power of the Contract Manufacturing Organizations (CMOs)/Contract Development Manufacturing Organizations (CDMOs), their participation in this project will be promoted under the government’s initiative to immediately cope with modalities and manufacturing methods of biopharmaceuticals. The government intends to support for biopharmaceutical CMOs/CDMOs in a particular to extend to gene/cell therapy product area that is expected to grow in the future. The strategies will be developed within the next fiscal year and then implemented as METI’s policies from 2022.
The proportion of biopharmaceuticals in the global pharmaceutical market tends to increase, among Top 100 products in sales, 53 products were biopharmaceuticals at the time of 2019. Biopharmaceuticals sold in Japan also tend to increase, while about 90% are manufactured overseas, and high dependence on foreign manufacturing sites is a challenge.
Among them, western countries and China develop their strategies in biotechnology area and increase the expenditures of research & development, while the competitive power of domestically developed biopharmaceuticals and diagnostic drugs is low, and the investment of research & development in private sectors is sluggish.
Thus, the METI has decided an establishment of review meeting to aim enhancement of the industry competitive power in biological area and creation of a new industry. In the future, the review meeting will discuss environmental improvement necessary for practical use of biopharmaceuticals and regenerative medicine products and compile into technology strategies. Although specific challenges to be investigated are “to be determined”, certain direction will be shown by budget requests for fiscal 2022 this summer, and details of the technology strategies will be reflected in the policies of the fiscal year.
Key policies include such as ▽Enhancement of the competitive power of the CMOs/CDMOs of biopharmaceuticals and regenerative medicine products, and ▽Research challenges to be tackled intensively.
For biopharmaceuticals, external resources of the CMOs/CDMOs tend to be actively utilized globally, and the market size currently increases to 500 billion yen in the world. The growth rate is expected to be 8% per year over the next 10 years in an estimation.
Such as Lonza in Switzerland and Samsung Biologics in South Korea have grown to global biopharmaceutical CMO overseas, while Fujifilm in Japan is expanding operations through M & A in Japan.
In the future, to ensure the domestic manufacturing bases regarding biopharmaceuticals and gene/cell therapy products, specific support measures for CMOs/CDMOs will be investigated.
Domestic manufacturing bases of regenerative medicine products that new products are expected to be marketed will be also reinforced. Since there are a few domestic CMOs/CDMOs of regenerative medicine products, research & development projects to make the biopharmaceutical CMOs/CDMOs extend to gene/cell therapy product area will be developed, and CDMOs who can immediately cope with investigational drug-scale process development/manufacturing used in clinical studies will also trained.
On the other hand, for research challenges to be tackled intensively, the review meeting of life science technological strategies will be established, and development of “smart cells” that produce high added-value new materials of which the production is difficult with chemical process will be promoted in the white biotechnology area as biotechnology in chemical industry.
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