China focus on R&D and biologics
India is the most lucrative location for low-cost manufacturing of specialty generics and the country is increasingly focusing on developing innovative products, although the country lags in macroeconomic indicators due to low healthcare spending, according to an international research report.
Comparatively, China is the most attractive site due to its strong focus on developing R&D infrastructure and capabilities specifically for biologics.
Singapore and Hong Kong have a conducive macroeconomic and biopharma environment, followed by Thailand. While the market is nascent, there are signs that strong growth and new regulatory and infrastructure reforms are ahead, said the report.
Specialty generics offer lucrative market opportunities to Asian drug manufacturers to increase profit margins by developing innovative, value-added alternatives of existing drugs to offset traditional generics’ shrinking margins in developed countries, said the “Regulatory and Infrastructure Reforms in India and China Catalyzing the Asian Specialty Generics Market” released by ResearchAndMarkets on 15 Mar 2021.
The report reviews drivers propelling specialty generics adoption in these countries. For example, the rising prevalence of chronic diseases such as diabetes and cancer, where specialty drugs primarily drive treatment, will drive the demand for economic and easy-to-administer generic formulations to improve access.
Self-administered medications using new drug delivery systems such as nasal sprays, auto-injectors, pen injectors, pre-filled syringes, and needle-free injectors offer convenience that will drive the specialty generics demand.
Specialty generics development provides competitive differentiation to companies compared to traditional generics, said the report.
Compared to the 505(b)(1) pathway for new drug approval (NDA), the 505(b)(2) pathway in the US offers faster approval, lower risk, and market exclusivity from 3 to 7 years in some instances when coupled with the correct development and regulatory strategies. #pharma #ayurveda #health #investment /fiinews.com
