Regulatory and Infrastructure Reforms in India and China Catalyzing the Asian Specialty Generics Market

Regulatory and Infrastructure Reforms in India and China Catalyzing the Asian Specialty Generics Market

  • February 2021 •
  • 39 pages •
  • Report ID: 6033759 •
  • Format: PDF
Transformational Health team provides critical insights into the Asian specialty generics market with this research service, highlighting growth opportunities, selected countries’ biopharmaceutical environment, and significant R&D, regulatory, and infrastructure reforms influencing its growth. The report examines similarities and contrasts between various Asian countries in specialty generics R&D, manufacturing, adoption, and access.

Specialty generics do not have a commonly accepted definition, often used interchangeably as complex generics.Specialty pharmaceuticals are often large, injectable, protein-based molecules produced through a biotechnology process.

But they may also be small molecules produced through traditional pharmaceutical manufacturing methods.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. The focus on improving the R&D landscape, especially for biologics, will attract global biopharmaceuticals to Asia due to the inherent advantage of a large patient pool and low-cost development and manufacturing.This 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, autoinjectors, pen injectors, prefilled 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. 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.