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With this research service, Frost & Sullivan’s Transformational Health team provides critical insights into the Asia specialty generics market highlighting the growth opportunities, key countries biopharmaceutical environment benchmarking, and highlights major R&D, regulatory and infrastructure reforms influencing its growth. Importantly, the study also identifies actionable growth opportunities for industry participants to profit upon. The report highlights the similarities and contrast between the different Asian countries in terms of biopharmaceutical industry environment for specialty generics R&D, manufacturing, adoption and access. There is no commonly accepted definition of specialty generics and is quite 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.

This report reviews the significant drivers that will propel the adoption of specialty generics in these countries. For example, rising prevalence of chronic diseases such as diabetes and cancer where treatment is primarily driven by specialty drugs will drive the demand for economical and easy to administer generic formulations in order to improve access. Convenience and benefits offered by self‐administered medications using new drug delivery systems such as nasal sprays, auto injectors, pen injectors, prefilled syringes and needle-free injectors will drive the demand for specialty generics. Specialty generics development provides a competitive differentiation to the companies compared to traditional generics. Also, compared to 505(b)(1) pathway for NDA, 505(b)(2) pathway in the US offers faster approval, lower risk and market exclusivity from 3 to 7 years in certain cases when coupled with right development and regulatory strategies.