SPECIALTY INJECTABLE GENERICS MARKET ANALYSIS
However, expensive and complex process to manufacture the biologics and generic injectables. Not all manufacturers can invest and sustain such investment especially in the ever increasing competition in the specialty injectables generics market.
The FDA implemented CGMP guidelines for manufacturing of generic sterile injectables. Moreover, these generic drugs are priced at reduced rates than that of the branded drugs leading to significantly low profit margins for manufacturers. Moreover, the FDA has enhanced efforts to enforce GMP on manufacturers and hence, they are unable to capitalize on generic drugs. This is expected to be factor hampering growth of the global specialty injectables generics market.
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