Global Generic Sterile Injectables Market – Restraints
Shortage of sterile injectable is expected to decrease the growth of the global generic sterile injectables market, over the forecast period. Sterile injectables shortage has increased by 200X over the last few years. This is primarily attributed to increasing demand from emerging economies – Asia Pacific and Latin America and limited production capacity of the plants. Supply side factors include physical constraints due to remarkably high standards in the chain of production and in the distribution of the products which are potentially very dangerous.
For instance, according to the Bloomberg Data published in August 2016, the top three manufacturers of generic sterile injectables including Pfizer, Sagent, and Hikma accounted for nearly 70% of the global volume as per the analysis of prescription data from Symphony Health. The shortages faced in the industry are primarily due to increased manufacturing issues, delay in supply, and shortage of API. There have been an exponential rise in the number of warnings to manufacturing faculties by the U.S. FDA, especially in India, which is among the largest generic manufacturers globally. This has led to shortage of generic sterile injectables in the global market.
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