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Nirmal Bang Report
Long acting / complex injections (suspension, recombinant peptides and carbohydrate iron complex) represent the single largest category in terms of sales within the overall complex generics opportunity in the U.S. market.
We estimate the cumulative market opportunity represented by the complex injectable category, where generic competition is expected over the next two-three years, is $8-9 billion.
Indian Pharmaceutical companies have seen some success in long acting injectables, but it is so far limited to the legacy oil based suspension products.
Currently, a large part of the sales of long acting injectable products in the U.S. market is based on biodegradable polymer systems with the majority using Poly Lactic-co-Glycolic Acid polymer, where generic players are yet to see a meaningful success.
Currently, there are ~36 long-acting therapies approved in the U.S. market and are based on release controlling polymer formulations.
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