Specialty Injectable Generics Market: Incur Rapid Extension During 2018 – 2026 With Top Key Players Pfizer, Teva Pharmaceutical Industries, Novartis AG, Baxter International, Mylan N.V.
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Moreover, expiration of the patents of majority of pharmaceutical and biotech products in the near future, especially in high value U.S. and Europe market is boosting the market growth. However, stringent regulatory guidelines and low profit margins and drug shortage is expected to hamper growth of the global specialty injectable generics market. The shortages faced in the industry are primarily due to increased manufacturing issues, delay in supply, and shortage of Active Pharmaceutical Ingredients (API).
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.
Major players operating in the global specialty injectable generics market include, Pfizer, Inc., Teva Pharmaceutical Industries Ltd., Novartis AG, Baxter International Inc., Mylan N.V., Fresenius SE & Co. KGaA, Endo International Plc., Hikma Pharmaceuticals PLC, Lupin Ltd., Sagent Pharmaceuticals, Inc., Cipla Limited , Sun Pharmaceutical Industries Limited, and Dr. Reddy's Laboratories.
Increasing prevalence of neurological disorders in North America is expected to bolster the market growth
North America holds dominant position in the specialty injectable generics market, owing to high prevalence of genetic disorders. According to the U.S. Pharmacist Journal, January 2018, around 1.2 million adults are diagnosed with early symptoms of brain disorders, annually, of which 21% are due to Alzheimer’s disease and the total number of new cases of Parkinson’s disease and traumatic brain injuries is around 135 million in the U.S.
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Moreover, North America is the largest generics drug and biosimilar market worldwide especially in segments of specialty disease and large annual generic/biosimilar prescription. According to report by the U.S. Department of Commerce’s International Trade Administration in 2016, U.S. generic drug sales reached an estimated US$ 70 billion, which is a quarter of the global market. This was due to a large number of drugs going off-patent and healthcare reforms favoring generics. Generics holds 22% of total prescription sales and its share in filled prescriptions increased from 19% in 1984 to 88% in 2015.
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