Specialty injectable is a high cost drug therapy that requires administration by injection, inhalation or infusion. This medication is indicated in treatment of chronic or life threatening diseases such as HIV, rheumatoid arthritis, hemophilia, cancer, cardiovascular diseases, infectious diseases, auto immune disorders, and other diseases.

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Increasing prevalence of chronic diseases such as cancer and cardiovascular diseases is a major factor driving the specialty injectable generics market growth. According to The National Cancer Institute, 2013, there are over 100 different types of cancers that can be described from the type of cells they are formed from. According to the American Cancer Society, 2017, cancer is the second most common cause of death in the U.S., which accounts for nearly 1 out of every 4 deaths.

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).

Increasing incidences of chronic diseases is expected to propel growth of the global specialty injectable generics market

Specialty injectable generics are used in treatment of complex disease condition such as cancer, hemophilia, HIV, Central Nervous System (CNS)-associated disorders, and others. High prevalence of cancer is expected to drive the market growth. According to World Health Organization (WHO), in 2012, cancer was the second leading cause of morbidity and mortality worldwide, with around 14 million new cases registered in 2012. In 2015, cancer was responsible for 8.8 million deaths, worldwide. Moreover, WHO stated that the number of new cases is expected to increase by around 70% by 2030.

Furthermore, increasing incidences of HIV/AIDS is propelling growth of the specialty injectable generics market over the forecast period. According to WHO, around 36.9 billion people were diagnosed with HIV in 2017, with nearly 1 in every 25 adults in Africa living with HIV.

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.

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.

Moreover, key players in the market are focused on receiving approval for generic products to enhance their product portfolio. For instance, in September 2017, Samsung Bioepis’ Ontruzant (SB3) a monoclonal antibody for treatment in breast cancer – was approved by European Medicines Agency (EMA).

Key Players

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.

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