SPECIALTY INJECTABLE GENERICS MARKET ANALYSIS

Global Specialty Injectable Generics Market – A Cost Effective Approach in Chronic Diseases Treatment

Specialty injectable generics play a major role in advanced healthcare as they are used in treatment of various complex, life-threatening diseases such as cancer, cardiovascular diseases, HIV, hemophilia, rheumatoid arthritis, auto immune disorders, and others.

The global specialty injectable generics market size was valued at US$ 31,300 million in 2017, and is expected to exhibit a CAGR of 10.4 % over the forecast period (2018 – 2026).

Figure 1. Global Specialty Injectable Generics Value (US$ Mn), by Region, 2017

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                                                                Source: Coherent Market Insights Analysis (2019)

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.

 Figure 2. Global Specialty Injectable Generics Market Share (%), by Product Type, 2018 and 2026

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                                                                      Source: Coherent Market Insights Analysis (2019)

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, 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.

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.