Generic Sterile Injectable Market Register Unwavering Growth with Top Players Baxter Inc., Fresenius Kabi, Pfizer/Hospira, Novartis/Sandoz, Teva, Hikma, Sun Pharma, Dr. Reddy’s, Mylan

The generic sterile injectable refers to biologics that are used for the treatment of various drugs and has same active ingredients to that of the branded versions of it, however the inactive contents of the drugs can be varied. The process of manufacturing generic sterile injectable is equivalent in the terms of the FDA regulations to that of the branded counterparts. A disease is characterized as chronic if it lasts for more than three months within the patient according to the U.S. National Center for Health Statistics. The chronic diseases are one of the major causes of mortality as these diseases cannot easily be cured by vaccines and healthcare medication. According to the World Health Organization (WHO) in 2015, the non- communicable chronic diseases attributes to over 38 million death per year. These diseases include Arthritis, diabetes, and asthma, cardiovascular diseases, cancer and also the viral diseases such as hepatitis C and HIV/AIDS. According to the 2013 fact sheet of Centers of Disease Control and Prevention, arthritis is suggested to be the most common cause of disability due to which 22 million doctor diagnosed patients have obstructed physical activity due to arthritis. The similar report suggests that almost half of the U.S. population, i.e. 47% people have at least one major risk factor for cardiovascular disease which mainly includes uncontrolled LDL cholesterol, high blood pressure and smoking habits. The high prevalence rates of these diseases will inadvertently boost the growth of the global generic sterile injectable market.

The global generic sterile injectable market was valued at US$ 42,900 million in 2015 and is expected to witness a CAGR of 10.2% during the forecast period (2017 – 2025).

The growing prevalence of chronic diseases and rapidly increasing ageing population that are highly susceptible to chronic diseases are the important factors effecting positively showing significant growth in generic sterile injectable market in North America. Growing number of chronic disorders such as cancer and diabetes as well as the consequent rise in demand for newer generic injectable across various countries in Europe would further fuel growth of the market in the region. However, stringent regulations by U.S. FDA such as, monitoring of the flexible intravenous (IV) solution bags from exposure to rough surfaces during labelling and packaging for any microscopic punctures or holes on the surface of the bag in order to avoid the microscopic defects that may lead to microbial contamination. However, the branded counterpart of the generic sterile injectable is way more expensive and thus, cannot be afforded by a common population. Difficulties faced by the manufacturing companies so as to meet the rising demands for these injectable in the hospitals, pharmacies and drugs stores is one of the major concerns that may result in hampering the growth of the market. However, various dominant key holders are involved in acquiring small pharmaceutical companies to build a robust product portfolio of generic sterile injectable to fulfill the demand of these medications.

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Key players indulged in strategic implementation of various policies for the product portfolio expansion of the generic sterile injectable

In 2016, Baxter acquired Claris’ Injectables, a 15 years old global generic injectable pharmaceutical company for the production of injectable medicines such as anesthesia and analgesics, anti-infective, renal, and critical care medications

Baxter has also recently signed an agreement with Dorizoe, an India based life sciences company manufacturing generic sterile injectable. The duo is expected to develop more than 20 generic injectable products including oncolytic and cardiovascular medicines.

According to FiercePharma, Fresenius Kabi is expected to show a revenue booster in the forecast years due to a major investment of US$ 250 million to turn a U.S. site for expanding the capabilities of the production of generic injectable and sterile injectable.

Pfizer marked its leading share in the generic sterile injectable market through its collaboration with Hospira in 2015.

Other landmark acquisitions for the boost of generic sterile injectable market consists Hikma acquiring the assets of the Bedford Laboratories and Sun Pharma’s acquisition of Pharmalucence in 2014 that resulted in benchmarking sales of generic sterile injectable.

The generic sterile injectable are FDA approved biologics that are used for the treatment of many diseases and disorders in the vast arena of the healthcare industry. The generic sterile injectable are very inexpensive as compared to that of their branded counterparts of these drugs and performs equally well. Thus, these Injectables are heavily in demand all the time and are used in majority of hospitals and clinics across the globe. However, due to the stringent FDA regulations for the production of these injectable, the rigorous demand satisfaction of these injectable has always been a constant challenge for the key players in the global generic sterile injectable market.

The generic sterile injectable market is expected to gain steady traction in the foreseeable future as the sterile injectable products find its application across a wide number of diseases and medical condition. Manufacturers are focused on increasing the production of generic sterile injectable to meet the rising demands without compromising on the quality of the injectable.

Market Dynamics

The growing incidence and prevalence of chronic as well as infectious diseases and musculoskeletal disorders is a key factor fueling growth of the global generic sterile injectable market. About 53% of the disease burden is contributed by non- communicable diseases in India according to the National Health System Resource Centre (NHSRC) in 2016, which accounts up to 37 million deaths in India annually. As per the Chronic Disease Prevention and Health Promotion by the Centers for Disease Control and prevention (CDC), 117 million people in the U.S., suffered from one or more chronic diseases and two of these chronic diseases, heart diseases and cancer jointly accounted nearly 48% of all the deaths. Apart from prevalence of chronic diseases, several other factors that are responsible to fuel the growth of generic sterile injectable market includes rise in prevalence of infectious diseases such as malaria and tuberculosis and its cost effective treatments in emerging economies as well as the musculoskeletal disorders such as osteoarthritis, rheumatoid arthritis and osteoporosis are also responsible for accelerating demand for generic sterile injectable. Product portfolio expansion and development of new products that can be used in the treatment of these diseases, are some of the other factors augmenting growth of the global generic sterile injectable market. However, the complex regulatory guidelines by FDA for production procedures and stringent regulations for ANDA filings are impeding growth of the global generic sterile injectable market.

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