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.
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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).
Figure 1. Global Generic Sterile Injectable Market Share, By Drug Type (%)
Source: Coherent Market Insights Analysis (2017)
Rapid increase in the prevalence of chronic diseases globally drives the global generic sterile injectable market
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.
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.
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