The global pharmaceutical market is highly regulated and requires regulatory approval by various drugs manufacturers before landing on the market. During past years drug shortages have been faced by healthcare professionals and patients worldwide partly due to inconsistence product release and extensive drug recalls. These basically includes drugs for cancer treatment, antibiotics and anesthesia as well as injectable electrolytes and vitamins. However, sterility remains the foremost factor for injectable drugs as these drugs are administered intravenously, intramuscularly rather than via gastrointestinal tract. New manufacturing is also coming on line. Drug makers rising interest in injectable could ease shortages. For example, many hospitals and doctors are integrating with compounding drug manufacturers in order to boost their sales and bring differentiated products in the generic drug injectable market segment. Also, according to the U.S. FDA, since 2012, the number of drug shortages have decreased to a significant levels escalating the market growth over the forecast period. For instance, in 2012 Pfizer Inc., recommenced the production of its cancer injectable drugs that were in short supply from past years. Additionally, new manufacturing units have also come online which is in turn driving the revenue growth of sterile injectable drugs market. For example, in 2013, Teva Pharmaceutical Industries Ltd. opened a new injectable line at its manufacturing unit in Hungary. The market for sterile injectable drugs is spurred by increasing number of drug manufacturers focusing on production of biologics along with number of antibody-drug conjugates and monoclonal antibodies entering the drug development and clinical pipeline.
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Rapid FDA approvals in sterile injectable drugs market along with shortening approval times for new drug development to help accelerate the drug supplies. This is expected to increase the revenue for sterile injectable drugs over the forecast period. For instance, in 2010 FDA reported, reduction in number of drug shortages reducing to 35 in 2013 from a high of 183 in 2011. Furthermore, growing interest in biologics and targeted therapies, especially in oncology applications has led to growing demand for sterile injectable drugs currently. However, the manufacturing process of sterile injectable drug is complex with high capital and operational cost leading to limited number of players making the market. Other factors such as delays in manufacturing or shipping, shortages in active pharmaceutical ingredients and stringent government regulations are expected to impact the global sterile injectable drug market in a negative way over the forecast period. The global sterile injectable drug market is expected to witness expanded market growth drug delivery systems and pre-filled syringes.
Increasing focus of pharmaceutical industry towards growing their therapeutic segments such as oncology, biologics contributes a larger part of sterile injectable drug development pipeline. Also, novel drug delivery systems delivering targeted therapies is gaining popularity leading to rapid growth of sterile injectable drug market over the forecast period.
On the basis of regional presence, global sterile injectable drugs market is segmented into five key regions viz. North America, Latin America, Europe, Asia Pacific, and Middle East & Africa. North America will continue to dominate the global sterile injectable drugs market. Large number of drug manufacturers in the U.S. are focusing on increasing their sales by opening new manufacturing facilities for developing sterile injectable drugs. This is expected to boost the revenues for the global sterile injectable drugs in North America over the forecast period. However it has been reported that Europe does not suffers from drug shortage supply attributed to higher price of generics in European countries.
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Some of the major players operating in global Sterile Injectable Drugs market are Pfizer Inc., Teva Pharmaceutical Industries Ltd., Johnson & Johnson, Sanofi S.A., Hikma Pharmaceuticals., Piramal Enterprises Limited and Sun Pharmaceutical Industries Limited Companies are involved in collaboration agreements for R&D in order to exploit maximum potential.
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