Intensifying chronic illnesses cases mainly, cancer is chiefly contributing in increasing the demand for sterile injectable drugs at the rapid rate globally. Expanding attentions of drug manufacturers on the production of drugs for the treatment of cancer is driving the product demand lucratively.
Earlier, the manufacturers used to face issues associated with regulatory policies on the compliance of sterile injectable drugs. Since the overall manufacturing process is extremely complex and highly expensive, approval of these drugs was considered as the long-standing process followed by the manufacturing practice.
Now, rapid approvals of injectable drugs by FDA has changed the market scenario at the global scale. The authorization by regulatory agencies has become efficient as well as less time consuming. The worldwide market is expected to cross over US$ 657 Bn by 2024. Also, the market is likely to witness a strong compound annual growth rate of over 7% during the foreseeable period of 2016-2024.
From Crisis to Innovation of Sterile Drug Products
A number of drug shortages in the United States propelled in 2011 and 2012, the estimated amount was around 80%, in terms of materials shortage. Therefore, there were several cases reported where drugs were purchased from numerous drug substitutions and unlicensed distributors. This led to the adverse reactions including patient’s deaths.
Between 2001 and 2014, the US faced more than 1789 shortages that were around 34% of the emergency drugs. According to a report by Associated Press in 2014, US hospitals witnessed the loss of more than $230 million per year. Drugs shortages in the region were extremely high in 2016. The drugs in shortest supply was the sterile injectable that were broadly used in acute and emergency care units. This resulted in heavy losses of the top most manufacturers across, in the terms of supplies, resources, finances, as well as the status.
Recent innovations such as advanced isolators, barrier systems, and packaging systems along with the advanced automation and robotics techniques have fueled the use of sterile injectable drugs in the market. Novel sterilization techniques such as E-beam surface sterilization has encouraged several manufacturers to use the technique while the production process. This slowly and gradually boosted their production efficiency and recovered them with the business losses.
Key Players Contributionr
Emergent bio-solutions, one of the prominent manufacturers of sterile injectable drugs focus on viral and microbial expression. This is precisely and prudently executed under the expert direction and rigorous controls. They manufacture products including GE Xcellerx fermenter and during all the stages of process comprising harvesting and culturing, and use single use containers.
GILEAD SCIENCES, INC. collaborated with WHO for cure and diagnostics of Visceral Leishmaniasis and Novo Nordisk A/S received a consent from the European Commission regarding the use of Fiasp. Fiasp acts fastest and majorly used for the treatment of adult diabetes.
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Sanofi, another key manufacturer recently traded Merial (animal health business) with Boehringer Ingelheim. The firm had also proclaimed its partnership with Walter Reed Army Institute of Research. This collaboration was for the development of a vaccine against the Zika Virus.