Benchmarking Successful Sterile Injectables Companies in Globally

The term sterile injectables are used to refer biologics that are utilized for the treatment of different drugs and possess similar active ingredients as that of the branded drugs. However, there can be various types of inactive contents of the drugs. The manufacturing process of generic sterile injectable is same as that of FDA regulatory terms for the branded counterparts.

Market Scenario:

As per the latest studies, there are over 2,400 sterile injectable products under development phase that will result in the advent of advanced products in the global sterile injectables market. However, the major driving factor of this market includes generic injectables products market. Large number of pharmaceutical firms is concentrated on development of generic injectables. Owing to the increased focus of firms on therapeutic segments such as oncology, biologics have become an integral component of the pharmaceutical industry’s development pipeline. Also, novel drug delivery systems that offer targeted therapies are gaining importance. Also, the regulatory body has reduced the approval timeline for biologics. These factors are leading to the expansion of sterile injectables market.

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However, the expansion as well as manufacturing process of sterile injectable products is very complex and needs large investment. Also, the manufacturing costs of injectable products are high as compared to conventional drugs. Further, the U.S. FDA has imposed complex regulations on manufacturing facilities and equipment. Also, the operational costs of sterile injectables are high as majority of the injectables are toxic as well as infectious in their natural state and, therefore, require high quality and care in their storage, manufacturing, packaging, and distribution. These factors are challenging the growth of sterile injectables market.

Key Players:

  • Amgen Corporation.
  • Eli Lilly.
  • Baxter International Inc.
  • AstraZeneca plc.
  • Merck & Co.
  • Novartis AG.
  • Novo Nordisk.
  • Johnson & Johnson.

The global sterile injectables market can be classified based on technology and region. On the basis of technology, the global market is classified into conventional dosages and novel formulations. Further based upon conventional dosages, it is segmented into solutions, and Lyophilized / Water for reconstitution. Based on novel formulations, the global market is further divided into depot injections, liposomes, nanoformulations, PEGylated formulations and implants.

Regional Analysis :

  • North America
  • Europe
  • Asia-Pacific (APAC)
  • Middle East
  • Africa (MEA)
  • Latin America

The North American region is anticipated to command the maximum market share and would lead the sterile injectables market during the forecast period. The presence of numerous pharmaceutical organizations in the North American market and favorable regulatory environment as well as large population base have led to the high growth rate and high demand for sterile injectables. However, the Asia-Pacific region is anticipated to register swift growth during the forecast period owing to the presence of large number of companies engaged in the development

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