Sterile APIs: Introduction

  • Sterile active pharmaceutical ingredients have drastically improved the standards of medical treatment. These active pharmaceutical ingredients (APIs) are highly effective in small doses, and require sophisticated manufacturing facilities and specialized technical capabilities.
  • Numerous APIs are sterilized unless the final dosage form is terminally sterilized or produced by a process including a sterilizing filtration step. APIs anticipated for usage in injectable products need to stringently comply with relevant specifications on pyrogens or bacterial endotoxins
  • The manufacture of sterile APIs is stringently controlled in order to minimize the risk of contamination with micro-organisms, endotoxins, and particles. If the final dosage form is not to be sterilized by filtration, the APIs should be practically free of particles.
  • Sterile dry powder APIs are achieved generally by freeze drying process (lyophilisation or cryodesiccation), which ensures product stability and improved shelf-life of products destined for clinical or commercial applications

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Key Drivers and Restraints of Global Sterile Dry Powder API market

  • Earlier, pharmaceutical companies were skeptical to outsource the manufacture of high potency APIs, and a majority of the manufacturing was confined to captive or in-house. A major factor was the risk of safety and patent infringement. However, pharmaceutical companies started experiencing shortage of sterile APIs, as they started to expand geographically. Furthermore, an increase in cost of drug development and commercialization added to the financial burden. Development of regulatory and legal framework has caused outsourcing to be the optimal option for the manufacture of sterile API.
  • Pharmaceutical companies can focus on core business activities such as drug development and commercialization, while also take advantage of technical expertise at CMOs instead of investing in expensive API manufacturing setup.
  • Patent expiry and subsequent launch of generic versions is a lucrative opportunity for pharmaceutical companies to expand their product portfolio and tap lucrative market segments in this technology driven market. Various biosimilars have been approved in Europe, while the U.S. FDA has approved only one biosimilar to date. Increase in research & development activities and constant attempts toward mimicking branded biological drugs are likely to pave the way for introduction of cost-effective treatment alternatives and consequently, drive the global sterile dry powder API market.

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Oncology Application to Lead Global Market

  • The global sterile dry powder API market can be segmented based on API type, application, and region
  • In terms of API type, the global sterile dry powder API market can be divided into synthetic and biological APIs
  • Based on application, the global sterile dry powder API market can be classified into oncology, anti-diabetic, cardiovascular, CNS, musculoskeletal, and other. The oncology segment is estimated to expand significantly owing to the introduction of innovative therapeutic options.

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Key Players Operating in Global Sterile Dry Powder API market

Leading players in the global sterile dry powder API market include:

  • Dr. Reddy’s Laboratories
  • Lonza Group
  • Sandoz International GmbH
  • Pfizer, Inc.
  • Merck KGaA

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