Sterile injectable therapies: Changing delivery formats revolutionizes lifecycle management

The sterile injectable drug market is evolving at a rapid pace. With a forecasted market value of 762.48 billion by 2028 from 52.88 billion in 2023¹, the segment's significance cannot be understated. A closer examination reveals the intricacies of this evolving landscape, specifically in the realm of delivery formats.

Emerging delivery formats and their importance
Delivery formats for sterile injectable therapies play a pivotal role in ensuring medication efficiency, speed-to-market, adaptability, cost-effectiveness, and patient convenience. A noticeable shift is suppliers transitioning biologics from bulk glass vials to prefilled syringes. This move prioritizes patient safety by mitigating dosing errors and offering straightforward medication administration. Prefilled syringes simplify the delivery process, reducing multiple preparatory steps and thus minimizing potential mistakes.

Yet, migrating to a different delivery format isn't a decision to be taken lightly. It requires an intricate balance of technical understanding, supply chain logistics, regulatory considerations, cost implications, and knowledge about product stability and quality.

Driving factors for the shift
Several elements are nudging the pharmaceutical industry towards this change:

• Market Dynamics: As the demand for the COVID-19 vaccine and treatments for chronic illnesses like diabetes, cancer, and cardiovascular disorders increases, there's a surge in the requirement for primary packaging.
  
• Cost and Supply: With a rising market, prices and supply availability are becoming a concern, pushing suppliers to rethink their drug delivery strategies.
  
• Product Differentiation: Changing the delivery method can offer a unique edge over competitors and even potentially extend patent production.
  
• Storage Considerations: There's a marked preference for shifting from frozen liquid vials to those stored at 2-8 degrees C due to the high costs associated with frozen storage.

Key considerations for transition
Changing delivery formats is a multi-faceted process. A few pivotal factors include material interaction, timelines, and regulatory considerations. With respect to material interaction, for example, it is crucial to understand how the drug interacts with its packaging. Transitioning from one format to another demands rigorous testing to ensure the drug's quality remains uncompromised.

In terms of project timeline, stability and compatibility tests consume significant time, which must be incorporated into the product's market launch strategy so key milestones are not delayed.

From the regulatory perspective, each change in delivery format, whether it’s altered vial dimensions or transition from one delivery method to another, will have regulatory implications that need to be meticulously addressed.

Conclusion
Switching delivery formats is more than a logistical decision; it's a strategic move, sometimes aimed at extending a drug's lifecycle. While the shift promises several advantages such as improved patient convenience and safety, it is a challenging, resource-intensive process that demands seamless collaboration across various teams, including quality, engineering, and regulatory. When executed with precision and foresight, the transition can yield substantial benefits, both for pharmaceutical companies and for patients and healthcare providers.