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:
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.
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.
Switching delivery formats: A lifecycle management strategy for sterile injectables
Switching delivery formats can be an effective strategy to enhance they lifecycle of your drug. This whitepaper provides insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another.
Patient-centric sterile injectables: Improving patient experience through formulation and delivery
Join us for an expert panel of biologics experts as we discuss patient-related characteristics that should inform drug product design decisions, product-related characteristics that can be modified to address the needs of the target patient populations and innovative technologies that can be used to address patient needs