Injection Device Design Evolution a Key to the Growth of Biological Drugs

(Amherst, NH) – Because of their ability to effectively treat refractory conditions by targeting specific biomarkers, biological drugs continue to be at the forefront of modern drug development. By focusing on interactions at the cellular level, biologicals provide relief to patients afflicted with chronic conditions. The need for ongoing treatment places a strong emphasis on the ability of biological drugs to be designed and packaged for self-administration by the patient, a focus that is being addressed by injection devices with enhanced patient features.

For the past fifteen years, device designers have been advancing the handheld injector design envelope, creating devices that are stronger, lighter, and more ergonomic, while adding features intended to automate delivery preparation and administration for enhanced safety and convenience. The result has been devices that allow patients to follow their treatment protocols in the comfort of their own homes, a development that has been instrumental in propelling and sustaining biological injectables to strong double-digit annual growth.

Coupled with the trend toward therapeutic self-care are concerns over patient adherence to dosing schedules, particularly for elderly patients and patients with conditions that result in compromised or limited manual dexterity. To limit the risk associated with missed doses, drug developers and their device partners are investigating ways to reduce dosing frequency.

Although the device landscape has diversified, for biologicals glass vials remain the most common primary drug container. But the predominance of vials across all biological drugs is shrinking, as new and derivative injection devices proliferate. Glass prefilled syringes, pen injectors and autoinjectors continue to make gains as new biologicals and biosimilars reach the market. This trend has already tilted the balance away from vials for autoimmune indications.

Because a significant number of injectable drugs are being formulated or re-formulated for self-administration, it has become essential for drug developers and their injection device partners to understand user preferences and to define usability features as they pertain to specific treatment groups. The critical nature of this requirement is further underscored by the design trend in specialty prefilled devices to incorporate a unique look-and-feel to devices in order to achieve product differentiation in the direct-to-consumer marketplace.

The emphasis on the injection device in the drug-device equation is creating new challenges for drug product managers. Selecting a device design early in the clinical development process increases the risk that changes in the drug’s formulation or properties may require a change in the device. This can result in the need for compatibility testing in mid-or late stage clinical testing, complicating an already time-critical phase on the road to product approval.

A second and more orderly product change is the post-marketing transition to more patient-friendly packaging. This may be as straightforward as placing an as-supplied glass prefilled syringe in an autoinjector for branding purposes and enhanced ease-of-use. A more aggressive change is the post-marketing migration in route of administration, which typically involves a switch from a vial-packaged drug for infusion to a handheld injector that can be used to administer the drug via subcutaneous injection. Such a change requires clinical testing and a revised drug label.

Biological drugs and the devices that deliver them are having a significant impact on healthcare therapeutics. These developments are detailed in a new and comprehensive report researched and written by Greystone Research Associates. The report – Injection Devices for Biological Drugs - analyzes injectable biological drugs and the injection devices that administer them. The report includes analysis of competitive factors, therapeutic class product positioning, supply chain factors, device market share, and the product activities of sector participants.

More information is available at http://www.greystoneassociates.org

Source: Greystone Research Associates

About Greystone

Greystone Research Associates is a medical technology consulting firm focused on the areas of medical market strategy, product commercialization, venture development, and market research. We assist medical and healthcare market participants in achieving their business objectives through the creation of detailed development strategies, product commercialization programs, and comprehensive market and technology research and analysis. Our market research publications are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets.

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Greystone Research Associates
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www.greystoneassociates.org

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