For developers and marketers of injectable drugs, the world has changed dramatically since the start of the millennium. Once completely focused on the therapeutic formulation and content to supply/ship the drug product in glass vials, today’s injectable product managers and their drug development colleagues are faced with a growing spectrum of device, administration and packaging choices, with the knowledge that beyond efficacy and physician detailing - the decisions they make are likely to have a material impact on the success of the product in the marketplace.
No longer a task that could be safely addressed late in the development cycle, strategies for injectable drugs are now being initiated during preclinical development and involve formulation requirements, delivery device/combination product decisions and packaging considerations. Formulation issues extend from dosing frequency and shelf life to reconstitution methods for lyophilized drugs. For drugs being developed for self-administration, device selection and design for custom injectors has become highly dependent on patient demographics and marketing research.
These dynamics are changing the way injectable drugs are conceived and developed in two fundamental ways. Drug development teams are becoming highly integrated across several functional disciplines, with successful teams embodying the principles of concurrent engineering very early in the design cycle. By allowing device specifiers, clinical trial specialists and packaging engineers to interface with drug developers over the course of the project, opportunities for integrating drug, device, and packaging can be identified and pursued with minimal risk and without delays to the development cycle.
The second significant change is the growing importance of partnerships and alliances among drug developers, device suppliers and packaging experts, essentially representing a second, external layer to the concurrent design and development project structure. This project team integration is becoming critical to getting sophisticated combination product injectables to market in a timely manner.
For injectables, developers must often anticipate the evolution of the product through a complex product life cycle that can include migration from one delivery/packaging stage to another over the course of the first twenty-four months, - a scenario that has not been uncommon for biologicals such as immune modulators, which are often commercialized in vials before migrating to prefilled devices. Experience with the new drug design paradigm is making this migration less necessary.
Patient-friendly devices such as pen injectors, autoinjectors that accept standard prefilled syringes, and needle-free injectors - while providing opportunities for branding, product differentiation, and patient satisfaction - provide further challenges to product managers and their teams. These device classes themselves are evolving rapidly as design advances that simplify the injection process and add safety features such as post-injection-event patient confirmation continue to evolve.
Prefilled syringes are the major driving force behind the decline in vials as they continue to proliferate across injectable drug classes and therapeutic indications. This market segment is supported by a growing ecosystem of CMO/CSOs, delivering services that include drug-device integration such as fill-and-finish, product testing to regulatory requirements, and device and packaging validation. An important dynamic here is the growing perception that geographic proximity to drug manufacturing can be an important competitive advantage for supply chain participants.
By imparting added safety and ease-of-use to prefilled syringes, autoinjectors are adding an incremental boost to the momentum already bestowed by underlying market forces, a momentum that has led to average annual unit growth rates for prefilled syringes of just under twelve percent over the past dozen years. Autoinjectors have advanced quite dramatically in the past 36 months as the introduction of disposable models has been quickly followed by improved ergonomics and safety features, helping prefilled syringes retain design win market share in the face of growing competition from pen injectors.
But pens continue to be the device option of choice for a number of high value biologics indicated for chronic conditions. In terms of branding, pen injectors continue to offer a superior platform due to the feature set that is already available in marketed products, one that autoinjectors continue to aspire to. This feature set comes at a price one that can be cost-justified for recombinant proteins priced at more than one thousand dollars per prescription.
In spite of rare successes such as the Sumavel DosePro combination product from Zogenix, needle-free injectors continue to be the step-child of injectable device technologies. Antares has made good strides in re-engineering its business model, adding an autoinjector (Vibex) product line that can be adapted to a variety of drugs and drug packaging options.
A comprehensive analysis of injectable drugs, markets and delivery/packaging strategies is the subject of a new and comprehensive report. The report Injectable Drug Delivery to 2018: Drugs, Device, Markets, Strategies and Forecasts - includes analysis of injectable drug products, evaluations of therapeutic markets, an examination of market factors, and profiles of market participants.
About Greystone Research Associates
Greystone Research Associates (greystoneassociates.org) 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.