Injection Device Design Evolution a Key to the Growth of Biological Drugs
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
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.
Greystone Research Associates
98 Route 101A
Amherst, NH 03031 USA
This release was published on openPR.
Permanent link to this press release:
Please set a link in the press area of your homepage to this press release on openPR. openPR disclaims liability for any content contained in this release.
You can edit or delete your press release Injection Device Design Evolution a Key to the Growth of Biological Drugs here
News-ID: 1281680 • Views: 141
More Releases from Greystone Research Associates
Seeking to Capitalize on New Device Technology Drug Companies are Reformulating …
(Amherst, NH) – As the pace of competition increases within the pharmaceutical and biotech industries, the concept of life cycle management is becoming a key component of drug product management. Much of the recent emphasis in this area has centered on efforts to extend patent rights protection. While reformulation has been and is an important approach, efforts to prolong IP benefits have only recently involved IV-to-SC drug re-engineering. This migration
Antibacterial Treatments that don’t Rely on Antibiotics Winding their way thro …
(Amherst, NH) – As bacteria grow resistant to conventional antibiotics, alternatives are being investigated, including antibodies, probiotics, bacteriophages, and antimicrobial peptides. The quest to replace the current generation of antibiotics is complicated by the methods that bacteria have acquired to evade attempts to destroy them – methods often referred to a virulence factors. A microorganism can possess a wide array of virulence factors. They may only express these virulence factors when
3D Printing Positioned to Address Issues that have Prevented Wide Adoption of Mi …
(Amherst, NH) – The promise of commercial microneedle drug delivery has been on the horizon for more than a decade. Like other compelling medical device innovations such as noninvasive glucose monitoring, the potential of the technology has yet to be realized due to the inability to solve the issues of reliable product performance from unit to unit and across a wide user population. To fully address the unmet need these technologies
Analysis of the Oncology Drug Pipeline Reveals Evolving Therapy Correlations and …
(Amherst, NH) – The almost two thousand active oncology clinical trials paint a picture of an evolving therapeutic sector that has established players moving quickly to realize the expanded benefits of recent treatment protocols. A dozen targeted treatments, using novel pathways and signaling, have achieved results that represent a new era in oncology and antineoplastic therapeutics. There approaches have attracted a growing number of drug developers anxious to profit from
More Releases for Amherst
Intradermal Drug Delivery Gaining Momentum as Technology and Benefits Converge
(Amherst, NH) – Evolution in drug delivery device design is changing the way a growing number of therapeutic substances are administered. This trend is being fostered by the desire by patients for more user friendly methods for self-medicating, and by the need for safer, more reliable drug products that improve compliance. For drugs capable of being administered across the skin, intradermal delivery is viewed as an approach that addresses these
New Aircraft Designs Creating Opportunities for High Performance Aerospace Coati …
(Amherst, NH) – As aerospace manufacturers and their engineering teams push the design envelope to create aircraft with better fuel efficiency and lower maintenance requirements, they are relying increasingly on engineered materials for a growing list of structural and non-structural elements and components. This trend is changing the way aircraft are developed, produced and maintained. It’s also presenting opportunities for specialty materials suppliers with products that can improve production
Evolution in Markets for Radiation Curable Coatings Creating Risks and Opportuni …
(Amherst, NH) – Recent advances in materials and equipment are creating new demand for radiation curable coatings in a number of industrial applications. This new demand is occurring as several technology advances are being brought into the marketplace. By removing some of the key limitations of radcure coatings, these advances are enabling radcure coatings to meet unique application requirements, opening up a number of new opportunities. Technical advances that are having
Drug Delivery Coatings Creating Opportunities for Developers and Practitioners
(Amherst, NH) – Advances in coating technology have given rise to a new generation of coating formulations that can reliably deliver therapeutic substances from the surface of an implanted medical device. In currently approved products, these devices provide a primary function, with the drug contributing therapeutic benefit that improves patient outcomes. Currently more than two dozen companies are pursuing specialty coatings capable of delivering APIs. These participants are exploring a
Adros Energy Expands Clean Energy Business with Energy Audit Services and opens …
Adros Energy; a leading green energy company in New England, announced today that they are opening a new headquarters in Amherst, NH after a successful 1st year of operation in the renewable energy market. The company was founded in January of 2009 and has found success during the incubation period of the company. The infrastructure building of the company in 2009 includes: • Revenue generation from its solar PV,
Esensors Adds New Websensor Features
July 22, 2008 – Amherst, NY – EM01B Websensor is an environmental sensor that provides accurate measurement of temperature, relative humidity and light over a network. This month, Esensors adds some new features to EM01B Websensor. The free Websensor Data Logger now enables users to easily export the data to other software tools for analysis. This allows the flexibility to generate custom data views and make data collection more