NEWS! Autoimmune Delivery Device Evolution

Uptake of Autoimmune Injectables Aided by Delivery Device Evolution


Product Design, Patient Preferences, Ease-of-Use Are Key Factors According to Greystone Research Associates


(Amherst, NH) – Autoimmune diseases, a group of chronic ailments that includes arthritis, psoriasis, lupus, and multiple sclerosis, afflict tens of millions of people worldwide and result in levels of morbidity that can significantly impact quality of life and longevity.  They represent some of the most difficult therapeutic challenges facing the healthcare community. The refractory nature of this family of diseases is rooted in the complexities and genetic underpinnings of the human immune response, resulting in a set of disease targets that are at once physiologically diverse and highly individualized.


In spite of recent progress, autoimmune diseases continue to represent an area of significant unmet need. Several autoimmune disorders such as lupus have yet to benefit from the current wave of biologicals. Side effects and safety profiles remain serious concerns and therapeutic limitations.


These challenges extend to the development process itself and can be formidable. Inclusion and exclusion criteria for clinical trial recruitment must be carefully designed to avoid excessive heterogeneity in the treatment population. The frequent unavailability of quantitative endpoints and relatively low patient retention rates and compliance levels add further risk.  But the commercial opportunities represented by this market continue to draw interest. More than a dozen potentially important candidates are currently winding their way through the development process.


Because biological drugs most often target chronic conditions, dosing strategies and treatment protocols must be developed for long-term use, often for self-administration by patients who may have limitations directly related to their condition. The powerful physiological effects of antibodies, hormones, enzymes and other biological drugs also increase the need for safety and adherence.


Currently, eighty percent of monoclonal antibodies indicated for autoimmune conditions are self-administered subcutaneously by via prefilled devices. Fusion proteins represent a special class of engineered biologicals that are designed to generate a highly specific therapeutic effect at a well-defined physiological site. The current generation of FDA-approved fusion proteins addresses indications in a range of conditions, led by autoimmunity. More than half of approved fusion proteins are currently administered subcutaneously and supplied in prefilled devices.


Self-administered autoimmune drugs and the devices that deliver them are having a significant impact on autoimmunity therapeutics. These developments are detailed in a new and comprehensive report researched and written by Greystone Research Associates. The report – Self-Administered Autoimmune Injectables: Drugs, Devices, Packaging, Therapeutics and Forecasts – analyzes drugs indicated for autoimmunity, how they’re administered and the way they’re packaged. 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


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.





Mark Smith

Voice: 603-595-4340


Source: Greystone Research Associates