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Therapeutic Antibody Drugs Being Designed for Self-Administration as Developers Seek Competitive Advantage

Pipeline Candidates Being Formulated for Subcutaneous Delivery Proliferating according to Greystone Research Associates

(Amherst, NH) – The administration of therapeutic antibodies is becoming an increasingly important healthcare treatment option for a growing number diseases and indications having broad implications for patient health and well-being. But to fully exploit the value of this class of therapeutics in both human and commercial terms, developers must successfully navigate the inherent limitations of antibody storage and administration, moving away from antibody infusion and toward injection as a route of administration.

Because of factors related to antibodies and to biological drugs as a class – factors that include temperature sensitivity and high viscosity – formulating therapeutic antibodies for injection presents several challenges. To circumvent these restrictive qualities, early recombinant antibodies that began to appear in the late 1990’s were initially formulated and supplied in vials for reconstitution prior to infusion. Antibody drug products indicated for chronic conditions such as autoimmunity were then often re-formulated, re-packaged and re-labeled into injectable form and re-introduced two to three years later to address the growing economic pressure and patient desire to avoid the need for out-patient infusion in favor of self-injection.

Evolution in antibody design, production, downstream processing and formulation have reached the point where introducing therapeutic antibody drugs in injectable form beginning with the initial drug filing is now possible and even becoming commonplace. More than two dozen mid-to-late stage clinical pipeline antibodies are being developed as subcutaneous formulations. This trend represents opportunities for device developers and challenges for drug marketers. The result will be growing competition, evolving options for product differentiation and the need to increasingly incorporate direct-to-consumer initiatives into product marketing plans.

The evolving therapeutic antibody landscape is detailed in a new and comprehensive report researched and written by Greystone Research Associates. Self-Administered Therapeutic Antibodies to 2020 analyzes the global market for therapeutic antibodies in three areas: approved injectables, transitioning infusion-to-injectable antibodies, and pipeline therapeutic antibodies. The report also analyzes demand drivers, development factors, market considerations, and strategic and economic factors, and provides profiles of market sector participants.

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

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.