(Amherst, NH) – Led by the proliferation of antibody-based drugs and candidates, biological drugs as a class continue to outpace all other NCEs in development pipelines and clinical trials. This shift away from small molecule drugs is creating opportunities for drug developers, device designers, packagers and pharmaceutical marketers.
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.
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 subcutaneous injection as a route of administration. 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.
Currently, 27% of recombinant antibodies are delivered subcutaneously via prefilled devices. The majority are supplied in vials, due primarily to the large number of mAbs approved for oncology indications and immune modulators such as Remicade and Tysabri which require administration by caregivers.
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. The three dozen fusion protein product candidates winding their way through the development process represent a much wider spectrum of therapeutic indications and protein engineering technology approaches. More than half of approved fusion proteins are currently administered subcutaneously and supplied in prefilled devices.
Among other important therapeutic protein drug classes, 70% of cytokines are supplied in prefilled devices, while all recombinant enzymes and blood factors are supplied for infusion in vials. Over 80% of hematopoietics and growth hormones are supplied for subcutaneous injection in prefilled injectors and syringes.
The rise in biosimilar regulatory filings is set to change the industry in a way not unlike the influence of generics on small molecule drug markets. But beyond regulatory approvals, a number of factors related to regional differences in the uptake of biosimilars must be factored into any multi-year forecast of the global injectable biosimilars market. Substitution and interchangeability, the rules for which also vary geographically, will ultimately by impacted by patient acceptance and caregiver confidence.
The evolving market for delivering therapeutic proteins is captured in a new and comprehensive publication researched and written by Greystone Research Associates. The Market for Delivering Therapeutic Proteins, 2016 - 2022 analyzes the global market for therapeutic protein packaging and delivery. The report examines competing drug delivery strategies by drug class, market segment and supplier, examines key therapeutic market segments, assesses the impact of the global therapeutic protein supply chain, and provides profiles of market sector participants.
More information is available at http://www.greystoneassociates.org
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.
Source: Greystone Research Associates
Last updated on: 03/10/2016
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