The administration of therapeutic immune modulators 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 drug storage and administration, moving away from infusion and toward injection as a route of administration. Antibody drug products indicated for chronic conditions such as autoimmunity are often re-formulated, re-packaged and re-labeled into injectable form and re-introduced two to three years post-market launch to address the growing economic pressure and patient desire to avoid the need for out-patient infusion in favor of self-injection. This report describes key factors in the trend toward patient enablement and self-administration.
Immunotherapeutic Drugs, Devices & Patient Enablement – What You Will Learn
• What approved immunotherapeutic drugs are indicated for self-administration, what is the as-supplied packaging, what are the device specifics, and who markets them?
• What are the major factors driving the migration of infusible immunotherapeutic drugs to formulations that can be packaged and administered subcutaneously?
• What is the size of the market for self-administered immunotherapeutic drugs today, who are the market share leaders, and what will the market share be in 2022?
• How important are drug developer-device manufacturer relationships and what are the key alliances in the industry?
• What are the essential design factors, technologies and market development issues for devices that can deliver injectable immunotherapeutics subcutaneously?
• What are the significant economic, technology, and regulatory factors affecting the market for immunotherapeutic drugs?
Immunotherapeutic Drugs, Devices & Patient Enablement – Summary of Contents
Biological Supply Chain Activity
FDA/EMA Immunotherapeutics Regulatory Overview
Cost per Dose and Managed Care
Product Design and Enablement Factors
Ease of Use
Device Development and As-Supplied Packaging
Device Supplier Segment Analysis
Pre- and Post-marketing Device Evolution
Self-administered Enabling Devices
Device Selection – Stability and Materials Issues
Manual Injection Autoinjectors
Automatic Injection Autoinjectors
Special Feature Autoinjectors
Variable Dose Autoinjectors
Self-administered Therapeutic Autoimmune Drug Assessment
Therapeutic Market Segment Analysis & Forecasts
Clinical Trial Protocols & Endpoints
Alliances and Partnerships