Product Code: JPE479K
Drug Formulation & Packaging Migration Creating Self-Dosing Opportunities
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?
Table of Contents
- Competitive Landscape
- Biological Supply Chain Activity
- FDA/EMA Immunotherapeutics Regulatory Overview
- Cost per Dose and Managed Care
- Product Design and Enablement Factors
- Ease of Use
- Patient Adherence
- Human Engineering/Ergonomics
- Patient-centered Design
- Patient Interface
- Patient Preferences
- 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
- Regulatory Factors
- Clinical Trial Protocols & Endpoints
- Alliances and Partnerships