The administration of therapeutic immune modulators is becoming an increasingly important healthcare treatment option for a growing number of 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 user acceptance and designed-in usability. The influence of biosimilars on as-supplied packaging strategies is yet to be determined, but the need for product differentiation in an increasingly crowded market segment will make product packaging a key competitive factor.
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Biological Autoimmune Therapeutics – What You Will Learn
• What are the approved biological drugs indicated for autoimmune conditions, what is the as-supplied packaging, and who markets them?
• What are the major factors driving the growth of biological drugs for treating autoimmunity?
• What is the size of the market biological autoimmune therapeutics drugs today, who are the market share leaders, and what will it 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 biological autoimmune drugs?
• What are the significant economic, technology, and regulatory factors affecting the market for immunotherapeutic drugs?
Biological Autoimmune Therapeutics – Summary of Contents
Unmet Patient Needs
Patient Population Factors
The Autoimmune Patient
The Informed Patient
Product Design & Patient Enablement Factors
Ease of Use
Regional Market Product Strategies
As-Supplied Packaging and Administration
Device Selection – Stability and Material Issues
Pre- and Post-Marketing Device Evolution
The Role of Prefilled Devices
Special Feature Autoinjectors
The Product Ecosystem
Supplier Resources – Geographic Distribution
Drug Supply Chain Activity
Product Analysis, Financial Performance & Forecasts
Autoimmune Therapeutics – Market Segment Analysis
Adult Rheumatoid Arthritis
Juvenile Idiopathic Arthritis
Clinical Trial Protocols & Endpoints
Alliances and Partnerships