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.
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?
- Unmet Patient Needs
- Drug Development
- Patient Population Factors
The Autoimmune Patient
- The Informed Patient
- Product Design & Patient Enablement Factors
- Ease of Use
- Patient Adherence
- Dosing Frequency
- Regional Market Product Strategies
As-Supplied Packaging and Administration
- Device Selection – Stability and Material Issues
- Human Engineering/Ergonomics
- Pre- and Post-Marketing Device Evolution
- The Role of Prefilled Devices
- Prefilled Syringes
- Special Feature Autoinjectors
- Pen Injectors
- Emerging Devices
The Product Ecosystem
- Supplier Relationships
- Supplier Resources – Geographic Distribution
- Drug Supply Chain Activity
Product Analysis, Financial Performance & Forecasts
Autoimmune Therapeutics – Market Segment Analysis
- Ankylosing Spondylitis
- Crohn’s Disease
- Adult Rheumatoid Arthritis
- Juvenile Idiopathic Arthritis
- Multiple Sclerosis
- Psoriatic Arthritis
- Ulcerative Colitis
- Regulatory Factors
- United State/FDA
- Clinical Trial Protocols & Endpoints
- Alliances and Partnerships
Research methodology is based on primary research in the form of in-depth interviews with key market participants, technology developers, distributors, industry experts, and market influencers, a list that includes regulatory officials, industry trade groups, and materials standards organizations.
Primary data is evaluated and normalized against secondary sources including trade journal articles, technical literature, industry publications, company data sheets and published information, and statistical data from government agencies and trade associations.
Forecasts and projections of market demand and future market activity are derived using standard modeling and statistical techniques.