The advantages of administering immunotherapeutic injectables subcutaneously is now well accepted and has been more-or-less institutionalized in the drug life cycle development process for non-oncology indications. 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. The migration to patient self-care presents several areas of concern. By making the patient the single point of failure for dosing adherence and successful drug delivery, devices and protocols must be developed and tested to a new, higher standard. New generation drug injection devices are increasingly being created to address patient adherence issues by making the delivery of injectable drugs less complicated and intimidating.
Self-Administered Autoimmune Injectables – What You Will Learn
- What approved drugs indicated for autoimmune conditions are marketed for self-administration, what is the as-supplied packaging, and who markets them?
- What are the major factors driving the migration of infusible drugs for treating autoimmunity to formulations that can be packaged and administered subcutaneously?
- What is the size of the market for self-administered autoimmune injectable 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 autoimmune drugs subcutaneously?
- What are the significant economic, technology, and regulatory factors affecting the market for immunotherapeutic drugs?
- Competitive Landscape
- Drug Supply Chain Activity
- Product Design and Enablement Factors
- Ease of Use
- Patient Adherence
- Dosing Frequency
- Human Engineering/Ergonomics
- Pre- and Post-Marketing Device Evolution
Self-administered Enabling Devices
- Device Selection – Stability and Material Issues
- Prefilled Syringes
- Special Feature Autoinjectors
- Pen Injectors
- Dual Chamber Pens
- Emerging Devices
Self-administered Therapeutic Autoimmune Drugs
- Fusion Proteins
Autoimmune Therapeutics Markets
- Ankylosing Spondylitis
- Crohn’s Disease
- Adult Rheumatoid Arthritis
- Juvenile Idiopathic Arthritis
- Multiple Sclerosis
- Psoriatic Arthritis
- Ulcerative Colitis
- Regulatory Factors
- 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.