Biological drugs continue to increase in terms of the absolute number of new approved drugs and as a percent of all approved drugs. In two of the largest (in terms of revenue) and fastest growing therapeutic segments – autoimmune diseases and oncology – the majority of drugs consist of monoclonal antibodies (mAbs). Therapeutic drugs consisting of proteins and peptides present unique drug packaging and delivery challenges. Often the dosing volume required to achieve a therapeutic effect requires the drug to be delivered via infusion, resulting in logistical, cost and safety issues. Drug developers and their delivery technology partners are attempting to address this limitation. The development of injectors capable of delivering drug volumes of 2 mL or higher subcutaneously is one promising method. This report examines this new class of devices and analyzes their potential impact on biological drug delivery.
- Analyzes and evaluates large volume injection devices and assesses risks and market potential
- Assesses large volume injection device product strategies, technologies and product development issues
- Provides assessments of large volume injection device products, key design factors and strategic device factors
- Examines infusible and injectable drugs by therapeutic segment and indication that present potential opportunities for market sector participants
- Profiles market sector participants, their product development activities and business strategies
WHAT YOU WILL LEARN
- What drugs are supplied or are being developed in large volume delivery devices, what are the device specifics, and who markets them?
- Who are the large volume injection device suppliers, their product strategies and their capabilities?
- What are the major factors driving large volume injectable/infusible drug delivery devices?
- How important are drug developer-device manufacturer relationships and what are the key alliances in the industry?
- What are the essential design factors, material selection issues, technologies and market development issues for large volume injection devices?
- What are the large volume injection device categories and what is their market potential?
- What are the significant economic, technology, and regulatory factors affecting the market for large volume injectable/infusible drug delivery devices? SHOW LESS READ MORE >
Large Volume Injectables Market Dynamics
The Trend toward Patient Self-Administration
Drug Delivery Device Evolution
Drug Development Trends
Large Volume Wearable Injectors – Design Factors
Volumes and Viscosities
Large Volume Delivery Devices
Unbranded Injector (Enable Injections)
Microinfusor (BD Medical)
Unbranded Injector (Roche)
SmartDose (West Pharmaceuticals)
SensePatch FD/SD (Sensile Medical)
Unbranded Injector (SteadyMed)
Precision Therapy/Flex Therapy (Unilife)
Large Volume Injection Devices – Near-Term Products
Herceptin SC (Roche/Halozyme)
Furosemide (scPharmaceuticals/Sensile Medical)
Therapeutic Market Segment Analysis & Forecasts
Inflammatory Autoimmune Diseases
Upper Respiratory Diseases
Self-Administration and Patient Compliance
Regulatory Guidance and Product Approvals
Drug Product Differentiation/Marketability
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.