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Large Volume Injection Devices for Self-Administration

  • ID: 2777967
  • Report
  • Greystone Associates
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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.

HIGHLIGHTS

- 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?
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Note: Product cover images may vary from those shown
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Executive Summary

Large Volume Injectables Market Dynamics

The Trend toward Patient Self-Administration
Drug Delivery Device Evolution
Enabling Technology
Drug Development Trends

Large Volume Wearable Injectors – Design Factors

Volumes and Viscosities
Flow Rates
Dosing Regimens
Patient Variability
Primary Packaging
Injection Methodology
Patient Interface

Large Volume Delivery Devices

Unbranded Injector (Enable Injections)
Microinfusor (BD Medical)
Unbranded Injector (Roche)
OmniPod (Insulet)
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)
GnRH (Ferring/Insulet)
Prostacyclin (SteadyMed)

Therapeutic Market Segment Analysis & Forecasts

Inflammatory Autoimmune Diseases
Blood Disorders
Cardiovascular
Neurology
Oncology
Metabolic Diseases
Multiple Sclerosis
Reproductive Health
Upper Respiratory Diseases

Market Factors

Self-Administration and Patient Compliance
Regulatory Guidance and Product Approvals
Drug Product Differentiation/Marketability

Company Profiles
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