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  4. > Large Volume Injection Devices for Self-Administration

Large Volume Injection Devices for Self-Administration

  • March 2014
  • -
  • Greystone Research Associates

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

Table Of Contents

Large Volume Injection Devices for Self-Administration
Summary of Contents
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 and 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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