The administration of therapeutic drugs via injection is an indispensable delivery method for numerous drugs critical to patient health and well-being. Now this segment is evolving in response to changing patient populations, new classes of powerful therapeutic drugs and healthcare administration initiatives. Population demographics and efforts by managed care providers to control healthcare costs are driving the growth in drug self-administration, particularly for chronic conditions, introducing a new class of naïve users to parenteral drug delivery. For Fill-and-Finish contractors, market proximity is an important competitive factor. As the use of prefilled syringes continues to grow, the issue of prefilled syringe safety has received increased attention, with both integrated prefillable safety syringes and safety solutions designed to accommodate existing prefillable syringes advancing commercially. This report analyzes eleven important prefilled syringe therapeutic segments and examines key regulatory, economic and competitive factors that represent potential barriers to commercial success.

Highlights

• Provides detailed analysis of prefilled syringe market segments, market dynamics and market demographics
• Analyzes therapeutic demand drivers and evaluates commercial prefilled syringe products in eleven major therapeutic segments
• Examines design factors, material selection issues, technologies and market development issues
• Charts product data, market share, and forecasts to 2018
• Profiles injectable drug and device participants, their product development activities, business strategies, and corporate alliances and affiliations

Table Of Contents

Table of Contents

Executive Summary

Injectable Drug Market Dynamics

Competitive Landscape
The Device Manufacturing Universe
Supply Chain Dynamics
Supply Chain Structure
Supplier Relationships and Supply Risk
Supplier Integration
Captive Capacity vs CMOs
Demand Drivers
Drug Discovery and Development Trends
Patient and Caregiver Sentiment
Diseases and Indications
Patient Demographics

The Prefilled Syringe Ecosystem and Supply Chain

Materials and Components
Evolving Technology
Alliances and Relationships
Syringe Manufacturers
Technology/Capabilities
Geographic Reach
Barriers to Entry
CMO’s - Beyond Fill and Finish
Value-added Services
Market Proximity
CMO Evolution
Testing, Services and Validation

Prefilled Syringes - Design Factors

Drug Stability and Shelf Life
Material Selection Issues
Point-of-Use Reconstitution
Caregiver Safety
Needle Configuration Strategies
Human Engineering/Ergonomics

Prefilled Syringes - Commercial Devices

Prefillable Therapeutic Injectables
Glass Prefillable Syringes
Plastic Prefillable Syringes
Ready-to-Fill Safety Syringes

Specialty Prefillable Syringes
Flush Syringes
Diluent Syringes
Imaging Agent Syringes

Competing Prefilled Devices
Bundled PFS + Autoinjector
Prefilled Pen Injectors
Prefilled Needle-free Injectors

Prefilled Syringe Market Segments

Prefilled Therapeutic Injectables

Anaphylaxis
Anticoagulants
Autoimmune Diseases
Emergency Medicine
Hepatitis
Hematopoietics and Related Erythropoiesis Stimulating Proteins
Metabolic Diseases
Neurology
Reproductive Health
Vaccines
?
Non-API Prefilled Syringe Segments

Catheterization
Reconstitution
Diagnostic Imaging?

Market Factors

Self-Administration and Patient Compliance
Insurance, Reimbursement, and Managed Care
Regulatory Guidance and Product Approvals
The Evolving PFS Ecosystem

Prefilled Syringes - Market Participant Profiles


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