Growth in high viscosity drugs is being driven by advances in biotechnology and host-vector engineering - advances that have led to a steady stream of biologics for a number of ailments and conditions. These powerful drugs come with a high cost-per-dose and the risk of significant side effects - factors that place an elevated emphasis on administration efficiency, safety and reliability.
Many drugs in this class are characterized by physical properties and sensitivities that challenge the drug commercialization ecosystem. For example, monoclonal antibodies, perhaps the most significant category in terms of therapeutic and commercial importance, typically possess viscosities that are well above the normal limits of subcutaneous injection devices and techniques. Without a technical solution, these high viscosity drugs are formulated and supplied for infusion, a trend that threatens to put additional pressure on patient logistics and healthcare economics. Drug developers and device designers are increasingly working in collaboration to address the goal of subcutaneous administration of high viscosity injectables.
Handheld Devices for High Viscosity Injectables - What You Will Learn
- What are the markets for therapeutic drugs with viscosities that cannot be delivered using standard self-injection devices and techniques?
- What are the technologies and devices that are aimed at positioning high viscosity drugs for subcutaneous injection?
- What are the design factors, material selection issues, formulation factors, and device capabilities and limitations of handheld devices that address the limitations of high viscosity drugs?
- Who are the high viscosity injectable drug and device participants, their product development activities, business strategies, and corporate alliances and affiliations?
- What are the key therapeutic sectors for high viscosity injectables?
- What does the market for high viscosity injectables look like today? What will it be in 2020?
- What is the impact of economic, technology, and regulatory factors on high viscosity drugs that can be administered via handheld devices?
Report Value Chain – Who Should Read this Report
- Drug Developers
- Device Suppliers
- Clinical Trial Mgmt
- Pharma Managers
- Biotech Managers
- Drug Marketers
- Industry Strategists
- Financial Analysts
- Management Consultants
- Clinical Managers
- Drug Distributors
- Pharma Regulators
- FDA Consultants
- Managed Care Managers
1. Executive Summary
2. The Market Opportunity
3. High Viscosity Drug Market Dynamics
- The Economics of Drug Delivery
- Market Drivers
- Growth of Biological Drugs
- Demographics and Disease Prevalence
- Innovation in Handheld Devices
- Managed Care and Healthcare Economics
- Competitive Landscape
- Risk Factors
4. High Viscosity Injection Devices - Design Factors
- Drug Properties
- Drug Storage Requirements
- Baseline Device Capabilities
- Primary Packaging
- Human Engineering/Ergonomics
- Formulation Technology
5. High Viscosity Drugs - Addressable Markets
- Legacy Drugs - IV-to-Subcutaneous Migration
- Drugs Currently Approved for Infusion
- Development-stage Biologicals
- Formulation-related High Viscosity
- Sustained Release Injectables
- Solubility-enhanced Formulations
6. Analysis of High Viscosity-Capable Handheld Devices
- Specialty Glass Syringes
- Specialty Autoinjectors
- Cyclic Olefin Prefillable Syringes
- Formulation-specific Devices
7. Near-term Therapeutic Sector Analysis
- Therapy Sectors
- Forecasts and Prospects
8. Market Factors
- Regulatory Issues
- Device Branding
- Quality by Design
- Ease of Use
9. Company Profiles