Injection Devices for Biological Drugs


injection devices for biological drugs  Injection Devices for Biological Drugs  •  October 2018  •  JD448K •  Price US $3,850



 

Biological drugs as a class continue to outpace all other NCEs in development pipelines and clinical trials. Because biological drugs most often target chronic conditions, dosing strategies and treatment protocols must be developed for long-term use, often for self-administration by patients who may have limitations directly related to their condition. The powerful physiological effects of antibodies, hormones, enzymes and other biological drugs also increase the need for safety and adherence. Cooperation between device designers and drug developers is occurring much earlier in the drug development cycle, allowing device designs in many cases to be tailored to the bioavailability targets and pharmacokinetic profiles of specific drug therapies. New injectable delivery device designs currently being developed will create new opportunities for alternative injection methods. Partnerships between device suppliers and pharmaceutical companies will foster market acceptance of new injection devices for a host of new therapies such as therapeutic vaccines, DNA-based drugs, and protein-derived biologics.

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Injection Devices for Biological Drugs – What You Will Learn

  •  What are the product and user requirements that drive the biological drug-device selection process?
  •  What are the essential design factors, technologies and market development issues for injection devices capable of administering biological dugs?
  •  What is the impact of development-stage biological manufacturing process changes on device go-to-market readiness and how has it changed in recent years?
  •  How do device selection decisions align across biological drug classes? Therapeutic targets? Market segments?
  •  What is the impact of drug-device dependencies on pre- and post-marketing product life cycle management?
  •  What are the significant economic, technology, and regulatory factors affecting the market for biological drug injection devices?

Injection Devices for Biological Drugs – Summary of Contents

 

Executive Summary

 

The Market Opportunity

Unmet Patient Needs

Device Material Selection Factors

Biosimilars

The Biological Drug Global Supply Chain

 

Biological Drug Delivery – Challenges and Limitations

Drug Stability

Pre- and Post-Manufacturing Engineering

Lyophilization and Reconstitution

Viscosities and Volumes

 

Drug Strategies & Therapeutic Protein Packaging

As-Supplied Packaging

Device Market Share

Device Supplier Segment Activity

Emerging Injection Devices for Biological Drugs

 

Injectable Biologicals – Product Analysis by Drug Class

Cytokines

Enzymes

Fusion Proteins

G-CSF/GM-CSF

Hematopoietics

Hormones

Immune Modulators

Insulins & GLP Analogs

Monoclonal Antibodies

Vaccines

 

Therapeutic Market Segment Analysis

Cardiovascular

Diabetes

Hematology

Immunology

Metabolic

Oncology

 

Market Factors

Regulatory Issues

Patient Preferences and Self-Administration

Pre- and Post-marketing Device Evolution

Compatibility Testing

 

Company Profiles