Protein Delivery

In recent years, the number of protein‐based pharmaceuticals reaching the marketplace has increased exponentially. The clinical application of these drugs is limited by a lack of desirable attributes for adequate absorption or distribution. It therefore becomes critical to formulate these drugs into safe, stable and efficacious delivery systems. Because these drugs face formidable enzymatic and penetration barriers when administered orally, peptide and protein drugs continue to be developed almost exclusively for parenteral administration. These combination drug-device products, where the drug and device are clinically tested and approved as a single product entity, are becoming one of the fastest new drug categories. On a unit basis, in spite of their higher cost protein drugs are growing in excess of fifteen percent annually. The growth of protein drug products is having a significant effect on the way drugs and devices are developed. 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.

Publication Date: July 2009

Table of Contents

Executive Summary

Protein Therapeutics Market Dynamics

Biological Drugs – The Risks & the Opportunities

The Protein Therapeutics Marketspace

Clinical Trials and Drug Approvals

The Competitive Landscape

Demographics, Managed Care and Growth

Formulating Protein Drugs for Administration

Formulation Strategies

Stability

Half‐Life & Therapeutic Protocols

Immunogenicity

Formulation Technologies

Lyophilization

Encapsulation

Post‐translational Modification

Dosing Frequency and Treatment Compliance

Protein Drug Commercialization Factors

Protein Formulation

Protein Drug Packaging and Shelf Life

Protein Delivery

Device Strategies

Market Factors

Dose Reproducibility

Protein Drug Distribution Strategies

Commercialization Opportunities & Risk Factors

Market and Regulatory Factors

Regulatory Issues

Ease‐of‐Use and Patient Compliance

IP and Biosimilars

Approved Protein Drugs – Current Strategies and Future Directions

Antibodies

Blood Proteins

Enzymes

Growth Factors

Hematopoietics

Hormones

Immune Modulators

Emerging Protein Therapy Classes

Protein Drug Pipeline Analysis - Candidates, Indications and Prospects

Protein Drug Therapeutics – Disease Segment Analysis

Anemia

Autoimmune Diseases

Cancer

Cardiology

Diabetes

Hepatitis

Hormone Replacement

Metabolic Disorders

Reproductive Medicine

Emerging Therapeutic Segments

Company Profiles, Product Portfolios & Prospects

About Our Reports

Our reports are carefully researched and written to provide timely and insightful analysis of key factors and developments shaping the commercial marketplace. The focused nature of our publications is designed to allow readers to identify emerging demand and growth opportunities in selected markets. Numerous charts, tables and graphs complement the text, with evaluations and assessments of current and probable future market developments, technology issues and business factors - information necessary to compete effectively in the global marketplace.