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Therapeutic Proteins to 2016. Drugs, Devices, Diseases, Markets and Forecasts
Greystone Associates, May 2012
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. 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.
Highlights:
- Analyzes approved therapeutic protein products and pipeline candidates and assesses the market potential for existing and probable future protein drugs
- Examines protein delivery design issues, packaging, distribution and technology factors
- Assesses the role of protein formulation decisions on therapeutic protein commercialization and market potential
- Examines historical protein drug data for nine major therapeutic segments and provides forecasts by disease segment to 2016
- Profiles therapeutic protein companies, their commercial products, product development activity, and business strategies
Executive Summary
Protein Therapeutics Market Dynamics
The Protein Therapeutics Marketspace
Clinical Trials and Drug Approvals
The Competitive Landscape
Demographics, Managed Care and Growth
Risks and Opportunities
Therapeutic Protein Commercialization - Success Factors
Formulating Protein Drugs
Formulation Strategies
Stability
Half-Life & Therapeutic Protocols
Immunogenicity
Protein Formulation Technologies
Post-translational Modification
Encapsulation Technologies
Lyophilization
Dosing Frequency and Treatment Compliance
Protein Packaging & Delivery
Injection
Pen Injectors - Dominant in Chronic Disease
Prefilled Syringes - Evolving Technology, Expanding Reach
Emerging Protein Injection Options
Inhalation
Dry Powder Inhalers -– Stability at a Price
Sprays/Aerosols - The Technical Challenges
Development-stage Packaging & Delivery Technologies
Oral
Proprietary Processes and Pipeline Prospects
Commercialization Potential & Risk Factors
Transdermal
Transdermal - Obstacles and Limitations
Microneedles - Engineering & Economics
Protein Drug Distribution Strategies
Protein Drugs – Drug Classes and Therapeutic Targets
Antibodies
Enzymes
Growth Factors
Hematopoietics
Hormones
Immune Modulators
Other Protein Therapy Classes
Protein Drug Therapeutics – Disease Segment Analysis & Forecasts
Autoimmune Diseases
Dominance of Antibodies & Cytokines
B-Cell Depleting Agents
Interferons
Interleukin Receptor Agonists
TNF Inhibitors
T-Cell Blocking Agents
Development-stage Candidates
Demand Patterns and Forecasts
Hematology
Anemia
Hemoglobinuria
Thrombocytopenia
Demand Patterns and Forecasts
Hereditary Diseases
Infectious Diseases
Hepatitis
RSV
Demand Patterns and Forecasts
Hormone Replacement
Increasing Competition in a Crowded Market
Demand Factors and Forecasts
Oncology
Key Therapeutic Sectors & Therapeutic Target Selection
Expanding Indications & Therapeutic Endpoints
Leading Oncology Protein Drug Products
Pipeline Candidates
Demand Data and Forecasts
Reproductive Medicine
Dominance of Leutinizing Hormones
Demand Data and Forecasts
Transplantation/Organ Rejection
Approve Protein Drugs
The Market Opportunity
Emerging Therapeutic Segments
Market and Regulatory Factors
Regulatory Issues
Ease-of-Use and Patient Compliance
IP and Biosimilars
Protein Drug Therapeutics - Company Profiles
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